Ijmrhs Vol 3 Issue 4

DOI: 10.5958/2319-5886.2014.00001.
International Journal of Medical Research

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Received: 9 April 2014
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 28 Jul 2014
Accepted: 29th Aug 2014
EFFECTIVENESS OF RESISTED ABDOMINAL EXERCISE VERSUS RESISTED DIAPHRAGMATIC

BREATHING EXERCISE ON CARDIO VASCULAR ENDURANCE IN SPORTS MEN
*Sathish Gopaladhas1, Anilkumar Panigrahy2, Elanchezhian Chinnavan3, Rishikesavan Ragupathy4

1
Professor, White Memorial College of Physiotherapy, Tamil Nadu, India

Department of Physiotherapy, Institute of Medical sciences and Sum Hospital, Odisha, India
3, 4
Lecturer, School of Physiotherapy, AIMST University, Malaysia
2
*Corresponding author email: gdssathish@gmail.com

ABSTRACT
Background and Purpose: The purpose of the study is to compare the effectiveness of resisted abdominal
exercise and resisted diaphragmatic breathing exercise on cardiovascular endurance to prescribe a fitness
program. Study design and setting: Experimental study, YMCA Fitness Foundation Academy, Pachaiyappa Arts
and Science College. Study Sample: 30 sports men. Inclusion criteria: Sportsmen with the age group of 18-30
years. Exclusion Criteria: Individuals with postural deviations like scoliosis, Kyphosis, cardiovascular diseases
like history of rheumatic heart disease, obstructive lung diseases, vascular problem in lower limb. Tools: Step up
and step down endurance test Procedure: 30 individuals are divided into two groups. Group-I was taught resisted
diaphragmatic breathing exercise. Group-II was taught resisted abdominal exercise. Pre-test values of step up and
step down, endurance level of athletes were assessed and documented. Total duration of the study is 8 weeks. At
the end of 8th week post-test endurance were reassessed using step test. Results: Paired t test was used to analyze
the effect of cardiovascular endurance. The post test mean values of all the variables of group-I were improved
than that of group-II (p<0.005). Conclusion: Resisted diaphragm breathing has shown improvement in
cardiovascular endurance in sports men.
Keywords: Resisted Abdominal exercise, Resisted diaphragmatic breathing exercise, Cardio vascular endurance,
Sports person
INTRODUCTION
The process of respiration plays an important role in
body energy production that is required to meet the
demands placed on body by various systems1.
Cardiovascular endurance is essential for sports like
football and hockey. Good endurance also sometimes
plays a decisive role in victory and helps in
preventing injuries related to poor fitness2. The body
derives energy from two systems of energy
production, namely aerobic and anaerobic. In aerobic
system, the oxidative metabolism of blood glucose
and muscle glycogen begins with glycolysis. Oxygen
helps in converting the lactic acid produced during
exercise to pyruvate. Pyruvate is not converted to
lactic acid, but is transported to the mitochondria,

where it is taken up and enters the Krebs cycle.
Formation of ATP through the ATP-PC system and
glycolysis does not involve oxygen and is called
anaerobic metabolism3.
Slow breathing and fast breathing techniques has
produced a significant increase in respiratory
pressures and respiratory endurance. They used to
condition their body using the breathing exercises
mentioned in our traditional yoga like Pranayama4.
Aerobic capacity of a person determines the
performance of an individual. The aerobic capacity is
determined by many factors such as age, sex, obesity,
785
Sathish et al.,
Int J Med Res Health Sci. 2014;3(4):785-789
exercise module, training state and muscle power2.

Skeletal muscles respond to training in well described
ways which depends on the characteristics of the
training load. Oxygen intake can be increased by
strengthening the respiratory muscles. The extent of
the muscle adaptation depends upon the application
of the principle of training such as overload,
specificity and reversibility5.
The first attempt to apply the general principles of
skeletal muscle training to respiratory muscles was
described nearly two decades ago. Aerobic capacity is
one of the important factors for marathon runners and
cross country skiers. Improvement of aerobic
capacity may enhance the cardio-respiratory fitness2.
This study was concentrated on strengthening the
respiratory muscles to improve uptake of oxygen and
thereby increasing aerobic capacity. For many
athletes, the core musculature is the weak link in the
kinetic chain. A strong core is critical because all
movements originated in trunk; this coupling action
connects movements of the lower body to those of the
upper body and vice versa6. Optimal core strength
and stability can promote efficient biomechanical
movement patterns and reduce the potential for
injuries. Resistance training is a valuable tool that can
contribute to the development of endurance athletes
of all levels and abilities3. Traditionally, coaches and
athletes were reluctant to certain level to include
strength training program because the extra bulk
would reduce cardiovascular performance. In recent
years, research has shown that strength training has
no adverse effect on aerobic capacity. In addition,
other benefits to the endurance athlete include:
maintaining proper muscular strength ratios,
increasing bone mineral density, enhancing
connective tissue, preventing overuse injuries,
improving lactate threshold and improving exercise
economy4.
Diaphragm has endurance properties which exceed
that of a limb muscle and also of abdominal muscle7.
Strengthening the diaphragm could also help in
improving general endurance as diaphragmatic
breathing is the only way to get air into the lower
third of our lungs, where two third of the blood
supply is in the body5. This breath technique may
improve the efficiency of the athletes lungs. It will
enhance the ability to metabolize oxygen.
Diaphragmatic breathing has been suggested by many
pioneers to improve endurance8, 9.
On the contrary the abdominal muscles are probably

one of the most targeted areas in the world of health
and fitness marketing. The abdominal exercises
comprised of curl ups followed by progressive
resisted exercise patterns, the exercise program is
progressed by manual weights6. Numerous fitness
experts and physiotherapists advocate strengthening
some component of the abdominal musculature to
prevent
musculoskeletal
injury,
overcome
deficiencies in sporting skill or generally enhance
performance6. Virtually every athlete is advised to
stabilize his back and pelvis. Abdominal training
programs have stayed at the top of exercises regime.
So the study is to determine the effective technique
among resisted abdominal exercise and resisted
diaphragmatic breathing exercise to improve
cardiovascular endurance.
MATERIALS AND METHODS
Ethical Clearance: The study was approved by the
Meenakshi College of Physiotherapy review board
and complies with the principle laid down in the
declaration of Helsinki in 2005.10
Study Design: Experimental study
Study Setting: YMCA Fitness Foundation Academy,
Pachiyappas Arts and Science College, Chennai
Inclusion criteria: Individuals in the age group of
18-30 years, only male subjects were included,
Hockey and football players, Non-smoking athletes
Exclusion criteria: Individuals with postural
deviations like scoliosis, kyphosis, cardiovascular
diseases like history of rheumatic heart diseases, any
obstructive lung diseases, any recent injury to chest
and vascular problems in lower limb.
Procedure:
The sampling technique used in this study was nonprobability sampling. Totally 30 both hockey and
football players were selected for this study and they
were divided into Group-I and Group-II consists of
15 subjects in each group respectively.
All the subjects were informed about the study and
their consent was obtained prior to training. The
subjects aerobic endurance was analyzed using
steptest2. All subjects underwent two minutes of the
warm up period, which consisted of stepping up and
down.
Group-I were taught resisted diaphragmatic breathing
exercise. Group-II was taught resisted abdominal
786
Sathish et al.,
exercise. Pre test values of step test, endurance levels

of athletes were assessed and documented. Total
duration of study was 8 weeks. At the end of 8th
week, endurance is reassessed using step test and
progression was recorded.
Exercise Prescription:
Group-I: Athletes included in the group-I was taught
resisted diaphragmatic breathing.
Resisted diaphragmatic breathing (Inspiratory muscle
strength training) is given by using weight plates. The
weight plates were placed on a folded Turkish towel
to prevent friction between weights and skin of the
subjects. The weights were placed on the epigastric
region. The weight is placed in such a way that one of
the corners touches the xiphisternum and other two
corners touches the anterior borders of the rib cage.
The subjects were in supine and directed to do the
breathing exercise11. Inspiratory muscle training was
done for 8 weeks with progressively increasing
weights in the following manner (table 1):
Table: 1. Progressions of Duration / Weight for
Group- I and Group- II
Duration
1st and 2nd week
3rd and 4th week
5th and 6th week
7th and 8th week
Weight
2 Kg
3 Kg
4 Kg
5 kg
Each session lasted for 30 minutes per day for six

days weekly for a period of 8 weeks. At the end of
the training, i.e. at the end of 8th week, the step test
performance of the subjects was assessed and score
was obtained in minutes12.
Group-II: The athletes included in group-II were
taught abdominal curl ups2. The athlete laid on his
back with his knees bent and arms crossed over his
chest with the weights held in hand. Simultaneously
lifts his head, neck, shoulders and shoulder blades off
the floor in a slow controlled manner for 2 seconds.
The position, pauses for 2 times and allow the rest of
the air out of the lungs. Then slowly lower to the
initial position barely allowing the shoulders to touch
the floor before he begins the next repetition. He
exhales as he lifts and inhales while lowering.
Athletes performed this exercise 20 times (1 set). An
interval of 2 minutes was given before starting the
next set. The session lasted for 30 minutes. The
subjects aerobic endurance was analyzed using step
Sathish et al.,
test which is measured in minutes 13. Abdominal curls

ups were done 6 days a week with an interval of not
exceeding 48 hours between each workout3. Resisted
abdominal exercise was done 8 weeks with
progressively overloading in according the
inspiratory muscle training method (Table 1) each
session lasted for 30 minutes and it was followed
twice a day. At the end of training, i.e. at the end of
8th week, step test performance of the subjects was
assessed and the score was obtained. All the
statistical analysis was performed using SPS Software
package (20.0 version). Values were presented as
mean, standard deviation and paired t test were
used to analyze the effect of resisted diaphragmatic
breathing exercise.
RESULTS
Table: 2. Comparison of Step test between Group-I
and Group-II before study:
Group
Mean SD
T-value
P- Value
(Minutes)
5.00 1.02
- 0.526
0.627
Group I
- 0.526
0.627
Group - II 4.57 1.01
Values are mean + SD and tests showed a statistical
insignificance before test (*p>0.005)
Using Independent sample t test, we compared both
the groups, the results showed both groups had very
less difference in the mean and standard deviation
and the P values were insignificant initially.
Table 3: Comparison of step test in Group I and
Group II (pre post test values)
Group
Pre Test
MeanSD
(Minutes)
Group -I 5.00 1.02
Group - II 4.57 1.01
Values are mean + SD
significance (*p<0.005)
Post Test
T-value P
Mean SD
Value
(Minutes)
10.80 1.02 -0.1738 0.00
4.45 0.39 -0.335 0.769
and tests showed a statistical
Paired t-test was done to compare the pretest and

Group-I and Group II. Significantly group II mean
lower than the Post test, Group I showed greater
increases in cardiovascular endurance than the other
group. So we conclude that the group-I which had
achieved the higher mean has developed better
endurance. Statistical significance was accepted at
p<0.005. The Pvalue of 0.001 suggests that there is
787
99.99%significance of the result. Subjects from the

group-I had improved better in cardiovascular
endurance.
DISCUSSION
The present study was designed to determine the
effectiveness of resisted diaphragmatic exercise and
resisted abdominal exercise and to compare the more
effective way to improve cardiovascular endurance.
The male athletes were selected for the study and
were divided into two groups. Group-I received
resisted diaphragmatic exercises while Group-II
received resisted abdominal exercise. The post-test
measures were calculated on the basis of step test
score and their results were tabulated. Both the
groups had registered an increase in their
cardiovascular endurance. But the statistical analysis
indicates that Group-I subjects who underwent
resisted diaphragmatic breathing exercise reported a
higher level of improved cardiovascular endurance.
This has been supported by various research papers:
They demonstrated that a significant improvement in
diaphragm thickness increased lung volumes and
exercise capacity in healthy individuals 3.
A study has proved that specific inspiratory muscle
training can increase the inspiratory muscle
performance in well trained athletes 13. A study stated
that the purpose of the endurance component is to
improve cardio-respiratory and musculoskeletal
function, which will be reflected in increased exercise
capacity 14. Also, this was supported by an author in
his book of exercise physiology stating that when
endurance training is added to strength training
additional improvements occur in endurance than that
was generated by strength training alone 8. The
resisted abdominal exercises which were prescribed
to Group-II is one of the widely performed exercises
irrespective of the type of sports. It is one of the most
focused areas of fitness and the exercise program
showed improvement in cardiovascular endurance in
athletes. The improvement in endurance of athletes
who underwent resisted abdominal exercise is
supported by a study, they pointed out that
strengthening the abdominal muscles helped in
improving the overall endurance in cyclists15.
Hence, both the interventions i.e. resisted
diaphragmatic breathing as well as resisted abdominal
exercise improved cardiovascular endurance. Group-I
who underwent resisted diaphragmatic exercise

showed an enhanced cardiovascular endurance than
the athletes who underwent resisted abdominal
exercise.
CONCLUSION
The study is found to be apparent; the results show
that the improvement in cardiovascular endurance
measured using resisted diaphragmatic breathing is
higher than that of resisted abdominal exercises.
Hence, this indicates that resisted diaphragmatic
breathing exercise can successfully be incorporated in
a fitness training program to improve cardiovascular
endurance for sportsmen.
ACKNOWLEDGMENT
The authors extend their gratitude to the Department
of Physical Education, Pachaiyappa Arts & Science
College, The Young Men Christian Association
(YMCA) College of Physical Education, Chennai and
the participants.
Conflicts of interest: Nil
REFERENCES
1. William D Mc Ardle, Frank I. Katch, Victor L.
Katch. Exercise Physiology: Energy, Nutrition,
and Human Performance. Lippincott Williams
and Wilkins publisher.1996; 4th Edn.
2. ACSM's Guidelines for Exercise Testing and
Prescription. American College of Sports
Medicine, Lippincott Williams & Wilkins
publisher.2006, 7th Edn.
3. Stephanie J Enright, Viswanathan B Unninathan,
Clare Heward, Louise Withnall and David H
Davies: Effect of High-Intensity Inspiratory
Muscle Training on Lung Volumes, Diaphragm
Thickness, and Exercise Capacity in Subjects
Who Are Healthy. Phys Ther. 2006 ;86(3):345-54
4. Madanmohan, Udupa K, Bhavanani AB,
Vijayalakshmi P, Surendiran A. Effect of slow
and fast pranayamas on reaction time and cardiorespiratory variables. Indian J Physiol
Pharmacol.2005; 49(3):313-8.
5. European Respiratory Monograph 31: Lung
Function Testing. Volume 31of European
respiratory Monograph, European Respiratory
Society. Chapter 4, 2005, 51-77.
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6. Hedrick, Allen MA. Training the Trunk for

Improved Athletic Performance. Strength and
Conditioning Journal.2005; 22(3):50-61.
7. Gandevia SC, McKenzie DK, Neering IR.
Endurance properties of respiratory and limb
muscles Respire Physiol. 1983; 53(1):47-61.
8. Scott K. Powers, Edward T. Howley- Exercise
Physiology: Theory and Application to Fitness
and Performance. Chapter 13, 2011, 8th Edn.
9. Leith DE, Bradley M. Ventilatory muscle
strength and endurance training. J Appl Physiol.
1976; 41(4):508-16.
10. Lesley D Henley, Denise m Frank. Reporting
ethical protections in Physical Therapy research
Physical Therapy; 2006; 86(4), 499-09.
11. Stanley John Winser, Priya Stanley, George
Tarion, Respiratory rehabilitation with abdominal
weights: a prospective study. Scientific
research.2010; 2(5):407-11.
12. Stanley John Winser, Jacob George, Priya
Stanley, George Tarion, A comparison study of
two breathing exercise techniques in tetra
plegics.Health.2009; 1(2):88-92.
13. Inbar O, Weiner P, Azgad Y, Rotstein A,
Weinstein. Y, Specific inspiratory muscle
training in welltrained endurance athlete Med
Sci Sports Exerc 2000; 32 (2):1233-7.
14. Mador MJ, MagalangUJ, KufelTJ. Twitch
Potentiation Following Voluntary Diaphragmatic
Contraction. Am.J.Resir. Crit. Care Med. 1994;
149(3):739-43.
15. Burke,
Edmund
R.Improved
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DOI: 10.5958/2319-5886.2014.00002.2

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Received: 5 June 2014
Research article
Coden: IJMRHS
Revised: 9th July 2014
Copyright @2014
ISSN: 2319-5886
Accepted: 11thAug 2014
EFFECT OF SLOW RHYTHMIC VOLUNTARY BREATHING PATTERN ON ISOMETRIC HANDGRIP

AMONG HEALTH CARE STUDENTS
*Rajajeyakumar M1, Janitha A2, Madanmohan3, BalachanderJ4

1
Assistant Professor, Department of Physiology, Chennai Medical College Hospital & Research Centre, Trichy
Senior Medical Officer, Bharat Heavy Electrical Limited, Main Hospital, Trichy
3
Professor& Head, Department of Physiology, Mahatma Gandhi Medical College & Research Centre,
Pondicherry
4
Professor & Head, Department of Cardiology, JIPMER, Pondicherry
2
*Corresponding author email:rajakumar60@gmail.com

ABSTRACT
Introduction: Hand grip strength is a widely used test in experimental and epidemiological studies. The measure
of hand grip strength is influenced by several factors, including age; gender; different angle of the shoulder,
elbow, forearm, and wrist; and posture. So we planned to study the effect of slow voluntary breathing exercise
(Savitri Pranayam) on the various strengths of isometric hand grip (IHG) among young health care students.
Methods: The present study was conducted on 60 volunteers 17-20 yrs. The subjects were randomly assigned to
Pranayam and control groups. They were divided into two groups: control (n=30), Savitri (n=30 Savitri group
were practiced slow yogic breathing for three months, Paired test was done to compare the values within group
and unpaired test was done to compare the values between male and female subjects. Results: In Savitri
Pranayam group, the blood pressure responses to IHG were higher in males, as compared to females. The rate
pressure product (RPP) also decreased during IHG 60%. A decrease in SBP and DBP was observed at the end of
the study period. Briefly, a gender difference in various parameters such as MAP, QTc existed in the control
group at the beginning of the study and the differences persisted at the end of three months. Conclusion: Our
study reported that slow Pranayam are known to enhance parasympathetic tone, produce a highly significant
decrease in oxygen consumption and psychosomatic relaxation.
Keywords: SavitriPranayam, Hand grip strength, Yoga, Maximum Voluntary Contraction.
INTRODUCTION
Pranayama is a part of the ancient Indian art of yoga,
which is the fourth step of Ashtangayoga. There are
more than ten types of Pranayam. Some are on slow
and soft rhythm and some are on fast and forceful
rhythm.1-4Pranayama is a controlled and conscious
breathing
exercise
which
involves
mental
concentration. Hand grip strength (HGS) is a widely
used test in experimental and epidemiological
studies.5 The measure of hand grip strength is
Rajajeyakumar et al.,
influenced by several factors, including age; gender;

different angle of the shoulder, elbow, forearm, and
wrist; and posture.6The rate pressure product (RPP) is
a reliable index of the myocardial oxygen
consumption and the cardiac work and it correlates
well with the myocardial oxygen consumption of
normal subjects as well as of patients with angina
pectoris.7Pranayam may influence the RPP by
altering the preload and/or the after load. Handgrip
790
strength is an important test to evaluate physical

fitness and nutritional status. HGS is a physiological
variable that is affected by a number of factors,
including age, gender, body size and posture etc.The
endurance of the muscle refers to its capacity to
withstand the power produced during the activity.
Poor muscle strength has also been found to be
associated with lower body weight and poor
nutritional status is associated with poor HGS.8In
view of this, the present work was planned, to study
the effect of pranayama training on cardiovascular
parameters like the heart rate, blood pressure, pulse
pressure, mean arterial pressure and the rate pressure
product.
OBJECTIVES
1. To assess the gender differences in HSG and
endurance in young males and females.
2. To assess the correlations between various
anthropometric and HGS on cardiovascular
parameters in young males and females.
The present study was conducted on 60 young right
handed healthy volunteers after obtaining ethical
clearance from the institutional Human Ethics
Committee. The duration of the study period was
between 2007 to 2008. Their age ranged between 1720 years (17.65 0.15), body weight between 46 - 65
kg (53.72 2.28) and height between 146 173 cm
(168.5 1.12). All volunteers underwent ENT,
mental or neurological examination at the beginning
of the study to rule out any major illness. The subjects
were randomly divided into control group and Savitri
Pranayam group. Each group consisted of 30
volunteers and was further divided into two sub
groups based on gender. The participants were
explained in detail about the study protocol and
informed consent was obtained from them after
meeting inclusion and exclusioncriteria.
Inclusion criteria: Subjects aged between 17 years
and 20 years of either gender.
Exclusion criteria: 1.Subjects who practiced yogic
techniques in past one year. 2. Subjects were unable
to practice pranayama due to physical and other
abnormalities. 3. Subjects with history of previous or
current organic diseases. 4. Non vegetarian, a high-fat
& energy, with regular physical activity.
Equipment used:
Blood pressure and heart rate were recorded with the
subject seated comfortably, using the noninvasive
automated BP monitor NIBP (Colin Press-Mate,
Model BP 8800, Colin Corporation Inc., Japan). This
measures BP by the oscillometric method. A standard
adult-size cuff measures 23 cm by 12 cm was used
for all subjects. Handgrip dynamometer (INCO India
Ltd Ambala) was used to measure the muscle strength
and endurance of the upper limbs, according to the
technique described and validated by Madanmohan et
al 2005.9
IHG at 10% of MVC:
This test assesses the
sympathetic reactivity of an individual. Using a
handgrip dynamometer, the volunteer was asked to do
maximum voluntary contraction (MVC) for a few
seconds. After five minutes rest, they were requested
to maintain 10% of MVC for up to one minute while
blood pressure was monitored in the non exercising
arm. The difference between the diastolic blood
pressure just before release of handgrip was taken as
the measure of the response.
IHG at 30% of MVC: The procedure was same as
that of IHG 10% of MVC; however, instead of 10%
the volunteer was asked to maintain 30% of his MVC
for a period of one minute.
IHG at 60% of MVC: Here, the volunteer was
asked to maintain 60% of his MVC for a period of
one minute.
Following these recordings, the volunteers were
trained in Savitri Pranayam and instructed to refrain
from any yogic practice or exercise depending on
whether they belonged to group II (Savitri group) or
group I (Control group) Each group consisted of 30
volunteers and was further divided into two sub
groups based on gender. After explaining the
procedure to the study subject and giving a
demonstration, they were asked to hold the handgrip
dynamometer in the dominant hand in sitting
position. 10 The forearm was extended over a table
and elbow flexed at 90. Subjects were asked to hold
the dynamometer and the second phalanx was against
the inner stirrup where they asked to grip the
dynamometer handle with as much force. The
handgrip muscle strength was recorded in kilograms
as indicated by the pointer on the dynamometer.
Three recordings were taken with a gap of two
minutes between each effort and the maximum value
was recorded for the analysis.
791
Parameters recorded:
The following parameters were recorded in all
volunteers at the beginning and end of three months
study period.
1. Anthropometry: BMI
2. Heart rate (HR)
3. Systolic blood pressure (SBP)
4. Diastolic blood pressure (DBP).
5. Rate Pressure product (RPP)
6. QTc interval
Procedure: Subjects were asked to report to the
recording laboratory between 4-6 pm. In general,
yoga practice is recommended in the morning or the
early evening. However, we should ensure that 3.5 to
4 Hrs.gap was maintained after Lunch. Evening yoga
practice can help calm the nervous system, reduce
physical, mental tension, unwind after a long day and
can even help with maintain normal sleep pattern.
Basal parameters like HR & BP were recorded by
using NIBP after 15 min rest in sitting posture. The
participants basal values (pre-yoga) were recorded.
The Pranayam group was taught Savitri Pranayam by
trained yoga teacher and practices same under our
direct supervision for 30 min per day, thrice per week
for a total duration of 12 weeks. They were
performed Pranayam for 5 minutes, followed by 5
min rest. Three such cycles were practiced by
subjects. Control group were not taught and did not
practice Savitri pranayam.
Procedure for Savitri Pranayam10
Savitri Pranayam was done by subject in sitting
posture (with erect spine) in a well-ventilated room. It
is ensured prior to the breathing exercise that there is
no nasal obstruction due to any medical problem like
a common cold. The exercise was performed in as
follows:
Subject is asked to breathe slowly, uniformly and
deeply with a ratio of 2:1:2:1 between inspiration
(purak) held in (kumbhak), expiration (rechak) and
held out (shunyak) phases. Our volunteers performed
the pranayam with a respiratory rate of three per
minute. The above mentioned parameters were
recorded in all volunteers of both control and savitri
pranayam groups at the end of three months study
period.
Calculation of R- R interval: ECG was acquired at
a rate of 1000 samples per second using the BIOPAC
MP 100 system and the BIOPAC AcqKnowledge
software 3.7.1 (BIOPAC Inc., USA) for at least 330
seconds. ECG was examined for artifacts and

ectopics and if present they were edited out and the
preceding and successive noise-free segments were
joined by linear interpolation with NN intervals (i.e.
Normal-to-normal RR intervals). When atrial or
ventricular premature complexes were encountered,
the preceding and the succeeding intervals were
excluded. The edited ECG was processed using an Rwave detector to obtain an RR interval tachogram. A
detailed account of techniques of R- R interval
analysis is mentioned in the Task Force Report of the
European Society of Cardiology, 1996.
Calculation of QTc: QT & QTc intervals were
analyzed by lab chart pro 6 software (AD
Instruments, Australia). The files were recorded from
the BIOPAC AcqKnowledge software 3.7.1 imported
into lab chart pro 6 software. The ECG Beat
Classifier enables the selection and removal of
unsatisfactory beats or groups of beats. Once the
appropriate setting has been chosen, the ECG
Analysis Module automatically detects the ECG beats
according to the ECG settings. The MLS360/6 ECG
Analysis Module for Windows automatically detects
and reports QT and QTc intervals, either online or
offline. The QTc interval was calculated by applying
Bazzet formula: QTc = QT/RR. The ECG Analysis
Module averages any chosen ECG beats within an
ECG recording. The number of ECG beats averaged
and analyzed together the mean QTc interval was
obtained from the same software. The ECG Table
View logs and displays selected ECG parameters.
Available parameters are chosen in the ECG Table
View dialog. Values for each ECG average are
automatically logged to the ECG Table View and can
be added to the Data Pad (Lab Charts internal
spreadsheet) or the parameters can also be exported to
graphing or statistical programs for further analysis.
Calculation of RPP: RPP was calculated (RPP = SP
HR / 100) as the product of systolic pressure and
heart rate It has been shown to correlate with
myocardial oxygen consumption during exercise in
patients with angina pectoris.11
Data analysis: Data was analyzed using the SPSS
statistical program (IBM SPSS statistics 21). An
unpaired t test was done to compare parameters
between male and female subjects and a paired t test
to compare values at the beginning and the end of the
study period. P value less than 0.05 was considered as
significant.
792
RESULTS
Control group: The control group was not subjected
to any Pranayam training. Tables 1, 2 give various
parameters measured in the control group at the
beginning and end of three months study period. All
the parameters measured during experimental
conditions were similar at the beginning and end of
the three months study period.
Table 1: Parameters of group I (control male) subjects
at the beginning and end of the three months study
period.
P value
Parameter
Beginning
End
72.73 1.58 0.699
Rest
HR 73.80 2.11
121.60 1.94 0.946
SBP 121.80 2.1
74.20 1.39 0.974
DBP 74.26 1.71
90.00 1.03 0.946
MAP 90.11 1.2
88.39 2.26 0.718
RPP 89.74 2.7
0.334 0.003 0.352
QTc 0.342 0.00
78.66 1.94 0.959
IHG
HR 78.86 2.0
10%
127.87 1.71 0.801
SBP 127.20 2.0
76.20 1.63 0.811
DBP 76.66 1.7
93.42 1.26 0.958
MAP 93.51 1.3
100.58 2.81 0.96
RPP 100.31 3.0
0.342 0.005 0.566
QTc 0.339 0.00
83.66 2.28 0.914
IHG
HR 83.20 2.2
30%
133.27 1.43 0.802
SBP 133.87 2.1
80.93 1.22 0.663
DBP 81.46 1.41
98.37 0.88 0.667
MAP 98.93 1.07
RPP 111.32 3.18 111.69 3.70 0.952
QTc 0.336 0.006 0.337 0.007 0.858
88.26 2.15 0.875
IHG
HR 87.60 2.26
60%
SBP 137.40 0.83 137.47 0.90 0.961
84.33 1.05 0.847
DBP 84.60 1.22
MAP 102.20 0.88 102.04 0.75 0.875
RPP 120.29 3.18 121.32 3.70 0.856
0.356 0.01 0.881
QTc 0.354 0.01
In contrast, BMI values were in the males

(23.110.508 to 23.180.514, p0. 67) and females
(21.740.623 to 21.910.667, p0. 33). In contrast,
Pranayam group, they were attained statistical
significance at the beginning and the end of the study.
The values were in the males (22.640.356 to
22.170.377, p0.001) and females (23.120.516 to
22.821.91, p0.019).
Savitri group: The volunteers of this group received
three months training in Savitri Pranayam. Tables 3,
4shown various parameters recorded in male and
female volunteers of Savitri group at the beginning
and end of three months study period. In male
subjects, QTc was increased at the end of the study
during rest from a value of 0.351 0.004 to 0.327
0.005, the increase being statistically significant (p
0.01). During IHG 60% the RPP decreased from an
initial value of 119.32 2.93 to 111.75 2.95, the

decrease being statistically significant (p 0.01).
Table 2: Parameters of group II (control female)
subjects at the beginning and end of the three months
study period
P value
Parameter
Beginning
End
76.53 1.81
0.839
Rest
HR 75.93 1.82
SBP 122.33 1.47 123.47 1.25 0.453
69.66 1.02
0.83
DBP 69.26 1.37
87.60 0.97
0.615
MAP 86.95 1.00
94.43 0.97
0.67
RPP 92.86 1.00
QTc 0.368 0.009 0.366 0.008 0.924
81.86 1.78
0.868
IHG
HR 81.40 1.75
10%
SBP 127.50 1.38 128.70 1.23 0.458
75.20 1.47
0.599
DBP 74.07 1.63
93.04 0.94
0.503
MAP 91.86 1.09
RPP 103.67 2.24 105.33 2.31 0.64
QTc 0.351 0.006 0.354 0.005 0.662
85.26 1.69
0.816
IHG
HR 84.60 1.72
30%
SBP 132.70 1.47 133.90 1.32 0.621
80.20 1.41
0.534
DBP 78.73 1.61
98.11 1.13
0.528
MAP 96.73 1.26
RPP 112.22 2.38 114.20 2.52 0.649
QTc 0.367 0.006 0.361 0.007 0.627
87.86 1.61
88.8 1.55
0.723
IHG
HR
60%
SBP 136.40 1.51 138.10 1.32 0.496
82.07 1.62
0.838
DBP 81.47 1.76
100.8 1.33
0.716
MAP 99.77 1.46
RPP 119.84 2.54 122.64 2.35 0.526
QTc 0.356 0.008 0.365 0.009 0.434
Table 3: Parameters of group II (Savitri male) subjects
at the beginning and end of the three months study
period
P value
Parameter
Beginning
End
65.933 1.48
0.078
Rest
HR 68.80 1.22
0.243
SBP 116.26 2.62 111.80 1.79
62.66 1.53
0.689
DBP 63.87 2.75
79.04 1.51
0.252
MAP 82.06 2.16
76.07 2.81
0.285
RPP 79.89 1.96
0.924
QTc 0.351 0.004 0.320.005**
73.80 1.65
72.00 1.40
0.491
IHG
HR
10%
SBP 131.33 1.83 127.87 2.99 0.318
74.80 3.28
0.587
DBP 77.20 2.04
92.49 3.07
0.47
MAP 95.24 1.66
92.17 3.07
0.225
RPP 96.92 1.96
QTc 0.343 0.005 0.329 0.009 0.293
75.60 1.61
0.717
IHG
HR 76.46 1.80
30%
SBP 135.66 2.39 132.20 3.05 0.27
75.40 3.38
0.446
DBP 79.00 3.55
94.33 3.12
0.381
MAP 97.88 3.05
RPP 104.00 3.75 100.20 3.25 0.347
QTc 0.355 0.008 0.345 0.011 0.418
83.00 1.43
0.9
IHG
HR 86.60 1.89
60%
SBP 137.86 2.05 134.60 2.51 0.273
78.40 2.67
0.32
DBP 82.06 1.74
0.213
MAP 100.66 1.49 97.13 2.31
RPP 119.32 2.93 111.7 2.95* 0.028
QTc 0.365 0.008 0.345 0.007 0.117
793
Table 4: Parameters of group II (Savitri female)

subjects at the beginning and end of the three
months study period
Parameter
Begining
End
P
value
72.40 1.21** 0.006
Rest
HR 77.00 1.00
SBP 114.80 2.62 111.26 2.93 0.426
63.40 2.10
0.28
DBP 67.66 2.83
79.35 2.15* 0.042
MAP 88.20 3.71
80.73 2.82
0.065
RPP 88.51 2.61
QTc 0.375 0.005 0.352 0.005* 0.014
82.66 1.75
0.188
IHG
HR 86.80 2.58
10%
SBP 128.53 2.84 120.86 2.90* 0.016
71.80 2.67* 0.021
DBP 79.66 3.65
87.13 2.36** 0.002
MAP 97.33 3.00
RPP 111.69 4.40 97.51 3.78** 0.004
QTc 0.370 0.008 0.354 0.006 0.165
87.80 1.97
0.154
IHG
HR 92.20 2.09
30%
SBP 131.06 2.58 124.53 3.47 0.152
76.13 3.88
0.787
DBP 77.53 2.79
92.26 3.57
0.503
MAP 95.37 2.41
RPP 120.93 3.85 109.57 4.46 0.09
QTc 0.379 0.009 0.360 0.006 0.066
89.13 2.04 0.57
IHG
HR 87.26 2.02
60%
SBP 126.13 3.54 128.53 3.73 0.647
74.60 2.54 0.899
DBP 75.13 3.58
92.57 2.74 0.663
MAP 94.66 4.27
RPP 109.88 3.64 114.90 4.78 0.403
QTc 0.361 0.008 0.369 0.005 0.29
$
Values are expressed as mean SEM.
Paired t test was applied to compare the parameters at
the beginning and end of the study. HR heart
rate,SBP systolic blood pressure, DBP diastolic
blood pressure, MAP mean arterial pressure, RPP
rate pressure product,QTc corrected QT interval,
IHG isometric handgrip.
*P0.05.,**P0.01,***P0.001
To summarize, The RPP was also decreased during
IHG 60%. The female subjects of Savitri group
exhibited a similar trend of decreasing, HR, MAP &
QTc during rest. Briefly, a gender difference in
various parameters such as MAP, QTc existed in the
control group at the beginning of the study and the
differences persisted at the end of three months in the
group. In the Savitri group, a similar trend was
evident at the beginning and the end of the study. In
savitri pranayam group, the blood pressure responses
to IHG were higher in males, as compared to females.
DISCUSSION
In our control group of male as well as female
volunteers the recorded cardiovascular parameters
were similar and BMI of both genders were not
attained statistical significance at the beginning and

the end of the three months study period. BMI was
significantly decreased in both male and female
Pranayam groups in compared with the control group.
Regular practice of Pranayam in the right manner can
help increase the metabolism and helps in burning off
more calories. It is important to realize that the
process of weight loss through Pranayama or most
other yoga forms slow and gradual. However, when
pranayama is modified by several levels, it can help
facilitate weight loss at a faster rate.
Savitri Pranayam group: Savitri Pranayam is a slow
type of breathing, known to enhance parasympathetic
tone. The results of this group are in accordance with
this. The heart rate and blood pressure during rest was
lower in male as well as female volunteers, but
attained statistical significance only in the latter. In
general, the rise in HR & BP in response to IHG was
less at the end of the study period. This may be due to
the improved autonomic tone resulting in an
increased parasympathetic drive, calming of stress
responses, neuroendocrine release of hormones and
thalamic generators. This blunting of the presser
response was more prominent during IHG 10% of
MVC and more so in the female group. The values in
the male volunteers did not attain statistical
significance. This is consistent with earlier reports
from our laboratory that Savitri Pranayam can
produce a highly significant decrease in oxygen
consumption and psychosomatic relaxation. The RPP
was also less after Savitri Pranayam training in both
male and female subjects. RPP is an index of
myocardial oxygen consumption and load on the
heart10,-12.This interesting finding of ours has great
applied value as this indicates that Savitri pranayam
can be used as an effective technique to reduce load
on the heart during stressful situations. Deep
breathing reduced blood pressure in male as well as
female subjects after Savitri pranayam.
At the beginning of the study, the resting HR, RPP,
and QTc were significantly higher in females (N=15)
as compared to males. During IHG exercise of
various grades of all values was higher in males
(N=15) volunteers, but the SBP attained statistical
significance. At the end of the study in this group
during rest, HR and QTc were higher in females as
compared to males, but the values were less as
compared to the values at the at the beginning of the
study period. Pramnic et al (2009)have reported that
794
pranayama increases frequency and duration of

inhibitory neural impulses by activating pulmonary
stretch receptors during above tidal volume inhalation
as in Hering Bruer reflex, which bring about
withdrawal of sympathetic tone in the skeletal muscle
blood vessels, leading to widespread vasodilatation,
thus causing decreases blood pressure and increases
heart rate.11 The gender difference in various
parameters during IHG exercise of different grades
existed after the three months study period. This is in
agreement with the reports of Madanmohan et al
(1983) that savitri pranayam (a slow, deep and
rhythmic breathing) produces a highly significant
decrease in HR and SBP.12,13 Also Sharma et al,
(2007) have reported that isometric exercise induced
rise in is blunted and a progressively lower
percentage increase is observed in a person practicing
shavasana.14-20
CONCLUSION
Our study has revealed a number of important facts
which can have important therapeutic implications.
The fact that Savitri Pranayam enhances
parasympathetic activity has been reproduced first
time in our study. Three month training and practice
in yogic- type breathing is sufficient to induce
beneficial change in autonomic functions, ECG
parameters and reaction time. The gender difference
was evident in all the parameters measured. Our
findings were in accordance with previous studies.
Therefore yogic breathing practices can be prescribed
to both healthy people and those with cardiovascular
autonomic dysfunction. Moreover, specific breathing
techniques can be advised depending on whether an
individual has high sympathetic or parasympathetic
tone. Hand grip strength is currently used worldwide
because it is a relatively cheap test that gives practical
information on muscle, nerve, bone, or joint
disorders.
LACUNAE & RECOMMENDATIONS:
The present study requiring a further randomized
controlled trial and a follow-up to determine the
impact of diet on Pranayam training. To standardize
the procedure and increase the reliability, as
otherwise the measurement error may be too large to
detect actual changes in strength. It must be borne in
mind that different kinds of dynamometers and
postures might change the results. Moreover, hand
grip strength is associated with bone mineral density,

impaired
cognition,
nutritional
status
and
20
cardiovascular disease risk factors . Therefore, from
a public health perspective, it is important to
standardize the procedure and increase the reliability.
It must be borne in mind that different kinds of
dynamometers and postures might change the results.
ACKNOWLEDGMENT
My sincere thanks to Dr Amudharaj D, Assistant
professor, Department of Physiology, Aarupadai
Veedu Medical College & Hospital Pondicherry,
helping me for providing the statistical analysis.
Conflict of interest: None
Source of funding: Nil
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796
DOI: 10.5958/2319-5886.2014.00003.4

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Received: 25 May 2014
Research article
Coden: IJMRHS
Revised: 30th June 2014
Copyright @2014
ISSN: 2319-5886
Accepted: 28th July 2014
PREVALENCE, CHARACTERIZATION AND CLINICAL SIGNIFICANCE OF KLEBSIELLA

PNEUMONIAE CARBAPENEMASE (KPC) PRODUCING KLEBSIELLA PNEUMONIAE
*
Sarita Nayak1, Suman Singh2, Soeb Jankhwala3, Riddhi Pradhan4
Microbiologist, State Surveillance Unit, Integrated Disease Surveillance Programme (IDSP), Gandhinagar,
Gujarat, India
2
Department of Microbiology, Pramukh Swami Medical College, Karamsad, Gujarat, India
3
Microbiologist, Sir Pratap General Hospital, Himmatnagar, Gujarat, India
4
Department of Microbiology, R. D. Gardi Medical College, Ujjain, Madhya Pradesh, India
*Corresponding author email: saritanayak7@gmail.com
ABSTRACT
Background: Klebsiella peumoniae, a capsulated gram negative bacillus is responsible for causing life threatening
infections in humans. Carbapenems are the drug of choice for serious infection caused by multidrug resistant
Klebsiella pneumoniae. The emergence of carbapenem resistance has made it extremely difficult to treat such
infections resulting in significant morbidity and mortality. Aims: To study the prevalence of carbapenem resistance
using ertapenem as a marker and to detect Klebsiella pneumoniae Carbapenemase (KPC) producing Klebsiella
pneumoniae as a mechanism of resistance. Material and Methods: The study included 102 patients from which
Klebsiella pneumoniae isolated. Identification and antibiotic susceptibility testing of Klebsiella pneumoniae was
performed on miniAPI (Analytical Profile Index, Semiautomated bacterial identification system) according to
Clinical and Laboratory Standards Institute (CLSI) guidelines of 2011. The modified Hodge test was performed for
detection of Carbapenemase production. Patients clinical and demographic details along with risk factors and comorbid conditions, type of response to antimicrobial therapy and mortality were collected. Results: The prevalence
of carbapenem resistance was found to be 30.41% with 16.6% KPC producing Klebsiella pneumoniae. The comorbid conditions like immunocompromised state (p =0.042), prior antibiotics therapy (p=0.047), previous
hospitalization (p =0.021), intensive care unit stay (p=0.047) and use of indwelling devices (p =0.013) were found
to be significantly associated with carbapenem resistance. Adverse clinical outcomes (death or worsening)
among patients infected with ertapenem resistant patients was found to be statistically significant than ertapenem
sensitive strains (p =0.008). Conclusions: A high degree of carbapenem resistance in present study is alarming
and poses therapeutic dilemmas for clinicians. Initiating timely and appropriate infection control measures along
with a strictly implemented antibiotic stewardship program are necessary to prevent their spread.
Keywords: Klebsiella pneumoniae, carbapenem, KPC produces Klebsiella pneumoniae, Co morbid conditions
INTRODUCTION
Antibiotics are life saving limited resources. They are
used to treat serious infections to prevent morbidity
and mortality. The indiscriminate and irrational use of
antibiotics today has resulted in development of
multidrug resistant strains in organisms commonly
associated with human infections.1,2 Antibiotic

resistance evolves naturally via natural selection
through random mutation, but it could also be
engineered by applying an evolutionary stress on a
population. Once such a gene is generated, bacteria
797
Sarita et al.,
can then transfer the genetic information in a

horizontal fashion by plasmid exchange. 3 One of
such gene is a KPC encoding gene. KPC is a class A
carbapenemase enzyme which hydrolyzes broad
spectrum beta lactum agents. The KPC encoding
genes are plasmid mediated and thus have great
potential for spread.4 Resistance to carbapenem by
such enzyme is a global concern due to limited
therapeutic options and their association with life
threatening infections. L arge referral hospitals and
teaching institutions are at great risk for a wide
spread outbreak of infections and responsible for the
spread of such strains from one location to another
and to other hospitals. Thus, detection of these
strains and knowledge about their prevalence is o f
utmost importance.
Klebsiella pneumoniae is ubiquitous in nature and can
be isolated from soil, farm production and different
water sources like lakes, rivers, sewage, fresh water.
They are the component of the normal microflora in
upper respiratory tract and gastrointestinal tract of
human being and mice. 5 Keeping in mind the
importance of Klebsiella pneumoniae as a human
pathogen and
their
emerging
carbapenem
resistance, this study was undertaken to identify
and characterize carbapenem resistant Klebsiella
pneumoniae from various clinical samples. Efforts
were also made to study the clinical details,
particularly the associated risk factors, co-morbid
conditions and outcome in patients infected with
these strains.
This is a cross-sectional descriptive study, approved
by institutional human research ethics committee of
our institution. The study was conducted on a total
number of 5455 clinical samples received and
processed from indoor patients admitted in Shree
Krishna Hospital, a tertiary care health centre located
in rural part of Gujarat, India from May 2011 to
April 2012. Informed consent was taken from
patients when detailed clinical history was required.
The study includes all the patients admitted in tertiary
care hospital from whom Klebsiella pneumoniae were
isolated from various clinical samples. Those
specimens from where Klebsiella pneumoniae was
isolated as laboratory contamination confirmed on the
basis of clinical correlation were excluded. The
isolates were identified to species level and
antimicrobial sensitivity was performed using

miniAPI system according to Clinical and Laboratory
Standards
Institute
(CLSI)
2011guidelines.6
Ertapenem disc (10g, Himedia, code-SD280-1VL)
was used as surrogate marker for detection of
carbapenem resistance. Ertapenem sensitivity was
performed by disk diffusion method (CLSI
2011guidelines). 6 Isolates, that were found resistant
to ertapenem, were considered as potential
carbapenemase
producers,
confirmation
of
carbapenemase production was done with the
Modified Hodge test. 7-9
The modified Hodge test (MHT):7 - 9 MuellerHinton agar plate was inoculated with a 1:10
dilution of a 0.5 McFarland suspension of E.coli
ATCC 25922 and inoculated for conuent growth
using a swab. A 10 g E rtapenem disk was placed
in the center, and each test isolate was streaked
from the disk to the edge of the plate along with
control strains.
After 1624 hours at 37 C of aerobic incubation,
plates were examined for a clover leaf-type
indentation at the intersection of the test organism
and the E. coli 25922, within the zone of inhibition
of the carbapenem susceptibility disk. MHT
positive test had a cloverleaf-like indentation of the
E.coli 25922 growing along the test organism
growth streak within the disk diffusion zone. MHT
negative test had no growth of the E.coli 25922
along the test organism growth streak within the
disc diffusion. Quality control was performed using
control strains using MHT positive Klebsiella
pneumoniae ATCC BAA-1705 and for negative
control Klebsiella pneumonia ATCC (American Type
Culture Collection) 700603.
Patients were grouped into two categories; one
included patients with infection by carbapenemase
producing strains and other with infection by
carbapenemase non -producing strains. Patients
clinical and demographic details were collected from
the case files as well as by history taking and physical
examination as and when required. Klebsiella
infections are mostly seen in people with a weakened
immune system. They may spread by inhalation or
contact through skin or mucus membrane and are also
spread by the indwelling devices or instruments used
in procedures contaminated with K. pneumonia.
Many of these infections are obtained as nosocomial
infections.
798
Sarita et al.,
During the study period of a year, a total of 5455

clinical samples were processed from indoor patients
with a culture positivity rate of 1571(28.8%).
Klebsiella pneumoniae were isolated from 102
(6.5%) samples. Klebsiella pneumoniae were isolated
more from male patients (68.6%) as compared to
female patients (31.4%). Ertapenem resistant isolates
in males (71%) were found to be more than in
females (29%). Even KPC producing isolates in
males (70.6%) were found more than females
(29.4%). Respiratory sample was the major sample
from which Klebsiella pneumoniae was isolated i.e.
41 (40.2%), followed by pus 24 (23.5%), urine 19
(18.6%) and blood 14 (13.7%). Distributions of
Clinical samples in relation to ertapenem sensitivity
are summarized in Table 1. Respiratory sample was
the major sample from which ertapenem resistant
Sarita et al.,
Others
Total
4(5.63)
71(69.6)
0 (0.0)
31 (30.4)
4 (3.9)
102 (100)
Specimen
SICU
Ward
Isolation
& Burns
Ward
Total
Table2: Distribution of Ertapenem

Resistant K. pneumoniae in Different
Locations (n=31)
NICU
RESULTS
Klebsiella pneumoniae was isolated i.e. 11/102

(35.5%) followed by pus 10 (32.3%). Respiratory
tract infection was the most common clinical
condition in Klebsiella pneumonia (37%) followed by
soft tissue infections (21%) even in ertapenem
resistant Klebsiella pneumoniae respiratory tract
infection (35.5%) was common followed by soft
tissue infections i.e. 25.8% .
Table 1: Distribution of Clinical Sample in
Relation to Ertapenem Sensitivity (n=102)
Ertapenem Ertapene
Specimen
Total
sensitive
Resistance (%)
(%)
(%)
Urine
13 (18.30) 6 (19.4)
19 (18.6)
Pus
14 (19.72) 10 (32.3)
24 (23.5)
Sputum/ET/
30 (42.25) 11 (35.5)
41 (40.2)
Blood
10 (14.08) 4 12.9)
14 (13.7)
TT
MICU
Data like age, sex, date of admission, date of culture

isolate, presence of risk factors (age, sex, indwelling
devices, duration of hospital stay, prior exposure to
antibiotics) and co-morbid conditions (liver
dysfunction, renal insufficiency, surgery/ invasive
procedure in last 30 days, chronic lung disease,
diabetes mellitus and heart disease), type of
antibiotics given and response to therapy were
collected. The co-morbid conditions were considered
as per the clinical diagnosis with supporting
laboratory data. Clinical outcome was evaluated in
terms of length of hospital, stay after the diagnosis of
infection, response to therapy and mortality. Death
was considered due to infection when it occurred
within two weeks from the diagnosis of infection with
evidence suggestive of active infection and absence
of any other fatal event. Patients were followed till
discharged from the hospital. Infections caused by
Klebsiella pneumonia are treatable with antimicrobials
like beta lactum, amino glycosides, quinolones, folic
acid inhibitors, nitrofurantoin and carbapenems.
Statistics: The Master Chart of the data of the
patients collected using the questionnaire was
computerized on day to day basis on Micro Soft Excel
2007. Descriptive statistics was used to describe the
observations of the study and Chi Square Test was
applied as a test of significance. The Odds ratio was
calculated wherever relevant. The tests of
significance were calculated using SPSS Version 16
software.
Blood
Pus
3
1
4
2
10
1
0
0
0
1
0
6
3
1
10
0
1
4
3
8
0
2
0
0
2
4
10
11
6
31
Sputum/ET/T
TUrine
Total
The prevalence of ertapenem resistance is 30.4%.

As seen in Table 2, the majority of ertapenem
resistant i.e. 21 out of 31. ( 67.74%) Klebsiella
pneumoniae w e r e isolated from ICUs ((MICU,
SICU, and NICU). Thus the location of patients in
the hospital was found to be a significant risk for
acquisition of infection by ertapenem resistant strains
of Klebsiella pneumoniae. An association of
Ertapenem resistant Klebsiella pneumoniae with
different co-morbid conditions is shown in Table 4.
Out of 102 Klebsiella pneumoniae isolated patients,
57 recovered, 29 worsened, nine died and seven
patients were discharged against medical advice.
Among nine patients who died, six were infected with
ertapenem resistant strains. Sixty percent of those
who were ertapenem resistant died or worsened
while remaining 39.3% survived. Among those who
799
were ertapenem sensitive, 31% died or worsened.

Adverse clinical outcomes (death or worsening)
among ertapenem resistant patients was found to
be statistically significant than ertapenem sensitive
patients (p value 0.008).
Among 31 ertapenem resistant strains, 17 (16.6 %)
were confirmed as KPC producers by Modified
Hodge test. Twelve i.e. 70.6% of KPC producing
Klebsiella pneumoniae were isolated from ICU
samples. Out of these six were isolated from pus

swabs, six from respiratory secretions, four from
urine and one from the blood. In 17 KPC strains, it
was found that imipenem w a s sensitive in e i g h t
isolates, tetracycline sensitive in s i x isolates and
cotrimoxazole sensitive in two isolates. Colistin
and polymyxin were found to be sensitive in all 17
KPC isolates.
Table 3: Association of Ertapenem Resistant K. pneumoniae with different co- morbid conditions (n= 31)
Co-morbid
condition
Immunocompromised
Ertapenem resistance Ertapenem Sensitive

YES
NO
12 (46.2%) 19 (25%)
YES
14 (53.8%)
NO
57 (75%)
Odds ratio (C.I)

p value
0.04294 2.571 (1.015-6.514)
Surgery in last 30 days 9 (34.6%) 22(28.9%) 17 (65.4%)
54 (71.1%)
0.58750 1.299 (0.5036-3.353)
Previous hospitalization
14 (46.7%) 17 (23.6%) 16 (53.3%)
55 (76.4%)
0.02107 2.831(1.151-6.964)
Prior Antibiotic
Indwelling device
ICU stay (days)
14 (43.8%) 17 (24.3%) 18 (56.3%) 53 (75.7%) 0.04735 2.425 (0.9991-5.885)

15 (42.9%) 16 (23.9%) 20 (57.1%) 51 (76.1%) 0.04790 2.391 (0.9978-.728)
21 (38.9%)
33 (61.1%)
2.418(0.9973-5.863)
0.04783
10 (20.8%)
38 (79.2%)
Ward stay (days)

DISCUSSION
Globally ertapenem resistance in Klebsiella

varies from 5-50% (Table 3). The prevalence of
ertapenem resistance is 30.4% in our study.
Resistance to imipenem and meropenem was high
(33 & 100%, respectively) i n ertapenem resistant
isolates. So the prevalence of carbapenem resistance
is on the high side in our study as compared to other
studies conducted all over the world. The strategies
recommended to prevent the spread of Klebsiella spp
in document of CDC and Healthcare Infection
Control practices Advisory Committee (HICPAC) is
hand hygiene, contact precautions, patient and staff
cohorting, healthcare personnel education, minimum
use of invasive devices, promote antimicrobial
stewardship and screening the patients15. Data
regarding nosocomial infections reported to the
CDC showed the prevalence of carbapenem
resistance among Klebsiella pneumoniae
Isolates increased from less than 1% in 2000 to 8%
in 2007. 16 In New York City, it rose from 9% in
2002 to 18% in 2004, and then further to 38% in
2008.16 Carbapenem resistance is increasing day by
day. In India there is limited literature available
regarding the prevalence of resistance to
carbapenems. Gupta et.al from Delhi reported

6.9% of Meropenem resistance and 4.3% of
Imipenem resistance in Klebsiella spp. 17
Table 4: Prevalence of Ertapenem Resistant
Klebsiella reported by different authors (20062012)
Ertapenem
Year of Place of
Authors
Resistance*
study
study
10
2006
Boston
Hyle EP et al
32
2008
Taiwan
Jiunn-Jong Wu et 13.5
2008-09 Pondicherry R.Mohamudha
et 20.3
al11
13
2008-09 Italy
Orsi
38
al12 GB et al
2010
Greece
A Zogorianou et
38.3
14
2012
India
present
study
30.4
al
*Ertapenem resistance in %
In one of the study conducted in India by R.
Mohamudha Parveen et al 20.3% resistance to
ertapenem has been reported.12 The prevalence rates
in our study are higher than other studies conducted
in India. There is an increasing trend of prevalence of
carbapenem resistance found in India in the recent
past. In the Meropenem Yearly Susceptibility Test
Information Collection Program (MYSTICP),
800
Sarita et al.,
meropenem resistance among clinical isolates of

Klebsiella pneumoniae increased signicantly from
0.6% in 2004 to 5.6% in 2008. Among isolates
reported to the National Healthcare, Safety
Network (NHSN) in 20062007, carbapenem
resistance was reported in up to 10.8% of K.
pneumoniae isolates that were associated with
certain device-related infections. 18
In the present study, ertapenem resistant isolates in
males 22 (71%) were found more than in females
9 (29%). Falagas et al, also reported similar sex
distribution with carbapenem resistant Klebsiella
pneumoniae infections. 19 I n his study, males
(71.6%) were more than females (28.4%). Even
KPC producing isolates were found more in males
(70.6%) than in females (29.4%). Maria Souli et
al, also reported similar findings where out of 18
patient, 10 male patients (55.6%) were infected with
KPC producing Klebsiella pneumoniae.20
There was a significant association of ertapenem
resistant isolates
in ICU patients, i.e. MICU
(32.3%) and SICU (32.3%) as compared to patients
in wards (p value = 0.048). such observations have
not been shared by other investigators. We found an
immunocompromised state (p= 0.043), prior
antibiotics (p=0. 048), ICU stay (p=0. 048), more
than one previous hospitalization (p=0. 01) and
indwelling devise use (p=0. 01) t o have
significant association with ertapenem resistance.
There is a need to be very careful while selecting
antibiotics in such cases and also need to have more
scrutiny over such cases.
Mitchell J. Schwaber et al,21 observed that when
risk factors for the recovery of Carbapenem
Resistance Klebsiella pneumoniae (CRKp) and
Carbapenem Sensitive Klebsiella pneumoniae
(CSKs) were compared; the prior receipt of
antibiotics was the risk factor unique to the CRKp
group. Orsi G B et al,1 3 also found that prior use
of certain antimicrobials, specifically carbapenems
and cephalosporins, are primary independent risk
factors for colonisation or infection with
ertapenem resistance. Hyle EP et al,10 observed that
risk
factors
for
ertapenem
resistant
enterobacteriaceae infection included intensive care
unit (ICU) stay, exposure to any antibiotic during
the 30 days prior to a positive culture result.
Adverse clinical outcomes (death or worsening in
60%) among ertapenem resistant patients was
found to be statistically significant than ertapenem

sensitive patients (p value 0.008). In one of the
case series describing the outcome of eight patients
with CRKp infections in the surgical intensive care
setting, six of eight patients died (75% mortality).19
The study by Hyle EP et al,10 showed that out of 62
case patients, 30-day outcomes from the time of
positive culture result were 24 (39%)discharges,
10(16%)deaths,
and
28
(44%) continued
hospitalizations. The final end point of the
hospitalization was discharged for 44 (71%) patients
and death in 18 (29%) patients. Despite the
universal concern regarding the emergence of
outbreaks because of CRKp, there is a scarcity of
information about risk factors and outcome for
CRKp infections. It is a time to understand the risk
factors and outcome of CRKp infections and prevent
the spread by strict adherence to hospital infection
control guidelines to prevent morbidity and mortality
from such infections.
The prevalence of KPC producing Klebsiella
pneumoniae is 16.6 % in hospitalized patients in our
centre. It contributed to 54.8% of carbapenem
resistance. As similar to our study, Varsha Gupta,
e t al22 also reported 33.3% carbapenemase
Klebsiella pneumoniae by modified Hodges test
and these isolates were 100% sensitive to colistin
by disc diffusion. A study conducted in Greece
(2010) by A Zogorianou et al,14 reported 66.4% of
KPC from 128 carbapenemase
producing
Klebsiella pneumoniae by molecular method.
There is a high contribution of KPC in carbapenem
resistance in our study. In our study, the number of
KPCs from ICUs, i.e. 12 (70.5%) was more than
non ICUs i.e. five (29.5%). In 17 KPC strains, it
was found that colistin and polymyxin were found
to be 1 0 0 % sensitive followed by imipenem
(47.06%), tetracycline (35.29%), cotrimoxazole
(11.76%) and amikacin (11.76%). Varsha Gupta, et
al22 also reported 100% sensitivity to colistin and
polymyxin. Maria Souli et al,20 observed that
more than 75% of KPC producers were
sensitive to gentamicin, colistin and fosfomycin.
Similar to our study, A Zogorianou et al14
reported
resistance
to
Amikacin
74%,
ciprofloxacilin 98%, co-trimoxazole 91% in
KPC producing Klebsiella pneumoniae. P Gaibani
et al23 also observed that the KPC-positive strains
were resistant to beta-lactams (including the 3rd
801
Sarita et al.,
and 4th generation cephalosporins) and to

fluoroquinolones, some of them are sensitive to
tetracycline and co-trimoxazole. Some of the
KPC-producing strains were still susceptible to
antimicrobials (cotrimoxazole, tetracycline) that are
not commonly used as alternative therapy for the
treatment of nosocomial infections caused by to
MDR (Multi Drug Resistant) gram-negative
organisms. So culture and antibiotic sensitivity are
utmost important to know the drug resistance in any
infection caused by Klebsiella pneumoniae.
CONCLUSION
We found a high prevalence of KPC producing
Klebsiella pneumoniae with high degree of
antimicrobial resistance in our study. This is a
challenge for clinicians as well as for administrators.
Formulating an antimicrobial policy and its strict
implementation with regular surveillance of KPC
producing isolates is needed along with appropriate
infection control measures to curtail its emergence
and spread.
ACKNOWLEDGEMENT
I would like to acknowledge Shree Krishna Hospital,
Karamsad, Anand, Gujarat for allowing me to conduct
this study and the staff of Microbiology Department
for supporting me to conduct this study.
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DOI: 10.5958/2319-5886.2014.00004.6

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Received: 9 July 2014
Research article
Coden: IJMRHS
Revised: 5th Sep 2014
Copyright @2014
ISSN: 2319-5886
Accepted: 15th Sep 2014
EFFECTS OF PRANAYAMA ON GALVANIC SKIN RESISTANCE (GSR), PULSE, BLOOD

PRESSURE IN PREHYPERTENSIVE PATIENTS (JNC 7) WHO ARE NOT ON TREATMENT
Dhodi Dinesh K 1, Bhagat Sagar B 2, Karan Thakkar 2, Peshattiwar Aishwarya V3, Arati Purnaye4, Sarika
Paradkar4
1
Assistant Professor, 2Senior Resident, 3UG Student, 4Junior Resident, Department of Pharmacology, Grant Govt.
Medical College & Sir JJ Group of Hospitals, Mumbai.
*Corresponding author email: dhodidinesh@gmail.com
ABSTRACT
Background: Psychological stress, in this era of urbanization, has become a part and parcel of our lives and has
lead to serious problem affecting different life situation and carries a wide range of health related disorders. Aims
& Objective: To observe the effects of Pranayama on GSR. Pulse rate and blood pressure. Material & Method:
This was an open labeled, prospective, uncontrolled, single centered, single arm, comparative, clinical
intervention study conducted in the Department of Pharmacology, Grant Govt. Medical College, Mumbai, over a
period of two months period August-September 2009 on 15 Prehypertensive subjects. Results: A total of 15
subjects who were Borderline hypertensive / Pre-Hypertensive, according to the JNC VII Classification, were
enrolled in the study. Of which 10 were male and 5 were females, all in the age group of 22-35 yrs with a BMI of
19.63 30.11 with an average of 24.80. No significant change was seen when baseline GSR reading was
compared with 15th day reading, but on 30th day significant change observed. When the baseline value of pulse
was compared with that of the 15th and 30th day, a good positive change was seen in resting pulse. Similarly, BP
recording also showed a good positive effect when baseline value was compared with that 15th and 30th day.
Conclusion: The study concludes that practicing Pranayama on a regular basis increases the parasympathetic
tone and blunts the sympathetic tone of the body. This has shown good beneficial effects on the Pulse, BP and
GSR.
Keywords: Galvanic Skin Resistance, Pranayama, Sympathetic tone.
INTRODUCTION
Cardiovascular diseases are one of the leading causes
of mortality and morbidity around the globe.1 High
Blood pressure (BP) is a major risk factor and is
associated with several types of cardiovascular
disease.2 A significant proportion, i.e., 57% of all
stroke deaths and 24% of all coronary heart disease
deaths in India can be attributed to hypertension. 3
Studies have shown that nearly two-fifths of the
Indian adult population are hypertensive. 4 Although
no direct cause has been identified for primary/
essential hypertension, the contributing factors are
Dinesh et al.,
sedentary lifestyle, smoking, stress, visceral obesity,

potassium deficiency, obesity, salt sensitivity, alcohol
intake, and vitamin D deficiency. Out of the above,
the most important risk factors are obesity and
psychological stress.5
Psychological stress, in this era of urbanization, has
become a part and parcel of our lives. Chronic stress
has become a serious problem affecting different life
situation and carries a wide range of health related
disorders
such
as
cardiovascular
disease,
cerebrovascular disease, Diabetes and Immunological
804
disorders. 6 There are no direct ways to quantify

stress, but its surrogate markers can be identified and
measured. One such parameter is the GSR (Galvanic
skin response), which can be measured with the help
of a POLYRITE machine.7 The Galvanic skin
response (GSR) is a highly sensitive parameter to
measure the sympathetic outflow. Changes in GSR
following exercise can be used to assess the stress
patterns in an individual.8
Several researchers have reported that a non
pharmacological measure, Pranayama, is effective in
stress related conditions. Pranayama is an age old
science that has been practiced for thousands of
years. It consists of ancient theories, observations,
and principles about the mind and body connection.
Pranayama is a Sanskrit word meaning "extension of
the prana or breath" or, more accurately, "extension
of the life force". Many yoga teachers advise that
Pranayama and exercise should be a part of our daily
routine.9 It helps by regulating the autonomic
functions of the body and thereby controls the blood
pressure.10 As the prehypertensive population is
increasing day by day, efforts need to be taken to
control hypertension at an early stage before starting
the drugs. Keeping this in mind, we conducted a
study in anti-hypertensive drug nave prehypertensive
patients with the objectives to observe the effects of
Pranayama on GSR. Pulse rate and blood pressure.
MATERIALS AND METHOD
This was an open labeled, prospective, uncontrolled,
single centered, single arm, comparative, clinical
intervention study conducted in the Department of
Pharmacology, Grant Govt. Medical College,
Mumbai, over a period of two months period AugustSeptember 2009 on 15 Prehypertensive subjects. The
intervention was Pranayama and the parameters
measured were Galvanic Skin Resistance (GSR),
Pulse rate and Blood pressure (BP) before and after
the intervention. The study commenced after
obtaining approval from the Institutional Ethics
Committee and written informed consent was taken
from all the subjects.
Pre-Hypertensive subjects of either sex aged between
18-50 years, who understood the study procedures
and those who were willing to co-operate and give
consent to the investigators were included in the
study. Subjects were randomly selected from the
teaching staff and postgraduate residents of
Pharmacology department. JNC VII classification

was used to label subjects as pre-hypertensive. 11
Exclusion criteria: Subjects on anti-hypertensive,
anxiolytics, anti-depressants, psychotropic drug
therapy, those consuming more than 2 units of
alcohol per day (1 unit is equal to 30 ml of hard
spirits/ 300ml of beer/ 250 ml of wine), those with
any other co-morbid conditions e.g. diabetes, asthma,
hypertension category beyond the pre-hypertension
stage as per the JNC VII and those using any other
non-pharmacological measures for stress reduction or
blood pressure control were excluded from the study.
Baseline readings for GSR, Pulse and BP were taken
on 16 channeled POLYRITE MACHINE (Model PP16, Manufacture- Medicaid System) in the
Department of Pharmacology. Polyrite machine has
the capacity to record various parameters like ECG,
EEG, EOG, EMG, ENG, Nerve conductions, PFT,
Wave over-lap facility, Pulse Analysis, Heart rate
variability analysis and identifies frequency
component of EEG signal delta, theta, alpha and beta
waves. Out of these, in our study, we have recorded
only the GSR, pulse rate and blood pressure.
All the subjects were trained under proper expert
guidance on the method of Anuloma Pranayama.
They performed breathing exercise every alternate
day for 30 minutes under observation, in the
department of pharmacology and at home on advice
for a month. Anuloma Pranayama was done by the
subjects sitting in padmasana position also called as
the lotus posture in which the individual sits cross
legged and feet are placed on opposite thighs, head
and neck relaxed, shoulders moved backwards and
the ribcage lifts, the hands rested on the knees in
Jnanamudra, in a well ventilated room and it was
ensured that they had no nasal obstruction. In the first
step subjects were asked to close their right nostril
with the thumb and to exhale the air slowly through
the left nostril, and then inhale back the air slowly
through the same nostril. Then they were asked to
close their left nostril with the ring finger and were
asked to exhale the air slowly through the right
nostril, and then inhale back the air slowly through
the same nostril. These two steps were repeated in a
cycle for 30 minutes in morning every day for a
month. Parameter such as GSR, PULSE and BP was
recorded on 15th day and 30th day of the cycle. Data
obtained on the 15th and 30th day was compared with
each other and with the pretest recordings. The data
805
Dinesh et al.,
was represented as mean and standard deviation. The

Student t test was used to determine the statistical
significance at p<0.05.
RESULTS
A total of 15 subjects who were Borderline
hypertensive / Pre-Hypertensive according to the JNC
VII Classification were enrolled in the study. Of
which 10 were male and 5 were females, all in the
age group of 22-35 yrs with BMI of 19.63 30.11
with an average of 24.80. No significant change seen
when baseline GSR reading was compared with 15th
day reading, but on 30th day significant change
observed. (Table1). When the baseline value of pulse
was compared with that of 15th and 30th day, a good
positive change was seen in resting pulse. (Table1).
Similarly BP recording also showed a good positive
effect when baseline value was compared with that
15th and 30th day. (Table1).
Table1: Effect of Pranayama on GSR, Pulse & BP
Parameter
Baseline
s
GSR
515.147.8
(kilo-ohms)
Pulse
73.80 2.5
(bpm)
Systolic BP
850.57
(mmHg)
Diastolic
BP
134.41.1
(mmHg)
A significant increase in the GSR reading was

observed on the 30th day of the study while a slight
increase was seen on the 15th day. This indicates a
significant decrease in the sympathetic tone following
daily practices of Pranayama.
Pranayama helps decrease the sympathetic tone and
simultaneously increases the parasympathetic tone by
a number of mechanisms.12, 13 It causes an increase in
the sensitivity of the baroreceptor reflex14 improves
the tissue oxygenation13 and favorably affects the
nervous system metabolism and autonomic
functions10. In contrast, a significant decrease was
seen in the baseline reading of pulse and on 15th and
30th day, which indicates a significant positive effect
of Pranayama on pulse. A significant drop in the
systolic and diastolic BP was also noted on 15th and
30th day of the study, this also shows a positive effect
of Pranayama on BP. Similar findings were seen
with other study conducted previously in
hypertensive patients. 15-16
15 th Day
30 th Day
CONCLUSION
528 40.0
*6219.2
The study concludes that practicing Pranayama on a

regular basis increases the parasympathetic tone and
blunts the sympathetic tone of body. This has shown
good beneficial effects on the Pulse, BP and GSR.
Hence Pranayama practice can be alternative to the
available non-pharmacological treatments used for
hypertension. But our study was a short span study;
whatever observation made cannot as such imply to
the larger population. Further studies on a large
number of individuals and for a long duration are
required to confirm the findings on a large scale.
Conflict of interest & Source of funding: Nil
69.4 2.6
67.1 1.8
80.21.6
78.21.3
131.31.6
128.51.4
P 0.05 Significant
Note: The results obtained on the day 15th and 30th
were compared to the baseline data.
DISCUSSION
The three parameters which we measured in our study
were GSR, Pulse and BP. GSR is the electrical
resistance offered by the skin to the passage of a
feeble electric current between two electrodes placed
on the skin of the forearm. The GSR of the skin
depends on a number of factors, the most important
being the presence or absence of sweat. Sweat
contains water and electrolytes and hence decreases
the resistance to passage of current, thereby
decreasing the GSR. An increase in the sympathetic
tone, increases sweating and thereby, decreases the
GSR.
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1. Murray CJL, Lopez AD. Mortality by cause for
eight regions of the world: Global Burden of
Disease Study. Lancet 1997; 349: 12691276.
2. Deedwania P, Gupta R. Hypertension in South
Asians.In: Izzo, Black (eds). Primer on
Hypertension. American Heart Association,
Dallas, USA, 2002.
3. Rodgers A, Lawes C, MacMahon S. Reducing
the global burden of blood pressure related
cardiovascular disease. J Hypertens 2000; 18(1):
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4. Mourya M, Mahajan AS, Singh NP, Jain AK.

The Jornal of alternative and complementary
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5. Yadav S, Boddula R, Genitta G, Bhatia V, Bansal
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north Indian population. Indian J Med Res
2008;128 :712-720
6. Cacioppo J, Tassinary L, Berntson G. Handbook
of Psychophysiology. Cambridge University
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7. W. Boucsein. Electrodermal activity. New York
and London: Plenum Press, 199
8. Handri, S, Nomura S, Kurosawa Y, Yajima K,
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Students Physiological Response Towards ELearning Courses Material by Using GSR Sensor.
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Conference on Computer and Information
Science, Yamagata, Japan, 1820 August 2010
9. Sengupta P. Health Impacts of Yoga and
Pranayama:
A
State-of-the-Art
Review.
International journalof preventive medicine
2012;3(7):444-458
10. Jerath R, Edry JW, Barnes VA, Jerath VS.
Physiology of long pranayamic breathing; neural
respiratory elements, may provide a mechanism
that explains how slow deep breathing shifts the
autonomic nervous system. Med Hypotheses
2006; 67: 566-71.
11. Chobanian AV. The seventh report of the Joint
National Committee on Prevention, Detection,
Evaluation, and Treatment of High Blood
Pressure: The JNC 7 report. JAMA 2003 May 21;
289:2560-72.
12. Bhargava R, Gogate MG, Mascarenhas JF.
Autonomic responses to breath holding and its
variations following pranayama. Indian J Physiol
Pharmacol 1988; 42: 257-64.
13. Pal GK, Velkumary S, Madanmohan. Effect of
short term practice of breathing exercises on
autonomic functions in normal human volunteers.
Indian J Med Res 2004;120: 115-21
14. Joseph CN, Porta C, Casucci G, Casiraghi N,
Maffeis M, Rossi M, et al. Slow breathing
improves arterial baroreflex sensitivity and
decreases
blood
pressure
in
essential
hypertension. Hypertension 2005; 46 : 714-8.
15. Kaushik RM, Kaushik R, Mahajan SK, Rajesh V.

Effects of mental relaxation and slow breathing in
essential hypertension. Complement Ther Med
2006; 14 : 120-6.
16. Pinheiro CH, Medeiros RA, Pinheiro DG,
Marinho Mde J. Spontaneous respiratory
modulation improves cardiovascular control in
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17. Pramanik T, Sharma HO, Mishra S, Mishra A,
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807
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DOI: 10.5958/2319-5886.2014.00005.8

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Volume 3 Issue 4
st
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
A CLINICAL STUDY OF SERUM PHOSPHATE AND MAGNESIUM IN TYPE II DIABETES

MELLITUS
*Revathi.R1, Julius Amaldas2
1
PhD Research scholar, Bharat University, 2Professor and Head, Department of Biochemistry, Balaji Dental
College
*Corresponding author email: revathi_3aug@yahoo.co.in
ABSTRACT
Objective: To assess serum phosphate and magnesium level in type-2 diabetic patients in comparison with those
of control subjects. Methodology: There were 100 diabetic patients and 100 age matched non-diabetic (control)
subjects included in this study. Serum phosphate, serum magnesium and fasting and postprandial blood sugar
measured among the diabetic and control groups using SPSS version 16.0 for analysis. Results: Serum phosphate
level was significantly lower in diabetic patients (2.92 0.75) as compared to control subjects (3.38 0.49).
Serum magnesium levels were significantly lower in diabetic patients (0.9 0.15) compared to controls (2.75
0.46) Conclusion: The study reveals that hyperglycemia may reduce serum levels of magnesium and phosphorus.
Keywords: Magnesium, phosphate, type 2 diabetes mellitus.
INTRODUCTION
Diabetes mellitus is a metabolic disorder which
affects many people in the world. Diabetes is
currently emerging as an important health problem
with a significant global burden1. Assuming that age
specific prevalence remains constant, the number of
people with diabetes in the world is expected to
approximately double between 2000 and 2030, based
solely upon demographic changes2 Accordingly, the
WHO has called the disease [the emerging
epidemic]3. Genetic and environmental factors
contribute to the pathogenesis of diabetes and acts as
a trigger for the disease among subjects at high-risk
because of inherited susceptibility. Earlier works
demonstrating the existence of glucose tolerance
factor in yeast with the identification of the active
component as trivalent chromium sparked off interest
on the status of other trace and macro elements in
health and diseases including diabetes. Direct
associations of trace macro elements with Diabetes
Revathi et al,
mellitus have been observed in many research

studies. Insulin action on reducing blood glucose was
reported to be potentiated by some trace elements as
chromium, magnesium, vanadium zinc, manganese
and phosphate. Mg depletion has a negative impact
on glucose homeostasis and insulin sensitivity in
patients with type 2 diabetes4, 5 as well as on the
evolution of complications such as, retinopathy,
thrombosis and hypertension6-8mostly age group
between 35- 60. Moreover, low serum Mg is a strong
independent predictor of the development of type 2
diabetes9Phosphorus is widely distributed element in
the human body. Diabetes mellitus may result in
whole body phosphate depletion due to osmotic
dieresis and decreased muscle mass. Therefore, the
aim of our study was to determine the serum levels of
phosphate and magnesium in diabetic patients and
control subjects and their association with age, gender
and glycemic status.
808
Int J Med Res Health Sci. 2014; 3(4): 808-812

This is a cross sectional study approach on diabetic
patients. It was conducted at the clinical chemistry
laboratory. Patients were enrolled based on the
following:
Inclusion criteria: All type 2 diabetic patients, both
genders, aged 30-65 years.
Exclusion criteria: Include past medical history of
hyperactive and hypothyroidism, current smokers,
heavy alcoholics. Chronic infection affects bone
(tuberculosis, osteomyelitis), bone tumors, chronic
renal failure, hematological disorders and connective
tissue disorders.
Study area and study population: One hundred
diabetic patients (50 males, 50 females), aged 30-65
years; and other 100 healthy subjects (matched for
age and sex), were included in the study. All subjects
Signed informed consent and filled questionnaires.
The study was approved by the ethical committee of
the faculty. Duration of the study is around 6 months.
Methodology: Blood samples were collected after a
twelve hour fasting period (Overnight fasting) under
aseptic. Conditions, the obtained blood sample were
centrifuged and plasma was separated. The plasma
was analyzed for the fasting and postprandial blood
sugar, estimated by GOD-POD method10.Serum
samples were separated from whole blood collected
into tubes without anticoagulant, after clotting was
complete, the tubes were then centrifuged at 2700g
for 10 minutes. Serum was removed and assayed for
magnesium and phosphorus. Taussky, H.H., and
Shorr, E.: a micro colorimetric method for the
Determination of Inorganic Phosphorus11. Gindler,
E.M. and D.A. Heth, a Colorimetric determination
with bound calmagite of magnesium in human blood
serum12.
Statistical analysis: Students t-test was performed
to analyze the difference in means between groups. P
value was considered significant when it is less than
or equal 0.001.
RESULT
Table1: Blood sugar levels
Blood sugar
variables
FBS(mg/dl)
PLBS(mg/dl)
Revathi et al,
Levels
Controls
Cases
<110
>110
<130
>130
100
0
100
0
38
62
14
86
P Value
<0.001
<0.001
The FBS and PLBS values of controls and cases are

shown in table1. In which 100% controls had <110
mg/dl. Whereas in case of diabetics 38% of them
showed < 110mg/dl and 62% of them showed
>110mg/dl. There is an increase in FBS values of
patients as compared to controls as statistically
significant (p<0.001). In case of PLBS 14% of them
showed <130 and 86% of them showed >130 mg/dl.
There is an increase in PPBS values of patients as
compared to controls as statistically significant
(p<0.001).
Table 2: Levels of serum phosphorus
Serum
Control
Cases
phosphorus
Decreased
0
62
(<2.5mg/dl)
Normal
(2.5- 100
38
4.5mg/dl)
Increased
0
0
(>4.5mg/dl)
Total
100
100
Inference
62% of patient had the serum
phosphorus is decreased in
cases with P<0.001
Serum phosphorus levels of controls and cases were
shown in table 2. 100% of controls showed a normal
serum phosphorus level in the range of 2.5-4.5 mg/dl
and in diabetic cases 62% showed decreased levels
than the normal range, i.e. <2.5mg/dl and the
remaining 38% of them were in normal range.
Serum magnesium levels of controls and cases were
shown in table 2.100% of controls showed normal
serum magnesium level in the range of 1.0-3.5/dl
mg/dl and in diabetic cases 56% showed decreased
levels than the normal range, i.e. <1.0 mg/dl and the
remaining 44% of them were in normal range (table:
3)
Table 3: Levels of serum magnesium
Serum
Control
Cases
magnesium
Decreased
0
56
(<1.0mg/dl)
Normal (1.0- 100
44
3.5mg/dl)
Increased
0
0
(>3.5mg/dl)
Total
100
100
Inference
56% of patient had the serum
magnesium is decreased in cases
with p<0.001
809
Table 4: Levels of FBS, PLBS, Serum phosphorus

and Serum magnesium
Biochemical
P
parameters
Controls Cases
value
FBS (mg/dl)
89.749.82 155.586.6
<0.001
PLBS (mg/dl)
112.32.65 245.2112.5
<0.001
Serum phosphorus 3.38 0.49 2.90.75

(mg/dl)
Serum
2.15 0.46 0.9 0.1
magnesium(mg/dl)
<0.001
<0.001
Levels of FBS, PPBS are significantly increased

compared to normal and serum phosphorus and
serum magnesium significantly decreased compared
to normal subjects
DISCUSSION
Diabetes mellitus is the most common chronic

metabolic disorder with high rate of morbidity
characterized by the impaired metabolism of
glucose and other energy yielding fuels as well
as by the late development of vascular and
neuropathic complications. Diabetes comprises a
group of disorders involving distinct pathogenic
mechanisms, for which hyperglycemia is the
common denominator. Hyperglycemia role in
turn plays an important role in disease related
complications. Like accelerated atherosclerosis,
retinopathy, nephropathy, neuropathy and
diabetic foot. In our study, we took 100 cases of
diabetes mellitus compared with 100 healthy
controls FBS, PPBS, serum magnesium and
serum phosphorus were estimated in the above
groups.
Blood Glucose: Blood glucose is the principal sugar
of mammalian blood. It normally amounts to 65110mgldl (FBS) and up to 160 mg/dl (PPBS) after a
high carbohydrate meal is a normal range. In general
repeated FBS levels > 126 mg/dl and PLBS > 200
mg/dl or higher are suggestive of diabetes. Diabetes
who are under control exhibit a wide variations in
their plasma glucose concentrations The diagnosis of
diabetes on the measurement of plasma glucose level
In our study the FBS values of the patient was
155.56, 86.67 mg/dl well above the American
diabetes association (ADA) criteria to diagnose
diabetes and the PLBS which was higher than upper
limit 245.28, 112.53 whereas control group had blood
glucose values as 89.74 9.82 and 112.32 12.65 for
FBS and PPBS respectively suggestive of

normoglycemia. These values correlate well with
clinical diagnosis.
Serum Phosphorus: Serum phosphorus is widely
distributed element in the human body. It is present in
both organic and inorganic forms, but only inorganic
phosphorus is measured. Inorganic phosphorus in the
form of hydroxy apatite (in bone) plays an important
role in structural support of the body and also
provides phosphate for intracellular and extracellular
fluid. Intracellular phosphate is also a component of
nucleotide derivatives such as NADP, ATP, GTP etc.,
is involved in nucleic acid structure, formation and
also in regulation of intermediately metabolism of
proteins, carbohydrates, fats, gene transcription and
cell growth. It also has a significant role as a body
buffer mechanism. Many studies have found
decreased in the concentration of phosphate in poorly
regulated diabetic patients and the level increases
when blood glucose is controlled. Gartner et al13in
their study in juvenile onset of diabetic patients found
that as plasma glucose decreased from 221 mg/dl to
95.5 mg/dl, serum inorganic phosphorus 4.9-5 mg/dl
In our studies, diabetes mellitus patients, showed a
decrease in serum phosphorus level 14 P<0.001.This is
in concordance with a study done by E. I. ugwuja.
Serum Magnesium: Mg is mainly an intracellular
cation, with less than 1% of total body content
present in the extracellular fluids. The Mg
concentration in serum represents not more than 0.3%
of total body Mg14. Nevertheless, serum or plasma
Mg measurement is the most readily available and
widely used test of Mg status. In human studies,
instituting a diet low in Mg produces a predictable
decline in serum Mg 15, 16, 17. However, there are a
number of reports of low Mg values in various blood
cells and tissues associated with normal
serum/plasma Mg concentrations 18. It appears,
therefore that plasma Mg concentration is an
insensitive, but a highly specific indicator of low Mg
status. Of the total Mg in serum, around 55% is
present as free ionized Mg2+, 15% are complexed to
anions (e.g. Bicarbonate, citrate and sulfate) and 30%
are bound to proteins, mainly albumin 19. It could
therefore be argued that in diabetics with
microalbuminuria, serum Mg might be reduced
because of lower serum albumin concentration.
Pickup etal20 found no difference in serum Mg
concentration between type 1 diabetics with
810
Revathi et al,
microalbuminuria or clinical proteinuria compared to

diabetics with normal albumin excretion. In contrast,
Corsonello et al., 21 demonstrated significantly lower
ionised serum Mg in type 2 diabetic patients with
microalbuminuria or clinical proteinuria. Similar to
findings from other countries in Europe and North
America, the mean plasma Mg concentration of the
type 2 diabetics was significantly lower than in
controls. The striking finding in our study was the
high prevalence of low plasma Mg concentrations
among the diabetic subjects. Serum Mg
concentrations of 44% of the diabetics were below
the reference range, a prevalence of low magnesium
status that is similar to that reported in type 2
diabetics in outpatient clinics in the US .
6.
7.
8.
9.
CONCLUSION
Our findings suggest that low magnesium status and
phosphorus in type 2 diabetes mellitus. Phosphorus
and magnesium depletion may increase the risk of
secondary complications, preventing low magnesium
and phosphorus status in diabetes may therefore be
beneficial in the management of the disease.
10.
11.
ACKNOWLEDGEMENT
The research for this study was supported by Karpaga
Vinayaga
Institute
of
Medical
Science,
Madhuranthagam.
Conflict of Interest: Nil
12.
13.
REFERENCES
1. Awad Mohamed Ahmed, Nada Hassan Ahmed.
Diabetes Mellitus in Sudan, Practical Diabetes Int
2001; 18(9):324-327.
2. Sarah Wild, Gojka Roglic, Anders Green,
Richard Sicree, Hilary King. GlobalPrevalence
of Diabetes, Diabetes Care; 2004: 279(5); 104753.
3. Ahmed AM, A Brief history of Diabetes Mellitus,
Saudi Med.J. 2002; 23: in press.
4. Durlach J, Rayssiguier Y. Donnes nouvelles sur
les relations entre magnsiumet hydrates de
carboneI. Donnes physiologiques. Magnesium
1983; 2: 174-91.
5. Nadler JL, Buchanan T, Natarajan R, Antonipillai
I, BergmanR, Rude R. Magnesium deficiency
produces insulin
resistance and
increased
14.
15.
16.
thromboxane synthesis. Hypertension 1993;

21:10249
Mather HM, Levin GE, Nisbet JA. Hypo
magnesemia and ischemic-heart-disease in
diabetes. Diabetes Care 1982; 5:4523.
McNair P, Christiansen C, Madsbad S, Lauritzen
E, Faber O, Binder C, et al. Hypomagnesemia, a
risk factor in diabetic retinopathy. Diabetes 1978;
27:10757.
Nadler JL, Malayan S, Luong H, Shaw S,
Natarajan RD, Rude RK. Intracellular free
magnesium deficiency plays a key role in
increased platelet reactivity in type II diabetes
mellitus. Diabetes Care 1992; 15:83541.
Kao WH, Folsom AR, Nieto FJ, Mo JP, Watson
RL, Brancati FL. Serum and dietary magnesium
and the risk for type 2 diabetes mellitus: the
Atherosclerosis Risk in Communities Study.
Arch Intern Med 1999; 159:21519.
Carl A. Burtis, Edward R. Ash wood, Estimation
of glucose by glucose oxidase method.Tietz.,
Text book of clinical chemistry.1994;24:778-780
Taussky HH, Shorr E. A Microcolorimetric
Method for the Determination of Inorganic
Phosphorus Biol. Chem. 1953; 202: 675-85
Gindler, E.M. and D.A. Heth, Colorimetric
determination with bound calmagite of
magnesium
in
human
blood
serum.
Clin.Chem.1971; 17: 662-664.
Gertner JM, Tamborlane WV, Horst RL. Mineral
metabolism in diabetes mellitus: changes
accompanying treatment with a portable
subcutaneous insulin infusion system. Journal of
clinical endocrinology and metabolism, 1980; 5
(5)862-66.
Ugwuja E, N Eze. A Comparative Study of
Serum Electrolytes, Total Protein, Calcium and
Phosphate among
Diabetic and HIV/AIDS
Patients in Abakaliki, South eastern, Nigeria. The
Internet Journal of Laboratory Medicine 2006;
3(2): 1.
Shils ME.Magnesium. In: Shils ME, Olson JE,
Shike M, Ross AC, eds. Modern nutrition in
health & disease. 9th ed. Baltimore: Williams &
Wilkins, 1998; 1: 16992.
Lukaski HC, Nielsen FH. Dietary magnesium
depletion affects metabolic responses during
submaximal exercise in postmenopausal women.
J Nutr 2002; 132: 9305.
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17. Rude RK, Stephen A, Nadler J. Determination of

red blood cell intracellular free magnesium by
nuclear magnetic resonance as an assessment of
magnesium depletion. Magnes Trace Elem 1991;
10:11721.
18. Shils ME. Experimental human magnesium
depletion. Medicine (Baltimore) 1969; (48):61
85.
19. Rude RK. Magnesium deficiency: a cause of
heterogeneous disease in humans. J Bone Miner
Res 1998; 13 :74958.
20. Pickup JC, Chusney GD, Crook MA, Viberti GC.
Hypo magnesaemia in IDDM patients with
microalbuminuria and clinical proteinuria.
Diabetologia 1994; 37:39.
21. Corsonello A, Ientile R, Buemi M, Cucinotta D,
Mauro VN, Macaione S, et al. Serum ionized
magnesium levels in type 2 diabetic patients with
microalbuminuria or clinical proteinuria. Am J
Nephrol 2000;20:18792
812
Revathi et al,
DOI: 10.5958/2319-5886.2014.00006.X

&
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Volume 3 Issue 4
st
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
IMPACT OF MATERNAL RISK FACTORS ON THE INCIDENCE OF LOW BIRTH WEIGHT

NEONATES IN SOUTHERN INDIA
U.N.Reddy1, VamshiPriya2, SwathiChacham3, SanaSalimKhan4, J Narsing Rao5, *Mohd Nasir Mohiuddin6
1
Professor and Head, 2Senior Resident, 3DM Neonatology, Assistant Professor, 4Junior Resident, 5Professor,
Department of Pediatrics Princess Esra Hospital, Deccan College of Medical sciences, Hyderabad, India,
6
pharm D, clinical pharmacist, Dept of Pediatrics, Princess esra Hospital, Deccan School of Pharmacy, Hyderabad
*Corresponding author email: muhammed_nasser7788@yahoo.com,
ABSTRACT
Introduction: Birth weight is recommended as one of the twelve global indicators for monitoring the health of
the community and is an important determinant of adverse perinatal and neonatal events. LBW infant carries five
times higher risk of dying in the neonatal period and three times more in infancy. Aims and Objectives: To
estimate the incidence of LBW and impact of various maternal and biosocial factors on the incidence of LBW
neonates in the study population. Material and methods: This prospective observational study was carried out in
Princess Esra hospital, a tertiary care hospital in south India, over a period of six months. All consecutive LBW
(single ton) neonates admitted to the neonatal intensive care unit were enrolled, while those born of multiple
gestation and those with major congenital malformations were excluded. Results: A total of 300 neonates were
included in the present study out of which 150 were LBW and 150 weighed 2500 gm. Higher maternal weight
(>60kgs) had low incidence of LBW neonates (p value-0.03). Illiterate women had a remarkably higher incidence
of LBW babies (p value-0.001). In primigravida incidence of LBW was 61.2%. Higher incidence of LBW was
seen in mothers with oligo hydramnios. Conclusions: This study showed that maternal age, weight, literacy level
and parity have a significant influence on the incidence of LBW. Incidence of LBW neonate in the study was
50%. Risk of having LBW neonates was higher in primigravida. There was a significant association between
LBW with oligo hydramnios and female gender.
Key words: Low Birth Weight, Neonate, Maternal weight, Age, Parity.
INTRODUCTION
The essential newborn care has been a challenge to
the pediatrician, more so the care of low birth weight
neonates. Birth weight is the single most important
marker of adverse perinatal and neonatal events.
Low birth weight (LBW) is defined by WHO as
birth weight <2500gms irrespective of gestation13.
Recognizing the importance of birth weight
measurements 34th world health assembly in 1981
recommended it to be one of the twelve global
indicators for monitoring health of the community1,

2
. Low birth weight accounts for 70% of all perinatal
and 50 % all infantile deaths. A low birth weight
infant carries five times higher risk of dying in the
neonatal period and 3 times more in
infancy3.According to WHO global estimates, out of
25 million low birth weight neonates born each year,
which consisted 70% of all live births nearly 95% of
them are found to be in developing countries of
813
U.N Reddy et al,
which 26% of all the live births in india4.Birth weight

is governed by two major processes; duration of
gestation and intrauterine growth rate. Thus LBW is
caused either by premature delivery or retarded
intrauterine growth (or a combination of both).
Prematurity is usually defined as a gestational age
less than 37 weeks. The causes of LBW are
multifactorial and the birth weight is determined by
the interaction of the both socio-demographic and
biological factors. 5Many socio-biological factors
have been postulated to determine the birth weight of
the newborn. The causes are classified into three
broad categories. Firstly, maternal causes in which
maternal
age,
weight,
height,
education,
socioeconomic status, ethnic differences, parity, birth
spacing and dietary intake are the factors. Secondly,
placental causes that includes: Fetoplacental and
uteroplacental insufficiency. Lastly, Fetal causes:
Normal Small Fetuses, fetal infection and fetal
abnormalities. Other factors that might have an
impact on the incidence of LBW are antenatal care,
maternal smoking, hard manual labor, genetic factors,
and sex of the neonate. The effect of these factors has
been shown to be dependent on the geographic location
of study6.
(singleton) neonates admitted to the neonatal

intensive care unit were enrolled, while those born
of multiple gestation and those with major
congenital malformations were excluded.And
Gestational age was assessed from last menstrual
period of the mother and by using new Ballard
scores in the neonate. Kuppuswamys scale7 was
used to assess the socioeconomic status of the
mother. All consecutive low birth weight (singleton)
neonates admitted in the neonatal intensive care unit
were enrolled, while those born of multiple gestation
and those with major congenital malformations were
excluded. This study involved the procedures which
were very simple, using the instrument available in
the hospital which did not cause any undue distress
to the babies or mothers. Moreover, all the
investigations were necessary. However a verbal
consent was obtained from institutional ethics
committee as well as from the enrolled subjects.
Data analysis: Epi info 2000 and SPSS version
10software were used to obtain the statistical results.
Odds ratio, with confidential interval for various risk
factors of LBW were done. Chi square test was used
for calculating P value and was considered significant
if < 0.05.
MATERIAL AND METHODS
RESULTS
The current study was a Hospital based prospective

observational study carried in Dept. of pediatrics in
princess esra hospital, Deccan College of medical
sciences, Hyderabad, Andhra Pradesh, India, over a
period of six months. A total of 300 neonates were
included in the present study, out of which 150 were
LBW and 150 weighed 2500gms. All relevant
maternal and neonatal data was documented on a
predesigned and pretested structured Performa.
Maternal details like maternal age, height, weight,
parity, consanguinity and maternal hemoglobin were
recorded after obtaining informed consent from the
parents. Demographic details like maternal
occupation, education, socioeconomic status,
community and paternal age were noted. Numbers of
antenatal checkups as well as antenatal
complications were documented. Delivery details
and neonatal details such as mode of delivery,
gender of the neonate, birth weight and gestational
age were documented. All consecutive LBW
During this observational study, a total of 300

neonates were included out of which 150 were LBW
and 150 weighed 2500 grams. Incidence of LBW
was 50 %. Maternal age ranged from 13 to 35 years
and was classified into 3 groups as <20 years, 20-29
years and >30 years.
Mothers in the age group of 20-29 had given birth to
babies with birth weight >2500 grams, which was
statistically significant as shown in (fig 1). This
group was further divided into two age groups of 2024 and 25-29 years. In this division statistical
significance was found in maternal age group of 2529 years (p-value: 0.028). Higher maternal weight
had higher birth weights which showed statistical
significance (p-value: 0.03). The P value was
significant in mothers weighing >60 kg (fig 2).
However, maternal height did not influence the
incidence of low birth babies.
814
U.N Reddy et al,
a higher incidence of LBW babies which had

statistical significance.
83.2%
73.3%
< 20
20-29
19.3%
12.6%
7.3%
< 2500 gms
4%
> 30
2500 gms
number of subjects
frequency
140
120
100
80
60
40
20
0
neonate birth weight
60
58
57 56
45
48
44
illiterates
40
primary
education
20
0
secondary
and above
< 2500 gms 2500 gms
Fig 1: Correlation between maternal age and

neonate birth weight.
39.3%
60
38% 39.3%
40
22.6%
12.6%
20
< 50
51-60
> 60
0
< 2500 gms
2500 gms
neonate birth weight
Fig 2: Influence of maternal weight on neonate

birth weight.
Lower birth weights were seen in neonates of manual
laborers with an incidence of 65.3%which had a trend
towards statistical significance (p-value: 0.07).
Working women with professional occupation had
significantly higher number of normal birth weight
babies.
150
86%
86%
100
50
house wife
labourer
11.3%
2.6%
6% 8%
< 2500 gms
2500 gms
others
Fig 3: Impact of maternal occupation on neonate

birth weight.
Maternal education ranged from illiteracy to
graduation. Maternal education was divided into three
groups as illiterates, primary education, and
secondary education and above. Illiterate women had
Fig4: Educational status of mother and its

influence on neonate birth weight.
The mothers in this study were divided into four
classes according to Kuppu swami scale taking into
consideration of maternal education, occupation and
family income6. Most of the mothers were in socio
economic class III. There was a higher incidence of
LBW in class IV though there was no statistical
significance. As the socioeconomic status improved
the birth weights increased. Parity ranged from 1-5
and was classified into three groups as Primigravida,
Multigravida and Grand Multi. There was a higher
incidence of LBW in primigravidas (p-value: 0.003).
120
100
80
60
40
20
0
56.8%
43.2%
61.2%
primi
38.8%
multi
66.6%
33.3%
< 2500 gms
2500 gms
neonate
birth
weight
48%
frequency
frequency
80
grand
multi
Fig 5: Parity distribution in neonate birth weight

As the parity increased incidence of LBW decreased.
In primigravidas the incidence of LBW was 61.2%.
Whereas in Multigravida the incidence was 43.2 %,
which was significant statistically (p-value: 0.006).
Higher incidence of LBW was seen with oligo
hydramnios during pregnancy. Out of 21 mothers
with oligohydramnios, 18 had LBW neonates
(18/21=86%). This was statistically significant with a
p value-0.001. Odds ratio was 6.7. As the study was
done in a tertiary level, all the modes of delivery were
noted. Cesarean included both emergency and
815
U.N Reddy et al,
elective. Vaginal deliveries included spontaneous,

episiotomy and forceps deliveries. A higher incidence
of LBW was seen in caesarean section delivery
compared to vaginal mode. Among 168 caesarean
section, 41.6% were low birth babies and among 132
vaginal deliveries 60.6% were low birth weights
which showed statistical significance (p-value:
0.001). Male babies were higher in number compared
to female babies in this study. Among male babies
45.1 % were LBW and among female babies 55.9 %
were LBW. There was a trend towards a lower
incidence of LBW in male babies (p-value: 0.08).
Number of antenatal checkups ranged from 0-12.
Mothers were classified into three groups- who did
not have any antenatal checkups, who had 1-3 ante
natal checkups and those with 4 checkups and above.
Among the mothers who did not have any antenatal
checkups the incidence of LBW was 48.6%. Among
those who had more than 4 checkups the incidence
was 48.6 %. There was no statistical significance
between number of checkups and birth weight. The
difference between 4 or more antenatal checkups and
those who did not have any checkups was nearly
insignificant. There was no correlation between birth
weight and paternal age. No association was noted for
consanguinity with birth weight.
DISCUSSION
LBW is one of the most serious challenges in
maternal and child health, especially in developing
countries like India. LBW neonates are at risk of
both short term (immediate) neonatal morbidity as
well as long term neonatal morbidities. Short term
neonatal
complications
include
metabolic
derangements like hypoglycemia, hypocalcaemia,
hypomagnesaemia
and
infection
related
consequences like meningitis, bone and joint
infections. Long term consequences like cerebral
palsy, hearing deficits and ocular abnormalities are
also highly prevalent in LBW neonates8. These
LBW neonates are at high risk of mortality due to
anatomical and functional immaturity of various
body organs. The present prospective study was
undertaken to estimate the incidence and
determinants of LBW, as majority of the published
studies were retrospective in nature. Maternal age
had a significant influence on the incidence of LBW
in the current study. Mothers aged between 20-29

years gave birth to neonates with normal birth
weight. Subgroup analysis showed a significantly
lower incidence of LBW neonates among mothers
aged between 25-29 years. This study was similar to
a study done by K.D as and Ganguly et al where the
higher birth weight of neonates was found in
mothers aged 25-29 years9. Similarly maternal
weight and neonatal birth weight showed a positive
relationship on linear regression analysis. As the
weight of the mother increased the birth weight of
the babies increased. These findings were similar to
a study done by Sushma Malik et.al.3Maternal height
and fathers age did not have any influence on the
neonatal birth weight in our study. Mothers who
were manual labors had higher incidence of LBW
neonates. This was similar to the study by Saroj
Pachauri and Marwah et al 6, 10. Illiterate mothers had
significantly higher incidence of LBW neonates,
Illiteracy is usually associated with poverty and
maternal malnutrition, hence may be associated with
higher incidence of low birth weight neonates. This
was supported by the study carried out by
SarojPachauri and S. M. Marwah et. al6, 10. However,
on linear regression analysis, a higher
socioeconomic status was associated with a lesser
incidence of low birth weight. This was similar to a
study done by N. Sreekumaram Nairetal11.
Statistically, there was no association between
neonatal birth weight and community and also there
was
no
significant
association
between
consanguinity, number of antenatal checkups and
low birth weight. This shows that the number of
antenatal checkups is not the only criteria, but also
the quality of antenatal care. There was a significant
association between parity and Birth weight. A
Multiparous woman is likely to have neonates with
higher birth weights. With successive pregnancy,
neonatal birth weight increases till 4th pregnancy.
Studies done by SushmaMalik3, D.K. Mukherjee et
al and N.J. Sethna et.al12also showed similar results.
In this study, mothers with systemic diseases and
obstetric complications were also included. Subjects
with systemic diseases were less and did not impart
any significance. However, patients presented with
obstetric complications like pregnancy induced
hypertension (PIH), oligo hydramnios, ante partum
816
U.N Reddy et al,
hemorrhage (abruption and placenta pravia) and

premature rupture of membranes showed significant
influence on the incidence of LBW. Out of 21
mothers with oligohydramnios, 18 had LBW
neonates (18/21=86%). This was statistically
significant with a p value-0.001, of LBW babies.
The incidence of LBW neonates was 80% with
maternal ante partum hemorrhage (APH), 66% with
maternal premature rupture of membranes and 59%
with maternal pregnancy induced hypertension PIH.
However, it was not statistically significant.
According to WHO, hemoglobin<11 gm % is
considered as anemia during pregnancy. In India Hb
< 10gm % is considered as anemia in pregnancy11.
Taking this into consideration, 18 % of the mothers
were anemic. There was no significant association
between maternal hemoglobin percentages with
neonatal birth weight. On statistical analysis a
significant association was found between birth
weight and mode of delivery, with statistically
significant value in the caesarean group. As majority
of the mothers with antenatal complications
underwent caesarean section and gave birth to LBW
babies, caesarean section was associated with a
higher incidence of LBW. Male neonates had higher
birth weights when compared to female neonates
and hence lower incidence of LBW babies, which
was similar to a study done by Makhija k and
Murthy et al 6.13. As male fetuses grow faster than
female fetuses, the incidence of LBW is lower in
male fetuses.
CONCLUSION
This prospective study was conducted to determine
the impact of various maternal and bio social factors
on the incidence of low birth neonates. There was a
remarkable relation between maternal weight, age,
parity and neonatal birth weight. Neonatal birth
weight is positively influenced by maternal weight
and parity. Maternal age between 20-29 years was
significantly associated with normal neonatal birth
weight. Mothers who were manual laborers had
higher incidence of low birth weight babies. Risk of
LBW was higher in primigravida. There was a
significant association between LBW and
oligohydramnios. Female neonates were more prone
to low birth weight than male babies as male fetuses
grow faster than female fetuses, the incidence of

LBW is higher in female fetuses. Paradoxically the
number of antenatal checkups did not have any
significant influence on the neonatal birth weight.
Maternal height, education, socioeconomic class,
paternal age, community and consanguinity also did
not have any significant impact on the neonatal birth
weight in the current study.
Strengths & limitations: This study being a
prospective observational study has the advantages of
any prospective study.
ACKNOWLEDGMENTS
We wish to express our heart full thanks and deep
sense of gratitude to the parents of the neonates who
helped throughout the study period and the nursing staff
whose contribution is invaluable.
We are also thankful to all our family members for their
encouragement.
Conflict of interest: Authors declare no conflict of
interest in with regard to this article.
REFERENCES
1. Kumar V, Datta N. Birth weight as an indicator of
health. Indian j Pediatr. 1984; 21(2):11318.
2. Briggs ND. Life depends on birth weight- The
second John Bateman Lawson memorial oration;
Trop. J Obstet. Gynecol. 2004;21(1):71-77
3. Sushma Malik, Radha G. Ghidiyal, RekhaUdani&
Prasad Waingankar. Maternal Biosocial Factors
Affecting Low Birth Weight. Indian J Pediatr
1997; 64:373-77.
4. Prof Pravati Tripathy. Clinical characteristics&
morbidity pattern among low birth weight babies.
International J of Sc Res Pub (IJSRP), 2014;
4(4):1-4. ISSN 2250-3153
5. Mondal B. Risk factor for low birth weight in
Nepali infants. Indian J Pediatr. 2000; 67(7): 47782
6. Makhija K, Murthy GVS, Kapoor SK, Lobo J.
Socio-biological determinants of birth weights.
Indian J Pediatr.1989; 56(5):639-43.
7. Sharma R. Kuppuswamys socio-economic status
scale revision for 2011 and formula for real time
updating. Indian J Pediatr 2012; 79(7):961-2.
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8. Al-saley E, Di Renzo GC. Actions needed to

improve maternal health. Int J Gynecology
Obstetric 2009; 106(2):115-19
9. Das K, Ganguly SS, Saha R, Ghosh BN Inter
relationship of birth weight with certain
biological & socio-economic factors. Ind J public
health. 1981; 25 (1): 11-9.
10. Sreekumaram Nair N, Phanea rao RS, Shalini
Chandrashekara Das Acharya, H. Vinod Bhat.
Sociodemographic and maternal determinants of
low birth weights: A Multivariate approach
Indian J Pediatr2000; 167(1): 9-14
11. Saroj Pachauri and S.M. Marwah.Socio economic
factors in relation to birth weight. Indian pediatr.
Aug 1970; 7(8): 462-70
12. Mukherjee Dk, Sethna NJ. Birth weight and its
relationship with certain maternal factors. Indian J
Pediatr 1970; 37(9): 460-64
13. Makhija K. Murthy GV. Sociobiological factors
influencing low birth weight a rural project
hospital.J Ind Med Assoc, SeptemberOctober
1989, 5 (56):639-43.
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DOI: 10.5958/2319-5886.2014.00007.1

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
nd
Received:22 Jun 2014
Research article
Coden: IJMRHS
Revised: 18th Aug 2014
Copyright @2014
ISSN: 2319-5886
IMPACT OF CLINICAL PLACEMENT ON RADIOGRAPHY STUDENTS IN GHANA

*Kyei KA1, Addo Bruce M2, Antwi WK1, David NA1
1
College of Health Sciences School of Allied Health, University of Ghana

AddoNational Centre for Radiotherapy Korle-Bu Teaching Hospital
3
College of Health Sciences School of Allied Health, University of Ghana
2
*Corresponding author email: adesco41@hotmail.com

ABSTRACT
Background: The clinical setting is one of the most valuable resources available to training institutions to prepare
students to competently care for patients and also execute certain tasks with little or no supervision. Aim: To
examine the impact of clinical placement on radiography students clinical experience. Methodology: A
quantitative study design using a Likert-Scale questionnaire was used to assess clinical practice-learning
environment. Data was analyzed using the Statistical Package for the Social Sciences Version 14.0 (SPSS). Forty
seven (47) undergraduate student radiographers participated in the study. Results: Students indicated they had
adequate knowledge and enjoyed their time on the clinical placement. They indicated that the staffs were
supportive, friendly and approachable. The students were also able to achieve their learning outcome during
placement, however feedbacks from supervisors, according to the students were inadequate and students were not
sure about the use of research findings by the clinical venues. Conclusion: Clinical placement had adequate
student support. It is important, however, to consider carefully where students have their clinical practice and at
what point of their studies the different placements should be carried out. A collaboration between the key
stakeholders is essential to ensure that students have a good experience at clinical placement.
Keywords: Radiography, Clinical experience, Radiography students, Educational support, Practitioner
INTRODUCTION
Clinical placement describes the practice of assisting
a student to acquire the required knowledge, skills
and attitudes in practical settings (such as health
service clinics, field work sites to meet the standards
defined by a university degree structure or
professional accrediting or licensing board 1. Clinical
placements form a significant component of the
training of radiographers in Ghana. It provides
opportunities for students to learn experientially, and
encourages them to actively learn from their
individual experiences2.
In the field of radiography, clinical education activity
is usually contained within undergraduate or
graduate-entry degree programmes. It frequently
involves students leaving the confines of the

university and undertaking practical patient or client
activities in a health or welfare and educational
setting with the educational support of a qualified
practitioner who is employed by the service or
agency1.
Sudgen3, asserts that clinical placement is course
work involving hands-on, direct care or service
experience and evaluation of the students skills,
variously referred to as clinical rotation, practicum or
internship. It is the mission of all tertiary institutions
to strive to provide quality education to all graduates4.
This however is provided both in the classroom and
in a clinical setting at the study site.
819
Kyei et al.,
The purpose and mission of every trained

radiographer is to promote high standards of patient
care and to practice with little or no supervision and
for that matter clinical placement play a role in the
preparation of students for practice in Ghana.
Due to the diversity and specification existing in the
radiography profession, there is the need for the
radiographer to develop the core knowledge and skill
in their practice. Job requirement and responsibilities
of a radiographer vary from every clinical room and
other practice sites, hence students need to equip
themselves to be able to integrate into any practice
setting5.
Aim Of the study
To examine the impact of clinical placement location
on radiography students experience.
Objectives of the study
The specific objectives of the study were
To evaluate students clinical supervision,
evaluation, confidence and assessment as carried
out during clinical placement.
To identify areas of strengths and/or limitations
of clinical placement venues.
To identify factors that contribute to a positive
clinical experience.
METHODOLOGY
Approval for the study was obtained from the
research ethics committee of a higher education
institution. The ethics approval was supported by
written permission for the study to be conducted at
the study site. All study participants gave informed
consent prior to the commencement of the study
The study design was a descriptive survey using
quantitative methods. All students undertaking
radiography course students within their third and
fourth year (N=47) were enrolled and recruited at
the time of the study. A convenience sampling using
a non - probability method was used to select
participants between six weeks in their clinical
rotation.
A self-structured questionnaire comprising closed
ended questions was employed to collect data for the
study. The questionnaire consisted of sociodemographic characteristics (1-5), relevance of
clinical placement; clinical duration and Likert-scale
statements with five response options rating from A
(strongly agree) to E (strongly disagree) that
addressed three main areas of placement: assessment
of practice, practice learning environment, and

student support.
Data was analyzed using SPSS version 14. For sociodemographic categorical data (e.g. age group, sex),
summary tables of counts and percentage were
presented with respect to these characteristics using
Pearsons chi-square tests to test for association.
Descriptive statistics involving tables of means,
standard deviations and inferential statistics were
employed as and when appropriate to describe the
data. Apart from reporting, mean and standard
deviation of scores, Pearsons chi squared test was
used to compare responses of different year groups in
the university and individuals in the same year group
at 0.05 level of significance. In some cases, graphical
presentations were provided to highlight the level of
differences. All statistical tests were declared
significant for p-value <0.05.
RESULTS
In all, 47 participants were enrolled in the study,
consisting of 28 males and 19 females. All
respondents returned their questionnaire, indicating a
100% outcome. Only 8.5% of the total population
were married. Almost 85% of the participants
indicated that staffs at various clinical rooms were
supportive to them during their clinical rotation. An
age group of 18 22 recorded the highest number of
respondents (44.7%) whiles 32+ recorded the lowest
number of respondents (4.3%). Almost all the
students (97.9) agree to the fact that clinical
placement was important. 74.5% of the students learn
through active experimentation. Students who also
learn best by reflective observation were 19.1%
(Table 1).
Thirty-one (66%) of the participants agreed that staff
were very supportive during their clinical rotation,
but three (6%) strongly disagreed with that. More
than half of the students (61.7%) concurred that the
clinical assessors were prepared for their role
recording response (Figure 2). Sixty-six percent of
students consented that the placement were
supportive to their profession whereas 68% indicated
that the practice experience and supervision offered
were appropriate to their level of competence. 53% of
the participants also indicated that supervision were
adequate. 81% of the participants indicated that staffs
were friendly and approachable.
820
Kyei et al.,
Table 3: Students received support from their

clinical supervisors (n=47).
30
25
21
17
Responses
strongly agree
Agree
not sure
disagree
Total
20
15
10
5
0
-5
18-22
23-27
28-32
32+
Frequency
6
25
10
6
47
Percent (%)
12.8
53.2
21.3
12.8
100
Table 4: The placement was supportive to my

professional growth (n=47).
Frequency
Fig 1: Age group distributions of respondents (n=47).
30
23
20
10
0
strongly agree not sure disagree strongly
agree
disagree
Frequency
Fig2: Clinical assessors were prepared for their role

(n=47).
Table 1: Students learning ability in the clinical
room (n=47).
Modes of learning in
clinical room
learn best by reflective
observation
learn through active
experimentation
learn through concrete
ideas
learn through abstract
ideas
none of the above
Total
Freque
ncy
Percent
(%)
19.1
35
74.5
2.1
2.1
1
47
2.2
100
Table 2: The staffs were supportive (n=47).

Responses
strongly agree
agree
not sure
Disagree
Total
Frequency
9
31
5
2
47
Percent (%)
19.1
66.0
10.6
4.3
100
10
-10
Responses
strongly agree
Agree
not sure
Disagree
Total
Frequency
9
31
4
3
47
Percent (%)
19.1
66.0
8.5
6.4
100
Table 5: The practice experience and supervision were

appropriate to my level of competence (n=47).
Responses
Frequency
Percent (%)
strongly agree
8
17.0
Agree
24
51.1
not sure
11
23.4
Disagree
3
6.4
strongly disagree
1
2.1
Total
47
100.0
Table 6: Orientation by clinical supervisor was
adequate (n=47).
Frequency
Percent(%)
Responses
strongly agree
Agree
not sure
Disagree
strongly disagree
Total
1
24
12
9
1
47
2.1
51.1
25.5
19.1
2.1
100.0
Table 7: The staffs were friendly and approachable

(n=47).
Responses
strongly agree
Agree
not sure
Disagree
Total
Frequency
12
26
7
2
47
Percent (%)
25.5
55.3
14.9
4.3
100
Inferential analyses done in Tables 8 and 9 indicated

that enhancement of clinical skills were dependent on
the appropriate practice experienced and the
supervision offered by the supervisors where as
professional growth of the students were dependent
on the support from the clinical supervisors.
821
Kyei et al.,
Inferential Analysis
Table 8: The practice experience and supervision
offered were appropriate to my level of
competence * the placement enhanced my
clinical skills
Responses
strongly Count
agree
Expected
Count
Count
Agree
Expected
Count
Count
not sure
Expected
Count
Dis
Count
agree
Expected
Count
strongly Count
disagree Expected
Count
Count
Total
Expected
Count
Agree
not
sure
Dis
agree
Total
2.4
4.4
1.0
0.2
14
24
7.1
13.3
3.1
0.5
24
11
3.3
6.1
1.4
0.2
11
0.9
1.7
0.4
0.1
0.3
0.6
0.1
0.0
14
26
47
14.0
26.0
6.0
1.0
47
strongly
agree
H0: The enhancement of clinical skills is independent

of the appropriate practice experience and supervision
offered
H1: The enhancement of clinical skills is dependent
on the appropriate practice experience and
supervision offered
Chi square (X2) test value is 31.8, Level of
significance () = 0.05, Degree of freedom (df) =12,
p- Value=0.001
The conclusion derived from this is that enhancement
of clinical skills is dependent on the appropriate
practice experience and supervision offered.
Table 9: I received support from my clinical
supervisors * the placement was supportive of my
professional growth
Respon
ses
strongl Count
y agree Expected
Count
Count
Agree
Expected
Count
Count
not
sure
Expected
Count
Disagre Count
e
Expected
Count
Count
Total
Expected
Count
strongly
agree
agree
not
sure
Dis
Total
agree
1.1
4.0
0.6
0.3
6.0
21
25
4.8
16.5
2.7
1.1
25
10
1.9
6.6
1.1
0.4
10
1.1
4.0
0.6
0.3
31
47
9.0
31.0
5.0
2.0
47
H0: The professional growth of the student is

independent of support from clinical supervisors
H1: The professional growth of the student is
dependent on the support from clinical supervisors
Chi square (X2) test value is 17.5, Level of
significance () = 0.05, Degree of freedom (df) =9
p- Value=0.041
The conclusions derived from the result indicate that
the professional growth of the student is dependent on
the support from clinical supervisors.
DISCUSSION
The majority of the respondents were within the ages
of 18-22. The sample characteristics are a
representative of students enrolled in this program.
Understanding the relevance and meaning of clinical
placement
Overall, almost all the respondents (97.9%) indicated
a high level of understanding about the meaning and
the relevance of clinical placement, which supports
the study by Chan6. In this study, it was identified
that the relevance of clinical placement cannot be
over emphasized. Students understand the need for
clinical placement as a requisite medium of equipping
themselves with the right knowledge and skills to
improve the quality of all diagnostics students and
patient management.
Majority of the respondents (74.5%) indicated that
they learn through active experimentation Table 1.
This was as a result of the fact that students are able
to perform credibly after they have been allowed to
try hands on examination under supervision. This was
in line with the term legitimate peripheral
participation, where students move from the
periphery into the centre of the occupation by active
experimentation as indicated by 7. This enhances the
competence and confidence of the student to handle
cases with less or no supervision and would further
curb the shortage of staffing which is a major
challenge of many health institutions.
Boggis, et al.,8 asserted the need for students to
participate in different clinical settings to practice
radiography and this as seen in Table 4, was
supportive to the growth of the students.
Clinical Placement Duration
Majority of the students indicated that the four week
clinical duration is enough, though (38.3%) stated
that hours spent for the period were not being enough.
This notwithstanding, 61.7% respondents agreed to
822
Kyei et al.,
the fact that the number of hours spent in the clinical

room was enough. This suggested that the existing
duration for clinical placement of students should be
more to help the students acquaint themselves with
the clinical environment as well as gain the necessary
skills. Nonetheless the amount of hours needed for
clinical is still subject to debate as indicated by
Penman and Oliver 2.
Students assessment, evaluation and satisfaction with
clinical placement:
The students, during the placement satisfactorily met
their placement objectives, enjoyed their time and
worked as a team with very willing and available
staff that assisted them in learning though there were
few challenges. Thus, the placement was a pleasant
learning experience for students. However, studies
have indicated that not all practice settings are able to
provide students with a positive learning
environment9. For example, in a study done by
Kleehammer, Hart & Fogel,10 in nursing results
indicated that students perceived placement
experience as challenging, unpredictable and stressful
particularly in the first clinical placement.
During clinical placement, evaluations provide
students with the opportunity to reflect and examine
issues of practice, enabling them to focus on
particular issues or concerns, e.g. adequate
orientation to the workplace, availability of assistance
from staff members and so forth. The challenge is to
maintain the quality of the placement experience or
improve such experiences. The responses to the
instrument showed that majority of the students were
impressed about placement they had and stated that it
was favorable (Table 3 and 6). Results of this survey
showed that the majority of students perceived their
clinical placement as rich in learning experiences
(Table 5). According to them, venues for placement
were supportive of learning, professional growth,
skills development and practice. Students
experiences with the clinical settings were pleasant
and the outcomes of the experiences satisfying.
Having been exposed to a wide range of clinical
experiences, many of the students reported that they
met their objectives, felt confident about working in
the same area in the future, and anticipated that other
students would benefit from the same clinical
experiences (Table 6). While the majority benefited
from their clinical placements, a few of the students
reported dissatisfaction as well. They rated particular
clinical venues poorly. These clinical venues might

benefit from ongoing feedback from students and
collaboration with the faculty.
Barriers to feedback process have been identified as
inadequate supervisor training and education,
unfavorable student learning environment and
insufficient time spent with students11. This may be
due to the fact that the conventional concept lacks
important competence to ensure that the trainees or
students are competent to practice, including
consistent guidance, measurement of performance
and feedback in a systematic and structured way as
part of the departmental policy12.
Feedback should be given to students regularly to
ensure that they have the best opportunity possible to
improve during the clinical experience.
CONCLUSION
It can be concluded that many of the experiences of
Radiography Students relating to the impact of
clinical placement locations were positive. However,
it is imperative to consider carefully where students
have their clinical practice and at what point of their
studies the different placements should be carried out.
A Collaboration between the key stakeholders is
essential to ensure that students have a good
experience at clinical placement.
Considering the aim of the study, which was to
examine the impact of clinical placement location on
radiography clinical experience, it is suggested that
Universities review their number of hours for clinical
placement in order to meet the standard and the
quality of coaching needed for each student. Again
feedback should be given to students regularly to
ensure that they have the best opportunity possible to
improve during the clinical experience.
Finally, professional bodies must make serious efforts
to identify barriers and facilitators of research
utilization in their respective locality. While training
institutions, professional body, clinical radiographers
and researchers must collaborate to develop and
implement strategies to enhance a research-based
practice in the placement venue in order to improve
practice.
Conlfict of interest: Nil
Source of funding : Nil
823
Kyei et al.,
REFERENCES
1. Rose M, Best, D. Transforming practice through
Clinical Education, professional supervision and
mentoring. New York, Elsevier Churchill
Livingstone, Oxford, pg 2005;1-10
2. Penman, J. & Oliver M. Meeting the challenges
of assessing clinical placement venue in a
bachelor of nursing programme. Nurse Educator.
2000;8: 410-415.
3. Sugden N. Meeting the Challenge of Expanding
Clinical Nursing Opportunities. In: Statewide
Clinical
Placement
Summit.
Wisconsin,
USA.2007
4. Frantz JM. & Rhoda JA. Assessing clinical
placement in a BSc. Physiotherapy program, The
Internet Journal of Allied Health Sciences and
Practice. 2007;5 (3):1-6
5. American Society of Radiologic Technology,
2007. wikipedia.org/wiki/American_Society_of_
Radiologic_Technologists. Accessed 2/10/ 2010
6. Chan D. Development of the clinical learning
environment inventory: using the theoretical
framework of the clinical leaming environment
studies to assess nursing students' perceptions of
the hospital as alearninv environment: Journal of
Nursing Education. 2002;41(2): 69-75.
7. Frances JA. & Quek F. Situated learning:
Legitimate peripheral participation. Boston,
Massachusetts, USA. 2011. http://vislab.cs.vt.
edu/~quek/Classes/Aware+EmbodiedInteraction/
BookReviews/SituatedLearningReview.pdf
8. Boggis C, Cook P, Denison A. The place of
clinical radiology and imaging in medical
education: objectives, content and delivery of
teaching. Royal college of Radiologist, Radiology
for Medical Students 3. 2011; http://www.rcr.ac.
uk/docs/radiology/pdf/MedicalStudentPaper3.pdf
9. Papp I, Markkanen M,Von Bonsdorff M. Clinical
environment as a learning environment: student
nurses perceptions concerning clinical learning
experiences. Nurse Education Today. 2003;23:
262-68.
10. Kleehammer K, Hart A, Fogel KJ. Nursing
students perception of anxiety-producing
situations in the clinical setting, Journal of
Nursing Education, 1990;29 (4):183-87.
11. Clynes MP, Raftery SEC. An essential element

of student learning in clinical practice. Nurse
Education in Practice. 2008;8 (6): 405-11.
12. Rodriguez-Paz JM, Kennedy M., Salas E.
Beyond See One, Do One, Teach One:
Toward a Different Training Paradigm. Quality
Safe Health Care. 2009; 18 (1): 63-68.
824
Kyei et al.,
DOI: 10.5958/2319-5886.2014.00008.3

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
rd
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
MANTRA, MUSIC AND REACTION TIMES: A STUDY OF ITS APPLIED ASPECTS

Varun Malhotra*, Rinku Garg, Usha Dhar, Neera Goel, Yogesh Tripathy, Iram Jaan, Sachit Goyal, Sumit Arora
Department of Physiology, Santosh Medical College, Ghaziabad, Uttar Pradesh, India
*Corresponding author email: malhotravarundr@gmail.com
ABSTRACT
Aims &Objectives: The mechanism of the effects of music is still under scientific study and needs to be
understood in a better way. We designed this study to see how music affects reaction time and concentration. The
aim of our study was to study the effect of Gayatri mantra on reaction time. Material and Methods: 30 healthy
subjects were selected for the study. Baseline record of Visual online Reaction time test was taken. Online visual
reaction time was measured during listening to Gayatri Mantra was taken. Results:The reaction times decreased
significantly p<0.001. Conclusion: Listening to music at work area reduces distractions, helps increase
concentration and delays fatigue. It can be used to heal tinnitus, as an educational tool to develop children with
special needs, Alzheimers disease, to improve motor skills in Parkinsonism and help alleviate pain after surgery.
Keywords: Mantra, Chanting, Music, Reaction Times, Concentration
INTRODUCTION
Music therapy probably began when the earliest
humans stomped or clapped to involve healing spirits
or to exercise a sick person's demons. Greek myths
contain metaphors for the healing power of music,
and musical cures were part of many ancient cultures
and religions. The healing effects of music on all
aspects of mind/body function are universally
accepted but not scientifically understood. Music is
the universal language of the souls devotion. 1
Music that is saturated with soul force is the real
universal music, understood by all hearts. Chants
bring ineffable joy, and are proof that God has
answered. Popular songs are usually inspired through
sentiment or passing interest. These songs are like
wet matches that do not produce any spark of divine
realizations1 But the Gayatri mantra born out of
depths of true devotion to God, brings boundless joy
and is a spiritualized song (mantra, chant). Such
songs like live matches produce the fire of God
awareness, whenever they are struck at the foundation
of devotion. There has been considerable interest in

how background sounds may influence an
individuals performance on various cognitive and
work tasks2. In a study by Smallwood and Schooler3
(2006), they discover mind wandering occurs when
the executive components of attention appear to shift
away from the primary task, leading to failures in task
performance and superficial representations of the
external environment. This study provided the
framework for future studies on cognitive distraction.
With the framework in place it is possible to branch
out into other interesting studies that focus on musical
influence on cognition involving distractions and
reaction times. Is it possible classical music can
increase productivity and cause one to focus, besides
boosting cognitive recall for students studying? Does
music really help students boost their cognitive
functioning?
Reaction speed is the ability to quick motor response
to definite stimulus, while the time that elapses
825
Varun Malhotra et al.,
Int J Med Res Health Sci. 2014; 3(4):825-828
between the sensory stimulation and the motor

reaction time is called reaction time. 4. This is the
time that elapses between a stimulus and response it.
This process consists of sensory and perceptual
process. After a stimulus is perceived by our
receptors (in our eyes, and ears), identification and
recognition in the central nervous system begin. If we
recognize a certain stimulus to be significant for us,
we respond, in the opposite case we ignore and do not
respond. The speed of identifying the stimulus is an
essential factor in this process. The last stage of the
response to the stimulus is a motor reaction which
involves clicking the computer mouse5. How music
effects the brain is still not clear. The mechanism of
the effects of music is still under scientific study and
needs to be understood in a better way. We designed
this study to see how music affects reaction time and
concentration.
This was a cross-sectional study done in Santosh
medical college Ghaziabad. Ethical approval of the
research committee was taken before starting the
study. 30 healthy subjects were selected for the study.
Baseline record of Visual Reaction time test was
taken using a computer online Windows 7. The
Online Reaction Time Test 6 consists of a traffic light
signal of red, yellow and green. The subject is
instructed to click on a button to begin when ready, to
wait for the stoplight to turn green, and click when it
turns green quickly. The average of five responses in
seconds is taken as reading. Online visual reaction
time was measured during listening to Gayatri Mantra
was taken. Gayatri mantra means We meditate on the
worshipable power and glory of Him who has created
the earth, the nether world and the heavens (i.e. the
universe), and who directs our understanding.
The duration of study was three months. Sound of
music kept low (audible). Healthy students with
normal hearing and Hindu religion were included in
the study. Students who had hearing problems as
tested by whispered voice test, complaints of tinnitus,
ear pain and students of a different religious faith who
did not want to hear the Gayatri mantra were
excluded. The mantra was listened early morning.
Our hypothesis is that stimulating music, such as
Gayatri mantra will shorten the reaction time to visual
stimuli, while without music, the reaction time will be

longer.
RESULTS
Results were analysed by paired t test using SPSS
version 17.0.
Fig 1: showing the online reaction time before and

during the Gayatri mantra session (p<0.001)
DISCUSSION
They are several factors that influence the reaction
time, such as age, gender, left handedness vs right,
practice, exercise, type of personality, the use of
stimulant
drugs,
hypothyroidism
and
7
hyperthyroidism, brain injury and illness . Music
helps promote brain development8, 9 It is well known
that music is used to manage organic disorders such
as pain, and for rehabilitation after a stroke or a
serious accident. It helps improve coordination and
alleviates perception of pain by stimulating an
increase in endorphins especially in polio patients.
The aged and patients with Parkinson's disease,
improve coordination and learn to walk with a
steadier gait by exercising to music. Singing or
playing certain musical instruments may contribute to
improved lung function. Singing is also used to
overcome speech disorders10.
Psychotherapy: Music and rhythm are used to
improve physical and psychological functioning and
provide an alternative means of communication for
persons who are unable to put their feelings and
thoughts into words. It is especially beneficial in
treating autistic and emotionally disturbed children10.
Music may also be used to calm agitated or
aggressive behavior; in some cases it also provides a
means of self-expression10,25. Music therapies and
826
dance help children to improve their coordination,

build muscle tone and strength, and gain self
confidence10,18,22,24,.
Special Education : Music helps improve the
coordination of children with neurological
disabilities, such as cerebral palsy, as well as those
who are blind or deaf. When incorporated into group
activities, it also contributes to socialization10.
Regular exposure to music is likely to be part of the
special education program for a hyperactive child
because of its calming effects. Parents can ask a
qualified music therapist to suggest kinds of music to
be played at home. Also, makes child music, on his
own may help him to expand his attention span10.
Art, dance and music therapies when instituted at an
early age help retarded children overcome physical
and social handicaps. These and play therapy can help
the child to express feelings of frustration and
anger10. Listening to music is a time honoured
method of relaxation19,20,21. To alleviate anxiety,
music therapists recommend soothing classical music
rather than loud, percussive types 11,12,13,16,. Music
associated with a happy event or time period can also
be beneficial10,14,15.
How it works: Old songs often spark remarkable
responses from Alzheimer's patients. Some
researchers believe that music activates a flow of
stored memory that is otherwise inaccessible. Even
when verbal memory fades, the ability to remember
and recognize music remains intact. Music therapists
find that playing songs popular during a patient's
youth, or music associated with a particular time and
place, jogs other memories and helps in retrieving
past experiences10,17. Research studies suggest that
musical experience may also trigger the production of
endorphins, brain chemicals that are natural
painkillers. Studies by anaesthologists indicate that
playing music during surgery reduces the need for
anaesthesia. Dentists have observed that their patients
don't need as much pain killer when music is being
played10,15.
In Canada, accredited music therapists must have
completed courses at Wilfrid Laurier University,
home to the Canadian Music Therapy Association.
Similar courses are being offered at SVYASA,
Banglore, India. To emotionally disturb or
developmentally handicapped drama, used as therapy
(an outgrowth of music therapy), is a valuable method
in healing method. Playing background music is
useful to mask tinnitus. If headphones are used, the

volume should be loud enough to mask the noise in
the ears, but not loud enough to cause further
damage10.
Sound or vibration is the most powerful force in the
universe. Music is a divine act, to be used not only for
pleasure but as a path to God realization. Vibrations
resulting from devoted singing lead to attunement
with the cosmic vibration or Aum1,26,27,28. Many men
and women testified to the God perception and the
healing of the body, mind and soul that has taken
place at a cosmic chant of O God Beautiful that
was sung for hours in USA1
Lacunae and Future Studies: Measuring the cortisol
levels and endorphins would help explain the effect
of music on neuroendocrine system. It would also
play an important role in understanding the
underlying physiology of the relaxation music on
decreasing reaction times and helping maintain the
alert, awake, aroused state. Duration of music and
therapy in various diseases needs to also be
scientifically studied.
CONCLUSION
Listening to Gayatri mantra decreases reaction time.
Listening to music at work area reduces distractions,
helps increase concentration and delays fatigue. It can
be used to heal tinnitus, as an educational tool to
develop children with special needs, Alzheimers
disease, to improve motor skills in Parkinsonism and
help alleviate pain after surgery.
ACKNOWLEDGEMENT
The authors wish to thank the subjects who participated willingly in this study. Authors acknowledge
the help received from the scholars whose articles are
cited and included in references of this manuscript.The authors are also grateful to the authors /
editors / publishers of all those articles, journals and
books from where the literature for this article has
been reviewed and discussed.
Conflict of interest: Nil
REFERENCES
1. Sri Sri Paramhansa Yogananda .Words of Cosmic
Chants Prelude 2005; xvii-xx
827
2. Furnham A, Allass K. The influence of musical

distraction of varying complexity on the cognitive
performance of extroverts and introverts.
European Journal of Personality 1999 ;13: 27-38.
3. Smallwood J, & Schooler JW. The restless mind.
Psychological Bulletin 2006;132 (6): 946-958.
4. trulc, M. Fiziologija Zivcvja [Physiology of
nerves]. Ljubljana: Medicinski razgledi 1989
5. Sanders, A. F. (Stage analysis of reaction
processes. In G. E. Stelmach J. Requin (Eds.),
Tutorials in motor behavior Amsterdam: North
Holland 1980; 33154.
6. Online
reaction
times.(http://getyourown
websitehere. com/ jswb/ rttest 01.html)
7. Brebner, J. T., & Welford, A. T. Introduction: a
historical background sketch. In A. T. Welford
(Ed.), Reaction Times. New York: Academic
Press. 1980;1-23
8. Mason, R. A. Audiation, cochlear function, and
the musical ear of Alfred Tomatis. Dissertation
Abstracts International 2001; 63:956.
9. Schellenberg, G. E., Nakata, T., Hunter, P. G., &
Tamoto, S. Exposure to music and cognitive
performance: Test of children and adults.
Psychology of Music , 2007;35: 5-19.
10. Genell J. Subak Sharpe.Music Therapy.
Approaches to Treatment. Reader's Digest. Guide
to Medical Cures & Treatments. A Complete A to
Z Sourcebook of Medical Treatments, Alternative
Options, and Home Remedies. 1996;54- 84.
11. G R. Music therapy: Proposed physiological
mechanisms and clinical implications. Clin Nurse
Spec 1997; 11: 43-50.
12. Chiu P, Kumar A. Music therapy; Loud noise or
soothing notes. International Pediatrics, 2003; 18:
204-08.
13. Hyde IM, Scalapino W. The influence of music
upon electrocardiograms and blood pressure. Am
J Physiol.1918; 46: 35-38.
14. Bernardi L, Sleight P, Bandinelli G, Cencetti S,
Fattorini L, Wdowezyc-Szulc J, et al. Effect of
rosary prayer and yoga mantras on autonomic
cardiovascular rhythms: comparative study. BMJ.
2001; 323: 1446-49.
15. Bernardi P, Porta C, Sleight P. Cardiovascular,
cerebrovascular and respiratory changes induced
by different type of music in musicians and non
musicians: the importance of silence. Heart
Journal. 2006; 92: 445-52.
16. Wendy E, J Knight, Nikki S. Richard PhD.
Relaxing music prevents stress induced increases
in subjective anxiety, systolic blood pressure and
heart rate in healthy males and females. Oxford
Journals. Journal of Music Therapy.2001; 38 (4):
254-72.
17. Burns J, Labbe E, Williams K et al. Perceived and

physiological indicators of relaxation; as different
as Mozart and Alice in chains. Appl
Psychophysiol Biofeedback.1999; 24:197-02.
18. Fernell J. Listening to music during ambulatory
ophthalmic surgery reduced blood pressure, heart
rate, and perceived stress. Evid Based Nurs.2002;
5:16.
19. S Chaffin, M Roy, W Gerin. Music can facilitate
blood pressure recovery from stress. British
Journal of Health and Psychology. 2004; 9 (3):
393-03.
20. Loomba RS, Arora R, Shah, Chandrasekar S,
Molnar J. Effect of music on systolic blood
pressure, diastolic blood pressure and heart rate; a
meta-analysis. Indian Heart Journal. 2012; 64 (3):
309-13.
21. Bekiroqlu T, Ovayolu N, Erqun Y, Ekerbicertic.
Effect of Turkish classical music on blood
pressure: a randomized controlled trial in
hypertensive elderly patients. Complement Ther
Med 2013; 21 (3); 147-54
22. White J. Effects of relaxing music on cardiac
autonomic balance and anxiety after acute
myocardial infarction. American Journal of
Critical Care, 1999; 8: 220-30
23. Bernardi L. Music and the heart. Journal of
American Heart Association. Circulation:
European Perspective in Cardiology. 2007; 11:
139-40.
24. Iriate Roteta A. Music therapy effectiveness to
decrease anxiety in mechanically ventilated
patients. Enfermeria Intensiva, 2003; 14: 4348:S1130-2399 (03) 78103-6.
25. Mockel M. Immediate physiological responses of
healthy volunteers to different types of music,
cardiovascular, hormonal and mental changes.
European Journal of Applied Physiology and
Occupational Physiology.1994; 68: 451-59.
26. Neera Goel, Varun Malhotra, Usha Dhar,
Archana, Niketa.Kapalbhati modifies visual
reaction time. International Journal of current
research and review 2013;5(13):105-09.
27. Varun Malhotra, Usha Dhar, Rinku Garg, Sameer
S, Archana S, Jayanti, Nivriti, Sushil .Anuloma
Viloma Pranayama Modifies Reaction Times and
Autonomic Activity of Heart: A Pilot Study.
International Journal of current research and
review October 2012; 4 ( 19):146-9
28. Rinku Garg, Usha Dhar. Effect of pranayama and
meditation on autonomic cardiorespiratory
variables in normal healthy volunteers. Indian J
of Public health Research and Development
2014;5(3):268-72
828
DOI: 10.5958/2319-5886.2014.00009.5

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
rd
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 4 Aug 2014
OCULAR MANIFESTATIONS IN HANSENS DISEASE- A CLINICAL STUDY

*Christina Samuel1, Sundararajan D2
1
Post graduate, 2HOD, Department Of Ophthalmology, Meenakshi Medical College, Kanchipuram, Tamil Nadu,
India
*Corresponding author email: tinachandar@gmail.com
ABSTRACT
Background: Leprosy or Hansens disease is a chronic mildly contagious granulomatous disease of tropical and
subtropical regions caused by the rod shaped bacillus, Mycobacterium leprae. It affects the skin, peripheral nerves
in the hands and feet, mucous membrane of nose, throat and eyes. When left untreated, it is capable of producing
various deformities and disfigurements. Aim: To study the ocular involvement in patients with Leprosy under the
parameters of age group, sex type and duration of leprosy. To study the different ocular manifestations and
identify the potentially sight threatening lesions and provide early management. Methods: This was a prospective
study which included 50 cases diagnosed with Hansens disease. Detailed history and thorough clinical
examination was done. Potentially sight threatening lesions were managed conservatively or surgically. Results:
Out of 50 cases of Leprosy, 58% had ocular involvement and majority were in the age group 21-40years. Ocular
involvement was predominantly seen in Lepromatous type with 35% having ocular lesions. The most common
ocular manifestation observed was superciliary madarosis (48%). Potentially sight threatening lesions accounted
for 72.4% of which lagophthalmos was common. No cases of blindness seen. Conclusion: Visual impairment is
preventable in Leprosy if detected early. The risk of ocular complications increases with the duration of the
disease, despite being treated with systemic anti-leprosy drugs.
Keywords: Leprosy (Hansens disease), Lepromatous, Tuberculoid, Slit skin smear, Ocular involvement
INTRODUCTION
Leprosy or Hansens disease is a chronic infectious
disease caused by an intracellular rod shaped acid fast
bacilli Mycobacterium leprae which affects the skin,
nasal mucosa, peripheral nerves and the anterior
segment of the eye.1 Mycobacterium leprae was
discovered by a Norwegian physician G.Armauer
Hansen in the year 1874.1 The most ancient writings
of SUSHRUTA SAMHITA compiled in 600 BC
refers to leprosy as Vat Rakta or Vat Shonita and
Kushtha 2, 3. Leprosy occurs in all ages and both
sexes. Male: Female ratio is 2:14. Leprosy bacillihave
a Predilection for neural tissue and their target is
Schwann cell. The fate and type of leprosy depends

on the resistance and immunity of the affected
individual5 (Jopling, Mc Douglass 1996). There are
11million cases throughout the world and about 1/3rd
have ocular manifestations.6 Prevalence of blindness
due to leprosy is 4.7% of the population in India.7,8
Various studies shows ocular involvement in Leprosy
patients. The frequency and types of involvement
depends on the duration and form of the disease.2, 9
Ocular lesions are common in lepromatous type
ofleprosy and presents with lepromatous nodules,
conjunctivitis, keratitis, pannus, scleritis and uveitis.
Lesions are rare in tuberculoid type of leprosy and are
829
Christina Samuel et al.,
secondary to the involvement of branches of facial

nerve which presents with paralytic lagophthalmos,
exposure keratitis and neurotrophic keratitis. Acute
iridocyclitis and scleritis are seen in type 2 lepra
reaction occurring in lepromatous leprosy.6 Blindness
has been reported in 7% of patients secondary to
lagophthalmos, uveitis, exposure keratitis and
cataract8. Proper attention and early detection can
prevent potentially sight threatening lesions.
MATERIALS AND METHOD
The present study was carried out in the outpatient
Department of Ophthalmology and inpatient
department of Dermatology at Meenakshi Medical
College and Hospital, Kanchipuram from March
2012-May 2014. In this study a total of 50 patients
were taken, 38 males and 12 females of the age group
20years and above. Prior to the study an informed
consent form from the patients and ethical clearance
was obtained from the Institutional Ethics
Committee. Inclusion Criteria: All diagnosed cases
of leprosy. Old and new cases, both genders and age
group of 20 years and above.Exclusion Criteria:Non
compliant patients, Patients with preexisting ocular
disorders due to other causes than leprosy.
Type of study: A cross sectional descriptive study for
a period of 14 months.
Procedure: Relevant details of both ocular and
systemic history, including details of lepra reaction
and clinical examination of patients were recorded on
a proforma. A detailed slit lamp examination of the
anterior segment of eye was done. Visual Acuity
recorded with help of Snellens chart10. Corneal
sensation was checked with a wisp of cotton. Intra
ocular pressure recorded with help of Schiotz
tonometer10. Fundus examination with 78 D and
Indirect
Ophthalmoscopy
was
done.
Lab
investigations like haemogram, ESR, Urine routine
and RBS done. Slit skin smear and skin biopsy from
the ear lobe was performed by the Dermatologist and
report obtained as positive for M.leprae (Ziehl
Neelsen technique)11.Patients were started on
systemic anti leprosy drugs (multi drug therapy) and
treatment for lepra reactions.
Common side effects documented in these patients
due to medications were diffuse pigmentation,
gastritis and light headedness. Patients with ocular
manifestations were treated accordingly to their need
of Lubricant eye drops, topical antibiotic with steroid
drops, eye ointments, frequent blinking exercises,

physiotherapy, and lid taping at night time and
spectacle correction.
RESULTS
In this study of 50 patients with leprosy, majority
belonged to the age group of 21-40years (46%). 76%
were males and 24% were females. Out of 50 cases,
30% were tuberculoid type, 22% lepromatous type
and 48% borderline type. Out of 50 cases 58% had
ocular involvement in which 45% were within the age
group 21-40years. Out of the 29 cases with ocular
involvement 72% were males. 35%with ocular
manifestations were of lepromatous type of leprosy.
41.4% gave a positive history of lepra reaction. The
ocular involvement was directly proportional to the
duration of leprosy. 55% had leprosy more than 5
years. Superciliary madarosis (48%) was the most
common ocular manifestation. The potentially sight
threatening lesions were Lagophthalmos (35%), seen
more in lepromatous type (14%). 28% had corneal
hypoesthesia, 21% with exposure keratitis, 17% had
corneal opacity, anterior uveitis and conjunctivitis
each accounted for 7%. It was interesting to note that
60% of patients with lagophthalmos had
exposurekeratitis.
Fig1: Ocular involvement in Leprosy
Fig2: Distribution of patients with ocular

involvement according to age
830
Fig 3: Distribution of ocular manifestations in

Leprosy
Fig 4: Lagophthalmos and relation with Exposure

Keratitis
DISCUSSION
The involvement ofthe eyess in leprosy is due tothe
infiltrationn of the tissues by the bacilli and damage
to the nerves12. In this study, 58% of the patients had
ocular involvement. This can be compared to other
studies of Wani.S.et al 2005 which showed 69% of
ocular involvement, Gnanadoss A S et al 1986
showed 59.2% 13. Studies conducted by Shields
shows 33% of potentially sight threatening lesions
which included keratitis, iritis, lagophthalmos and
secondary glaucoma14. In our study the potentially
sight threatening lesions were lagophthalmos,
exposure keratitis, uveitis, corneal hypoesthesia and
corneal opacity which accounted nearly for 72.4%.
Majority of the patients in our study were of the age
group 21-40 years and male predominance was seen
in both for, affected eyes with leprosy (76%) and
ocular involvement (72%). This can be compared
with the study by Wani.S et al (82.6%) 12 which also
showed predominance for men. This study further
shows that ocular manifestation were seen more in

lepromatous leprosy (75.36%) followed by borderline
(14.49%) and tuberculoid leprosy (10.14%) 12. In our
study conducted, ocular involvement was 35% in
lepramotous, 31% in borderline and 17% in
tuberculoid type. The reason being that M.leprae has
a favourable environment in the anterior segment of
the eye and the bacilli are found more in lepromatous
type of leprosy. Madarosis was the commonest ocular
manifestation in our study, which was about 48%
when compared to Shields 1974 (54%) 14 and
Acharaya B P (59.2%)15 and Wani. S. et al
(72.46%)12. Lagophthalmos accounts for 35% in our
studywhen compared to Wani.S et al (28.98%)12 ,
Acharaya B P (34.3%)15 , Lamba et al 1983 (13%)16 ,
Shields 1974 (29%)14 and Weerekon 1972 (27%)17.
Lagophthalmos is commonly associated with lepra
reaction in the face and damage to the facial nerve
and also depends in patients with lepromatous leprosy
(14%) which is similar to the observation by Wani.S
et al (18.84%) 12. In this study corneal involvement
was seen in 66% of the patients, corneal hypoesthesia
28%, exposure keratitis 21% and corneal opacity in
17%. In the study conducted by Wani.S et al corneal
involvement (36.23%) 12 . Radhakrishnan N et al
observed that the major cause of blindness in leprosy
was exposure keratitis due to lagophthalmos (23%)
and leucoma (25%) 18. Cataractous changes in lens
were seen in 17% of the patients, but it was not a
complication due to leprosy or MDT but merely due
to senile lens changes in the older age group of the
patients in our study. This is also supported by the
study from Gnanadoss A S et al13. Iris pearls seen in
anterior uveitis are said to be the pathognomic of
leprosy 19, 20. But in our study uveitis was observed
only in 7% of the patients when compared to Wani S
et al12 which showed 31.88%. This probably is due to
the small sample size of our study and also the
duration of leprosy not been more than 10 years for
all patients, because uveitis is seen mostly in chronic
cases of leprosy. This is supported by various studies,
like Lamba 1983 16 (14%), Hornblass 197321 (16%)
and Gnanadoss A S et al 198613 (5.6%). In this study
all patients with ocular manifestations were either
treated formerly (58.6%) or presently (41.4%) with
systemic anti leprosy drugs. Courtright et al
suggested that ocular pathology will still occur in
MDT treated leprosy patients22. This treatment does
not prevent the occurrence of ocular lesions12. The
831
duration of MDT has been for 12 months and should

be completed at least within the first18 months after
diagnosis of Hansens disease. Moreover, once the
patient is on treatment the ocular reaction is seen
more in the first 6-12 months due to reactions23. The
progressive leprosy related lesions are the result of
chronic nerve damage.
5.
6.
7.
CONCLUSION
The risk of ocular lesions increases with the duration
of disease, lepra reaction and facial patches in this
reaction. Screening of all patients affected with
leprosy can help in identifying the potentially sight
threatening lesions which can be treated early. Visual
impairment if detected early is preventable. The Multi
Drug therapy for leprosy has improved the outcome
of the affected with leprosy, but does not retard the
development of ocular complication.
Limitations:Owing to the small sample size in this
study many other ocular manifestations could not be
assessed.
A
relationship
between
uveitis,
Complicated cataract and leprosy can be suggested if
the patients present with a longer duration of leprosy
more than 10 years, as in this study we had only 4
patients in that category.
8.
9.
10.
11.
12.
13.
14.
ACKNOWLEDGEMENT
It is with the sense of accomplishment and deep
gratitude that we dedicate the work to all those who
have been instrumental in its completion.
We are greatly thankful to the RMO, Meenakshi
Medical College, Hospital and Research Institute,
Kanchipuram. To our Colleagues and Staffs of the
Department of Ophthalmology and Dermatology for
their timely help, support and constant guidance in
our work.
15.
16.
17.
18.
19.
20.
REFERENCES
1. Lewallen, Paul Courtright. An over view of
ocular leprosy after two decades of multidrug
therapy. International Ophthalmology Clinics world blindness. 2004, 47(3):87-99.
2. Dharmendra. History of spread and decline of
leprosy. Leprosy. Vol I, Bombay: Kothari
Medical Publishing House. 1989,197(1);7-21
3. Rastogi N, Rastogi RC. Leprosy in ancient India.
Int J Lepr 1984; 52:541-3.
4. Park K. Epidemiology of Communicable
Diseases. Parks Textbook of Preventive and
21.
22.
23.
Social Medicine. Jabalapur: M/S Banarsidas

Bhanot Publishers, 17th ed., 2002; 242-53.
The disease In: Handbook of Leprosy, 5th ed.,
Delhi CBS Publishers and distribution; 1996; 1053.
Sihota. Tandon disease of uveal tract. Parsons
Diseases of the Eye. Elsivier publications. New
Delhi. 20th Edition. Chapter 17, 2007; 239-72.
Thompson Allardice et al, Patterns of ocular
morbidity and blindness in leprosy: Leprosy
review 2006;77(2):130-40.
Ffytche TJ. Residual sight threatening lesions in
leprosy patient completing Multidrug therapy and
Sulphone monotherapy, Lepr. Rev. 1991; 62: 3543.
Mark J. Mannis Mascai, Arthur. Leprosy, chapter
62. Eye and skin disease, Lippincott- Raven
publishers, 1996; 543-50.
Samuel. A Study of Fundus changes in Myopia.
Derang A Jariwala. Socio- demographic and
environmental correlates of leprosy: A hospital
based case control study. National Journal of
Community Medicine. 2013; 4(3):369-73.
Junaid S. Wani, Saiba Rashid MS. Ocular
manifestations in leprosy- A clinical study; JKPractitioner 2005; 12(1): 14-17.
Gnanadoss AS, Rajendran N. Ocular lesions in
Hansens (leprosy). IJO 1986; 34:19-23
Jerry A Shields, George O Waring. Ocular
findings in Leprosy.AJO. 1974;77: 880-90.
Acharaya B P. Ocular involvement in Leprosy- A
study in mining areas of India. IJO 1978; 26:214.
Lamba PA, Arthanariswaran: Leprosy India.
Indian Journal of Leprosy.1983, 55; 490.
Lloyd Weerekon:Ocular Leprosy in CeylonBJO.
1969. July 53(7); 457-465.
Radhakrishnan N, Albert S. Blindness due to
leprosy. IJO 1980; 28:19-21.
Ffytche TJ, Trans. Ophthal. Soc. U.K.
1981,101:325.
Hogeweg, M. Keunen JE: Prevention of
blindness in Leprosy and the role of the Vision
2020 programme. Eye. 2005; 19 (2); 1099-05.
Albert Hornblass.Ocular Leprosy in South
Vietnam.AJO.1973, 75 (1):478-480.
Courtright P, Lu Fang Hu. Multi drug therapy
and eye diseases in leprosy. A cross sectional
study in Peoples Republic of China. Int. J.
Epidemiol. 1994; 23(4):835-42.
Margreet Hogeweg, Prevention of Blindness due
to
Leprosy.
Year
2011.
ICEH,
http://www.iceh.org.uk .
832
DOI: 10.5958/2319-5886.2014.00010.1

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 4 Aug 2014
Accepted: 1st Sep 2014
DEVELOPMENT AND VALIDATION OF A SENSORIZED NEONATAL INTUBATION SKILL

TRAINER FOR SIMULATION BASED EDUCATION ENHANCEMENT
*Tognarelli Selene1, Baldoli I1, Scaramuzzo RT2,3, Ciantelli M2, Cecchi F1, Gentile M2, Laschi C1, Sigali E2,
Menciassi A1, Cuttano A2
1
The BioRobotics Institute, Scuola Superiore Sant'Anna, Pontedera, Pisa

Centro di Formazione e Simulazione Neonatale NINA, U.O. Neonatologia, Azienda Ospedaliera
Universitaria Pisana, Pisa (Italy)
3
Istituto di Scienze della Vita, Scuola Superiore SantAnna, Pisa (Italy)
2
* Corresponding author email: s.tognarelli@sssup.it

ABSTRACT
Introduction: Oro-tracheal intubation requires a great deal of clinical experience to avoid serious complications.
The level of attention needed is even greater in the neonatal field due to newborns' unique anatomical features.
Therefore, specific skill trainers become fundamental in training programs for residents and expert clinicians.
However, the current commercial devices are totally passive and, as a result, the operator receives no feedback on
the accuracy of the procedure. Materials and Methods: An active sensorized skill trainer for neonatal intubation
was designed and assembled by fixing force sensors on a commercial infant simulator. A dedicated user-friendly
interface was developed which provided both visual (red or green light) and audio (alarm or winning sound) realtime feedback during intubation. The active neonatal skill trainer was included in a comparative analysis with
passive traditional systems, and involved 10 residents in Anesthesiology without previous experience in neonatal
intubation. Data on execution times and alarm conditions were gathered. Results: Based on experimental results,
the best trainees' performances were obtained with the active skill trainer after a previous training session with a
passive intubation mannequin. In addition, by evaluating the number of sensors-laryngoscope contacts, the
superior gingival arch and neck emerged as critical anatomical landmarks contacted during any intubation
procedure. Conclusions: The active simulator can be considered an innovative instrument for neonatal intubation
training. The proposed device potentially represents a valid learning instrument which can shorten the intubation
task learning curve.
Keywords: Medical simulation, Clinical training, Neonatal intubation, Sensorization
INTRODUCTION
Endotracheal intubation (EI) is recommended in
several clinical scenarios; when the patient is
unconscious or cannot breathe on his own, EI helps to
prevent suffocation or obstruction of the air passage.
By guaranteeing prolonged positive-pressure
ventilation, EI relieves critical upper airway
Tognarelli et al.,
obstruction, assists in bronchial hygiene when

secretions cannot be cleared, provides a route for
selective bronchial ventilation when diaphragmatic
hernia is suspected, and allows direct tracheal
culture1. EI remains the "gold standard" in airway
management, however, intubation requires a great
Int J Med Res Health Sci. 2014;3(4);833-839
833
deal of clinical experience, since the manoeuvre has

to be both quick (i.e. no longer than 20 seconds) to
minimize hypoxia and performed correctly to avoid
complications. Indeed, EI can cause trauma (to the
trachea, hypopharynx, vocal cords, arytenoids, lips,
gums), lead to misplacement into the oesophagus or
bronchus, and provoke fracture or dislocation of the
cervical spine, temporo-mandibular joint or arytenoid
cartilages 2.
EI procedure involves the placement of a plastic tube
into the windpipe (trachea), through the mouth or the
nose. Newborns and infants have particular
anatomical and physiological features that make the
management of airways even more difficult, both in
the case of nasal and oral intubation (Table 1) 3-5.
The most relevant complications related to neonatal
airway management can be connected to:
a) Minor neonatal tolerance to the oxygen deprivation
respect to adults. In newborns, because of the small
diameter of airways, a minimal trauma can lead to a
fatal airway obstruction. Moreover, the infants
possess compensatory mechanisms that are
proportional to the patients age and newborns
functional residual capacity is linked to their body
size with a metabolism that is at least twice that of
adults. Therefore, in case of ventilator problems they
may encounter hypoxia;
b) Reduced possibility of clinical features indicating
difficulty of IE because of the patients lack of
cooperation;
c) Limited availability of instrumentation.
Due to the small size of neonatal airways, dedicated
instruments are necessary to avoid difficulties.
Available systems for neonatal intubation include the
Miller and Macintosh blades, which have specific
dimensions for both at term and preterm newborns 6,
and adaptable fiber-optic laryngoscopes, commonly
employed in other neonatal and paediatric fields 7.
As highlighted in the literature, the use of simulationbased training in neonatal clinical education is
quickly growing 8. It is a safe and effective procedure
for the practice and acquisition of clinical skills
needed for patient care. In particular, mannequinbased simulators allow learners to improve teamworking, crisis management and resolution. With
such training, caregivers work in real-life scenarios
and can make mistakes without risks, thus favouring
learning 9. In this framework, specific neonatal skill
trainers are fundamental means both for residents
Tognarelli et al.,
educational programs and in the context of continuing

medical education (CME) training for health
operators. With regards to the neonatal EI procedure,
dedicated commercial neonatal skill trainers are
available made up of the head-neck structure and
airways. To our knowledge, the main products on the
market are: Infant Delux Simulation Head
(Simulaids),
Neonatal
Intubation
Trainer
(Laerdal), Infant Airway Management Trainer
(NascoLifeform), and AirsimBaby (Trucorps).
These devices are totally passive, and provide no
feedback on the accuracy of the procedure during the
performance. Consequently, the presence of an expert
is always required as a supervisor to the simulated
procedure. Active skill trainers for intubation
procedures already exist in the literature, but only for
adults 10,11. Based on these considerations, an active
neonatal skill-trainer able to give immediate feedback
on the accuracy of the ongoing manoeuvre could be a
fundamental step forward for simulation-based
education programs. In this framework, the authors
worked on the sensorization of a commercial
neonatal mannequin (head-neck) to allow the operator
to verify, in real-time, the proper execution and the
outcome of the intubation procedure.
Table 1: Main differences in airway anatomy
between adults and infants/ newborns
Cartilage
Minor diameter
Tongue
Infant/Newborn
Pronounced
occiput
Soft
Cricoid ring
Relatively larger
Arytenoids
Glottis
Leaning
Cartilage for 1/2
Epiglottis
Short, U form
Larynx level
C2-C3
Head
Adult
Flatocciput
Stiff
Vocalcords
Relatively
smaller
Horizontal
Cartilage
for 1/4
Plan,
flexible
C4-C5-C6

To obtain an intuitive neonatal intubation skill trainer
with real time feedback information, we modified a
Laerdal Neonatal Intubation Trainer by fixing
force/contact sensors in important anatomic areas that
have been identified by the clinicians to be vulnerable
to injury during actual real patient intubation on the
basis of their previous clinical experience4. The
834
superior and inferior gingival arches, epiglottis, neck

and trachea were designated as the anatomical points
mainly subject to significant stress during intubation
manoeuvres. Commercial force sensors (FSR400
short, Interlink Electronics, CA, USA) were attached
on the identified critical points and then connected to
a signal conditioning circuit and subsequently to a
data acquisition system (Multifunction DAQ System
NI USB-6218, National Instruments, USA). In order
to make a compact device and to minimize the
hardware
modifications,
thus
limiting
the
psychological component due to the differences
between this new system and the passive Neonatal
Intubation Trainer of Laerdal, the hardware
components were lodged in a case placed at the skill
trainer base (Fig 1).
Fig 1: Laerdal Neonatal Intubation Trainer

modified by fixing FSR force sensors on anatomical
points subject to major stress during the intubation
manoeuvre. Hardware components for signal
conditioning and acquisition were placed in a case
that can be inserted under the base of the skill
trainer.
With regards to the gingival arches and epiglottis, a

survey was carried out with 15 skilled neonatologists
to find sensor signal thresholds (i.e. 0.35 N and 1 N
for gingival arches and epiglottis sensors
respectively) related to dangerous stress for each
specific point (Fig 2.a). Alternatively, sensors placed
at the base of the neck and in the trachea were used as
switches; the former is able to assess if the neck is in
the correct sniffing position or if it is subject to iperextension 3, while the latter points out the insertion of
the cannula in the trachea, informing the operator
about the positive outcome of the manoeuvre (Fig
2.b). The conceptual scheme of the proposed analysis
is summarized in Fig 3.
Labview (LabVIEW, National Instruments, USA)
software with a dedicated graphic user interface
(GUI) was developed to evaluate the intubation
manoeuvre execution modality (Fig 2).
Tognarelli et al.,
Fig 2: Labview graphic user interface (GUI) of the

dedicated software developed to evaluate the
intubation execution modality. The GUI is composed
of: a) FSR force sensors positions in the Laerdal
Neonatal Intubation Trainer, b) warning lights
indicating stress levels (green light for untouched
condition, orange light for sensor-blade harmless
contact, red light and warning sound for stressed
contact condition) and the possible positive outcome
of the operation (green light and winning sound in
the Trachea led).
Fig 3: Flowchart of the analysis of the clinicians'

performances in neonatal intubation procedures.
The GUI is highly user friendly and is able to advise
with control orange to red lights and warning sounds
if the identified critical points are subjected to
harmless or dangerous stress. Being the trachea
sensor used for having a double check on the proper
execution of the intubation procedure, this is the only
sensor-blade contact signaled with a winning sound
and a green light on the GUI. The developed active
neonatal skill trainer was included in an effective
comparative study with traditional systems, involving
a group of 10 residents in Anesthesiology, with no
previous experience in neonatal intubation. No
laboratory devices or research tools have been
involved in the comparison because the final aim of
the study was to evaluate the effectiveness of the
active intubation skill trainer, referring to the
commercially available systems currently used in the
clinical practice and in simulation-based educational
programs. The residents were randomized into two
835
groups (Group A - 5 subjects and Group B - 5

subjects) and different training sessions (TS) were
planned. A qualitative and quantitative comparison
between the subjects' performances with sensorized
and sensorless neonatal skill trainers was carried out.
As a first step, Group A was involved in an intubation
training session by using a Miller straight blade
laryngoscope and a traditional head-neck sensorless
mannequin (TS1-A); five consecutive attempts were
performed for each subject. At the same time, but in a
different room, Group B was trained with a
videolaryngoscope (C-mac Storzstraight blade) on
the same sensorless mannequin (TS1-B) and also in
this case five attempts were considered for each
subject. After that, both groups tested their abilities
with our innovative sensorized active device (TS2-A
and TS2-B). As with the previous TS, five
consecutive attempts were provided to all trainees in
order to evaluate training improvements in terms of
both execution times and alarm conditions.
Execution time of each performance were gathered
and alarm conditions presented during the program
running were counted; further, collected data were
statistically analysed. Finally, a qualitative
questionnaire on the training experience with the
sensorized skill trainer was given to the residents.
Fig 4: Comparison between the intubation time for

subjects of Group A during the traditional and
sensorised training sessions with error bars (panel A)
and for subject of Group B with videolaryngoscope
and sensorized skill trainer (panel B).
In addition, by comparing the data collected for

Group A and Group B in TS2, we observed that
intubation times for Group A were much lower than
for Group B (p0.01) as reported in Fig 5.
RESULTS
To investigate the effectiveness of the active
intubation skill trainer as a training system within
simulation-based educational programs, we asked the
selected residents to complete both training sessions
as soon as possible.
Within TS1-A (traditional head-neck sensorless
mannequin
coupled
with
straight
blade
laryngoscope), residents' mean intubation time ranged
from 21 to 33 s (MDSD=295 s). On the contrary,
values decreased up to 12-27 s (MDSD=176 s) in
TS2-A (active intubation skill trainer) (Fig 4A).
The intubation times for TS1-B and TS2-B were in
the range 13-25 s and 17-58 s respectively (Fig 4B),
showing a mean intubation value of 166 s with the
videolaryngoscope which grew up to 4015 s when
the intubation procedure was accomplished with the
custom active skill trainer.
Tognarelli et al.,
Fig 5: Intubation time of Group A and Group B

by using the active skill trainer.
Finally, in order to identify the critical points exposed
to higher stress during the intubation training
sessions, the alarm conditions collected during the
program running were recorded and further
investigated. For all the residents, the superior
gingival arch and the neck are the anatomical points
which were repeatedly stressed during an intubation
procedure.
836
Fig 6: Graphic interface showing the applied forces

analysis during a simulation. Force levels are
indicated as connected to warning light activation.
DISCUSSION
Based on our preliminary introductive considerations,
we developed an active neonatal skill-trainer able to
give immediate feedback of the accuracy of the
ongoing manoeuvres fixing force sensors in specific
anatomical positions of the Laerdal commercially
available neonatal intubation trainer. In our opinion,
the idea of modifying a traditional simulator by
adding commercially available force sensors
guarantees high system stability, repeatability and
intuitiveness. Actually described manipulations of the
existing system alter the manufacturers warranty,
even though the aim of the study is the evaluation of
the technology feasibility. Nevertheless, specific
warranty agreements with Leardal are under
investigation to obtain a new commercial device.
System capabilities were investigated by means of a
dedicated training session with a well-framed training
protocol. Residents' performances in terms of
intubation time and number of red lights, and
consequent alarms for stressed contact conditions,
were analyzed. Based on the experimental
comparison between TS1-A and TS2-A, the active
sensorized system led to a significant reduction of
mean intubation time and related errors (Fig 4A).
This result can be explained by considering that
during the active training session, the subjects gave
much more attention to the intubation manoeuvres
due to the alarm. Taking in mind that intubation
actions require a great clinical experience, since the
manoeuvre has to be both quick and performed
correctly to avoid complications (e.g. Trauma to the
trachea, hypopharynx, vocal cords and lips,
misplacement into the oesophagus or bronchus,
fracture or dislocation of the cervical spine, temporomandibular joint or arytenoid cartilages), this result
Tognarelli et al.,
represents an essential issue of the study and

highlights the good potentialities of the device.
Different behaviors were observed by interchanging
the developed sensorized system with a
videolaryngoscope set-up. The results for Group B
with the active skill trainer (TS2-B) were higher if
compared with the time employed by the same
subjects with the video laryngoscope system (TS1-B)
(Fig 4B). This outcome highlights the importance of
training for the non-expert subject. Group A used the
same mannequin and laryngoscope for both test
sessions; the only difference was related to the fixed
sensors in the critical points, which led to lower times
probably associated to higher concentration, as
already pointed out. On the contrary, Group B testing
sessions involved first a video laryngoscope and then
a traditional laryngoscope.
The better working condition showed by the video
laryngoscope led to results which are not comparable
with the active TS. This statement is confirmed by
literature evidence12-14.
Moreover, it is worth mentioning that for Group B a
significant increase of execution time during the first
attempts of TS2-B produced a psychological stress on
the subjects which led to an increase of intubation
time moving from the first to the last attempt (data
not shown). Diametrically opposite was the
psychological condition of Group A subjects during
the TS2-A: the higher attention paid by the residents
to the intubation manouvers led to better results in
terms of procedural time.
We showed that the developed sensorized skill trainer
guarantees a real time feedback on the effectiveness
of the intubation manoeuvres and a higher learner
concentration. Finally, by evaluating the number of
sensors-laryngoscope contacts, superior gingival arch
and neck were recognized as the critical anatomical
points mainly stressed during an intubation
procedure. This result provides important information
for residents training, allowing toimprove their
intubation methodology. Moreover, it could also be
used for obtaining quantitative information about
forces employed by the residents during the
procedure: by exploiting the FSR datasheet, the
voltage data can be converted into their pressure
equivalent value (Fig 6). Such information could be
used to perform an analysis on potentially damaging
stress levels.
837
From a clinical viewpoint, the developed system

represents an efficient means for clinicians'
simulation-based education enhancement, as pointed
out also by the residents at the end of the training
course. Both control lights and warning sounds are
efficient feedbacks of residents performances: the
trainees use the only warning sounds for improving
their manoeuvres, on the contrary the trainers need to
have a double check on the GUI for identifying the
point of damage. Moreover, by means of the
qualitative questionnaire on the training experience,
the residents highlighted the simplicity and the
intuitiveness of this innovative device coupled with a
user-friendly interface. However, being this a
preliminary investigation of technological feasibility,
the obtained outcomes can be considered as
validation results and no statistical relevance has been
demonstrated.
On the other hand, from a technical viewpoint, a
limitation for the system stability is related to the
intrinsic weakness of the FSR force sensors, stressed
by using cyanoacrylate glue for fixing the force
sensors on the silicon structure of the mannequin. The
glue makes the sensor base rigid, increasing its
fracture risk. To guarantee better technical
performances, the inclusion of the sensor under the
mannequin silicon structures during the system
manufacturing process could be investigated. By
avoiding the glue and reducing the direct contact
between the laryngoscope and the active part of the
sensors, system robustness and measurement
precision could be easily improved.
CONCLUSION
Based on the observed results, the developed
sensorized infant simulator may represent an
innovative turning point for the CME program. It
maintains a playful feature, but, at the same time, it
offers a valid means for a rapid and incisive learning
of the neonatal oral-trachea intubation procedure,
which is usually recognized as one of the most
difficult paediatric interventions. The obtained results
confirm the achievement of this goal.
ACKOWLEDGEMENTS
This paper was partially supported by MERESSINA
Project, funded by AGENAS Commissione
Nazionale per la Formazione Continua - Italian
Tognarelli et al.,
Ministry of Health, grant Sviluppo e ricerca sulle

metodologie innovative nella formazione continua
anno 2011 (Grant n. Codice gara: 4353869. An
approval number of funding Codice CIG:
4415895FD1) and by Azienda Ospedaliera
Universitaria Pisana (Pisa, Italy). The authors wish to
thank Dr. Michele Coceani for his invaluable help
during the English revision, and Mr A. Melani and G.
Passetti for manufacturing the prototype.
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&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
rd
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 4 Aug 2014
TOOTHBRUSH DISINFECTION A MYTH OR REALITY? A COMPARATIVE EVALUATION OF

4% DISODIUM EDTA, 10% SODIUM PERBORATE IN THE DISINFECTION OF TOOTHBRUSHES:
CLINICOMICROBIOLOGICAL STUDY
*Nilofer Sultan Sheikh1, Nilima Rajhans2, Nilkanth Mhaske3, Nikesh Moolya3, Sudip HM
1
Second year Postgraduate student, 2Professor& Head, 3Reader, 4Senior Lecturer, Department of Periodontics,
Late Shree Yashwantrao Chavan Memorial Medical and Rural Development Foundations Dental College and
Hospital, Ahmednagar, Maharashtra.
*Corresponding author email:dr.nilu18sheikh@gmail.com
ABSTRACT
Aim: The aim of this randomized clinical trial was to evaluate the bacterial survival rate on toothbrushes and
efficacy of their decontamination by4% disodium ethyl diamine acetic acid [EDTA], 10% sodium perborate and
compared with control. Methods: Thirty subjects with chronic periodontitis enrolled in this randomized
controlled clinical trial were provided with autoclaved toothbrushes which were free from microorganisms.
Brushing instructions were given to each participant. Toothbrushes were collected from all study participants after
1 week and were placed with head down position in an autoclaved test tube containing sterile peptone water.
Toothbrushes collected were sent for aerobic culture in laboratory for growth of micro-organisms. Incubation was
done for 24 hours at 370C.The toothbrushes were then divided into three groups and immersed in
disinfectantslike4% disodium EDTA, 10% sodium perborate and their efficacy was evaluated by aerobic culture
analysis. Chi Square test was used for statistical analysis of the data. Results: Escherichia coli, Pseudomonas
Aeroginosa, Streptococci and Klebsiella species were recovered from the samples. The results obtained showed
that 4% Disodium EDTA showed 100% efficacy, whereas 10% Sodium perborate showed 40% effectiveness in
decontaminating the toothbrushes. Distilled water as a control showed least effectiveness in cleaning
toothbrushes. Conclusion: After single brushing toothbrushes get contaminated by a wide array of bacterias
which a major cause of concern is. As contaminated toothbrush can reintroduce microorganisms into the oral
cavity, it is therefore recommended for individuals to use solutions like 4% Disodium EDTA, which proved to be
an effective disinfecting agent for decontaminating toothbrushes.
Keywords: Toothbrush, Microorganisms, Ethylenediaminetetraaceticacid, Sodium perborate.
INTRODUCTION
The most common oral hygiene aid used to improve
the oral health of an individual is the toothbrush.
After a single use, within thirty seconds to four
minutes it gets contaminated by a wide array of
bacteria, viruses, yeasts and fungi present both in oral
cavity and storage area of toothbrushes.1These microorganisms remain viable for periods ranging from 24
hours to 7 days. These contaminated toothbrushes

might play a role in systemic and oral diseases.
Injuries to oral tissues are aggravated by the use of
contaminated toothbrushes when compared with
sterile ones and may even cause septicaemia after
brushingTransient bacteraemia can be induced by
tooth brushing, increasing the potential risk of
840
Nilofer et al.,
Int J Med Research Health Sci. 2014;3(4):840-846
transmission, which may be exacerbated in people

with gingivitis and periodontiti2,3.Knowledge of
toothbrush contamination is yet void among the
population and in the literature as well.Different
brushing techniques have been described in the
literature, but there is inadequate information about
the maintenance of toothbrushes to avoid their
contamination with micro-organisms. Hence there is
a need for disinfection methods that are rapidly
effective, non-toxic and that can be easily
implemented. Modern dentistry strongly emphasizes
on prevention and bio security regarding how
toothbrushes should be appropriately stored, used and
disinfected. It is essential to decontaminate
toothbrushes in order to eliminate pathogenic microorganisms transmitted to used toothbrushes from oral
cavity or from other toothbrushes and storage
area4.Soaking the toothbrush in alcohol was one of
the first recommended procedures for toothbrush
disinfection in 19205.Later in 1929 Kauffmann6 listed
some methods for sanitation and drying of
toothbrushes such as sunlight and table salt to absorb
their moisture and to keep the brush in a closed
container with a preparation containing formaldehyde
for its disinfection, other methods included the use of
ultravioletlight 7 immersion in a disinfecting
solution8,9 and spraying of antimicrobial solution on
bristles.10,12.Tetra sodium EDTA has been reported to
be effective in killing mature bio films on
toothbrushes, reducing the viable count by more than
99%. The ability of Tetra sodium EDTA to neutralize
both enveloped and nonenveloped viruses are also
important in relation to minimizing the cross
infection risks associated with toothbrushes.13, 14.
Sodium perborates are the group of oxidants that
possess a high spectrum of activity and are
environment friendly.15, 16. Amongst the herbal agents
literature has reported Neem [Azadirachtaindica] that
has many medicinal properties and it has been used in
India since ancient times as the preferred medicine
for treating teeth and gum diseases. It has therapeutic
activities such as antiulcer, antiseptic, insecticidal,
astringent and for cleaning teeth in gingivitis and
periodontitis.17, 18 The purpose of this chapter was to
evaluate the bacterial survival rate on toothbrushes
and to assess the efficacy of their decontamination by
immersing them in different disinfectants such as 4%
tetra sodium EDTA, 10% sodium perborate in regard
to bacterial contamination.

Thirty patients (twenty males and ten females) aged
more than 35 years suffering from chronic
periodontitis having an attachment loss of 3-5 mm
were randomly selected from the outpatient
Department of Periodontology, YashwantraoChavan
Memorial and Rural Development Foundations
Dental College, Ahmednagar, Maharashtra, India.
Ethical clearance for the study was approved by the
Ethics Committee of YCMM & RDFS University.
Subjects using antibiotics, mouthwashes, chewing
gums, tobacco and subjects with oral or systemic
disease or undergoing any dental treatment were
excluded from the study. Informed consent regarding
the benefits and the protocol of the study was
obtained from all the participants. A total of thirty
Toothbrushes procured from ICPA Pharmaceuticals,
Mumbai, India were autoclaved and given to each
participant to ensure that the new toothbrushes were
free from contamination before its use by study
subjects. The duration of the study was 1 week. At
the beginning each participant was given the
following oral hygiene instructions like brushing
twice daily with the toothpaste by Modified Bass
technique for a time period of two to five minutes.
All the study participants were instructed to use the
toothbrush exclusively and not to share it with
anyone.The toothbrushes were placed upright in a
rack and were kept isolated17. At the end of one week,
the toothbrushes were collected from all study
participants and stored in the test tubes containing
sterile peptone water up to the level of the head of the
toothbrush and closed with autoclaved cotton rolls.
Each toothbrush was decapitated using a sterilized
end cutting nippers and the heat transferred to a tube
containing 10 ml of sterile phosphate buffered saline
(P.B.S) 19.The contents were then subjected to
vigorous mixing for 60 seconds (Hook and Tucker
instruments LTD/England), ultrasonication for 30
seconds by using an ultrasonic device (England),
followed by further vortex mixing for 15seconds1.
Ten fold dilutions in (P.B.S) were then prepared for
each toothbrush head and 0.1% of the appropriate
dilutions were spread on duplicate of blood agar,
nutrient agar and Mac Conkeys agar media with a
sterilized spreader. The plates were incubated
aerobically at37degree Celsius for 48hours and
assessed for bacterial growth20, 21. Test tubes
841
Nilofer et al.,
containing Sabourauds dextrose agar media slant

were sub cultured by stroking with nichrome loop and
incubated at 27 degree Celsius for 48-72 hours to
assess fungal growth4. The different patterns of
colonies of micro-organisms were identified by
observing their colony morphology, gram staining
and biochemical reactions.
Preparation of disinfectant solutions: 4% disodium
EDTA was obtained by diluting 4gm of powder of
disodium EDTA in 100ml of sterile distilled
water.10% sodium perborate was prepared by
diluting 10 gm. of powder of sodium perborate in
100ml of sterile water. Commercially available
distilled water served as the control group.The tooth
brush heads were divided into three groups [Group I,
II, III] and immersed in disinfectants for 20 minutes.
Group I include 4% EDTA, Group II include sodium
perborate, and Group III include control. Control
groups of 10 toothbrushes contaminated with the
tested microorganisms were immersed into sterile
deionized water instead of the disinfectant
solution.After the immersion period; the toothbrushes
were transferred to tubes containing sterile distilled
water for 2 seconds to eliminate the excess of the
disinfectant. Then the solutions were discarded and
toothbrushes were kept in the containers, with the
head of the toothbrushes facing outwards for air
drying4. The collected data was analysed statistically
and Chi square test was used at the 5% significance
level.
streptococci. Group III showed increased microbial

counts of Escherichia coli followed by Streptococci,
Klebsiella and Pseudomonas Aeroginosa. The
percentage of bacterial contamination is observed in
Table 2 and Graph 1. The comparison between
control group and Group II is displayed in
Table3.The effect of disinfectants on microorganisms
isolated from contaminated Toothbrushes is displayed
in Table 4 and Graph 2. Statistically significant
results were observed between Group I& Group II,
and between Group I, Group III while no statistically
significant results were obtained between Group I &
Group II
Fig 1: Growth of E.coli on MacConkeys agar
Fig 2: Growth of Pseudomonas Aeroginosa on

MacConkeys agar.
RESULTS
In the present study, the toothbrushes showed
contamination with Escherichia. Coli, Pseudomonas
Aeroginosa, Streptococci, and Klebsiella. Maximum
species of micro-organisms that were found in sample
were of E.coli followed by streptococci, Klebsiella&
Pseudomonas Aeroginosa. No fungal growth was
found in any of the samples.The types of
microorganisms isolated from the toothbrushes that
were incubated on the various media are shown in Fig
1, 2, 3, 4. The comparison of decontamination effect
[reduction in the number and percentage of microorganisms] of different disinfectant solutions is
displayed in Table 1.Table1 showed that there was no
colony forming units per toothbrush in Group I,
whereas Group II showed increased microbial counts
of Escherichia coli followed by Klebsiella,
Pseudomonas Aeroginosa, with no or least counts of
Fig 3: Growths of Streptococci on Blood Agar.
Fig: 4 Growth of Klebsiella on Blood Agar.

842
Nilofer et al.,
Table: 1 Colony forming units / toothbrush & the

efficacy of disinfectant.
Disinfectant 4% Disodium 10%Sodium Control
EDTA
Perborate
E.coli
00
58000
61500
P. Aeroginosa 00
1400
1500
Streptococci 00
00
9000
Klebsiella
00
1700
1300
*Median values [cfu/toothbrush] of four microbial
species counts according to disinfectant used.
Statistically significant reduction of microbial count
with group I [p 0.01]
Group I [4% disodium EDTA] showed 100% results
by showing no growth of micro-organisms on any of
the toothbrushes.
Group II [10% sodium perborate] showed only 40%
reduction in the microbial load on toothbrushes.
Group III [control] showed 0% reduction of the
microbial load on toothbrushes.
Table3: Comparison between control group and

sodium perborate group.
Group III[Control]
10
Group II[10%Sodium Perborate ] 4
Chi-Square test
0.4
P - Value
0.50
Significance
NS
Statistically Nonsignificant [ p 0.001]

Table 4: Effect of disinfectants on microorganisms
isolated from contaminated toothbrushes.
Group
Aerobic bacteria
Fungus
Group I
No growth
No
(4%DisodiumEDTA)
growth
Group
II(10%
Sodium perborate)
Group III(Control)
Table 2 Percentage of bacterial contamination.

4%Disodium
EDTA
10% Sodium
Perborate
Control
00
10
00
40%
100%
Fig 5: Showing
contamination
percentage
Escherichia coli
Streptococci
Klebsiella species
Escherichia coli
Pseudomonas
species
Streptococci
Klebsiella species
No
growth
No
growth
DISCUSSION
of
bacterial
Fig 6 : Showing percentage of effectiveness of each

disinfectant.
Plaque is the etiologic agent in periodontal disease

and the removal of plaque is the most important step
toward a hygienic oral cavity. Removal of plaque is
performed with various oral hygiene devices, of
which toothbrush is the commonly used one. After
brushing, and also during storage, the toothbrush may
get contaminated with some microbes. So storage
condition of toothbrushes is an important factor for
bacterial survival22.Dayoub reported that the number
of micro-organisms in the toothbrushes kept in
aerated conditions was lower than in the toothbrushes
stored in plastic bags. They have also mentioned that
bacterial contamination can be reduced by washing
toothbrushes after use & drying in aerated
condition23.In the present study patients suffering
from chronic periodontitis were selected to assess the
bacterial contamination of toothbrushes. Cultivation
of plaque microorganisms from sites of chronic
periodontitisreveals high percentages of aerobic and
anaerobic bacteria species as reported in various
studies24,25. The results obtained in this study showed
that the micro-organisms isolated were Escherica.
Coli, Pseudomonas Aeroginosa, Streptococci, and
Klebsiella. The species that were present in the
highest percentage was of Eserchiacoli and the last
species was of Pseudomonas Aeroginosa. There was
843
Nilofer et al.,
no fungal growth in any of the toothbrushes, which is

somewhat similar to the study done by Sogi etal
where 30% growth of micro-organisms was seen after
first day of usage of toothbrush which increased to
100% by the end of twenty eight days. The isolated
microorganisms were staphylococcus pyogenes,
Klebsiella, E.coli, Proteus species and beta
haemolytic Streptococcus faecalis26 whereas another
study by Grewal and Kaur reported 40% of growth of
microorganisms after first day of usage, which
reached to 100% by the end of 1 month that was
maintained up to 3 months. The microorganisms
isolated were Klebsiella, E.coli and Streptococcus
faecalis27. Caudry reported that a wet environment
increases
bacterial
growth
and
cross
contamination8.As the number of days increases, the
number of micro-organisms will also increase in the
toothbrush bio film. Just like growth media, which
have properties of nutrients, moisture and storing in a
cool environment, toothbrush may act as an enriched
petri dish on a stick which may lead to bacterial
growth28.
Taji
identified
Candida,
Corynebacterium,
Pseudomonasand coli forms in used toothbrushes1.
Other studies concluded that these microorganisms
may survive for more than 6 hours after utilization of
the toothbrush. These authors correlated these results
with the possibility of cross-infection, which is of
great importance, particularly among children and
immunocompromised patients, and reinforced the
role of the daily disinfection of toothbrushes29, 30.
According to Devine et al. 13 there is a need for
disinfection methods that are rapidly effective, costeffective, and nontoxic that can be easily
implemented. However, most of the proposed
methods, such as Chlorhexidinegluconate9, 11, tetra
sodium EDTA and UV sanitization13, 29 fail mainly in
terms of cost-effectiveness and ease of
implementation.
The results of the present study regarding the high
effectiveness of EDTA are in accordance with
previous results, and the total absence of viable
microorganisms was observed after immersion for 20
minutes. 4% disodium EDTA has also shown 100%
efficacy in decontaminating toothbrushes. It has been
suggested that it severely damages permeability
barriers in the microbial species. EDTA damage is
caused by removal of either ca++ or Mg++ ions or
both from bacterial cell envelop13. In the present
study, 10% sodium perborate failed to reduce any

microbial contamination on toothbrushes. Sodium
perborate-based tablets are indicated for the cleansing
of prostheses and orthodontic appliances associated
with mechanical action11. Some authors have
observed the antimicrobial activity of these products
on prostheses31, 32. Harrison et al and McCabe et al.
observed that sodium perborate-based tablets
contributed significantly to the treatment of prosthetic
stomatitis32, 33.
Literature has suggested use of 3% Neem juice as an
effective disinfectant in decontaminating the
toothbrushes. Neem [Azadirachtaindica] is very
popular for having medicinal properties. 3% Neem
extracts can reduce up to 86% streptococcus mutans
in toothbrushes18. Another study conducted by Padma
K Bhatt etal showed 88% reduction of streptococcus
mutans in toothbrushes. This is may be due to
presence of Polyphenol tannins present in the extract
which could effectively bind to the surface associated
bacterial proteins, resulting in bacterial aggregation
thus effectively reduces the bacterial count17. The
design of the toothbrush in terms of filament
anchoring may have an effect on the retention of
microorganisms on the toothbrush33.These days there
are toothbrush sanitizer or germ terminator and
antibacterial storage systems that use an ultraviolet
bulb or steam combined with a proprietary automatic
drying process to kill 99.99 % of the microorganisms
present on toothbrushes7. In the absence of such
products in our markets the method used to minimize
contamination is by soaking the toothbrush in an
antimicrobial solution like EDTA and Neem, rinsing
the bristles thoroughly after each use, and storing in
an upright position which will help drain the water
and dry the brush faster. Although the evaluation of
the efficiency of toothbrush disinfectants is
recognized by means of the methodology used in this
study, it is necessary for this analysis to be
complemented by other tests, such as evaluation of
the action of disinfectants against specific anaerobic
microorganisms found in periodontal disease. It is
also necessary to use a larger and consequently more
representative sample of the studied population, with
the purpose of seeking more significant and more
scientifically reliable results. It is suggested that
future studies should be conducted to evaluate the
cleaning capacity of different disinfectants used at
present, in different concentrations and exposure
844
Nilofer et al.,
times and use the best disinfectant to maintain

toothbrushes for a long term basis.
CONCLUSION
Based on the results, it can be concluded that 4%
disodium EDTA proved to be an effective
disinfectant agent in reducing the microbial counts
and detachment of biofilms from the contaminated
toothbrushes. There is a need for disinfection
methods that are rapidly effective, nontoxic and
easily implemented. These studies thus indicate that
Disodium EDTA solution has disinfection
applications in the oral care field.
Clinical significance: Even though we have basic
knowledge regarding disinfection procedures for our
instruments & environment, certain things are
practically not implemented such as decontamination
of toothbrushes. In the medical field, some of the
diseases might have been unnoticed, which could be
transmitted through contaminated toothbrushes.
Therefore, there is a necessity to concentrate on
disinfection of toothbrushes thereby preventing
infections, re-infections or cross infections.
ACKNOWLEDGEMENTS
The authors would like to thank ICPA
Pharmaceuticals, Mumbai, India for the donation of
the toothbrushes used in the study and Department of
Microbiology, YCMM and RDF Dental College,
Ahmednagar, India for their microbiological analysis
used in the study.
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Nilofer et al.,
DOI: 10.5958/2319-5886.2014.00012.5

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
Received: 8th July 2014
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
Revised: 22nd July 2014
PATTERN OF FRACTURES AND DISLOCATIONS IN A TERTIARY CARE HOSPITAL, NORTH

EAST KARNATAKA
Bhaskara K1, *Padmanabha T S2, Nandini T3, Sindhu4,
1
Department of Orthopaedics, Bidar Institute of Medical Sciences, Bidar, Karnataka, India

Department of Pharmacology, Bidar Institute of Medical Sciences, Bidar, Karnataka, India
3
Department of Pharmacology, Sri Siddhartha Medical College, Tumkur, Karnataka, India
4
Internee, Bidar Institute of Medical Sciences, Bidar, Karnataka, India
2
*Corresponding author email: padmanabhatsp@gmail.com

ABSTRACT
Background: Trauma including accidents are todays world concern forming a major non-communicable
epidemic accounting for mortality and morbidity. The aim of the study was to determine and account the types of
fractures and dislocations presented to Bidar Institute of Medical Sciences (BRIMS), Bidar, Karnataka, India.
Methods and Material: This study is of retrospective in nature with a review of hospital inpatient case sheets of
orthopaedic department in our hospital presented between July 2011 to Dec 2011. The data gathered was analysed
by percentages. Results: Out of 132 cases analysed males (82.56%), outnumbered female (17.42%); 67.42 % of
cases were between 18-45 years age group; femur (22.17 %) was the most commonly involved bone followed by
tibia (13.21%), foot (10.85%); tibia & fibular (8.96%) involvement. Less common were spine (0.47%), vertebra
(0.94%) and scapula (0.94%). Fracture-dislocation was more common in lower limb (59.91% - ankle joint was
most common-50%) compared to upper limb (30.66%- shoulder joint: 12.5%). Conclusions: Among of 132
cases admitted 212 fractures & dislocation was noted. Male (82.56%) was more common than females (17.42%).
Age group most commonly involved was between 18-45 years (67.42%). Fracture was more common in femur
(22.17%) & dislocation was common in hip (42.86%) because of high velocity injury. Approach towards the
prevention of accidents by effective safety education, good roads and early intervention which is the need of the
hour. Effective drugs should be made available in the casuality so that crush injuries are managed without
complications like septicemia and tetanus.
Key words: fracture, pattern, dislocation, tertiary hospital.
INTRODUCTION
Man has to pay a heavy price due to altered fast life
as a result of the rapid advent of progress in
technology. These added to the fast life to meet the
needs of daily, are prone to accidents. These factors
are precipitated by poorly engineered road leading to
heavy casualty resulting in varied pattern of fractures
and dislocations. The presentation of trauma picture
follows a particular pattern, dictated by the huge
movement of population to meet the social needs and
during particular season namely rainy and summer.

This has added a huge burden to the society, resulting
in morbidity and mortality and really a deep concern
and liability to the nation at large. Due to high
velocity injury as a result of RTA (Road Traffic
Accidents), industrial accidents, train accidents, the
presentation of fracture pattern and types are varied
and challenging. It requires a highly effective trauma
Padmanabha et al.,
Int J Med Res Health Sci.2014; 3(4): 847-850
847
team care to prevent mortality and morbidity. The

fractures and dislocations require highly skilled care.
Accidents accounts for the 5th leading cause of
mortality, which accounts for 5.2% of all mortality,
according to 1996 who report1.Though the rates is
noticeably decreased in developed country, still it is a
burning problem in developing countries2. The
leading cause of death and disability for people under
45 years in the industrialized world is due to injury3, 4.
The accident is a major epidemic non-communicable
disease in the world. It has resulted in a
socioeconomic loss to the country and the community
at large RTA poses a major problem in huge
proportions in many places, mostly in industrialized
populations. Bidar that bridges Hyderabad to
northeast Karnataka, leading to Mumbai is highly
congested, busy road accounting for major casualty
that reports to BRIMS teaching hospital. The institute
serves as a major teaching care hospital catering part
of Medak district of Andrapradesh, northeast of
Karnataka, Maharastra. Hence the aim of this study
was to know the types of fractures and dislocations
due to RTA, and train accidents presenting to BRIMS
Teaching Hospital, Bidar.
A retrospective study was done, with an object of
analyzing the data available on trauma cases in the
orthopaedic inpatient department of BRIMS,
Teaching Hospital and Bidar. The study pattern
includes the fracture and dislocation due to RTA and
train accidents, OPD data has been purposefully
excluded from the study. The Institutional Ethical
clearance was obtained. The mode of study was
retrospective in nature and confined only to the
inpatient data, including both males and females, and
all age groups were included. The case sheets were
compiled and analysed from the MLC (Medico Legal
Case) record section as all RTA cases come under
medicolegal section. The information that gathered
from the record department compromised of patient
data, mode of injury, types of fracture and
dislocation. The collected data was compiled and
subjected to simple analysis and were expresses as
percentages. Inclusion criteria) Inpatients with
Fractures and dislocations due to RTA and train
accidents admitted to orthopaedic; b) both males and
females of all the age groups were included.
Exclusion criteria: a) All pathological fractures due to
infections were excluded; b) Patient not willing to

participate / discharged against medical advice was
excluded from the study.
RESULTS
Out of 132 cases analysed male 109 (82.56%),
outnumbered female 23 (17.42%). 67.42 % was
between 18-45 years age group followed by >45
years (19.70%) & <18 years 17 (12.88%); femur
(22.17 %) was the most commonly involved bone
followed by tibia (13.21%), foot (10.85%) ;tibia &
fibula (8.96%), humerus (8.01%), clavicle (7.55%),
radius only (6.60%); ribs, patella, hand were around
3-4% involved. Less common was vertebra (1.42%),
scapula (0.94%) (table-1). Fracture-dislocation (table2) was more common in lower limb (59.91% - ankle
joint was most common-50%) when compared to
upper limb (30.66%- shoulder joint: 12.5%) (Table3). Dislocation (table-4) was common with hip
(42.86%) followed by shoulder & ankle each
accounted for 28.57%.
Table: 1- Pattern of Bone Involvement.
No of
Percentage
Bone
cases
(%)
Femur
48
22.17
Tibia Only
28
13.21
Foot
23
10.85
Tibia And
19
8.96
Fibula
Humerus
17
8.01
Clavicle
16
7.55
Radius Only
14
6.60
Ribs
8
3.77
Patella
7
3.30
Hand
7
3.30
Radius And
6
2.83
Ulna
Pelvis
6
2.83
Facial Bone
4
1.89
Ulna Only
3
1.42
Vertebra
3
1.42
Fibula Only
2
0.94
Scapula
2
0.94
Total
212
100
848
Padmanabha et al.,
Table-2: Fracture Distribution Involving On Axial

Bones
Fracture Distribution No of cases %
Upper Limb
65
30.66
Lower Limb
127
59.91
Others
20
9.43
Total
212
100
Table-3: Fracture Involving Joints and Associated
with Dislocations
Joints
No of cases %
Upper Limb Joints
Shoulder
2
12.5
Wrist
1
6.25
Lower Limb Joints
Ankle
8
50
Hip
3
18.75
Knee
2
12.5
Total
16
100
Table-4: Simple Dislocation
Dislocations No of cases
Hip
3(Post:2right & 1left)
Shoulder
2(Ant:1right & 1 Left )
Ankle
2
Total
7
%
42.86
28.57
28.57
100
DISCUSSION
In our retrospective planned study most common age
group was between 18-45 years followed by >45
years. Age group between 18-45 years the most
productive, highly stressful period & mobile group
aiming to settle in life accounting for 67.42%. Above
45 years age group are generally prone to trauma
because of age factor accounting for 20%. Age
grouped in our scenario was similar to Meena et al5
involving 3rd & 4th decade; & Okoro et al6 study
showed 4th decade population was more commonly
involved. Jhan et al7 study showed that between age
group of 20 40 years, 53 % of the victims were
involved in a tertiary hospital in South India.
Male to female ratio in present study was 4.73:1
which was slightly higher when compared to
Swarnkar m et al8 (3.9:1) & in contrast both Meena
et5 al & Okoro et al6 studies showed male to female
ratio of 1.8:1
In our study lower limb involvement (59.91%) is
much higher compared to upper limb (30.66%)
involvement, which was in similar to Okoro i o etal6,
Akiodeo et al9 & Achibong et al10. But in another

study done by Meena et al5 showed upper limb
(70%) more commonly involved than lower limb
(20%). Because of varied risk factors, road traffic
varies from one location to another location, thus the
overall most common bone involved in present study
was femur (22.17%) followed by only tibial
involvement (13.21%). And in the upper limb
humerus (8.01%) was the most common bone
followed by clavicle (7.55%) & radius (6.60%).
Present study includes fractures more commonly due
to RTA, which was incomparable with other studies11,
12, 13
CONCLUSION
The study reviews the incidence of fractures due to
RTA, is more and on par with other tertiary teaching
hospital. Among of 132 cases admitted 212 fractures
& dislocation was noted. Male (82.56%) was more
common than females (17.42%). The age group most
commonly involved was between 18-45 years
(67.42%). The fracture was more common in the
femur (22.17%) & dislocation was common in hip
(42.86%) because of high velocity injury. It is need to
stress upon the multi level approach Highly skilled
and trained trauma team; use of Effective drugs,
including broad spectrum antibiotics that can cover
gram positive, gram negative, aerobes & anaerobic
organism; and immunoglobulins should be made
available in the casualty so that fractures and
dislocations with crush injuries are managed without
complications like septicaemia and tetanus and can
deliver proper care, thereby preventing morbidity and
mortality.
ACKNOWLEDGMENT
We thank the respondent for cooperation. My special
thanks to Dr. Vittal B G, who helped and provided
constant comfort and technical support during the
course of this study.
Conflict of the study: Nil
REFERENCES
1. Maciaux M, Romer CJ. Accidents in children
and young adults. Major public health problem.
Wld hlth stat Quart 1986;39:227-31
849
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2. Onotade FJ, Fatusi OA, Ojo MA. Call hour

maxillofacial emergencies presenting to a Nigeria
teaching hospital. African Journal of oral health.
2004; 1(1):17-24.
3. Zwi A. The public burden of injury in developing
countries: a critical review of literature .Trop.
Dis. Bull. 1993;90:5-45
4. Forjouh SN, Gyebi-Ofosu E. Injury surveillance:
should it be concern to developing countries? J
Pub. Hlth. Pol. Autumn 1993;14(3):355-9.
5. Meena RK, Singh AM, Singh CA, Chishti S,
Kumar AG, Langshong R. Pattern Of Fractures
And Dislocations In A Tertiary Hospital In North
East India . The Internet Journal of
Epidemiology: 2013;11(1)
6. Okaro IO, Ohadugha CO. The anatomic pattern
of fractures and dislocations among accident
victims in owerri, Nigeria. Nig jorn of surg
research 2006;8:54-56
7. Jha N, Srinivasa DK, Roy G, Jagadish S . Injury
pattern among Road traffic accident cases: a
study from south India. Indian journ of comm.
Med. 2003; 28 (2) : 85-90
8. Swarnkar M, Singh P, Dwivedi S. Pattern of
trauma in Central India.-an epidemiological study
with special reference to mode of injury .The Int
Journ of Ep.2010; 9(1):
9. Akiode O, Shonebi O, Musa A, Sule C.Major
limb amputations: an audit of indications in a
Suburban surgical practice. J Natl Med Assoc.
2005;97(1):74-78
10. Achibong A E, Onuba O. Fracture in children in
South-eastern Nigeria. Centr.Afr. J.Medicine
1996;42(12):340-43
11. Shaheen MA, Madr AA, al-kbudary N, Kham
FA. Mosalem A, Sabet N. Pattern of accidental
fractures and dislocations in Saudi Arabia. Injury
1990; 21(6):347-50.
12. Patil S S, Kakade R V, Durgawale P M, Kkade S
V. Pattern of road traffic injuries. A study from
western maharastra. Indian J community
medicine; 2008; 33(1):56-7
13. Thanni L O, Kehinde O A.Trauma at Nigerain
teaching hospital; pattern and documentation of
presentation. Afr Health Sc 2006;6(2):104-07
850
Padmanabha et al.,
DOI: 10.5958/2319-5886.2014.00013.7

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 5 Aug 2014
Accepted: 31st Aug 2014
A STUDY OF BREASTFEEDING AND COMPLEMENTARY FEEDING PRACTICES WITH

EMPHASIS ON MISCONCEPTIONS AMONGST THE WOMEN WITH UNDER TWO YEAR
CHILDREN IN RURAL AREA
Rahalkar Ashwinee A1, *Phalke Deepak B2, Phalke Vaishali D3
1
Student, Final MBBS, Rural Medical College, Pravara Institute of Medical Sciences, Loni, Maharashtra, India
Professor, Department of Community Medicine, Pravara Institute of Medical Sciences, Loni, Maharashtra
2,3
*Corresponding author email: deephalke@yahoo.co.in

ABSTRACT
Context: Breastfeeding is one of the most important determinants of child survival, birth spacing, and the
prevention of childhood infections. The beneficial effects of breastfeeding depend on its initiation, duration, and
the age at which the breastfed child is weaned. The complementary feeding pattern also plays a very important
role in the growth and development of the child. Aims & objectives: To study breastfeeding and complementary
feeding practices adopted by women of Loni area. To study the socio-cultural factors influencing breastfeeding
and complementary feeding practices. Settings and Design: Descriptive cross sectional study Methods and
Material: 150 women fulfilling eligibility criteria were taken up for the study for duration of two months. A
detailed questionnaire was given to the mothers and results were analysed later on. Statistical analysis used: Chi
square test Results: In 4.6% cases prelacteal food was given. Colostrum was given in 90% cases, while in 10% it
was not given. Only 50.6% babies were breastfed within 1 hour, Complementary feeding was started after 6
months in 84% babies, before 6 months in 4% and 12% did not know when to start weaning. Majority (58%) said
no to breastfeeding when mother was ill while 56.5% women had no change in their diet after delivery. Mothers
educational status was associated with proper breastfeeding practices while parity and socioeconomic factors had
no significant impact. Conclusions: Most of the women adopted appropriate practices regarding breastfeeding
and complementary feeding, but still misconceptions were noted. Thus more awareness should be created
regarding this topic.
Keywords: Breast feeding, Complementary feeding, Sociocultural practices
INTRODUCTION
For almost all infants, breast milk remains the
simplest, healthiest, and least expensive food, which
fulfils their requirement1. Breastfeeding is one of the
most important determinants of child survival, birth
spacing, and the prevention of childhood infections.
Under any circumstances, breast milk is the ideal
food for the infant. Proper implementation of
recommendations regarding breastfeeding and
complementary feeding will respectively prevent
13% and 6% (total=19%) deaths in under 5 age
Ashwinee et al.,
group2. A great asset in India is that on an average

Indian mother, although poor in nutritional status, has
a remarkable ability to breastfeed her infant for
prolonged periods, sometimes extending up to nearly
2 years and beyond. Longitudinal and cross sectional
studies indicate that poor Indian women secrete as
much as 400-600 ml of milk per day during the first
year3
It has been well documented that breastfeeding has
many beneficial effects on the baby as well as the
851
mother. It has been observed that infants between 0-5

months who have not been breastfed have a sevenfold and five-fold increased risks of death due to
diarrhoea and pneumonia, respectively, than infants
who have been exclusively breastfed. Also, nonexclusive rather than exclusive breastfeeding results
in more than twofold increased risk of dying due to
pneumonia and diarrhoea with higher risk in 6-11
month old infants1
The complementary feeding pattern also plays a very
important role in the growth and development of the
child. Complementary feeding means gradual
withdrawal of the child from breast milk and giving
supplementary food. There is very little data available
on socio-cultural practices in rural areas, owing to
location of medical colleges mostly in urban areas.
Since present study is conducted in a tertiary care
hospital of rural area, it brings an interesting
perspective regarding problems of childrens nutrition
in rural community.
METHODS
It is a descriptive cross sectional study conducted
among 150 lactating mothers who attended Paediatrics
OPD and wards during the study period (May 2013 to
June 2013) in a Tertiary care hospital attached to
medical college in a rural area of western Maharashtra.
The institutional ethical committee clearance was
obtained before initiation of the study. Women having
children in the age group of 0-2 years were enrolled
for the study. While women suffering from infectious
diseases like HIV and those suffering from contagious
diseases in the area of the nipple were excluded.
Study design: - It is a descriptive cross sectional
study conducted in Tertiary care hospital. Women
fulfilling the eligibility criteria were enrolled. A
detailed questionnaire was made in consultation with
the research committee. The questionnaire was
translated into the local language (Marathi) and was

used to assess knowledge and practices related to
breastfeeding and complementary feeding after
obtaining verbal consent of the participants. Women
having children of any sex i.e. male or female were
included in the study.
The questionnaire covered the following parametersMothers age, gravida, parity and educational status,
occupation of both parents, per capita income per
month, various practices related to breastfeeding like
an initiation of breastfeeding, giving colostrum,
giving pre-lacteal feed, period of exclusive
breastfeeding etc. knowledge regarding the
advantages of giving colostrum, continuing/
discontinued breastfeeding when a child is suffering
from diarrhoea, age of initiation of complementary
feeding type of supplementary food given, changes in
mothers diet after delivery. Pamphlets showing
appropriate breastfeeding position as per the Infant
and Young Child Feeding (IYCF) module was used
to ask the mothers if they breastfed their children in
the same manner. And later on, pamphlets were given
to the mothers to educate them. Once the
questionnaire was filled, doubts related to the same
were clarified.
Study Duration- May 2013 to December 2013
STATISTICAL ANALYSIS
The data was collected. Statistical analysis using Chi
square test was done to see the association between
socio cultural-factors and breastfeeding and
complementary feeding practices.
RESULTS
It was seen that 7/150 babies were given pre-lacteal
feed. Sugar water, cow milk, goat milk, jiggery and
honey were given as pre-lacteal feed.
Table 1: Education v/s knowledge and practices related to breastfeeding

Mothers educational status Nil/
Primary Secondary
Chi square P values
Graduation
education
education
value
Advantages
of Yes
4/19 (21.0%)
40/114 (54.4%) 11/17(64.7%)
*P<0.05
colostrums
No
15/19 (78.9%)
74/114 (45.6%) 6/17 (35.3%) 7.88
Colostrum given or Yes
18/19 (94.7%)
110/114 (96.5%) 17/17 (100%)
P>0.05
not
0.082
No
1/19 (5.3%)
4/114 (3.5%)
0
* Statistically significant
It was seen that, mothers who were graduates or had
protects the baby against infections, as compared to
secondary level education knew that colostrum
those having a primary or nil education. Even then,
852
Ashwinee et al.,
colostrum was given by majority of the women from

all three groups. Thus, education was positively
associated with awareness regarding advantages of
colostrum while no association was seen between
educational status and practice of giving colostrum.
Table 2: Initiation of breastfeeding
Initiation of
Number of
%
breastfeeding
women
Within 1 hour of birth
76/150
50.5
Within 2-5 hours of
38/150
25.3
birth
1 day-1 month after
36/150
24.3
birth
50% of mothers initiated breastfeeding within 1 hour
after birth. It was observed that in some cases
breastfeeding was initiated after a day up to 1 month
after birth.
Table 3: Parity versus complementary feeding
practices
Parameter
Primipara
Multipara
Complementary
1/32
2/67 (2.9%)
feeding before 6
(3.1%)
months
Complementary
31/32
65/67
feeding after 6
(96.9%)
(97.0%)
months
Chi square value
0.005
P value
>0.05
99/150 babies were given supplementary food; while
in 51 exclusive breastfeeding was done.
No significant correlation was observed between
parity and complementary feeding practices. In primi
as well as multi para, complementary feeding was
done after 6 months in majority of the cases.
Table 4: Changes in mothers diet after delivery
Number of women
Diet
%
No change
83
56.6
Additional diet 35
23.4
Less diet
29
19.4
Liquid diet
1
0.6
Majority of the women made no changes in their diet
after delivery. A few, in fact, consumed less than
normal diet.
It was observed that per capita income per month had
no impact on the duration of exclusive breastfeeding.
Most of the women in both groups had done
exclusive breastfeeding up to 6 months of age.
Majority of the women were aware that feeding
should be continued even when the child is suffering
from diarrhoea. But still some said no to feed when

the child was suffering from diarrhoea (fig: 1)
Table 5: Association between economic status and
duration of exclusive breastfeeding
>Rs 900 per er <Rs 900 per
person
per person per
month
month
Exclusive breastfeeding
for more than 6 months
for less than 6 months
for less than 6 months
Chi square value
P value
86
38
17
3.95
>0.05
Fig 1- Should breast feeding be continued when child

is suffering from diarrhoea
Should feeding be continued when

child is suffering from diarrhoea?
19.40%
4.60%
76%
Yes
No
Dont know
DISCUSSION
As per IYCF guidelines pre-lacteal feed should not be
given to a baby. Even then, as per the traditional
practice, pre-lacteal feed was given to little babies.
Although in few women, this misconception of giving
pre-lacteal feed was observed.
Ideally breastfeeding should be initiated within one
hour after birth2. However, as per table 2, in this
study, it was found that only half of total number of
women initiated breastfeeding within first hour of
birth. While a quarter of them started it within 2-5
hours after birth i.e. total three quarter of mothers
initiated breastfeeding on the first day after birth.
Thus, the correct practice of initiation of
breastfeeding immediately after birth was not adopted
by all mothers showing another misconception in our
area. In contrast to this, only a quarter of women
started breastfeeding their babies on the first day of
birth in rural areas of Punjab4. While, higher number
of mothers initiated breastfeeding within first 2 hours
853
Ashwinee et al.,
of birth in another study carried out in a rural area of

Maharashtra5.However, as per National family health
survey III (NFHS III) it was found that less than one
fourth (23%) of women in India2 and more than half
(52%) women of Maharashtra initiated breastfeeding
early2. Thus, the results of our study were comparable
to that of the regional figure of Maharashtra but not
comparable to national figures. According to table I,
majority of the mothers gave colostrum to their
babies, but still one tenth discarded it. This is a
misconception that colostrum should not be given,
which was seen in some women. Even though
colostrum was given by most of the mothers,
awareness regarding its advantages was seen in very
few. Exclusive breastfeeding for 6 months has a
potential to reduce under 5 mortality rate by 13%.
Although most of the babies were exclusively
breastfed for more than 6 months, there were few
who started complementary feeding before 6 months
of age and some did not know till what age exclusive
breastfeeding should be done. Studies have shown
that sometimes exclusive breastfeeding is done much
beyond 6 months, which is insufficient to fulfil the
childs nutritional demand and thus should be
discouraged7 and in our study also few such cases
were found where exclusive breastfeeding was done
much beyond 6 months. Hence, awareness regarding
the age of exclusive breastfeeding was seen in most
of the women, however not seen in all.
At the time of antenatal counseling, emphasis should
be placed on importance about the advantages of
breastfeeding thereby improves breastfeeding
practices8. Even then, only one-fifth of the women
were told about appropriate breastfeeding methods
and its advantages during antenatal counseling. So,
not all women were told about the method and
advantages of breastfeeding, antenatal counseling
should have been done ideally. Nutritional demand of
women increases during pregnancy and further
increases during lactation9. Thus, appropriate changes
in the diet should be done after delivery. As seen in
table 4, not even one fourth of the women had an
additional diet after delivery there by proving that
knowledge regarding changes in mothers diet after
delivery was poor. As per WHO guidelines, it is
recommended that breastfeeding should be continued
even when the child is suffering from diarrhoea. But
still, as per figure 1, almost more than one quarter of
women said no to breastfeeding when the child was
Ashwinee et al.,
suffering from diarrhoea, showing that misconception

related to feeding practices when child was having
diarrhoea was present. In primi as well as multi para,
complementary feeding was done after 6 months in
most of the cases. As observed in table 3, no
association was seen between parity of the mother
and age of introduction of complementary feeding
Also according to table 5, no association was
observed between socioeconomic status and duration
of exclusive breastfeeding as it was done up to 6
months in most of the women belonging to different
socio-economic classes.
Thus,
knowledge
and
practices
regarding
breastfeeding and complementary feeding were
influenced by-mothers educational status. But no
significant variations were seen due to factors likeparity of the mother and socioeconomic status.
CONCLUSION
Though majority of the women adopted appropriate
breastfeeding and complementary feeding practices,
there is still need of creating awareness regarding
breastfeeding and complementary feeding practices
as misconception of not giving colostrum, giving of
pre-lacteal feed and late initiation of breastfeeding
were existing. Also, some women did not know about
the age at which supplementary food should be
introduced. There were inadequate changes in
mothers diet after delivery and feeding was not done
when child was suffering from diarrhoea. Thus, there
is need of educating the women regarding
breastfeeding and complementary feeding practices.
LIMITATIONS
A larger sample size would yield better results for
generalization. This is a hospital based study thus the
results cannot be generalized. Recall bias of
participants is also a limitation.
RECOMMENDATIONS
The antenatal counselling regarding importance of
colostrums & breastfeeding practices should be
given. Doctors, nurses, postgraduates and interns
should help the mother for initiation of breastfeeding.
Drawbacks of bottle feeding must be emphasized.
Audio-visual aids like a television set showing proper
breastfeeding and weaning practices should be
provided in gynaecology and paediatrics OPD.
Removing misconceptions & misbelievers regarding
854
breastfeeding and complementary feeding during

ANC and PNC is necessary.
ACKNOWLEDGEMENT
Authors acknowledge support from Indian Council of
Medical Research, New Delhi for supporting this
research through an STS - program for year 20132014; Ref ID 2013-00287
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International Journal of tropical disease and
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by Maharashtra University of Health Sciences,
UNICEF, Breast Feeding Promotion Network of
India(Maharashtra State Branch), Rajmata Jijau
Mother Child Health & Nutrition Mission, Govt.
of Maharashtra, ICDS, DWCD, Dept. of Family
Welfare, Govt. of Maharashtra, 2005
3. Park K, Textbook of Preventive and Social
Medicine. 2013 22nd edition ; 497-99.
4. Bulletin of Breastfeeding Promotion Network of
India 2012; 35: 5
5. Deshpande JD, Giri PA, Phalke DB, Phalke VD,
Kalakoti P, Aarif MM. Socio-cultural practices in
relation to breastfeeding, weaning and child
rearing among Indian mothers and assessment of
nutritional status of children under five in rural
India. Australasian Medical Journal AMJ 2010;
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6. Ghai OP. Textbook of Essentials of Pediatrics,
2012 ;7th edition, 122
7. Khan ME. Breastfeeding and weaning practices
in India. Asia Pacific Population Journal 1990; 5:
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8. Mattar CN, Chong YS, Chan YS, Chew A, Tan
P, Chan YH, Rauff MH. Simple antenatal
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9. Park K. Textbook of Preventive and Social
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855
Ashwinee et al.,
DOI: 10.5958/2319-5886.2014.00014.9

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Revised: 10thAug 2014
Copyright @2014
ISSN: 2319-5886
A DESCRIPTIVE STUDY ON PREVALENCE OF BACTERIAL PATHOGENS IN DIABETIC ULCER

AND INTERVENTIONAL COMPONENT FOR THE PREVENTION OF FOOT ULCERS
Jerlin Priya1, Rajamanickam Rajkumar2, Bakthasingh3
1
Principal, Annammal College of Nursing, Kuzhithurai, Kanyakumari District, Tamil Nadu-629163,

Professor, Department of Community Medicine, Meenakshi Medical College, Kanchipuram, Tamil Nadu
3
Microbiologist, Joyce Clinical Lab, Marthandam, Kanyakumari District, Tamil Nadu-629156,
*Corresponding author email: jerlinmsnaccn@gmail.com

ABSTRACT
Diabetes is considered to have reached epidemic proportions worldwide. The most distressing complication of
diabetes is foot ulcer and is the major cause of lower limb amputation. Hence, they require a prolonged hospital
stay to combat more serious complications like gangrene and lower limb amputation. Early detection and prompt
treatment help in alleviating the ulceration. Methods: The present study was conducted among 50 diabetes
patients. Study subjects were selected using non probability purposive sampling technique. Pus samples were
collected by using sterile swabs in a sterile manner from the ulcerated area. The wounds are washed vigorously
with normal saline solution before collection of specimen. The specimens were transported immediately to the
laboratory for culture. The clinical specimens were first screened microscopically by Grams stain, and then
cultured on blood agar (aerobically and an aerobically), MacConkey agar and Robertson cooked meat broth for 48
hours at 37C in 5-10 percent CO2 and bacterias were isolated. Results: The socio demographic profile of the
present study reveals that males were predominant among the study population. Type II diabetes was more
common, majority of study subjects are suffering from diabetes for more than 5 years and are treated with oral
hypoglycemic drugs. The wound size was 2cms in majority of study subjects. The bacteriological profile of
diabetic ulcer reveals that a majority of 23 (46%) had growth of Staphylococcus aureus and 19 (38%) had growth
of klebsiella and a minimum of 6 (12%) and 2 (4%) had grown of Pseudomonas and Staphylococcus albus.
Conclusion: Early detection of these bacterial pathogens helps to minimize the disease progress.
Key words: Foot ulcer, Gram stains, Mac Conkey agar, Robertson cooked meat broth
INTRODUCTION
Diabetes is a chronic disorder that leads to serious
damage to many body systems. Globally, it is
estimated that 285 million people as of 2010 had
diabetes, out of which 90% of the cases constituting
Type II. A total of 366 million people have diabetes
in 2011. The International diabetes federation
estimates that 381 million people had diabetes in
20131. The prevalence of diabetes for all age-groups
worldwide was estimated to be 2.8% in 2000 and
4.4% in 2030. The total number of people with

diabetes is projected to rise from 171 million in 2000
to 366 million in 20302. In India the prevalence of
diabetes is more pronounced in urban areas, and is
roughly double than those in rural areas2-4. Also, the
prevalence is higher in men <60 years of age and in
women at older ages due to demographic changes5.
One of the horrendous manifestations of diabetes on
any patient is diabetic foot ulcer which means an
Priya et al.,
856
open sore or wound occurs on the bottom of the foot

resulting in ulcerations, infections, and gangrene. The
critical triad most commonly seen among patients
with diabetic foot ulcers includes peripheral sensory
neuropathy, deformity, and trauma. Annually the
incidence of foot ulceration is 1.0-4.1% and
prevalence is 4-10%. The principle causative factors
are peripheral neuropathy, vascular compromise,
ulceration and infections. Foot infections are a
common and serious problem in person with
diabetes3. Patients with diabetic foot infections most
commonly end up in serious complications of
gangrene formation and amputation. Most Diabetic
foot infections are poly microbial with aerobic gram
positive cocci and especially staphylococcus, the
most common causative organisms4. Delay in wound
healing, Inadequate treatment of foot infection and
bacterial resistance often end up in limb loss and the
treatment for complicated lesions becomes
challenging and rewarding, hence appropriate
treatment for diabetic foot ulcer remains
underestimated. Hence, the present study reveals the
prevalence of pathogens in diabetic foot ulcer among
patients in Type II diabetes mellitus. The authors
recommend a program called SAFE Self
Awareness & Foot Examination, if followed
meticulously, will prevent foot ulcers in diabetic
patients.
Hence the researcher did a descriptive study to
identify the prevalence of bacterial pathogens in
diabetic ulcer and interventional component for the
prevention of foot ulcers in selected hospitals at
Kanyakumari District. The main objectives are to
determine the common pathogens isolated from
diabetic ulcer and to recommend strategies for
prevention SAFE programme.
The investigator selected non experimental
descriptive research design on basis of problem and
objectives to be accomplished. The population of the
study was patients with diabetic ulcers with
controlled blood sugar values. The study setting was
selected hospitals at Kanyakumari district. The
researcher used non probability purposive sampling
technique and drawn 50 samples. Formal approval
was obtained from the Institutional review board and
Institutional ethical committee. Official permission
was obtained from the Medical officer of selected
Priya et al.,
study settings. Both written and oral information

about the study were given in local language to the
study participants. They were requested to participate
voluntarily in the study. The data collection
procedure was carried out in the month of July 2013.
Inclusion criteria
1. Patients of both male and female sex.
2. With history of diabetes for 5 yrs and above.
3. Patients with diabetic foot ulcer with controlled
blood sugar values.
4. Patients willing to participate in the study.
5. Age 40 and above with known diabetes mellitus.
6. Patient who are conscious.
Exclusion criteria
1. Patients with diabetic ulcer with elevated blood
sugar values of more than 250 mg/dl.
2. Patients with complicated lesions.
3. Patients with Arterial occlusive disorders.
Isolation of bacteria from diabetic ulcer
Sampling
Sample size was computed through power analysis.
The estimated sample size was 48. Considering the
attrition rate of 10%, the sample size was rounded to
50. Patients with diabetic wound, ulcer who fulfilled
the Inclusion criteria were included in the present
study. Both sexes were included with controlled
blood sugar values. Samples were collected after the
wounds are washed vigorously with normal saline
solution. Using sterile swabs (Hi media), the fresh
wound area from the margins and edges of an ulcer
were wiped with the cotton swab. The wound swabs
were then transported to the laboratory for culture.
Then, using various differentials and selective media,
the samples were cultured aerobically and an
aerobically and bacterial pathogens were isolated
using standard biochemical tests like Catalase
coagulase oxidase test, Indole MR-VP test, Citrate
test, TSI test.
Staining: This includes the microscopic appearance
of a stained preparation of the wound swab using
differential staining procedures is used. A gram
stained film prepared from wound swabs and from
culture were observed.
Plating: The collected swabs are subjected for
observation by Gram staining and isolation by
aerobic and anaerobic culturing using standard
techniques and media.
857
Aerobic Isolation: Collected swabs were streaked

over appropriate media. The media used are nutrient
agar, mac conkey agar, blood agar. The streaked
plates were incubated at 37c for 24 hours. After
incubation, the plates were observed for growth and
the isolated colonies were identified by
morphological by gram staining. Bacterial pathogens
were identified by conventional biochemical methods
according to standard microbiological techniques
[Kelly].
Anaerobic Isolation: Swabs with pus were
inoculated in freshly prepared tubes of Robertson
cooked meat broth. The top layer of the media is
covered with melted paraffin wax, So that oxygen
entering into the media is prevented. The top of the
tube is cotton plugged and was again dipped in wax.
The tubes were incubated in 37c for 3 days in order
to identify the growth of saccrolytic, proteolytic
anaerobes.
RESULTS
Table 1: Socio demographic profile of study subjects
S.No Variables
Frequency %
1.
2.
3.
4.
5.
6.
7.
Age in years
31-40
41-50
51-60
61 & above
Sex
Male
Female
Type of diabetes
mellitus
Type I
Type II
Duration of illness
5 years
6-10 years
11-15 years
15 years
Blood
sugar
controlled with
Oral hypoglycemic
Insulin
Alternative treatment
Others
Size of the ulcer
2 cms
2- 5 cms
5- 10 cms
10 cms & above
Random blood sugar
< 200 mg/dl
>200 mg/dl
10
10
30
20
20
60
40
10
80
20
2
48
4
96
20
30
-
40
60
-
45
2
3
90
4
6
35
15
-
70
30
-
24
26
48
52
Bacteriological profile
4%
12%
46%
Staphylococcus
aureaus
Klebsiella
Pseudomonas
38%
Staphylococcus
albus
Fig 1 - Bacteriological profile of diabetic ulcer

DISCUSSION
Table 1 reveals the socio demographic profile of
patients with diabetic ulcer. Among them majority of
30(60%) were in the age group of more than 60 years
and males were found predominant in the study
population, Also, 48(96%) were having Type II
diabetes. Similar findings were obtained in other
studies stating Type II was more predominant than
other types.5 The majority 30 (60%) of diabetic ulcers
in this study were seen in patients who have been
known to be suffering from diabetes for longer than 5
years. It is predominant that a majority of the 45
(90%) of diabetes patients in this study is under oral
hypoglycemic therapy. Also, majority 35 (70%) of
the study group had the ulcer size of 2 cms.
Regarding the blood sugar value of study participants
24 (48%) had less than 200 mg/dl and 26 (52%) had
more than 200 mg/dl.
Figure 1 reveals the bacteriological profile of
diabetic ulcer of the study population. Majority of 23
(46%) of diabetic ulcers had growth of
staphylococcus aureus, 19 (38%) had growth of
Klebsiella, minimum 6 (12%) of diabetic ulcer had
pseudomonas growth and least of 2 (4%) had growth
of staphylococcus albus in the diabetic ulcer.
Staphylococcus aureus, the predominant bacterium in
wound infection, which is similar to the finding made
by Banashankari et al. (2012)6. The frequently
reported organisms such as Klebsiella species and
Pseudomonas species were also common in the
present study. No evidence of anaerobic bacteria is
observed in the present study. However, it was also
evident in other studies that Gram-negative bacteria,
Gram-positive bacteria and few fungal species are
858
Priya et al.,
reported as more common microbes present in

diabetic foot infection7.
CONCLUSION
National Diabetes, Hypertension and Cardio Vascular

Diseases Control Programme.
Limitations: The investigator had difficulties in
sample selection.
Commonest bacterial pathogen isolated in this study

was Staphylococcus aureus, Klebsiella, and
Pseudomonas. This study will serve as a valuable
reference material for future investigators. Large
scale studies can be conducted. Early detection of
bacterial pathogen helps to minimize the disease
progress.
Safe programme
Prevention is better than cure. Emphasizing this
principle, the author proposes a daily procedure for
the patient, called self awareness & foot
examination safe.
Self awareness for a diabetic patient about foot care
helps in the following types of prevention.
Primordial prevention: Even before the risk factors
set in we should educate how to avoid such risks,
which will cause injuries. The patient is taught to
examine his foot every day for about 10 minutes, in
broad daylight, and check for any injury, callosities,
red, inflamed spots, examine in between the toes for
any colour changes, infections. He should also be
taught to take care of his toenails, cut them only after
soaking the feet in warm water for about 5 minutes.
Test for sensory loss in feet, will be done by health
care providers specially trained in this, and the patient
should seek their help to protect injuries to feet. Oral
intake of Vitamin B complex, especially Pyridoxine,
10mg per day, is very helpful in controlling
peripheral neuropathy.
Primary prevention: The patient should use proper
footwear, preferably without any buckles, metals, and
the inner sole should be made up of Micro Cellular
Rubber. The patient can wear soft footwear in the
house and also the outside foot wear should have a
strong bottom layer which will prevent thorn pricks
and other injuries.
Secondary prevention: The patient should seek
medical advice and attention even for even minor
injuries and should not manage the injuries by self.
Tertiary prevention: Medical/ Surgical management
and rehabilitation services should be sought by the
patient in appropriate time and the Government and
private health care systems are well established for
such health care services, especially under the
ACKNOWLEDGEMENT
Priya et al.,
The Investigator expresses heartfelt gratitude to her

guide for his valuable guidance, continued support
and expert suggestions to complete the present study
and also the study participants for their cooperation
throughout the study.
REFERENCES
1. Kovacs. www.expresshealthcare.in
2. Sundresh et al, Impact of patient counselling on
outcomes of Diabetic foot ulcer patients,
International journal of medical and applied
sciences, 2013, 4(2): 1-16.
3. Sampath Kumar et al, A comprehensive Review
of clinical features of management and Remedies,
Diabetes epidemic in India, 2012, 2(1):1-16.
4. Kannan Iyanar, Isolation and antibiotic
susceptibility of bacteria from foot infections in
the patients with diabetes mellitus, International
Journal of Research in Medical Sciences,
International Journal of Research in Medical
Science, 2014, 2(2), 457-60.
5. Sarah wild et al, Global prevalence of Diabetes,
American Diabetes Association, Diabetes care.
2004, 27(5): 1047-53.
6. Banashankari, G.S., H.K. Rudresh and Harsha,
A.H. 2012. Prevalence of Gram Negative
Bacteria
in
Diabetic
Foot-A
ClinicoMicrobiological Study. Al Ameen .J. Med. Sci.
2012; 5(3): 224 -32.
7. Mathangi, Prbhakaran, Prevalence of Bacteria
Isolated from Type 2 Diabetic Foot Ulcers and
the Antibiotic Susceptibility Pattern, International
Journal of current Microbiology and Applied
sciences, 2013, 10(2):329-37
8. Mohan et al, Epidemiology of type 2 diabetes:
Indian scenario, Madras Diabetes Research
Foundation & Dr Mohans Diabetes Specialities
Centre, Chennai, Indian Council of Medical
Research, New Delhi & Office of the World
Health Organization. 2010.
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9. William J Jeffcoate, Keith G Harding, Diabetic

foot ulcers, The lancet, 2000; 9(3): 1-5
10. Clarke EAM et al, The role of the podiatrist in
managing the diabetic foot ulcer, Wound Healing
Southern Africa, 2008, 1(1), 40-42.
11. International Diabetes Federation. Diabetes and
foot care time to act. International Diabetes
Federation. Brussels. 2005. www.idf.org/book
shop.
12. Williams Textbook of Endocrinology (12th
edition), Philadelphia, Elsevier/Saunders. 137135.
13. Kelly MT, Brenner DJ, Farmer JJ III.
Enterobacteriaceae. In: Lennette EH, Hausler WJ
Jr, Shadomy HJ, editors. Manual of clinical
microbiology, 4th ed. Washington DC: American
Society for Microbiology; 1986. 263-77
14. Banashankari, G.S., H.K. Rudresh and Harsha,
A.H..Prevalence of Gram Negative Bacteria in
Diabetic Foot-A Clinico- Microbiological Study.
Al Ameen .J. Med. Sci. 2012; 5(3): 224 -32.
15. Clinical. Diabetes journals.org. Diabetes Care,
2014;37:s 2-3.
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Priya et al.,
DOI: 10.5958/2319-5886.2014.00015.0

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
Coden: IJMRHS
Received: 5thJune 2014
Research article
Copyright @2014
ISSN: 2319-5886
CLINICO-BACTERIOLOGICAL PROFILE OF DIABETIC FOOT ULCER AMONG THE PATIENTS

ATTENDING RURAL TERTIARY HEALTH CARE CENTRE
Chavan SK1, Karande GS2, *Mohite RV3
1
Assistant professor, 2Professor and Head, Dept. of Microbiology, Krishna Institute of Medical Sciences Karad,
India
3
Assistant professor, Dept. of Community Medicine, Krishna Institute of Medical Sciences Karad, India
*Corresponding author email: rajsinhmohite124@gmail.com
ABSTRACT
Background: Worldwide diabetic foot is a major medical problem leading to disability and economic instability
to family and country. Objectives: To assess the clinical and bacteriological profile of diabetic foot ulcer among
rural Indian residents and its association with demographic factors. Methodology: Hospital based cross-sectional
study was carried out in the rural tertiary care centre during the year 2010 to 2012. A total 78 diabetic foot ulcer
cases were enrolled, interviewed, clinically examined and bacteriological assed as per structured questionnaire
and methods. Results: Maximum, 70.51% cases were above the age of 50 years with higher proportion, 76.9%
seen in males. The majority of cases, 97.4% were belonged to type II DM with maximum, 48.7% cases had a
duration of ulcer less than of ten days. Maximum, 67.94% ulcers were seen on Right foot, 53.8% ulcers were of
grade III and above. Neuropathy, the major associated complication was seen in 68% cases and average 1.8
bacteria were identified per sample. Conclusion: As the grade of diabetic foot ulcer is increased, the bacterial
count is also increased.
Keywords: Diabetic foot ulcer, bacterial isolates, neuropathy
INTRODUCTION
Diabetes Mellitus (DM) is a chronic disorder
affecting a large segment of the population and in the
present scenario, it act as a major public health
problem in India1. India acts as home for DM and
currently carrying the load of 42 million cases and
ranking the top most country among the list of the ten
nations with the most affected with diabetes2. Among
diabetic patients, foot ulcer is the most common
complication accounts 15% during their lifetime3.
Diabetic foot lead to limb amputation has major
impact on an individual, not only physical deformity,
but also lead to economically dependent and socially
deprived4.
The alarming fact is that, India has more people with

DM than any other country and incidence of diabetic
foot problem as well as limb/foot amputations remain
very high, accounting up to 20 % of diabetes related
hospital admission. This can be attributed to several
social and cultural practices viz., barefoot walking,
inadequate facilities for diabetes care and education,
and poor socioeconomic conditions5. Worldwide,
diabetic foot lesions are considered as major medical,
social and economic problem and are the leading
cause of hospitalization for patients with
diabetes6.Though, there is an obvious increase in
861
Mohite et al.,
diabetic foot care awareness, there are tremendous

gaps in routine diabetic foot evaluation.
The aim of the present study was to assess the clinic bacteriological profile of diabetic foot ulcer among
the diabetic patients admitted to a tertiary care
hospital located in a rural area of western
Maharashtra, India. The changes in lifestyle lead to
increase the burden of Diabetes in Maharashtra state,
India and which was estimated at 6 million by the
year 20117,8. Similarly, maximum cases were from
age group 20-70 years, which further affect the
economic growth of the country.
A cross sectional study was conducted in tertiary
health care centre located in a rural area of western
Maharashtra, India. The study was conducted during
the period of year 2010 to 2012. A total 78 diabetic
patients with foot ulcers admitted at a surgical ward
during the study period were enrolled in the study as
per inclusion criteria of the study.
Inclusion criteria: Diabetic patients with foot ulcer
admitted in rural tertiary health care centre during the
study period and willing to participate in the study.
Exclusion criteria: ICU, critical cases and not
willing cases. Statistical analysis was carried out after
the raw data entered into MS Excel and analysed into
frequency
percentage
distribution.
Statistical
association and correlation was determined by using
chi-square test and correlation coefficient.
Ethical consideration: Institutional ethical clearance
was obtained before starting the study and consent
also obtained from study subjects.
Foot ulcer patients were categorized into six grades
based on Wagner classification system9. A pre-tested
structured questionnaire was utilized to collect the
information pertained to medical history, examination
in details and investigation reports. A detailed
medical history was taken from all the patients
regarding age, sex, type of DM, grade and duration of
diabetic foot ulcer and associated complications etc.
by personal interview method and clinical
examination.
Physical examination was carried out to identify
associated medical complications such as Wagners
grade, hypertension, nephropathy, edema, and
retinopathy. Sensory neuropathy was assessed by
ability to sense touch with 10 gram monofilament and
tuning fork7. The temperature of the patient was also
recorded by using clinical thermometer. The

adequacy of peripheral circulation was done by
palpating the posterior tibial artery and the dorsalis
pedis artery. The foot was examined for the presence
of callus or any other abnormality. Touch, pain and
joint position sensation were examined in the foot.
Foul smell, local rise of temperature, discharge and
discoloration of the surrounding area was noted. The
base of the ulcer was palpated to assess the depth of
the ulcer. When osteomyelitis (to assess bone
involvement) was suspected, the foot X-ray was
done. The specimens were collected in a sterile
culture tube before starting the antibiotics. All these
specimens were immediately transported and
processed in the Department of Microbiology as per
the standard guidelines of Clinical and Laboratory
Standard Institute (CLSI-2011) by a researcher.
The foot ulcer in which only one organism isolated as
a causative agent categorized as monomicrobial
infection
like
staphylococci,
streptococci,
Pseudomonas, klebssiela etc., Whereas more than
one organism isolated categorized as polymicrobial
infection.
Statistical test: Chi-square test (2) and correlation
coefficient (r) was worked out to find out statistical
significant difference and linear relation between
variables. SPSS version 17, as statistical software was
used to analyse the data.
RESULTS
Table 1: Distribution of cases according to Age and Sex
Age
( years)
11-20
21-30
31-40
41-50
51-60
Male (%)
Female (%)
Total (%)
1(1.3%)
2(2.6%)
6(7.6%)
13(16.7%)
14(17.9%)
0
0
0
1(1.3%)
4(5.1%)
1(1.3%)
2(2.6%)
6(7.6%)
14(17.9%)
18(23%)
61-70
15(19.2%)
6(7.6%)
21(29%)
71-80
7(8.9%)
5(6.4%)
12(15.3%)
81-90
2(2.6%)
1(1.3%)
3(3.8%)
91-100
1(1.3%)
1(1.3%)
60(76.9%) 18(23.1%)
78(100%)
Chi-square = 9.07, p value = 0.002*
2
(Age: =43.42, p = 0.0001*, Sex: 2=9.07, p =
0.002*,*= p is significant at 95% confidence interval)
A total of 78 diabetic foot ulcer cases were
interviewed,
examined
and
bacteriological
investigated
Total
862
Mohite et al.,
The lowest and highest age at occurrence of diabetic

foot ulcer was 18 and 92 years. Maximum,70.51%
cases were above the age of 50 years and as age
increases, the chance of getting of Diabetic foot ulcer
also increases(2=43.42, p = 0.0001*).The proportion
of male cases were higher,76.9% as compared to
females, 23.1% and difference was statistically
significant (2=9.07, p = 0.002*) (Table 1).
Table 2: Distribution of cases, according to
Clinical criteria:
The majority of patients, 97.4% were belonged to

Type II DM and the duration of DM was about 2 to 5
years seen maximum in 33.3% patients. However,
16.6% patients were unknown about the duration of
illness. Maximum, 48.7% cases having ulcer was of
duration less than of 10 years and maximum, 53.84%
ulcers were of grade III and IV types. Majority of
ulcers, 67.94% were located on Rt. Foot of which
maximum, 60.37% were present over the sole area
(Table 2).
Frequency
Frequency
Table 3: Diabetic foot ulcer with associated
Variables (%)
Variables
(%)
complications
Frequency (%)
Types of DM:
Duration of Ulcer (dyas)
Associated complications
Type I DM 2 (2.6%)
< 10
38(48.7%)
Neuropathy
30 (38.5%)
Type
II 76
Hypertension (HTN)
4 (5.1%)
DM
(97.4%)
10-20
21(26.9%)
Peripheral
Vascular
Disease 3 (3.9%)
(PVD)
12(15.4%)
Duration of DM (years) 20-30
Neuropathy + PVD
6 (7.7%)
1
13 (16.6%) > 30
7(8.9%)
2-5
26 (33.3%) Grade of Ulcer:
HTN + PVD
1(1.3%)
6-10
15 (19.2%) Grade I
7(8.97%)
HTN + Neuropathy
7 (9%)
11- 15
8 (10.2%)
Grade II
17(21.79%)
Nephropathy
1(1.3%)
15 years
3 (3.8%)
Grade III
20(25.64%)
Retinopathy
1(1.3%)
Neuro+PVD+HTN+Nephropathy
1(1.3%)
Grade IV
22(28.20%)
Not
Others
3 (3.9%)
known
13 (16.6%) Grade V
12(15.38%)
No
complication
25 (32%)
Site of Ulcer:
Out
of
a
78
patients,
maximum
68%
were suffering
SoleToes and others
from one or more of DM associated complications.
Rt. Foot
53(67.94%) 32(60.37%) 21(39.62%)
Lt. Foot
25(32.05%) 18(72%)
7(28%)
The Peripheral Neuropathy, most common associated
complication was seen in 56.4 %cases (Table 3).
Table 4: Correlation between Grade of ulcer and Bacterial isolates
Ulcer
No.
Mono microbial
Poly microbial infection
Grade
of cases
Infection
Two
Three
> Three
I
7
5
2
II
17
6
7
4
III
20
11
4
3
2
IV
22
11
5
4
V
12
1
10
1
(Correlation coefficient(r)= 0.94 with CI of 0.34 -0.99 at 95% , p=0.01*)
A total of 134 bacterial isolates were found from 78
patients, of which mono and poly -microbial isolates
were 34 and 100 respectively. The maximum, 53.8%
bacterial isolates were seen in ulcer grade III and IV
and as the grade of ulcer increases, the number of
bacterial isolates also increases and showing linear
positive correlation as indicated by the correlation
coefficient (r = 0.94, p=0. 01*). The average number
of bacteria found was 1.8 per sample (Table 4).
Total
organisms
9
32
36
33
24
Isolates per
case
1.2
1.8
1.8
1.6
2
In poly-microbial isolates, two bacteria found in two

cases were totaled as four bacteria, similarly for three
and more for total number of isolates.
Table 5: Treatment outcome of patient with
diabetic foot ulcer
Frequency (%)
Treatment outcome of cases
Debridement
25 (32%)
Amputation
19 (24.3%)
Improved
27 (34.6%)
Expired
4(5.1%)
Against medical advice discharge
3(3.8%)
863
Mohite et al.,
A total of 78 patients were admitted of which 34.6%

cases were totally improved from ulcer whereas
debridement and amputation was required for 32%
and 24.3% cases respectively. The 5.1% cases were
expired during treatment mainly due to multiple
organ failure and age of cases (Table 5).
DISCUSSION
Among diabetics, infected foot ulcer lead to dreaded
complications like gangrene and amputations which
is most often follows trauma to neuropathic foot.
The present study depicts the mean age of the study
population was 59.5 years with more than 70% cases
were above the age of 50 years and as age increases
the chance of getting a foot ulcer also increases
(p<0.05). Similar findings have also been reported by
Bansal E, 20085and Kahn O et al, 197410. Most of our
patients did not have access to diagnostic facilities as
they were from rural areas this could be a reason for
higher mean age of patients. The proportions of male
patients with diabetic foot ulcer have been higher
(76.9%) than females. Similar findings have also
been reported by Bansal E, 20085 and Banashankari
G, 201211. The male population predominated the
studies and may be due to the fact that males are
more involved in outdoor activities in the Indian
scenario and is thus more prone to injuries which can
predispose to ulcers.
Our study reveals the mean duration of diabetes was
6.5 years, which is almost close comparison to the
study of Samaga M et al, 200812. In our study Type II
diabetes mellitus predominates and similar findings
have also been reported by Bansal E, 20085,
Gadepalli R, et al, 20066 and Paul S et al, 200913.
Whereas study by Sapico F, et al, 198414 Type I
diabetes mellitus predominates Type II. The average
duration of foot ulcer observed in this study was 18.9
days with maximum, 47.8% cases having duration of
less than 10 days.
Maximum, 53.80% of the cases had ulcers of Grade
III and IV, whereas, 12 patients had extensive
gangrene i.e. Grade V. The higher proportion of foot
ulcer has been predominately seen on Right leg,
67.9% with majority of lesions located over sole area.
A similar finding has also been observed by
Banashankari G et al, 201211.
The peripheral neuropathy, a major associated
complication (56.45%) was observed in this study. A
similar finding has also been observed by Shailesh K,
201215.However, Paul S, et al, 200913 observed

neuropathy in 33.3% of cases, whereas Banashankari
G et al, 201211 reported in 76% of cases. The feet
were the target of peripheral neuropathy leading
chiefly to sensory deficit and autonomic dysfunction
could be the cause for high proportion. Our study
documented 55.3% of diabetic foot ulcers are
polymicrobial similar findings recorded in study by
Gadepalli R et al, 20066in contrast to findings of
Dhanasekaran G et al, 200316, documented
monomicrobial infection in 84% patients. The
average of 1.8 bacteria per sample was reported in
our study. Study by Kahn O et al, 197410 and Raja N,
200717 documented 1.47 isolates per sample while
Gadepalli R et al, 20066 showed 2.3 organisms per
sample. Staphylococcus was the most predominant
pathogen which was isolated in our study and similar
findings was recorded by Gadepalli R et al, 20066
There is a positive correlation between bacterial
count and the grade of ulcer as indicated by the
correlation coefficient (p<0.05). Similar results have
been also reported by Paul S, 200913 and Jain M et al,
201218. In the present study, the diabetic foot
infections are polymicrobial in nature and as the
grade of ulcer increased, the prevalence of isolates
also increased. This could be due to widespread use
of broad spectrum antibiotics, leading to survival
advantage of resistance bacteria.
CONCLUSION
Diabetic foot ulcers are more common in and above
5thdecade of life with male preponderance. As the
grade of ulcer increased, the number of bacterial
isolates also increased. Knowledge of diabetes and
care of limbs are of paramount importance to reduce
the diabetes associated complications.
ACKNOWLEDGEMENT
We, the authors acknowledge to Dr AY Kshirsagar,
Medical Director, Krishna Hospital and Medical
Research Centre Karad support this study.
Complicit of interest: None decelerated.
REFERENCES
1. Anandi C, Alaguraja D, Natarajan V,
Ramanathan M, Subramanian CS, Thulasiram M,
Sumithra S. Bacteriology of diabetic foot
lesions. Indian J Med Microbiol 2004; 22(3):
175-178.
864
Mohite et al.,
2. Wild S, Roiglic G, Grren A, Sicree R, King H.

Global prevalence of diabetes. Diabetic care.
2009;27:1047-53.
3. Shankhdhar K, Shankhdhar U, Shankhdhar S.
Diabetic foot problem in India:An overview and
potential simple approaches in a developing
country. Current Diabetes Reports 2008;8(6):452457.
4. Shobhana R, Rao P, Lavanya A, Ramachandran
A. Cost burden to diabetic patients with foot
complications: a study from Southern India.
JAssoc Physicians India 2000;48(12):1147-1150.
5. Bansal E, Garg A, Bhatia S, Attri AK, Chandar J.
Spectrum of microbial flora in diabetic foot
ulcers. 2008; 51(2): 204-208.
6. Gadepalli R, Dhawan B, Sreenivas V, Kapil A,
Ammini AC, Chaudhry R. A clinicmicrobiological Study of Diabetic Foot ulcers in
an Indian Tertiary Care Hospital. Diabetes Care,
2006; 29(6): 1727-1731.
7. Deo S, Zantye A, Mokal R, Mithbawkar S, Rane
S, Thakur K. To identify the risk factors for high
prevalence of diabetes and impaired glucose
tolerance in Indian rural population. Int J
DiabetesDev Countries 2006;26:19-23
8. Chow C, Raju P, Raju R, Reddy K, Cardona M,
Celermajer DS, et al. The prevalence
and
management of diabetes in rural India. Diabetes
Care 2006;29(7):1717-8.
9. Wagner FW. The dysvascular foot :a system for
diagnosis
and
treatment.
Foot
Ankle
1981;2(2):64-122.
10. Kahn O, Wagner W, Bessman AN. Mortality of
Diabetic Patients Treated Surgically for Lower
Limb Infections and / or Gangrene. Diabetes
1974; 23(4) : 287 - 292.
11. Banashankari GS, Rudresh HK, Harsha AH.
Prevalence of Gram negative bacteria in diabetic
foot- A clinic microbiological study. 2012;
5(3):224-232.
12. Samaga M. Bacteriologica (Aerobic and
Anaerobic) profile of diabetic foot ulcer. A thesis
submitted to RajivGandhi University of Health
Sciences, Bangalore. 2008.
13. Paul S, Barai L, Jahan A, Haq A. A
bacteriological study of diabetic foot infection in
an Urban Tertiary Core Hospital of Dhaka City.
Ibrahim Med. Coll. J. 2009; 3(2): 50-54.

14. Sapico FL, Witte Jl_, Canawati HN,
Montgomerie JZ, Bessman AN. The Infected
Foot of The Diabetic Patient : Quantitative
Microbiology and Analysis of Clinical Features.
Rev Infect Dis 1984; 6(1):S171-SI176.
15. Sahil S, Kumar A, Kumar S, Singh S, Gupta S,
T.B. Singh Prevalence of Diabetic Foot Ulcer
and Associated Risk Factors in Diabetic Pateints
From North IndiaJournal of Diabetic Foot
Complications 2012;4(3): 83-91.
16. Dhansekaran G, Satry G. Viswanathan M.
Microbial pattern of Soft tissue infections in
diabetic patients in South India. Asian J. Diabet.
2003; 5(3):8-10.
17. Raja NS. Microbiology of diabetic foot infections
in a teaching hospital in Malaysia: a retrospective
study of a194 cases. Journal of Microbial
Immunol Infect. 2007; 40(1):37-44.
18. Jain M, Patel M, Sood N, Modi D , Vegad M.
Spectrum Of Microbial Flora In Diabetic Foot
Ulcer And Its Antibiotic Sensitivity Pattern In
Tertiary Care Hospital In Ahmedabad, Gujrat.
National Journal Of Medical Research. July
2012; 2(3): 345
865
Mohite et al.,
DOI: 10.5958/2319-5886.2014.00016.2

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Health Sciences
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Volume 3 Issue 4
Coden: IJMRHS
th
Research article
Copyright @2014
ISSN: 2319-5886
COMPARATIVE EVALUATION OF AZELASTINE AND

TREATMENT OF SPRING CATARRH (VERNAL CATARRH)
FLUOROMETHOLONE
IN
THE
*Ather Mohammed1, Nasreen2

1
Professor, Department of Ophthalmology, Gandhi Medical College, Hyderabad

Assistant Professor, Department of Pharmacology, Osmania Medical College, Hyderabad
*Corresponding author email: ather11258@gmail.com

ABSTRACT
Aim and Objective: To study and compare the efficacy of FML &Azelastin eye drops in relieving symptoms &
regressing signs of VKC. Methodology: This Prospective Interventional study conducted at Sarojini Devi eye
hospital, Hyderabad which is a regional institute of Ophthalmology during the period July 2004 to July 2005. The
100 patients of spring catarrh reported to SD eye hospital during the period were randomly divided into 2 groups
of 50 each. Group I were given Fluorometholone 0.25% eye drops four times daily for a period of 4 weeks. Group
II were given Azelastine HCl 0.05% eye drops four times daily for a period of 4 weeks. Results: Documented by
taking symptomatic relief of patient, Clinical improvement of signs, reduction in Eosinophils and Mast cells on
histopathological examination. Conclusion: This study shows that Fluorometholone is superior to Azelastine in
relieving Symptoms and regression of signs in the cases of Vernal catarrh.
Keywords: Vernalkeratoconjunctivitis (VKC), FML(Fluorometholone), Azelastine, Eosinophils, Mast cells
INTRODUCTION
Vernalkeratoconjunctivitis is a seasonal disease
which occurs in summer season in India. Dust,
pollens and Ultraviolet rays are considered as
aetiological factors. The disease runs a chronic
course. The present treatment modalities can provide
symptomatic relief for a short duration of time, but
not offer any cure. The recurrences every year
remains a problem1.
Fluorometholone is a synthetic corticosteroid. It acts
by induction of phospholipase A2 inhibitory proteins
which controls synthesis of mediators of
inflammation as Prostaglandins and leukotrienes by
inhibiting the release of common precursor,
Arachidonic acid2.Azelastine is a selective H1
antagonist and inhibitor of Histamine and other
mediators of inflammation from Mast cells2.
Incidence of the disease is common in first and

second decade3. Common symptoms are itching,
foreign body sensation, and watering 4. Signs are ropy
discharge, cobblestone papillae on tarsal conjunctiva
and limbal nodules 4.
Ather et al.,
Fig1: Cobblestone papillae on torsal conjunctiva

866
This study has the approved by the ethics committee

of Osmania Medical College. There is no financial
interest to be disclosed. This study was conducted at
Sarojini Devi eye hospital, Hyderabad during the
period July 2004 to July 2005. 100 patients of vernal
catarrh between the age group of 10-30 years were
selected. Of these, 90 were males and 10 were
females. The patient didnt receive any treatment for
the past one month. 100 patients were randomly
divided by simple random technique into two groups
of 50 each. Group I were given Fluorometholone
0.25% eye drops 4 times daily for a period of 4
weeks. Group II receivedAzelastine 0.05% eye drops
4 times daily for 4 weeks.Adult patients were
informed about the study and informed consent taken
in their mother tongue. Minor patients attenders
(either of the parent) were explained about the study
and informed consent taken in front of witness.
Patients with complications of VKC5 like shield
ulcer, glaucoma and other ocular disorders were
excluded from the study. The patients were evaluated
at 0,1, and 4 weeks using relief from symptoms and
improvement of signs using a slit lamp.
The symptoms were Itching, Foreign body sensation,
tearing, discomfort which were graded between 0 to
grade III6, 7.The improvement in signs were classified
as Conjunctival hyperaemia, Papillary hypertrophy,
Limbal nodules, Quantity of discharge which were
graded between 0 to grade III depending upon
absence, mild, moderate and severe involvement6, 7.
Conjunctival scrapping from palpebral and bulbar
conjunctiva were taken from both eyes and
Leishmans staining was done to see the Eosinophils
and Mast cells in the smear both before and after
treatment.
Taking into consideration the probability of a positive
outcome was P = 68% 6, 7 and the expected fallout or
error as L= 14%
Q = 1-P = 100-68 = 32%
Sample size is calculated as:
4
4 68 32
=
= 44.40816
14 14
Ather et al.,
100 patients were studied and treated. Majority of

patients were in the age group of 1-10 years ie.50%.
11-20 years formed 45%, whereas 21-30 years group
formed 5%. Males were 90% as against 10% females.
The earliest symptom to respond to the treatment with
both drugs was itching and tearing followed by
discomfort. Although the patients responding at the
end of the first week were more in group I
(Fluorometholone) as compared to group II
(Azelastine). At the end of 4 weeks relief from
itching, watering and discomfort was 100% with
Fluorometholone group, whereas in the Azelastine
group only about 80%were relieved.
The earliest sign to show regression after first week
of treatment was Conjunctival hyperaemia followed
by discharge. Though the patients showing regression
were more in Group I.
At the end 4 weeks regression of Conjunctival
hyperaemia and discharge was 100% in group I and
92 % in group II. Papillary hypertrophy showed a
regression in 84% in group I and 40% in group II at
the end of 4 weeks. Limbal nodules have shown
regression only in 50% of cases in group I and 32%
in group II.
150
Percentage
Which is approximately 45, hence3 a round figure of

50 was taken as sample size.
RESULTS
Symptoms
100
50
Group 1(FML)
Group2(Azelastine)
Graph1: Comparison of symptoms in group1 &

group 2 after 4th week.
150
Percentage
Aim and objectives

To study and compare the efficacy of FML and
Azelastine eye drops in relieving the symptoms and
regressing signs of VKC
100
50
0
Signs
Group1(FML)
Group
2(Azelastine)
Graph2: Comparison of signs in group 1 & group

2 after 4th week.
867
Histopathology at the end of 4 weeks had shown

decreased cellularity and complete absence of
Eosinophils and Mast cells in Group I, but group II
patients had shown persistence of Eosinophils.
In this study Fluorometholoneis more effective in
relieving subjective complaints of patients and in
regression of signs both at the end of 1 week and 4
weeks. Even histopathological study shows the
superiority of Fluorometholone when compared to
Azelastine.
Fig 2: Group1 before treatment

Eosinophilsand mast cells (HPF) 40x
showing
Fig3: Group 1 4 weeks after Treatment with FML

showing no eosinophils and mast cells (HPF) 40x
Fig 5: Group 2after 4 weeks treatment with

azelastine still showingoccasional eosinophils and
mast cells in 40x (HPF)
For testing the statistical significance of above
findings Chi square test was performed.
Fluorometholone was found to be superior to
Azelastine with statistical significance as shown in
table for symptoms like itching, tearing, FB sensation
and discomfort. Regression of signs like Conjunctival
hyperaemia, papillary hypertrophy and discharge was
found to be statistically significant as shown in the
table. Limbal nodule doesnt show any significant
difference between two groups.
Table1: Comparison between symptoms of
Group1 & Group2
Symptoms
P Value
Itching
< 0.0032**
FB Sensation
< 0.1614*
Tearing
< 0.0001***
Discomfort
0.0032**
th
using Chi-Square test after4 Week.
Table2: Comparison of signs between Group 1 &
Group
Signs
P Values
Conjunctival Hyperaemia 0.0218**
Papillary Hypertrophy
0.0001*
Limbal Nodules
0.0673***
Discharge
0.0412**
2 using Chi-Square test after 4thweek.
*Very Significant
** Significant
*** Not
significant
DISCUSSION
This study using FML &Azelastine was conducted to
show the limitation of Azelastine as first line drug in
Fig4:Group2
before
treatment
Eosinophils and mast cells (HPF) 40x.
showing
868
Ather et al.,
the treatment of Spring catarrh. The earliest symptom

to respond with both the drug was itching and tearing
Followed by discomfort. At the end of one month the
relief from itching, tearing and discomfort was 100%
in group1, whereas it was only 80% in group 2
patients.
The earliest sign to show regression after 1st week of
treatment was conjunctival hyperaemia followed by
discharge.70% of patients in group 1 had shown
regression in papillary hypertrophy as compared to
only 10% in group 2. At the end of one month, the
regression in conjunctival hyperaemia and discharge
was 100% in group 1 as compared to 92% in group
2.The papillary hypertrophy regressed in 84% in
group 1 and 40% in group 2. The Limbal nodules
have shown regression only in50% of cases in Group
1 and 32% in group 2.
CONCLUSION
This study shows that Fluorometholone is superior to
Azelastine in relieving Symptoms and regression of
signs in the cases of Vernal catarrh. It can be used as
a drug of first choice to relieve symptoms and signs.
ACKNOWLEDGEMENT
I acknowledge all my patients and their attenders for
their cooperation in the study
Conflict of Interest: There is no conflict of interest
REFERENCES
1. Duke Elders, Leigh AG, Diseases of outer eye,
System of ophthalmology, St Louis horby co
1965;8: 573.
2. Goodman& Gilmans, The pharmacological basis
of therapeutics, 11th edition, 2005:1724 25
3. Lcdutta, Incidence of spring catarrh, Ocular
allergy review 2000;2: 57.
4. Kansky Jack J, Clinical features of vkc, 4th
edition, Butterworth, 2000, 66-68.
5. Occular complications of VKC. Canadian Journal
of ophthalmology 1999,34: 88 92.
6. Tabbaraalkharashi, Efficacy of FML in treatment
of spring catarrh, BJO 1999 ;83(2): 180 84.
7. Bomini et al, effectiveness of Na Chromogylgate
in VKC eye1995; 6: 648 52.
8. Bomini. VKC revisited ophthalmology 2000;107:
1157-63
869
Ather et al.,
DOI: 10.5958/2319-5886.2014.00017.4

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Volume 3 Issue 4
Coden: IJMRHS
rd
Research article
Copyright @2014
ISSN: 2319-5886
PEAK EXPIRATORY FLOW RATE IN ASYMPTOMATIC MALE WORKERS EXPOSED TO

CHEMICAL FUMES, IN VARIOUS INDUSTRIES OF HYDERABAD
Padaki Samata K1, Dambal Amrut 2, Kokiwar Prashant3
1
Assistant professor, Department of Physiology, Mallareddy Institute of Medical Sciences, Hyderabad

Assistant professor, Department of Biochemistry, Mallareddy Institute of Medical Sciences, Hyderabad
3
Professor, Department of Community Medicine, Mallareddy Institute of Medical Sciences, Hyderabad
2
*Corresponding author email: drsamatapadaki@gmail.com

ABSTRACT
Context: The prevalence of occupational health hazards and mortality has been reported to be unusually high
among people of India. Although developed countries are very much careful about the health in occupations it is
quite neglected in the developing countries like India. Aims: To record PEFR in asymptomatic male workers
exposed to chemical fumes for more than 2 years and compare the results with age matched unexposed, healthy
male controls. Methods and Material: This was a comparative study between 50 asymptomatic male workers
exposed to chemical fumes for more than 2 years in various industries located at Jeedimetla Industrial Area and
50 unexposed healthy male individuals from general population. The sampling was done by simple random
sampling (lottery method). The data was collected in the Research Laboratory of Physiology. Anthropometry like
weight, height, was measured and the PEFR test was performed in the standing position by taking a deep
inspiration and then blowing out as hard and as quickly as possible with their nose closed. Data was analyzed by
using SPSS package and was expressed in terms of mean SD. Results: It was observed that mean PEFR was
statistically highly significant in cases (p = 0.0001), and PEFR decreased with increase in duration of exposure.
Conclusions: Thus, it can be concluded that apparently healthy individuals may also have abnormal PEFR
findings. Hence, a regular check on these parameters will help them in reducing the chances of its manifestation at
a future date.
Key words: Peak expiratory flow rate; PM10; Chemical fumes; Peak flow meter.
INTRODUCTION
Pollution and its effect on the people is a global
threat. It is increasing day by day due to effluents and
emissions from industries, solid waste disposal,
automobile exhaust and degradation of soil by
removing the green belt and high use of pesticides.
The particulate matter that remains in a suspended
state in the troposphere, such as solid particles (from
combustion processes, industrial activities and natural
sources), liquid droplets etc. Floating in the air is
referred to as Particulate pollutants. 1 Of greatest
Samata et al.,
concern to the public health are the

particles
smaller enough to be inhaled into the deepest parts of
the lung. These particles are less than 10 microns in
diameter, about l/7th the thickness of a human hair
and are known as PM10.2 PM10 is a major
component of air pollution that threatens both our
health and environment. A large number of
epidemiological studies have shown that day-to-day
variations in concentrations of particles are associated
with adverse effects on health. These include
870
increased daily deaths, increased admissions of

patients to hospitals suffering from heart and lung
disorders and a worsening of the condition like
asthma.3
All employers and self-employed people have duties
under health and safety law to assess risks in the
workplace. The risk assessment forms the basis of the
Safety Statement that is required for all workplaces.
The Safety, Health and Welfare at Work (Chemical
Agents) Regulations, 2001 specifically obliges
employers and self-employed persons to assess the
risks arising from the use or presence of chemical
agents in the workplace.4 This is intended to help
employers in assessing the risks that relate to
chemical agents in the workplace and in determining
adequate precautions or control measures to
safeguard health and safety. The intention is to
prevent accidents or work related ill-health in the
workplace. The effects of hazardous chemicals may
be immediate or long-term and range from mild eye
irritation to chronic lung disease.
In diagnosis and treatment of respiratory diseases, the
assessment of lung functions is of considerable
importance, key tests being vital capacity (VC),
forced vital capacity (FVC), maximum expiratory
flow rate (MEFR) or peak expiratory flow rate
(PEFR), maximum ventilator volume (MVV).5 So,
normal reference values for lung function tests of any
population need to be assessed. PEFR measurement
by peak flow meter is an easy way to measure lung
functions in field study.6,7
PEFR is the maximum rate of air flow achieved
during a forced expiration after maximal
inspiration.5,6,7 Lung functions including PEFR are
affected by various factors such as sex, body surface
area, physical activity, posture, environment, racial
differences etc.8,9,10,11 However, there is scanty
literature about PEFR in Jeedimetla population of
Hyderabad where many industries are located. So,
this study was taken up to detect any PEFR changes
occurring significantly in asymptomatic workers,
exposed to chemical fumes in various industries
located at Jeedimetla Industrial Area, Hyderabad and
to study the prevalence of such abnormal PEFR
findings and thereby predict future respiratory
diseases in these individuals.
For different respiratory disease treatment, routine
lung function measurement is required to follow up
the patients. And for this reason PEFR is one of the
Samata et al.,
best choices. This is a simple method of measuring

airway obstruction and it will detect moderate or
severe disease. The simplicity of the method is its
main advantage. It measures the airflow through the
bronchi and thus the degree of obstruction in the
airways.
MATERIAL AND METHODS:
Source of data: This is a comparative cross-sectional
study between asymptomatic male workers exposed
to chemical fumes like azodicarbonamide, unheated
polyvinyl chloride, nitrites etc for more than 2 years
in various industries located at Jeedimetla Industrial
Area and age matched unexposed healthy male
individuals from general population. This area was
selected as it is served by the Malla Reddy Hospital.
Ethical Clearance was obtained by the Institutions
Ethical Clearance Committee. There are about 25
industries using various chemicals. Permission was
obtained from the concerned staff and only those
industries that permitted us to perform the study on
their workers were selected.
An initial survey was done to list out the
asymptomatic male workers who were exposed to the
chemical fumes and the unexposed workers. The
sample size was calculated by the formula 4pq/E2 and
the sampling procedure was done by simple random
sampling (lottery method).12 50 cases were randomly
selected from this group. Age matched 50 healthy
male individuals were taken as controls from the
general population.
Inclusion criteria:
1. Apparently healthy male workers exposed to
chemical fumes for more than 2 years.
2. Apparently healthy age matched controls not
exposed to chemical fumes.
Exclusion criteria:
1. Subjects with exposure to chemical fumes for less
than 2 years.
2. Subjects with previously diagnosed pulmonary
diseases and recent hospitalizations.
3. Subjects on any medications.
4. Subjects with smoking history or tobacco chewing,
past or present.
5. Subjects with symptoms of cough, haemoptysis,
wheeze etc.
6. Subjects not consenting for PEFR study.
Instruments used were vertical height scale, weighing
machine and Peak Flow Meter Breathe-O meter of
871
Cipla Company. A pre-designed questionnaire was

given consisting of objective-type questions with
multiple choice responses. All the participants were
requested to fill the form which was verified
thoroughly by interview. The weight in kilograms and
height in meters was measured as per the standard
guidelines laid down by World Health Organization.13
Height (HT) was measured in barefoot to the nearest
0.1cm using a vertical height scale. Body weight
(WT) was recorded to the nearest 0.1 kg using a
portable weighing machine. Body Mass Index14 was
calculated using the standard formula weight (in Kg)
divided by height (in metre) squared (kg/m2).
General Physical Examination as well as Systemic
Examination was done to rule out the exclusion
criteria. Vital signs like Pulse (beats/min), Blood
Pressure (BP) (mmHg), Respiratory rate (RR)
(cycles/min) and temperature (C) were noted. Blood
pressure (systolic-SBP, diastolic-DBP) was recorded
in the supine position in the right upper arm after the
subject had rested for at least 5 minutes with a
standard mercury sphygmomanometer (Diamond) to
the nearest 2 mm Hg.15 After a thorough history
taking and clinical examination; the procedure was
explained to the subjects. Prior to recording the
subjects PEFR, the use of the instrument was
repeatedly demonstrated and explained.16 The PEFR
test was performed in the standing position with the
peak flow meter held horizontally. A tight fitting
disposable cardboard mouthpiece was inserted in the
inlet nozzle. The subjects were asked to take deep
inspiration and then blow out as hard and as quickly
as possible with their nose closed. The procedure was
repeated three times and the best of three ratings were
recorded.16 The PEFR was recorded in L/min and
compared with the predicted normal values for that
height using the formula PEFR (L/min) = [Height
(cm) - 80] x 5
If the subject suffered from any health problems
during the course of the study or if his PEFR was
abnormal, then treatment was given at the Malla
Reddy Hospital. At the end of the study, health
education was given to all the participants regarding
personal protective measures.
Statistical methods: Data was analyzed by applying
appropriate statistical tests by using SPSS package
version number 14. Data was expressed in terms of
mean SD.
Unpairedt test was applied to estimate the

difference between two groups of population. P value
< 0.05 was taken as significant.
RESULTS
Table 1: Age wise distribution of Cases and
Controls
Number of Number of
Age (years)
Cases (N)
Controls (N)
21 30
10 (20%)
10 (20%)
31 40
14 (28%)
14 (28%)
41 50
11 (22%)
10 (20%)
51 60
13 (26%)
14 (28%)
61 70
2 (4%)
2 (4%)
Total
50 (100%)
50 (100%)
The cases and controls were classified into five
different age groups and were statistically nonsignificant.
Table 2: Anthropometric Characteristics in Cases
and Controls
Cases
Controls
Anthropometry
(N = 50)
(N = 50)
Height (cms)
157.5 6.74
155.2 4.12
Weight (kg)
48.4 4.82
50.9 4.08
Body Mass
19.67 0.715 21.21 0.33
Index (kg/m2)
Height: The mean height (in cms) in cases was 157.5
6.74 and in controls was 155.2 4.12. Weight: The
mean weight (in kgs) in cases was 48.4 4.82 and in
controls was 50.9 4.08. Body Mass Index: The
mean BMI (in kg/m2) in cases was 19.67 0.715 and
in controls was 21.21 0.33.
Table 3: Height and Peak Expiratory Flow Rate in
two groups
Age
(yrs)
21 30
Obtaine
d
Group
PEFR(l/
min)
Cases
150.5 5.8 352.5 4.12 350.1 4.7
Height
(cms)
Control 152.2 3.1 361.0 0.02 360.5 2.0

Cases
31 40
152.4 6.2 362.2 0.5 300.7 4.4
Control 150.2 1.1 360.0 0.01 361.5 2.4

Cases
41 50
Predicted
PEFR
(l/min)
151.9 7.1
359.84.2
321.2 2.3
Control 152.2 3.1
358.01.0
358.4 2.1
Cases
153.6 4.2
368.00.4
304.7 3.4
Control 154.2 4.1
369.00.4
368.5 2.1
Unpaired
t test
t = 6.4387
p = 0.0001*
t = 44.7612
p = 0.0001*
t = 38.5781
p = 0.0001*
t = 57.9368
51 60
Cases
61 70
159.7 7.2 398.5 4.4 322.2 0.3
Control 158.2 3.1 396.8 1.2
390. 6.9
p = 0.0001*
t = 13.9267
p = 0.0051*
*p < 0.001 (Highly Significant)

872
Samata et al.,
PEFR values were compared in cases and controls

depending upon their age group and height by
applying unpairedt test. Subjects in various age
groups of 21 70 years had reduced mean PEFR
(l/min) which was highly significant. (p = 0.0001).
Although in the age group of 31 40, 51 60 and 61
70 there was a significant difference between the
predicted PEFR and the obtained PEFR, the other two
age groups of 21 30 (years) and 41 50 (years) did
not show considerable differences in the mean PEFR
values. Mean PEFR values were compared between
cases and controls. It was found that the mean PEFR
was significantly reduced among cases when
compared to controls across all age groups (p =
0.0001).
Table 4. Duration of Exposure and PEFR
Duration of
PEFR
Number
Exposure
(l/min)
of Cases
< 5 years
321.21 2.3
20
> 5 years
292.31 3.2
30
t = 34.7902
p = 0.0001
In 20 subjects with duration of exposure of 2 - 5 years

the mean PEFR (l/min) was 321.21 2.3.
In 30 subjects with duration of exposure of more than
5 years the mean PEFR (l/min) was 292.31 3.2.
This difference was statistically significant (p =
0.0001). Hence, it can be concluded that as the
duration of exposure is more, the PEFR will decrease.
DISCUSSION
The prevalence of occupational health hazards and
mortality has been reported to be unusually high
among people of India. Although developed countries
are very much careful about the health in occupations
it is quite neglected in the developing countries like
India. There is a widespread misconception that
occupational health is mainly concerned with industry
and industrialized countries. But in a country like
India, millions of people work as daily wages, labour
like stone grinding, paddy thrashing, weaving etc.
These workers often face health hazards during
occupational activities. For example, in agricultural
fields with increasing use of chemicals either as
fertilizers, insecticides, pesticides agricultural
workers are exposed to toxic hazards from these
chemicals and particulate pollutants and thus face a
multitude of health problems.
Under the WHS Regulations, a hazardous chemical is

any substance, mixture or article that satisfies the
criteria of one or more Globally Harmonized System
of Classification and Labeling of Chemicals (GHS)
hazard classes.17 In our study the subjects were
exposed to various chemical fumes and dust like
polyvinylchloride, azodicarbonamide etc. PEFR
measurement by peak flow meter is an easy way to
assess lung capacity and ventilatory functions of the
subjects. The lung function tests, including PEFR are
influenced by various factors such as age, body size,
physical activity, and environmental condition. 9,10
In this present comparative study, we have compared
the age, anthropometric characteristics, mainly height
and PEFR of 50 asymptomatic male workers exposed
to chemical fumes for more than 2 years and 50 age
matched apparently healthy unexposed controls from
the general population. PEFR values were compared
in cases and controls, depending upon their age group
and height. Subjects in all age groups had reduced
mean PEFR (l/min) which was highly significant (p =
0.0001). In the age group of 31 40, 51 60 and 61
70 years, there was a significant difference between
the predicted PEFR and the obtained PEFR but the
other two age groups of 21 30 and 41 50 years,
did not show considerable differences in the mean
PEFR values. On comparing the mean PEFR values
with the controls, all the age groups showed
statistically highly significant p values (p = 0.0001).
In a similar study done by Dhungel et al18 they
observed that the age of the subjects was significant
(p < 0.01) correlated with PEFR even when BMI was
controlled. Height of the subjects was found to be
significantly correlated with PEFR when weight was
partialed out but weight of the subjects was not
significantly correlated when height was partialed
out. So, they concluded from the above findings that
height was the main factor which may influence
PEFR but not the weight.
Our study also showed that PEFR decreases with
increase in duration of exposure. The t value was
34.7902 and p = 0.0001 which was highly significant.
Dust exposure present a significant risk in some
workplaces, usually occur where combustible dusts
(or fibers, for example from paper, grain, finely
divided organic compounds and metals) have
accumulated and are then disturbed and released into
the air, coming into contact with an ignition source.
Common ways in which dusts can be disturbed
873
Samata et al.,
include from wind, when opening doors or windows,

during cleaning or sweeping up of waste or using
compressed air to blow out material accumulated in
crevices, gaps or in machinery. Dust-air mixtures can
be classified as hazardous atmospheres in the same
way as other flammable materials like vapors from
flammable liquids and gases.19,20,21 Limitations of our
study were the small sample size, and we did not
correlate the duration of exposure with PEFR, and the
BMI with PEFR, which would be our future projects.
We also did not estimate for any airway disorders, or
other hazards of industrial fume exposure.
to identify changes in the persons health status

because of exposure to certain substances.
ACKNOWLEDGEMENT
I would like to convey my gratitude to the Indian
Council of Medical Research for accepting this
research proposal for STS-2013 and giving the
scholarship for the concerned student. I thank the
Dean and the Department of Physiology, MRIMS, for
their constant support and encouragement throughout
the course of this study.
CONCLUSION
Industrial workers may develop respiratory

changes depending upon the chemical fumes and
dust exposure.
PEFR decreases with increase in duration of
exposure to fumes and dust.
A risk assessment is mandatory for hazardous
chemicals, for example, when working with
asbestos.
It will help to identify which workers are at risk
of exposure
Determine what sources and processes are
causing that risk
Identify what kind of control measures should be
implemented
Check the effectiveness of existing control
measures.
Maintenance of control measures may involve the
following:
Regular inspections of control measures
Supervision to ensure whether workers are using
the control measures properly
Preventive and testing programs for chemical
storage and handling systems
Periodic air monitoring to ensure that engineering
and administrative controls remain effective.
Information, training, instruction and supervision
must be provided not only to workers but to other
persons at the workplace such as visitors. It must be
provided in such a way that it is easily understood.
The extent of training should depend on the nature of
the hazards and the complexity of the work
procedures and control measures required to
minimize the risks. Health monitoring is to be taught
REFERENCES
1. Debray P, Misra J, Ghosh C. Peak expiratory

flow rate and cardio-respiratory fitness of Bengali
workers exposed to dust and plant source
particulate matters. Indian Journal of Community
Medicine 2002; 27(4):171- 76.
2. Donaldson K, Brown DM, Mitchell C, Dineva M,
Beswick PH, Gilmour P et al. Free radical
activity of PM10: iron-mediated generation of
hydroxyl radicals. Environ Health Perspect. 1997;
105(5):1285-89.
3. HMSO. Committee on the Medical Effects of Air
Pollutants. Non-Biological Particles and Health.
London, 1995.
4. Health and safety authority, 10 Hogan Place,
Dublin 2. 2004. www.hsa.ie
5. Pocock G, Christopher DR. Human Physiology:
the basis of medicine. Oxford University press,
1999:337.
6. Wright BM, Mc Kerrow CB. Maximum Forced
Expiratory Flow as a measure of ventilatory
capacity. British Med J 1959; 2(5159):1041-47.
7. Agarwal AN. Measurement of interpretation of
peak expiratory flow. Indian J Physiol
Pharmacol. 1998; 42(4):567-68.
8. Singh HD, Peri S. Peak expiratory flow rates in
South Indian adults. Indian J Physiol Pharmacol.
1979; 23(4):315-20.
9. Benjaponpitak S, Direkwattanachai C, Kraisarin
C, Sasisakulporn C. Peak expiratory flow rate
values of students in Bangkok. J Med Assoc
Thai. 1999; 82:137-43.
10. Srinivas P, Chia YC, Poi PJ, Ibrahim S. Peak
expiratory flow rate in elderly Malaysians. Med J
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Malaysia. 1999; 54(1):11-21.

11. Raju PS, Prasad KV, Ramana YV, Murthy KJ.
Pulmonary function tests in Indian girls prediction equations. Indian J Pediatr. 2004;
71(10):893-97.
12. Armitage P, Berry G, Matthews JNS. Statistical
methods in Medical Research. Blackwell
Publishing. 2002; 4th ed: 137-46.
13. World Health OrganizationPhysical status: The
use and interpretation of anthropometry: WHO
Tech Rep series 1995; 854:424-38.
14. WHO: Global Database on Body Mass Index.
BMIclassification2004http;//apps.who.int/bmi/in
dex.
15. Mancia G. Methods for assessing blood pressure
values in humans. Hypertension. 1983;5(5) :III5III13.
16. Ghai CL. A textbook of Practical Physiology.
Jaypee Brothers Medical Publishers (P) LTD.
2013; 8th edition: 154-56.
17. Managing risks of hazardous chemicals in the
workplace. Code of Practice 2012.
18. Dhungel KU, Parthasarathy D, Dipali S. Peak
expiratory flow rate of Nepalese children and
young adults. Kathmandu University Medical
Journal. 2008; 6(3):346-54.
19. Soutar CA, Copland LH, Thornley PE, Hurley JF,
Ottery J, Adams WGF, et.al. Epidemiological
study of respiratory disease in workers exposed to
polyvinylchloride dust. Thorax. 1980; 35:644-52.
20. Soutar CA, Gauld S. Clinical studies of workers
exposed to polyvinylchloride dust. Thorax 1983;
38: 834-39.
21. AJM Slovak. Occupational asthma caused by a
plastics blowing agent, azodicarbonamide.
Thorax. 1981; 36:906-09.
875
Samata et al.,
DOI: 10.5958/2319-5886.2014.00018.6

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Volume 3 Issue 4
Coden: IJMRHS
th
Research article
Copyright @2014
ISSN: 2319-5886
MORPHOLOGY OF PRONATOR QUADRATUS MUSCLE: A CADAVERIC STUDY

Dr Jadhav Surekha D*, Dr Gosavi Shilpa N, Dr Zambare Balbhim R
Department of Anatomy, Padamashree Dr. VithalraoVikhe Patil Foundation Medical College, Ahmednagar,
Maharashtra, India
*Corresponding author email: drsurekhadjadhav@gmail.com
ABSTRACT
Objective: Pronator quadratus plays an important role in movement and stabilization of radius and ulna in distal
radio-ulnar joint and used as a flap in traumatic injuries of the distal part of the forearm. Aim: The aim of this
study was to delineate the morphology of pronator quadratus muscle. Material and methods: A total of 60
forearms (Rt- 30; Lt-30) from 30 Indian cadavers were evaluated. Careful dissection of each forearm was done
and extent of radial and ulnar attachments of pronator quadratus, width of proximal and distal borders of it was
taken. Also, observed additional heads, attachment of origin and insertion of pronator quadratus muscle. Results:
Width of proximal and distal borders of pronator quadratus were 28.6mm and 30.2mm respectively on right side
and on left it was 28.7mm and 30.1 mm respectively. It had a single head in 33.33%, double heads in 60.00% and
three heads in 06.66%. Extents of its radial and ulnar attachments were 45.1 mm and 45.4 mm on right side and
45 mm and 45.5mm on left side respectively. Conclusion: These observations have significant value and are
applicable to plastic surgeons, clinicians, anatomists and this study will provide additional information for them.
Keywords: Pronator quadratus, Radius, Ulna, Variations.
INTRODUCTION
Pronator quadrates (PQ) is a flat and quadrangular
muscle, which lies in a deep flexor compartment of
the forearm. It takes origin from the oblique ridge on
distal part of the anterior surface of the shaft of the
ulna, its adjoining medial area and a strong
aponeurosis which covers the medial third of the
muscle. Fibers of PQ muscle are directed laterally
and slightly downwards and inserted into the distal
fourth of anterior border and palmar surface of the
lower one fourth of the shaft of the radius. Deepest
fibers of PQ are inserted into the triangular area
which is present above the ulnar notch of the radius. 1
It is a prime mover for pronation in all positions of
elbow flexion and extension and deeper fibers oppose
the separation of distal ends of radius and ulna. It is
Surekha et al.,
innervated by the anterior interosseous nerve, which

is the branch of the median nerve. 2, 3
Standard textbook of anatomy describes PQ muscle
has a single head and its variations are not well
documented in textbooks. There are few research
reports which reported the variations of heads of PQ
muscle. Annis 4 quoted in his paper that, Stuart
studied the anatomy of PQ and described dual headed
nature (superficial and deep heads) of this muscle. PQ
plays an important role in stabilization of the radius
and ulna in the distal radio- ulnar joint.2 Grafts of PQ
are used to restore vascularity to proximal carpal row
after aseptic necrosis 5 and as a vascularized tissue
flaps in the traumatic injuries of distal forearm.6 Also,
pedicle bone grafting of it can be used to treat
876
pseudoarthrosis of scaphoid bone.7 Variations of PQ

may be the cause of anterior interosseus syndrome
(KilohNevin syndrome) or PQ myofascial pain
syndrome.4 Very few prior studies have investigated
the PQ muscle but the anatomical information was
limited. In this reason, the aim of this study was to
delineate the morphology of PQ muscle.
MATERIAL & METHODS
Sixty embalmed (right-30; left- 30) upper limbs from
30 Indian adult cadavers (age range of 5072 years)
of male gender were analysed for this study. The
study was conducted in the Department of Anatomy,
PDVVPFS Medical College, Ahmednagar, India. All
upper limbs were free from any deformity, fracture
and pathology. Also, upper limbs with previous
surgical scars and congenital deformities and partially
amputated limbs were excluded from our study.
Careful dissection of the anterior compartment of
each forearm was done and PQ was cleaned
meticulously. The proximal and distal attachments
and additional attachments of the PQ muscles were
carefully analysed. Anatomical variations in the
number of heads of the PQ muscle were recorded and
photographed. Extent of radial and ulnar attachments,
width of proximal and distal borders of PQ was taken
with the help of digital Vernier calliper accuracy up
to 0.01 mm. Nerve supply and blood supply of PQ
muscle were observed.
Type II: Deep head of PQ which was extending

proximally in triangular shape which had more
attachment on radius (n=02); [Fig.2b].
Type III: Deep head of PQ was covered by
superficial head of it (n=14); [Fig.2c].
Type IV: Distally superficial head of PQ which had
tendinous insertion on radius and proximally its deep
head with more attachment on radius (n=01); [Fig
3a].
Type V: Two separate rectangular heads of PQ (n=
04); [Fig.3b].
Type VI: Superficial head of PQ was taking origin
from lower part of ulna and inserted on carpal bones
(scaphoid, lunate) and few fibers on brachioradialis
muscle(n=01); [Fig.3c].
Type VII: Type I and distally separate slip arising
from ulnar side of superficial head of PQ which was
attached on capsule of distal radio-ulnar joint (n=01);
[Fig.4a].
Type VIII: Distal triangular superficial head of PQ
with tendinous apex at ulna and deep head of PQ
extended proximally (n=01); [Fig. 4b].
Type IX: Distal rectangular superficial head of PQ
and proximally triangular deep head of pronator
quadratus with apex at radius (n= 1); [Fig. 4c].
RESULTS
We observed the different heads of pronator
quadratus muscle (Table 1). Variations of PQ were
more common on left side.
Table 1- Showing the incidence of number of heads
of pronator quadratus [n=60]
Pronator
Single head Double head Triple
quadratus (Fig.1a)
(Fig. 1b)
head
(Fig.1c)
20
36
04
Number
%
(rt: 7; lt: 13)
(rt:12 ; lt:24 )
(rt:1;t:3)
33.33
60.00
06.66
Fig.1a- Showing single head of pronator quadratus.

1b: Showing double head of pronatorquadratus. 1c:
Showing three head of pronator quadratus
PQS- Superficial head ofpronator quadratus, PQd
Deep head of pronator quadratus
We observed different types of double heads (i.e.

superficial and deep) of PQ and classified as followsType I: Deep head of PQ was extending proximally
in triangular shape which had more attachment on
ulna(n=11); [Fig. 2a].
Surekha et al.,
877
PQs- Superficial head of pronator quadratus, PQd

Deep head of pronator quadrates, Black arrow is
showing separate slip of pronator quadratus.
Fig. 2a: Showing Type I pronator quadratus muscle. 2b:

Showing Type II pronator quadratus. 2c: Showing Type
III pronator quadratus.
Deep head of pronator quadratus
We observed, additional attachment of fibers of PQ

on bracheoradialis muscle in 2 (Fig. 3c), on carpal
bones in 4 (Fig.3c) and on capsule of DRUJ (Fig. 4a)
in 2 cadavers.
Radial and ulnar attachments of PQ (Table-2) in
48.50% of cases were at the same level. In remaining
cases i.e. 51.50%, ulnar attachment exceeds radial
attachment by 3 to 7 mm or radial attachment exceeds
ulnar attachment by 2 to 5 mm.
Table 2:
Showing the mean of various
attachments and width of PQ
Mean of various attachments of PQ Rt
Lt
Extent of radial attachment of PQ 45.1mm 45.0mm
Extent of ulnar attachment of PQ
45.4mm 45.5mm
Width of proximal border of PQ
28.6mm 28.7mm
Width of distal border of PQ
30.2mm 30.1mm
In all specimens, the PQ muscle was supplied by
anterior interossious nerve and anterior interossious
blood vessels. These structures were passing in a
plane deep to the deep head of PQ muscle.
DISCUSSION
Fig. 3a: Showing Type IV pronator quadratus. 3b:

Showing Type V pronator quadratus. 3c: Showing Type
VI pronator quadratus
Deep head of pronator quadrates BR- Brachioradialis,
Deep head of pronatorquadratus, S- Scaphoid, LLunate, T- Triquetral, P- Pisiform. Black arrows are
showing different direction of fibers of both heads of
PQ.
Fig 4a: Showing Type VII pronator quadratus. 4b:

Showing Type VIII pronator quadratus (PQs) 4c:
Showing Type IX pronator quadratus.
Surekha et al.,
Precise knowledge of anatomical variations is very

important because it may influence clinical diagnosis,
investigations and interventional performance such as
laparoscopy, endoscopy, magnetic resonance imaging
and computerized tomography.8 Pronator quadratus is
the deep muscle of flexor compartment of forearm
which is considered to be free from variations. 1 Das
et al 9 quoted that, absence of PQ muscle was reported
by Kahle et al and Barus and Elze. However, present
study did not reported absence of PQ muscle.
Johnson and Shrewsbury10 and Koebkeet al.11
reported double heads of PQ. They described that,
deep head of PQ was completely covered by
superficial head of PQ. Present study also reported
same type of PQ in 23.33% (Fig. 6). Macalister12
described nine varieties of PQ muscle having double
and triple heads. He quoted that, suppressed PQ was
reported by Otto and Meckel and bi-triangular form
of PQ observed by Barton. In present study, we
observed double heads PQ in 60% and triple heads in
6.66 % of cadavers (Table 1; Fig. 1b, 1c).
Representation of double heads PQ showed wide
variations, as mentioned above. We observed two
878
separate rectangular heads of PQ muscle while

Macalister12 observed triangular heads of PQ muscle.
Variations described by Macalister12were different
when we compared with our findings.
We observed additional attachment of insertion of PQ
muscle into carpal bones and the capsule of distal
radio- ulnar joint (Fig. 3c, 4a). A similar observation
was made by Macalister 12and in addition, he
observed attachment into the anterior annular
ligament, metacarpal bone of the thumb. In two
cadavers we observed that, few fibers of PQ muscle
were attached to brachioradialis muscle (Fig.3c). We
did not find any report of such attachment of PQ
muscle in literature. Demir et al13 reported, a case of
double heads of PQ in which an aponeurotic structure
coming from superficial head joined to the anterior
surface of lower part of the radius.
Fontanic et al 14 studied the anatomic basis of PQ flap
and reported the radial and ulnar attachments were at
the same level in 50% of cases. In our study, we
noted the radial and ulnar extent of PQ muscle (Table
2) and it was at the same level in 47.50% of cases.
We observed slightly lower values than Fontanic et
al14 which may be because of racial variations or
number of sample size which is more in our study. In
all cases, including with extra heads of PQ muscle,
the anterior interossious nerve was running on a plane
deep to the deep head of PQ muscle. All heads were
supplied from deep to superficial surface. Branches to
the superficial head were reaching after piercing the
deep head of PQ muscle.
CONCLUSION
Pronator quadratus muscle is not free from variations.
This study reported that, PQ muscle may have single,
double and triple heads. Double or triple heads of it
may compress the branches of anterior interossious
nerve and produce symptoms. However, extra heads
may be used for transplant surgeries. Therefore,
precise knowledge of variations of it may be helpful
for hand surgeons while planning transplant
surgeries, to prevent iatrogenic trauma and to
diagnose KilohNevin syndrome. Our study reported
high incidence of variations of PQ muscle further
studies should be performed with the help of new
techniques which will throw more light on anatomy
of this muscle.
Surekha et al.,
REFERENCES
1. Standring S. Grays Anatomy. The anatomical
basis of clinical practice. London: Elsevier
Churchill Livingstone. 2008; 40th Edn, 848
2. BasmajianJV, Deluca CJ. Muscles alive: their
functions revealed by electromyography.
Baltimore: Williams and Wilkins. 1985; 5thEdn,
241.
3. Sinnatamby CS. Lasts Anatomy Regional and
applied. Churchill Livingstone, Edinburgh.2000;
10th Edn, 64-5.
4. Annis R S. Pronator quadratus a forgotten
muscle: a case report. J Can Chiropr Assoc. 2003;
47: 17-20.
5. Braun RM. Viable pedicle bone grafting in the
wrist. In: Urbania JRMicrosurgery for major limb
reconstruction. Mosby, St Louis, 1987, 220-29.
6. Kupfer D, Lister G. The pronator quadratus
muscle flap: coverage of the osteomized radius
following elevations- of the radial forearm flap.
Plast Reconst Surg. 1992; 90: 1093-95.
7. Papp CH, Maurer H, Ausserlechner M, Wood D.
Reconstruction of pseudoarthrosis of the scaphoid
bone utilizing an osteomuscular pronator
quadratus transposition flap. Anatomical and
clinical considerations. Eur. J Plast. Surg. 1993;
16: 787- 98.
8. Jones DG, Dias GJ, Mercer S, Zhang M,
Nicholoson HD. Clinical anatomy research in a
research
driven
anatomy
department.
ClinAnat2002; 15:228-32.
9. Das S, Suhaimi FH, Latiff AA, Othman F.
Anomalous pronator quadratus muscle: a case
report. Eur J Anat. 2008; 12: 123-25.
10. Johnson RK, Shrewsbury MM. The pronator
quadratus in motion and in stabilization of the
radius and ulna at distal radioulnar joint. J Hand
Surg. 1976; 3: 205-9.
11. Koebke J, Werner J, Piening H. The quadrate
pronator muscle a morphological and functional
analysis. AnatAnz 1984; 157: 311-18.
12. Macalister Alexander. TheVarieties of the
Pronator Quadratus. J AnatPhysiol1870; 5: 32
34.
13. Demir S, Sarikcioglu L, Oguz N. Bilateral
pronator quadratus muscle variation. Annals of
Medical Sciences 2001; 10: 180-181.
14. Fontanic C, Millo F, Blancke D, Mestdagh H.
Anatomic basis of pronator quadratus flap.
SurgRadiiolAnat 1992; 14: 295-99.
879
DOI: 10.5958/2319-5886.2014.00019.8

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Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
Coden: IJMRHS
nd
Received: 2 Aug 2014
Research article
Copyright @2014
ISSN: 2319-5886
EMOTIONAL DISTURBANCES AMONG ADULT DIABETIC PATIENTS ATTENDING DIABETIC

CLINIC IN A MALAYSIAN GENERAL HOSPITAL
*Ali Sabri Radeef1, Ramli Musa1, Nik Nur Fatnoon Binti Nik Ahmad2, Ghasak Ghazi Faisal3
1
Department of Psychiatry, Kulliyyah of Medicine, International Islamic University Malaysia

Department of Internal Medicine, Kulliyyah of Medicine, International Islamic University Malaysia
3
Department of Basic Medical Science, Kulliyyah of Dentistry, International Islamic University Malaysia
2
*Corresponding author email:alisabri1973@yahoo.com

ABSTRACT
Introduction: Emotional disturbances such as depression, anxiety and stress play an important role in the
management of diabetes mellitus since their presence can adversely affect glycemic control, quality of life and
compliance with medications. Despite this, emotional disturbances are consistently under-diagnosed and undertreated by physicians in general practice. Objectives: This study aims to determine the prevalence and severity of
emotional disturbances among diabetic patients Methodology: This is a cross sectional study conducted on a
sample of 200 patients with diabetes mellitus attending the diabetic clinic at the Hospital Tengku Ampuan Afzan,
Pahang state, Malaysia. The prevalence and severity of depressive, anxiety and stress symptoms were assessed in
those diabetic patients by using the self-rating Bahasa Malaysia version of the Depression, Anxiety and Stress
Scales (DASS-42). Results: The prevalence of depression, anxiety, and stress among diabetic patients was 13.5%,
28%, 11% respectively. Most of the patients with emotional disturbances had moderate depression and anxiety
symptoms. However, stress symptoms were mild. Although females showed higher prevalence of emotional
disturbances, only anxiety was significantly higher than males. Conclusion: Diabetic patients are at risk to develop
psychiatric illnesses in the form of depression, anxiety and stress. Anxiety symptoms were more prominent than
depression and stress in diabetic patients.
Keywords: Depression, Anxiety, Stress, Diabetic Patients, Malaysia
INTRODUCTION
Diabetes mellitus is considered as a serious
worldwide health issue and developing countries are
in paramount risk.1The prevalence of diabetes is
expected to rise worldwide and the number of
diabetic patient is expected to be around 366 million
by the year 2030 compared to 171 million in 2000.2
In Malaysia, the Malaysian National Health
Morbidity Survey III (NHMS III) was conducted in
2006 revealed that the prevalence of diabetes mellitus
in those above 18 years was 11.6%.This was higher
than the previous survey (NHMS II) in 1996 which
showed the prevalence to be 8.3%. 3 In 2011, the
prevalence has increased to be 15.2% among the

Malaysian population. 4Since diabetes is associated
with a high rate of complications whether they are
physical, mental, or functional, urgent efforts are
required to address this issue. Steps are needed to
improve the healthcare personnels' awareness of
achieving the goals, provide adequate resources,
improve patients' diabetes self-management skills and
enhance the patient-healthcare personnel relationship
to achieve the goals.5Early detection and treatment of
emotional disturbances in the form of depression,
anxiety and stress is important to control diabetes.
880
Ali et al.,
Psychological factors may affect glycemiccontrol in

diabetic patients through endocrine changes that
occurred during stressful experiences can lead to
endocrine changes. In addition to that, during stress,
patients are more prone to be less compliant withthe
treatment plan. 6Stress is defined as the bodys nonspecific response to demands placed on it, related to
disturbing events in the environment. 7, 8 Duration of
diabetes is an indicator of chronic stress and is a risk
factor for medical complications and psychological
disturbance.9, 10 Stress may affect the onset of
diabetes, can have a harmful effect on glycemic
control and can affect quality of life.11Symptoms of
depression include persistent low mood, loss of
pleasure (anhedonia), loss of weight or appetite, lack
of energy, general malaise, disturbed sleep,
diminished concentration, feeling of worthlessness,
hopelessness and helplessness, death wishes and
recurrent suicidal ideation. The severity of these
symptoms can be assessed by using rating scales for
depressive symptoms like Beck Depression
Inventory- second edition (BID-II) 12 and Depression,
Anxiety, Stress Scale (DASS-42).13Since the presence
of depression has been associated with defective
glycemic control14and the main aim of diabetic
treatment is preservation of good glycemic control, it
is important to detect and manage depression early.
Depression is associated with impaired quality of life
15
, poor treatment adherence16, 17, increase the cost of
health care18, 19and increased risks of complications
and mortality.20, 21, 22
Anxiety is a condition that is characterized by intense
feeling of dread, accompanied by somatic symptoms
that indicate a hyperactive autonomic nervous system
such as tachycardia, sweating, dry mouth, frequent or
urgent micturition and diarrhoea. Anxiety impairs
cognition and may produce distortions of
perception.23Despite that diabetes is associated with
increased risk of anxiety and depression, 24there is
under detection of rates of these emotional problems
in diabetes patients.25Therefore, this study aimed to
determine the rate of emotional disturbances in

the form of depression, anxiety and stress
symptoms among adult diabetic patients and also
to assess the severity of these symptoms by using
the Bahasa Malaysia version of the Depression
Anxiety and Stress Scales (DASS). Based on the
above, this study is a type of liaison psychiatry
Ali et al.,
with significant community services as it aids the

control of diabetes by early detection of
emotional disturbances leading to better
compliance to treatment and improving patients
lifestyle.
This study is a cross sectional study. The selection of
the subjects was based on stratified quota sampling
conducted on a sample of patients with diabetes
mellitus attending the diabetic clinic at the Hospital
Tengku Ampuan Afzan, Pahang state, Malaysia. The
estimated sample size for this study was 200 patients
for achieving statistical valid results which were
achieved. All the diabetic patients attending the
diabetic clinic who fit the inclusion criteria were
approached by the researchers and included in this
study. The inclusion criteria for the participants are a
patient in the age group between 18 - 60 years old and
patients who were able to give written consent. The
exclusion criteria of this study include those who are
not conversant in Bahasa Malaysia or English. Prior
conducting this study, Institutional Approval from the
director of Hospital Tengku Ampuan Afzan, then
approval from National Medical Research Register
(NMRR) was obtained to conduct the study. Ethical
approval was obtained from the Ministry of Health,
Medical Research Ethics Committee (MREC) and
International Islamic University Malaysia Research
Ethical Committee prior to conducting the study.
Informed consent was obtained from the participants
after the nature of the procedure was fully explained.
The participation was entirely on a voluntary basis.
All participants were ensured of the confidentiality and
that information gathered will only be used for
research purposes. The patients were informed that the
data collected for one time only so the participants
only took part once in this study. Various subjects
were being approached from all ages, gender, ethnicity
monthly income, duration of the illness.
The Depression Anxiety Stress Scale-42 (DASS42):13The emotional disturbances were determined by
assessing the severity of depressive, anxiety and stress
symptoms in diabetic patients by using the self-rating
Bahasa Malaysia/English version of the Depression
Anxiety and Stress Scale (DASS-42) which had been
translated and validated previously by researchers 26.
Subjects were asked to use 4-point severity/frequency
scales to rate the extent to which they have
881
experienced each statement over the past week.

Scores for Depression, Anxiety and Stress were
calculated by summing the scores for the relevant
items. Statistical analysis: Statistical analysis for the
obtained data was assessed using Statistical Package
for the Social Sciences software program (SPSS)
version 20.0.Chi-squared test (x2) and Fischers exact
tests were used to test the association of different
factors with emotional disturbances. Significance was
set at p< 0.05
RESULTS
between 46 to 60 years old, employed and obtained a

secondary school level of education (Table 1). The
prevalence of depression, anxiety and stress among
participating patients was found to be 13.5%, 28%
and 11% respectively (Table2).Regarding the severity
of the emotional disturbances, it was found that 5% of
the patients had mild depression while 6% and 2.5%
of the patients had moderate and severe/ extremely
severe depression respectively. In assessing the
severity of anxiety, it was found that 9.5%, 11% and
7.5% of the participated diabetic patient had mild,
moderate and severe/extremely severe anxiety
respectively. For stress, it was found that, 7%, 3.5%
and 0.5% of the participated diabetic patient had
mild, moderate and severe/extremely severe stress
respectively (Table 2).
The majority of the participated patients (75%) were

Malay while 13.5% were Indians. Chinese patients
were obviously underrepresented in this study.
Female patients were slightly over presented than
males (54.5%, 45.5 respectively). The majority were
married, from the middle income group, aged
Table 1: The association of different factors with emotional disturbances among diabetic patients
Total
Depression
Anxiety
Stress
P
No.
N*
Dep. Pvalue N*
Anx.
value N* Str.
Male
91
80
11
0.6
73
18
0.026 82 9
Female
109
93
16
71
38
96 13
Age
18-30
21
18
3
1.00
13
8
0.394 18 3
31-45
45
39
6
31
14
38 7
46-60
134
116
18
100
34
122 12
Race
Malays
150
133
17
0.043
110
40
0.100 133 17
Chinese/Others
23
21
2
19
4
21 2
Indians
27
19
8
15
12
24 3
Marital status
Married
172
149
23
1.00
123
49
0.822 154 18
Divorced/single
28
24
4
21
7
24 4
Household income
RM1000
75
63
12
0.786
53
22
0.803 67 8
RM 1001-5000
110
96
14
81
29
98 12
>RM 5000
11
10
1
9
2
9
2
Level of education
Illiterate/Primary school 46
41
5
0.276
36
10
0.209 44 2
Secondary school
104
86
18
69
35
90 14
Tertiary education
50
46
4
39
11
44 6
Occupation
Employed
126
109
17
1.00
93
33
0.505 110 16
Unemployed
74
64
10
51
23
68 6
Duration of Illness
5 year and less
47
45
2
0.023
34
13
0.91
44 3
>5 years
153
128
25
112
41
134 19
Presence of chronic illness
No
73
62
11
0.62
51
22
0.45
63 10
Yes
127
111
16
95
32
115
P
value
0.826
0.097
0.654
0.521
0.701
0.259
0.359
0.30
0.36
12
Chi-square test value (Fishers Exact 2-sided p value), N*: normal; Dep: Depression; Anx: Anxiety; Str:Stress
882
Ali et al.,
In assessing the association between different factors

with depression, anxiety and stress, we found that
although the rate of depression, anxiety and stress is
higher among female patients, only anxiety was
statistically significant (P-value <0.05). Regarding
the relation between the race and emotional
disturbance, this study revealed that depression was
statistically significant (p-value <0.05).
This study revealed that depression, anxiety and
stress were higher in more patients with diabetes
longer than 5 years, however, only depression was
statistically significant. Our findings revealed that
there was no significant association between
depression, anxiety and stress with factors including
age, marital status, household income, occupation,
level of education and the presence of co-morbid
chronic illness (Table 1).
Table 2: The severity of emotional disturbances in
the form Depression, Anxiety, and Stress
symptoms among diabetic patients:
Depression
(13.5)
N (%)
Anxiety
(28)
N (%)
Stress
(11)
N (%)
Normal
(no emotional
disturbances)
Mild
Moderate
Severe/Extremely
severe
173
(86.5)
144
(72)
178 (89)
10 (5.0)
19 (9.5)
14 (7.0)
12 (6.0)
22 (11)
7 (3.5)
5 (2.5)
15 (7.5)
1 (0.5)
Total
200
200
200
The percentage of individuals who had an

emotional disturbance
DISCUSSION
The prevalence of depression, anxiety and stress in
this study is comparable with a similar study done in
Malaysia among diabetic patients in primary care as it
had shown that the overall prevalence of depression,
anxiety and stress were 11.5%, 30.5% and 12.5%
respectively.27 But our results were much lower than
other study done in Qatar as the prevalence of
depression, anxiety and stress was found to be 52.5%,
73% and 70%.28
The rate of depression in this study is comparable to
previous studies such as a study done in United Arab
Emirates with a rate of 12.5%29, another study in
India has shown the rate to be 16.9%30
Regarding the rate of anxiety, it was found that it is

slightly higher than another study done on diabetic
patients attending a secondary care clinic in Germany
in which it was 25.2% 31, yet it is much lower than
another study in which the rate was 40%. 32 The
reasons behind getting different rates of depression,
anxiety and stress may be because of using different
assessment tools, sample size, cultural differences,
impact of diabetic complications, quality of life, the
presence of social support, and duration of diabetes.
In assessing the association between different factors
with depression, anxiety and stress, we found that
although the rate of depression, anxiety and stress is
higher among female than male patients, only anxiety
was statistically significant, while previous studies
revealed that depression, anxiety and stress symptoms
were significantly associated with sex of the diabetic
patients, with a higher prevalence in women.27, 28
however, in another study using Hospital Anxiety and
Depression Scale (HADS), no differences were
observed between males and females and the scores
for depression and anxiety were comparable.30
This study revealed that depression was statistically
significant with race, this is consistent with previous
studies which revealed that ethnicity can be a
predictor for depression. 27, 33
Previous studies have found that duration of diabetes
has also been found to be associated with a higher
prevalence of depression. 27, 28, 34
This study revealed that depression, anxiety and
stress were higher in patient with diabetes longer than
5 years, however, only depression was statistically
significant. This is comparable with previous
studies.35
CONCLUSION
Finally, we conclude that diabetic patients are at risk
to develop emotional disturbances in the form of
depression, anxiety and stress symptoms. Anxiety
symptoms were more prominent than depression and
stress in diabetic patients. Strategies are needed to be
implemented such as early detection, proper
management of these psychological disturbances,
provide psychoeducation for patients and their
families to ensure proper control of diabetes, maintain
good quality of life, and better treatment adherence.
883
Ali et al.,
ACKNOWLEDGEMENTS
We wish to extend our sincere gratitude to
International Islamic University Malaysia for funding
this project and to the administrative personnel and
medical staff in the Hospital Tengku Ampuan Afzan
for the kindness of giving permission to conduct this
study and for their cooperation. I also would like to
express my appreciations to all patients for their
participation and consent.
Funding: A research grant sponsored by the
Research Management Centre, International Islamic
University Malaysia was obtained for conducting this
research.
10.
11.
12.
13.

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DOI: 10.5958/2319-5886.2014.00020.4

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 10 Sep 2014
LEVEL OF STRESS IN FINAL YEAR MBBS STUDENTS AT RURAL MEDICAL COLLEGE: A

CROSS-SECTIONAL STUDY
*Shelke Umesh S1, Kunkulol Rahul R2, Narwane Sandeep P3
1
Undergraduate Student1, Professor2, Assistant Professor3, Department of Pharmacology, Rural Medical College
(PIMS-DU), Loni, Ahmednagar, Maharashtra
*Corresponding author email: umeshshelke01@gmail.com
ABSTRACT
Introduction: Stress, defined as an imbalance between environmental conditions necessary for survival and the
ability of individuals to adapt to those conditions, have a high prevalence in MBBS students. A variety of
stressors play a significant role in developing stress. Objective:To study the level of stress and stressors
responsible in Final MBBS students of Rural Medical College, Loni. Methods: A descriptive cross sectional
study was carried out in 100 students (50 of either sex) willing to participate in the study. They were subjected to
fill the Medical Student Stressor Questionnaire, which consists of 40 questions for evaluating the stressors and
severity of stress perceived by the subjects. Results: 71% subjects perceived moderate stress, while 13% and
16% perceived high and mild stress respectively. Academic stressor counted for moderate stress in 63% and high
stress in 24 % of subjects, which was higher than other stressors. Conclusion: Academic stressors being the major
stressor perceived, Strategies are required to decrease the burden of academic stress in the students.
Keywords: Stress, Medical Student Stressor Questionnaire, Medical students
INTRODUCTION
Stress is defined as an imbalance between
environmental conditions necessary for survival and
the ability of individuals to adapt to those conditions.
1
Studies have revealed a high prevalence of stress in
medical students, ranging from 30% to 50%.2-7
Learning a lot of new information in a relatively short
time, with the pressure of exams, cause development
of stress in medical students.8 A stressor is defined as
a personal or environmental event that causes
stress.9,10
Stressors of medical students can be grouped into
academic related, intrapersonal and interpersonal
related, teaching and learning-related, social related,
drive and desire related and group activities related
stressors.3 One or more of such stressors might act at
the same time and contribute in development of stress
among students.
Excessive amount of stress in medical training

predisposes students to have difficulties in solving
interpersonal conflicts, sleeping disorder, decreased
attention, reduced concentration, temptation to cheat
on exams, depression, loss of objectivity, increased
incidence of errors, and improper behavior, such as
negligence. Stress may also manifest in the form of
headaches, gastrointestinal disorders, coronary heart
disease, impaired judgments, absenteeism, selfmedication, suicidal ideation, depression and the
consumption of drugs and alcohol. 11,12
A few studies in India have studied the prevalence of
stress and stressors responsible in medical students.
The present study (references from folder Indian
references) was planned to study of stress in last year
medical students at Rural Medical College.
886
Umesh et al.,
METHODS
A descriptive cross sectional study was conducted
with a study population of 100 medical students (50
of either sex) in III MBBS from Rural Medical
College, Loni, Ahmednagar. Duration of the study
conducted form 1st February 2014 to 1st March 2014.
IEC approval was taken before the commencement of
study.
Students who were ready to give consent were
enrolled in the study and inclusion and exclusion
criteria were applied. III MBBS students (third
semester) of either sex consenting to participate were
included in the study. Students not ready to
participate or of other year were excluded from the
study.
The participants were subjected to medical Student
Stressor Questionnaire (MSSQ)3
The MSSQ consists of 40 items representing the six
stressor domains. Each item was answered in the
form of score as shown in table 1
Table 1: Scoring of items in MSSQ scale
Grades
Details
0
No stress
1
Mild stress
2
Moderate stress
3
High stress.
4
Severe stress.
The 40 items were divided into sections A (20 items)
and B (20 items) respectively. Total score of A and B
of each domain was divided by following value and
results were interpreted. 3
1. Academic related stressors (ARS) =13
2. Intrapersonal and interpersonal related stressors
(IRS) =7
3. Teaching and learning-related stressors (TLRS) =7
4. Social related stressors (SRS) =6
5. Drive and desire related stressors (DRS) =3
6. Group activities related stressors (GARS) =4
Interpretation:
0.00-1.00 causes mild stress
1.01-2-00 causes moderate stress
2.01-3.00 causes high stress.
3.01-4.00 causes Severe stress.
The mildest type of stress means it does not cause any
or mild stress. The moderate type indicated that it
caused reasonable, but manageable stress. The
highest type of stress indicated lot of stress and
causes
emotional
disturbances and mildly
compromises daily activities. The severe stress

indicates severe emotional disturbances and
compromise of daily activities.
Statistical Analysis: Data were analysed by Chisquare test.
RESULTS
Moderate type of stress due to academic related
stressors was commonly seen in final year MBBS
students in both genders. 33% females and 30%
males showed Moderate type of stress. 15% females
showed a high type of stress as compared to 9% in
males. Severe type of stress was seen in one meal.
80% of males and 96% of females suffered from
moderate, high or severe type of stress due to
academic related stressors. (Table 2)
Table 2: Distribution between Academic related
stressors (ARS) and Gender
Type
of Males
Females Total
Stress Caused (%)
(%)
(%)
due to ARS
Mild (0-1)
10(20%) 2(4%)
12(12%)
Moderate(1-2) 30(60%) 33(66%) 63(63%)
High
9(18%) 15(30%) 24(24%)
Severe
1(2%)
0(0%)
1(1%)
50(100%) 50(100%) 100(100%)
Value of =7.976, d.f. = 3, significant, p<0.05
By applying Chi-square test there is a significant
association between ARS and gender (p<0.05)
Table 3: Distribution between Intrapersonal and
interpersonal related stressors (IRS)
Type of
Males
Females Total
Stress Caused (%)
(%)
(%)
due to IRS
Mild
15(30%) 13(26%) 28(28%)
Moderate
25(50%) 29(58%) 54(54%)
High
10(20%) 8(16%) 18(18%)
Severe
0(0%)
0(0%)
0(0%)
50(100%) 50(100%) 100(100%)
Table 3 shows the frequency of stress due to IRS.
Moderate type of stress due to intrapersonal and
interpersonal related stressors in final year MBBS
students was higher in both genders. 29% females
and 25% males showed the moderate type of stress.
10% males and 8% females showed a high type of
stress due to intrapersonal and interpersonal related
stressors. 70% of males and 74% of females suffered
from moderate to high type of stress in this category.
887
Umesh et al.,
Table 4: Distribution between Teaching and

learning-related stressors (TLRS) and Gender.
Type
of Males
Females Total
Stress Caused (%)
(%)
(%)
due to TLRS
Mild
17(34%) 11(22%) 28(28%)
Moderate
29(58%) 30(60%) 59(59%)
High
4(8%)
9(18%) 13(13%)
Severe
0(0%)
0(0%)
0(0%)
50(100%) 50(100%) 100(100%)
Value of =3.226, d.f.=2, significant, p<0.05
By applying g Chi-square test there is a significant
association between Teaching and learning-related
stressors (TLRS) and sex (p<0.05)
Table 4 showed more number of moderate type of
stress due to teaching and learning-related stressors
(TLRS) in the final year MBBS students in both
genders. 30% females and 29% males showed the
moderate type of stress. 17% males showed a mild
type of stress and 9% females showed a high type of
stress due to teaching and learning-related stressors
(TLRS). 66% of males and 78% of females suffered
from moderate to high type of stress.
Table 5: Distribution between Social related
stressors (SRS) and Gender
Type of Stress
Males
Females Total
Caused due to
(%)
(%)
(%)
SRS
Mild
Moderate
High
Severe
20(40%) 14(28%) 34(34%)

26(52%) 28(64%) 54(54%)
4(8%)
8(16%) 12(12%)
0(0%)
0(0%)
0(0%)
50(100%) 50(100%) 100(100%)
Table 5 displays the more moderate type of stress due
to social related stressors (SRS) in final year MBBS
students in both genders. 28% females and 26%
males showed the moderate type of stress. 20% males
showed a mild type of stress and 8% females showed
a high type of stress due to social related stressors
(SRS). 60% of males and 80% of females showed
moderate to high type of stress.
Table 6: Association between Drive and desire
related stressors (DRS) and Gender
Type of Stress Males
Females Total
Caused due to (%)
(%)
(%)
DRS
Mild
Moderate
High
Severe
31(62%)
16(32%)
3(6%)
0(0%)
50(100%)
24(48%)
19(38%)
5(10%)
2(4%)
50(50%)
55(55%)
35(35%)
8(8%)
2(2%)
100(100%)
Value of =3.648, d.f.=3, significant, p<0.05

By applying g Chi-square test there is a significant
association between Drive and desire related stressors
(DRS) and sex (p<0.05)
Table 6 shows more subjects showing mild type of
stress due to drive and desire related stressors (DRS)
in the final year MBBS students in both genders. 31
% males and 24% females showed the moderate type
of stress. 19% females showed a mild type of stress,
5% females showed a high type of stress and 2%
femalesshowedsevere type of stress due to drive and
desire related stressors (DRS). 38% of males and
52% of females showed moderate to severe type of
stress.
Table 7: Association between Group activities
related stressors (GARS) and Gender
Type of
Males
Females Total
Stress Caused (%)
(%)
(%)
due to GARS
Mild
21(42%) 18(36%) 39(39%)
Moderate
22(44%) 23(46%) 45(45%)
High
6(12%) 8(16%) 14(14%)
Severe
1(2%)
1(2%)
2(2%)
50(100%) 50(100%) 100(100%)
Table 7 showed a more moderate type of stress due to
group activities related stressors (GARS) in the final
year MBBS students in both genders. 22 % males and
23% females showed the moderate type of stress.
21% males showed a mild type of stress, 8% females
showed a high type of stress and 1%
males&femalesshowedSevere type of stress due to
group activities related stressors (GARS).
Table 8 Stressors according to rank of mean degree of
stress perceived by medical students. Test and
examinations were the only item that caused
moderate to high stress among students. All other
items fell under the category of mild to moderate
stress except working with computers and talking to
patients about personal problems.
Degree of stress classification: 0 - 1.00 is causing nil
to mild stress, 1.01 2.00 is causing mild to
moderate stress, 2.01 3.00 is causing moderate to
high stress and 3.01 4.00 is causing high to severe
stress7
888
Umesh et al.,
Table 8: Stressors according to rank of mean degree of

stress perceived by medical students (by MSSQ)
Item
Causing moderate to high stress
Tests/examinations
Causing mild to moderate stress
Getting poor marks
Large amount of content to be learnt
Not enough medical skill practice
Facing illness or death of the patients
Need to do well (self-expectation)
Lack of time to review what have
been learnt
Unjustified grading process
Quota system in examinations
Heavy workload
Need to do well (imposed by others)
Uncertainty of what is expected of me
Frequent interruption of my work by
others
Conflict with teacher(s)
Lack of recognition for work done
Verbal or physical abuse by teacher(s)
Unable to answer questions from
patients
Conflict with personnel(s)
Learning context - full of competition
Family responsibilities
Inappropriate assignments
Verbal or physical abuse by
personnel(s)
Teacher - lack of teaching skills
Poor motivation to leam
Verbal or physical abuse by other
student(s)
Not enough feedback from teacher (s)
Lack of time for family and friends
Participation in class presentation
Unable to answer the questions from
the teachers
Having difficulty understanding the
content
Feeling of incompetence
Falling behind ill reading schedule
Conflicts with other students
Participation in class discussion
Lack of guidance from teacher (s)
Mean SD
2.171.11
1.961.26
1.91.13
1.881.16
1.881.30
1.851.18
1.841.08
1.811.18
1.781.29
1.731.13
1.711.17
1.691.19
1.681.09
1.661.04
1.640.99
1.631.20
1.591.17
1.571.24
1.481.11
1.481.31
1.470.96
1.471.18
1.461.29
1.431.16
1.411.23
1.410.96
1.41.01
1.391.18
1.360.97
1.330.92
1.331.08
1.311.10
1.250.99
1.161.14
1.141.05
Item
Not enough study material
Unwillingness to study medicine
Parental wish for you to study
medicine
Causing nil to mild stress
Working with computers
Talking to patients about personal
problems'
Mean SD
1.131.12
1.021.04
1.011.22
0.941.07
0.710.94
DISCUSSION
MSSQ having a high score in a particular stressor
group generally indicates that the subjects perceive
events, conditions or situations from that particular
group as causing the subjects stress. The scores,
however, do require frank and honest response in
order for it to be of any use. The scores are also
affected by factors which can falsely increase or
lower the scores, but generally the validity and
reliability studies have indicated that the scores from
the questionnaire are highly trustworthy.8
Personal and environmental events that cause stress
are known as stressors9,10. Stressors of medical
students are grouped into six categories.
Academic related stressors refer to any event related
to the academics of the students. Interpersonal and
intrapersonal related stressors refer to any form of
relationships between and within individuals that
cause stress. Teaching and learning related stressors
refer to any events related to teaching or learning that
causes stress. Social related stressors refer to any
form of community and societal relationships that
cause stress. Drive and desire related stressors refer to
any form of internal or external forces that influence
ones attitude, emotion, thought and behaviour which
subsequently cause stress. Group activities related
stressors refer to any group events and interactions
that cause stress13.
In present study moderate type of stress caused due
all the 6 stressors was commonly seen in both
genders of final year MBBS students. Statistically
significant difference was seen in males and females
with respect to academic related, teaching related and
drive and desire related stressors. This difference was
also noted in a study by Waghachavare et.al.14
Our study showed 58% of males and 64% of females
perceiving moderate to high type of stress. This was
higher as compared to studies conducted in Malaysia
889
Umesh et al.,
which were 29.1 % to 41.9% in government

institutes2,5,6 and 46.2% in a private school6, as
measured by GHQ-12.In a study on medical student
conducted in GS medical college, it was observed
that 73% of students perceived stress15. Zungsself
rating scale for depression was used for the study. In
the study by Waghachavareet.al.14,which used DASS21 and GAD scales, stress was perceived by 34 % of
medical students. There was a significant difference
between males and females perceiving stress.
The academic related stressor had 63% of population
in the moderate type of stress, while it became 88%
when moderate to severe type of stress added
together. Academic related stressor was followed by
intra and interpersonal related, teaching and learning
related, social related, group related and drive and
desire related stressors. The academic factor was
higher stressor as compared to physical, emotional
and social factors in the study conducted in GS
medical college.
Studies have revealed that the stressors affecting
medical students well-being seem to be related to the
medical training, especially academic matters3, 6, 14-19.
On ranking the items depending upon the mean level
of stress that the students perceived, it was found that
the stress related to the academics was highest (Table
7). This finding supports the findings of the study
done by Yusoff et al.2
CONCLUSION
The study showed high prevalence of stress among
students with respect to different stressors. Academic
stressors have significant association with stress
among students. Females show more stress as
compared to males. Strategies are required to
decrease the burden of academic stress in the
students.
Acknowledgement: Final MBBS students (Batch
2011 and 2012) and Mr. Hemant Pawar (Statistician),
Department of Pharmacology &Research cell, Rural
Medical College (PIMS- DU), Loni.
Source of funding : Nil
REFERENCES
1. Rosenham D L, Seligman M E. Abnormal
psychology. 2nd ed. New York: Norton; 1989.
2. Muhamad SBY, Ahmad FAR, Yaacob MJ.

Prevalence and sources of stress among medical
students in UniversitiSains Malaysia [Thesis].
Medical Education: UniversitiSains Malaysia
(USM), Mei; 2009.
3. Muhamad SBY, Ahmad FAR, Yaacob MJ. The
development and validity of the Medical Student
Stressor Questionnaire (MSSQ). ASEAN Journal
of Psychiatry. 2010; 11 (1): Available online:
http://www.aseanjournalofpsychiatry.org/oe1110
5.htm
4. Zaid ZA, Chan SC, Ho, JJ.). Emotional disorders
among medical students in a Malaysian private
medical
school.
Singapore
Med
J.
2007;48(10):895-99
5. Sherina MS, Lekhraj R, Nadarajan K. Prevalence
of emotional disorder among medical students in
a Malaysian university. Asia Pacific Family
Medicine. 2003; 2:213-17
6. Saipanish, R. Stress among medical students in a
Thai medical school. Med Teach. 2003;
25(5):502-06
7. Miller, PM, Surtees, PG. (1991). Psychological
symptoms and their course in first-year medical
students as assessed by the Interval General
Health
Questionnaire
(I-GHQ).
Br
J
Psychiatry.1991; 159:199-207
8. Yussof M, Baba A. Prevalence and associated
factors of stress, anxiety and depression among
prospective medical students. Asian Journal of
Psychiatry.2013;59 (2),12833
9. Lazarus RS. Theory-Based Stress Measurement.
Psychology Inquiry. 1990; 1 (1):3-13.
10. Lazarus RS, Folkman S. Stress, appraisal, and
coping. New York: Springer; 1984.
11. ORourke M, Hammond S. The Medical Student
Stress Prole: a tool for stress audit in medical
training. Medical Education. 2010; 27 (44):1027
37.
12. Dahlin M, Nilsson C, Stotzer E, Runeson B.
Mental distress, alcohol use and help-seeking
among medical and business students: A crosssectional comparative study. BMC Med Educ.
2011;11:92
13. Muhamad SBY, Ahmad FAR. The Medical
Student Stressor Questionnaire (MSSQ) Manual .
1st edi.
Malaysia: KKMED Publications;
2010:1-25
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14. Waghachavare VB, Dhumale GB, Kadam YR,

Gore AD. A Study of Stress among Students of
Professional Colleges from an Urban area in
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Sultan
Qaboos
University
Med
J.2013;13(3):429-36
15. Supe AN. A study of stress in medical students at
Seth G.S. Medical College. J Postgrad Med.1998;
44:1-6
16. Aktekin M, Karaman T, Senol YY, Erdem S,
Erengin H, Akaydin M. Anxiety, depression and
stressful life events among medical students: a
prospective study in Antalya,Turkey. Medical
Education. 2001; 35(1):12-7
17. Guthrie EA., Black D, Shaw CM, Hamilton J,
Creed FH, Tomenson B. Embarking upon a
medical career: psychological morbidity in first
year medical students. Med Educ. 1995; 29(5):
337-41
18. Kaufman DM, Day V, Mensink D. Stressors in
1st-year medical school: comparison of a
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Teaching and Learning in Medicine. 1996; 8(4),
188-94
19. Kaufman DM, Day V, Mensink D. Stressors in
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891
Umesh et al.,
DOI: 10.5958/2319-5886.2014.00021.6

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Copyright@2014
ISSN: 2319-5886
th
CLINICO-EPIDEMIOLOGICAL PROFILE OF INFLAMMATORY

DISEASES IN A TERTIARY CARE CENTRE IN EAST INDIA
AND
INFECTIVE
SKIN
*Vishal Prakash Giri1, Om Prakash Giri2, Sudhir Kumar Gupta3, Shubhra Kanodia4
1
Assistant Professor, Department of Pharmacology, Teerthanker Mahaveer Medical College and Research Centre,
Moradabad, Uttar Pradesh, India
2
Professor and Head, Department of Pulmonary Medicine, Darbhanga Medical College and Hospital, Darbhanga,
Bihar, India
3
Senior Resident, Department of Dermatology and STD, Darbhanga Medical College and Hospital, Darbhanga, Bihar,
India
4
Post Graduate Student, Department of Oral Medicine and Radiology, Teerthanker Mahaveer Dental College and
Research Centre, Moradabad, Uttar Pradesh, India
*Corresponding author email: drvpgiri@gmail.com

ABSTRACT
Background: Darbhanga is a municipal corporation and town of the old Darbhanga Raj, it has a humid
subtropical climate. Several studies have reported about pattern of skin diseases in different districts of India,
but there is no such report from Darbhanga. This prompted us to conduct the present study. Aim: To
observe the clinical and epidemiological profile of inflammatory and infectious skin diseases at Darbhanga.
Methodology : The present retrospective study was conducted from medical records of Dermatology outpatient department of Darbhanga Medical College and Hospital, Darbhanga .Total 1134
patients of
inflammatory and infective skin diseases were selected for study. Their demographic data (age and gender) and
disease data (type of skin infection) were recorded for analysis. Results: Analysis revealed that majority
(597; 52.65% ) of skin diseases belonged to inflammatory group followed by infective group
(537;47.35%). Of the inflammatory group, allergic contact dermatitis (209;18.43%) was the most
common entity followed by irritant contact dermatitis (180; 15.87 %), seborrheic dermatitis (120 ;10.58%),
atopic dermatitis (50; 4.41%), psoriasis (20;1.76 %) and pompholyx (18;1.59 %). Of the infective group,
bacterial infection was the most common disease (349 ; 30.78%). Followed by parasitic infection (127 ;
11.20%), fungal infection (58 ; 5.11%) and viral infection (3;0.26%). Conclusion: Skin disorders are
common in Darbhanga and incidence of inflammatory skin diseases is slightly higher than that of
infective skin diseases.
Keywords: Inflammatory skin diseases, Infective skin diseases, Skin disease pattern.
INTRODUCTION
Skin disease is very common. The skin disease
can be as disabling as a disease of other organ
systems. The disability
consists
of physical,
emotional and social components. Each geographical

region has its own spectrum of skin diseases due to
the local fauna. Although some diseases are same
892
Vishal et al.,
all over the world, the pattern differs markedly

from place to place. 1 Inflammatory and infective
skin diseases are the commonest skin diseases.
Inflammatory skin diseases include allergic contact
dermatitis, irritant contact dermatitis, seborrheic
dermatitis, atopic dermatitis, psoriasis and
pompholyx (vesiculobullous hand eczema). Infective
skin diseases include bacterial infections (impetigo
contagiosa, ecthyma, folliculitis, furunculosis,
pyogenic paronychia), parasitic infections (scabies,
pediculosis) , superficial fungal infections ( tinea
infections, pitiriasis versicolor) and viral infection
(molluscum contagiosum ).2 The aim of present
study was to observe pattern of inflammatory and
infective skin diseases at Darbhanga (Bihar), India.
The relevant data available from medical case
records of the Dermatology out-patient department
(OPD) of Darbhanga Medical College
and
Hospital were collected during the period July
2012 to January 2014. Total 1134 (one thousand
one hundred
thirty
four)
patients
with
inflammatory and infective skin diseases were
selected for the
present retrospective study.
Demographic data (age and gender) and Disease
data (type of disease) were noted to study the
clinico-epidemiological profile.
RESULTS
Total 1134 cases were analyzed and out of
them 597 (52.65%) cases had inflammatory skin
diseases and 537 (47.35%) infective skin diseases.
Among the inflammatory skin diseases, allergic
contact dermatitis
was the most common 209
(18.43%) disease followed by irritant contact
dermatitis 180 (15.87%), seborrheic dermatitis 120
(10. 58%), atopic dermatitis 50 (4.41%), psoriasis 20
(1.76%) and pompholyx 18 (1.59 %). [Table1]
Among the infective skin diseases
bacterial
infections affected 349 (30.78%) patients and out
of them 158 (13.58%) had impetigo contagiosa
while remaining had ecthyma 133 (11.73%),
folliculitis 25 (2.20 %), furunculosis 20 (1.76%) and
pyogenic
paronychia 13 (1.15%). Parasitic
infections were the next most common group 127
(11.20%), out of which scabies contributed to 122
(10.76%) and Pediculosis 5 (0.44 %). Fungal

diseases were observed in total 58 (5.11%) cases
comprising of tinea infections 38 (3.35%) and
pitiriasis versicolor 20 (1.76 %). Viral infection
molluscum
contagiosum
was observed in 3
(0.26%) patients. [Table 2] 580 (51.15%) patients
were female and 554 (48.85%) were male with
a female / male ratio of 1.05 :1.
Allergic
contact
dermatitis (105 : 9.26 %),
seborrheic dermatitis (71: 6.26 %) and psoriasis
(11: 0.57 %) were common in males while irritant
contact dermatitis (99 : 8.73 %), atopic dermatitis
(31:2.73 %) and pompholyx (10 :0.88 %) had
increased
incidence
in
females. Impetigo
contagiosa 86 (7.58%), folliculitis (15:1.32 %),
furunculosis (12:1.06%), pyogenic
paronychia
(8:0.70%), scabies (66:5.82 %) and molluscum
contagiosum (3:0.26 %) were common in females
whereas males were frequently affected with
ecthyma (72:6.35%), pediculosis 3(0 .26 %), tinea
infections (22:1.94% ) and pitiriasis versicolor
(11:0.97 %). [Table 1 & 2 ].
In the present study 369 (32.54%) pediatric (1-14
years age) and 765 (67.46%) adult cases were
observed. Age distribution showed that majority
of patients were in the age group of 21 -40
years with 356 (31.39%) cases followed by 15-20
years age group with 172 (15.17%) cases.
Table 1: Pattern of skin inflammation in both
sexes
Male
Female
Total
Diseases
No.
No.
No.
105
9.26
104
9.17
209
18.4
81
7.14
99
8.73
180
15.8
71
6.26
49
4.32
120
10.5
19
1.68
31
2.73
50
4.41
11
0.97
0.79
20
1.76
Pompholyx
0.71
10
0.88
18
1.59
Total
295
26.0
302
26.63
597
52.6
Allergic
contact
dermatitis
Irritant
contact
dermatitis
Seborrheic
dermatitis
Atopic
dermatitis
Psoriasis
893
Vishal et al.,
Table 2: Pattern of skin infection in both sexes

Diseases
Impetigo
contagiosa
Ecthyma
Male
No.
Female
Total
No.
No.
72
6.35
86
7.58
158
13.93
72
6.35
61
5.38
133
11.73
Folliculitis
10
0.88
15
1.32
25
2.20
Furunculosis
Pyogenic
paronychia
Scabies
Pediculosis
Tinea
infections
Pitiriasis
versicolor
Molluscum
contagiosum
Total
0.70
12
1.06
20
1.76
0.44
0.70
13
1.15
56
4.94
66
5.82
122
10.76
0.26
0.18
0.44
22
1.94
16
1.41
38
3.35
11
0.97
0.79
20
1.76
00
00
0.26
0.26
Table 4: Pattern of skin inflammation in different age

groups
21-40 y
Diseases
Allergic
contact
dermatitis
Irritant
contact
dermatitis
Seborrheic
dermatitis
Atopic
dermatitis
Psoriasis
Pompholyx
Total
41-60 y
60 y
No.
No
No.
80
7.05
47
4.1
45
3.97
104
9.17
30
2.6
0.53
40
3.53
20
1.7
10
0.88
20
1.76
0.2
10
0.09
13
8
265
1.15
0.71
23.3
3
00
103
0.2
00
9.08
4
00
75
0.35
00
6.61
Table 5: Pattern of skin infection in different age groups

1-5 years
6-14 years
15-20 years
No.
No.
No.
Impetigo
contagiosa
96
8.47
37
3.26
15
1.32
Ecthyma
59
5.20
35
3.09
23
2.02
1
1
0.09
0.09
1
1
0.09
0.09
3
4
0.26
0.35
00
00
0.09
0.09
Scabies
37
3.26
34
3.00
23
2.03
Pediculosis
Tinea
infections
Pitiriasis
versicolor
Molluscum
contagiosum
Total
00
00
00
00
0.26
0.35
0.35
Diseases
259
22.8
278
24.52
537
47.35
Pediatric cases were predominantly affected with

impetigo contagiosa 133 (11.73 % ), ecthyma 94
(8.29%), scabies 71 (6.26%) and molluscum
contagiosum 3 (0.26 % ) whereas adult patients
had increased incidence of folliculitis 23 (2.03%),
furunculosis 18 (1.59 % ), pyogenic paronychia 12
(1.06 %), pediculosis 5 (0.44%), tinea infections
33(2.91% ), pitiriasis versicolor 20 (1.76 % ),
allergic contact dermatitis 205 (18.08%), irritant
contact
dermatitis 167 (14.73 %), seborrheic
dermatitis 99 (8.73%), atopic dermatitis 37( 3.26 %),
psoriasis 20(1.76%) and pompholyx 11(0.97%).
[Table 3-6]
Table 3: Pattern of skin inflammation in different age
groups
1-5 Years 6-14Years 15-20 Years
Diseases
No. %
No. %
No. %
Allergic
contact
00
00
4
0.35 33
2.91
dermatitis
Irritant
contact
6
0.53
7
0.62 27
2.38
dermatitis
Seborrheic
7
0.62 14 1.23 29
2.56
dermatitis
Atopic
8
0.71
5
0.44
4
0.35
dermatitis
Psoriasis
00
00
00
00
00
00
Pompholyx
2
0.18
5
0.44
3
0.26
Total
23 2.03 35 3.09 96
8.47
Folliculitis
Furunculosis
Pyogenic
paronychia
1
00
0.09
00
4
00
00
00
00
0.18
0.09
00
00
197
17.37
114
10.05
76
6.70
Table 6: Pattern of skin infection in different age groups
Diseases
Impetigo
contagiosa
Ecthyma
Folliculitis
Furunculosis
Pyogenic
paronychia
Scabies
Pediculosis
Tinea infections
Pitiriasis
versicolor
Molluscum
contagiosum
Total
21- 40Years
No
%
41-60years
No
%
60 years
No.
%
0.62
0.26
00
00
8
15
10
0.70
1.32
0.88
4
4
3
0.35
0.35
0.26
4
1
1
0.35
0.09
0.09
0.35
0.53
0.09
20
00
17
1.76
00
1.50
4
00
10
0.35
00
0.88
4
2
2
0.35
0.18
0.18
10
0.88
0.79
0.09
00
00
00
00
00
00
91
8.02
43
3.80
16
1.41
894
Vishal et al.,
DISCUSSION
The prevalence of non-infective skin diseases
have outstripped that of infectious skin diseases
in some studies varying from 40. 90% to 58.70
%.3-7 Further this trend was noticed in our
present study with inflammatory skin diseases
accounting for 52.65% cases. However, some other
studies have reported a higher prevalence of
infective skin diseases varying from 59.10 % to
89.70%.8-12 In contrast, infective skin diseases
accounted only 537 (47.35%) cases in our present
study .
In the inflammatory skin diseases group, allergic
contact dermatitis was commonest 209 (18.43 %)
disorder followed by irritant contact dermatitis
180 (15.87%) in the present study. However
seborrheic dermatitis have been
reported as
commonest disorder
at Kolkata and contact
13,14
dermatitis at Mangalore.
Among infective skin
diseases, bacterial infections were more common
in the present study followed by parasitic, fungal
and viral infections . Unlike our study, Ashokan N
et al from Kerala and Agrawal S et al from
Uttarakhand have reported highest incidence of
fungal diseases.
In pediatric cases, bacterial infections have been
observed as
the commonest
skin infection
followed by parasitic, fungal and viral infections in
the present study. A similar pattern has also been
reported
in
a study from Rajasthan
and
dissimilar results have been reported from Kashmir
Valley where viral infections were seen as most
common disorder followed by fungal, bacterial,
parasitic and mycobacterial infections and from
Maharashtra where parasitic infections were most
common.15-17
In our study, patients of 21-40 years age group
formed the largest group and preponderance of
females has been observed. A similar pattern has
also been reported by Kuruvilla M etal.11 Male
preponderance has been reported
in other
studies.10-12
CONCLUSION
We conclude that skin disorders are common in
Darbhanga and incidence of inflammatory skin
diseases is slightly higher than that of

skin diseases.
infective
ACKNOWLEDGMENT
We are thankful to staff of the medical record
section Darbhanga Medical College and Hospital,
Darbhanga for their co-operation during the study.
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common
skin
diseases, 17 th ed. Arnold Publications Inc ,
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2. William DJ , Timothy GB , Dirk ME , eds.
Andrewsdiseases of skin: Clinical dermatology,
11thed. Elsevier Inc,2011 : 247 -53
3. Das KK. Pattern of dermatological diseases in
gauhati medical college and hospital Guwahati.
Indian J Dermatol Venereol Leprol 2003;69: 1618.
4. Devi T, Zamzachin G, Pattern of skin diseases
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5. Gangadharan C, Joseph A , Sarojini PA .Pattern
of skin diseases in Kerala . Indian J Dermatol
Venereol Leprol .1976 ;42 : 49-51
6. Ashokan N, Prathap P, Ajithkumar K, Ambooken
B, Binesh VG, Geoge S. Pattern of skin diseases
among patients attending a tertiary care
teaching hospital in Kerala . Indian J Dermatol
2009 ; 75 : 517-18.
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of
skin
diseases
in kumaun region of
Uttarakhand . Indian J Dermatol Venereol Leprol
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8. Grover S, Ranyal RK, Bedi KA . A cross section
of skin diseases in rural Allahabad . Indian J
Dermatol 2008;53 ; 179-81
9. Sayal SK ,Das AL ,Gupta CM . Pattern of skin
diseases among civil population and armed
forces personnel at Pune . Indian J Dermatol
Venereol Leprol 1997 ; 63 : 29-32
10. Dayal SG ,Gupta GP . A cross section of skin
diseases in Bundelkhand region, UP. Indian J
Dermatol Venereol 1977 ; 43 :258-61.
11. Kuruvilla M, Sridhar KS, Kumar P, Rao G.
Pattern of skin diseases in Bantawal Taluq
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Dakshin Kanada . Indian Journal Dermatol

Venerol 2000;66 :247-8 .
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diseases in an Indian village . Indian j Med Sci
2003 ; 57: 108-10
Kuruvilla M, Dubey S ,Gahalaut P. Pattern of
skin diseases among migrant construction
workers in Mangalore . Indian J Dermatol
Venereol Leprol 2006 ; 72 :129-32 .
Das DA, Haldar HS, Das DJ, Mazumdar MG ,
Biswas BS , Sarkar SJ . Dermatological disease
pattern in an urban institution in Kolkata .Indian
J Dermatol 2005 ; 50 : 22-24 .
Balal M , Khare AK , Gupta LK , Mittal A ,
Kuldeep CM. Pattern of pediatric dermatosis in a
tertiary care centre of South West Rajasthan .
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Hassan I, Ahmad K, Yaseen A .Pattern of
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DOI: 10.5958/2319-5886.2014.00022.8

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
AN INEXPENSIVE AND INNOVATIVE CORRECTION OF MEDIAL COMPARTMENTAL

OSTEOARTHRITIS KNEE JOINT BY HIGH TIBIAL LATERAL CLOSED WEDGE OSTEOTOMY IN
A RURAL SET UP
Prasad DV1,*Arun AA2, Tushar Chaudhari2, Sagar Jawale2, Shakthi Panda2, Abhinav Jadhav2, Deepak Dathrange2
1
Professor, 2Resident, Dept of Orthopaedics, Rural Medical College and Pravara Rural Hospital, Loni,
Maharashtra, India
*Corresponding author email: arunjy24@gmail.com
ABSTRACT
Osteoarthritis of Knee joint with Varus deformity causes considerable disability. Operative treatment aims at
shifting the mechanical load bearing axis to the less affected compartment of the knee to relieve the symptoms.
Exclusion Criteria: Non-walkers due to generalized arthropathies / medical comorbidities, Flexion deformity > 10
degrees, Range of motion < 90 degrees, Active rheumatoid arthritis, Infection, Lateral compartment involvement,
>1cm lateral subluxation in standing A-P X rays of both knees. Methodology: 32 (12 Males and 20 Females)
cases of Medial compartment osteoarthritis presenting in our OPD between 2008-2012 were treated by HTOand
cortical screw and SS wire fixation (TBW Technique). Results: Evaluation of results was done based on knee
rating scale by Japanese orthopaedic association. 22 cases were Excellent, 8 cases were good. One case of failure,
an iatrogenic intracondylar fracture of Tibia, and another secondary haematoma under the suture line, aspirated
and complete healing was achieved. Patients had good range of motion, were able to squat and sit cross legged
comfortably. Conclusion: HTO by Closed Medial wedge osteotomy and fixation with cortical screw and SS wire
provides a good alternative to unicompartmental knee Arthroplasty and even Total knee Arthroplasty (may be up
to 10-15 years) in patients with Medial compartmental osteoarthritis. It is a cost effective technique with the use
of minimum hardware and early postoperative mobilization in patients who cannot afford Knee Arthroplasty in a
Rural set up.
Keywords: Medial Compartmental Osteoarthritis, High Tibial osteotomy (HTO), Tension Band Wiring (TBW).
INTRODUCTION
Osteoarthritis of the Knee is a Chronic debilitating
disease excessive pressure leads to breakdown of the
cartilage matrix, architectural changes in the
subchondral bone, further altering the joint
geometry1,2. Most of the patients present with
unicompartmental
osteoarthritis
(Medial
compartment) with varus deformity compromising
their day to day activities and finally leading to
painful arthrosis. Prevalence of osteoarthritis of knee
is 5% to 13% in India. Our cultural and religious
Prasad et al.,
habits and daily activities need most of the Indians,

particularly in the rural side to squat and sit cross
legged. With unicompartmental or total arthroplasty
sitting
cross
legged
or
squatting
are
restricted3.Osteotomy of the tibia was originally used
to address osteoarthritis of the knee with an objective
to shift load bearing from one arthritic tibiofemoral
compartment to the other less affected compartment4,
5,6
(Unloading of Involved Joint) Whereas in HTO
(using double TBW and 2 cortical screws with
897
washers), patient is mobilised in immediate

postoperative period and patient can resume sitting
cross legged and squatting. This procedure is cheap
and cost effective as compared to other procedures,
the cost of implants being approximately Rs.500 to
600 only. One of the biggest advantages of HTO is
need for knee arthroplasty can be postponed for a
minimum period of 12- 15 years as found in
literature.3 The knee consists of 3 compartments: the
medial tibio-femoral, the lateral tibio-femoral and
patello-femoral. Out of which medial tibio-femoral
compartment is most commonly affected1. We
studied the effect of TBW with 2 cortical screws in
32 cases of uni-compartmental O.A. of Knee joint.
Biomechanics: In the standing position and chiefly
during walking, the body weight tends to adduct the
femur on the tibia, increasing thus the load on the
medial compartment. The lateral muscular forces tend
to adjust a dynamic equilibrium in the knees. The
lateral force and the body weight result in an overload
distribution of about 60% in the medial compartment
and 40% in the lateral compartment. In medial
compartment arthritis; the resulting lateral force is
displaced medially. Limb alignment is altered and
more loads are then distributed medially with
subsequent degenerative lesions. This progressive
joint destruction causes knee deformity1,7, which, in a
vicious circle, aggravates arthritis in the medial
compartment, resulting in a varus deformity at knee
joint. Various methods of treatment in High Tibial
Osteotomy (HTO) are- plaster cast, External fixator,
Coventry plate, Broad dynamic compression plate,
Locking compression plate, Joshi's external
stabilization
system,
TBW
(minimal
instrumentation)8. Jackson was the first to report his
experience with femoral and tibial osteotomies to
treat osteoarthritis with associated valgus and varus
knee alignment8,9. Tension Band Wiring Principle in
HTO: By using double TBW distracting forces are
converted into converging forces at the lateral closed
wedge osteotomy site by anchoring the Tension band
around the Iliotibial band at its attachment at the
Gerdys tubercle which helps in early mobilization of
the patient.
32 cases (12 Males and 20 Females) of Medial
compartment osteoarthritis, majority between the age
group of 50-65 years presenting in the OPD of Rural
Medical college and hospital, Loni between the

period of 2008-2013, were treated by High Tibial
closed wedge osteotomy and 2 cortical screw, 2
washers and Double Stainless Steel wire fixation
(TBW Technique). Japanese Orthopaedic association
scoring was used for assessment of cases after taking
ethical clearance.
Inclusion criteria: People with degenerative disease
of knee (osteoarthritis) between the age of 45 to 65
years. a) Who are walking independently or with one
stick. b) Who accepted repairing the joint than
replacing. Male and Female patients between 55-70
years
age,
having
Medial
compartmental
osteoarthritis presenting with Pain. Patients with
Knee Flexion up to 90 with full extension possible.
Patients able to squat and sit cross legged. A written
informed consent of the participants was taken before
initiation of the study.
Exclusion criteria: Non walkers due to generalised
arthropathies or medical morbidity. Flexion deformity
of knee more than 10 degrees or range of motion less
than 90 degrees, Active rheumatoid arthritis or active
infection, Grossly symptomatic lateral compartment
involvement, more than 1 cm lateral subluxation of
tibia as judged by standing AP x-rays of both knees.
Grossly advanced arthritis or tricompartment arthritis.
Preoperative Assessments
A) Preoperative Planning
i. Patient assessment: Patients age, career, level of
activity, previous history of surgery on the knee, and
expectation were taken into consideration before
deciding upon surgery. Closing wedge HTO may be
more beneficial in reducing the risk of nonunion than
opening wedge HTO for heavy-smoking patients10.
The ROM, degree of deformity, ligamentous
instability, and leg length discrepancy should be
assessed through physical examination. Valgus HTO
can be performed for minor or moderate medial
instability that can be caused by bone loss in medial
compartment osteoarthritis. The status of the hip joint
can have an influence on the medial osteoarthritis of
the ipsilateral knee. Abduction of the hip that occurs
during the stance period increases stress on the lateral
compartment of the knee, which gives rise to the
involvement of the stabilizers (gluteus maximus,
tensor fascia latae, and biceps femoris) that results in
higher forces on the lateral knee11. Therefore, hip
abductor muscle weakness or restriction or ankylosis
of the hip joint should be treated prior to HTO.
898
Prasad et al.,
ii. Radiographic assessment: Multiple views should

be obtained for preoperative radiographic assessment:
bilateral weight-bearing anterior-posterior views in
full extension, tunnel views with the knee in 30o of
flexion, Rosenberg views with the knee in 45o of
flexion, lateral views, and skyline views. The severity
of medial osteoarthritis and bone loss evaluated from
the anterior-posterior views and patellar height
measured from the lateral views. A severe patella alta
may necessitate the combined use of tibial tubercle
osteotomy and closing/opening HTO. Lower limb
alignment is accessed from the full length
radiographs of the lower extremity that visualizes the
alignment of the hip, knee, and ankle joints. Magnetic
resonance imaging can be helpful in detecting
intraosseous lesions, meniscal tears, ligamentous
lesions, osteochondral defects, osteonecrosis, or
subchondraledema.
Fig 1: Showing the mechanical and anatomical axis
iii. Correction angle calculation: In normal lower

extremities, the centre of the hip is in line with the
centre of the knee and the centre of the ankle and the
mechanical axis, a line that connects the dots, is 0o
(Fig. 1). The ideal postoperative lower limb
alignment is considered as 3o-5oof valgus from the
mechanical axis or 8o-10oof anatomical valgus in
most studies. The Correction angle () is calculated in
the standing position as postulated by Fujisawa Y,
Masuhara K, ShiomiS12 or in the supine position as
postulated by K. Ogata, I. Yoshii, H. Kawamura et al.
The distal osteotomy line is determined referring to
the angle and the wedge bone between the
osteotomy lines is removed (Fig. 2A).
Prasad et al.,
Fig 2A: showing calculation of angle &2B showing

the endpoints used for exposure during surgery
Opening wedge HTO is planned in a similar fashion

like the closing wedge HTO. The proximal osteotomy
line is drawn from a point 3-4.5 cm inferior to the
medial knee joint line to the tip of the fibular head
from which another same length line is drawn
obliquely by the angle. The line that runs between
the endpoints of each line is used for exposure during
surgery (Fig. 2a, 2B). In HTO for medial
compartment osteoarthritis without knee instability,
efforts should be made to maintain the preoperative
anatomical posterior tibial slope. Some recent clinical
studies have shown that the use of navigation systems
contributed to the preciseness, accuracy, and
reproducibility of HTO.
B) HTO Techniques: There are various HTO
techniques including closing wedge osteotomy,
opening wedge osteotomy, dome osteotomy,
progressive callus distraction, and chevron
osteotomy. Of these, opening wedge HTO and
closing wedge HTO are most commonly performed
Medial Opening Wedge Osteotomy13
Surgical technique: The patient is placed in the
supine position on a radiolucent operating table and a
tourniquet is applied. A 5-cm vertical incision is
made over the center between the medial aspect of
the tibial tuberosity and the posteromedial aspect of
the tibia below the joint line. The pesanserinus is
detached from the tibia to expose the superficial
medial collateral ligament. The distal portion of the
exposed ligament is separated from bone and a blunt
retractor is inserted posterior to the medial collateral
ligament and the tibia to protect the neurovascular
structures posterior to the incision line. After
identifying the medial border of the patellar tendon,
subperiosteal dissection is performed from the tibial
tuberosity to the posteromedial aspect of the tibia.
899
Two guide wires are inserted at a point 3.5-4 cm

below the medial joint line and passed obliquely 1 cm
below the lateral articular margin of the tibia towards
the tip of the fibular head. After checking the
appropriate location with a fluoroscope, a tibial
osteotomy is performed immediately below the guide
wires using an oscillating saw or an osteotome.
Ensure the osteotomy line extends from the tibial
tuberosity along the posteromedial aspect of the tibia
to 1 cm medial to the the lateral tibial cortex and is in
parallel with the posterior tibial slope on the sagittal
plane. The mobility of the osteotomy site is checked
and the osteotomy is opened with a valgus force. If
the opening of the osteotomy seems insufficient, use
2 or 3 stacked osteotomes to reduce the risk of
intraarticular fractures. Subsequently, a calibrated
wedge is inserted until the osteotomy is opened to the
desired extent. Ensure with fluoroscopy when a long
alignment rod or wire cable is cantered over the hip
joint and the ankle joint, it lies at 62.5% of the width
of the tibial plateau. Once the desired degree of
correction is achieved, internal fixation of a metal
plate is performed. There are various types of metal
plates, including the Puddu plate, Tomofix, Aesculap
(dual) plate, -plates with or without a spacer
(rectangular or tapered). Among these, spacer plates
are most commonly used and the metal block should
be identical to the calibrated wedge. The proximal
fixation screws should be used under fluoroscopic
guidance and the defect should be grafted using iliac
crest autograft, allograft, or a bone substitute. For
defects 10 mm, cortico cancellous autografts or
allografts are used, whereas for small defects, bone
grafting is optional.
Other Techniqu: : Other HTO techniques include
dome osteotomy, progressive callus distraction using
an external fixator, and chevron osteotomy
Our Operative Technique: After assessing the patient

clinically and radiographically as mentioned above
the patient is posted for corrective surgery.
In Supine position, on a radiolucent table under
image intensifier the proximal aspect of tibia was
approached through Lateral inverted L shaped
incision. Close lateral wedge osteotomy was done and
angle of the wedge to be removed was determined pre
operatively with the help of radiographs. Lateral
wedge osteotomy done 1.5 cm distal to joint margin
to avoid fracture of tibial plateau intraoperatively
(Fig.4). Height of wedge is taken dependent on varus
angle calculated from x-rays, for each degree 1 mm
height of wedge is taken. 2 cortical screws fixed
distal to osteotomy site.
Fig 4: Showing the site for Close lateral wedge

osteotomy
Fig 5A : 1st screw 2.5 cm distal to osteotomy site.

5B: 2nd screw 2.5 cm distal to proximal screw.
An 18G Stainless Steel wire is passed around Gerdys
tubercle taking the anchor of Iliotibial bands
attachment at Gerdys tubercle wires are configured
in a figure of eight and tightened around the screw
with washers and screws are tightened into tibial shaft
(Fig 5A& 5B). As the wires are tightened, lateral
wedge osteotomy is closed. (Fig 6)
Fig 3: Showing the pre operative clinical and x-ray images
900
Prasad et al.,
Fig 6 : Showing the lateral wedge osteotomy is

closure
Wound is closed in layers over suction drain.
Mobilization is started as soon as the patient can start
tolerating the pain in bed and after 3 weeks patient is
allowed to weight bear after application of long knee
brace and with the help of a walker. Patient was
encouraged to flex the knee when, because of the
TBW principle compression occurs at the osteotomy
site and after 8 weeks patient is encouraged to walk
full weight bearing without the help of a walker.
Fig 7 Showing the post operative clinical and xray

images
RESULTS
Majority of our cases were between the age group of
50-65 years. Observation by Japanese Orthopaedic
association scoring was done, according to following
points: Pain while walking, Pain while descending
and ascending stairs, Range of motion, Joint effusion.
22 cases were Excellent and 8 cases were good.
(Table 1)
One case of failure, an iatrogenic intracondylar
fracture of Tibia, and another secondary haematoma
under the suture line, aspirated and complete healing
was achieved. Patients had a good range of motion.
Were able to squatt and sit cross legged comfortably
(Fig 7.8)
Table.1:Showing the results of the operated cases
No.of Cases
Excellent
22
Good
8
Failure (iatrogenic intracondylar
1
fracture of Tibia)
Suture line complication
1
Total
32
Fig 8: Showing Range of motion of the Patient 5

years post-op
DISSCUSSION
Medial compartmental osteoarthritis knee joint with
varus deformity should be considered a malalignment
with maldistribution of weight contributing to
degenerative changes. 2,7,14 Success rates of 88% at 10
years and 83% at 9 years are reported after HTO for
medial compartment arthritis in the literature.Current
prosthetic knee arthroplasty techniques have provided
successful results in over 93% of patients at 10
years3. The role of osteotomy has decreased in the
face of these outstanding results from joint
replacement. Prosthetic arthroplasty requires activity
modification to protect the implant. The implant also
has a finite life span and may require repeat surgery
to replace failed devices. Realignment osteotomy is
viewed as a way to allow unrestricted patient activity
and to delay the time to joint replacement surgery. 15
Particularly in rural setup, it is an economical cost
effective surgery without altering the patients
lifestyle. HTO allows reasonably pain free knees,
restoring weight bearing axis and improving motion
in most of them, particularly in the rural and poor
901
Prasad et al.,
population as well as the religious requirement of

various populations where day to day activities needs
to squat and sitting cross legged. Thus, by a simple
and effective procedure, Medial compartmental
osteoarthritis even up to 10-12 degrees can be
corrected by HTO and TBW technique with
achievement of a good range of movements and
functional stability thus avoiding the need for total
joint replacement in near future.
CONCLUSION
HTO by Closed Medial wedge osteotomy and
fixation with cortical screw and SS wire provides a
good alternative to unicompartmental knee
Arthroplasty and even Total knee Arthroplasty (may
be up to 10-15 years) in patients with Medial
compartmental osteoarthritis. It is a cost effective
technique with the use of minimum hardware and
early postoperative mobilization in patients who
cannot afford Knee Arthroplasty in a Rural set up.
ACKNOWLEDGEMENT
We acknowledge the co-operation and support given
to us in this endeavour by the Department of
Orthopaedics as well as the faculty and staff of the
Operation theatre in our hospital.
Conflict of Interest: Authors declared there was no
conflict of interest
REFERENCES
1. Bouillet R, Van gayer P. Larthrose du genou
Etude pathog {233} unique et traitement. Ada
Orthopaedica. Belgica,1961):27;5.
2. Wright J, Heck D, Hawker G. Rates of Tibial
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Clin Orthop 1995;319:266.
3. Hinman RS, Hunt MA, Creaby MW, Wrigley
TV, McManus FJ, Bennell KL. Hip muscle
weakness in individuals with medial knee
osteoarthritis. Arthritis Care Res (Hoboken).
2010;62:1190-3
4. Helal B. The Pain in Primary Osteoarthritis of the
Knee. Its Causes and Treatment by Osteotomy.
Postgraduate Medical Journal. 1965: 41;172.
5. Jakob RP, Jacobi M. Closing wedge osteotomy of
the tibial head in treatment of single compartment
arthrosis. Orthopade. 2004;33:143-52.
6. Ogata K, Yoshii I, Kawamura H. Standing

radiographs cannot determine the correction in
high tibial osteotomy. J Bone Joint Surg [Br]
1991; 73-B :927-31.
7. Hutchinson CR, Cho B, Wong N. Proximal
Valgus Tibial Osteotomy for Osteoarthritis of the
Knee. Instr Course Lect. 1999;48:131
8. A WD, Toksvig-Larsen S. Cigarette smoking
delays bone healing: a prospective study of 200
patients operated on by the hemicallotasis
technique. Acta Orthop Scand. 2004;75:347-51.
9. Conventry MB. Upper tibial osteotomy for
osteoarthritis. J Bone Joint Surg Am.
1985;67:1136-40
10. Paley D, Maar DC, Herzenberg JE. New
Concepts in High Tibial Osteotomy for Medial
Compartment Osteoarthritis. Orthop Clin North
Am 1994;25:483
11. Fujisawa Y, Masuhara K, Shiomi S. The effect of
high tibial osteotomy on osteoarthritis of the
knee. An arthroscopic study of 54 knee joints.
Orthop Clin North Am. 1979;10:585-608
12. Dugdale TW, Noyes FR, Styer D. Preoperative
planning for high tibial osteotomy. The effect of
lateral tibiofemoral separation and tibiofemoral
length. ClinOrthopRelat Res. 1992;274:248-64
13. Amendola A. Unicompartmental osteoarthritis in
the active patient: the role of high tibial
osteotomy. Arthroscopy. 2003;19 Suppl (1):10916
14. Campbell JP, Jackson JP. Treatment of
Osteoarthritis of the Hip by Osteotomy. Journal
of Bone and Joint Surgery. 1956;38-B: 468.
15. Font-Rodriguez DE, Scuderi GR, Insall JN.
Survivorship of Cemented Total Knee
Arthroplasty. Clin Orthop 1997;345:70
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DOI: 10.5958/2319-5886.2014.00023.X

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Coden: IJMRHS
Revised: 3rd Sep 2014
Copyright @2014
ISSN: 2319-5886
Research article
RELATION BETWEEN DIABETES MELLITUS TYPE 2 AND COGNITIVE IMPAIRMENT: A

PREDICTOR OF ALZHEIMERS DISEASE
*Rajeshkanna NR1, Valli S2, Thuvaragah P3
1
Assistant Professor, Department of Pathology, Chettinad Hospital and Research Institute India
Intern, Department of Psychiatry, CHRI, India
3
Resident Medical Officer, Department of Medicine, CHRI, India
2
*Corresponding author email: rajeshthuva@gmail.com

ABSTRACT
Introduction: Cognitive impairment is an important emerging problem since it is considered as the forerunner of
dementia. Diabetes is one of the risk factors for dementia, but the mechanism by which it causes it is still under
research. Across the world, Alzheimers disease is by far the single most common cause of dementia and more
research is focused on this global health problem. Aim: The study was taken to evaluate the association between
cognitive dysfunction and glycemic control in type 2 diabetic individuals. Materials and Methods: This was a
case-control, cross-sectional study done for individuals with and without Diabetes mellitus. Mini Mental state
examination (MMSE) was administered and those who scores below 24 was taken as an indicator of cognitive
impairment and they were given questionnaires of Blessed Dementia Scale and Hachinski Ischemic Score (HIS).
Results: Total 60 (30-cases and 30-controls) were taken up for the study. The mean age was 66.8 for males and
63.5 for females with a male: female ratio of 0.764.The HbA1c levels were 5.65% (SD: 0 .75) for controls (B) and
8.20% (SD: 1.88) for the cases (A) (p value <.001). The mean Mini Mental State Examination (MMSE) score for
cases (A) was 23.18 (S.D-0.445) and for controls (B) was 25.10(S.D- 4.16).There was a significant correlation
between the level of HbA1c and MMSE scores (PCC: 0.537 with Sig.2 tailed <0.01). The diabetic people showed
significant positive correlation between MMSE and BDS-A (PCC:0.756(**)). Conclusion: The results of our study
strongly favours that uncontrolled diabetes mellitus type2 is an independent risk factor for cognitive dysfunction
and dementia especially Alzheimers type.
Keywords: Cognitive impairment, HbA1c, dementia, Alzheimers disease, Diabetes mellitus
INTRODUCTION
Diabetes mellitus is one of the most common human
ailments, especially in the modern era which results
in a long term complications and disability. It is an
important risk factor for the leading causes of death
resulting from cardiovascular and cerebral-vascular
events worldwide. Diabetes affects virtually every
tissue in almost all the systems of the human body
and its complications cause huge socioeconomic
burden1.
Diabetes mellitus is a metabolic disorder of multiple

etiologies
and
characterized
by
chronic
hyperglycaemia with disturbances of carbohydrate,
fat and protein metabolism resulting from defects in
insulin secretion or tissue resistance or both2.The
aetiology is multi-factorial and the pathogenesis are
complex. Traditionally it has been classified into two
types: Type 1 and Type 2. Type 1 diabetes is due to
deficient insulin secretion, the pivotal hormone in
903
Rajeshkanna et al.,
glucose metabolism. It is common in young age and

also known as Insulin Dependent Diabetes Mellitus,
(IDDM). Type 2 is common in older adults where
insulin resistance is primary one with a relative
insulin deficiency. Hence it is known as Non-Insulin
dependent Diabetes Mellitus (NIDDM). Type 2
Diabetes Mellitus is commonly associated with
obesity, dyslipidaemia and constitutes an important
component of the so-called metabolic syndrome.
These co-morbidities increase the complications of
diabetes Type 2 several-fold3.
Longstanding hyperglycaemia is an independent risk
for complications of Diabetes especially neurological
manifestations4. The irreversible combination of
glucose with haemoglobin produces HbA1a, b, c.
These forms of haemoglobin are good indicators of
long term blood sugar level. Since the HbA1c
fraction is not confounded by the level of other
reducing sugars, it carries more validity5. Both the
duration and level of control of Diabetes as indicated
by the HbA1c values have correlation with
complications of diabetes6.The level of control of
hyperglycaemias is indicated by HbA1c which
reflects for the previous three months. Hence we have
taken HbA1c values of the subjects as a variable.
Dementia is one of the leading causes of death and
most important cause of disability above 50 years of
age. It is a syndrome characterized by cognitive
impairment and executive dysfunction. Dementia has
a variety of causes. Hence the pathogenesis, course,
management and prognosis vary differently. Across
the World, Alzheimers disease and Vascular
Dementia constitute more than 60% of total cases.
Some of the risk factors for both forms of Dementia
are same. Alzheimers disease is by far the single
most common cause of Dementia and much of the
research in recent times focussed on this global health
problem because of its impact on the growth and
socioeconomic aspects7.
According to the recent estimates, around 24.3
million people have Dementia worldwide with an
incidence of 4.6 million new cases every year.
Among them around 60% live in the developing
countries where it has been projected to increase by
more than 300 percent by 2040. In India the
prevalence of Dementia was found to be 33.6 per
thousand. Alzheimers disease 54%: Vascular
Dementia-39%7. With increase of life expectancy in
India the burden and care of people with Dementia

would be a challenge.
It has been found that cognitive impairment occurs
gradually and in stages, ultimately resulting in
Dementia. There are several stages starting from
normalcy to late dementia8.The progression of
cognitive impairment have been described as
follows8:
1. No cognitive impairment 2. Mild Cognitive
Impairment (MCI) 3. Cognitive Impairment-No
Dementia (CIND) 4. Dementia.
Mild Cognitive Impairment is a clinical label which
includes elderly subjects with short-term or long-term
memory impairment and with no significant daily
functional disability. The diagnosis of Mild Cognitive
Impairment is made when a subject reports a gradual
decline of cognitive functions for at least a six month
period. Prevalence of Mild Cognitive Impairment is
found to be 3% to 19% in adults older than 65 years9.
Conversion rate from Mild Cognitive Impairment to
Alzheimers disease is 12% per year. People who are
cognitively impaired not demented (CIND) are at a
greater risk of progressing into Dementia usually to
Alzheimers disease and Wentzel et al showing 46%
of CIND patients progress to dementia in 5 years of
time10.
Mini Mental State examination (MMSE) is a
commonly used and reliable scale for assessing
cognitive level of an individual11. It is easy and quick
to administer at the bedside. It assesses several
aspects of cognition and those who score less than
24/30 are considered to be having cognitive
impairment. The MMSE includes specific questions
related to attention, orientation, memory, calculation,
and language. The measure's scoring is based on 30
total points, and impairment is indicated by a score of
24 or lower. MMSE has overall sensitivity 64% and
specificity 96%6, 12. Blessed Dementia Scale is widely
used scale to assess the types and severity of
Dementia13. It has been shown to discriminate mild
cognitive impairment and dementia. Hachinski
Ischemic Score is a validated scale for Vascular
Dementia14. Since many of our subjects are
hypertensive it is prudent to account for the
confounding factors like hypertension. The study was
taken to evaluate the association between cognitive
dysfunction and glycemic control in type2 diabetic
individuals which can be analysed by HbA1c.
904
Rajeshkanna et al.,
Aim and objectives: The aim of the study is to assess

the cognitive function in elderly people with type 2
diabetic individuals and to screen them for dementia
particularly of Alzheimers type if their cognition is
impaired.
MATERIALS AND METHODOLOGY
Type of Study: This was a case-control, crosssectional study. Patients attending medical outpatient
department for management of diabetes were chosen
as cases (Group A, N = 30). Controls were taken from
non-diabetic, healthy volunteers from the hospital
(Group B, N=30)
Study Area and duration: The study was carried out
for six months (between June and December, 2011) at
Chettinad Hospital and Research Institute.
Ethical Committee Clearance: The study was
started after obtaining the Ethical clearance from the
Human Ethics committee of the institution
Inclusion Criteria: Diabetic individuals above 50
years of age, both sex attending the diabetic clinic for
a regular follow-up were included. Patients with
hypertension were also included to alleviate the bias.
The patients were confirmed as Type II Diabetes
mellitus based on the American diabetic association
criteria 2013 (Diabetes mellitus: HbA1c >7% and
non-diabetic, HbA1c < 7%)10
Exclusion criteria: The following patients were
excluded from the study: Liver dysfunction, Thyroid
disorder, Type I diabetes mellitus, Post stroke
patients, Epileptic patients, History of previous head
injury, Patients with psychiatric illness, Diabetic
patients with complications like foot gangrene and
diabetic ketoacidosis
Method and Procedure:
After establishing rapport with the patients, an
informed consent was obtained. A general proforma
was given which included the demographic
particulars, past history of significant medical and
surgical conditions. Family history and their
treatment history were also obtained.
Blood pressure was recorded for all individuals on the
left upper arm in the supine position. Three readings
were taken from all patients at an interval of 15
minutes and the mean was calculated. A general
examination of the patients was also done. This
included the state of consciousness and orientation of
the patients since administration of the scales requires
proper orientation with full consciousness.
In all cases and controls HbA1c levels were

measured, by using the Biorad High Performance
Liquid Chromatography Analyser.
For these individuals (both cases and controls), Mini
Mental state examination (MMSE) 11 was
administered which consists of two sets of 12
questions in total. The first set of questions was
mainly used to test their memory and ability to recall
which was for 21 marks and the second set of
questions to test their executive abilities was for 9
marks. A score of less than 24 (out of 30) was taken
as an indicator of cognitive impairment. People who
scored 24 or more were considered as cognitively
intact.
Subjects with scores<24 on MMSE (mild to severe
cognitive impairment) were given questionnaires of
Blessed Dementia Scale to screen them for Dementia.
In our study one of the individual from control group
discontinued from the study and so only 23 subjects
were then screened for dementia using Blessed
Dementia Scale (BDS-part A; part B)13 and Hachinski
Ischemic Score (HIS)14. Blessed Dementia Scale
consists of 2 parts. The first is the InformationMemory-Concentration test which is administered to
the patient (BDS-A) and its maximum score is 37. It
assesses the memory of the patients. The second is a
caregiver scale which is information regarding the
patients activities of daily living and personality
(BDS-B) and its maximum score is 28. This caregiver
scale can be used in patients with mild, moderate, or
severe impairment13. Hachinski Ischemic Score (HIS)
was used to differentiate vascular dementia from
Alzheimers dementia. The score ranges from 0 to 18.
The score >7 favour the diagnosis of vascular
dementia 14.
Statistical analysis: Analysis was done with the
SPSS software version-16
RESULTS
Table: 1. Total number of Subjects (Case group (A) and
control (B) taken up for this study.
Number of subjects
Case group (A)
Control group (B)
Male (26)
13
13
Female(34)
17
17
Total
30
30
905
Rajeshkanna et al.,
Fig 4: Associationof glycosylatedhemoglobin level with

duration of Diabetes mellitus
Fig 1: Average glycosylated hemoglobin of males and
females of both cases (A) and control (B)groups
Table: 3. Mean Mini Mental State Examination

scores of subjects with and without hypertension and
diabetes mellitus of both cases (A) and control (B)
groups.
DM-HTN-MMSE
(mean score)
HTN- YES
HTN-NO
DM-YES
23.5
23.07
DM-NO
25.04
26.91
Fig: 2. Mean total Mini Mental State Examination

(MMSE) score of males and females of both cases (A)
and control (B) groups.
Table: 2. Mean and Standard deviation in mini mental
state examination score of diabetic and non-diabetic
individuals.
DM
YES
NO
Total
MMSEI Score
15.43.7
18.03.0
16.73.6
MMSEII Score
7.61.5
7.11.0
7.81.32
Fig 3: Association between HbA1c values and the

MMSE score for cognitive impairment
Fig 5: Mean Blessed Dementia Scale scores (Part A and

Part B) of those who scored less than 24 in Mini-Mental
State Examination.
Fig 6: Mean Hachinski Ischemic Score for those who

scored less than 24 in Mini-Mental State Examination.
906
Rajeshkanna et al.,
Table: 4.Correlations
BDSA
BDSA Pearson Correlation
1
Sig. (2-tailed)
N
23
BDSB Pearson Correlation -.420*
Sig. (2-tailed)
.046
N
23
MMS Pearson Correlation .756**
ET
Sig. (2-tailed)
.000
N
23
HB
Pearson Correlation -.116
Sig. (2-tailed)
.598
N
23
MMS
BDSB ET
HB
-.420* .756** -.116
.046
.000
.598
23
23
23
1
-.083 .015
.706
.946
23
23
23
-.083
1
-.537**
.706
.000
23
60
60
**
.015 -.537
1
.946
.000
23
60
60
* Correlation is significant at the 0.05 level (2-tailed).

** Correlation is significant at the 0.01 level (2tailed).
Fig 7: Relation between Blessed Dementia Scale-Part A

and the glycosylated Hemoglobin levels of those who
Fig 8: Relation between Blessed Dementia Scale-Part B

and the glycosylated Hemoglobin levels of those who
Rajeshkanna et al.,
Fig 9: Relation between Hachinski ischemic score and

the glycosylated Hemoglobin levels of those who scored
less than 24 in Mini-Mental State Examination
DISCUSSION
In both the cases and controls (Table-1), there was a
slight preponderance of females which was
nevertheless not so significant. The mean age of these
individuals were 66.8 for males and 63.5 for females
with a range of age between 50 and 87.There were
slightly higher number of female patients (case-17;
control-17) who came to the Diabetic Outpatient
department than the male patients (case-13; control13) with a male: female ratio of 0.764.Appropriate
measures were taken at the time of analysis to correct
for this relative sex bias. The sexual predilection
might reflect the prevalence of the diabetes in the
general population15,16.
The lower limit of age was kept at 50 since diabetes
mellitus type2 and its complications were more
common at this age group17. There was a decline in
the MMSE score as age advanced but the correlation
was not significant (Pearsons correlation -0.014).
With respect to age and parameters like BDS and
HIS, there was no significant correlation.
In our study, the cases were identified by self-report
and then only HbA1c levels were obtained indicating
a good level of correlation and makes HbA1c, as a
valid and reliable indicator of diabetes in its own
right18. The latest HbA1c level of all subjects (figure1) were obtained and it was 5.65% (SD: 0.75) for
controls (B) and 8.20% (SD: 1.88) for the cases (A)
with significant differences between the groups (p
value <. 001). The results add strength to the old age
claim that HbA1c is a good indicator of long term
sugar level19. The International Diabetes Federation
and American College of Endocrinology recommend
HbA1c values below 48mmol/mol (6.5%), while
American Diabetes Association recommends that the
907
HbA1c be below 53mmol/mol (7.0%) for most and

values above indicate a diabetic state until proved
otherwise20.
It was also noted that complications of diabetes were
positively correlated with the level of HbA1c21. The
higher level of HbA1c in cases also reveals about the
poor glycemic control which means that more effort
is needed on issues like compliance.
HbA1c level had been shown to be associated with
cognitive functions even in the non-diabetic
population.Yaffe et al had shown that those with
HbA1C level 7%, the age-adjusted risk for
developing mild cognitive impairment was increased
nearly 4-fold (OR= 3.70; 95% CI 1.51-9.09) and the
risk was increased nearly 3-fold for developing
dementia (OR=2.86; 95% CI 1.17-6.98)22. People
with HbA1c 7% who had not been diagnosed with
diabetes were also significantly at higher risk (odds
ratio = 4.8 95% CI: 1.1 to 21.6) of developing
dementia23. But some studies have found no relation
between HbA1c level and cognition, even in diabetic
individuals24.From the study (figure: 2) the mean
Mini Mental State Examination (MMSE) score for
diabetic individuals was 23.18 (S.D-0.445) indicating
decreased cognitive functions and for non-diabetic
individuals the mean Mini Mental State Examination
(MMSE) score was 25.10 (S.D- 4.16).
In our study the (table: 2) shows that the mean score
in part-I of Mini Mental State Examination (for
21marks) which is used to assess the memory was
15.4333 (standard deviation-3.7205) among diabetic
individuals and for non-diabetic individuals being
18.00 (standard deviation-3.0286). The mean score in
Part II (for 9 marks) which is used to assess the
executive function was 7.6833 (standard deviation1.5452) among diabetic individuals (n=30) and 7.100
(standard
deviation-1.053)
for
non-diabetic
individuals (n=30). Diabetic individuals are found to
have low scores in memory function test as given in
the table whereas the executive functions are
preserved among both the diabetic and non-diabetic
group. Our study supports the findings of former
studies where there was a correlation between HbA1c
and cognitive decline22-24. The scatter diagram
(figure: 3) shows that a decline in cognitive function
is
associated
with
increased
glycosylated
haemoglobin levels.That is, individuals who had poor
glycemic control, performed worse in Mini Mental
State Examination than those subjects who had
controlled glycemic levels. There was significant

negative correlation between HbA1c level and
MMSE scores (Table-4:**correlation coefficient).
From (Table: 3) patients having only diabetes are
seen to have the least performances in Mini-Mental
State Examination. Whereas the presence of
hypertension with Diabetes individuals has no
significant correlation with Mini Mental State
Examination scores and there is no significant
association between HbA1c level and the parameters
like hypertension.
The proposed ideas behind higher level of HbA1c and
cognitive decline are many and controversial. There
are large numbers of studies which states the
existence of links between diabetes mellitus,
cognitive impairment and dementia of Alzheimers
disease25-31.They are basically divided into two
schools of thought. First one state that the cognitive
decline is due to micro vascular changes, whereas
second one states that there is a direct insult to the
neurons by the glycatedend products. The Advanced
glycation end products (AGEs) are proteins or lipids
that become glycated after exposure to glucose.
AGEs are prevalent in the diabetic vasculature and
contribute to the development of atherosclerosis.
They also block nitric oxide activity in the
endothelium and cause the production of reactive
oxygen species32. Alzheimers dementia is
characterized by neuronal plaques and recent
evidence suggests the role of reactive oxygen species
with the advanced glycation end-products (AGEs) in
the pathogenesis. Chronic hyperglycaemia enhances
the generation of advanced glycation end-products.
Interaction between the AGEs and their receptors
(RAGE) elicit immunological mechanisms with the
ultimate damage to the neurons. The toxic effects of
persistent hyperglycaemia and the molecular
pathways are being studied extensively worldwide33.
By all these mechanisms they injure the neurons,
especially those responsible for higher cognitive
functions like memory since they are more vulnerable
even to the slightest hypoxic insult. With the resultant
damage or death of such neurons at molecular level,
dementia manifests itself clinically.
The duration of diabetes ranges from 1 to 15 years
(mean 6.3years). In our study (Figure-4) the HbA1c
level shows positive correlation with the duration of
diabetes explaining the cognitive decline with higher
level of HbA1c in the long run. This is in accordance
908
Rajeshkanna et al.,
with the studies elsewhere showing the duration of

diabetes as a crucial risk factor for the
complications34.
From our study (table: 4) the significant correlation
between the level of HbA1c and MMSE scores
(Pearsons correlation:-0.537 with Sig. 2tailed <0.01)
even after adjusting for age, diabetic status and
hypertension support the role of the above mentioned
results. The diabetic people show a significant
positive correlation between MMSE and BDS-A
(Pearson correlation: 0.756 (**)). MMSE score
correlates significantly with BDS - B scores
indicating more care giver burden in people with
impaired cognitive abilities. There is a slight negative
correlation found between the level of HbA1c with
BDS-A but no significant correlation with BDS-B
scores (table-4 and figure-7 and 8). The positive
correlation between HbA1c and HIS score (figure-9)
in our study support the hypothesis, but such
correlation was not significant in our study.
CONCLUSION
Since diabetes mellitus is a growing health problem
with its impact on not only for the individuals, but
also for the society at large and it is the need of the
hour to implement strategies to manage
hyperglycaemia early and effectively as possible. The
results of our study strongly favour uncontrolled
diabetes mellitus type2 is an independent risk factor
for cognitive dysfunction and dementia especially
Alzheimers type. Hence, by managing diabetes
effectively, we can modify the course of Alzheimers
disease. This will reduce the disability of the patients
as well as the burden of the care-givers.
Conflict of interest - Nil
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Rajeshkanna et al.,
DOI: 10.5958/2319-5886.2014.00024.1

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Copyright@2014
ISSN: 2319-5886
th
Accepted: 28rd Sep 2014
EVALUATION OF MAJOR RISK FACTORS RELATED TO DEPRESSION AMONG MEDICAL

STUDENTS OF NRS MEDICAL COLLEGE
*Mukhopadhyay Prianka1, Sain Sonali1, Mandal Nirmal Kumar2, Saha Tushar Kanti 1, Dey Indira2,
Chattopadhyay Amitava1,
1
Assistant Professor; 2Associate Professor, Department of Community Medicine, NRS Medical College, Kolkata
* Corresponding author email: docprianka@yahoo.co.in

ABSTRACT
Background and objectives: Medical students experience depression, burnout, and mental illness at a higher rate
than general population. A better understanding of related risk factors can help target appropriate support services
for them. The aim of the study was to assess the occurrence of depression and identify its risk factors among
undergraduate students in a medical College in Kolkata, India. Methodology: A descriptive, cross-sectional study
using a two stage, stratified cluster sampling technique was used to select a sample of 289 students. Data were
collected using a self-administered, anonymous questionnaire based on Becks Depression Inventory II. Results:
The mean score of students on depression scale was 10.4710.39. 22.5 % of students tested positive for some
form of depression while 6.2% had severe to extreme depression. The risk factors of depressive symptoms
identified were older age, lower family income, students who did not choose admission in MBBS course on their
own, had addictions, felt negatively about results, faced difficulty with study course and had relationship issues.
Students with relationship issues in their personal lives were 3.7 times more likely to exhibit depressive symptoms
than without them. Students who faced difficulty coping with study course were 2.18 times more likely to exhibit
depressive symptoms than without them. Conclusion: Academic performance alone doesnt influence the mental
health of students, rather factors like older age, socioeconomic status, role in choice of medical career, negative
perception of academic performance, difficulty with study course and relationship issues are also important.
Keywords: Depression, Medical students.
INTRODUCTION
Mental and behavioural problems are increasingly
assuming public health importance due to increased
prevalence resulting in considerable morbidity and
disability. Global estimates reveal depression as the
fourth leading cause of disease burden and disability.1
Depression is mostly under reported and presents
with nonspecific physical symptoms. Less than one
fourth of such cases are correctly diagnosed while
many are treated with medicines of doubtful
efficacy.2 Depression resulting in suicides claims 850
Prianka et al.,
million lives annually and represents one of the major

causes of death in 15 to 35 years age group.3
Medical students and residents have even higher rates
of depression, a common stress-related challenge that
impairs quality of life and job satisfaction and
predisposes those affected to general medical
illness.4,5 In addition, this co-morbidity is associated
with an increased risk of suicide, evaluated by
attempted and completed suicides.6 Medical education
is long in duration and consists of immense academic
911
pressure leading to stress, depression and burnout.

Studies have reported prevalence of depression in
medical students ranging from 10.2% to 71.2%.7
There may be several factors responsible for this
situation, such as poor academic and professional
performance, exhaustive academic courses and
training, contact with diseases and death.8
Additionally lack of awareness regarding the problem
and stigma attached with it pose serious obstacles in
identifying and addressing this problem In effect
depression remains an iceberg disease among medical
students. Studies done more commonly in developed
countries have reported that medical students, the
future caregivers, experience depression, burnout and
mental illness at a higher rate than the general
population, with mental health deteriorating over the
course of medical training.9,10.
There is a lack of data regarding the prevalence of
depression and the role of the precipitating factors of
depression in medical students in India. Assessing the
burden of depression among medical students can
inform us of their status of mental health and related
risk factors. In the long run, promoting students
well-being will benefit patients, the public, and the
profession, in addition to the individual.
OBJECTIVES
To assess the magnitude of self reported depression
among medical students and identify the influencing
risk factors.
A descriptive, cross-sectional study was done among
medical students of Nil Ratan Sircar Medical College
& Hospital, West Bengal, India. The undergraduate
medical course is divided into 9 semesters with 4
MBBS examinations conducted at the end of 2nd, 5th,
7th and 9th semesters and 4 ongoing semesters at a
given point of time. The study protocol was approved
by the Institutional Ethical Committee and informed
consent form was obtained from participants.
Approximately 150 students, typically aged between
1819 years, enter 1st semester after clearing a
competitive entrance examination. As the prevalence
of depression among medical students varied greatly,
ranging from 10.2% to 71.2% an optimum prevalence
of 50% was used for sample size estimation. Using a
8 % allowable error and design effect of 2, sample
Prianka et al.,
size was estimated as 240. Taking into account a 10%

non response rate the sample size was calculated to
be 264. A two stage, stratified cluster sampling
technique was used to select study participants. From
4 ongoing semesters, 2 semesters were chosen
randomly. Next all students from those 2 semesters
were approached to participate in the present study.
After excluding the non respondents and incomplete
questionnaires, final sample size was 289. Data were
collected from the students using a self-administered,
anonymous questionnaire from all students present in
the class.
The purpose of the study was explained and they
were informed about the confidentiality of the
reports. Those who were absent were followed up
twice. Participation was purely on a voluntary basis.
The questionnaire was divided into 2 parts, first part
comprised of questions related to social-demographic
information and certain risk factors like academic
performance, relationship issues, stressful situations
at home etc that may contribute to depression. 2nd part
was used to assess the intensity of depression using
Becks Depression Inventory II (BDIII). BDIII is a
frequently used instrument that has good
psychometric properties with high internal
consistency, good testretest reliability, good
construct and concurrent validity with other common
measures of depression in clinical and nonclinical
samples. The BDIII is more consonant with the
American
Psychiatric
Associations
(1994)
Diagnostic and Statistical Manual of Mental
Disorders (4th ed.; DSMIV) diagnostic criteria for
major depressive episode than the earlier forms.11,12,13
The study design was approved by the ethical and
research committee of the institute. Data were
analyzed using SPSS version 10. Association
between depression and socio demographic and other
risk factors were assessed by univariate analysis and
binary logistic regression.
RESULTS
The mean age of students was 19.78 0.78 years.
28.37 % students were females and 20.76 % students
came from a rural background. 15.57 % students were
addicted to smoking and 4.15 % to alcohol (more
than 4 days a week). 60.9% students were unsatisfied
with the academic facilities (library, lecture theatre
/demonstration rooms, canteen etc) and 41.52 %
912
students found difficulties coping with the study

course. About 1/3rd of the students had problems
related to health, stressful situations at home and
relationship issues (Table 2). The mean score of
students using Becks Depression Inventory II was
10.47 10.39. It was found that 22.5 % of students
tested positive for some form of depression using a
cutoff score of 17 in the BDI II scale (Fig 1). About
6.2% had severe to extreme depression. Increasing
age was associated with an increased likelihood of
exhibiting depression, but increase in family income
was associated with a reduction in the likelihood of
having depression.
(Table 1) On the basis of univariate analysis,
depressive symptoms were significantly higher in
students who did not choose admission in MBBS
course on their own, had lower marks in last MBBS,
felt negatively about results, faced difficulty with
study course, we're worried due to health or stressful
situations in the family and had relationship issues.
(Table 2) When controlling for other variables in
multiple logistic regression, the variables worry due
to health and stress at home lost its significance
but the other variables remained significant. Students
with relationship issues in their personal lives were
3.7 times more likely to exhibit depressive symptoms
than without them. Students who faced difficulty
coping with study course were 2.18 times more likely
to exhibit depressive symptoms than without them.
(Table 3)
No significant association of depression was found
with other risk factors such as gender, residence,
religion, family size, and satisfaction with academic
facilities. (Table 3). The model explained 46.9 %
(Nagelkerke R2) of the variance in depression and
correctly classified 83.0% of cases. For the model,
the Hosmer-Lemeshow test gave a Chi-square value
of 7.67 (p = 0.47), showing that the predicted model
is not significantly different from the actual data,
indicating a good model fit.
Total Score Levels of Depression using Beck's
Depression Inventory II :
0-10 = These ups and downs are considered normal,
11-16 = Mild mood disturbance, 17-20 = Borderline
clinical depression, 21-30 = Moderate depression, 3140 = Severe depression, over 40 = Extreme
depression
11.07%
4.84% 1.38%
0-10
5.19%
11-16
12.11%
17-20
65.40%
21-30
31-40
>40
Fig1: Becks Depression Inventory II Score of

medical students
Table1: Sociodemographic characteristics of

study participants.
Sociodemo-graphic
characteristics
Age in years
18
19
20
21
22
Sex
Male
Female
Religion
Hindu
Muslim
Residence
Urban
Normal
n = 221
Depressed
n = 68
85
100
26
3
18
31
18
1
153
54
68
14
203
18
62
6
265
24
177
52
21
198
11
48
170
54
>4
51
Current place of stay
Hostelite
116
14
19
2
4
229
60
11
32
246
224
65
34
Day scholar
105
34
Addiction (most commonly)
Nil
196
33
Smoking
Ganja
Alcohol
7
103
131
44
4
207
82
Rural
44
16
Monthly Family income (Rupees)
< 5000
2
9
5000 - 10000
> 10000
Family size
4
Total
N=28
9
26
1
8
150
139
229
45
3
12
P
value
11 0.02*
.6
2.
65
0.10
0.
03
0.89
0.
41
0.52
25 0.00*
.0
0.
18
0.66
0.
13
0.72
52 0.00*
.
* = P<0.05
913
Prianka et al.,
Table2: Distribution of some risk factors of

depression among study participants.
Risk factors Normal Depressed
of depression =221
=68
Reasons for admission in MBBS
Own choice
163
28
Financial
7
2
opportunity
Parents
51
38
expectations
Marks obtained in last MBBS
50%-60%
26
14
60%-70%
185
46
> 70%
10
8
Feelings about results
Not satisfied
176
38
Satisfied
38
23
Very
7
7
satisfied
Difficulty with study course
No
146
23
Yes
75
45
Satisfaction with academic facilities
No
87
26
Yes
134
42
Worry due to health
No
139
32
Yes
82
36
Stressful situation at home
No
173
42
Yes
48
26
Relationship Issues
No
174
27
Yes
47
41
Total
=289
P
value
191
26.53
0.00*
40
231
18
8.98
0.01*
214
61
16.22
0.00*
169
120
22.26
0.00*
113
176
0.03
0.86
171
118
5.39
0.02*
215
74
7.33
0.00*
201
37.39
0.00*
9
89
14
88
* = P<0.05
Table 3: Correlates of depression among medical
students using binary logistic regression.
Correlates of
B
S.E. Wald
depression
Age
.558 .255 4.786
Sex
-.191 .439 .189
Religion
-.092 .600 .023
Residence
-.276 .467 .348
Family income
-1.274 .360 12.544
Family members
-.134 .185 .526
Hostelite/Day scholar .489 .385 1.612
Addiction
.643 .244 6.929
Reasonsfor admission .641 .196 10.727
in MBBS
Marks obtained in
-.274 .390 .492
last MBBS
Feelings about results -.679 .315 4.654
Difficulty with study .780 .368 4.490
course
Satisfaction with
.402 .382 1.107
academic facilities
Worry due to health
.203 .373 .294
Stress at home
.279 .393 .502
Relationship issues
1.313 .379 11.996
Constant
-8.683 5.133 2.861
df Sig.
Exp(B)
1
1
1
1
1
1
1
1
1
.029*
.663
.878
.555
.000*
.468
.204
.008*
.001*
1.747
.826
.912
.759
.280
.875
1.630
1.902
1.898
.483
.760
1 .031*
1 .034*
.507
2.182
.293
1.495
1 .588
1 .479
1 .001*
1 .091
1.225
1.321
3.717
.000
DISCUSSION
Despite the huge burden of depression globally its
detection and treatment remains a challenge. Medical
students have a higher prevalence of depression than
the general population. 4,5 Studying medicine is an
intense experience and the course is a demanding
one. The pressure of huge syllabus, rigorous training
schedule, elaborate examination or observing very
sick patients can make them fall victims to different
mental health disorders. Additionally, medical
students are often reluctant to seek help due to stigma
associated with the disease. In the present study the
overall prevalence of depressive symptoms by
screening was found to be 22.5%, which is quite high
and similar to other studies.14,15 However some other
studies have reported lower prevalence.16,17 These
differences could be due to different scales used for
assessment, different study areas, different academic
environment in medical colleges and different
methods of study. It remains important to identify
such students, especially the more vulnerable with
severe to extreme forms of depression early and to
encourage them to seek and receive appropriate help.
Depression is a feminized issue across different
countries, affecting women twice more than as
men.18,19 Contrary to this, the present study found no
evidence that women were more likely than men to
experience depression. This may be due to favourable
background characteristics like higher family income,
urban residence, smaller family size and parental
support among the majority of medical students.
Other studies have similarly shown no differences in
depressive symptoms between male and female
students. 20,21
Older age was found to be related with depression.
Older students may experience more stress due to
financial pressures, employment concerns or other
familial responsibilities and expectations resulting in
depression. Family income was also found to be
associated with depression similar to a study done by
Lorant et al who reported that depression was 1.81
times more in the lowest socioeconomic group
compared to those in the highest socioeconomic
group.22,23 Scope of financial support to meritorious
students belonging to economically weaker
background, like scholarships can be enhanced in
such cases.
* = P<0.05
914
Prianka et al.,
Students with addiction were more likely to exhibit

depressive symptoms than without them. However, as
the study was cross-sectional, it could not be
ascertained whether addiction played a causal role or
it was the outcome of depression. Various studies
have reported substance abuse and alcoholism among
medical students and junior doctors under
stress.24,25,26
Family environment and parental support system can
have a profound effect on the mental health of
students.27,28 Staying away from home as in case of
hostelites, decision making role in choosing ones
own career, worry due to health, loss of a loved one
in the family or other relationship issues can lead to
stress and depression. In India there are tremendous
expectations of parents from their children to pursue
A list professional careers like medical and
engineering. In the process children often are forced
to take up careers in those fields against their choice
and when they fail to cope up, it results in depression.
The findings of the present study corroborate the
association between students decision making role in
choice of their own career and relationship issues
with depression.
One interesting finding of the study was that both the
students perception of their own academic
performance and marks obtained in MBBS were
found to be associated with depression in univariate
analysis. However, when other predictors were taken
into account marks obtained in MBBS was no
longer significant. Nevertheless, peer pressure from
competition and higher self expectations on academic
performances has reportedly been associated with
depression. Peer pressure can also lead to negative
feelings regarding ones own academic performance.
Students who faced difficulty with the study course
had higher depression scores than their counterparts.
Similar result was observed by T Alvi.29
Medical students are the doctors of tomorrow and it is
important they are given the right support at an early
stage in their training to prevent them from
depression and anxiety. As part of this process, new
approaches may be needed in medical colleges by the
involvement of College administrators, student
associations and physicians develop targeted primary
prevention strategies, screening and diagnostic
programs and accessible early intervention while
ensuring confidentiality of the students. 9 Access to
medical and other health services must be made

available to them in a confidential and enabling
environment with clear referral pathways and models
of care with the assurance that seeking help will not
affect their career progression.30 At the same time
education and awareness of medical students should
be provided to reduce the stigma of depression. While
evaluation of the existing medical curriculum may be
necessary to make the medical course less stressful.
CONCLUSION
The findings of the present study highlight the fact
that depression is a problem among medical students.
Besides academic performance, factors like older age,
socioeconomic status, role in the choice of a medical
career, negative perception of academic performance,
difficulty with study course and relationship issues
are also important. It is important for medical
institutes to identify such vulnerable students and
develop adequate and appropriate support services for
them.
Limitations of the study: Firstly, BDI II was used as
a screening tool and no definite psychiatric diagnosis
of the medical students could be made. Also, there
was no scope of referring the students screened with
positive symptoms for confirmation and treatment, as
anonymity was maintained. The study was
undertaken in only one medical college, hence
limiting the generalisability of the results. As the
study was cross-sectional in design, no follow up was
done; hence it could not be ascertained if depression
was persistent or varied during the course of MBBS.
Lastly, all risk factors could not be accounted for.
Future longitudinal studies involving larger sample
across several medical colleges are necessary to
ascertain the prevalence and different causal factors
in a better way.
ACKNOWLEDGEMENT
The authors are grateful to all the students who
participated in the present study.
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Dahlin M, Joneborg N, Runeson B. Stress and
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Martins LA. The characteristics of depressive
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Sokratous S, Merkouris A, Middleton N, and
Karanikola M. The association between stressful
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(2012) Quality of Life of Medical Students in
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Schwenk TL, Davis L, Wimsatt L A. Depression,
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Students. JAMA, 2010; 304 (11): 1181-0.
Roberts L W. Understanding Depression and
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14. Bostanci M, Ozdel O, Oguzhanoglu NK, Ozdel
L, Ergin A, Ergin N, Atesci F, Karadag F:
Depressive symptomatology among university
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J: Prevalence and persistence of depression
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DOI: 10.5958/2319-5886.2014.00025.3

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
ADENOSINE DEAMINASE ACTIVITY AND INSULIN IN TYPE 2 DIABETES MELLITUS: DOES

ADENOSINE DEAMINASE AFFECTS INSULIN LEVEL?
*Shaikh Sahema M1, Panchal Mittal A2, Sadariya Bhavesh B3, Sharma Hariom M4, Bharat Bhoi2
1
Tutor, 2Resident Doctor, 4Professor & Head, Department of Biochemistry, Govt. Medical College, Bhavnagar,
Gujarat,
3
Assistant Professor, Department of Biochemistry, Pacific Medical College, Bhiloka-bedla, Udaipur, Rajasthan,
*Corresponding author email: drsahema88@gmail.com
ABSTRACT
Aim: Correlation between Adenosine Deaminase activity and Insulin level in patients with Type 2 Diabetes
Mellitus. Material & Method: We measured the serum level of Adenosine Deaminase (ADA), Insulin and
Fasting Plasma Glucose (FPG) in 50 patients with type 2 diabetes and 50 healthy controls. Subjects included in
study were known diabetics for 5 years or more. Results: The levels of Serum Adenosine Deaminase and Insulin
were highly significant (p<0.001) in study group in comparison to control group. Adenosine Deaminase was
positively correlated with Fasting Plasma Glucose (r=0.6146, p<0.001) and Insulin (r=0.3022, p<0.05) in diabetic
patients. Insulin was positively correlated with Fasting Plasma Glucose (r=0.4728, p<0.001) in diabetic patients.
Conclusion: Present study concludes that serum Adenosine Deaminase activity and Insulin levels significantly
increased in type 2 diabetes mellitus. Both Adenosine Deaminase and Insulin positively correlated with each other
and also with Fasting Plasma Glucose. As adenosine deaminase can serve as an immunological marker and has a
probable role in oxidative stress along with its effect on insulin actions by decreasing levels of adenosine,
Adenosine Deaminase can be a useful parameter in the pathophysiology of type 2 diabetes mellitus.
Keywords: Adenosine Deaminase, Insulin, Fasting Plasma Glucose, Adenosine, Type 2 Diabetes Mellitus
INTRODUCTION
Diabetes is not one disease, but rather is a
heterogeneous group of syndromes characterized by
an elevation of fasting blood glucose caused by a
relative or absolute deficiency in insulin1. According
to recent estimates by the International Diabetes
Federation (IDF), approximately 285 million people
worldwide (6.6%) in the 2079 year age group had
diabetes in 2010 and by 2030, 438 million people
(7.8%) of the adult population, is expected to have
diabetes. In India, the estimated no. of diabetics was
50.8 million in 2010 and expected to rise to 87.0
million by 20302.
Adenosine
deaminase
(ADA)
(Adenosine
Aminohydrolase, EC 3.5.4.4) is an enzyme of purine
metabolism which acts on adenosine and other
adenosine nucleoside analogues and catalyze its
hydrolytic cleavage into inosine and ammonia, so it
causes reduction in the levels of adenosine.
Adenosine mimics the action of insulin on glucose
and lipid metabolism in adipose tissue and the
myocardium, while it inhibits the effect of insulin on
total hepatic glucose output, which suggests that
adenosine, causes local insulin resistance in the liver3.
Adenosine is an agent which primarily decreases
cyclic AMP accumulation, whereas insulin acts to
918
Sahema et al.,
inhibit lipolysis via a noncyclic AMP-dependent

mechanism. Under appropriate conditions one can see
a marked synergism between the antilipolytic effects
of insulin and adenosine. John N. Fain et al.
suggested that insulin cannot inhibit lipolysis due to
high concentrations of lipolytic agents unless cyclic
AMP accumulation is maintained at low levels by
adenosine4.
Main biological activity of ADA is detected in T
lymphocyte function, so it was considered as a good
marker of cell mediated immunity and it has a crucial
role in lymphocyte proliferation and differentiation5.
Impaired lymphocyte function and enhanced
susceptibility to infections is a common feature of
human diabetes6.
Studies have reported elevated ADA activity in type 2
diabetes 3,7,8,18 which concluded ADA as a marker of
oxidative stress and lipid peroxidation in diabetes
while Anju Gill et al. reported that there is an
increase in the serum Insulin level with an increase in
HbA1c levels in type 2 diabetes mellitus6.
In the view of increasing burden of diabetes and as
adenosine mimics action of insulin we studied ADA
and insulin both in type 2 diabetes mellitus patients.
In the present cross-sectional study, we included 50
type 2 diabetes mellitus patients having the disease
for 5 or more years and were in the age group of 35-
74 years and of either sex. The patients were on oral

hypoglycemic drugs and were attending the Out
Patients Department of Medicine at Sir Takhtsinhji
Hospital, Bhavnagar, Gujarat. A group of 50 normal,
healthy individuals from the same population served
as controls. The study protocol was approved by an
Institutional review board of Maharaja Krishna
kumarsinhji Bhavnagar University.
Patients on insulin therapy, having complications of
Diabetes Mellitus, pre existing infection and use of
medications like steroids were excluded from the
study. After enrolling in the study, a detailed medical
history and the informed consent were obtained. A
thorough explanation of the procedure of this study
was given to the subjects.
Venous Blood samples were collected in a fasting
state for estimation of Fasting Plasma Glucose,
Serum Insulin and Serum ADA. Fasting plasma
glucose were analyzed by GOD POD method9,
estimation of serum ADA done by Guisti
Colorimetric Method10 on fully auto analyzer I Lab
650 while estimation of serum Insulin was done by
Eliza method11 on Biorad Eliza reader at Clinical
Biochemistry Section, Laboratory Services Sir
Takhtsinhji Hospital, Bhavnagar, Gujarat.
Statistical analysis: Numerical variables are reported
in terms of mean and standard deviation. Comparison
between two groups was made with the unpaired
student-t test. Correlations were calculated with
Pearson product moment correlation coefficient by
using graphpad prism version 6.0 statistical software.
RESULTS
Table 1: Comparison of FPG, ADA and Insulin in type 2 diabetes patients and healthy subjects
Parameter
Biological
Diabetic patients
Healthy
Statistical
Reference Interval
Subjects
Significance
FPG (mg/dl)
70-100 mg/dl
165.0690.60
90.88 6.483
t= 5.774 **p<0.001
Serum ADA (U/L) 0-15 U/L
24.52 9.733
16.516.26
t=4.891**p<0.001
Insulin (IU/mL)
2-25IU/mL
17.93 10.38
8.75 3.465
t=5.930 **p<0.001
Note: *p < 0.05 significant, **p < 0.001 highly significant, #p0.05 not significant
The difference in FPG, ADA and Insulin were highly
significant (p<0.001) in type 2 diabetic patients in
comparison to control group (table 1).
In diabetic patient's serum ADA levels were positively
correlated with FPG (r=0.6146, p<0.001) (Fig.2) and

Insulin (r=0.3022, p=0.0330) (Fig 1), While Insulin
levels were positively correlated with FPG (r=0.4728,
p<0.001) (Fig 3).
919
Sahema et al.,
Fig 1: Correlation between ADA and Insulin in

type 2 diabetic patients
Fig 2: Correlation between ADA and FPG in type

2 diabetic patients
Fig 3: Correlation between Insulin and FPG in

type 2 diabetes patients
DISCUSSION
Diabetes Mellitus comprises a group of common
metabolic disorders that share the phenotype of
hyperglycaemia and results from a defect in insulin
secretion, insulin action or both. Insulin deficiency in
turn leads to chronic hyperglycaemia with
disturbances of carbohydrate, fat and protein
metabolism12. At present due to obesity, the age of
onset of diabetes in children and adolescents has been
decreased to less than 30 years and it is of great

concern as future generations may be burdened with
morbidity and mortality at the height of their
productivity, potentially affecting the workforce and
healthcare resources of the countries across the
world13. Physiological roles of ADA can be seen in
connection with adenosine whose concentration can
be modulated by enzymatic action of ADA.
Immunological disturbances in type 2 diabetic
individuals have an association with cell mediated
responses. Adenosine deaminase, an enzyme
distributed in human tissues, was considered as a
good marker of cell mediated immunity3.
Hyperglycaemia in type 2 diabetes is associated with
increased oxidative stress and according to Gitanjali
G et al. ADA has got a role in increasing lipid
peroxidation by reactive oxygen species generation,
as they observed positive correlation of ADA with
Malondialdehyde (MDA) levels7.
Insulin resistance is the first detectable abnormality
found in type 2 diabetes mellitus and it is defined as a
reduced response of target tissues such as the skeletal
muscle, liver and adipocytes to insulin.
Hyperglycemia and hyperinsulinemia themselves can
impair insulin secretion and insulin sensitivity. The
body becomes more resistant to insulin with
increasing duration of diabetes, and according to
Meena Verma et al., HbA1c and Insulin levels
significantly increase with the duration of diabetes
and showed a significant correlation for age, sex and
duration of diabetes14 while Zarghami et al.15 and
Anju gill et al.7 reported elevated levels of insulin in
type 2 diabetes subjects in comparison to healthy
controls. Our study supports them.
Adenosine potentiates insulin and contraction
stimulated glucose transport in skeletal muscles by
enhancing the increase in GLUT-4 at the cell surface
and raised the possibility of decreased adenosine
production or action by increased level of adenosine
deaminase could play a causative role in insulin
resistance16. Joanna Rutkiewicz et al. in 1990
concluded in their study that insulin is involved in the
regulation of activity of adenosine deaminase in
different rat tissues17.
In the present study, serum ADA and Insulin levels
were markedly increased in type 2 diabetic patients
(p<0.0001) in comparison to healthy subjects while
ADA (r=0.6146, p<0.001) and Insulin (r=0.4728,
p<0.001) positively correlate with FPG, which is
920
Sahema et al.,
highly significant. Positive significant correlation was

also present between ADA and Insulin (r=0.3022,
p<0.05).Our study found ADA as a marker of
glycemic status in type 2 diabetes patients.
CONCLUSION
It is concluded from the present study that serum
ADA and insulin significantly increased in type 2
diabetics and correlated with each other and also with
FPG. In the present time, ADA has been viewed as a
parameter of interest in type 2 diabetes due to its role
in oxidative stress, as a marker of cell mediated
immunity along with its effects on insulin by altering
levels of adenosine. Therefore, ADA can be used as
an important parameter in the patients of type 2
diabetes mellitus.
Acknowledgment: Authors gratefully acknowledge
all participants of medicine OPD, Institution,
Department and clinical biochemistry laboratory for
technical help and cooperation.
REFERENCES
1. Pamela C. Champe, Richard A. Harvey, Denise
R. Ferrier. Lippincotts Illustrated reviews, 3rd
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no.336.
2. Ramachandran A, Das AK, Joshi SR, Yajnik CS,
Shah S, Prasanna Kumar KM. Current Status of
Diabetes in India and Need for Novel Therapeutic
Agents. Supplement to JAPI. 2010;58:7-9
3. Gohel Mg, Sirajwala Hb, Kalaria Tr, Kamariya
Cp. A Study of Serum Adenosine Deaminase
Level in Patients with Type 2 Diabetes Mellitus
and its correlation with glycemic control.
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Sciences 2013;2(3):259-67
4. Fain JN, Wieser PB. Effect of Adenosine
Deaminase on cyclic adenosine monophosphate
accumulation, lipolysis, and glucose metabolism
of fat cells. J. Biol. Chem. 1975, 250:1027-34
5. Kaur A, Kukreja S, Malhotra N, Neha. Serum
Adenosine Deaminase Activity and Its
Correlation with Glycated Haemoglobin Levels
in Patients of Type 2 Diabetes Mellitus. Journal
of Clinical and Diagnostic Research. 2012,6(2):
252-256
6. Sakowicz-Burkiewicz M, Pawelczyk T. Recent
advances in understanding the relationship
between adenosine metabolism and the function
of T and B lymphocytes in diabetes. Journal of

Physiology and Pharmacology 2011;62(5):505-12
7. Anju Gill, Shhiba Kukreja, Naresh Malhotra,
Namrata Chhabra. Correlation of Serum Insulin
and the Serum Uric Acid Levels with the
Glycated Haemoglobin Levels in Patients of
Type 2 Diabetes Mellitus. Journal of Clinical and
Diagnostic Research. 2013;7(7):1295-1297
8. Gitanjali G, Sudeep G, Neerja, Mili G, Deepak A,
Priyanka S. The Effect of Hyperglycaemia on
some biochemical parameters in Diabetes
Mellitus. Journal of Clinical and Diagnostic
Research. 2010;4:3181-86
9. Teitz textbook of Clinical Chemistry and
Molecular Diagnosticsfifth edition Chapter no.
26, Carbohydrates. Page No- 720.
10. Giusti G, Galanti B. Colorimetric Method.
Adenosine deaminase. In: Bergmeyer HU (ed).
Methods of enzymatic analysis.
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level by ELISA. Practical course: Basic
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page 3-4
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the Expert Committee on the Diagnosis and
Classification of Diabetes Mellitus. Diabetes
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13. Sunita Singh. A Review: The Genetics of Type 2
Diabetes Mellitus. Journal of Scientific Research,
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Dr. P.G. Raman. Effect of increasing duration of
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Sahema et al.,
DOI: 10.5958/2319-5886.2014.00026.5

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
ETIOLOGY, CLINICAL PROFILE, SEVERITY AND OUTCOME OF ACUTE PANCREATITIS IN RELATION

TO BED SIDE INDEX FOR SEVERITY OF ACUTE PANCREATITIS BISAP AND CT SEVERITY INDEX [CTSI]
SCORES
*Bezwada Srinivasa Rao1, Matta SreeVani2, V.Sarat Chandra3.

1
Associate Professor, 3Senior Resident, Department of Medicine, Siddhartha Medical College, NTRUHS, Vijayawada,
Andhra Pradesh, India
2
Assistant Professor, Department of Biochemistry, Siddhartha Medical College, NTRUHS, Vijayawada, Andhra
Pradesh, India
*Corresponding author email: drbezsri@gmail.com

ABSTRACT
Background: Acute pancreatitis is an inflammatory process of the pancreas with involvement of regional tissues
or remote organ systems and with potentially devastating consequences. Early prediction of outcome of acute
pancreatitis within 24 hrs by clinically based bed Side Index of Severity of Acute Pancreatitis [BISAP] Score
and radiological based CT Severity Index [CTSI] later on being useful in initiation of early treatment, assessing
severity, to prevent morbidity and mortality. In those who survive, it can progress to chronic pancreatitis resulting
in malabsorption and permanent diabetes. Aim: The aim was to study aetiology, clinical profile, severity,
outcome of acute pancreatitis in relation to BISAP Score and CTSI. Materials and Methods: This was an
observational and prospective study. The present study enrolled 55 patients who were diagnosed as acute
pancreatitis and patients with chronic pancreatitis were excluded from the study. Vital data like pulse rate, blood
Pressure, temperature, respiratory rate, conscious level using Glasgow coma scale, serum amylase, lipase, Chest
x-ray, US abdomen and CT abdomen [both CECT & NCCT] were done. BISAP Score was obtained at the time of
presentation or within 24 hours of presentation and radiological based CT Severity Index [CTSI] was calculated
using the Balthazar grading system and Necrosis Scoring system to assess the severity, morbidity and mortality.
The results: In this study, the most common aetiology being alcohol intake followed by gall stones. BISAP Score
< 2 predicted mild pancreatitis, Score > 3 had organ dysfunction and Score 4 had 100% mortality. The relation
between CTSI score and Organ dysfunction showed increased organic dysfunction and higher mortality with
higher CTSI Scores. p value < 0.0001 was calculated using Pearson Chi-square test and found to be statistically
significant. Conclusions: Both BISAP and CTSI scores had positive correlation with morbidity and mortality.
Key words: Acute pancreatitis, BISAP Score, Balthazar Grading, CT Severity Index, Chronic pancreatitis
INTRODUCTION
Acute pancreatitis is an inflammatory process of the
pancreas with varying involvement of regional tissues
or remote organ systems1-5 and with potentially
devastating consequences. The diagnosis of mild
disease may be missed and death may occur before
Srinivasarao et al.,
diagnosis in 10% patients with severe disease. Acute

pancreatitis runs a benign course in Asian countries
and the aetiology is different from that of the western
population. Gall stones and alcohol abuse account for
70% of cases of acute pancreatitis. The most common
cause of acute pancreatitis is gallstones, including
922
Int J Med Res Health sci. 2014;3(4):922-928
microlithiasis, which accounts for 35 to 40 percent of

cases with only 3 to 7 percent of patients developing
gallstone pancreatitis 6. The risk of developing acute
pancreatitis in patients with gallstones is greater in
men, but more women develop this disorder since
gallstones occur with increased frequency in women.
Alcohol may act by increasing the synthesis of
enzymes by pancreatic acinar cells. Not all acute
alcoholic pancreatitis patients progress to chronic
pancreatitis, even with continued alcohol abuse.
Triglyceride concentrations above 1000mg/dl can
precipitate attacks of acute pancreatitis in 1.3 to
3.8%. Hypercalcemia can lead to acute pancreatitis
due to deposition of calcium in the pancreatic duct
and activation of trypsinogen within the pancreatic
parenchyma. The incidence of acute pancreatitis
increases with age.
The clinical features and the severity of acute
pancreatitis are related to extrapancreatic organ
failure secondary to the patients systemic
inflammatory response syndrome (SIRS) elicited by
acinar cell injury.7 The intrapancreatic release of
active pancreatic enzymes leads to pancreatic
autodigestion, setting up a vicious cycle of active
enzymes damaging vascular endothelium, interstitium
and acinar cells. The destruction spreads along the
gland and into the peripancreatic tissues. The
spectrum of acute pancreatitis ranges from interstitial
pancreatitis, which is a mild and self limited disorder
to necrotizing pancreatitis. Almost all patients with
acute pancreatitis have acute upper abdominal pain at
onset8 are typically accompanied in approximately 90
percent of patients by nausea, vomiting, restlessness,
agitation and relieves on bending forward. The
warning signs of pancreatitis include fever suggesting
infection, hypovolaemia due to fluid accumulation,
Grey turner sign (flank discolouration) and Cullens
sign
(periumblical
discoloration)
suggesting
haemorrhagic pancreatitis, visual loss due to
protesters retinopathy and tetany due to severe
hypokalemia / fulminant pancreatitis. Fever is an
important sign in patients with acute pancreatitis and
is mediated by inflammatory cytokines in the first
week. Fever in the second or third week is due to
infection of the necrotic tissue and is much more
significant. Patients with acute pancreatitis may be
dyspnoeic due pleural effusion and may go into
respiratory failure.
The diagnosis of acute pancreatitis is based on typical

abdominal pain, 3 fold elevation in serum amylase
or lipase level 9 and confirmatory findings on crosssectional abdominal imaging. The sensitivity of
serum lipase for the diagnosis of acute pancreatitis
ranges from 85 to 100 percent in various reports.9-11
Lipase measurements is more specific than serum
amylase in patients with alcoholic pancreatitis
presenting late to the physician. A diffusely enlarged,
hypoechoic pancreas is the classic ultrasonographic
finding in acute pancreatitis. Computerised
Tomographic scan (CT scan) of abdomen is the most
important in the diagnosis of acute pancreatitis, intra
abdominal complications and for assessment of
severity when results are combined with the Ranson
score.12 Contrast enhanced CT [CECT] distinguishes
edematous from necrotizing pancreatitis. CT is more
accurate than ultrasonography in the diagnosis of
severe pancreatic necrosis 90 versus 73 percent in one
report 2. Patients with higher CTSI scores are likely to
have a prolonged hospital course and higher mortality
than patients with lower scores.3 CT Severity Index is
best evaluated three to five days into hospitalization
because it may not be possible to distinguish
interstitial from necrotizing pancreatitis on contrast
enhanced CT scan on the day of admission. The
likelihood of prolonged pancreatitis or a serious
complication is negligible when the CTSI score is 1
or 2 and low with scores of 3-6 and with a score of 710 had a 92% morbidity rate and 17% mortality rate.
CT Severity index 4 equals an unenhanced CT score
plus necrosis score. Score 6 indicates severe
disease. Magnetic resonance imaging [MRI] can
distinguish the pancreatic necrosis seen on CT into
necrotic pancreatic parenchyma, peripancreatic
necrotic fluid collection, hemorrhagic foci, abscess,
pseudocyst and pancreatic duct disruptions. MRI has
greater sensitivity to detect mild acute pancreatitis
compared to CT.
Routine clinical assessment identifies only 34 to 44
percent of patients with severe acute pancreatitis.
With the exception of the APACHE II system, the
other systems like Ranson, Glasgow, Banks, and
Agarwal and Pitchumoni take 48 hours to complete,
can be used only once, and do not have a high degree
of sensitivity and specificity. The APACHE II has
good negative value and modest positive predictive
value for predicting severe acute pancreatitis and can
be accurate at 24hrs. Clinical assessment for severe
923
pancreatitis by SIRS, BISAP score, Organ failure

scoring systems within first 24 hours as accurate as
most scoring systems. In SIRS four variables are
taken each assigned one point. A SIRS score of 2 or
more reliably predicted severe acute pancreatitis at
the bedside and can be done daily.
Bedside Index of Severity in Acute Pancreatitis
[BISAP] 11 a new scoring system was developed for
bedside assessment of severity of acute pancreatitis. It
consists of five variables, each assigned one point.
The composite score of sum of all points is obtained
within first 24 hours of admission. A BISAP score is
simple to calculate requires only those vital signs,
laboratories, and imaging that are commonly obtained
at the time of presentation or within 24 hours of
presentation. A score of 3 within 24 hours of
presentation carry a 7.4 to12.7 fold higher risk of
developing organ failure and persistent organ failure
respectively than those with scores < 3. Thus BISAP
score could be used to stratify patients by risk within
24 hours of presentation for clinical care and to
predict mortality. Organ failure was defined as a
score of 2 in one or more of the three (respiratory,
renal, and cardiovascular) out of the five organ
systems. Organ failure is calculated during the first 72
hours of hospitalization based on the most extreme
laboratory value or clinical measurement during each
24 hour period. Outcomes are worse in those with
organ failure within 48 hours of presentation and in
those > 48 hours had a persistent organ failure.
Approximately 75% to 80% of patients with acute
pancreatitis have a resolution of the disease process
(interstitial pancreatitis) and in 25% of patients
develop a more protracted course, often related to the
necrotizing process (necrotizing pancreatitis) lasting
weeks to months. Most of the deaths occur within the
first or second week, usually of multiorgan failure
due to associated pancreatic infection. In those who
survive, severe pancreatic necrosis can scar the
pancreas with subsequent obstructive chronic
pancreatitis resulting in permanent diabetes and
malabsorption. In this background, the present study
has been undertaken to study the aetiology, clinical
profile, severity and outcome of acute pancreatitis in
relation to BISAP and CTSI.
Aim of study
The aim is to study aetiology, clinical profile, severity
assessment using clinical criteria BISAP score,
radiological criteria CT Severity Index score and their

correlation to the outcome of acute pancreatitis.
This is prospective and observational study. Ethical
clearance was obtained from the institutional ethics
committee of Siddhartha Medical College. Informed
consent was taken from the patients in their own
language before collecting data. The present study
enrolled 55 patients with acute abdomen who were
diagnosed as acute pancreatitis based on elevated
serum amylase, lipase levels and/or radiological
evidence by ultrasound or CT scan abdomen. Patients
with Chronic pancreatitis were excluded from the
study. The duration of study was over a period of two
years. Laboratory tests like serum amylase, lipase,
haemogram, liver function tests, serum triglyceride,
Blood Urea Nitrogen BUN, serum creatinine, blood
glucose, lactate dehydrogenase, serum calcium,
arterial blood gas analysis were done. BISAP Score 11
and Organ failure score were calculated using clinical
parameters shown in Table:1&2
Table 1: BISAP score13
Parameter
Points given
Blood Urea Nitrogen > 25 mg/dl

Impaired mental status (Glasgow coma
score <15)
Age > 60 years
Pleural effusion detected on imaging
(chest radiograph / chest CT / Ultrasound
chest)
SIRS
Heart rate > 90 beats per min
Respiratory rate >20 per min
or PaCO2 <32 mm Hg
Temperature >38C or <36C
White blood cell count >12000/cu.mm
or <4000/cu.mm or Band forms >10%
1
1
1
1
1
(at least any
one of
these)
Table: 2 Criteria for organ failure based on

Marshall scoring system
Organ system
Respiratory
(PaO2/FiO2)
>40
0
301 400
201 300
101 200
<101
Renal
(S.creatinine(m
g/dL)
Cardiovascular
(systolic blood
pressure,
mm/Hg)
1.5
>1.5 1.9
>1.9 3.5
>3.55.0
>5.0
>90
<90,
fluid
respon
sive
<90,
fluid
nonresp
onsive
<90,
PH <
7.3
<90
PH<
7.2
924
Grade
A
D
E
Unenhanced ct findings
Score
Normal pancreas: normal size, sharply

defined, smooth contour, homogenous
enhancement, retroperitoneal Peri
pancreatic fat without enhancement
Focal or Diffuse enlargement of the
pancreas, contour may show irregularity,
enhancement may be inhomogenous but
there is no peripancreatic inflammation
Peripancreatic inflammation with intrinsic
pancreatic abnormalities
Intrapancreatic or Extrapancreatic fluid

collections
Two or more large collections of gas in
the pancreas or retroperitoneum.
Out of the 55 patients in the study, males and

females included are in the ratio 4.5:1 and the
majority were in their fourth decade. Most common
aetiology was alcoholic consumption by 51%,
idiopathic in 49%, followed by gallstones in 16.4%.
All the patients had abdominal pain at presentation
with a characteristic feature radiation of the pain to
the back (spine) was present in 43 (78%) of the
patients, vomiting in 47 (85.45%) followed by fever
in 20% 0f patients. Epigastric tenderness was the
most common clinical finding in 50 patients (91%)
followed by tachypnea in 48 patients (87%), sluggish
bowel sounds (42%), tachycardia (23.60%), Pleural
effusions in 18% of patients as shown in Fig:1.
50
40
30
20
10
0
Table 4:
Necrosis score based on Contrast
Enhanced CT scan findings
Necrosis percent
SCORE
< 33
33 50
50
4
6
RESULTS
A total of 55 patients with acute abdomen who were
diagnosed as acute pancreatitis based on elevated
serum amylase and/or lipase levels and radiological
findings with ultrasound and CT abdomen were
included in the study. BISAP and CTSI scores were
calculated and independently checked for correlation
with outcome of acute pancreatitis. Statistical
analysis was done using Pearson`s Chi-square test.
(Pearsons chi square test is one of the several types of
chi-squared tests. Here we used it to know whether
the values are statistically significant or not.) P-value
< 0.0001, p value is for comparison of outcome in the
study with both BISAP and CTSI scores
independently. Both Scores had statistically
significant correlation to outcome.) was calculated
which is highly significant. The results of this study
are shown in the figures given below.
50 48
23
13 10 10 9 9
7 5 5 3
2
epi.tenderness
tachypnea
sluggish bowel
tachycardia
abd.distension
absent breath
icterus
absent bowel
bil.crepitations
alt.sensorium
free fluid
dif.tenderness
shock
CTSI Score 3 was calculated with Balthazar grading 13

and Necrosis score using NCCT and CECT abdomen
findings given in Table:3&4.
Table: 3 Balthazar grading13 based upon
unenhanced CT findings.
no.of.pts
Fig 1: Clinical findings at the time of admission

Serum amylase in 26 patients (47%) and serum lipase
in 45 patients (82%) were elevated to greater than 3
times of upper limit of normal. Median value of
amylase was 532 U/l and lipase was 988 U/l.
Leukocytosis in 33 patients (60%) azotemia in 15
patients (25%).
BISAP Score and Organic failure score were
calculated from their variables. Fig:2 below shows
positive correlation between BISAP Score and
organic dysfunction.
20
15
10
3
4
Fig 2: Correlation of BISAP Score and organ

failure in acute pancreatitis
925
20
15
16
14
13
10
Recovered
4
Died
0
0
No.of patients
37
1 3
1 1
necrosi necrosi necrosi necrosi

s score s score s score s score
0
2
4
6
recovery
37
8
1
1
death
Recovered
Died
0-3
37
4-7
8
8 - 10
2
Fig 5: Outcome in relation CT Severity Index

[CTSI]
Fig 3: Outcome of patients in relation to BISAP

Score
BISAP Score was independently checked for
correlation with outcome. p value < 0.0001 was
calculated using Pearson Chi-square test and found to
be statistically significant. CT severity index [CTSI]
was calculated using the Balthazar grading system
and Necrosis Scoring system. Necrosis Scoring is
based on CECT abdomen findings. Fig:4 below
shows positive
correlation between pancreatic
necrosis and outcome.
40
35
30
25
20
15
10
5
0
40
35
30
25
20
15
10
5
0
No of pts
Fig 3 below shows positive correlation between

BISAP Scores and outcome. In this study 48
(87.30%) recovered completely and 7 patients
(12.70%) had mortality.
Fig4: Relation between pancreatic necrosis and

outcome in acute pancreatitis
The relation between CTSI and Organ dysfunction
and outcome of patients was observed and it showed
increased organic dysfunction and higher mortality
with higher CTSI Scores as shown in Fig 5
CT Severity index was independently checked for
correlation with outcome. p value < 0.0001 was
calculated using Pearson Chi-square test and found to
be statistically significant.
DISCUSSION
Acute pancreatitis is an inflammatory process of the
pancreas with varying involvement of other regional
tissues or remote organ systems 1 and with potentially
devastating consequences. The spectrum of acute
pancreatitis ranges from interstitial pancreatitis,
which is mild and self limited disorder to necrotizing
pancreatitis. Clinical assessment for severity of
pancreatitis by SIRS, BISAP score and Organ failure
scoring systems within first 24 hours are as accurate
as most scoring systems. CT scan of abdomen is the
most important imaging test for the diagnosis of acute
pancreatitis, intra abdominal complications and for
assessment of severity. CT is more accurate than
ultrasonography in the diagnosis of severe pancreatic
necrosis.2 Contrast
enhanced
CT
[CECT]
distinguishes
edematous
from
necrotizing
pancreatitis.
CT Severity index 3 equals an
unenhanced CT score plus necrosis score. Necrosis
Score is based on CECT Scan findings as per
Table:4.
In this study the aetiology, clinical profile, severity
and outcome of 55 patients with acute pancreatitis
were studied. An attempt was made to assess the
severity by clinical criteria like BISAP Score as per
Table:1 and radiological criteria like CTSI as per
Table: 3&4.. The disease is common in males when
compared to females. Out of the 55 patients, 45
patients (81.8%) were males and 10 patients (18.2%)
were females. The male: female ratio was 4.5:1 which
is closely related to a study by Baig SJ,
Abdur
Rahed.4 Majority of the patients were in their fourth
decade (31%), followed by fifth decade (22%), third
decade (20%), second decade (16%) and sixth decade
926
(9%) similar to a study by Garg PK, Khanna S,

Bohidar NP.5 In our study, the most common
aetiology was alcohol intake (51%) followed by gall
stones (16.4%) and in 27% of the patients, no
aetiology could be identified. In studies by Garg PK,
Khanna S, Bohidar NP 5 and by Gislason H, Horn A,
Hoem A, Imsland AK et al 7 the proportion of
gallstone pancreatitis was highest followed by
alcoholic pancreatitis. In our study the numbers of
female patients were less; this may be the cause for
the smaller proportion of gallstone pancreatitis 6. In a
study done by SJ Baig et al 4 the aetiologies were
similar to that of in our study. In this study abdominal
pain 8 with radiation to the back was present in all 55
patients (100%) followed by epigastric pain in 31
patients. Vomitings were predominantly nonbilious in
47 patients (85.45%) and fever in 20% of the patients.
Epigastric tenderness was the most common clinical
finding in 50 patients (91%) followed by tachypnea in
48 patients (87%), sluggish bowel sounds (42%),
tachycardia (23.60%), Pleural effusions in 18% of
patients and altered sensorium in 5 patients as per Fig
1
Serum Amylase9, 10 measurements were done at
presentation to the hospital. In 47% of patients, it was
elevated to > 3 times of upper limit of normal.
Studies done previously show that the serum amylase
values rise within 6 hours of onset and remain
elevated for 3-5 days. In our study, the mean duration
between symptom onset and presentation to hospital
was 4.7 days and this may be the reason for serum
amylase levels being in the normal range in the rest of
the patients (53%). Lipase 9,10 is elevated in 82% of
the patients at presentation making it a more sensitive
test for diagnosing acute pancreatitis especially for
patients presenting after a few days to the hospital.
In this study BISAP Score as per Table:1 and
Organic failure score as per Table:2 were calculated
from their variables and a positive correlation noted
between them in acute pancreatitis as shown in Fig:2.
Out of 55 patients included in the study, 48 patients
(87.30%) recovered completely and 7 patients
(12.70%) had a mortality as shown in Fig:3 In this
study a BISAP score of 4 had 100% mortality and
Score 3 predicted the development of organ
dysfunction, persistent organ failure, necrosis and
increased mortality and this correlated with a study
done by Vikesh Singh; Beichen et al. CTSI calculated
by using the Balthazar grading system 13 and Necrosis
Scoring system as per Tables 3&4. Necrosis Scoring

was done based on CECT abdomen findings as per
Table:4 Two patients were excluded as they had renal
failure and CECT scan could not be done. Out of 53
patients, Necrosis Score 0% in 37 patients (69.80%)
and all showed recovery (100%). Necrosis Score 2
was present in 10 patients, out of which 8 patients
recovered and 2 patients died. Necrosis Score 4 was
present in 4 patients and Necrosis Score 6 was
present in 2 patients as shown in Fig:4 This study
showed positive correlation between Necrosis Score
and organic dysfunction and mortality as in study by
Tenner S; Sica G; Hughes M: et al. 14 Fig:5 shows the
outcome of acute pancreatitis in relation to CT
severity index. Out of 53 patients, 37 (69.81%)
patients had CTSI Score 0-3, 12 (22.64%) patients
had score 4-7 and 4 patients had score 8-10. In this
study, the CT severity index was found to be a good
marker for assessing the prognosis and outcome of
acute pancreatitis. Out of 53 patients, 47 patients
(88.67%) recovered and 6 patients (11,32%) had
mortality. Outcome results of this study were
correlated with studies done by Simchuk EJ: Traverso
LW: Nukui Y, et al 3 All the patients who had organ
dysfunction had necrosis on CT. The relation
between CTSI and Organ dysfunction was observed
and it showed increased organic dysfunction 21%,
58%, 33% with CTSI Scores 0-3,4-7,8-10
respectively, and higher mortality with higher CTSI
Scores which correlated with studies done by G
Gurlyek; Emir S; Saglam A et al 15. One drawback in
the study was that CECT abdomen could not be done
in patients who had acute renal failure and hence
necrosis might have been missed, implying that the
degree of correlation between necrosis and mortality/
organ dysfunction might be still stronger.
CONCLUSIONS
A composite of BISAP Score during the first 24
hours and CTSI Score after 72 hours of admission to
the hospital predicted the outcome in terms of organ
dysfunction and mortality in acute pancreatitis. These
scores are helpful in initiation of early effective
treatment and prevention of complications like
chronic pancreatitis, malabsorption and permanent
diabetes.
Limitations of the study: The limitation of present
study includes smaller sample size, two patients were
excluded as CECT abdomen could not be done as
927
they developed acute renal failure and hence necrosis

might have been missed, implying that the degree of
correlation between necrosis and mortality/ organ
dysfunction might be still stronger.
7.
ACKNOWLEDGEMENT
Authors are thankful to postgraduate students in the
department of Medicine for their co-operation in the
study.
8.
9.

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incidence, aetiology and severity of acute
pancreatitis in Bergen, Norway: Scandinavian
Journal of Surgery 2004;93: 2933.
Swaroop VS, Chari ST. Severe acute pancreatitis;
Clain JE JAMA 2004;291(23):2865
Treacy J, Williams A, Bais R, Willson K,
Worthley C, Reece J, Bessell J, Thomas D.
Evaluation of amylase and lipase in diagnosis of
acute pancreatitisANZ J Surg 2001 ; 71(10):57782.
Keim V, Teich N, Fiedler F, Hartig W, Thiele
G, Mossner J. A comparision of lipase and
amylase in the diagnosis of acute oancreatitis in
patients with abdominal pain. Pancreas 1998;
16(1):45-9.
A Prospective Evaluation of the Bedside Index
for Severity in Acute Pancreatitis Score in
Assessing Mortality and Intermediate Markers of
Severityin Acute Pancreatitis. Vikesh Singh;
Beichen U; Wu: Am J Gastroenterol 2009;
104:96671; doi: 10.1038/ajg.2009.28;
Ranson JH, Turner JW, Roses DF, Respiratory
complications in acute pancreatitis. Ann Surg
1974; 179:557.
Balthazar EJ, Robinson DL, Megibow AJ,
Ranson JH. Acute pancreatitis: value of CT in
establishing prognosis. Radiology 1990; 174:
3316.
Tenner S, Sica G, Hughes M, Noordhoek E,
Feng S, Zinner M, Banks PA. Relationship of
necrosis to organ failure in severe acute
pancreatitis. Gastroenterology 1997 ; 113(3):89903
Gurleyik G, Emir S, Kilicoglu G, Arman A,
Saglam A. Computed tomography severity index,
APACHE II score, and serum CRP concentration
for Predicting the severity of Acute Pancreatitis:
JOP. J Pancreas (Online) 2005; 6(5):562-67.
928
DOI: 10.5958/2319-5886.2014.00027.7

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Revised: 2nd Sep 2014
Copyright @2014
ISSN: 2319-5886
Accepted: 28thSep 2014
IMMEDIATE MOBILISATION WITH COMPLETE WEIGHT BEARING AFTER UNCEMENTED

TOTAL HIP REPLACEMENT IN ELDERLY
*Sankarlingam P1, Shivraj V2, V R Subramaniyam3
1
Professor and HOD, 2Final year Postgraduate, 3Assistant Professor, Department of Orthopaedics, Meenakshi
Medical College and Research Institute, Enathur, Kancheepuram, Tamil Nadu
*Corresponding author email: sanklink@yahoo.com
ABSTRACT
This prospective study was analyzed in 23 patients who were allowed to do immediate weight bearing after
uncemented total hip arthroplasty. Immediate mobilization shortened the hospital stay and facilitated early
rehabilitation of hip. Immediate mobilization was started on postoperative Day 3 rather than Day 7 without any
adverse consequences to the patients. A series of 23 elderly patients of age more than 60 years, who were
diagnosed with conditions such as avascular necrosis of hip, non union of fracture neck of femur, trochanteric non
union and rheumatoid arthritis, underwent uncemented total hip replacement and immediate mobilization was
started in our hospital. Patients were evaluated by Harris Hip Scoring Scale. All ambulated patients had painless
hip and the mean Harris Hip Score was 85. There were no incidence of stem subsidence, acetabular component
loosening, and heterotrophic ossification. This data concluded that early intensive rehabilitation yielded faster
attainment of short-term functional milestones in fewer days.
Keywords: Uncemented total hip replacement, Elderly, Early weight bearing, Immediate mobilization, Harris
Hip Score.
INTRODUCTION
Uncemented total hip replacement is commonly done
in many health centres for various indications but
immediate weight bearing to tolerance is not
practiced in many centres. Rehabilitation is essential
to minimize the disability after surgery. The main
goal in treatment of avascular necrosis of hip, non
union of fracture neck of femur, trochanteric non
union and rheumatoid arthritis with uncemented total
hip arthroplasty in mobile elderly patients is to restore
the walking ability as early as possible.1 Immediate
mobilization shortened the hospital stay and
facilitated early rehabilitation of hip2. Earlier,
immediate weight bearing was thought to be
inappropriate, due to absence of osseous integration
of femoral stem and acetabular shell, hence only
partial weight bearing was allowed for at least 6

weeks after surgery3, but later it was found that no
adverse effects due to immediate mobilization with
complete weight bearing occurred after uncemented
total hip arthroplasty. We report a series of 23 cases
treated by uncemented total hip arthroplasty who
were allowed to do immediate mobilization with
complete weight bearing.
This prospective study was initiated after the
approval of the Ethical Committee of Meenakshi
Medical College. Twenty three elderly patients with
mean age of 65 years (range 55-85 years) were
929
Sankarlingam et al.,
operated by orthopaedics department in Meenakshi

Medical College over two years of period from 2012
June to 2014 June. 9 cases of avascular necrosis of
hip, 12 cases of non union neck of femur, 1 case of
trochanteric non union and 1 case of rheumatoid
arthritis were operated and treated with uncemented
total hip arthroplasty. Patients were followed up for 3
months, 6 months, 12 months and then yearly. All
patients had multiple Co morbidities. 20 had
hypertension with diabetes mellitus, 2 had chronic
renal failure and 1 had rheumatoid arthritis. All
patients fell into4 ASA (American Society of
Anesthesiologist) grade III (15 patients) and ASA
grade IV (8 patients). Informed consent was taken
from all the patients before the surgery. Combined
spinal and epidural anaesthesia was given to all
patients. We used anterolateral approach, with patient
in supine position. Hip replacement was performed
with 5uncemented hydroxyapetite coated stem (Smith
and Nephew, USA) and reflection Cup, cross linked
poly (Smith and Nephew,USA) in 11 patients and
6
mallory-head cup, arcom poly insert, proximally
porous coated stem (Biomed, USA) in 12 patients .
Stability in axial and rotational plane was assessed
before insertion of femoral stem. Prophylactic
intravenous antibiotics were used in all patients. All
patients were given DVT (Deep Vein Thrombosis)
prophylaxis from 1stpost operative day onwards. Side
turning in bed was allowed on 1st post operative day,
patients were made to stand on 2nd post operative day
with walker and walking was allowed with full
weight bearing as tolerated, patients were discharged
on 12th post operative day in walking condition after
suture removal .Patients were reviewed post
operatively after 4 weeks and followed by reviews at
6 weeks, 3 months, 12 months and then yearly.
Clinical and radiological evaluation was done for all
the patients at each follow up. Harris Hip Score used
as clinical outcome measures. Radiological
evaluation, including anteroposterior radiographs at 3
months, 6 months, 12 months and yearly for
evaluation of 7stem subsidence or loosening as well
as to look for 8acetabular erosion, protrusion and
9
heterotrophic ossification.
Table 1: Harris hip score
Age/Diagnosis
Harris hip score

6 weeks
60/Rt Non Union NOF

67/Rt Non Union NOF
62/Lt Non Union NOF
68/AVN Lt Hip
65/Lt Non Union NOF
70/AVN Rt Hip
66/Rt Non Union NOF
70/AVN Rt Hip
67/Lt Non Union NOF
61/AVN Rt Hip
64/Rt Non Union NOF
61/RA Rt Hip
60/Rt Non Union NOF
66/AVN Rt Hip
70/Lt Non Union NOF
67/Lt Non Union NOF
67/Trochanteric Non
Union Rt Hip
65/AVN Rt Hip
68/AVN Lt Hip
62/Rt Non Union NOF
61/AVN Lt Hip
65/AVN Lt Hip
70/Lt Non union NOF
65/AVN Rt Hip
3months 12 months
86
87
88
88
86
88
87
88
86
87
88
87
89
88
89
87
86
90
90
91
92
93
93
92
92
93
92
90
91
92
94
93
90
90
94
96
96
98
96
96
94
98
97
96
96
97
96
98
94
94
96
88
89
89
88
88
86
88
94
93
93
91
90
92
93
96
95
97
97
96
98
97
AVN- Avascular Necrosis of Hip, NOF- Neck of

Femur, RA- Rheumatoid Arthritis
RESULTS
Duration of hospital stay was 12 days (7-20 days),
patients were walking with full weight bearing with
walker support on the day of discharge. At 4 weeks of
follow up all the patients walked without a walker
with full weight bearing. There were no infection or
dislocation and no incidence of DVT. All ambulated
patients had painless hip and the mean 10Harris Hip
Score was 85 at 12 days of the postoperative period.
The Harris Hip score was evaluated for all 23 patients
at 6 weeks, 3 months and 12 months and the mean
average hip score was 88 at 6 weeks, 93 at 3 months
and 97 at 12 months
930
DISCUSSION
Fig 1: Progress of patients evaluated by Harris

Hip Score representedbyh bar diagram
Fig 2: Pre Operative Radiograph
Fig 3: Post Operative Radiograph of patient at 6

weeks
Fig 4: Uncemented Total Hip Arthroplasty

Implants
Uncemented total hip arthroplasty is done for various

indications, but only partial weight bearing is
practiced in many centres for 6 to 12 weeks. By
partial weight bearing, functional recovery may be
inhibited and muscle atrophy and loss of bone
mineral density increased. In addition, 11load on the
contralateral hip and upper extremities is significantly
higher when less weight is put on the operated lower
limb (Rao et al. 1998).12 Immediate weight bearing
after uncemented total hip arthroplasty shortens the
length of stay in hospital, reduces the risk of deep
venous thrombosis (Leali et al. 2002)13 promotes the
functional recovery with less usage of ambulatory
devices (Kishida et al. 2001).14 Ritter et al. (1995)
found that in growth of bone in single-stage, bilateral
uncemented total hip arthroplasty was not adversely
affected by weight bearing if initial stability of both
the metaphysical and diaphyseal portions of the
femur had been achieved. This conclusion may not
have been valid, however, because of the lack of a
protected weight bearing control group. 15Anderson et
al. (2001) did not find significant differences in hip
extension, muscle strength, gait velocity, pain, and
walking pattern 6 months after surgery between 10
patients who practiced late weight bearing and 11
patients who practiced immediate weight bearing.
16
Boden et al. (2004) in a prospective study of 20
patients who were operated with an uncemented
hydroxyapetite-coated total hip arthroplasty found
that immediate weight bearing had a positive effect
on the bone mineral density around the stem of the
prosthesis, and especially its distal part. Stem
migration was also evaluated, but with conventional
radiography. We found there was no migration of
components after full weight bearing during the first
6 weeks postoperatively, at 3 months, and at the oneyear follow up. All of our patients progressed to full
weight bearing without support at 6 weeks of follow
up (Fig 3).17 Osseous Integration of components
occurred in all hips without any radiolucent lines
between components and the bone. All the patients
experienced satisfactory pain relief and day to day
activities were carried out without any difficulty.
CONCLUSION
According to this study, full weight bearing
immediately after surgery as much as tolerated is
justified in uncemented total hip arthroplasty.
931
Immediate unrestricted weight bearing after

uncemented total hip arthroplasty gave good results
with no complications.
ACKNOWLEDGMENT
9.
This publication is the result of two years of work
whereby I have been accompanied and supported

by many people. I take this opportunity to
express my gratitude to our beloved Chancellor,
Vice Chancellor, Dean, Vice Principal, PG
director for their guidance throughout this work.
I would like to thank my assistants and
postgraduates for helping me throughout this
study period.
10.
11.

12.
REFERENCES
1. Marya, R Thukral, R Hasan, and M Tripathi .
Cementless bipolar hemiarthroplasty in femoral
neck fractures in elderly Indian J Orthopaedics.
2011 May-Jun; 45(3): 236242.
2. Mallory, Thomas. H. Preparation of the
Proximal Femur in Cementless Total Hip
Revision. Journal name.1988 2(4):235-39
3. Truike M Thien, Lennart Ahnfelt, Mikael
Eriksson, Christer Strmberg, and Johan
Krrholm. Immediate weight bearing after
uncemented total hip arthroplasty with an
anteverted stem. Acta Orthopaedics 2007; 78
(6);678-81
4. Saklad, Meyer M.D. Grading Of Patients for
Surgical Procedures. Clinical Orthopaedics
2002, 2 (3):2-3
5. Robert B. Bourne, Ernesto De Santis, Wayne M.
Goldstein, Gianni L. Maistrelli, John W. Mc
Cutchen, Cecil H. Rorabeck), James P. Waddell,
Smith and Nephew Synergy Cementless Stem
Surgical Technique Manual.
www.smithnephew.com.
6. Taperloc Biomet Complete Hip System Manual.
www.biomet.com.
7. Gruen, Thomas, Mcneice, Gregory, Amstutz,
Harlan.C, Modes of Failure of Cemented StemType Femoral Components. A Radiographic
Analysis of Loosening Clinical Orthopaedics &
Related Research: 1979; 141;17-27.
8. Sochart, David H. Relationship of Acetabular
13.
14.
15.
16.
17.
Wear to Osteolysis and Loosening in Total Hip

Arthroplasty. Clinical Orthopaedics & Related
Research: June 1999
Rockwood, JG Horne. Heterotopic ossification
following uncemented total hip arthroplasty., ,
1990;5;4346
Nizar N. Mahomed, David CA, Brian J.
McGrory, William HH. The Harris hip score.
Comparison of patient self-report with surgeon
assessment. The Journal of Arthroplasty. 2005;
16(5):57580.
Rao RR, Sharkey PF, Hozack WJ, Eng K,
Rothman RH. Immediate Weight bearing after
Uncemented Total Hip Arthroplasty. Clinical
Orthopaedics 1998; (349): 156-62.
Leali A, Fetto J, Moroz A. Prevention of
Thromboembolism Disease after non-cemented
hip arthroplasty. A multimodal approach. Acta
Orthopaedics 2002; 68 (2): 128-34
Kishida Y, Sugano N, Sakai T, Nishii T,
Haraguchi K,Ohzono K, et al. Full weightbearing after Cementless Total Hip Arthroplasty.
International Orthopaedics 2001; 25 (1): 25-8.
Ritter M A, Albohm M J, Keating E M, Faris P
M, MedingJ B. Comparative outcomes of total
Joint Arthroplasty. Joint Arthroplasty 1995; 10
(6): 737-41.
Andersson L, Wesslau A, Boden H, Dalen N.
Immediate or late weight bearing after
Uncemented Total Hip Arthroplasty: A study of
functional recovery. Joint Arthroplasty 2001; 16
(8): 1063-5
Boden H, Adolphson P. No adverse effects of
early weight bearing after uncemented total hip
arthroplasty: A Random study of 20 patients.
Acta Orthopaedics 2004; 75 (1): 21-9.
Ashraf AR, Matthew JK, Victor M. Goldberg,
Clinical and Radiographic Outcomes of Total
Hip Arthroplasty with Insertion of an
Anatomically Designed Femoral Component
without Cement for the Treatment of Primary
Osteoarthritis. A Study with a Minimum of Six
Years of Follow-up. J Bone Joint Surgery Am,
1999;81(2):210-218
932
DOI: 10.5958/2319-5886.2014.00028.9

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Research article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
OPEN-LABEL OBSERVATIONAL STUDY TO DETERMINE THE SUCCESS RATE OF FIRST CYCLE

INTRA UTERINE INSEMINATION (IUI) INVOLVING LUTEAL PHASE SUPPORT WITH ORAL
NATURAL OR SYNTHETIC PROGESTERONE
*Gopinath PM1, Desai RR2

1
Consultant, Centre for Assisted Reproduction, Sooriya Hospital, Chennai, Tamil Nadu, India
Senior Resident, Department of Pharmacology, Krishna Institute of Medical Sciences, Karad, Maharashtra, India
*Corresponding author email: pmgnath@gmail.com

ABSTRACT
IUI has been associated with a pregnancy rate of 1020% per patient, with wide variation, especially in patients
undergoing super ovulation for unexplained infertility, female age and amount of motile sperm while receiving
adequate luteal phase support. The current study was planned as an epidemiological survey to determine the
success rate of IUI when supported with oral natural or synthetic progesterone. Consecutive sixty IUI cycles in
women with unexplained infertility were evaluated for serum progesterone levels while assessing the pregnancy
rates following the insemination procedure. Patients received either oral natural micronized progesterone
sustained release or synthetic progestin (Dydrogesterone) formulation once or twice a day respectively for two to
four weeks till the next menses. Pregnancy was confirmed by urinary & biochemical investigation. Three (5%)
cases had pregnancy at the first IUI cycle. Sr. Progesterone levels were maintained at 14 ng/ml for 56 (93.3%)
patients during the mid-luteal phase. There were no side effects reported during the luteal phase administration of
oral progesterone. The pregnancy rates could be related to strategy for monofollicular development, first cycle
assessment and trend for a lower motile fraction noted in the current study.
Key words: Intrauterine Insemination, Unexplained infertility, Dydrogesterone, Oral natural micronized
progesterone sustained release
INTRODUCTION
Intrauterine insemination (IUI) is often used for the
management of infertility presenting with various
causes, including cervical factor, ovulatory
dysfunction, endometriosis, immunological causes,
male factor and unexplained infertility. IUI is
generally considered to be an intermediate step before
application of sophisticated assisted reproductive
techniques like In-vitro Fertilization (IVF-ET) or
Intracytoplasmic Sperm Injection (ICSI).
The overall success rate of IUI remains controversial
with pregnancy rates in the range of 10%-20% (per
cycle), and cumulative pregnancy rates are in the

30%-45% range1. The pregnancy or delivery rates are
often confounded by several factors, including
superovulation for unexplained infertility, female age
and amount of motile sperm while receiving adequate
luteal phase support2.
Following IUI, progesterone is usually supplemented
during the luteal phase to facilitate better
implantation of the embryo and sustenance in the
ART of pregnancy. In such cases, oral administration
of natural micronized progesterone as sustained
933
Gopinath et al.,
release (SR) preparation offers consistent tissue

concentrations for endometrial support offering once
a day dosage convenience thereby improving the
patient compliance. The slow, sustained release
kinetics of progesterone by SR formulation
minimizes drug exposure to liver metabolic enzymes
at individual time points, thereby offering sustained
action with minimal central side effects including
Drowsiness due to the active metabolite
Allopregnanolone3.
This observational study was conducted to evaluate
the success rate during the first cycle of IUI with
luteal phase support involving oral progesterone
supplementation.
MATERIALS & METHODS
by the Investigator. The stimulation protocol included

Clomiphene citrate with/without HMG injection.
Tablet Clomiphene citrate 100 mg was started from
day 2 of menstrual cycle for 5 days with Inj HMG 75
IU being administered on alternate days from day 5.
Inj Human chorionic gonadotropin (HCG) 5000 IU
was administered intramuscularly with IUI procedure
within the next 48 hrs. Following IUI procedure, on
day 22+/-1, the serum progesterone levels were
assessed following administration of either
Dydrogesterone (10 mg bid) or oral NMP sustained
release preparation (400 mg once a day at bedtime)
for four weeks. In case of missed menses, patients
were requested for urinary pregnancy test for further
confirmation by biochemical investigation.
RESULTS
This open label, prospective, observational study was

conducted in the out-patient department of Sooriya
Hospital, Chennai with approval from an Independent
Ethics Committee and written informed consent from
the patients. The study is registered with Central Trial
Registry India (CTRI/2014/02/004407). Sixty women
with unexplained infertility aged >18 to 33 years
were prospectively enrolled in this observational
study between June and November 13. Exclusion
criteria included women with a history of
Progesterone use in the past three months, tubal
insufficiency or obstruction, including Endometriosis
or Polycystic Ovarian Syndrome, psychoactive
disease or on antidepressants, smoking, myocardial
infarction, stroke, cardiovascular/circulatory or
clotting disorders; AST and / or ALT > 2.5 x ULN,
Serum creatinine > 1.5 mg/dl. Women with
Uncontrolled hypertension, hypercholesterolemia or
diabetes, Women on oral anticoagulants or prolonged
use of high doses of NSAIDs and those are
hypersensitive to natural micronized progesterone or
Dydrogesterone.
At the first visit, detailed history, physical
examination and medications of the subjects were
recorded. They were, then, subjected to IUI
procedure. Subsequent to IUI procedure, oral
progesterone,
including
natural
micronized
progesterone and Dydrogesterone supplement was
prescribed for 4 weeks. Dose administered was as per
prescribing information sheet information for
respective formulations. IUI was conducted using
natural or stimulation protocol as deemed appropriate
Prospectively 60 patients with unexplained infertility

were observed. The baseline demographics are
presented in Table 1.
Table 1: Baseline demographics of 60 patients
Characteristics
N= 60
Mean age
28.3 yrs
Mean Height
160.2 cms
Mean Weight
62.25 kg
Obstetric History (Mean)
G
0.2
P
0.08
A
0.1
L
0.05
Menstrual Cycle
< 3 days
1
3 days
38
> 3 days
21
The serum progesterone levels were calculated at Day
23 and are presented in Table 2 and Fig. 1
Fig. 1: Serum Progesterone levels of 60 patients
934
Gopinath et al.,
Table 2: Serum Progesterone levels of 60 patients

Sr. Progesterone levels
Patients (%)
10 ng/ml
96.7
14 ng/ml
93.3
Comparison of Serum Progesterone levels in Natural
Progesterone and Dydrogesterone presented in and
Fig. 2. Table 3 and Table 4 show Serum Progesterone
levels in Natural and artificial progesterone
respectively.
Table 3: Serum Progesterone levels in Natural
progesterone
Serum Progesterone
Natural Progesterone
Levels
(n= 30)
10 ng/ml
93.3 %
14 ng/ml
90 %
Table 4: Serum Progesterone levels in synthetic
progesterone
Serum Progesterone
Dydrogesterone
Levels
(n= 30)
100 %
10 ng/ml
14 ng/ml
96.7 %
Fig 2: Comparison of Serum Progesterone levels

in Natural progesterone and Dydrogesterone
The mean serum progesterone achieved in the both
groups were 46.2 and 51.7 ng/ml for oral NMP
sustained release preparation and Dydrogesterone
respectively, with no significant difference between
the levels achieved (p>0.05). The overall pregnancy
rate was 5% (3/60). Out of these 2 pregnancies were
reported in patients who were administered natural
micronized progesterone and 1 pregnancy was
reported in patients with Dydrogesterone.
DISCUSSION
For the right candidate, IUI is usually a successful,
easy, and a safe infertility treatment option preceded
by natural or stimulation protocol. Multiple factors
need to be assessed when deciding about the choice
of treatment. The patient's age, the duration of
infertility, ovarian function, etiology of infertility,
semen characteristics, the status of the tubes, and the
presence of other gynecologic or medical problems
all have to be considered. The two most important
benefits of IUI are the simplicity of the treatment and
the low cost4. The reported pregnancy rates per cycle
range from 8 to 22%. Several prognostic factors have
been incriminated in determining the success rate of
IUI procedure and include factors like patients
obstetric history, duration or type of infertility,
presence of stimulation protocol, follicular
monitoring, endometrial thickness, and timing of IUI
and semen parameters like post wash motility,
morphology and total motile fraction
The current study was conducted as an open-label,
observational, surveillance study to assess the success
rate of IUI procedure for the first cycle while
determining the concomitant prognostic or
confounding variables including serum progesterone
levels achieved during the Luteal phase with oral
supplementation
We obtained a pregnancy rate for the first cycle as
5% (3/60). No major congenital anomaly was
recorded nor were there any multiple pregnancies.
Several factors could probably explain lower
pregnancy rates in our setting, including
monofollicular development with Natural cycle, first
cycle assessment and trend for a lower motile
fraction. In recommending treatment options,
clinicians usually weigh several factors, including
treatment cost, feasibility and compliance of patients
to treatment strategies or monitoring protocols and
patient profile. Natural IUI offers complimentary yet
comprehensive evidence of ovarian hyperstimulation
and high-order multiple pregnancies avoidance. A
combined analysis of the literature on unexplained
infertility yielded estimated pregnancy rates of 4
percent per cycle for Natural IUI cycles, 8 per cent
per cycle for superovulation cycles, and 18 per cent
per cycle for Stimulated IUI cycles. Although to the
best of our knowledge, there have been no previous
large-scale, randomized comparisons between
935
Gopinath et al.,
Natural and stimulated IUI cycles, a randomized trial

conducted highlighted significantly higher birth rates
(5.6 times higher) with superovulation and
intrauterine insemination compared with no treatment
among women with minimal or mild endometriosis5,6.
The current study evaluated the success rate for the
first cycle of IUI since available literature suggests
relatively constant rates for the first three to seven
cycles7, 8.
Similarly, during the LPS, serum progesterone levels
to achieve for the continued sustenance of pregnancy
are ideally 14 ng/ml9. Around 93.3% of the patients
achieved these levels with no significant differences
between the groups receiving natural or synthetic
progesterone i.e. Dydrogesterone. Oral natural
micronized progesterone as 400 mg sustained release
formulation was administered for once a day
administered at bedtime. The formulation was well
tolerated with none of the patients reporting central
side effects, including drowsiness the next day
This study represents one of the first clinical trial to
evaluate the success rate of IUI procedure using oral
natural progesterone as Luteal phase support after
Pouly et al (1996)10 reported 29.9% PR with IVF-ET
following
oral
micronized
progesterone
administration of 300 mg/day in divided dosages.
The study was limited was a small sample size that
was observational in nature and needs to be explored
further within a larger, randomized clinical trial
settings to further evaluate the likely confounding
variables that may explain the success rate of IUI
procedure especially the natural cycles without
stimulation protocol. The study was further
exploratory in nature trying to determine also the
close relationship of serum progesterone levels
achieved with oral progesterone supplement
administered as LPS and may need to be again
evaluated for Cumulative success or pregnancy rate
for confirmation of this association
CONCLUSION
Natural IUI represents an important treatment option
for women with unexplained infertility, especially
when female age is <35 years. The Low pregnancy
rate observed during the first cycle of evaluation may
not be related with therapeutic levels achieved with
oral natural or synthetic progesterone supplements
Acknowledgement: The authors would like to

acknowledge Dr. K. Krishnaprasad and Dr. Anoop
Hajare for the study analysis support.
Conflict of Interest None
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Sanguinet P, Copin H. Predictive factors for
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menopausal gonadotropin with intrauterine
insemination in the treatment of infertility.
Obstetrics & Gynecology. 1993; 82(5):780-6.
9. http://www.mhra.gov.uk/home/groups/plp/documents/websiteresources/con2033921.pdf
10. Pouly JL, Bassil S, Frydman R, Hedon B,
Nicollet B, Prada Y et al. Endocrinology: Luteal
support after in-vitro fertilization: Crinone 8%, a
sustained release vaginal progesterone gel, versus
Utrogestan, an oral micronized progesterone.
Human Reproduction. 1996;11(10):2085-9.
936
Gopinath et al.,
DOI: 10.5958/2319-5886.2014.00029.0

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
Coden: IJMRHS
th
Research article
Copyright @2014
ISSN: 2319-5886
IS POSTOPERATIVE HYPOCALCAEMIA A LIFE THREATENING COMPLICATION FOLLOWING

THYROIDECTOMIES? A PROSPECTIVE STUDY IN THE RURAL POPULATION OF KANCHIPURAM
*SundarPrakash S1, Chandra Prabha J2

1
Assistant Professor, Department of General Surgery, Meenakshi Medical College and Research Institute,
Kanchipuram
2
Final year PG, Department of Physiology, Department of General Surgery, Meenakshi Medical College and
Research Institute, Kanchipuram.
*Corresponding author email: drssp1967@gmail.com
ABSTRACT
Hypocalcaemia is one of the commonest complications that can occur after thyroidectomies. Permanent
hypocalcaemia following thyroidectomy causes considerable morbidity. This prospective observational study aims
to define the factors likely to predict hypocalcaemia following thyroidectomy. Materials and Methods: 59 Patients
who were subjected to all types of thyroidectomy during February 2012 to January 2014 were studied
retrospectively. Preoperative and postoperative Serum Calcium was estimated in all the patients. Results: The
incidence of hypocalcaemia increased with increasing age groups. Out of 59 cases, 19 patients developed temporary
hypocalcaemia postoperatively (32%). None of the patient had permanent hypocalcaemia. Of these cases 5% had
hemithyroidectomy, 26% sub total thyroidectomy, 67% near total thyroidectomy, 64%total thyroidectomy and 67%
completion thyroidectomy. Conclusion: Hypocalcaemia is a serious postoperative complication of thyroidectomies.
It should be promptly diagnosed and treated early. All types of thyroidectomies should be investigated for
hypocalcaemia. Care should be taken in exploring the parathyroid glands intraoperatively is an excellent method to
prevent permanent hypocalcaemia.
Key words: Hypocalcaemia, Thyroidectomy, Serum Calcium, Parathyroids.
INTRODUCTION
Thyroidectomy is one of the commonest surgeries
done in India. The two most common complications
of thyroid surgeries are recurrent laryngeal nerve
injury and hypocalcaemia. These and other major
complications typically occur in less than 5% of the
case.
Thedor
Kocher
reported
first
100
thyroidectomies in 1883 and noted the presence of
tetany in many cases. William Halsted (1852-1922)
was one of the first surgeons to advocate meticulous
surgical techniques to prevent injuries to parathyroid
glands and so greatly contributed to the prevention of

this serious complication which together with
bleeding and laryngeal nerve injury had made early
thyroid surgeries so dangerous. In the 21st century,
thyroidectomy has become safe and effective with
improved outcomes and minimal morbidity. This is in
part due to the awareness of the anatomical
relationship of the parathyroid gland to the thyroid,
which is important in preventing postoperative
hypocalcaemia. Nonetheless, the incidence of
937
Sundar Prakash et al.,
hypocalcaemia following thyroidectomy remains

significantly high in the range of 1.6% to 50%, with
permanent hypocalcaemia occurring in 1.5% to 4% of
the cases. According to a study by Thomusch1et al,
regardless of a surgeons experience, an incidental
parathyroid gland features occasionally in the
pathology reports of thyroid specimens. The postoperative hypocalcaemia is frequently observed
within 2-5 days after total or subtotal thyroidectomy,
requiring exogenous replacement therapy to alleviate
the clinical symptoms. We selected this study as we
came across a few number of cases in the urban health
center where we did the study. Many studies were
done on this topic to stress the importance of
postoperative hypocalcaemia in thyroidectomy cases.
In a study by Herranzetal2showed the incidence and
management of postoperative hypocalcaemia in total
thyroidectomies. Our study was done in all types of
thyroidectomies as post-operative hypocalcaemia can
occur in any type of thyroidectomy.
The exact pathogenesis of hypocalcaemia in
postoperative patients is difficult to explain. It is
however, varies in different pathological conditions of
thyroid gland and the type of surgical intervention.
Graves disease, malignancy, total thyroidectomy and
parathyroid gland ischaemia/injury are the main
causes of lowering serum calcium concentration.
Hypoparathyroidism is an additional event whereas
hypocalcaemia is relatively common after total
thyroidectomy.According to a study by Sokouti Ma et
al3, hypocalcaemia is a common and usually transient
but in some cases can become permanent due to loss
of functioning parathyroid gland after total
thyroidectomies. This can cause significant
discomfort in affected patients who will eventually
need to take oral calcium and Vitamin D for a long
time.
To minimize parathyroid injury, an attempt to look for
all the parathyroid glands and preserve their blood
supply was done during the operation. However, it is
difficult to find all parathyroid glands and to preserve
these identified parathyroid glands due to the high
probability of inflicting damage to their blood supply
during the search process and dissection. Also, the
extent of thyroidectomy and node dissection increases
the likelihood of damaging the blood supply of the
parathyroid glands. Intraoperative extensive handling,
bleeding, distorted anatomy, fibrosis, adhesions and
even surgeons experience are related to parathyroid

injuries.
In a study by Rajeev Parameswaran4, parathyroid auto
transplantation can reduce the incidence of
hypocalcaemia, when unintentionally removed or
devascularised parathyroid glands were found intraoperatively. Sometimes, parathyroid gland may be
found within the postoperative specimen, when it was
unknowingly removed with the thyroid or lymph node
during the operation.
Aims and objectives
The aims of our study were
1. To identify the incidence of parathyroid gland
injuries.
2. To analyze the reasons for injuries.
3. To analyze the serum calcium level
postoperatively.
This prospective study was carried out from February
2012 to January 2014 in Meenakshi Medical College
and Research Institute, Kanchipuram. After obtaining
Ethical Committee clearance and consent from the
patients, 59 cases of goiters who underwent
thyroidectomies in our hospital were studied.
Inclusion criteria: 1. All thyroidectomise 2. All age
groups 3. Both genders 4. Euthyroid patients
Exclusion criteria: 1. Patients with chemotherapy
and radiotherapy 2. Recurrent thyroid surgeries 3.
Cardiac patients
As this study was performed in different units in the
Departments of General Surgery and ENT, patients
were operated by different surgeons performing or not
preferring the active identification of the parathyroid
glands to avoid injury to parathyroid glands. Along
with a brief history and clinical examination and
routine laboratory investigations, Ultrasonogram of
thyroid, Fine Needle Aspiration Cytology (FNAC)
were performed in all the patients, Baseline total
serum calcium was done in all the patients on the
preoperative day, second and seventh postoperative
days. Normal range for total serum calcium 8.5 to
10.5 mg/dl and ionized serum calcium 4.5 to 5.6
mg/dl were considered in all the cases (Davidsons
Principles and Practice of Medicine).Depending on
the extent of resection of thyroid tissue, surgery was
categorized as hemi, subtotal, near total or total
thyroidectomy. Identification and preservation of
938
1. The preserved type a grossly tan parathyroid

gland with intact blood supply.
2. The color changed type a grossly congested and
having a low chance of survival.
3. The auto-transplantation type an isolated
parathyroid
gland
implanted
into
the
sternocleidomastoid muscle.
4. The removed type a parathyroid gland being
removed with the thyroid gland due to its proximity to
the cancer or were incidentally found in the biopsy
report.
5. The non-identified type - parathyroid gland not
found during operation.
Successful preservation of parathyroid glands was
considered for the first type and the remaining were
considered non-preservation of parathyroid gland.
Data derived in this study was in the form of mean or
percentages. In one place Fishers Exact Test was
applied to know the significance of the identification
of parathyroid glands intra-operatively.
RESULTS
In this study, 59 cases with goitres that underwent
thyroid surgeries in our hospital were studied.
Age distribution in our study, the maximum age
recorded was 69 years and minimum age recorded
was 21 years. The number of patients who developed
hypocalcaemia in our study was 19. The following
Graph 1 shows the relationship between age and
hypocalcaemia.
20
NUMBER OF
PATIENTS
parathyroid glands were done. Reasons for nonidentifications or sacrifice of parathyroid glands was
surgeons choice, adhesions, distorted anatomy,
bleeding or fibrosis. In this study, we also studied the
experience of the operating surgeons playing a role in
outcome of thyroid surgery and incidence of
parathyroid gland injuries.
The following symptoms of hypocalcaemia were
observed
1. Oral, perioral or acral paraesthesia
2. Carpopedal spasm
3. Tetany
4. Hyperactive tendon reflexes
5. Laryngospasm
6. ECG changes
Postoperative total serum calcium was measured after
48 hours and on 7th day or at the time of discharge for
biochemical evidence of early and delayed onset
hypocalcaemia as the evidence of parathyroid gland
injury either in the form of devascularisation or its
removal. Iodized calcium levels were done in all cases
that had low total serum calcium levels or had signs
and symptoms of hypocalcaemia and in cases where
serum calcium level was low but patients were
asymptomatic. Patients developing symptoms of
hypocalcaemia were asked to continue calcium and
vitamin D supplements for additional seven days after
discharge. Patients were asked for follow up after 3
months or earlier if symptoms of hypocalcaemia
occur. None of our patients came with symptoms of
hypocalcaemia. These patients were assumed to have
normocalcaemia both clinically and biochemically,
therefore calcium levels were not repeated in these
patients.Measurement of postoperative serum
parathormone (PTH) as the evidence of parathyroid
gland injury was not taken into account due to
inaccessibility and high cost of this investigation at
our centre because majority of our patients were from
poor socio-economic strata.
Then patients were followed for histopathology report
(HPR) to see for accidental removal of parathyroid
glands as reason for hypocalcaemia. In the rest of all
cases of hypocalcaemias, possibility of parathyroid
gland
injuries
were
considered
due
to
devascularisation or ischemia or direct trauma to
parathyroid glands rather than its complete removal.
The handling of the parathyroid glands during
operation was divided into 5 types:
15
No of patients
10
5
28%
12%
46%
50%
67%
No of patients
who developed
hypocalcaemia
AGE GROUP
Fig-1: Relationship between age and the number of

patients who developed hypocalcaemia.
Out of 19 cases who developed symptoms of
hypocalcaemia in 48 hours postoperatively, 16 cases
had low total and ionized serum calcium and 3 cases
had normal total serum calcium but low iodized serum
calcium level. Out of remaining 40 cases, 3 cases
found to have low total serum calcium level but
normal iodized calcium level.
939
Mean total serum calcium
9.4
9.2
Mean of
total serum
calcium
level
9
8.8
8.6
8.4
8.2
Time of test
Fig 2: Mean total serum calcium levels

Diagnosis and hypocalcaemia, In this study all 59
patients were in euthyroid state. 19 patients had
hypocalcaemia (32%). The table 1 shows the different
diagnosis and its relationship to hypocalcaemia.
Table 1: Relationship between diagnosis and
patients who developed hypocalcaemia
Diagnosis
No. of
No of patients %
patients developed
hypocalcaemia
Colloid goitre
16
03
19
Solitary Nodule
09
01
11
(adenoma)
MNG
10
04
40
Papillary
12
07
58
Carcinoma
Follicular
02
01
50
carcinoma
Hashimotos
10
03
30
thyroiditis
Table 2: Patients who developed hypocalcaemia
after different type of operation
Type of
operation
Number
of
patients
Hemithyroidectomy
Subtotal
thyroidectomy
Near-total
thyroidectomy
Total
thyroidectomy
Completion
thyroidectomy
Total
20
Number of
patients who
developed
hypocalcaemia
01
19
05
26
03
02
67
14
09
64
03
02
67
59
19
05
Table 2 shows the relationship between type of

operation done and the number of patients who
developed hypocalcaemia. All the patients who

developed hypocalcaemia were temporary only. On
the 7th postoperative day all patients reverted to
normocalcaemia.
Identification of parathyroid glands
In our study, identification of parathyroid glands was
done according to the type of surgery done, i.e. all 4
parathyroid glands were attempted to identify in all
thyroidectomies, but parathyroid glands of only
respective sides were identified and preserved in case
of right or left hemithyroidectomy and completion
thyroidectomy. Out of 59 cases all parathyroid glands
with respect to operative procedure were identified in
39 cases.
Fig 3: Left superior thyroid seen during subtotal

thyroidectomy
Of these 39 cases, in 36 cases all parathyroid glands
with respect to operative procedure were attempted to
identify and preserve. In 2 cases parathyroid glands
were identified, but 1 was sacrificed in each due to
proximity to the tumor. In 1 case, accidentally
removed parathyroid gland was identified on table and
was
autotransplanted
in
ipsilateral
sternocleidomastoid.
Table 3: Hypocalcaemia when parathyroid gland is
seen
Parathyroid
gland
Seen
Temporary
hypocalcae
mia
Seen in
HPR
With
hypocalc
aemia
Seen in
HPR
Without
hypocal
caemia
All
preserved
Sacrificed
Autotranspl
anted
Total
36
2
1
1
0
0
0
0
0
39
940
Number of patients
35
79%
55%
30
25
Hypocalcaem
ia present
20
15
10
21%
45%
Hypocalcaem
ia absent
5
0
Seen
Not seen
Fig 4: Significance of identifying parathyroid glands
Reasons for hypocalcaemia

In our study, intraoperative identification of
parathyroid glands carries 0.677 times risk of
developing hypocalcaemia. But after the application
of Fischers Exact Test (p value = 0.3), this difference
is found to be statistically insignificant. Graph 4
shows the comparison of identification of parathyroid
gland in HPR and hypocalcaemia
Number of patients
Out of 39 cases where parathyroid glands were seen

and identified, 8 cases developed hypocalcaemia
(21%).
In remaining 20 cases, parathyroid glands were not
seen. Out of which in 16 cases parathyroid glands
were not seen due to Surgeons choice; 2 cases due
bleeding and in 2 cases due to fibrosis and distorted
anatomy.
Table 4: Hypocalcaemia when parathyroid gland is
not seen
Parathyro No Temporary Seen in Seen in
id Gland
see hypocalcae HPR
HPR
n
mia
With
Without
hypocal hypocalc
caemia aemia
Surgeons 16
8
2
1
Choice
Bleeding
2
1
1
0
Fibrosis/
2
2
0
0
distorted
anatomy
Total
20
11
3
1
In 20 cases were parathyroid glands were not seen
during surgery 11 developed hypocalcaemia (55%).
The following Graph 3explains the significance of
identifying the parathyroid glands during surgery.
60
50
40
30
20
10
0
Number of
patients
Hypocalca
emia
Parathyroid
gland in HPR
No
Parathyroid
gland in HPR
HPR Report
Fig 5: Parathyroid gland in HPR and
hypocalcaemia
Out of 19 cases developing hypocalcaemia, 4 cases
were considered due to accidental removal as seen in
histopathology report and 15 cases were probably due
to devascularisation or injury to parathyroid glands.
DISCUSSION
Inadvertent parathyroid excision and hypocalcaemia
are well recognized complications of thyroid surgery.
The exact pathogenesis of hypocalcaemia in
postoperative patients is difficult to explain. Graves
disease, malignancy, total thyroidectomy and
parathyroid gland ischemia / injury are the main
causes of lowering serum calcium concentration.
In a study by Baldassarre R L et al5, the incidence of
hypocalcaemia increases with age group. In our study
also the incidence of hypocalcaemia was more in the
later age group, almost 50% in cases between 40 and
70 years of age group.
Amongst 59 patients studied, preoperatively all were
within normal limits. Postoperatively 19 patients
(32%) developed only temporary hypocalcaemia
which all reverted back to normal on the 7th
postoperative day owing to oral calcium and Vitamin
D supplements for a short period. None of our patients
developed permanent hypocalcaemia. In a study by
Rajnikanthetal6 in 364 patients showed 28% of
patients developing hypocalcaemia. This is on par
with our study. In another study by PfleidererA Get
al7 43% of patients developed temporary
hypocalcaemia and 5% developed permanent
hypocalcaemia. This study had high incidence when
compared to ours.
In a study by Moore et al8 confirmed that iodized
calcium accounts for the biologically active form of
941
serum calcium and subsequently demonstrated the

crucial role of iodized calcium in the calcium
homeostasis of healthy individuals and patients with
parathyroid abnormalities. In our study also out of 19
cases who developed symptoms of hypocalcaemia 48
hrs postoperatively, 16 patients had low total and
iodized calcium levels and 3 cases had normal serum
calcium and low iodized calcium levels. Out of the
remaining 40 cases, 3 cases had low total calcium and
normal iodized calcium levels.
In our study, out of 59 patients, maximum number of
patients operated was colloid goitre, MNG and
Papillary carcinoma of thyroid accounting for 64% of
cases. In our study, the number of malignant cases
was24% and benign cases were 76%. In a study by
Rajnikanthetal6, 59% were benign and 41% were
malignant.
In a study by HanyAlyetal9, the incidence of
postoperative hypocalcaemia was higher in malignant
cases (25%) and in toxic goitre (11%), while in MNG
it was 4% and 10% in Hashimotos thyroiditis. In our
study 57% of malignant cases had hypocalcaemia and
only 24% of benign cases suffered from
hypocalcaemia. This is owing to other factors like
age, bleeding, adhesions or a distorted anatomy.
In our study, maximum number of patients underwent
hemithyroidectomy (34%) and minimum number of
patients underwent near total and completion
thyroidectomies (each 5%); subtotal thyroidectomy
(32%); total thyroidectomy (24%). In our study
hypocalcaemia was seen in 67% of patients
undergoing completion thyroidectomy; 67% in near
total thyroidectomy; 26% in subtotal thyroidectomy;
64% in total thyroidectomy and 5% in
hemithyroidectomy. In a study by Akram Rajput et
al10, transient hypocalcaemia was seen in 54% of
patients undergoing total thyroidectomy; 50% with
completion thyroidectomy; 29% with subtotal
thyroidectomy and 23% with hemithyroidectomy. In
our study only 5% of patients developed
hypoglycaemia after hemithyroidectomy. In a study
by PfleidererA G et al7, completion thyroidectomy
was performed in patients found to have a malignancy
in the thyroid lobe previously removed. Patients
having a completion thyroidectomy appeared to be
less likely to develop hypocalcaemia. According to
them this two stage procedure may have resulted in
lower incidence of hypocalcaemia since the
parathyroids on the side of the previous lobectomy

may have had time to recover their function prior to
the completion thyroidectomy.
Differences in outcome after thyroidectomy in our
study could be due to our centre being less in volume
for neck surgeries; surgeons with less experience in
neck surgeries and no new techniques are employed.
Out of 39 patients where parathyroid glands were
attempted to identify and preserve, 8 patients
developed hypocalcaemia (21%). In only one case the
parathyroid gland was identified by the pathologist.
Out of 2 cases where 1 parathyroid gland was
sacrificed due to proximity to tumour mass. 1 patient
developed hypocalcaemia but none showed
parathyroid gland in the histopathology report. This
indicates that there is a possibility of parathyroid
gland being misidentified by the surgeon. So the
hypocalcaemia developed in this case could be due to
devascularisation of parathyroid glands.
In 1 case parathyroid gland was accidentally removed
but
was
auto
transplanted
in
ipsilateral
sternocleidomastoid. This patient did not develop
hypocalcaemia. This proves that auto transplantation
is an important procedure if parathyroid gland was
identified after accidental removal.
Out of 16 cases where parathyroid glands were not
seen
by
surgeons
choice,
8
developed
hypocalcaemia. In 2 cases parathyroid glands were
not seen due to bleeding and one developed
hypocalcaemia. In another 2 cases parathyroid glands
were not seen due to distorted anatomy and fibrosis
and both developed hypocalcaemia. This is a clear
indicator of the importance of parathyroid gland
identification during surgery.
In our study, intraoperative identification of
parathyroid glands carries 0.677 times risk of
developing hypocalcaemia postoperatively. But after
the application of Fischers Exact Test (p value = 0.3)
this difference is found to be statistically insignificant.
This may be due to the smaller sample size.
In our study, in 5 cases parathyroid glands were seen
in histopathology report. So the incidence of
inadvertent removal of parathyroid gland in our study
was 8%. In a study by Rajnikanthetal6, the incidence
of in advertent removal of parathyroid gland was
13%. In another study by Gamal Ahmed Khairyetal11it
was 16%.
942
The role of identifying parathyroid glands in the

prevention of hypocalcaemia has been debated in
literature. Rimpl and Wahl et12however advocated that
identification of at least three parathyroid glands to
avoid hypocalcaemia. Walsh et al13 found no
association with the number of parathyroid glands
identified. On the other hand, a study by PfleidererA
Get al7 suggested that the identification of the
parathyroid glands was not a safeguard and in fact,
increased the risk of hypocalcaemia probably related
to either direct trauma or disruption of the blood
supply due to surgical manipulation. But our study
clearly indicates that identification of parathyroid
glands were important to avoid postoperative
hypocalcaemia.
Thomusch et al1 emphasized that at least 2 parathyroid
glands should be identified and preserved to prevent
hypoparathyroidism and they found that the additional
benefit was evident by having more than two
identified and preserved parathyroid glands. Our study
also showed the same results.
The location of parathyroid glands may vary but
unnecessary dissection to locate them should not be
carried out as it may be more hazardous than not
seeing them. We also did the same and the results
were much better.
In general, the parathyroid injury should be avoided
intraoperatively and this depends upon so many
factors like age of the patient, thyroid status,
experience of the surgeon, identification of
parathyroid glands intraoperatively and so on.
CONCLUSION
In our study hypocalcaemia secondary to parathyroid
gland injuries were due to devascularisation (79%)
and rest of the patients (21%) were probably due to
accidental removal of parathyroid glands.
Parathyroid injuries were more when parathyroid
glands were not searched actively due to bleeding,
distorted anatomy or fibrosis.
Identification and preservation of parathyroid glands
during thyroidectomy has less chances of developing
hypocalcaemia postoperatively.
The incidence of developing postoperative
hypocalcaemia in all thyroid surgeries was 32%. The
incidence of hypocalcaemia was 21% when
parathyroid glands were attempted to identify and see
intraoperatively.
Incidence of hypocalcaemia was 55% when

parathyroid glands were not seen intraoperatively.
Iodized calcium levels rather than the total serum
calcium levels are responsible for developing or not
developing symptoms of hypocalcaemia.
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Brumund, and Michael Bouvet, Predictors of
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944
DOI: 10.5958/2319-5886.2014.00030.7

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
Coden: IJMRHS
th
Research article
Copyright @2014
ISSN: 2319-5886
FUNCTIONAL OUTCOME WITH BIPOLAR HEMIARTHROPLASTY AS AGAINST TOTAL HIP

ARTHROPLASTY IN INTRACAPSULAR FRACTURE NECK FEMUR
*Tuteja Sanesh V1, Mansukhani Sameer A2, Mukhi Shyamlal R3
1
Senior Resident, Department of Orthopaedics, Dr. DY Patil Medical College and Hospital, Nerul, Navi Mumbai
Assistant Professor, Department of Orthopaedics, Dr. DY Patil Medical College and Hospital, Nerul, Navi
Mumbai
3
Professor, Department of Orthopaedics, K. J Somaiya Medical College and Hospital, Sion, Mumbai
2
*Corresponding author email: stuteja@hotmail.com

ABSTRACT
Rationale: Internal fixation is considered a reliable method for an undisplaced intracapsular fracture and also for
displaced intracapsular fractures in young patients. A unipolar or bipolar hemiarthroplasty is preferred for these
fractures in elderly patients with low functional demands. However, controversy exists regarding the choice of
prosthesis in patients with displaced intracapsular femoral neck fractures in relatively young and active adults.
Design: 45 patients with displaced intracapsular femur neck were randomized to undergo a Total hip arthroplasty
or a Bipolar hemiarthroplasty. The outcome was assessed with the use of the Harris hip score and the Mobility
score of Parker and Palmer. Results: The mean age of the patients was 63.54 years. The mean blood loss was
higher in Group 2 (THA) [545.24 134. 07 ml] as against Group 1 (BH) [443.75 88.84 ml] (p= 0.004). The
mean duration of surgery in Group 2 [121.90 20. 40 mins] was significantly higher as compared to that in Group
1 (BH) [87.50 10. 52 mins]. No significant difference was observed in the mean postoperative Mobility Score at
the end of 6 months amongst the 2 groups. The Harris Hip Score at the end of 6 months was Excellent for 9
patients, Good for 27 patients, Fair for 6 patients and Poor for 2 patients. 40 patients were able to do their daily
activities and 4 were unable to do so owing to their general medical condition. Conclusion: Total Hip
Arthroplasty offers better functional outcome in early follow-up and can be used for treating for these fractures in
this age group.
Key words: Bipolar Hemiarthroplasty, Total Hip Arthroplasty, Fracture Neck Femur, Proximal Femoral Fracture.
INTRODUCTION
Proximal femoral fractures are common orthopaedic
injuries in older patients; typically occurring in the
neck, the intertrochanteric and sub trochanteric
regions. They impair mobility, cause excessive
morbidity, mortality, loss of independence and also
account for more than two-thirds of all hospital days
due to fracture. 1Displaced, unstable fractures of the
femoral neck generally represent an indication for
early surgical intervention. The surgical treatment for
displaced intracapsular femoral neck fractures in

relatively young and active has always been
controversial.2, 3 Established treatment options include
internal fixation, hemiarthroplasty, where the head of
the femur is replaced with a prosthetic implant or
total hip replacement, which essentially includes,
replacing the femoral head as well as the acetabulum
with a prosthetic implant.
945
Tuteja SV et al.,
The proponents of arthroplasty suggest that replacing

the femoral head eliminates the risk of revision
surgery due to serious complications such as head
necrosis or nonunion.4 There appears to be a
consensus that unipolar or bipolar hemiarthroplasty is
the preferred treatment for displaced intracapsular
fractures in elderly patients with low functional
demands. However, the choice of prosthesis for the
joint replacement in patients with displaced intracapsular femoral neck fractures, especially in
relatively young and active adults have been a matter
of debate. 5
Well recognized goals of surgical treatment are
immediate pain relief, early mobilization and
maintenance of independent living. In addition to
these prerequisites, the ideal implant must be
associated with a low risk of surgical complications
and subsequent revision. At best, patients should not
be hampered by the treated hip during their remaining
lifetime. 6, 7
The aim of this study was to compare the clinical
outcome in elderly patients undergoing Primary Total
Hip Arthroplasty as against Bipolar Hemiarthroplasty
in intracapsular fracture neck femur. The primary
outcome measured was Functional outcome. The
revision rate of surgery, mortality and complication
rate were secondary outcomes.
The study was carried out in a tertiary institution with
well established Orthopaedic and Anesthesia set up.
The Institutional Ethics Committee approval and
written informed consent were obtained for all the
participants in the study.
Forty five patients with displaced intracapsular femur
neck undergoing replacement arthroplasty were
randomized
to
receive
either
a
bipolar
hemiarthroplasty or a Total Hip Arthroplasty and
were followed up at a period of 1 month from the day
of discharge, monthly for the first 3 months and every
3 monthly, then onwards till the end of the study.
Inclusion Criteria:
a) Patients above the age of 50 years with a
displaced intracapsular fracture neck of Femur.
Exclusion Criteria:
a) Suspected pathological fracture or metastatic
disease
b) Bedridden, barely mobile patients or one with
significant dementia.
c) A patient who refused surgery.

Each patient was evaluated preoperatively and scored
on their mobility prior to the injury based on the
Mobility Score of Parker and Palmer. All patients
were given Bucks skin traction8. The average
duration between the occurrence of fracture and day
of operation was noted preoperatively. All patients
were operated under Regional combined spinal
epidural anesthesia and were operated using the
posterior approach to the hip. Prophylactic antibiotics
were administered intravenously one hour prior to
surgery.
Intraoperative parameters measured were:
a) Total duration of surgery,
b) Amount of blood loss
c) Units of blood transfused intraoperatively.
d) Any intraoperative complications, including
neurovascular injury, hemorrhage, fractures and
complications of cementing
e) Complications due to morbid conditions or death
were noted.
All patients were started on static quadriceps exercises
and foot and ankle mobilization exercises on the 2nd
post operative day and were made to sit by edge of the
bed and dynamic knee mobilization was started by 3rd
day post operative. The patients were made to walk
with the help of walker starting 3rd day post
operatively depending on the pain relief and comfort
of the patient. Postoperative complication namely
infection, bedsore, thromboembolism, dislocation,
urinary tract infection, implant failure or loosening,
septicemia or any complication due to associated
morbid condition were treated accordingly before
discharging the patients from the hospital and the total
duration of hospitalization was noted.
The patients were followed up every month for the
first 3 months and then every 3 months from then on.
During each visit, the patient was assessed clinical by
noting:(a) pain relief complete /partial /no relief,
(b) shortening in cm, (c)standing unable /partial
weight bearing /full weight bearing, (d) walking
unable to walk/ with walker/ with cane, unaided:
inside house /outside house /go shopping, visit
relative, (e) distance walked unlimited /inside house
/bed and chair, (f) climbing stairs without using
railing /using railing /unable to climb, (g) wear
footwear ease /difficulty /unable to wear, (h) sitting
on a chair comfortable /not possible, (i) range of
movement, (j) deformity (k) able to do routine work
946
Tuteja SV et al.,
yes /no, (l) Overall satisfaction with surgery

completely satisfied /partially satisfied /not satisfied
and radiological by obtaining an antero-posterior
radiograph of Pelvis with both hips. Functional
Outcome was measured at final follow up using
HARRIS HIP SCORE9and Mobility Score of
PARKER and PALMER.10
RESULTS
Statistical Analysis: The parameters were tested for
statistical significance depending on their distribution
either by a Students t-test or a Mann-Whitney U test.
Dichotomous variables were analyzed using a chisquared test or Fishers exact test as appropriate. The
paired T-test was used to assess the difference in
preoperative and postoperative difference in the
Mobility score of Parker and Plamer. A p-value <
0.05 considered statistically significant.
The study included 24 patients treated by Bipolar
Hemiarthroplasty (Group 1) and 21 patients treated
by a Total Hip arthroplasty (Group 2). The mean
follow up for Group 1 (BH) was 10.17 months (6
21 months), for Group 2 (THA) was 9.7 months (6
22 months). No patient was lost to follow up.
Table 1: Demographic and pre operative data
Parameter
Bipolar
THA
P
(n =24)
(n = 21)
value
63.54
63.52 (50 0.995+
Mean age
(50 84) 82)
(range)
8 : 16
8 : 13
0.491+
Sex - M:F
7 : 14
0.205+
Side right : left 12: 12
Type of injury
24
21
Low velocity
0
0
High velocity
2.00.62 1.8 0.68 0.228+
ASA Grading
4
7
1
15
11
2
5
3
3
7.11.57 6.92.03 0.693+
Pre op Mobilty
Score of Parker
and Palmer +
S.D
2.01.12 1.80.85 0.734+
Trauma
surgery
interval + S.D
+ = not significant * = significant (p-value < 0.05)
All patients in the 2 groups were comparable to each
other in terms of their mean age, sex ratio, the side of
the limb involved, Pre operative Mobility Score of

Parker and Palmer and Trauma Surgery interval.
Table 2: Intraoperative data
Parameter
Mean
intraoperative
time (minutes) +
S.D
Mean blood loss
(ml) +S.D
Mean blood
transfusion in ml
+ S.D
Mean
hospitalization
time (days) + S.D
Bipolar
(n = 24)
87.50
10.52
THA (n
=21)
+
121.90
20.401
P
value
+
0.001*
443.75 +
88.84
545.24
+134.075
481.25 +
248.82
516.66
210.55
0.611+
17.33
5.378
16.71
4.326
0.670+
0.004*

The mean blood loss was higher in Group 2 (THA)
[545.24 134. 07 ml] as against Group 1 (BH)
[443.75 88.84 ml] (p= 0.004). The mean duration of
surgery in Group 2 [121.90 20. 40 mins] was
significantly higher as compared to that in Group 1
(BH) [87.50 10. 52 mins].
The total volume of blood transfused (in ml) and the
total duration of hospital stay were comparable
amongst the 2 groups. There were no intraoperative
complications observed. 1 female patient died of
pulmonary embolism on the 2nd postoperative day in
Group 1 (BH) which could be attributed to
cementing.
Table 3: Complications
Complications
A) EARLY
1. Bed sore
2. UTI
3. Thrombophlebitis
4. Foot drop
5. Pulmonary
embolism
6. Septicemia
7. Wound infection
B) LATE *
1. Hip dislocation
2. MORTALITY
3. IMPLANT
LOOSENING (at final
follow up)
4. REOPERATION
Bipolar
(n = 24)
THA
(n = 21)
P
value
0.407+
0.48+
0.97+
4(16.66%)
1 (4.16%)
1(4.16%)
1(4.16%)
2 ( 8.33%)
2(9.52)
1
(4.76%)
0
0
0
0
1(4.16%)
0
0
1 (4.16%)
1(4.16%)
1 (4.16%)
3(14.28)
0
0
NA
0.32+
0.331+
0.26+
0.32+
0.32+
0.467+
0.32+
0.32+
0.14+
* late complications were considered after the death

of 1 patients.
947
Tuteja SV et al.,
Among the early complications, 6 patients had bed

sores (four in Group 1 and two in Group 2), 2 had
urinary tract infections (one each in Group 1 and
Group 2), one patient had thrombophlebitis (Group 1)
and 1 patient had a superficial infection (Group 1).
One patient from Group 1 developed a foot drop. All
patients were treated for these complications using
appropriate measures before discharge. The
distribution of the above in the two groups was not
found to be statistically significant [p value 0.407]
One patient in Group 1 (BH) and 3 patients in Group
2 (THA) suffered dislocation of the hip. All except
one dislocation (one in Group 1 and two in Group 2)
occurred within the first two weeks after surgery. The
only dislocation in Group 1 (BH) and one dislocation
in Group 2 (THA) occurred when the patient was
being made to sit from a supine position from bed.
One dislocation in Group 2 occurred while the patient
was being shifted to the ward from the operating
room. One dislocation occurred at 3 weeks post
surgery when the patient was rising from the toilet
chair. One dislocation in Group 2 occurred in the first
week post surgery, which was closed reduced. The
patient suffered another dislocation 3 weeks post
surgery and was subsequently.
Table 4: Functional assessment
Parameter
Walks unaided FWB
(weeks) + S.D
Bipolar
(n = 24)
6.3 0.7
Pain (at 6 months) (%)

No
14 (60.9%)
Slight
5 (21.7%)
Mild
4 (174%)
Moderate
0
Severe
0
Mean Limb Length
Discrepancy (cms)
(at 6 months) + S.D
THA
(n = 21)
6.1 0.8
16(76.19%)
4 (19.0%)
1 (4.8%)
0
0
patients, 15 from Group 1 (BH) [60.9%] while 16

were from Group 2 (THA) [76.2%]. Nine patients
[20.5%] reported slight pain at 6 months, 5 patients
[21.7%] from Group 1 (BH) as compared to 4
patients [19%] in Group 2 (THA). 90.9%of the
patients in the study group were able to do daily
activities.
No significant difference was observed in the mean
postoperative Mobility Score at the end of 6 months
amongst the 2 groups. The mean postoperative
Mobility score of Parker and Palmer at the end of 6
months decreased from the preoperative score in both
the groups. [p< 0.001]
The Harris Hip Score at the end of 6 months was
Excellent for 9 patients, Good for 27, Fair for 6 and
Poor for 2 patients. 4 were unable to do to do their
daily activities owing to their general medical
condition.
P
value
0.193
0.376
0.47 0.66
0.59 0.64
0.557
Able to do daily activities

Yes (%)
7 (70%)
No (%)
3 (30%)
Post op Mobility
5.96 1.79
12 (75%)
4 (25%)
6.29 1.64
0.339
Fig 1. Total hip Arthroplasty A: Preoperative

Right Transcervical fracture neck femur, B:
Immediate post operative C: Dislocation in first
week, D: 6 month follow-up.
0.531
Score by Parker and

Palmer (at 6 months)
+ S.D
Harris Hip Score (at 6 months) (%)

Excellent
5 (21.7%)
4 (19.0%)
Good
13 (56.5%) 14(66.7%)
Fair
(13%)
3 (14.3%)
Poor
2 (8.7%)
0 (0.00)
0.560
All the above p values are not significant

The time to full weight bearing (FWB) was similar in
both the groups. 31out of 45 patients [68.2%]
reported no pain at 6 months follow up. Of the 31
Fig 2: Bipolar Hemi arthroplasty. A &B:

Preoperative Left Transcervical fracture neck
femur, C: Post operative, D: 3 month follow-up, E:
14 month follow-up.
948
Tuteja SV et al.,
DISCUSSION
As the elderly population increases, the occurrence of
a femoral neck fracture is becoming more common,
hence increasing their socioeconomic importance.
11
These fractures can be devastating injuries that
require medical and surgical treatment and consume
considerable health care resources. The goal of
treatment of these fractures is restoration of pre
fracture function without associated morbidity.
Satisfactory recovery of pre fracture ambulatory
status correlates with younger age, co-morbid
medical conditions, competent mental status, male
gender, community support structure and pre fracture
ambulatory status. 12
Out of the 45 patients, 24 patients were operated by
Bipolar Hemiarthroplasty and 21 by Total Hip
Arthroplasty and were followed up for an average
period of 10 months [Group 1 for 10.17 4.58
months and Group 2 for 9.57 4.51 months]. The
duration of the study was 26 months. All the fractures
occurred as a result of a low velocity trauma as a
result of a fall at home. A cemented stem was used in
5 out of the 24 cases in Group 1 and in one patient
belonging to Group 2. The choice of a particular type
of stem was left to the discretion of the operating
surgeon after discussing the cost factor with the
patient. The un-cemented Total Hip arthroplasty was
performed using a Ceramic head on ceramic
acetabular lining whereas for the cemented Total Hip
arthroplasty, a metal head on polyethylene acetabular
lining was used.
The mean age of the study group was 63.53 years.
Other baseline parameters such as the sex ratio, side
involved and ASA grading were compared between
the two groups. 30 patients were females 16 in
group 1 [BH] and 13 in Group 2 [THA] indicating a
higher incidence of osteoporosis in elderly, post
menopausal females [p value 0.491]. The mean blood
loss in Group 1 (BH), 443.75 88.84 ml was lower
than Group 2 (THA), 545.23 134.075 ml [p value
0.004]. The mean duration of surgery in the Group 2
(THA) [121.90 mins 20.40] was much more than
that in Group 1 (BH) [87.50 mins 10.52] [p-value
0.002].
M.P. J. van den Beckerom et al13, in their study found
the duration of surgery to be longer in THA group
[28% > 1.5 hours versus 12% > 1.5 hours]. The intra-
operative blood loss was also found to be higher in

the THA group (26% > 500ml versus 7% > 500ml).
Bloomfield el al14 in their study showed that the mean
blood loss in the THA group was 460 ml (100 to
1100 ml) and, in the bipolar group was 320 ml (50 to
850 ml) with the mean duration of surgery being 102
mins and 78 mins respectively, both were statistically
significant. Hopley et al6 in their analysis observed
that a Total Hip Replacement lengthened the duration
of surgery by 11 minutes on an average (4 to 19
minutes), which is similar to our study. The mean
volume of blood transfused in Group 2 (THA)[516.66
+ 210.55] was more than Group 1 (BH)[481.25 +
248.82], the difference was not significant [p value
0.611]. The higher volume of blood transfusion in
comparison to blood loss is attributed to low
preoperative haemoglobin in patients belonging to
either group. Keating et al15 in their study concluded
that patients undergoing a total hip arthroplasty were
more likely to receive a blood transfusion as
compared to bipolar hemiarthroplasty which is
similar to the present study. The mean duration of
hospital stay was comparable in the two Groups and
the difference was not significant.
Early complications among the study group were
24.44% [37.5% Group 1, 14.28% Group 2]. Bed sore
was the most frequent in both the groups [16.66% in
Group 1 & 9.52% in Group 2]. All the bedsores were
superficial and responded well to local dressing and
subsequently healed with patient mobilization. 4 out
of the six bedsores occurred in females and all
occurred in patients where the trauma- surgery
interval [3.5 days] was increased as compared to the
study group [1.96 0.99] due to delay in obtaining
fitness for surgery. Pulmonary embolism was the
second most frequent [4.4% overall]. Both the
patients were from Group 1 (BH) whereas no
pulmonary embolism occurred in Group 2 (THA).
Other early complications namely Urinary tract
infection, Foot drop and wound infection [4.16%
each], all of which occurred in Group 1 (BH).
Beckerom et al13 reported early complication in 34
patients (25%) in the bipolar hemiarthroplasty group
in comparision to 28 patients (24%) in the Total hip
arthroplasty group (p = 0.93).
Hopley et al6 observed the general complications to
be slightly more often following Total Hip
Arthroplasty than after Bipolar Hemiarthroplasty. In
comparison, the present study found a high
949
Tuteja SV et al.,
occurrence of complications in the Bipolar

Hemiarthroplasty group [37.5%].
Dislocation occurred in 4 patients [8.8%], one patient
[4.16%] from Group 1 (BH) and three patients
[14.28%] from Group 2 (THA). All patients were
operated by the posterior approach16. Three
dislocations [1 in Group 1 (BH) and 2 in Group 2
(THA)] occurred within the first two weeks after
surgery and were attributed to inability to maintain
limb abduction especially during moving out of bed.
The only dislocation in Group 1 (BH) and one
dislocation in Group 2 (THA) occurred when the
patient was being made to sit from a supine position
from bed. One dislocation in Group 2 (THA)
occurred while the patient was being shifted to the
ward from the operating room. They were treated by
closed reduction using the Allis maneuver consisting
of longitudinal traction along the femur followed by
flexion of the affected hip for 900. The reduction was
completed by external rotation of the hip. An
assistant stabilizes the pelvis throughout the
procedure. Alternatively, the East Baltimore lift or
Stimsons anti gravity method can be used. 17, 18 None
suffered another episode of dislocation in the followup period. One dislocation occurred in the first week
post surgery, which was closed reduced. The patient
suffered another dislocation 3 weeks post surgery
when the patient was rising from a chair. This surgery
was subsequently revised using a larger size skirted
head to increase the offset and soft tissue repair
(Figure. 1). The patient did not suffer any subsequent
dislocations and had a good hip function at 6 months
follow-up.
The fracture patient is not accustomed to careful
positioning of the affected hip, and hence may be
more likely to move his hip into at-risk positions
postoperatively, increasing his chance for dislocation.
20, 21, 22
Dislocation occurred in 4.16 % in Group 1 and

14.28% in the Group 2 which is similar to the study
by K. Karthik et al23 , W. H. TAINE et al24 and
Tidermark et al25 and have attributed the posterior
approach as a reason for higher dislocation following
prosthetic replacement.
Dorr et al26 has attributed the increase rate of
dislocation in the THA group due to the enhanced
stability of the bipolar hemiarthroplasty owing to the
large acetabular shell in this group. This has made the
orthopaedic surgeon hesitant to recommend it for

active elderly patients.5
Late complications, including mortality occurred in 7
patients [15%], 19.04% of patients in Group 2 (THA)
as compared to 12.5% of patients in Group 1 (BH).
There was one mortality in the study population
[2.2%], 4.16% in Group 1 (BH) as compared to no
mortality in Group 2 which is lower that other
studies. 6, 15 This may be due to a relatively younger
sample size as compared to the other studies.
Implant loosening was observed in one patient in the
study group [2.2%]. It occurred in Group 1 (BH)
when the patient followed up 14 months post surgery
(Figure. 2). The patient complained of minimal
anterior thigh pain, however maintained good hip
function. This is attributed to first generation
cementing technique27. The patient was advised to
follow up regularly and the need for operation in the
future.
The mean weeks of unaided full weight bearing
(FWB) in Group 1 (BH) [6.35 0. 71 weeks] and
Group 2 (THA) [6.14 0.85 weeks] were comparable.
31 patients [68.2%] reported no pain at 6 months
follow- up; 15 were from Group 1 (BH) [60.9%] and
16 were from Group 2 (THA) [76.2%].
Nine patients [20.5%] reported slight pain at 6
months, 5 [21.7%] from Group 1 (BH) as compared
to 4 [19%] from Group 2 (THA).
Mild pain was reported in 5 patients [11.4%] in the
study group requiring infrequent analgesic use, 4
from Group 1 (BH) [17.4%] and 1 patient from group
2 (THA) [4.8%].
The mean limb length discrepancy (LLD) in
centimeters was more in Group 2 (THA) [0.59 0.64
cms] as compared to Group 1 (BH) [0.47 0.66 cms]
which is comparable to other studies. 28, 29, 30
It is universally perceived when shortening exceeds
10 mm and lengthening 6 mm.30 Two patients from
the THA group and one patient from the Bipolar
hemiarthroplasty group complained of perception of
limb length discrepancy. They were subsequently
managed with a shoe raise
At the end of 6 months, 90.9% patients were able to
do daily activities, 20 patients [86.9%] from Group 1
(BH) as against 20 patients [95.23%] in Group 2
(THA). Two patients from Group 1 (BH) and one
patient from Group 2 (THA) reported inability to do
daily activities owing to their general medical
condition and advanced age of the patients.
950
Tuteja SV et al.,
The mean preoperative mobility score of Parker and

Palmer (Table. 4) (Chart. 10) was 7.26 1.54 in
Group 1(BH) and 6.95 2.03 for Group 2 (THA).
Post operative mobility scores of Parker and Palmer
was 5.96 1.79 in Group 1 (BH) as against 6.29
1.64 in Group 2 (THA). The comparison of pre
operative and post operative scores showed a
statistically significant decrease in Group 1 (BH)
[1.21] as compared to Group 2 (THA) [0.67] [p value
0.011].
9 patients [20.5%] had an excellent Harris Hip Score.
(5 in the bipolar group [21.73%] and 4 in THA group
[19.04%]), 27 patients [61.4%] had a good result (13
in the bipolar group [56.52%] and 14 in THA group
[66.7%]), 6 patients had a fair result (3 each in
Group 1 (BH) [13%] and THA group [14.3%]), and 2
patients [4.54%] had a poor result both of which were
from the bipolar group. None of the patients had a
poor result in the THA group.
The outcome was marginally better in patients going
for Total hip Arthroplasty with 85.7% patients having
either an excellent or good result as compared
78.26% of the patients in Group 1 (BH). These
findings are similar to the study by Iorio et al31 with
superior outcome in patients following Total Hip
Arthroplasty. Bloomfield et al14 in their randomized
study comparing bipolar hemiarthroplasty with total
hip arthroplasty involving 120 patients reported
similar results at 4 and 12 months follow-up. They
attributed the poorer scores in the Bipolar
Hemiarthroplasty group to early acetabular wear
following prosthetic replacement.
Keating et al32 concluded that the best clinical and
functional outcomes in the study were observed after
total hip arthroplasty.
In contrast, K Karthik George et al23 reported better
Harris Hip Score in the Bipolar Hemiarthroplasty
group [86.93] in comparison to total hip arthroplasty
[83.82]. The difference was however not statistically
significant. Primary osteoarthritis of the hip is
uncommon in the south Asian population.33 They
suggested in their findings that in a resource limited
countries like India, Bipolar hemiarthroplasty would
be the preferred treatment option in fracture neck
femur. We agree with this opinion that, a Total Hip
Arthroplasty would significantly increase the surgical
costs borne by the health care system as well as
increase surgical duration and increased blood loss,
both of which may contribute to postoperative
morbidity. All of the following have the potential to

increase the overall treatment expense.
The Early conversion of a Bipolar to Unipolar Device
and subsequent acetabular wear may contribute to
poor functional outcome post surgery. 34, 35 Total hip
arthroplasty may eliminate the possibility of
acetabular cartilage erosion, which may cause pain
and lead to inferior clinical result. 6
The findings in the present study of early follow up
suggests that even though, the mean blood loss and
the mean duration of surgery were significantly more,
the functional results following total hip arthroplasty
were superior to hemiarthroplasty for the treatment of
independent, and active patients suffering from
displaced intra capsular fracture neck femur.
Both groups experienced functional deterioration
postoperatively as compared with the preoperative
scores as per the mobility score of Parker and Palmer;
however, patients in the total hip arthroplasty group
had less deterioration.
CONCLUSION
In a resource-poor country like India with low life
expectancy of 66.4 years as compared to the western
countries (80 years) 36 and where primary
osteoarthritis of the hip is uncommon, the bipolar
hemiarthroplasty
provides
functional
results
comparable with the Total Hip Arthoplasty with
lower surgical duration, relatively easy procedure and
lower complication rates. The surgeon may take into
account the patients' level of activity and
independence, and quality of bone and joint while
choosing between the two options; Total Hip
Arthroplasty been reserved for patients with preexisting acetabular disease, younger, and more active
patients who are likely to tolerate the vigor of an
extensive surgery and benefit more from Total Hip
Arthroplasty than older, less active patients.
However, long term outcome following the two
surgeries, especially in the South Asian population is
a topic for additional investigation. The limitation of
this study was, the sample size and the short follow
up period.
ACKNOWLEDGEMENT
The authors acknowledge the immense help received
from the scholars whose articles are cited and
included in references of this manuscript. The authors
are also grateful to authors/editors/publishers of all
951
Tuteja SV et al.,
those articles, journals and books from where the

literature for this article has been reviewed and
discussed.
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2. Parker M, Johansen A. Hip fracture. BMJ. 2006;
333: 27-30
3. Garden RS. Low-angle fixation in fractures of
the femoral neck. J Bone Joint Surg Br. 1961; 43:
647-63.
4. Chua D, Jagal SB, Schatzker J. An orthopedic
surgeon survey on the treatment of displaced
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Volume 3 Issue 4
Coden: IJMRHS
th
Research article
Copyright @2014
ISSN: 2319-5886
PREVALENCE OF MULTIDRUG RESISTANT PATHOGENS IN CHILDREN WITH URINARY

TRACT INFECTION: A RETROSPECTIVE ANALYSIS
*Srinivasan S1, Madhusudhan NS 2
1
Associate Professor, 2Assistant Professor, Department of Microbiology, Indira Gandhi Medical College & RI,
Pondicherry
*Corresponding author email:
drsriniv@yahoo.co.in
ABSTRACT
Urinary tract infection (UTI) is one of the commonest medical problems in children. It can distress the child and
may cause kidney damage. Prompt diagnosis and effective treatment can prevent complications in the child. But
treatment of UTI in children has now become a challenge due to the emergence of multidrug resistant bacteria.
Aims & Objectives: To know the bacteriological profile and susceptibility pattern of urinary tract infections in
children and to know the prevalence of multidrug resistant uropathogens. Materials & Methods: A retrospective
analysis was done on all paediatric urine samples for a period of one year. A total of 1581 samples were included
in the study. Antimicrobial susceptibility testing was done on samples showing significant growth by Kirby-Bauer
disc diffusion method. Statistical analysis: Prevalence and pattern were analyzed using proportions and
percentages. Results: E.coli was the most predominant organism (56%) causing UTI in children followed by
Klebsiella sp (17%). Fifty three percent of gram negative organisms isolated from children were found to be
multidrug resistant. Majority of E. coli isolates were found to be highly resistant to Ampicillin (91%) and
Cotrimoxazole (82%) and highly sensitive to Imipenem (99%) and Amikacin (93%). Conclusion: Paediatric UTI
was common in children less than 5 years of age. Gram negative bacteria (E. coli and Klebsiella sp) were more
common than gram positive bacteria. Our study revealed that multidrug resistance was higher in E.coli.
Keywords: Children, Urinary tract infection, Multidrug resistance, E.coli
INTRODUCTION
Urinary tract infections are common among
paediatric age group and are important cause of
morbidity. UTI may vary by gender and age. Many
occasions it may be difficult to make a diagnosis of
UTI in children as the presenting symptoms like fever
and chills are usually nonspecific. An early urine
culture and sensitivity can guide to a proper diagnosis
and treatment. Although several microorganisms are
responsible for UTI, E.coli, Klebsiella sp and Proteus
sp are the most common cause of urinary tract
infection in children1.Treatment is often started
empirically based on the local prevalence of

organisms and susceptibility pattern. Presently this
situation is challenging to the treating paediatricians
as multidrug resistant organisms are on the rise
among children.2 Multidrug resistance is defined as
resistance to two or more different structural classes
of antimicrobial agents3. Multidrug resistance has
become a universal phenomenon across organisms
and may complicate the therapeutic management of
infections. Antibiotic resistance can cause serious
disease and is an important public health problem.
954
Srinivasan et al.,
Drug resistance has been a common occurrence in

infections among adults and elderly, but now it is
frequently seen in children as well. Overuse and use
of incomplete course of antibiotics as well as
empirical antibiotic therapy have been the major
contributing factor in the development of multidrug
resistant bacteria4. To reduce the rate of resistance it
is pertinent to initiate antibiotic therapy after
microbiological confirmation. In a study conducted
by Mohammed et al5 in Delhi, E.coli was the
predominant pathogen causing UTI and resistance
against different generation of cephalosporin was
found to be 6080 % in paediatric patients. There are
various studies on the prevalence of drug resistance in
adults with urinary tract infections6, 7, but there are
very few studies on children. Hence this study was
taken up in our hospital to know the bacteriological
profile and susceptibility pattern of organisms
causing UTI among children and also to know the
prevalence of multidrug resistant uropathogens.
This is a retrospective descriptive study undertaken to
analyze the data collected during the period of one
year from January 2013 to December 2013 in the
department of Microbiology at a tertiary care
hospital. Institutional ethical clearance has been
obtained. The data analysed included all midstream
urine samples received from children (<14y) of age
from paediatric ward with provisional diagnosis
mentioned as UTI in the laboratory requisition forms.
Children having fever with obvious foci of infection
like Respiratory tract infections were excluded from
the study. A total of 1581 samples were included.
Direct gram staining was done on uncentrifuged urine
samples and culture was done on CLED (Cystine
Lactose
Electrolyte
Deficient)
agar
by
semiquantitaive technique8. Samples showing >105
col/ml were taken as significant. Organisms were
identified by standard microbiological procedures8.
Antimicrobial sensitivity testing was done by Kirby
Bauer disc diffusion method as per CLSI guidelines9.
E. coli ATCC 25922, and P. aeruginosa ATCC
27853 were used as controls. Ampicillin (10g), cotrimoxazole (1.25/23.75 g), cefuroxime (30 g),
norfloxacin (10 g), nitrofurantoin (300 g), and
amikacin (30 g) were used as I line agents. If three
or more agents are found to be resistant then,
ceftriaxone (30 g), cefepime (30 g), piperacillin tazobactam (100/10 g), imipenem (10 g) and
meropenem (10 g) were used as II line agents. All
antibiotic discs were from Himedia Laboratories,
Mumbai. The isolates were reported as Susceptible
(S), Intermediate (I) and Resistant) as per CLSI
guidelines9.
RESULTS
A total of 1581 samples were included in the study,
out of which 229 samples (14%) showed significant
growth. Out of 229 samples 206 were gram negative
bacilli (90%) and 23 were gram positive cocci (10%).
Among these 229 cases, males (52%) were
marginally affected more than females (48%). UTI
was predominantly seen in the age group between 05years. The age wise distribution of the prevalence of
UTI is shown in table 1.
Table 1: Age wise distribution of isolates
S.no
Age
Isolates (%)
1.
1-5 yrs
131 (57%)
2.
5 10 yrs
63 (27%)
3.
Above 10 but 35 (15%)
below 14 years
Among gram negative bacteria, E.coli was the
predominant isolate (56%) followed by klebsiella sp
(17%) and Proteus sp (6%). The isolation of various
pathogens is depicted in table 2. Among gram
positive cocci, Enterococcus faecalis was the
predominant isolate (98%). The majority of isolates
of E.coli was found to be highly resistant to
ampicillin (91%) followed by co-trimoxazole (82%).
It was also found to be resistant to norfloxacin (68%),
ceftriaxone (76%) and meropenem (77%). Klebsiella
sp was found to be most resistant to ceftriaxone
(70%) and meropenem (50%). All gram negative
bacteria in general were found to be highly sensitive
to nitrofurantoin, amikacin, imipenem and
piperacillin tazobactam.
Non fermenting gram negative bacteria was highly
resistant to nitrofurantoin (90%), while it was
sensitive to all other agents (table 3). Enterococcus
faecalis which was the predominant isolate among
gram positive cocci was highly resistant to
norfloxacin (80%) but sensitive to other agents
(Table 4). Among 206 isolates of gram negative
bacilli, 123 isolates (53%) were found to be resistant
955
Srinivasan et al.,
to 3 or more drugs and hence considered to be

multidrug resistant.
Multidrug resistance was not found among gram
positive organisms. Among gram negative organisms
MDR was more prevalent in E. coli (75%) followed
by Klebsiella sp (28%).
Table showing percentage (%) of gram negative and
gram positive isolates with multidrug resistant
organisms.
Table 2: Pattern of isolates
Organisms
Isolates
(%)
GNB (Gram negative bacilli)
MDR isolates
( %)
E.coli
Klebsiella sp
Citrobacter sp
Enterobacter sp
Non fermenting GNB
Proteus sp
116 (56%)
35 (17%)
9 (4%)
8 (4%)
22 (11%)
16 (7%)
88 (42%)
10 (5%)
7 (3%)
5 (2%)
5 (2%)
8 (4%)
Total
206 (90%)
GPC (Gram positive Cocci)
Enterococcus faecalis
23 (10%)
123 (53%)
0
Table 3: Number (%) of Gram negative bacteria

resistant to antimicrobial agents
Anti
bioti
c
AMP
CoT
CXM
NX
NT
CTR
AMK
CPM
PIT
IM
MR
E. coli
n=116
(%)
105/116
(90%)
95/116
(82%)
81/106
(76%)
72/106
(68%)
13/113
(12%)
85/113
(75%)
7/114
(6%)
59/92
(64%)
12/106
(11%)
1/106
(1%)
70/106
(66%)
Klebsiell
a sp
n= 35
35/35
(100%)
26/35
(74%)
21/32
(66%)
11/33
(33%)
10/34
(29.4%)
22/35
(63%)
6/35
(17%)
15/31
(50%)
3/35
(9%)
2/33
(6%)
12/30
(40%)
Proteus
sp
n = 16
11/16
(70%)
11/16
(70%)
6/12
(50%)
2/12
(17%)
11/15
(73%)
1/16
(7%)
2/15
(13%)
8/15
(53%)
2/15
(13%)
1/15
(6%)
4/14
(28%)
Nonfermenting
GNB
(n=22)
6/22
(28%)
2/18
(12%)
4/18
(23%)
3/18
(17%)
2/19
(11%)
7/19
(39%)
2/18
(12%)
2/18
(12%)
1/18
(5%)
1/18
(5%)
3/18
(17%)
Amp = ampicillin, CoT = Cotrimoxazole, Cxm=

cefuroxime, Nx = norfloxacin, Nt = Nitrofurantoin,
Ctr = ceftriaxone, Amk = amikacin, Cpm = cefepime,
Srinivasan et al.,
PIT = piperacillin tazobactam, Im = imipenem, MR

= meropenem
Table 4: Number of isolates (%) of Enterococcus
faecalis resistant to antimicrobial agents
Organism
Amp
Gen
Nx
Nt
Enterococcus 6/21
7/21
16/21 3/21
sp
(33%) (39%) (80%) (15%)
Gen = gentamicin, LZ = linezolid,
DISCUSSION
The appropriate choice of empiric antibiotic for a
child with UTI requires adequate knowledge of the
prevalence of organisms and resistance pattern. The
emergence of multidrug resistant organisms is a cause
of concern worldwide. This study describes the
resistance profile of uropathogens and the prevalence
of multidrug organisms among children. In this study,
we isolated 229 (14%) uropathogens out of 1581
samples from children. In a similar study conducted
by shreshta et al10, 60 uropathogens (16%) were
obtained from 372 samples. UTI is a common
problem in children, but the prevalence varies with
age and sex of children11. Our study showed a
marginally higher positivity of UTI among males
(52%) compared to females (48%). A similar result
was seen in a study conducted by Patel P et al12. The
majority of infections was seen in children under the
age of 5 years (57%) which could be attributed to
ineffective toilet training in this age group and the
chance of ascending infection from the urethra which
can lead to complications like recurrent infections
and pyelonephritis13.
Gram negative bacteria were the predominant cause
of UTI when compared to gram positive bacteria3.
Our study revealed E.coli as the predominant
organism (56%) causing UTI among children. There
are several studies showing E.coli as the significant
pathogen causing UTI12,14. Klebsiella sp was the
second most predominant organism followed by
nonfermenting gram negative bacilli and proteus sp
in our study.
With regard to sensitivity pattern, E.coli was found to
be sensitive only to higher antibiotics like imipenem
(99%) piperacillin tazobactam (89%) and amikacin
(94%) while front line antibiotics like ampicillin and
cotrimoxazole which are often used by paediatricians
to treat UTI showed a high resistance (90% and 82%
respectively). In a similar study conducted by Patel
956
L
0
(0
P12, E.coli was found to be highly sensitive to

gentamicin, amikacin and piperacillin -tazobactam .
Our study showed nitrofurantoin having lesser
resistance to gram negative bacilli when compared to
ampicillin and cotrimoxazole which was observed in
other studies also10, 15,16. As E. coli resistant to
trimethoprim - sulphamethoxazole and Fluoro
quinolones has become more common, nitrofurantoin
has become an important oral agent in the treatment
of uncomplicated urinary tract infection17.
With increasing resistance to ampicillin and co
trimoxazole1,2, physicians started using quinolones
and cephalosporins as first line agents. But
unfortunately due to excessive use of these agents
resistance is fast emerging in these agents too18.A
study conducted by NK Ganguly et al19 showed that
one of the main reasons for antibiotic resistance
seems to be increased use of antibiotics. They have
documented that between 2005 and 2009 the unit of
antibiotics sold increased by about 40 percent and
particularly sale of cephalosporins strikingly
increased by about 60 percent. Even in our study
norfloxacin showed 68% resistance and ceftriaxone, a
III generation cephalosporins showed 75% resistance.
The present study revealed that all gram negative
bacteria had a high sensitivity to nitrofurantoin,
amikacin and imipenem which is concurrent to other
studies conducted in other parts of India as well15.
Enterococcus faecalis a gram positive bacteria, in
contrast to gram negative bacteria was found to be
sensitive to all antibiotics except to norfloxacin.
In the present study prevalence of multidrug resistant
organisms among gram negative bacilli was about
53%, which means 123 organisms out of 206 were
resistant to two or more different structural classes of
antibiotics. Among 123 MDR isolates, maximum
isolates (75%) were E.coli. Similar studies conducted
elsewhere also showed that maximum MDR isolates
were seen in E.coli 10,19,20. Since E.coli is the major
causative organism causing UTI across age group,
various drugs are being used in hospitals empirically
for treating E.coli which leads to drug resistance
imipenem(99%),
nitrofurantoin(88%)
and
piperacillin-tazobactam(89%) and was highly
resistant to ampicillin (90%) and cotrimoxazole
(82%). Paediatricians can hence defer using
ampicillin and cotrimoxazole as first line agents and
rather prefer nitrofurantoin and amikacin to treat UTI
in children. The only disadvantage being amikacin
has to be administered only intravenously.
Ceftriaxone used commonly to treat children admitted
with UTI, henceforth may have to be used only after
obtaining the sensitivity report as there is emerging
resistance (75%) to this drug as seen in the present
study. Our study showed that the prevalence rate of
multidrug resistant isolates was 53% among gram
negative bacilli. As susceptibility pattern is changing
around the globe, a regular monitoring of antibiotic
resistance pattern is required to ensure proper therapy
for children with urinary tract infections.
Limitation of study: Although our sample size is
large, the number of cases analyzed with significant
growth is less which is a limitation of our study.
ACKNOWLEDGEMENT
Sincere thanks to the tutors and the technicians in the
Dept of Microbiology for their help during this work.
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DOI: 10.5958/2319-5886.2014.00032.0

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Health Sciences
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Volume 3 Issue 4
th
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
Research article
REVIEW OF RENAL BIOPSY DATABASE: A SINGLE CENTRE SOUTH INDIAN STUDY

*Clement Wilfred Devadass1, Vijaya Mysorekar V2, Gireesh MS3, Mahesh E4, Gurudev KC5, Radhika K6
1
Associate Professor, 2Senior Professor and Head, Department of Pathology, M.S. Ramaiah Medical College and
Hospitals, Bangalore, India
3
Associate Professor, 4Professor, 5Professor and Head, Department of Nephrology, M.S. Ramaiah Medical
College and Hospitals, Bangalore, India
6
Lecturer and statistician, Department of Community Medicine, M.S. Ramaiah Medical College and Hospitals
Bangalore, India
*Corresponding author email:clement.wilfred@yahoo.com
ABSTRACT
Background: The epidemiology of biopsy- proven renal disease (BPRD) provides information that is useful for
clinical practice and investigation. India lacks a national renal data registry system and there is a scarcity of
information on the pattern of BPRD in South India. Objectives: To determine the occurrence and analyse the
epidemiology of BPRD in our local (South Indian) population. Material and Methods: A retrospective review of
reports of native renal biopsies performed on patients at a tertiary care hospital in South India, from 2008 to 2013
was undertaken. All renal biopsies were studied by light and immunofluorescence microscopy and were classified
into primary glomerulonephritis (PGN), secondary glomerulonephritis (SGN), tubulointerstitial nephritis, vascular
nephropathy, hereditary nephritis, end stage renal disease and biopsies exhibiting no significant pathology.
Results: A total of 661 cases were included in the study. The most common clinical syndrome as an indication for
renal biopsy was NS (29%). PGN was the most common BPRD, accounting for 42.3 % of the cases. Minimal
change disease (33.6%) was the commonest PGN followed by membranous nephropathy (15.7%) and focal
segmental glomerulosclerosis (12.6%). Diabetic nephropathy (76.9%) was the commonest SGN (14.7%) followed
by lupus nephritis. Conclusion: Our study represents an important contribution to understanding the
epidemiology of renal disease in South India. The distribution pattern of PGN largely corresponds to the
distribution pattern described in other South Indian studies. However, there is a wide variation of major histologic
patterns of PGN across the world.
Keywords: Epidemiology, glomerulonephritis, nephritic syndrome, renal biopsy, renal disease.
INTRODUCTION
Renal biopsy is an established and vital procedure
that is indispensable in the investigation and
management of patients with renal disease.1 The
epidemiology of biopsy- proven renal disease
(BPRD) provides critical insights about the
occurrence of renal disease and this information is not
only useful for clinical practice and investigation but
Clement et al.,
is vital for future research into renal disease. The

prevalence of renal disease varies according to the
geographic area, demography and race and is
influenced by the socioeconomic conditions,
prevalence of infectious diseases and indications for
renal biopsy.2,3 Unlike certain regions, where
community based renal biopsy registries exist, there
959
Int J Med Res Health Sci.2014;3(4):959-966
is no such documentation in India.4-6 Further there is

scarcity of information on the pattern of renal disease
in the native South Indian population.
The aim of the present study was to determine the
occurrence and analyse the epidemiology of BPRD in
a tertiary care hospital in South India.
The records of all patients who underwent a renal
biopsy at M. S Ramaiah Hospitals, Bangalore from
September 2008 to September 2013 were
retrospectively reviewed, after obtaining institutional
ethical clearance. Information regarding patients age,
gender, indication of renal biopsy, underlying
conditions associated with renal disease, laboratory
investigations like serum creatinine, 24-hour urinary
protein and serological data (Antinuclear antibodies,
Antineutrophil cytoplasmic antibodies, anti-double
stranded DNA, C3) were collected. Inadequate
biopsies, a second biopsy in re-biopsy patients and
renal allograft biopsies were excluded from the
analysis.
The indications for renal biopsy were categorised into
the following subgroups: nephrotic syndrome (NS),
acute nephritic syndrome (ANS), acute renal failure
(ARF), chronic renal failure (CRF), rapidly
progressive renal failure (RPRF), asymptomatic
urinary abnormality [non-nephrotic proteinuria (< 3.5
g/24 hr) [NNPU] or hematuria ( 3 red cells/
high power ield)] and hypertension with renal
dysfunction.2,7 NS was defined as heavy proteinuria
(> 3.5 g/24 hr or 4+ proteinuria) and serum albumin <
2.5 g/dL.2,4,8 The clinical diagnosis of ANS was made
based on rapid onset of oedema, oliguria,
hypertension, hematuria, mild to moderate proteinuria
and reducedGFR.4,6 ARF was defined as rapid(over
hours to weeks) and usually reversible decline in
GFR occurring, either in the setting of pre-existing
normal renal function or with pre-existing renal
disease and RIFLE Criteria was followed to identify
these cases. 9 As per NKF KDOQI Guidelines, CRF
was defined as either kidney damage (structural or
functional abnormalities of the kidney manifest by
either: Pathological abnormalities; or Markers of
kidney damage, including abnormalities in the
composition of the blood or urine, or abnormalities in
imaging tests)or GFR <60 mL/min/1.73 m2 for 3
months.10 RPRF was defined as progressive renal
impairment (deterioration of GFR, associated with
azotemia) over a period of few weeks, with presence

of normal sized kidneys on ultrasonographic
examination. 11
All the biopsy specimens were processed for light and
immunofluorescence microscopy as per standard
protocol by the same group of technicians and
examined by the same group of pathologists. For light
microscopy, 3- 4 m thick sections were stained with
Hematoxylin and Eosin, Massons trichrome,
periodic acid Schiff and Jones silver methanamine.
Special stains (Congo red) were used when
warranted. Immunofluorescence study was done
using fluorescein isothiocyanate (FITC) conjugated
rabbit antihuman immunoglobulin (Ig) G, IgM, IgA,
and C3 antibodies from Biogenex. The final diagnosis
was made for each case on the basis of both clinical
and
histological
investigations.
Histological
categories were classified as follows: i) Primary
glomerulonephritis (PGN) which included 8 groups
minimal change disease (MCD), membranous
nephropathy
(MN),
focal
and
segmental
glomerulosclerosis (FSGS), membranoproliferative
glomerulonephritis (MPGN),chronic glomerulonephritis
(CGN), Crescentic glomerulonephritis (CreGN),
Diffuse proliferative glomerulonephritis (DPGN) and
IgA nephropathy (IgAN);
ii) Secondary
glomerulonephritis (SGN) which included 8 groupsdiabetic nephropathy (DN), lupus nephritis (LN),
amyloidosis, Goodpasture syndrome (GPS), HenochSchonlein purpura ( HSP), light chain deposit disease
(LCDD), haemolytic- uremic syndrome ( HUS)/
thrombotic microangiopathy (TMA) and rheumatoid
arthritis (RA); iii) Tubulointerstitial nephritis ( TIN)
which included acute TIN, chronic TIN, acute kidney
injury/ acute tubular necrosis ( AKI/ATN), myeloma
cast
nephropathy,
nephrocalcinosis,
juvenile
nephronophthisis, granulomatous interstitial nephritis,
analgesic nephropathy and systemic sclerosis; iv)
Vascular nephropathy (VN) which included benign
nephrosclerosis (BNS), malignant nephrosclerosis
(MNS), vasculitis and renal cortical necrosis (RCN);
v) Hereditary nephritis comprising of Alport
syndrome; vi) End stage renal disease ( ESRD),
which included biopsies exhibiting severe interstitial
fibrosis and tubular atrophy with advanced
glomerulosclerosis and arteriosclerosis, and vii)
Biopsies exhibiting no significant pathology.
Statistical analysis: The incidence of each type of
renal disease and biopsy indication were computed.
960
Clement et al.,
Quantitative data were expressed as mean or median.

Qualitative data were expressed as numbers and
percentages.
RESULTS
Of 752 cases analysed, 91 cases comprising of 72
renal allograft biopsies and 19 inadequate biopsies
were excluded. The remaining 661 cases, included in
the study had a male: female ratio of 1.66 with a
mean age of 42.8 years and a range of 8 months to 78
years.
The number of biopsies performed each year
increased annually as depicted in Figure 1.
Fig1: Renal biopsies performed each year.

Table 1 Clinical indications of renal biopsy
Table 2: Distribution of glomerular disease by age
Disease
< 10
10-20
21-30
31-40
MCD
25
14
19
15
MN
0
3
14
8
FSGS
2
5
9
6
MPGN
0
3
5
8
CGN
0
3
5
5
CreGN
0
5
5
3
DPGN
4
6
2
4
IgA N
0
1
4
7
DN
0
0
1
16
LN
0
6
7
7
Amyloidosis 0
0
0
0
The distribution and frequency of different renal
diseases are shown in Table 3. PGN accounted for
42.3% of the cases and was the most common
BPRD. MCD was the commonest PGN followed by
Clinical Diagnosis
Number of renal biopsies

*( percentages)
NS
192 (29%)
CRF
120 (18.2%)
ARF
99 (14.9%)
RPRF
70 (10.6%)
Non-nephrotic
66 (10%)
proteinuria
Hypertension with renal 52 (7.9%)
dysfunction
ANS
40 (6.1%)
Hematuria
22 (3.3%)
Total
661 (100%)
*Only the first renal biopsy in each case was
considered.
The clinical indications for renal biopsy are depicted
in Table 1 with NS being the commonest followed by
CRF.
Table 2 shows the clinical syndrome associated with
each histological category. The most common cause
of NS was MCD followed by MN and FSGS and the
most common cause of ANS was DPGN followed by
MPGN. The most frequent causes of CRF, ARF,
RPRF, NNPU and hematuria respectively were
Chronic TIN, Acute TIN, CreGN, DN and IgAN.
The distribution of glomerular disease by age is
shown in Table 4. Most of the PGN were diagnosed
between 2nd and 3rd decade
41-50
51-60
61-70
71-80
Median age
11
6
6
0
25
8
8
4
0
32.5
4
6
4
0
35.8
6
5
0
0
32.5
4
3
2
1
32
4
1
3
0
36.7
2
0
2
0
32.5
3
2
0
1
35
18
39
31
5
54.7
0
1
0
0
24.3
1
0
1
0
MN. The most common SGN was DN. The most
common TIN was chronic TIN followed by acute
TIN and the most common VN was BNS.
961
Clement et al.,
Table3: Clinical presentation of each histological category

Histological
NS
CRF
ARF
RPRF
NNPU Hypertension ANS
Diagnosis
MCD
89 (46.4)
2(1.7)
1(1.0)
4(6.1)
MN
38 (19.8)
3(2.5)
4(6.1)
FSGS
22(11.5)
4(3.3)
1(1.0)
1(1.4)
7(10.6)
1(2.5)
MPGN
8(4.2)
3(2.5)
7(10.0)
1(1.5)
8(20)
CGN
14(11.7)
2(2.0)
3(4.3)
1(1.5)
2(3.8)
1(2.5)
CreGN
1(0.8)
1(1.0) 16(22.9)
3(7.5)
DPGN
4(2.1)
1(1.0)
4(5.7)
1(1.9)
10(25)
IgAN
3(1.6)
2(1.7)
2(2.9)
1(1.5)
3(7.5)
DN
17(8.9) 23(19.2) 19(19.2) 3(4.3) 21(31.8)
18(34.6)
5(12.5)
LN
8(4.2)
2(1.7)
3(4.3)
1(1.5)
6(15)
Amyloidosis
2(1.0)
HUS/TMA
2(2.0)
GPS
2(2.9)
RA
2(3.0)
HSP
1(1.0)
1(1.5)
LCDD
1(0.8)
1(1.0)
Congenital
1(1.0)
Alport
AcuteTIN
6(5.0)
20(20.2) 5(7.1)
6(9.1)
6(11.5)
2(5.0)
ChronicTIN
33(27.5)
9(9.1)
6(8.6)
7(10.6)
6(11.5)
Analgesic
3(2.5)
1(1.0)
Granuloma
1(0.8)
AKI/ATN
10(10.1) 3(4.3)
Myeloma cast
1(0.8)
1(1.0)
Nephropathy
Medullary
1(1.0)
-
Hematuria Total
7(31.8)
4(18.2)
1(4.5)
1(4.5)
1(4.5)
2(9.1)
-
96
45
36
27
23
21
20
18
110
21
2
2
2
2
2
2
1
1
46
63
4
1
13
2
Nephronopthisis
Systemic
Sclerosis
1(1.0)
Nephrocalcinosis
1(1.0)
BNS
11(9.2)
1(1.0)
14(26.9)
MNS
1(0.8)
2(2.0)
5(7.1)
RCN
2(2.9)
Vasculitis
2(2.0)
1(1.4)
ESRD
1(0.5)
9(7.5)
1(1.0)
4(5.7)
1(1.5)
1(2.5)
No signf
19(19.2) 3(4.3)
9(13.6)
5(9.6)
6(27.3)
Total
192
120
99
70
66
52
40
22
Hypertension=hypertension with raised renal parameters; No signf= No significant pathology. Figures in
parenthesis represent percentage of that particular clinical presentation.
1
26
8
2
3
17
42
661
DISCUSSION
This report provides comprehensive information
about the occurrence, demographics and clinical
syndromes of renal diseases diagnosed by renal
biopsy, over a period of five years in a single tertiary
care centre in South India. The study reflects the
pattern and prevalence of BPRD of moderate to
severe intensity rather than the true prevalence of the
disease, as only those with significant disease severity
are likely to be biopsied.
Table 5 demonstrates the comparison of our basic

data with other published studies. Similar to the
majority of other published studies worldwide, PGN
was the most predominant renal disease in our study,
followed by SGN and TIN. 3,5,7,8,12-19 The hereditary
and vascular nephropathies were less frequent in
majority of the studies.
962
Clement et al.,
Table 4: Comparison of our basic data with other published studies
*These figures represent percent of total renal disease; ** these figures represent percentage calculated out of
total PGN; ***these figures represent percentage calculated out of total SGN; PIGN= Post infectious
glomerulonephritis; Non IgA MGN= Non IgA Mesangioproliferative glomerulonephritis.
Similar to other studies around the world, including
South India, NS was the most frequent indication for
renal biopsy accounting for 29% of the
cases.3,7,8,12,13,18 However, asymptomatic urinary
abnormality was found to be more frequent in the
Italian registry and Japanese study, perhaps reflecting
a greater tendency to biopsy asymptomatic
proteinuria and hematuria. 4,5,7
Our gender distribution with male predominance was
similar to many other epidemiological studies.
3,7,12,13,17,19
however, gender distribution was balanced
in Brazilian, Serbian and Korean studies. 2,8,18 This
partly may be explained by the higher relative
frequency of LN, which occurs more frequently in
women, in the latter studies.
MCD, MN and FSGS have been the three most
frequently diagnosed PGN, comprising 69.1% of the
latter. MCD was the commonest PGN and
commonest cause of NS in our study, which is in
concordance with another South Indian study
(Hyderabad) and other studies from Morocco and

Bahrain.2,7,15 MCD exhibits variable geographic
distribution, European studies and a South Indian
study conducted at Vellore have shown a decline in
the relative frequency of MCD.5,8,12,19 It is the most
common cause of NS in children, with 80% of
histological verified cases occurring in children < 6
years and a male: female (M:F) ratio of 2:1.20 In our
study, MCD comprised 33.6% of PGN, peaked in the
first decade of life and was more common in males
(M: F, 1.6:1).
MN is cited as the most common cause of adult NS in
most widely used renal pathology text books.7,8,20 In
our study it was the second most frequent PGN
(15.7%) and most common cause of NS in adults with
peak incidence in the third and fourth decades of life
and a M:F ratio of 1.1:1. There is a worldwide
increase in the incidence of FSGS, which has become
the main cause of NS instead of MN, especially in
countries with preponderant black and Hispanic
963
Clement et al.,
Americans.3, 8,21 However, in many European

countries (Italy and Serbia)
and United Arab
Emirates (UAE), it is still common and previews as
the commonest cause of NS. 5,8
The prevalence of FSGS has increased from <10% to
25% of PGN in the past 20 years.22 New
environmental causes and broadened morphological
definition of FSGS may partly explain this increasing
trend.21,23 It was the third commonest PGN (12.6%) in
our study. Two other South Indian studies conducted
at Vellore and Hyderabad have reported FSGS as the
second commonest PGN and studies from Pakistan,
Brazil and Arab countries have quoted it as the
commonest PGN.3,12,13,14,18 The disease is relatively
more common in adults and males (M:F, 1.4:1) with
44% to 74% presenting as NS.23 In our study the peak
age at presentation was third decade and 61% of
FSGS cases presented with NS with M: F ratio of
2.3:1.
IgA nephropathy was the least frequent PGN (6.3%)
in our study, a pattern similar to other South Indian
studies, some South Asian (Pakistan) and West Asian
studies (Iran and Bahrain). 3,12,13,15,22 However, it is the
commonest PGN in Europe, Estonia, West Germany
and some East Asian countries ( Japan,
Korea).2,4,5,16,17, 21 Even though it is considered as the
most common glomerular disease worldwide, its
detection rate varies depending on biopsy indications
and mass urinary screening programs for
asymptomatic urinary abnormalities.2,7 Further high
prevalence in certain populations may be related to
genetic background. 2
A decreasing incidence of MPGN has been reported
in different parts of the world probably due to
improved socioeconomic conditions and reduction in
the regional endemic diseases. 3,15,18 However, it was
the second commonest PGN in a study conducted in
Nepal and a high frequency was found in Romania,
attributable to the higher prevalence of infectious
diseases like streptococcal infection and Hepatitis B
and C. 19,24 In our study MPGN comprised 9.4% of all
PGN, which is slightly higher compared to other
South Indian studies conducted at Vellore (5.2%) and
Hyderabad (7.5%). 3,12
The commonest SGN in our study was DN
comprising 77% of all SGD, followed by LN. In the
many studies worldwide, including East and West
Asian, European, South American and Arab
countries, LN was the most frequent SGN and the
Clement et al.,
prevalence of DN was low. 2,7,8,14,15,18,19 This variation

is due to different selection criteria for renal biopsy in
these patients. In the absence of clinical data
suggestive of another disease (Non-diabetic renal
disease, NDRD), DN is usually diagnosed without a
renal biopsy, further, patients with superimposed
retinopathy and long disease duration are generally
not considered for biopsy irrespective of the severity
of renal syndromes.2,8 Given the relatively higher
prevalence of NDRD in our set up, we adopt a more
liberalised biopsy procedure and all diabetics ,
irrespective of presence or absence of retinopathy
and disease duration, with the slightest clinical
suspicion of superimposed NDRD are biopsied. 25
Certain studies from Pakistan and UAE have reported
a high frequency of amyloidosis. However, despite
the higher prevalence of tuberculosis and other
infectious diseases, amyloidosis comprised only 1.2%
of SGN in our study. This is because the disease is
confirmed in suspected cases by gingival or
abdominal fat pad biopsies rather than renal biopsy.
TIN are generally diagnosed based on clinical data
and other less invasive procedures rather than renal
biopsy, accounting for their less frequency in many
studies.8 Compared to the other two South Indian
studies, our study shows a relatively high frequency
of TIN (20% of BPRD). This is because we biopsy
these cases more frequently as we believe that i) TIN
and other renal diseases with renal failure/
insufficiency cannot be often differentiated based on
clinical and laboratory data ii) with an early diagnosis
most acute TIN can be successfully treated and iii)
delayed diagnosis leading to delayed treatment of
acute TIN, may lead to interstitial fibrosis.
Drawing accurate conclusions from and making
comparisons with other published studies from same
and different countries was difficult, as there were
several biases related to racial and geographic
characteristics, renal biopsy indications, different
patho-physiological classifications and categorisation
of clinical syndromes.
CONCLUSION
We have documented the demographics of BPRD in
our South Indian patient population. The distribution
pattern of PGN largely corresponds to the distribution
pattern described in other South Indian studies.
However, there is a wide variation of major histologic
patterns of PGN across the world. Our study
964
represents an important contribution to understanding

the epidemiology of renal disease in South India.
Finally, in order to obtain an accurate overview of the
epidemiology of BPRD in our country, it is
imperative to maintain a national registry with
participation from the many Nephrology Centers.
Acknowledgement
Dr. A.C Ashok, Principal and Dean, M.S Ramaiah
Medical College and Hospitals for his support and
encouragement.
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DOI: 10.5958/2319-5886.2014.00033.2

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
Coden: IJMRHS
st
Research article
Copyright @2014
ISSN: 2319-5886
VALUE OF ELECTROCARDIOGRAM IN PREDIALYTIC CHRONIC KIDNEY DISEASE PATIENT

WITHOUT KNOWN CORONARY ARTERY DISEASE
*Dutta PK1, Das S2
1
Department of Nephrology, Chittagong Medical College, Bangladesh

Department of medicine, Chittagong Medical College, Bangladesh
*Corresponding author email: duttaprd@gmail.com

ABSTRACT
Chronic Kidney disease (CKD) is a pressing public health burden occurring in about 10% of the population. The
majority of them die before reaching End Stage Renal Disease (ESRD) due to cardiovascular disease (CVD).
Hypertension (HTN) and anaemia are two reversible factors for progression of CKD. Besides asymptomatic
coronary artery disease, the electrolyte abnormalities such as hyperkalaemia and hypocalcaemia also subject these
patients to sudden cardiac death. This study is aimed at to see the changes in electrocardiogram (ECG) in
hospitalized predialytic CKD patients due to these abnormalities. Methods: This is a 6 months cross-sectional
study carried out at Chittagong Medical College Hospital in Chittagong, Bangladesh. 50 patients with stages 3, 4
and 5 CKD were recruited from the Nephrology and Medicine wards. Patients with prior history of coronary artery
disease, cardiomyopathy, valvular heart disease and dialysis were excluded. All had their standard 12lead
electrocardiogram (ECG) recorded and various findings were critically studied and interpreted independently by
two consultant physicians including a cardiologist. Data analysis was done using SPSS version 19. Results: LVH
(left ventricular hypertrophy) (66%), LAE (left atrial enlargement) (30%) and unrecognized myocardial infarction
(28%) were very common ECG abnormalities in our predialytic CKD patients. HTN, anaemia, late presentation,
and male gender appear to be associated with ECG abnormalities. Though 28 patients (56%) were hyperkalaemic
only 9 patients (38%) of them had tall tented T wave in ECG. Conclusion: Detection of HTN and anaemia in male
predialytic CKD patients will arouse suspicion which will help in early detection of cardiac outcome by ECG
abnormality which will help in taking treatment strategy in resource limited country.
Keywords: Chronic Kidney Disease, Electrocardiogram, Cardiovascular disease. Left Ventricular Hypertrophy,
INTRODUCTION
The numbers of patients affected by chronic kidney
disease (CKD) are increasing globally1.The
progressive nature of chronic kidney failure and the
ensuing end-stage renal disease (ESRD) necessitating
renal replacement therapy (RRT) is imposing a
substantial burden on global healthcare resources.
Only developed countries have sufficient wealth to
meet the cost of renal replacement therapy RRT. If

pathophysiology of CKD is well understood, it helps
in early detection and prevention and so less costly
therapy to prevent progression 2. CKD has an
increased risk of not only ESRD, but majority of
moderate CKD patients die from CVD before
reaching ESRD 3-5. CKD patients are at high risk of
Dutta et al.,
967
CVD, which account for 40-50% of the deaths in this

population6,7. HTN, dyslipidaemia and diabetes (DM)
are major risk factors for the development of
endothelial dysfunction and progression of
atherosclerosis. Elevated Inflammatory mediators and
renin-angiotensin system in CKD will also lead to
increased prevalence of coronary artery disease, heart
failure, stroke and peripheral arterial disease.
Prevention and treatment of CVD are a major
consideration in the management of individuals with
CKD8. The cardiovascular risk attributable to CKD is
not restricted to those requiring renal replacement
therapy, but is evident even in predialytic CKD 9.
Even non diabetic CKD is associated with increased
risk of cardiovascular (CV) morbidity and mortality
10,11
. Sudden cardiac death constitutes 62% of the CV
mortality in ESRD probably due to CVD resulting
from myocardial structural changes, electrolyte
imbalance, and autonomic dysfunction12.The factors
contributory to cardiac abnormalities include
anaemia, HTN, volume overload, ischaemic heart
disease, uraemic cardiomyopathy, electrolyte
imbalance, hyperlipidaemia, and arteriovenous
fistula13-15. Near about 18 million people have CKD
in
Bangladesh16.
The
occurrence
of
electrocardiographic (ECG) changes in uraemic
patients has been recognized for decade.
Electrocardiography is readily available and an
inexpensive tool to assess the burden of
cardiovascular disease. An association of resting
electrocardiographic
markers
with
clinical
cardiovascular events could promote 12 lead ECG as
a clinical tool for cardiovascular risk stratification in
the CKD setting for which reliable markers of
subclinical cardiovascular disease are otherwise
lacking especially in resource poor nation like
Bangladesh. In most of Asian patients, prognosis of
patients with advanced CKD is very poor because of
late referral and inability to pay for treatment. It is
thought that majority of these patients would have
died from cardiovascular events in the earlier stages
of CKD without access to any health facility. Resting
electrocardiographic abnormalities are common in
CKD, even in nondialytic patients and independently
predict future clinical CV events in this setting 7, 17.
Electrocardiographic abnormalities like Q-T interval
prolongation which often occur with left ventricular
hypertrophy (LVH) may predispose renal failure
patients to various forms of arrhythmias and sudden
death 18-20. An Italian survey has shown that ECG

abnormalities (Rhythm abnormalities, intraventricular
conduction defects, ventricular repolarization
alterations, and left axis deviation) are independently
associated with the presence of CKD 21. Knowledge
about CVD in CKD will help in early mortality risk
prediction as well as reduction of repeated
hospitalization. This study aimed to determine
prevalence and pattern of electrocardiographic
abnormalities among predialytic CKD patients and its
association with anaemia, HTN and electrolyte
abnormality in Chittagong Medical College Hospital,
a tertiary hospital in southern part of Bangladesh.
Dutta et al.,

It is a cross sectional observational study carried out
in Nephrology and Medicine, Department of CMCH,
Chittagong through October 2012 to March 2013.
The study was approved by Chittagong Medical
College ethical review committee. Fifty consecutive
predialytic CKD patients irrespective of age were
enrolled. Patients on dialysis; with valvular heart
disease, cardiomyopathy prior to diagnosis of
Chronic Kidney Disease and with known coronary
artery disease were excluded. Stages of CKD were
defined by Cockcroft-Gault equation3. Previous
coronary artery disease is defined as history of acute
coronary syndrome- STEMI/ NSTEMI/ UNSTABLE
ANGINA (as per patients' self documented past
medical record); or a history of revascularization
(CABG/STENTING). Socioeconomic status (SES)
was measured using a scale of Rahman M et al.
supported by ICDDRB, after partial modification22.
LVH was defined as Sokolow-Lyon Criteria (S wave
in lead V1 + R wave in lead V5 or V6> 3.50 mV or R
wave in lead avL 1.1 mV23. LAE was taken as the
Prolonged P wave duration > 120 msec in lead II
23
.The Q-T interval is the interval from the beginning
of the QRS complex to the end of the T wave. Values
more than 0.44 second was considered as
prolonged23. Corrected QT interval, or Q-Tc, defined
as Q-Tc = QT/R-R. Unrecognized myocardial
infarction was defined as the presence of diagnostic
Q-wave abnormalities without self-reported. The T
waves were normal in more than 50% of patients with
hypocalcemia, but decreased T-wave voltage and
even negative to deeply negative T waves have been
reported. Tall, widened and characteristically shaped
tall peaked T wave, widening of QRS complex,
968
bizarre intraventricular conduction disturbance,

progressive diminution and eventual disappearance of
P wave were taken as hyperkalaemia. Serum
Potassium more than 5.5mmol/l was considered as
Hyperkalaemia24. Serum calcium less than 2.1 mmol/l
or 8.5 mg/dl (after correction with serum albumin)
was considered as hypocalcaemia. Haemoglobin level
less than 13.5 g/dL (135 g/L) for men and less than
12.0 g/dl (120 g/L) for women (KDOQI 2006) was
considered as anaemia6. Hypertension was defined as
systolic BP more than 140 mm of Hg, diastolic BP
more than 90 mm of Hg or requiring
antihypertensive6 From all eligible subjects after
getting written consent, clinical history was taken and
clinical examination was done to elicit findings
related to renal diseases and its complication. Related
investigations like RBS, S. creatinine, Hb%, Serum
K+, Serum Ca+, Serum albumin were also done. Urine
was collected as a fresh morning sample in a sterile
container and 10cc venous blood was collected. All
investigations were done in Clinical Pathology and
Nephrology departments of CMCH.
Resting
electrocardiography was done. After explaining the
procedure to the subjects to allay anxiety, the upper
clothing, and all accessory dressings (watches,
necklaces, and rings) were removed. The ECG leads
were placed accordingly, in line with the
recommendation of the American Heart Association
guidelines. The calibrations were 1 mV=10 mm (10
small squares) on the vertical line and ECG speed of
25 and 50 mm/s were used. Lead II was used as the
rhythm strip. The ECGs were analysed quantitatively
to obtain heart rate, rhythm, QRS axis, P wave, QRS
morphology, PR interval. QT intervals in each of the
leads were measured. At least three consecutive
cycles were measured for each lead and then
averaged. All relevant data were noted in the pre
tested data sheet. Quantitative data were expressed as
mean and standard deviation and qualitative data
were expressed as frequency distribution and
percentage. Statistical analysis: Statistical analysis
was performed by using SPSS (Statistical Package for
Social Sciences) for windows version 19.0. 95%
confidence limit was taken. Probability value <0.05
was considered as level of significance.
RESULTS
patients was 37.24 years. Two-thirds patients came

from lower middle class family. Most of the patients
were in Stage 5 of CKD [table 1]. Eighty percent of
patients had HTN and HTN prevalence in stage 5 is
statistically significant than stage 3. The overall
prevalence of unrecognized MI in this study was 28%
(14 among 50 patients) and distributed in stage 3 to
stage 5 CKD patients but not significant [table 2]. 33
patients out of 50 (66%) had anaemia, demonstrated
that the prevalence of anaemia in the different stages
of CKD was considerably elevated. The prevalence
also increased as CKD progressed (fig1).
Among 33 (66%) anaemic patients, 10 patients had
unrecognized MI, whereas among 17 (34%) patients
without anaemia, 4 patients had unrecognized MI. So
it was not significant [table 3].
The overall prevalence of ECG evidence of LVH was
33 (66%) and was found in all three stages of CKD
(stage 3 to 5) which is statistically not significant.
Among 50 patients, 15 (30%) patients had LAE
which was distributed in all three stages (3 to 5) of
CKD but more LAE were present in stage 5 CKD
patients, i.e. 9 patients (30%). However, this
distribution was not statistically significant. There
were 11 (22%) patients with prolonged Q-TC and
distributed in stage 3 to stage 5 CKD patients. This
distribution was also not significant [table 4].
Among 33 anaemic patients, 28 patients had ECG
evidence of LVH. This distribution was significant
[table4].
Hyperkalaemia was found in all three stages of CKD,
overall prevalence 56% (28 patient out of 50), most
of them 18 (36%) in stage 5. It was not significant.
There were 14 (28%) patients with biochemical
evidence of hypocalcemia and distributed in all three
stages of CKD patient, its association with different
stages of CKD is not significant (table 5)
28 patients had hyperkalaemia and 22 patients had no
hyperkalaemia. Among 28 hyperkalaemic patients 25
patients had serum potassium in the range of 5.5-6.5
and 8 of these patients had tall peaked T wave. On the
other hand 3 patients had serum potassium level >6.5
mmol/l, only 1 patient had tall peaked T wave.
Among 22 patients with serum potassium < 5.5
mmol/l, only 1 patient had tall peaked T wave (table
7).
More than two-thirds of patients were male and only

one fifth were hard workers. Mean age of the
969
Dutta et al.,
Table 1:
(n=50)
Baseline characteristics of subjects
Characteristics
Frequency
Sex
Male
35
Female
15
Socioeconomic Status*
Lower class
10
Lower
33
middle class
Upper
5
Middle Class
Upper Class
2
Characteristics
Stages of CKD
Stage 3
7
Stage 4
13
Stage 5
30
Percent
70
30
20
66
Table 3: Association of anaemia with, un

recognized MI:
Unrecognized MI*
Total
Anaemia
Present
Present
10(30.3)
Absent
23(69.7)
33
Absent
4(23.5)
13(76.5)
17
Total
14(28)
36 (72)
50
10
*Chi square value = .255, DF= 1, p= 0.613;

parenthesis shows percentage
Table4. Association of LVH, LAE and

prolonged Q-Tc with CKD
14
26
60
CKD
*Ref: 22
Table 2. Cardiovascular events (n=50)
Characteristics
HTN
Stage 3
Stage 4
Stage 5
Unrecognized MI
Stage 3
Stage 4
Stage 5
Characteristics
Stages of CKD
Stage 3
Stage 4
Stage 5
Frequency
Percent
2
8
30
5
20
75*
2
4
8
14.3
28.6
57.1
7
13
30
14
26
60
*p value = .001; p value = .962 (compared to sum of

stages 2&3)
LVH
LAE
stage
Table
IV. Association of
prolonged Q-Tc with CKD
Prolonged
LVH, Q-Tc
LAE
%
withi
n
stage
71.4
Present
/total
pts
%
within
stage
Present
/
Total
pts
5/7
2/7
8/13
61.5
20/30
66.7*
and
28.5
Prese
nt
/total
pts
1/7
%
withi
n
stage
14.3
4/13
30.7
5/13
38.5
9/30
30
5/30
16.7
*p = 0.899; P = 0.995; p=0.247

Table 5: Association of anaemia with ECG
evidence of LVH
Anaemia
ECG evidence of LVH*
Present
Present
28
Absent
5
Total
33
Absent
12
17
Total
33
17
50
*Chi square value = 15.366, DF= 1, p= 0.00

Table 6. Association of Hyperkalaemia and
Hypocalcaemia with different stages of CLKD
CKD
Hyperkalaemia
Hypocalcaemia
stage
Present %within Present/ %wit
/
stage
total pts hin
total pts
Stage
3
4/7
57.1
1/7
14.3
Fig 1: Relation of anaemia (Hb gm/dl) with stages of
CKD; as CKD stages progress hemoglobin levels also
declining. (p=0.001)
6/13
46.2
4/13
30.8
18/30
60 *
9/30
30
* Chi square value =.710, DF=2, P= 0.701; Chi

square value = 2.762, DF= 2, p= 0.683
970
Dutta et al.,
Table 7: Association of tall peaked T wave with

serum potassium level
Serum
K+
level
(mmol/
l)
<5.
5
5.5
6.5
>6.5
Hyperkalaemia(n=50)
Yes(n=28)
No(n=22)
Tall tented T
Tall tented T
Present
Absent
Presen
Absent
(n=9)
(n=19)
t
(n=21)
(n=1)
Count
Count
Count
Count
0
0
1(4.5
21(95.
%)
5%)
8(28.5
17(60.7
0
0
%)
%)
1(3.5%)
2(7.1%)
DISCUSSION
In this hospital-based study, predialytic CKD patients
were evaluated for ECG changes who had no history
of coronary artery disease, cardiomyopathy and
valvular heart disease.
In the present study male to female ratio was 2.3. The
mean age of all patients was 37.24 years like other
studies in Nigeria and other parts of Bangladesh but
unlike developed countries25,26,27. Most of the patients
were sedentary and moderate workers (40% each)
and belonged to the lower middle class families
(66%) 22. Patients admitting the Government medical
college hospital are mostly from lower middle class.
Most of the patients (60%) were at stage 5 as
classified by Cockcroft and Gault formula. This was
due to the fact that in our country patient did not get
admitted till they are severely symptomatic.
The leading electrocardiographic abnormalities
among our CKD patients were LVH (66%), LAE
(30%), unrecognized myocardial infarction (28%),
prolonged Q-Tc (22%) and tall peaked T wave
(20%). The prevalence of LVH in this study was
below the study by Nwankwo et al and higher than
that by Chijioke et al possibly due to higher
prevalence of HTN and predialytic patients 17,19.
There is gender variation (male preponderance) in
proportion of LVH in CKD patients due to
differences in body size28, 29. It is also true in our
study. The very high prevalence of LVH among our
patients appears to be related to late presentation and
poor control of blood pressure. Costa et al. found
sensitivities
above
50%
for
all
the
electrocardiographic LVH criteria in a study30,.
Paoletti et al stated that left ventricular hypertrophy
was the strongest predictor of fatal arrhythmias in
ESRD patients 31. Furthermore, regression of

electrocardiographic LVH is associated with
reduction in adverse cardiovascular outcomes32.
Therefore, the ECG-LVH remains of value for the
diagnosis and follow-up of target organ damage
among patients with CKD.
Like Kajmi et al in our study, 66% of patients had
anaemia, which gradually increased with progression
of CKD 33, . In this study, we also tried to correlate
ECG evidence of LVH with the presence of anaemia;
the prevalence of ECG evidence of LVH between
those with and without anaemia was statistically
significant. Different studies have shown an
association between anaemia and hospitalization,
quality of life and mortality in CKD patients, with the
mortality risk increasing as the haemoglobin level
falls below 10gm/dl, 34
In our study total 40 (80%) patients had hypertension
and among them 30 (60%) patients with stage 5. Here
we tried to correlate presence of HTN with stages of
CKD; it was significantly distributed reflecting
prevalence of HTN increases as renal function
declines. Natalia Ridao et al showed 60.5%
prevalence of HTN35, 36.
LVH regression is expected to reduce cardiac
arrhythmias, new onset cardiac failure and sudden
death 37. Therefore, if we try to intervene LVH by
prompt treatment of HTN and anaemia especially in
resource poor nations like ours, we can halt
progression of CKD and reduce the incidence of
cardiovascular mortality.
In our study we found out of 28 hyperkalaemic
patients 9 patients had tall T wave whereas 1patient
had tall T wave without biochemical evidence of
hyperkalaemia. And only out of 3 patients with
potassium level above 6.5 mmol/l one patient had tall
peaked T wave. In one published series out of 127
patients with serum potassium concentrations ranging
between 6 and 9.3mEq/L, only 46% of ECG was
noted to have changes suggestive of hyperkalaemia,
including peaking of T waves38, 39 . There are multiple
case reports of patients with renal failure who
presented without significant ECG changes despite
markedly elevated potassium levels40. It has been
postulated that cardiac and neuromuscular
complications of hyperkalaemia are less evident in
ESRD patients due to variable serum calcium
concentration 41.
971
Dutta et al.,
Unrecognized myocardial infarction found in 14

patients (28%); 8 of them in stage 5, which is higher
than the previous report, which showed that, the
prevalence of unrecognized myocardial infarction
was 13% compared with 4% in those without CKD42.
This may be explained by less access of our
population to health care facilities, as a result, there is
a high prevalence of incident diagnosis of
unrecognized MI. Moreover CKD stages 3 to 5 were
included in our study rather than CKD stages 4 and 5.
We also tried to correlate unrecognized MI with
anaemia, but here it was statistically not significant.
We overlooked ST-T changes as because there is a
high prevalence of non-specific ST-T changes in
CKD patient and is thought to be due to LVH,
volume overload and electrolyte abnormalities
typically seen in CKD patients. Baseline ECG
abnormalities are much rarer in the general
population, occurring in only 8.5% of men and 7.7%
of women43. In this study
out of 14 (28%)
hypocalcaemia patients we found 11 patients (22% of
total study population) with prolonged Q-Tc, a
substrate for torsades de pointes and ventricular
tachycardia which was distributed in all stages of
CKD mostly in stage 5 (5 patients) . It is likely that
the progression of CKD, probably through its
association with heart disease or progressive cardiac
calcification, is the main explanation for this
tendency toward prolonged Q-Tc44.
Limitations: Limitations of this study was small
sample size, single center study, absence of long term
follow up, use of only baseline ECG for evaluation of
CVD and use of only self reported documents to
exclude previous CVD.
ACKNOWLEDGEMENTS
We propose thanks to the Director, Chittagong
Medical College Hospital, Principal Chittagong
Medical College, all doctors and technical staff of
the Department of Nephrology for their sincere cooperation. We would also like to express our
gratitude to the patients for their co-operation
during the study.
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In conclusion, LVH, LAE, unrecognized myocardial

infarction, were very common ECG abnormalities in
our pre dialytic CKD patients which was most
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male patients. An ECG should be enlisted in the
initial investigation in CKD patients as a screening
test which guides the clinician for further evaluation
of cardiovascular disease. We should use biochemical
level of serum potassium for management of
hyperkalaemia in advanced CKD patient rather than
ECG evidence of hyperkalaemia, as ECG evidence of
hyperkalaemia is less pronounced in advanced CKD
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Murray DC, Barre PE. Serial Change in
Echocardiograph Parameters and Cardiac
Outcome in ESRD. J Am Soc Nephrol 1998;
9:249.
Acker CG, Johnson JP, Palevsky PM, Greenberg
A: Hyperkalemia in hospitalized patients: Causes,
adequacy of treatment, and results of an attempt
to improve physician compliance with published
therapy guidelines. Arch Intern Med 1998;
158(8): 91724
Martinez-Vea A, Bardaji A, Garcia C, Oliver JA.
Severe
hyperkalemia
with
minimal
electrocardiographic manifestations: A report of
seven cases. J Electrocardiol 1999; 32(1): 4549.
Szerlip HM, Weiss J, Singer I. Profound
hyperkalemia
without
manifestations. Am J Kidney Dis 1986; 7: 461
65
Rizk DV, Gutierrez O, Levitan EB, McClellan
WM, Safford M, Solaiman EZ et al. Prevalence
and prognosis of unrecognized myocardial
infarctions in chronic kidney disease. Nephrol
Dial Transplant. 2012; 27(9):3482-8.
Kannel WB, Anderson K, McGee DL, Degatano
LS, Stampfer MJ. Nonspecific electro-
cardiographic abnormality as a predictor of

coronary heart disease: the Framingham Study.
Am Heart J 1987; 113(1): 370-6.
43. Ghosh B, Brojen T, Banerjee S, Singh N ,Sing S,
Sharma OP et al. The high prevalence of chronic
kidney disease-mineral bone disorders: A
hospital-based cross-sectional study. Indian J
Nephrol. 2012; 22(4):285-91.
44. Mozos I, Serban C,Rodica M. International
journal of collaborative Research on internal
medicine& public Health 2012;4(22):2084-91
974
Dutta et al.,
DOI: 10.5958/2319-5886.2014.00034.4

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Short communication
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 20 Aug 2014
PRESCRIPTION EVENT MONITORING STUDY TO ASSESS THE SAFETY PROFILE OF ORAL

NATURAL MICRONIZED PROGESTERONE SUSTAINED RELEASE IN INDIA
*Purandare AC1, Hajare A2, Krishnaprasad K2, Bhargava A2
1
Obstetrician & Gynaecologist, Chowpatty Maternity & Gynecology Hospital, Chowpatty, Mumbai
Medical Services, Glenmark Pharmaceuticals, Mumbai
*Corresponding author email: drameyacp@gmail.com

ABSTRACT
Background: Role of natural micronized progesterone (NMP) in various therapeutic conditions, including luteal
phase correction and luteal phase support (LPS) has been very well highlighted1, 2. It offers better safety profile on
long term administration with ancillary immunomodulatory and anti-inflammatory properties3. Oral NMP in the
form of sustained release (SR) offers better patient compliance due to once a day dosage schedule4. This employs
a novel matrix technology for the release of progesterone in small pulses into the systemic circulation over a
period of 24 hours, thereby minimizing the hepatic metabolism related side effects including sedation or
drowsiness. Objective: To study the safety profile of oral NMP SR (Dubagest SR), a PEM study was conducted
in the outpatient settings in India. Materials and methods: PEM study is a method employed worldwide to
provide useful safety information on the drug when prescribed in Real-life clinic settings. Patients with bad
obstetric history (BOH) or unexplained infertility were prescribed either 300 or 400 mg SR once a day following
induction with Natural or Stimulated ART cycle for two months. Safety information related as Events was
captured on the Study questionnaire sheet provided to 35 doctors across India for five patients at each centre
between March and May 13.Results: 153 patients completed the study with a mean of 27yrs& 55kgs. In
infertility patients with BOH 87% patients had 2 abortions. The formulation was prescribed for Luteal Phase
Support in Unexplained infertility (43.8%) or BOH (50%) and Secondary Amenorrhoea (5.9%). Oral NMP 300
mg SR was the most commonly prescribed formulation. The formulation was well tolerated with side effects
including drowsiness (0.6%), hyperemesis (1.3%)& giddiness (0.6%) that were mild and transient. Two patients
reported Spotting that disappeared on continued therapy and in other case probably related to reappearance of
menses. Conclusion: Oral NMP SR is a clinically feasible option for LPS especially in BOH cases having
Insignificant side effect profile for improved compliance.
975
Purandare et al.,
%100
pts
80
60
43.8%
50%
40
20
5.9%
0
LPS in
Unexplained
infertility
LPS in BOH
Sec
Amenorrhea
2. Frishman G, Klock S, Luciano A, Nulsen J.

Efficacy of oral micronized progesterone in
the treatment of luteal phase defects. Journal
of reproductive medicine. 1995;40(7):521-4.
3. Cedars MI. Progesterone: Uses in ART and
prevention of pregnancy loss. The Journal of
Family Practice. 2007; (Suppl - 1):9-13.
4. Kyurkchiev D, Ivanova-Todorova E,
Kyurkchiev SD. New target cells of the
immunomodulatory effects of progesterone.
Reproductive
biomedicine
online.
2010;21(3):304-11.
Fig 1: Clinical indications for oral NMP SR
Fig. 3 - LPS
in BOH
Fig. 2 - LPS in
unexplained
infertility
% pts
5
4
3
2
1
1.3%
0.6%
0.6%
0
Drowsiness
Hyperemesis
Giddiness
Fig. 3: Side effects with oral NMP SR

Paper was presented as Oral presentation by Dr.
Purandare AC at AICOG 2013 conference held at
Patna
REFERENCES
1. Schindler AE, Druckmann R, Huber J,

Pasqualini JR, Schweppe KW, Thijssen JH.
Classification and pharmacology of
progestins. Maturitas. 2003;46:7-16.
976
Purandare et al.,
DOI: 10.5958/2319-5886.2014.00035.6

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
Received: 6th June 2014
Review article
STEM CELLS IN ENDODONTIC THERAPY
*Sita Rama Kumar M1, Madhu Varma K2, Kalyan Satish R3, Manikya kumar Nanduri.R4, Murali Krishnam Raju S5,
Mohan rao6
1
Senior Lecturer, 2,3Professor, Department of Conservative Dentistry and Endodontics, Vishnu dental college,
Bhimavaram, Andhra Pradesh, India
4
Senior Lecturer, Department of Pedodontics, Lenora Institute of Dental Sciences, Rajahmundry, Andhra Pradesh,
India
5
Senior Lecturer, Department of Conservative Dentistry and Endodontics, GSL Dental College, Rajahmundry, Andhra
Pradesh, India
6
Senior Lecturer, Department of Conservative Dentistry and Endodontics, Anil Neerukonda Institute of Dental
sciences, Vishakapatnam, Andhra Pradesh, India
*Corresponding author email: sitaramrajubds@gmail.com.

ABSTRACT
Stem cells have the remarkable potential to develop into many different cell types in the body. Serving as a sort of
repair system for the body, they can theoretically divide without limit to replenish other cells as long as the person or
animal is still alive. However, progress in stem cell biology and tissue engineering may present new options for
replacing heavily damaged or lost teeth, or even individual tooth structures. The goal of this review is to discuss the
potential impact of dental pulp stem cells on regenerative endodontics.
Keywords: Dental pulp complex stem cells, Periodontal ligament stem cells, Stem cells from human-exfoliated
deciduous teeth, Stem Cells from apical papilla.
INTRODUCTION
The complex structural composition of teeth ensures
both hardness and durability. These structures are
vulnerable to trauma and bacterial infections. As
ameloblasts are lost during eruption and odontoblasts
can create new dentine only on a dentine-pulp border, a
damaged tooth cannot self-repair. However, teeth show
a degree of reparative processes such as a tertiary
dentine formation. Once the odontoblast layer is
damaged, odontoblast-like cells are recruited from
somewhere within the pulp. Loss of the tooth, jawbone
or both, due to periodontal disease, dental caries, trauma
or some genetic disorders, affects not only basic mouth
functions but aesthetic appearance and quality of life.
Current dentistry resolves these problems using
autologous tissue grafts or metallic implants. These
treatments have some limitations such as an adjoining

tooth damage, bone resorption etc. The stem cell
bioengineered tooth is a promising way of single tooth
restoration. Some studies have reported that after dental
pulp necrosis, dental pulp complex stem cells (DPSCs)
can be used for the creation of dental pulp, which after
implantation into the shaped root canals has affinity for
the dentine1.More recently the potential use of stem
cells in dental pulp tissue engineering has boosted much
interest in the field of Regenerative Endodontics.
Stem cells are defined as clonogenic cells capable of
both self- renewal and multilineage differentiation since
they are thought to be undifferentiated cells with
varying degrees of potency and plasticity2. They
977
Sita Rama Kumar et al.,
differentiate into one daughter stem cell and one

progenitor cell.
Classification of stem cells:
I. Stem cells can be classified according to their
plasticity: i) Totipotent stem cell ii) Pluripotent stem
cell. iii) Multipotent stem cell.
II. Stem cells can be classified according to their
growth stage3:
a) Embryonic stem cells - located within the inner
cell mass of the blastocyst stage of development.
These stem cells have the highest potential to
regenerate and repair diseased tissue and organs in
the body.
b) Postnatal stem cells/ Adult stem cells - that have
been isolated from various tissues including bone
marrow, neural tissue, dental pulp and periodontal
ligament. These are multipotent stem cells capable
of differentiating into more than one cell type, but
not all cell types.
III. Stem cells often categorized by their source.
a) Autologous stem cells - are obtained from the same
individual to whom they will be implanted.
b) Allogeneic stem cells - originate from a donor of
the same species.
c) Xenogenic cells - are those isolated from
individuals of another species.
Characteristics of stem cells:
1. Totipotency: generate all types of cells, including
germ cells (ESCs).
2. Pluripotency: generate all types of cells except cells of
the embryonic membrane.
Induced pluripotent stem cells (IPS) are an evolving
concept in which 3-4 genes found in the stem cells are
transfected into the donor cells using appropriate
vectors. The stem cells, thus derived by culturing will
have properties almost like embryonic stem cells.
3. Multipotency: differentiate into more than one mature
cell (MSC).
4. Self-renewal: divide without differentiation and create
everlasting supply.
5. Plasticity: MSCs have plasticity and can undergo
differentiation. The trigger for plasticity is stress or
tissue injury which up regulates the stem cells and
releases chemo attractants and growth factors.
Various sources for postnatal dental stem cells have
been successfully studied:
Permanent teeth - Dental pulp stem cells (DPSC):
derived from third molar4.
Deciduous teeth - Stem cells from human-exfoliated

deciduous teeth (SHED): stem cells are present
within the pulp tissue of deciduous teeth6.
Periodontal ligament - Periodontal ligament stem
cells6 (PDLSC).
Stem Cells from apical papilla7 (SCAP).
Stem cells from supernumerary tooth Mesiodens8.
Stem cells from teeth extracted for orthodontic
purposes9.
Dental follicle progenitor cells10.
Stem cells from human natal dental pulp11 (hNDP).
The Stem Cells that are found in the pulp of deciduous
and permanent teeth are adult multipotent mesenchymal
Stem Cells. The central region of the pulp contains large
nerve trunks and blood vessels. This area is lined
peripherally by a specialized odontogenic area which
has three layers (from innermost to outermost)
1. Cell rich zone; innermost pulp layer which contains
fibroblasts and undifferentiated mesenchymal Stem
Cells.
2. Cell free zone (zone of Weil) which is rich in both
capillaries and nerve networks. The nerve plexus of
Rashkow are located in this zone.
3. Odontoblastic layer; outermost layer which
contains odontoblasts and lies next to the predentin
and mature dentin.
Dental pulp stem cells (DPSC): Mesenchymal stem
cells that are isolated from the dental pulp of permanent
teeth, are termed as Dental Pulp Stem Cells12 (DPSC).
Dental follicle stem cells (DFSCs) are isolated from
mesenchymal tissue localized around developing tooth
germ. This source of stem cells can be easily obtained
from follicles of impacted third molars13. DFSCs are
recognized as progenitors for cementoblasts, PDL stem
cells, osteoblasts as well as neural cells. DFSCs have the
capacity to induce calcification processes in vitro and in
vivo. Experiments undertaken with DFSCs revealed
their potential for use in tissue engineering applications,
including periodontal and bone regeneration. DFSCs are
recognized as osteogenesis and dentinogenesis
inductors, but have not shown ability to produce dentinpulp complex formation14, 15. DPSCs have three
advantages over other more widely researched stem cell
sources. The first is that they are possibly more prone to
forming neurons than other stem cells. The second
advantage is that there are fewer ethical consideration
than those which shroud other stem cells. Thirdly, they
are more easily isolated than other stem cells, such as
MSCs from the bone marrow and NSCs from cadavers.
The factors which make dental stem cells unique are:
978
They are plentiful and easy to collect. Unlike

harvesting bone marrow stem cells, which requires
invasive surgery and cord blood stem cells, which
are only available at birth, dental stem cells can be
collected from baby teeth and wisdom teeth which
would otherwise be discarded.
Dental stem cells are highly proliferative, growing
better in culture than many other types of adult stem
cells.
Dental stem cells have been reported to be more
immature than other sources of mesenchymal stem
cells (MSCs), thus may offer greater potential.
Dental stem cells are adult stem cells and are not the
subject of the same ethical concerns as embryonic
stem cells. (http://www.store-a-tooth.com/).
Stem cells from Human Exfoliated Deciduous teeth
(SHED): Mesenchymal stem cells that are isolated from
the dental pulp of exfoliated deciduous teeth, are termed
as Stem cells from Human Exfoliated Deciduous teeth5
(SHED). SHED were identified to be a population of
highly proliferative clonogenic cells capable of
differentiating into a variety of cell types including
neural cells, adipocytes and odontoblasts5. Deciduous
teeth are the ideal resource of stem cells to repair
damaged tooth structures, induce bone regeneration and
possibly treat neuronal tissue injury or degenerative
diseases. The difference between dental stem cells and
cord blood stem cells are dental pulp contains mostly
mesenchymal stem cells while cord blood consists
predominantly of hematopoietic stem cells; bone
marrow contains both types of stem cells. While cord
blood stem cells have proven valuable in the
regeneration of blood cell types, dental stem cells are
able to regenerate solid tissue types that cord blood are
less well suited for - such as potentially repairing
connective tissues, dental tissues, neuronal tissue and
bone. (http://www.store-a-tooth.com/).
SHED are distinct from DPSC with respect to their
higher proliferation rate, increased cell population
doublings, viability, osteoinductive capacities and
failure to reconstitute a dentin pulp like complex.
Types of Stem Cells in Human Exfoliated Deciduous
teeth (SHED):
Adipocytes; Adipocytes have successfully been used to
treat cardiovascular disease, spine and orthopedic
conditions, congestive heart failure, Crohns disease,
and to be used in plastic surgery16,17.
Chondrocytes and Osteoblasts: Chondrocytes and
Osteoblasts have successfully been used to grow bone
and cartilage suitable for transplant. They have also

been used to grow intact teeth in animals5,18-20.
Mesenchymal; Mesenchymal stem cells have the
potential to treat neuronal degenerative disorders such
as Alzheimers and Parkinsons diseases, cerebral palsy,
as well as a host of other disorders5,17,20-23.Mesenchymal
stem cells have more therapeutic potential than other
type of adult stem cells5,20,23.
Periodontal ligament stem cells (PDLSC):
The PDL is a specialized tissue located between the
cementum and the alveolar bone and has as a role the
maintenance and support of the teeth. Periodontal
ligament stem cells (PDLSC), are isolated from the root
surface of extracted teeth. These cells could be isolated
as plastic-adherent, colony-forming cells, but display a
low potential for osteo-genic differentiation under in
vitro conditions. PDL stem cells differentiate into cells
or tissues very similar to periodontium. Moreover, PDL
stem cells transplanted into immune
Compromised mice and rats demonstrated the capacity
for tissue regeneration and periodontal repair24. It has
been shown that a functional periodontium could
successfully be established using PDL stem cells25.
Once the cells have been processed and stored in
freezers, all biological activity has stopped, as a result,
cells that have been properly banked can be stored
almost indefinitely. Human cells have been effectively
stored for up to 50 years.
Stem Cells from the apical papilla (SCAP):
Mesenchymal stem cells that are isolated from the apical
end of developing tooth roots, are termed as Stem Cells
from the Apical Papilla (SCAP). Stem cells from the
apical part of the human dental papilla (SCAP) have
been isolated and their potential to differentiate into
odontoblasts was compared to that of the periodontal
ligament stem cells26 (PDLSC). SCAP exhibit a higher
proliferative rate and appears more effective than
PDLSC for tooth formation. Importantly, SCAP are
easily accessible since they can be isolated from human
third molars.
Stem cells from the dental follicle (DFSCs): The
dental follicle is a mesenchymal tissue that surrounds
the developing tooth germ. During tooth root formation,
periodontal components, such as cementum, periodontal
ligament (PDL), and alveolar bone, are created by dental
follicle progenitors27. DFSCs were found to be able to
differentiate into osteoblasts / cementoblasts,
adipocytes, and neurons. In addition, immortalized
dental follicle cells were transplanted into
979
immunodeficient mice and were able to recreate a new

periodontal ligament (PDL)-like tissue after 4 weeks27.
Sources of dental stem cells: In a child the most
accessible stem cells are from the oral cavity. For
deciduous teeth, the best candidates are moderately
resorbed canine and incisors with the presence of
healthy pulp. Most Deciduous Molars are not candidates
because of their resorption pattern. In children, other
sources of easily accessible stem cells are
supernumerary teeth, mesiodens and over retained
deciduous teeth associated with congenitally missing
permanent teeth.
Potential applications of stem cells in dentistry28
The regenerative potential of adult stem cells obtained
from various sources, including dental tissues has been
of interest for clinicians over the past years and most
research is directed toward achieving the following:
Regeneration of damaged coronal dentin and pulp
Regeneration of resorbed root, cervical or apical
dentin, and repair perforations
Periodontal regeneration
Repair and replacement of bone in craniofacial defects
Whole tooth regeneration.
Role of dental stem cells in regenerative medicine29
Regenerative medicine is to regenerate fully functional
tissues or organs that can replace lost or damaged ones
occurred during diseases, injury and aging. The dynamic
features of isolated dental stem cells revealed much
potential for their use in regenerative medicine and
tissue engineering.
1. Dental Pulp Regeneration. 2. Bio-Root Engineering.
3. Neural Regeneration.
Dental stem cell banking: Dental stem cell banking
i.e., the process of storing stem cells obtained from
patients deciduous teeth and wisdom teeth, may be one
strategy to realize the potential of dental-stem-cell-based
regenerative therapy30-32. Recently, cell/tissue banks in
the dental eld has been planned and placed into
practice in several countries, e.g.,
1. Advanced Center for Tissue Engineering Ltd., Tokyo,
Japan (http://www.acte group.com/).
2. Teeth Bank Co., Ltd., Hiroshima, Japan
(http://www.teethbank.jp/).
3.
Store-A-Tooth
TM,
Lexington,
USA
(http://www.store-a-tooth.com/).
4. BioEDEN, Austin, USA (http://www.bioeden.com/).
5. Stemade Biotech Pvt. Ltd., Mumbai, India
(http://www.stemade.com/).
We can collect baby teeth for dental stem cell banking at

home,
with
the
following
restrictions:
(http://www.store-a-tooth.com/).
1. There must be a blood supply to the tooth when
it is removed that is, the tooth should bleed
slightly when removed.
2. The tooth must be banked using our Cultured
Cell Service, so lab tests can be performed to
confirm the presence of stem cells prior to
cryopreservation.
The cost to process and store stem cells for 20 years $1,250, Annually- $95.00, Monthly- $9.50.
Stem cells in endodontic therapy
Stem cells in the dental pulp: The fraction of
multipotent stem cells in the dental pulp is small33 and
the location of these cells are not clearly known, but
their phenotype is suggestive of their presence in
perivascular niches34. Both DPSC and SHED cells are
originated from the dental pulp, they exhibit significant
differences.
For
example,
during
osteogenic
differentiation, SHED present higher levels of alkaline
phosphatase activity and osteocalcin production, and
higher proliferative rate than DPSC5,35,36. SHED and
DPSC cells are capable of regenerating dentin and pulplike tissues in vivo2,5,37,38.
Stem cells and caries-induced dentinogenesis: The
dental pulp is a highly vascularized and innervated
connective tissue responsible for maintaining the tooth
vitality and able to respond to injuries. Dentinogenesis
is a unique process, which involves the interaction
between odontoblasts, endothelial cells, and nerves39.
The odontoblasts, ecto-mesenchymal derived cells, are
the first cells to respond to the injury caused by bacterial
invasion during caries progression40. The endothelial
cells and nerve cells located in the vicinity of the carious
lesion modulate the odontoblastic response41-43. Primary
odontoblasts are induced to secrete a dentin matrix that
mineralizes as reactionary dentin in response to shallow
caries44,45. This type of tertiary dentin protects the dental
pulp from irritants and maintains dental pulp integrity.
Stem cells and pulp angiogenesis: Vascular
endothelial growth factor (VEGF) is a potent inducer of
endothelial cell differentiation and survival, and it is the
most effective angiogenic factor46-48. VEGF also plays a
critical role on the control of vascular permeability
during physiological and pathological events48. VEGF is
strongly expressed by odontoblasts and in the subodontoblastic layer in vivo49-51.VEGF is potently
expressed in dental pulp tissues of teeth undergoing
980
caries-induced pulpitis, by immunohistochemical

studies52.
Application of stem cells in regenerative
endodontics:
Implantation: In pulp implantation, replacement pulp
tissue is transplanted into clean and shaped root canal
systems. The source of pulp tissue may be a purified
pulp stem cell line that is disease or pathogen-free or is
created from cells taken from a biopsy, that has been
grown in the laboratory. Stem cell treatment is not
dangerous.
Pulp revascularization: Pulp necrosis of an immature
tooth as a result of caries or trauma could arrest further
development of the root, leaving the tooth with thin root
canal walls and blunderbuss apices. Regeneration of the
pulpal tissue of an infected immature tooth might take
place if suitable environment is possible with absence of
intrapulpal infection. The pulpal space might become
repopulated with mesenchymal cells arising from dental
papilla or apical periodontium53,54.
Whole tooth regeneration: Tooth-like tissues have
been generated by the seeding of different cell types on
biodegradable scaffolds. A common methodology is to
harvest cells, expand and differentiate cells in vitro, seed
cells onto scaffolds, and implant them in vivo, in some
cases, the scaffolds are re-implanted into an extracted
tooth socket or the jaw. Ikeda et al, 2009 reported a
successful fully functioning tooth replacement in an
adult mouse achieved through the transplantation of
bioengineered tooth germ into the alveolar bone in the
lost tooth region55. This technology was proposed as a
model for future organ replacement therapies. In many
cases teeth with cavities works. However, teeth with
extensive decay, or where there is reason to believe that
the pulp has been compromised, should be discarded.
A possible risk of some stem cell treatments may be the
development of tumors or cancers. For example, when
cells are grown in culture (a process called expansion),
the cells may lose the normal mechanisms that control
growth or may lose the ability to specialize into the cell
types you need. Also, embryonic stem cells will need to
be directed into more mature cell types or they may
form tumors called teratomas. Other possible risks
include infection, tissue rejection, complications arising
from the medical procedure itself and many unforeseen
risks.
FUTURE CHALLENGES:
1. A major challenge facing regenerative techniques is
the ability to obtain a sufficient number of
autogenous cells for scaffold seeding.
2. For regeneration of the dental pulp, fabrication of

vascularized scaffolds is likely a key requirement.
3. Advances in growth factors or drugs to control the
activity of cells must be sought out.
The understanding of the mechanisms underlying pulp
angiogenic responses is critical for the development of
new, targeted therapies that aim at the conservation of
dental pulp viability. However, developments in this
area have the potential to revolutionize the way that we
practice clinical Endodontics in the future.
CONCLUSION
Stem cells are critical for the physiology of the dental
pulp and for the response of this tissue to injury. Recent
findings have unveiled dental pulp stem cells as
potential therapeutic targets in cases of reversible
pulpitis. Importantly, these cells may become the
primary strategy for the revitalization of necrotic
immature permanent teeth. Such discoveries have the
potential to fundamentally change the paradigms of
conservative vital pulp and root canal therapy, and
perhaps allow for the treatment in the future of
conditions that are presently untreatable in Dentistry.
Therefore, endodontist should recognize the potential of
the emerging eld of regenerative endodontics and the
possibility of obtaining stem cells during conventional
dental treatments that can be banked for autologous
therapeutic use in the future.
Acknowledgment: The authors would like to thank the
Vishnu dental college.
Conflict of interest: No
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DOI: 10.5958/2319-5886.2014.00036.8

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Health Sciences
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Volume 3 Issue 4
Coden: IJMRHS
nd
Review article
Copyright @2014
ISSN: 2319-5886
THE PATIENT REGISTRY: A HIGH IMPACT TOOL FOR REAL WORLD EVIDENCE
*BarickUttam1, MohantyRituraj2, GowdaArun3
1
Clinical Research Consultant, 2Associate Project Manager, 3Director, focus scientific research centre, Part of
phamax Market Access Pvt. Ltd.,KMJ Ascend,19,1stCross, 17th C Main, Fifth Block, Koramangala, Bangalore,
Karnataka, India
*Corresponding author email:uttam.barick@fs-researchcenter.com
ABSTRACT
Background: In this world of seemingly infinite data across domains, one strives to acquire better tools and
methodologies to fully exploit available data. This process begins with meticulous planning to gather relevant
information and continues until there is an output in the form of credible evidence. The ability to generate realworld evidence would take such a process to new level: the factors that influence these processes under real-world
conditions are varied, unpredictable, and unregulated. Results obtained in highly regulated or controlled
conditions are universally accepted and sought after for regulatory approvals, but performance indicators in the
real world will set the tone for the future. Hence, the demands for very reliant and robust tools and mechanisms
for gathering evidence are all the more prominent and necessary. Patient registries fill this gap and stand tall
among the various tools that could deliver the desired end results with acceptable accuracy. Over the years,
pharmaceutical companies, along with policymakers and other stakeholders, have been actively involved in the
development of such registries. Aims: Here we provide an overview of the usefulness of registries for the various
stakeholders in healthcare in terms of conduct, approach, and barriers to initiating such studies. Conclusion: One
of the impediments for the wider appeal and utility of registries is low awareness among the public and
policymakers. Incorporating them as a part of the standard global healthcare system would involve setting up a
regulatory framework.
Keywords: Patient registry, Real world evidence, Stakeholders, Classical randomized clinical trials, Health
economics
INTRODUCTION
Healthcare stakeholders the world over- from
decision makers to sponsors to physicians are
increasingly recognizing the need for more-credible,
real-world information that will allow a better
understanding of disease and its treatment beyond the
traditional randomized clinical trial (RCT). In
particular, there is a huge demand for credible
evidence on the safety and efficacy of a product once
it is already on the market, that is, the so-called postmarketing studies.1Regulators, for example, are
demanding observational studies to substantiate
Barick Uttam et al.,
claims of efficacy and safety in a broader range of

patients following approval.2Moreover, patient
groups have focused their efforts toward ensuring
outcome-informed therapy rather than having patients
simply submit to any treatment available. However,
this is not possible without first collecting reliable
data. Unfortunately, such real-world data must be
collected in line with rigorous clinical practices but
outside the controls and constraints of traditional
RCTs. Over the years, post-marketing studies have
significantly evolved in terms of both their objectives
984
and scope and are thus gaining rapid acceptance. Of

particular interest is a type of observational postmarketing study called a patient registry. The need
of the hour is to understand the complete impact of a
product, especially its safety profile, under real-world
conditions for which they are actually used. Thus,
such studies could provide the real-world
observational data so strongly demanded by
healthcare stakeholders2. However, registries
represent an emerging area that has not quite received
the attention it deserves from stakeholders the world
over. In particular, while the need for patient
registries is well understood in a general sense, few
stakeholders are aware of how such a study should be
conducted, when a registry becomes necessary, and
what the results of a registry can and cannot be used
for. Thus, the present article attempts to present a
review of the current state of the art as regards patient
registries. In what follows, we first define patient
registries as they are understood today and list the
different types of such studies. Next, we briefly
describe the usefulness of registries to various
stakeholders and identify the key stakeholder for such
studies. Subsequently, we define the most appropriate
time for registry to be conducted in terms of realizing
the maximum impact.Finally,we provide guidance on
how stakeholders can approach the problem of
conducting a registry and also enumerate the barriers
to initiating such a study.
PATIENTREGISTRIESDEMYSTIFIED
The Agency for Healthcare Research and Quality (a
part of the U.S. Department for Health and Human
Services) defines a patient registry as an organized
system that uses observational study methods to collect
uniform data (clinical and other) to evaluate specified
outcomes for a population defined by a particular
disease, condition, or exposure, and that serves one or
more predetermined scientific, clinical, or policy
purposes.3There are, basically, three categories of
patient registries:
1. Product registry : Patient is exposed to a drug or a
device
2. Health services registry: Patient is exposed to a
particular healthcare service
3. Disease or condition registry: Patient suffering
from a particular disease or condition
As registries are defined by a limited set of exclusion
criteria, they collect data from a broader range of the
population (e.g., children, elderly, pregnant women,

different racial and ethnic groups, and those with
multiple co-morbidities). More over, the data are
obtained in a more realistic setting, hence better
representing the real-world patient experience. A
patient registry can assess a products effectiveness
over time and is therefore particularly useful in
understanding the safety and efficacy profile of a
product in populations and conditions that are not
generally studied in traditional RCTs. In addition to the
clinical and safety evidence, patient registries have
proven very useful in initiatives focused on healthrelated quality of life (HRQoL) and health
economics/outcomes
research
(HE/OR).4Indeed,
registries can often offer more comprehensive data
otherwise inaccessible from classical RCTs or other
data sources, including:
1. Health outcomes
2. Patient-reported outcomes
3. Burden of diseases
4. Effectiveness of a product
5. Safety surveillance data
6. Treatment compliance
7. Reimbursement and impact of reimbursement policy
In sum, there are four key benefits that serve as the
typical goals of real-world evidence, which can be
organized under the convenient mnemonic TEAM:
Track the natural history of disease

Evaluate clinical or comparative effectiveness of a
product
Allow stakeholders to have evidence based data
Measure or Monitor the safety profile of a product
What is at stake for different stakeholders?

A properly designed patient registry has the ability to
address objectives of all stakeholders, as shown in Fig
1.The stakeholders and their objectives could be
summarized as follows:
Pharmaceutical companies
Gain market access
Maintain formulary status
Encourage product use
Challenge a therapy combination
Uncover safety concerns
Understand Risk Evaluation and Mitigation
Strategy (REMS)3,5
985
Who are the most influential pharmaceutical

stakeholders?
The influence of payers is rising substantially in the
pharmaceutical marketplace (Fig 2). Owing to the rise
in healthcare costs, there is crowding in therapeutic
categories and little to differentiate one product from its
competitors. In this scenario, payers have gained
considerable influence and now seek to engender robust
strategic relationships with pharmaceutical companies
to achieve superior cost-effective patient outcomes.
This is where real-world data comes into play and aids
in fulfilling the objectives of different stakeholders.8
Fig1. Real world evidence caters to the interests of
all stakeholders
Payers
(Patient registries have the most relevance from the
payers perspective)
Understand cost-effective healthcare systems
Evaluate large numbers of patients/consumers
Expand the role of the study sponsor as thought
partner in medical specialties6,7
Health administrators
Heighten disease awareness
Evaluate and assist in improving quality of
care7
Policymakers and regulators
Cost-effective healthcare system
Better understand the effects of a particular
intervention or sets of interventions on a
disease process3
Track long-term safety outcomes, mitigate risk,
and monitor off-label use
Support research and scientific inquiry
Obtain evidence on health coverage and
healthcare decisions3
Physicians
Track the natural history of the disease of
interest as well as the impact of therapeutic
interventions3
Track practice patterns and outcomes for
quality-improvement initiatives
Assist in recruitment for clinical trials
Better understand treatment selection and
affordability
Fig 2: Influence of pharmaceutical stakeholders in

percentage
Product/health services registry or disease registry?
A product/health services registry provides a deeper
understanding of the utilization and outcomes of a
specific drug, device, or healthcare service. This kind of
registry can only be initiated after the drug/device has
been launched in the market or the service is in place.
Disease registries, by contrast, assess the natural history
of a particular disease and shed light on its management
and outcomes. This kind of registry can be initiated
well before the launch of a drug or a device. It is a
proactive approach that allows a pharmaceutical
company to collect valuable information prior to the
launch of a product. In other words, these registries
help companies assess all possible parameters and
outcomes in order to ensure smooth entry into relevant
markets.
The question is When?
A registry can be initiated at any time by the sponsor;
however, it may be most appropriate if the registry is
initiated at or before the launch of initial marketing,
when a new indication is approved, or when there is a
986
specific need to evaluate nonclinical data. Concerning

the specific needs that would necessitate a registry, the
U.S. Food and Drug Administration (FDA)
recommends that a sponsor consider the following
factors when deciding to establish a registry: 9
The types of additional risk information desired
The attainability of that information through
other methods; and
The feasibility of establishing the registry
Furthermore, a registry mandates the development of
protocols that provide:
Objectives for the registry
A review of the literature, and
A summary of relevant animal and human data
The FDA also suggests that protocols also contain
detailed descriptions of the following:
Plans for systematic patient recruitment and
follow-up
Methods for data collection, management, and
analysis, and
Conditions under which the registry will be
terminated
A registry-based monitoring system should involve
precise data collection forms that ensure data quality
and integrity, with validation of registry findings
through medical record sampling or health care
provider interviews.9
Rare diseases patient registries
Data pertaining to rare diseases is valuable and of high
interest to researchers, industrial partners, healthcare
professionals, patients and patient organizations, and,
ultimately, for the community. However, databases are
expensive to establish and maintain as they require
extensive collaboration among many healthcare
providers and meticulous management. Thus, for rare
diseases, patient registries have some specific
additional features beyond the benefits listed above:
Due to small number of cases worldwide and
the complex nature of these diseases, collection
of data becomes difficult owing to a need for a
large geographical coverage, usually transnational.
It becomes important and desirable to trace
family-related cases as most of rare diseases are
genetic in origin.
Even though the cost of establishing and maintaining a
rare disease patient registry is almost at par with any
other patient registry, the budgets are more difficult to

obtain for the former.10
How to conduct a registry?
The real world itself is an inherently and constantly
changing system. Therefore, it seems obvious that
conducting a real-world observational study requires
considerable expertise. Although, in many ways,
registries are identical to traditional RCTs, and they
cannot be designed or managed on similar lines. Indeed,
designing a patient registry to meet the objectives of
different stakeholders is a significant challenge. What is
needed is a robust understanding of the disease
scenario, a strong background in observational research,
and niche expertise (to understand the scope and
requirements from a stakeholders perspective) that
might not be demonstrated by traditional clinical
research organizations (CROs).The right partner should
demonstrate the following key strengths:
Strong scientific background
Dedicated project management team
Technical and site management competence
Global experience in real world studies
Educating stakeholders about the purpose and benefits
of registries is also an important role that a partner
plays throughout the process. Furthermore, a properly
designed patient registry can bring a wealth of valuable
data that can significantly impact decision making for
various stakeholders. Thus, registries often prove to be
worthwhile in terms of the actual return on the projects
investment. Hence, from an organizational point of
view, selecting the right partner is the key to the
ultimate success of the project.1
DISCUSSION
A significant gap in understanding has been observed to
exist regarding the concept and importance of patient
registries vis--vis conventional RCTs. The most
significant barrier at present is the stakeholders lack of
understanding of the impact and the benefits of realworld evidence. Furthermore, this large gap in
understanding is also reflected in lagging regulations at
the national or regional level. Indeed, most countries
have no specific guidelines to govern the conduct of
registries. Nevertheless, regulatory guidance on
conducting this type of study is evolving. According to
the U.S. FDA, through the creation of registries, a
sponsor can evaluate safety signals identified from
spontaneous case reports, literature reports, or other
987
sources, and the factors that affect the risk of adverse

outcomes such as dose, timing of exposure, or patient
characteristics.9 Hence, presently, there is no way to
conduct such studies without the regulatory or ethics
committees approval/notification. All stakeholders
bear equal social responsibility to set standards that
ensure registry studies are properly understood and
conducted in order to produce significant/reliable
evidence in support of the objectives of all the
stakeholders.
CONCLUSION
Registries have been shown to be widely useful and
have now gained acceptance from the research
community.However, the low awareness of the need for
and utility of registries among the public and
policymakers hinders widespread adoption. Regardless,
once a clear regulatory framework is in place, registries
will become a standard part of the global healthcare
system.
4.
5.
6.
ACKNOWLEDGMENT
The authors would like to acknowledge the efforts of
Phani Kishore Thimmaraju, phamax and Anup Nair and
Anil Sharma, focus scientific research center
(FSRC).We would also like to thank phamax and their
team for supporting us in the development of this
article.
7.
CONFLICT OF INTEREST
The authors declare that there are no conflicts of
interests regarding the publication of this paper.
8.
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DOI: 10.5958/2319-5886.2014.00037.X

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Review article
IMMUNOGENETICS AND
AUTOIMMUNE HEPATITIS
GENETIC
Coden: IJMRHS
Revised: 1st Sep 2014
SUSCEPTIBILITY
Copyright @2014
ISSN: 2319-5886
IN
THE
PATHOGENESIS
OF
Das Anup K
Professor of Medicine & I/C Hepatology Unit, Assam Medical College Hospital, Dibrugarh, Assam, India
*Corresponding author Email: anupkrdas5@gmail.com
ABSTRACT
Autoimmune hepatitis is a progressive liver disease. Its pathogenesis is unclear, but needs a trigger to initiate the
disease in a genetically susceptible person. The susceptibility is partly related to MHCII class genes, and more so
with human leukocyte antigen (HLA). Several mechanisms have been proposed which, however, cannot fully
explain the immunologic findings in autoimmune hepatitis. The susceptibility to any autoimmune disease is
determined by several factors where genetic and immunological alterations, along with, environmental factor are
active. MHCII antigens as a marker for AIH, or a predictor of treatment response and prognosis has been
investigated. Since MHCII antigens show significant ethnic heterogeneity, mutations in MHCII may merely act as
only precursors of the surface markers of immune cells, which can be of significance, because the changes in
HLA and MHC are missing in certain populations. One such marker is the CTLA-4 (CD152) gene mutation,
reported in the phenotypes representing susceptibility to AIH. Other candidate genes of cytokines, TNF, TGFbeta1 etc, have also been investigated but with unvalidated results. Paediatric AIH show differences in genetic
susceptibility. Genetic susceptibility or resistance to AIH may be associated with polypeptides in DRB1 with
certain amino-acid sequences. Understanding which genes are implicated in genesis and/or disease progression
will obviously help to identify key pathways in AIH and provide better insights into its pathogenesis. But studies
to identify responsible genes are complex because of the complex trait of AIH.
Key words: Autoimmune hepatitis, Genetic susceptibility, Genetics, Immunogenetics, Hepatitis, Pathogenesis,
genetic studies, Polymorphism
INTRODUCTION
Autoimmune hepatitis (AIH) is a chronic hepatitis
occurring in children and adults of all ages and can
progress to cirrhosis, characterized by autoimmune
features, including the presence of circulating auto
antibodies and high serum globulin concentrations.
There are two major groups Type 1 and Type 2 AIH
according to the auto antibodies present. The classical
form of AIH, Type 1 AIH, is characterized by
circulating antinuclear antibodies
(ANA), antismooth muscle antibodies (ASMA) alone or in
Anup
combination, and Type 2 AIH is defined by the

presence of anti liver-kidney- microsomes antibodies
(ALKM-1) with or without liver cytosol antigen
(ALC-1). Variant forms of AIH, called overlap
syndromes, also have associated features of other
forms of chronic liver disease, particularly primary
biliary cirrhosis or primary sclerosing cholangitis.
The diagnosis is made in patients with compatible
clinical signs, symptoms, and histology and
laboratory abnormalities after excluding other causes
989
of chronic hepatitis. Laboratory and histological

abnormalities include abnormal liver function tests,
increased total IgG levels, serologic markers (ANA,
SMA, anti-LKM-1, or anti-LC1), and interface
hepatitis in liver biopsy. It has issued Diagnosis of
AIH includes a) characteristic serologic and
histological findings and b) the exclusion of other
types of chronic liver disease as per the American
Association for the Study of Liver Diseases
(AASLD), 20101 guidelines. However, the
nonspecific histologic changes in AIH make the
measurement of auto antibodies and IgG or gamma
globulin important in diagnosing AIH. A scoring
system earlier developed2 and subsequently revised3
by the International Autoimmune Hepatitis Group to
standardize the diagnosis for population studies and
clinical trials has shown to be of limited value in
individual cases. A less complicated system using
simplified criteria was proposed to be used in
individual patients; and is based upon titers of auto
antibodies, IgG levels, liver histology, and exclusion
of viral hepatitis 4. A probable diagnosis of AIH is
made if the total points are six, while a definite
diagnosis is made if the total points are 7.
Pathogenesis: The pathogenesis of AIH is still
obscure and complex, but the circulating auto
antibodies do not have any role in it. The liver is
continuously exposed to a large number of antigens
includes food, intestinal organisms, toxins, malignant
cells, including self-body antigens. But compared to
lymph nodes, the immune responses in liver are not
uniformly effective at times. Since the liver has a
central role in the induction and maintenance of
immune tolerance, AIH occurs primarily due to
immune system dysregulation, resulting in
progressive liver cell destruction consequent to a loss
of immune tolerance towards hepatocytes. The exact
origin of the immune dysregulation in AIH is still
unknown, but the current hypothesis is that it is the
consequence of an environmental triggering event
(virus, medications) in a genetically susceptible
individual of a particular sex and age (females and
young age). Most pathogens have specific pathogenassociated molecular patterns (PAMP) to which Tolllike receptor (TLR) can bind. These TLR can be
stimulated by environmental triggers to create an
environment whereby an auto-antigens may be
actively present in the genesis of inflammation in
auto-immune diseases. Usually up-regulation of
Anup
important pro-inflammatory genes like type 1

interferons are then quickly and efficiently induced
by these TLRs when there is liver infection.
Therefore, TLR stimulation would result in
circulating auto or self-antigens creating a proinflammatory state which in turn would lead to
augmented activation of specific immune-reactive
cells. This is evidenced by demonstration of higher
levels of several different hepatic TLRs like TLR3,
TLR4 and TLR9 in primary biliary cirrhosis.5,6
Rationale for investigating genes in any complex
autoimmune disease are that: (a) the information will
be useful in disease diagnosis and population
screening, (b) which will provide useful prognostic
indices for disease management, especially the
development of individualized treatment regimens in
transplantation, but also in autoimmune and viral
diseases and, (c) and will lead to a better
understanding of the pathogenesis of these diseases.
The complexities of genetic background and
susceptibility in AIH: Autoimmune liver diseases
are not Mendelian autosomal or sex-linked genetic
traits. There is no simple pattern of inheritance in
AIH that can be explained by a single gene and
therefore it is a genetically complex disease. It is
known that nearly all human genes are polymorphic.
Complex traits involve one or more genes (alleles)
acting alone or in combination and alters (increases or
reduce) the risk of a disease and so AIH can be
termed as a polygenic disorder. Complex traits were
earlier called polygenic (involving multiple genes),
multifactorial (implying interactions between the host
gene and other environmental factors) or oligogenic
(mutations in several different genes causing the
same disease).
The extent of heritable component in AIH is still
debatable and weak. However, HLA-DRB1*03
(DR3) and DRB1*1301 (DR13) and HLADQB1*0201 are reported to be transmitted to
patients compared to unaffected siblings in type 1 and
2 AIH, respectively in families of AIH.7 It is
important to recognize that in different geographic
regions and ethnic groups, different susceptibility
alleles may exist which may reflect differing
triggering antigens. For example, epidemiologic
studies in European and North-American caucasians
characteristically demonstrate a high prevalence of a
HLA B8, DR3 and DR4 haplotype.8
990
Naturally occurring genetic polymorphisms generally

determine the susceptibility of an individual to
autoimmune
diseases.
Single
nucleotide
polymorphisms (SNPs) are the commonest
polymorphism (90% of all polymorphism) done by
scanning the entire candidate gene. SNPs evolves
probably due to microbial pressure and as a
consequence of natural selection for enhanced
resistance/susceptibility to certain pathogens. But
identifying disease promoting mutation (DPM) and
polymorphism (DPP) in a genetically complex
disease like AIH is not simple. Because an
association does not necessarily imply a primary
relationship between the polymorphism and disease,
but may be due to linkage disequilibrium between the
polymorphism and DPM elsewhere in the same gene
or a neighbouring gene. Currently, the best strategy
for investigating a gene possibly will be to identify
the informant SNPs and investigate SNP- haplotypes
using these informative SNPs as tags-termed
haplotype tagging. 9
Association analyses usually focus on genes that
affect the immune system belonging to both the
human leukocyte antigen (HLA) and non-HLA
immune modulator genes and is the basis of most of
the work in AIH due to paucity of multiple families to
study, 10 low levels of penetrance, late onset and a few
family members being involved. Besides the MHC
susceptibility genes, other non-MHC genes may also
be involved in autoimmune processes in AIH,
especially those which regulate the immune responses
to antigens, like CTLA-4. SNPs within the cytotoxic
T-lymphocyte antigen-4 (CTLA-4) gene have been
implicated in AIH.11 The gene encoding CTLA-4 on
chromosome 2q33 may influence autoimmunity and
is more common in type 1 AIH and may represent a
second susceptibility allele. 12 CTLA-4 is an example
of genetic variants with risk for developing different
human autoimmune diseases and is also associated
with an increased risk of infections with parasites,
viruses and invasive bacterial infections.13,14 But,
definite evidence of any particular infectious agent or
CTLA 4 gene polymorphisms is related to the
disease onset or an increased susceptibility to AIH
in different regions15 since there are reports of a
number of other SNPs of various other genes also
which are associated with increased susceptibility to
AIH in different populations/ethnic groups.16,17,18,19,20
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Conversely, CTLA-4 can also prevent the

development of autoimmune disease due to the
inhibition of T cell responses by negatively regulating
peripheral T cell function 21 but with differential
expression levels among T cell subsets. CTLA-4
variants may also influence the susceptibility of an
individual towards infection. It is, however, unclear
whether CTLA-4 acts directly on the T cell that
expresses it or acts on the antigen-presenting cell
(either by binding of the ligand B7 by CTLA-4 which
leads to back-signalling into antigen-presenting cells
or by down-regulating B7 expression) .22
To sum up, over expression of CTLA-4 inhibits T cell
activation, facilitating infections and subsequent
tissue damage due to impaired bacterial clearance;
with or without specific activation in T cell
subpopulations like T regulatory cells, allowing tissue
damage due to auto reactive T cells This needs to be
addressed in further studies. Conversely, infection
may modulate the surface expression of the CTLA-4
ligands, CD80 and CD86 on APCs. In order to
understand these mechanisms, animal models need to
be developed which complement clinical and
epidemiological studies for AIH.
The most accepted consensus is that susceptibility to
develop Type 1 AIH is due mainly to genes encoding
HLA DRB1 alleles within the MHC class. T cell
activation is also likely to be involved in the
pathogenesis of AIH because MHC molecules also
present antigens to CD4 cells. The reasons for the
greater influence of specific HLA haplotypes for
example,
in
AIH
compared
to
other
immunoregulatory genes, lies either with the
dominant role played by key MHC alleles in the
immune response and/or with the potential for each
haplotype to encode multiple susceptibility alleles
which may have an additive contribution to disease
risk.
To detect other susceptibility genes, a genome-wide
study23 of 400 Japanese Type 1 autoimmune hepatitis
patients reported two microsatellite markers on
chromosomes 11 and 18, though no specific or
unique proteins were found near or in those markers.
The search for more of such markers may be helpful
in the future. In addition to MHC I and II classes,
SNPs can also exist in the MHC class III region (e.g.
TNF IgA, cytokines, vitamin D receptor, CD45 and
Fas receptor and CA genes) and have been associated
with susceptibility to AIH.
991
Ethnic variations in susceptibility to AIH: Studies

suggest that there are probably three different models
in AIH, and different genetic associations exist in
different
populations
as
discussed
below.
Additionally the peptides presented by HLA
molecules to the T cell may be antigenically different.
In Japan, Argentina, and Mexico, susceptibility to
AIH is attributed to DRB1*0405 and DRB1*0404,
alleles with arginine replacing lysine at position 71,
the motif LLEQ-R being shared with DRB1*0401
andDRB1*0301.24 In Europe and North America,
susceptibility to Type 1 AIH is associated with the
presence
of
HLA DR3 (DRB1*0301)
and DR4 (DRB1*0401), both
alleles showing a
lysine residue at position 71 of the DRB1 polypeptide
and the LLEQKR amino acid sequence at positions
67 to 72.10 This implies that the K or R at position 71
in relation to LLEQ-R may be important for
developing susceptibility to AIH, auto antigen
binding, complementary to this amino acid sequence.
Another model based on valine/glycine at position 86
of the DR- polypeptide has been suggested,
signifying an important HLA association in AIH
patients from Argentina and Brazil. 25 Thirdly, in a
study from Japan, patients with AIH type 1 were
found to have DRB1alleles with histidine at position
1325 Thus, these HLA associations may be different
from the geographically unique local environmental
triggers that precipitate Type 1 AIH in different
environments. However, auto antigenically the target
(hepatocytes) remains the same to initiate AIH.
It is
noteworthy
that presence of the
HLA DRB1*1301 allele, which identifies the risk of
paediatric Type 1 AIH in South America, is also
associated with a chronic hepatitis A viral infection
which may be a part of molecular mimicry. To
summarize, from the discussion above, it appears that
genetic susceptibility or resistance to AIH may be
related to a specific amino acid sequence within
DRB1. Those with the DRB1*0301 are younger
patients and treatment failure is frequent in them. A
severe disease and higher requirement of liver
transplantation characterizes those who are associated
with HLA B8. AIH with DRB1*0401-DRB4*0103
also develop additional autoimmune disorders like
thyroiditis or diabetes mellitus more commonly.
Association of HLA-B8 and HLA DR3 has also been
found to be predictive of a lower achieving remission,
frequent relapses, end-stage liver diseases and need
Anup
for
liver
transplantations.26,27
A
linkage
disequilibrium study in families of AIH patients has
confirmed that, HLA-DRB1*03 (DR3) and
DRB1*1301 (DR13) as well as HLA-DQB1*0201
were selectively transmitted to patients compared to
unaffected siblings in type 1 and type 2 AIH,
respectively.27 Another study has suggested that
HLA-DR13 by itself alone could be another risk
factor.28
From a small study done in western India, DRB1*14
was the allele associated with AIH in India.29 A point
to be noted is that possible differences in the
occurrence of HLA alleles between both patients and
normal subjects of same populations can affect the
frequency of the disease across different regions as
well.
Reasons for ethnic variations of genetic
susceptibility: When the findings of studies based on
different populations vary there occurs a questionshould one always expect studies in different
populations to concur? It can depend on the degree of
racial or ethnic separation or the degree of geographic
isolation of the tested populations with different
genetic profiles. So, we cannot expect the English and
Norwegian populations to vary as much as the
English and Japanese. This also explains the
differences between MHC-encoded susceptibility to
Type 1 AIH in Brazilian versus North American and
European whites in a well conducted study.30
Similarly, DRB1*03 alleles were more common in
American patients with type 1 AIH than German
Type 2 AIH patients (51% vs 17%); but DRB1*0301
was more frequently found in Type 1 AIH (51% vs
17%). The frequency of DRB1*04 alleles was also
higher (64%) in the Type 1 patients after exclusion of
the DR1*03 alleles. In contrast, patients with Type 2
AIH more frequently had DRB1*07, DRB1*15; and
DQB1*06, DRB4*01 and DQB1*06 also occurred
more frequently in the Type 2 German patients than
in healthy US subjects31 suggesting a distinct
variation in ethnicity.
These differences in susceptibility alleles among
various ethnic groups can partially be explained by
the shared motif hypothesis as discussed above which
proposes that multiple alleles can encode for identical
motifs within HLA class II. For example,
susceptibility alleles reportedly will encode the motifs
at position 67-72 of class II HLA in 94% of Type 1
AIH patients. In contrast, HLA-DB1*1501
992
(associated with a reduced risk to develop type 1

AIH), encodes for the ILEQAR motif,7, 31 that is
distinctly different from LLEQKR or LLEQRR
sequences.
The potential role of allelic variations within several
genes encoding components of the innate and
adaptive immune system suggests some disturbances
of host resistance to microbial infection and their
implication in the initiation and/or perpetuation of
inflammatory processes.
Hepatitis viruses (e.g.
Hepatitis C) probably triggers a non-specific
autoimmune reaction by facilitating activated CD4
cells to interact with autoantigens and thus initiate
liver damage. Experimental studies show that these
CD4+ T cells activated by hepatocytes are more likely
to transform into Th2 cells and impair the CD8 cell
function. 33 hence the innate immune system Overexpression/up-regulation of pro-inflammatory genes
may also be involved in the development of
autoimmune inflammation in the liver through the
innate immune system in the liver as the liver is an
organ with special innate immune characteristics.
Any hepatitis (viral, toxic) can also trigger AIH by
possibly expressing the MHC class II molecule by
damaged hepatocytes. The autoimmune triggering
effects of drugs and chemicals like minocyclin,
statins and herbs reported with AIH are also well
known but not fully understood at present. Possible
explanations may be the hepatotoxic effects releasing
autoantigens, followed by an up-regulation of
immunoregulatory proteins like P450s, or by hapten
production by modifying this abnormal or existing
hepatic protein, making them significantly
immunogenic to produce AIH. However, this will
probably take a long time to manifest as a significant
disease clinically.
A peculiar Type 2 AIH is described, affecting ~ 20%
of patients with autoimmune polyendocrino-pathycandidiasis-ectodermal dystrophy (APECED), also
called autoimmune polyendocrine syndrome 1, which
is an autosomal recessive disorder caused by
homozygous mutations in the AIRE1 gene. It is
characterized by autoimmune diseases like a primary
adrenocortical failure, hypoparathyroidism and
chronic candidiasis. The AIRE1 gene sequence
consists of 14 exons containing 50 different
mutations, with a 13 bp deletion at nucleotide 964 in
exon 8 accounting for more than 70% of APECED
Anup
alleles in the UK.34 But common mutations in

the AIRE gene do not play a major role in AIH.35
Genetic susceptibility in type 2 AIH: Type 2 AIH
patients frequently present a more severe disease
course and are usually resistant to treatment. HLADQB1*0201 was found to be significantly associated
with susceptibility to Type 2 AIH in a recent study. 36
DR3 or DR7, both associated with Type 2 AIH,
shows a linkage disequilibrium with DQ2.
Interestingly, HLA-DRB1*03 was found associated
with Type 2 AIH patients which show both LKM1
and LC1 antibodies in their sera, while HLADRB1*07 was predominant amongst Type 2 AIH
patients, whose only serological marker was antiLKM1, signifying HLA alleles can also modulate
autoantigenic humoral response in AIH. Other reports
show that susceptibility to Type 2 AIH is conferred
by HLA DR7 (DRB1*0701) and DR3 (DRB1*0301);
and DRB1*0701 predicts a more aggressive disease
and poor prognosis.37 Xenoimmunisation with
plasmid DNA coding for Type 2 human autoantigens
was performed in three mouse strains which differ in
their MHC and/or non-MHC genes to study the
genetic susceptibility to AIH in an animal study.38
This study showed that both MHC and non-MHC
genes may be involved in increased susceptibility for
Type2 AIH.
For Type 2 AIH, HLA-DRB1*07 has been observed
more in German, Brazilian and British populations
while HLA-DRB1*03 was found as a risk factor in
Spanish patients.39,40,41 again confirming an ethnic
variability for susceptibility.
Genetic susceptibility in overlap syndromes: It is
known that PBC, AIH and PSC are the three major
immune-mediated hepatopathies. Variant forms of
these diseases are called overlap syndromes, but no
standard definition exists. Patients with overlap
syndromes present with both hepatitic (AIH) and
cholestatic (PBC, PSC) serum liver tests and exhibit
histological features of AIH and PBC or PSC. A
similar genetic predisposition may play a role in the
development of these overlaps syndromes as all three
disorders share some common genetic susceptibility
factors. It's already known that the MHC-genes tend
to play an important role in determining the risk in
AIH and PSC, and a lesser role in PBC. Studies have
already identified a number of other potential
candidate genes for these diseases with weaker
effects on disease risk. 42, 44
993
Genetic differences in pediatric AIH: Evidence in

support of pediatric AIH and adult AIH clinically
being different with particular genetic associations
exist. Brazilian type I AIH children showed a strong
association with the HLA-DRB1*1301-DQB1*0603
haplotype. 44 Similarly, in Argentina, HLADRB1*1301 was the primary susceptibility allele,
whereas HLA-DRB1*1302, which differs from HLADRB1*1301 by only 1 amino acid, appeared to be
protective in children with Type 1 AIH.45 These
findings therefore reveals that different HLA-DRB1
allotypes confer susceptibility to type 1 AIH in
children and adults. This raises the possibility that
pediatric and adult AIH, especially Type1, may be
triggered by different trigger factors even within the
same ethnic community. It is clear that understanding
which genes are implicated in the genesis and/or
disease progression will obviously help to identify
key pathways in AIH and provide better insights into
its pathogenesis.
CONCLUSION
AIH is a complex trait disease. The exact
mechanism of its pathogenesis is not fully known.
Knowledge of the genetic predispositions for
autoimmune hepatitis may, however elucidate the key
pathogenic mechanisms, identify etiologic agents,
characterize
susceptible
populations,
predict
prognosis, and target new therapies. Current
hypotheses suggest that AIH is triggered by an
environmental factor in a genetically susceptible host.
Multiple genes may interact to produce a permissive
gene pool'' that determines both disease risk and
phenotype, across different ethnic groups. More
research is needed because at present it is not known
how many susceptibility genes may be present in
AIH. The absence of large numbers of multiplex
families is a problem for those trying to determine the
exact role of genes in AIH. Traditionally genetic
diseases are identified and mapped by linkage
analysis which is the gold standard for gene
mapping. When such families are few, as in AIH,
genetic mapping may be performed by association
analysis. Case control association analysis in such
cases can produce very powerful results; it is also a
practical option for the study of genes in diseases
with a small heritable component. But the sample
sizes required, will be very large as the quality of any
case-control association study is directly proportional
Anup
to the numbers studied. Future studies on AIH are

needed to consider gene to gene interaction and also
haplotype tagging. Because a better understanding of
the disease would help discover specific and targeted
immune-therapies with less side effects if and when
the offending genes are identified in future.
Conflict of Interest: None to declare
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Fernandez, Hugo Fainboim, Mirta Ciocca,
Margarita Ramonet, Isabel Badia, Jorge Daruich,
Jorge Findor, Hugo Tanno,Cristina Can EroVelasco, Leonardo Fainboim Pediatric and Adult
Forms of Type I Autoimmune Hepatitis in
Argentina: Evidence for Differential Genetic
Predisposition Hepatology. 1999; 30(6):1374-80.
996
DOI: 10.5958/2319-5886.2014.00038.1

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Review article
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
CHECKING AND CORRECTING COMPLIANCE: FOCUSING RENAL PATIENTS

*Bakshi Anjani1, Singh Kalyani 2
1
Ph.D. Scholar, 2Associate Professor, Department of Food and Nutrition, Lady Irwin College, Delhi University,
New Delhi, India
*Corresponding author email: anjanibakshi04@gmail.com
ABSTRACT
Compliance is a behaviour resulting from a specific set of cues and consequences. It is a self-care behaviour
which entails obedience to a directive whereas noncompliance is self-care deficit, which calls for rejection of
particular behaviour which may result in dissonance and may lead to the development of metabolic abnormalities
in renal patients. To understand compliance, it is necessary to look for modifying and enabling factors affecting
readiness to undertake recommended behaviour. It has been recognised that poverty, denial of illness, lack of
control over life, non-supportive environment, old age, female gender and lower socioeconomic status, affect
compliance, which is assumed to be a major obstruction to the effective management of disease and therapeutic
disciplines. Diverse direct as well as indirect methods have been identified to measure compliance. Out of
numerous methods, none of the methods appear to be completely reliable and valid, although biological assay is
considered most accurate among all, as it is not affected by human judgements. To prevent complications due to
noncompliance, measures should be adopted for improvement which not only entails role of physician and
dietician but also of family. In health care system, compliance check is of prime importance, while aiming for
better quality of care and management of patients.
Keywords: Compliance, Compliant Behaviour, Management of patients, Renal
INTRODUCTION
Compliance means when the patient accomplishes is
doctor's/ dietician orders with regard to the medical
and dietary regimen. According to Webster's
dictionary compliance is an "Acquiescence to a wish,
request, or demand" or "a disposition or tendency to
yield to the will of others.1It can also be defined as
class of behaviours resulting from a specific set of
cues and consequences. It takes into account patient's
active, intentional and responsible process of selfcare, in which the patient works to maintain his or her
health in close collaboration with the healthcare
staff.2 Dracup and Meleis (1982), defined compliance
as the extent to which an individual chooses
behaviours that coincide with a clinical prescription3,

whereas Hussey and Gilliland (1989), defined
compliance as the positive behaviour that patients
exhibit when moving towards mutually defined
therapeutic goals.4 Presently, there is no approved
definition of compliance. Therefore alternative terms
like adherence, co-operation, mutuality and
therapeutic alliance has been used.5
Compliance seems to be simple yet is a difficult and
complex issue. It is not a unitary construct, but rather,
a matrix of component parts in which a variety of
factors separately influence those constituents.6
However, it has been regarded as the most important
997
Anjani et al.,
matter in successful treatment of patients with End

stage renal disease (ESRD).7The emphasis on
compliance is given by Dracup and Meleis (1982)
who confirms that the most well established health
care regimens are worthless if a patient chooses not to
comply with there commendations of the health care
system.3Therefore, there is a need to study
compliance deeply, to understand various factors and
methods of finding compliance, to find out how
closely noncompliance and health complications in
renal patients exists and number of ways which can
be adopted for improving compliance.
Some theoretical models of compliance are explained
below to understand the nature of compliance:
Personality trait model: Compliance behaviour is
related to enduring and presumably unchanging,
personality
characteristics
(e.g.,
immature,
impulsive, uncooperative)
Psychodynamic model: It highlights the
psychological meaning of the illness and treatment
situation to the patient and the conscious or
unconscious fears, anxieties and psychological
conflicts that may be result of compliance.8
Sociocultural model: It
stresses
upon the
importance of group roles, beliefs, practices and
taboos as they affect health beliefs and compliance
to medical regimens
Cognitive theory model: It considers that humans
are sensible decision makers and that attitudes,
beliefs, values, intentions, and especially
information are vital elements of compliance9
Health belief model: Formulated by Rosenstock
(1966). It considers10
1) The individual's subjective state of "readiness to
take action" associated with particular health
conditions, depending on the perception of
perceived "susceptibility" and the "severity" of the
disease and its consequences.
2) The individual's estimation of the health behaviour
in terms of its feasibility and efficaciousness,
considering physical, psychological, financial, and
other costs or "barriers" involved in the expected
action.
3) "Internal factors" (e.g., perception of bodily states)
or
"External
factors(e.g.,
interpersonal
interactions, mass media communications) to
trigger the appropriate health behaviour.11
Factors for compliance : Compliance is complex
and influenced by various variables such as age and
Anjani et al.,
sex; socioeconomic, intellectual, and educational

levels; medical knowledge; recreational and
vocational energy demands; acceptance or denial of
illness; time from onset of illness; patient memory;
smoking habits; self-motivation; and exercise goalsetting.12
Poverty: Poor patients are less demanding and noncomplaining, hence more compliant13
Health locus of control and family support : As
defined by Rotter, 1966, locus of control refers to
the degree to which individuals perceive events in
their lives as being a consequence of their own
actions.14It may be internal in which actions have
causal relationships with originated consequences
and external locus of control points events to
external forces such as fate and chance. On review,
it is believed that an individuals sense of control
over life influences compliance rather than beliefs
about health specifically. 15
Acceptance: Acceptance of permanence of disease
and its influence on everyday life.16
Knowledge: In renal study, patients on
hemodialysis with appropriate, consistent, and
sufficient educationand reinforcement with the
complicated renal diet, supportiveenvironment,
andadequate knowledge on diet have better
compliance. 17
Importance of compliance in renal disease :
In renal disease, kidneys cannot excrete components
like phosphorus and potassium resulting in their build
up in the blood, causing imbalances which leads to
serious metabolic disturbances.18,19 Hence renal
patients are on restricted diet to prevent acidosis,
hyperkalemia, hyperphosphatemia, oedema and high
serum urea nitrogen.20,21Also, renal patients have to
compensate for the kidneys inability to excrete fluids
by restricting fluid intake, since fluid overload can
result in pulmonary oedema and concomitant
cardiovascular damage19whereas noncompliance with
potassium content in diet can lead to cardiac arrest
and death.22In addition these patients take a variety of
medications, to take care of kidney failure and
underlying co-morbidities. Therefore, renal diseases
necessitate dietary and fluid restrictions, in addition
to medication in daily regimen, to limit protein,
sodium, and potassium intake. If compliance to the
dietary prescription is missing in patients regimen
then it may lead to the development of renal
osteodystrophy,
metastaticcalcifications
and
998
premature death (phosphate and binder non

adherence);cardiac arrhythmia (potassium nonadherence); fluid overload with pulmonary oedema,
left ventricular hypertrophy and heart failure (fluid
and
sodium
non-adherence);
and
protein23
energymalnutrition. In studies, compliance with
dietary and fluid restrictions has been described to
turn down the risk of symptoms and medical
complications, improve patients quality of life, and
increase life expectancy by 20 years or more.24,25Thus
manipulation of diet is vital along with the
compliance to slow down the loss of kidney
function26,27
Methods to measure compliance in general and
renal patients : The ideal method of measurement
should maximize cooperation and minimize
sensitization of patients, should be objective, able to
reproduce data and should minimize cost.28According
to Gordis (1976), there are two general approaches to
the assessment of compliance: (a) direct measures
such as biochemical determinations of blood or
urinary levels of a medication or nutrient; and (b)
indirect measures based on health outcome (e.g.,
weight loss), or patient interview.29
I)
Direct Methods:
1) Biochemical assessment: Biochemical assessment
is a direct method for measuring dietary and fluid
compliance among patients. It is a true test to
measure compliance and is unaffected by the human
judgements. It is objective, reliable and easily
quantifiable method, however, is costly and patients
may alter their behaviour if they get to know that they
are tested. In addition, other factors which may
influence are physical characteristics of the individual
and time when the measure is taken.30Biochemical
assessment includes measurement of blood potassium
and phosphorus levels to assess potassium and
phosphorus intake. Phosphorus levels in the blood are
measured to reflect both diet and medication
compliance, which also reflect deterioration of the
kidney as the disease progresses. However, both
serum potassium and serum phosphorus levels can be
altered by the presence of catabolic process or by the
extent of the adequacy of the dialysis treatment.
Urea nitrogen appearance rate, is an another
biochemical measure which is a simple and accurate
method to assess dietary compliance. If there is any
change in dietary protein intake then the primary
metabolic response is through change in urinary
nitrogen excretion.31This method assesses compliance

by finding differences between prescribed intake and
calculated total waste nitrogen excretion.
2) Direct Questioning includes perceptions of
patients compliant behaviour, doctors' perceptions of
the patients' compliant behaviour, and an independent
review of patients' medical records.32It is considered
as an easy and universally applicable method,
quantitative and useful measure of medication
compliance which can also be assessed by pill count.
It overcomes the disadvantage of recall and selfreporting method, however, it has a few limitations of
not defining exactly the beginning of pill
consumption, dosage, frequency and cancellation of
side effects due to over compliance and under
compliance.28In addition, this technique is not usually
appropriate, applicable or affordable in the routine
clinical care of patients33and is difficult to make
patients bring all the medication with them to clinic
visits.
II)
Indirect Methods:
1)Weight gain during dialysis session:
Intersession weight gain is an indirect measure of
compliance. It gives a measure of dietary compliance
with sodium and fluid restrictions.25It is calculated by
subtracting from each patient's predialysis weight
with postdialysis weight. However, assessment of
Interdialytic weight is influenced by various factors,
such as failure to adjust for varying lengths of time
between dialysis treatments (they varied from 2 to 3
days); failure to take account of the fact that some
patients had urine output; lack of standardized
measurement procedures for obtaining prepostdialysis weight gains and errors in recording prepostdialysis weights.30For further investigations other
direct methods are regarded as more useful than
indirect methods.34
2) Dietary methods: Dietary methods assess
compliance by three dietary measures according to
Brown (1968)
Subjective rating by nutritionist,
Semi objective rating based on recall of
consumption of restricted foods, and
7-day food records35
Though dietary data is difficult to interpret, gather
and quantify,36 it sensitizes patients that their
behaviour is being monitored,28 thus grossly
exaggerate compliance.37In addition there is a
problem of objectivity which is innate in dietary
999
Anjani et al.,
measures of compliance.38Altogether it depends on

what questions are asked and how they are
asked.39However it has been used to measure how
closely patients eating behaviour is close to the
dietary recommendations. For this purpose method
should be (a) reproducible, (b) valid, (c)
representative of habitual food intake, and (d)
feasible.40It has been seen that if multiple and
repeated measures of compliance are taken, they will
better apply in both clinical and research settings.
3) Checking Dietary Knowledge: According to
Parmenter et al. (2000), knowledge is considered as a
very important factor which influences eating
behaviour41and
adherence
with
dietary
42
regimen. Dietary knowledge questionnaire was used
in a study on hemodialysis patients to judge dietary
knowledge questions on potassium, phosphorus,
sodium, and fluid intake based on the content of the
dietary leaflet given to patients43
4) Patient Diary: Patient diary is the most prevalent
and alternative measurement strategy to subside
shortcomings of retrospective recall.44It captures
experience close to the time of its occurrence, thus
giving more accurate and less biased data. But there
are limitations using diary method such as patient
readiness to keep a diary or not, 45fake or backfill
written entries so as to give the appearance of good
compliance; therefore electronic medical devices
have also been used to track patient behaviour. 46, 47, 48
5) Attendance at appointments: An important
measure of compliance, which applies to all patient
population. 49
Compliance comprises of complex actions,
intentions, emotions and phenomena that may not be
directly observable.50Out of numerous methods, no
method appears to be adequately reliable and valid.
There is a chance of overestimation due to biased
measurement errors.51However, biological assays are
considered as the most accurate method and
interviews the least accurate, with pill counts falling
somewhere in between52
Non compliance
Noncompliance is an obstruction to the efficient
practice of medicine since it is a burdensome and
complicated task, and requires comprehension of both
behavioural issues and nutritional management.36
Patients who miss their regular outpatient visits and
regular blood urine tests and failure to comply with
medication regimen
are considered as non-
compliant.53,54Noncomplianceaffects the general

delivery of health care, interferes with achievement of
therapeutic goals and is a barrier to delivery of
effective
medical
care.55Evenwell-established
healthcare regimens are worthless if patient chooses
not to comply,3 making it a significant factor to bear
in mind while treating patients.
Barriers to compliance: It becomes vital to
understand the barriers to adherence, to help health
professionals plan and implement more intensive
interventions and to assist patients in achieving
beneficial lifestyle changes56
1) Disease condition : Non compliancein Chronic
kidneydisease is due to the presence of anorexia
due to uraemia, gastroparesis, especially in
diabetics, intraperitoneal instillation of dialysate in
peritoneal dialysis, increased serum levels of
leptin, concurrent illness and hospitalisation, as
well as increased pro-inflammatory cytokines23
2) Regimen Restrictions: Regimen is a combination
of prescriptions (behaviour to be initiated) and
proscriptions
(behaviour
to
be
57
prohibited). Restrictions made on regimen and
personal
habits,
become
cause
of
58
noncompliance, specifically for those patients
who are on pre dialysis and dialysis with dietary
restrictions i.e. restriction of fluid, potassium and
sodium intake34becausedietary restrictions are
restrictive and is a method of control and
characterized by absence of cures. It has been
observed that patients are frequently noncompliant with the phosphorus than potassium
because of difficulty in reducing amounts of
chocolate, cola drinks, meat, fish, eggs, and milk
and other dairy products as compared to potassium
rich fruits and vegetables. Sodium restriction also
makes diet unpalatable, hence difficult to accept.59
3) Provider and Patient relation
a) Nature and quality of provider-patient
interaction60:It is believed that when doctors fail
to clearly convey the importance of a regimen to
the patient, there is an equivalent failure on the
part of the patient to comply.61Sometimes it is
result of limited knowledge of nutrition among
physician.62
b) Mode of communication: It has been noted that
verbally communicated advice without written
instructions make patients tend to forget
information on the disease and its consequences43
1000
Anjani et al.,
c) Low compliance has been observed when

patients have a lack of choice of plan or
physician63
d) Plan of visit: Patients are scheduled for many
shorter visits without respect to individual visit
complexity making them adhere less to their
follow up visits.
e) Lack of time and counselling skills64
4) Patient related factors:
a) Patient perception: Many time perception of
patient to the usefulness of the therapeutic diet is
outweighed by their traditional beliefs65and
perception of not viewing themselves as ill which
creates optimistic bias.
b) Influence: Influence of family members, friends,
and associates may conflict with the medical
advice and sometimes cancel out the doctor's
potential authority. In addition, family dissonance
is also closely associated with noncompliance.66
c) Situational barriers: Such as being away from
home, prescriptions expiry, or thirst7affect
compliance.
d) Additional burden: Compliance is also affected by
the state where patient has to accept that he is ill
although he is not evidently disabled and therefore
not allowed to escape from his work duties and
responsibilities.36
e) Dependency: Patients who require family support,
considered to be dependent on their families, in
turn negatively self-perceive by ignoring and not
complying with the regimen.67It also takes into
account dependency of meal preparation which
may be altered if knowledge of the diet and
disease is not communicated well.22
f) Low Frustration Tolerance: Patients with low
frustration tolerance usually insist that they know
and understand the restrictions but that they cannot
comply with it.68
g) Acting Out: It is an unconscious psychiccondition
observed in dialysis patients e.g. unconscious
hostility and aggression.68
h) Excessive Gain From Sick Role: Sympathy, social
benefit which patients gain from their
surroundings increase abuse of the medical
regimen. Therefore, some patients continue this
state to solve their primary gain of reducing
conflict and anxiety by abusing their diets.68
i) Suicidal Behaviour: Narrowing of interests,
avoidance of interpersonal relations, lack of future
Anjani et al.,
vision, depression, make patient fed up of his/her

own condition.68
j) Inadequate understanding and knowledge about
the regimen and poor recall which is influenced by
shorter words and use of technical terminology,
results in patient remembering only the first half of
the doctors advice.69
Improving compliance: Various modes and sources
as given below should be considered for improving
compliance.
1) Patient Management and Treatment:
When managing patients, it is vital to shorten the
length of therapy
Follow up visits should be planned as soon as initial
visit is over.
Make changes one by one and adding next
objective later.
Improving Interview method: Better Interviewing
skills improve efficiency and cut costs, increase
enrolment, and help retain satisfied physicians in
the practice group.70Some points need to be
considered while interviewing: listening actively to
the patients story71,paying attention to the
emotional agenda, use empathic statements, solicit
patient attribution., take advantage of the patients
personal knowledge, establish agreement on goals
of individual visits and medical care by involving
patients in their care72and building trust with the
patient70
2) Role of Care Providers:
a) Physician influence is dominant in treatment
since he is the primary contact to the patient,
hence his influence on patient to come for follow
up visit is vital.73Follow up visits should be
planned well keeping patients convenience in
mind and making them aware of the reason of
their next visit. Follow up visit provides patient
with a feeling of accomplishment and a sense of
the treatment's importance. Factors to be kept in
mind are convenience of scheduled appointment,
availability of transportation, impact of visit on
employment and delays experienced in the total
process of receiving services.74It has been
demonstrated in one study that spending extra 5
minutes with patients, improves quality of care,
compliance with instruction to return for a
follow-up visit and knowledge among
patients.73,75 Good communication skills76and
positive interaction32 is vital to enhance
1001
satisfaction and hence compliance. Satisfaction,

respect towards patients' concerns, providing
information about condition and progress, sincere
concern and sympathy77are also beneficial
components in provider patient interaction.
b) Skilful dieticians play a vital role in dietary
compliance because they consider patients food
preferences, plan diet with adequate calories, and
make proper distribution of foods with
encouragement to comply27, 78They are critical to
ensure that the regimen is nutritionally sufficient
and that the food preferences of a patient are
included when recipes are planned. According to
Glanz (1979), dieticians influence their patients
to apply more influence strategies by involving
patients in the counselling sessions for
appropriate health attitudes and compliance
behaviours.39To improve compliance, the initial
dietary regimen should be simple, with
complexities added gradually. Compliant
behaviour can also be improved in dialysis
patients by reducing environment barriers such as
suggesting alternative ways to make the renal diet
more palatable, such as the use of curry powder,
garlic powder or onion powder.79It is hence
important to identify environmental factors to
help care providers to inculcate changes in
efficient manner e.g. for patients on fluid
restriction can be counselled to keep fluids away
at meal times, sucking iceor eating hard candies
when watching television or reading, to reduce
dryness of the mouth.
Other alternatives in the diet can be made for renal
patients such as using fresh or frozen ingredients
containing less salt, using different cooking skills
such as frying or poaching, using lemon juice,
fresh or dried herbs, spices or spice mixes
without added salt to flavor food., avoiding food
prepared with monosodium glutamate and when
going to a restaurant or visiting friends and
family, ask to have meals prepared with a little or
no salt59
Counselling and Education by Dietician: Dietary
counselling motivates patients to make changes.
It involves identifying patients and their stages in
relation to adoption of a renal diet.80It has been
seen that positive health motivations increase the
likelihood of individual compliance81which is
based on patients readiness to change.43
Awareness of patients culture, food habits,

beliefs, and practices help care providers
streamline counselling. It also brings selfmanagement, which involves alteration and
changes in the old habits. 33The patient
centredcounselling steps for dietary change
should increase the patients awareness of his/her
diet related risks, provide the patient with
nutrition knowledge, increasethe patients
confidence in his/her ability to make dietary
changes and enhance skills needed for long term
adherence to dietary change plans. 82
c) Role of Family : Several studies reviewed the
importance of family and cooperation of family
members in dealing with the health problem,83
influencing food behaviour84 and nutritional
status.85Family members assist and encourage
patient compliance. In addition, stable home
situations are also necessary to make patient
complaint.
d) Reinforcers in Practice: Through various studies,
it has been validated that if patients are provided
with some reinforcers, then compliance increases.
It includes the social reinforcers (praise and
conversations) or the tangible reinforcers (i.e.
access to early sessions and preferred
meals),34introducing token economy program if
there is decreased fluid weight gain among
dialysis patients,86additional time spent with the
care provider or giving lottery tickets, which
create incentives for achieving compliance goals.
3) Mode Of Communication
a) Weekly telephone contact in a study proved to be
beneficial in modifying patients' health beliefs
and, through this mechanism, improved
compliance.87 Mail and telephone reminders,
remind patients of upcoming appointments.88
Telephone call is cost-effective, feasible way of
motivating people to manage a chronic
condition89but have a few limitations such as ,
difficulty in assessing health problem if the caller
cannot be seen, and difficulty in assessing the
effect of a telephone call on a patients behaviour90
b) Individualized instructions should be given in
writing format for later reference since patient
tends to forget and essential elements of the
message should be repeated by the patient's after
care provider, to recall and enhance the specific
actions required to adhere on the treatment plan88
1002
Anjani et al.,
CONCLUSION
Compliance is not integrated, but rather, a description
of various component parts. Individuals sense of
control over lifeinfluence compliance rather than
beliefs about health specifically. It is the patient
noncompliance which affects the performance of
medical care, resulting in progression of the primary
disease and its complications. Evenwell-established
healthcare regimens are worthless if patient chooses
not to comply. Major findings of this study are that
the compliance with one aspect of the regimen
represents compliance with other components of the
regimen as well. It has been seen that the dietary
compliance cannot be improved by only nutrition
education or by increasing patients knowledge. In
addition, among all methods, no method of
compliance measurement appears to be adequately
reliable and valid. There is a chance of over
estimation due to biased measurement errors.
However, biological assay is considered the precise
method to measure compliance among all. In
improving compliance, no single, specific strategy
will work to enhance compliance for all patients. It
has been found that a partnership with the patient will
establish greater influence on the patients
compliance.
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Anjani et al.,
DOI: 10.5958/2319-5886.2014.00039.3

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Health Sciences
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Volume 3 Issue 4
Received: 25th May 2014
Coden: IJMRHS
Revised: 30th June 2014
Copyright @2014
ISSN: 2319-5886
Accepted: 28th July 2014
Case report
ISOLATED COMPLETE CORPUS CALLOSAL AGENESIS
*Jaiganesh S1, Venkateshwaran A1, Naresh Kumar C2, Rajasekhar KV3
1
Assistant Professor, 2Post Graduate student, 3Professor& Head, Department of Radiodiagnosis, Meenakshi
Medical College and Research Institute, Kanchipuram, Tamilnadu, India
*Corresponding author email: drjenesh@gmail.com
ABSTRACT
Isolated complete corpus callosal agenesis is a rare entity. Usually this condition will be an associated finding in
other syndromes. 3 month old male child came with complaints of deformed foot on both sides, not having a
social smile and neck holding. Patient referred to the Radiology department for MRI brain which showed
complete absence of corpus callosum, widely separated and parallely placed lateral ventricles, colpocephaly, high
riding of 3rd ventricle and absence of cingulate gyrus and radial arrangement of gyri along the interhemispheric
fissure. Hence it was reported as isolated complete corpus callosal agenesis and this article describes the
Embryogenesis, anatomy, developmental anomalies and its clinical manifestations & prognosis.
Keywords: Corpus; Callosum, Colpocephaly, Agenesis
INTRODUCTION
Corpus callosum is the largest commissure in the
central nervous system which connects the both
cerebral hemispheres1. Agenesis of corpus callosum
is a rare disorder that is present at birth(congenital).
Corpus callosal agenesis is found in about 5 per 1000
births.1 Agenesis of the corpus callosum is an
uncommon cerebral malformation that has been
reported in 1 in 19,000 unselected autopsies and 2.3%
of children with mental retardation.2,3 Its absence may
be partial or complete, depending on the stage at
which callosal development is arrested.4 Corpus
callosal agenesis can occur as an isolated abnormality
or it can be associated with central nervous system or
other abnormalities. Prognosis depends on the extent
and severity of malformations. Prenatally diagnosed,
isolated agenesis of the corpus callosum is usually
associated with a favorable outcome.5 Mental
retardation does not worsen in Corpus callosal
agenesis. Isolated corpus callosal agenesis is
infrequent with sulcal and infratentorial abnormalities
Jaiganesh et al.,
as common findings.6 Sulcation delay was present in

most fetuses with corpus callosal agenesis, including
those with good neurodevelopmental outcome and
suggests a more global white matter dysplasia6.
Although many children with the disorder have
average intelligence and lead normal lives,
neuropsychological testing reveals subtle differences
in higher cortical function compared to individuals of
the same age and education without Agenesis of
Corpus Callosum. Here this article describes a
newborn having complete corpus callosal agenesis as
an isolated abnormality. Unfortunately the mother of
this child didnt undergone antenatal ultrasound;
hence this abnormality was not diagnosed early.
CASE HISTORY
3 month old male child came to the Paediatric
outpatient department our college with complaints of
deformed foot on both sides, not having a social smile
and neck holding (usually occurs at 3 months of age).
1006
Patient referred to the Radiology department for MRI

brain which showed complete absence of corpus
callosum, widely separated and parallely placed
lateral ventricles, colpocephaly(narrow frontal horns
and wide occipital horns), high riding of 3rd ventricle
and absence of cingulate gyrus and radial
arrangement of gyri along the interhemispheric
fissure. Hence it was reported as isolated complete
corpus callosal agenesis.
Fig 4: T2W coronal image shows high riding of 3rd

ventricle.
DISCUSSION
Fig.1: T1W axial and parasagittal image shows dilated

occipital
horn
with
pointed
frontal
horns
(colpocephaly)
Fig 2: T1W axial image shows widely spaced parallel

lateral ventricles and no corpus callosum is seen.
Fig 3: Sagittal FLAIR image shows absent corpus

callosum, cingulate gyrus and radial arrangement of
gyri (sunburst pattern)
Jaiganesh et al.,
Embryology: Corpus callosum is the largest neural

commissure connecting the two cerebral hemispheres.
The development of the corpus callosum occurs
between the 12th and 16-20th weeks of gestation.7,8 At
12 weeks gestation, it starts to develop from the
lamina terminalis near the anterior end of the 3rd
ventricle as a bundle of fibers connecting both
hemispheres. It begins with the genu and then
continues posteriorly along the body to the splenium.
The rostrum is the last part to be formed. In primary
agenesis parts of the corpus callosum which form
before the insult will be present whereas later parts
will be absent. Presence of the rostrum essentially
excludes primary agenesis.
Normal corpus callosum measures 17 mm at 18
weeks and 44 mm at term.7 Callosal agenesis can
occur either due to inflammatory or vascular insults
around 12-18 weeks.8 Agenesis can be partial or
complete depending on the time of insult to the
development of corpus callosum. Earlier insult leads
to complete agenesis while later causes partial
agenesis especially affects the posterior part and
rostrum. The mechanisms leading to Agenesis of
corpus callosum is not very clear; however defective
migration of the callosal axons or an abnormality of
the callosal neurons has been suggested.9 Isolated
Agenesis of corpus callosum can be sporadic,
autosomal recessive or dominant, or X-linked9.
Though multiple chromosomes are responsible for the
development of the corpus callosum (1, 8, 13, 15, 18,
21, and X), no definite gene was identified yet for
isolated Agenesis of corpus callosum.9 Even the
condition can be diagnosed during antenatal period,
1007
there is no treatment available to correct this anomaly

during antenatal period. Clinical features include
intellectual deficit (80%) and/or easily controlled
epilepsy and/or behavioural disorders9. However,
clinical findings vary widely, ranging from
asymptomatic cases with normal intellectual
capacities to those with severe intellectual deficit9.
CCA is generally discovered when the child starts
school and although febrile seizures appear to be
more frequent in CCA patients than in the general
population, epilepsy is rare. Behavioural troubles
seem to be frequent and may be the first sign of the
malformation.
Findings observed such as: 10
Disproportionate enlargement of occipital horns
(colpocephaly).
Pointed anterior ends of lateral ventricle.
Lateral displacement of both medial and lateral
walls of lateral ventricles.
Absent cingulate gyrus and sulci.
Radiating
gyri
and
sulci
(sunburst
appearance)along the interhemispheric fissure.
High riding of 3rd ventricle.
On coronal CT and MR scans the medial borders
of the parallel lateral ventricles appear concave
and indented by the longitudinally oriented fiber
tracts (Probst bundles).
Sometimes in partial agenesis undeveloped
corpus callosum is replaced by fat.
It can be associated with some central nervous system
(CNS) abnormalities such as Chiari malformations,
arachnoid cyst, heterotopias, cephaloceles, anomalies
of neuronal migration including lissencephaly,
schizencephaly, pachygyria and polymicrogyria,
encephaloceles,
Dandy-Walker
malformations,
holoprosencephaly,
and
olivopontocerebellar
degeneration.11
Or may be associated with some chromosomal
aberrations (8, 11, 13-15, 18 and rarely chromosome
6)12, inborn errors of metabolism or genetic
syndromes such as Andermann Syndrome (peripheral
neuropathy with corpus callosum agenesis). Aicardi
Syndrome (infantile spasms, ocular anomalies and
agenesis of corpus callosum), Shapiro's syndrome
(paroxysmal hypothermia with agenesis of corpus
callosum) and sporadically with foetal alcohol
syndrome, Leigh's syndrome.13
Jaiganesh et al.,
CONCLUSION
Prognosis for isolated Corpus callosal agenesis is
good and have normal developmental outcome but
15% are handicapped. Isolated Agenesis of corpus
callosum can even be an occasional finding in the
investigation of children with mental retardation or
microcephaly. Treatment is symptomatic and consists
of physiotherapy, speech therapy, antiepileptic drugs
and psychotherapy. Isolated CCA appears to be
related to a better prognosis than associated CCA,
with up to 80% of isolated CCA cases having a
normal outcome. Nevertheless, parents should be
informed that learning difficulties (associated with
slowness, distractibility and attention deficit) may
develop and require appropriate rehabilitation.
REFERENCES
1. Pilu G, Nicolaides KH. Diagnosis of Fetal
Abnormalities. The 18-23 week scan. London:
Parthenon Publishing; 1999: 9-10.
2. Grogono JL. Children with agenesis of the corpus
callosum. Dev Med Child Neurol. 1968; 10: 613
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3. Freytag E, Lindenberg R. Neuropathic findings in
patients of a hospital for the mentally deficient: A
survey of 359 cases. Hopkins Med J. 1967; 121:
37992.
4. Sangram Singh and Saurabh Garge. Agenesis of
the corpus callosum. J Pediatr Neurosci. 2010;
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5. Sotiriadis A, Makrydimas G. Neurodevelopment
after prenatal diagnosis of isolated agenesis of the
corpus callosum: an integrative review. Am J
Obstet Gynecol. 2012 Apr 206(4): 337. e1-5.
6. Tang PH, Bartha AI, Norton ME, Barkovich AJ,
Sherr EH, Glenn OA. Agenesis of the Corpus
Callosum: An MR Imaging Analysis of
Associated Abnormalities in the Fetus. AJNR.
2009;30: 257-63.
7. Carol MR, Ants Toi Diagnostic ultrasound..
Elsevier Mosby; 2005; vol2, 3rd edition 1132,
1258-60
8. Luis F. Goncalves, Maria Veronica Munoz Rojas,
Florianopolis, Agenesis of the Corpus Callosum.
Brazil 2000-08-11-14
www.thefetus.net
Updated 08.22.2007 by Frantisek Grochal, MD.
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9. Marie-Laure Moutard. Isolated Corpus Callosum

Agenesis.
June
2007.
URL
http://www.orpha.net/consor/cgibin/OC_Exp.php?Lng=GB&Expert=200
10. Osborn AG. Diagnostic neuroradiology. St Louis:
Mosby. 1994; 1st edition: 29-35.
11. Barkovitch AJ, Norman D. Anomalies of the
corpus callosum: correlation with further
anomalies of the brain. AJR AM J Roentgenol
1988; 151:171-79.
12. Desai AK, Bhide AG, Bhalerao SA. Agenesis of
corpus callosum - a rare case. Journal name.
1999;45(1):20-22
13. Gelot A, Lewin F, Moraine C. Agenesis of corpus
callosum - Neuropathological study and
physiopathologic hypothesis. J Neurochirurgie
1998; 44:74-84.
Jaiganesh et al.,
1009
DOI: 10.5958/2319-5886.2014.00040.X

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Received: 17 May 2014
Case report
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 28 June 2014
Accepted: 17th Jul 2014
OVARIAN ECTOPIC PREGNANCY- A CASE REPORT

Hiremath PB1, *Nidhi Bansal2, SPArunkumar3, Lavanya M4, Sandhya Panjeta Gulia5, Premaleela KGM6,Reshma
Hiremath7
1
Associate Professor, 2Assistant Professor, 6Professor, Dept of Obstetrics & Gynecology, SVMCH & RC, Ariyur,
Puducherry
3
Prof &Head, 4Assistant Professor, 5Associate Professor, Dept. of Pathology, SVMCH & RC, Ariyur, Puducherry
7
IMO, Mapusa, Goa
*
Corresponding author email: drnidhibansal@gmail.com
ABSTRACT
Ectopic pregnancy (implantation anywhere outside the normal uterine cavity) is the most common pregnancy
complication leading to mortality. In the era of artificial reproductive techniques and liberated life style, ectopic
pregnancy is not rare. However, ovarian pregnancy is an uncommonly encountered variety of ectopic pregnancy,
and a definitive preoperative diagnosis is very challenging. Intraoperative findings and histopathology usually
provide the final diagnosis. High serum beta human chorionic gonadotrophin levels, lack of an intrauterine
gestational sac, tubo ovarian mass on ultrasonography (USG), patients risk factors, in addition to the
Spiegelbergs criteria gives a high probability of ovarian pregnancy. Management with surgical approach is
required in all cases. We have made an attempt to present a case of ovarian pregnancy, consistent with
Spiegelbergs criteria. Our case demonstrates the difficulty in preoperative and intra operative diagnosis of
ovarian ectopic, the final confirmation has been made by histopathology.
Keywords: Ectopic pregnancy, Ovary, Risk factor, Haemoperitoneum, Pelvic inflammatory disease.
INTRODUCTION
The incidence of ectopic pregnancy has been on the
rise over the past two decades. It has increased from 1
in 150 pregnancies to about 1 in 40 pregnancies in the
present times. Ectopic gestation may be extrauterine
(tubal, ovarian, abdominal) or uterine(interstitial,
rudimentary horn of the bicornuate uterus, cervical,
caesarean scar)1. Ovarian pregnancy is a rare variant
of ectopic pregnancy, with a reported incidence of
1/7000 - 1/40,000 pregnancies2, 3. It remains a
challenge for the diagnosis, even today, in spite of the
availability of sophisticated diagnostic technologies.
There are very few reports of an accurate
preoperative diagnosis, utilizing ultrasonography.
Most commonly, patients undergo surgery for
suspected ruptured tubal ectopic pregnancy,
hemorrhagic corpus luteum or hemorrhagic ovarian
cyst. Fortunately, the final diagnosis is provided by
histopathological examination, otherwise, it would

have remained enigmatic, creating a confusion for the
clinicians. It is not easy, even for the pathologist to
confirm the final diagnosis, but, with great difficulty,
using the Spiegelbergs criteria, a team of efficient
pathologists, can provide an accurate diagnosis.
Nidhi et al.,
CASE REPORT
A 25 year old female, P3L3, not sterilized, was
admitted in the emergency ward of Sri
Venkateshwaraa Medical college and research
centre, Ariyur, Pondicherry, with history of acute
onset of abdominal pain , not associated with any
vomiting, loose stools or giddiness. On enquiry,
patient gave a history of one and a half month of
amenorrhea.On examination, patient had a pulse rate
1010
of 90/min, blood pressure of 90/60mmhg and severe

pallor was present.On abdominal examination,
generalized tenderness was noted all over the
abdomen. Urine pregnancy test was positive. On
clinical assessment, a diagnosis of ruptured ectopic
pregnancy was made. Blood samples collected for
the routine investigations. Hb: 7.3G%, PCV: 24%,
Blood group: O positive.Ultrasound examination of
abdomen and pelvis showed evidence of gross free
fluid in the peritoneal cavity with no evidence of
intrauterine or extrauterine gestational sac. Patient
was taken for emergency laparotomy and proceed.
Intraoperatively,
approximately
1500ml
of
haemoperitoneum was noted with a normal uterus
and grossly normal tubes. A small bleeding point was
seen at the tip of the right ovary with normal left
ovary. In view of normal tubes and suspicious lesion
on the right ovary, the decision was made for right
salphingo-ovariotomy. As the patient was willing for
sterilization, left partial salphingectomy and dilatation
and curettage was done. Intraoperatively surgeon was
summoned and surgical cause for haemoperitoneum
was ruled out.
Post operatively, the patient received 2 units of blood
and the declining trend of serum beta HCG was
noted. The patient recovered and was discharged.
Histopathology report showed secretory endometrium
and tubes showed normal histology with no evidence
of chorionic tissue. Right ovary showed ovarian
stroma with immature villous tissue, consisting of
cytotrophoblast and syncytiotrophoblast surrounded
by blood clots. [Fig.1] The final impression of
Ovarian ectopic pregnancy was given.
Fig 1: High magnificati (n(40x) view of ovarian

ectopic
DISCUSSION
Ovarian ectopic pregnancy is rare and can be
associated with high morbidity and mortality rates in
reproductive aged women. Ovarian Ectopic
pregnancy (OEP) is still a diagnostic dilemma. It is
difficult to make a diagnosis even during the surgery.
About a century ago, Spiegelberg4 had defined four
criteria for the diagnosis of primary OEP that; (a) the
tube on the affected side must be normal, (b) the
gestational sac must occupy the habitual place of the
ovary, (c) it must be connected to the uterus by the
utero-ovarian ligament, (d) unequivocal ovarian
tissue must be histologically demonstrated in the wall
of the sac. The most common clinical presentations in
patients with OEP are a period of amenorrhea, pain
abdomen and bleeding per vaginum5. Ovarian ectopic
pregnancy is associated with risk factors like artificial
reproductive technologies (ART), intrauterine
contraceptive devices (IUCD), Endometriosis and
pelvic inflammatory disease (PID). 6
Sensitivity of Transvaginal sonography (TVS) is
more than 90% in the diagnosis of ectopic pregnancy.
It is now the imaging modality of choice. Diagnosis is
based on the visualization of an ectopic mass rather
than the inability to visualize an intrauterine
pregnancy. Specific sonographic criteria have been
outlined for the diagnosis of tubal and non-tubal
pregnancies7. In a study of 25 cases of ovarian
pregnancies , the most significant finding was the
inability to distinguish an ovarian pregnancy from a
hemorrhagic ovary or ruptured corpus luteum8. They
are twice as likely to be diagnosed at surgery or
following the pathological diagnosis9. Age of the
patient and fertility status guides the clinician in
deciding the treatment options. In the present era, the
most common treatment approach is the laparoscopy.
However, in our case, laparoscopy was not attempted
due to the lack of skilled laparoscopic team at the
time of admission. Intraoperatively, removal of the
entire ovary, including the ectopic pregnancy or
wedge resection of the ovary is usually attempted10.
Etoposide or methotrexate have been reported as a
medical treatment option in the postoperative period
if beta HCG level (normal level less than 25IU in
nonpregnant woman) remains high, indicating
persistent trophoblastic disease11. There is a chance of
recurrence of ectopic pregnancy in 15% cases,
whatever be the modality of treatment, however,
1011
Nidhi et al.,
there is a high chance of normal pregnancy too. The

commonest cause for ectopic gestation is the PID and
therefore early diagnosis and appropriate treatment
would decrease the incidence of ectopic pregnancy1.
CONCLUSION
Presently ectopic pregnancy is not an uncommon
clinical entity, more so in the era of artificial
reproductive technologies. However, ovarian ectopic
is rarely diagnosed in the preoperative period, in spite
of advanced investigative modalities. The final
diagnosis is usually by histopathology.
9. J. Hallat. Primary ovarian pregnancy. A report of

twenty-five cases. American Journal of Obstetrics
& Gynecology. 1982;143:5060 .
10. Hseyin Cengiz, Cihan Kaya, Murat Ekin, Hakan
Graslan, Hediye Dadeviren, Levent Yasar.
Ovarian Ectopic Pregnancy: Association with
Intrauterine Contraceptive Device. Cukurova
Medical Journal. 2013; 38 (3): 520-24
11. Stein MW, Ricci ZJ, Novak L, Robert SJH,
Koenigsberg M. Sonographic comparison of the
tubal ring of ectopic pregnancy with the corpus
luteum. J Ultrasound Med. 2004;23:5762
REFERENCES
1. Padubidri VG, DaftarySN. Ectopic Gestation.
Shaws textbook of Gynaecology, 15th Ed.
Elsevier. New Delhi; 2011: 266-81
2. Itoh H, Ishihara A, Koita H. Ovarian pregnancy:
report of four cases and review of literature.
Pathol Int. 2003; 53(11):806-09
3. Salas Valien JS, Reyero Alvarez MP.Ectopic
ovarian pregnancy.An Med Interna. 1995;12(4):
192-24
4. Kraemer B, Kraemer E, Guengoer E, JuhaszBoess I. Ovarian ectopic pregnancy: diagnosis,
treatment, correlation to Carnegie stage 16 and
review based on a clinical case. Fertil Steril 2009;
92:392.e1315.
5. Grimes HG, Nosal RA, Gallaghar JC. Ovarian
pregnancy: a series of 24 cases. Obstet Gynecol.
1983;61:17480
6. Comstock C, Huston K, Lee W.The
ultrasonographic appearance of ovarian ectopic
pregnancies. Obstet Gynecol.2005;105:42-5.
7. Kirk E, Bourne T. Diagnosis of ectopic
pregnancy with ultrasound, BestPractice &
Research Clinical Obstetrics and Gynaecology.
2009; 2(4):125-29
8. Patel Y, Wanyonyi SZ, Rana FS. Laparoscopic
management of an ovarian ectopic pregnancy
case report. East African Medical Journal. 2008;
85:20104
1012
Nidhi et al.,
DOI: 10.5958/2319-5886.2014.00041.1

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Received: 28 Feb 2014
Case report
GOLDENHAR SYNDROME: A CASE
VERTEBRAL MANIFESTATIONS
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 28 Apr 2014
Accepted: 18thJuly 2014
REPORT
WITH
FACIAL
OCULAR
AURICULAR
Kotian Rashmishree R1, *Vinuta Hegde1, Atul P. Sattur 2, Krishna N. Burde3, Venkatesh G. Naikmasur2
Postgraduate student, 2Professor, 3Professor and Head, Department of Oral Medicine & Radiology, S D M
College of Dental Sciences & Hospital, Dharwad, Karnataka, India.
*
Corresponding author email: kotianrashmishree@gmail.com
ABSTRACT
Goldenhars Syndrome (GS) is a rare condition described initially by Von Arlt. It is characterized by a
combination of anomalies: epibulbar tumors, preauricular tags and malformation of the ears. In 1963, Gorlin
suggested the name oculo-auriculo-vertebral (OAV) dysplasia for this condition and also included vertebral
anomalies as signs of the syndrome. The malformations are said to arise from the first and second branchial
arches. This work reports a case of GS in 11-years-old boy with the clinical signs of pseudo macrostomia,
preauricular tags and epibulbar tumours.
Keywords: Epibulbar Tumours, Goldenhar Syndrome, Preauricular Tags, Macrostomia.
INTRODUCTION
There are several synonyms of Goldenhar Syndrome,
which are Facio-Auriculo-Vertebral Sequence
(FAVS), Oculo-Auricle-Vertebral spectrum (OAVS)
and First and Second Branchial Arch Syndrome. GS
is caused by both genetic and environmental factors.
It is often referred to as Hemifacial Microsomia
when it primarily involves the jaw, mouth and ear on
one side of the body.1 The characteristic asymmetrical
malformations of the face, eye and ear were first
recorded by the German physician Von Arlt in the
19th century but in 1952 a French Ophthalmologist,
Goldehnar Maurice reviewed the subjects and
described the condition as a combination of several
anomalies such as Dermal / Epibulbar tumors,
Preauricular Appendages and Malformed Ears.2 The
malformations of this syndrome arise from defects in
the 1st and 2nd branchial arches.3 Currently no
genetic/DNA test is available for GS; hence prenatal
diagnosis and treatment is not possible.4 The
prevalence of this condition ranges from 1:3500 to
1:5600 live births with a male to female ratio of 3:2.5
CASE REPORT
Rashmishree et al.,
An 11-years-old boy presented with multiple decayed

teeth to SDM College of Dental Sciences and
Hospital, Dharwad. Extra oral examination showed a
crease over the left lateral commissure of the mouth,
which was surgically treated and epibulbar tumors of
both the eyes for which he underwent two surgeries
till date (Fig 1a and 1b).
Fig 1: (a) lateral crease on the left side of the mouth (b)
epibulbar tumors in both the eyes.
1013
He had a convex profile. The left external helix was

anteriorly rotated compared to right ear with a
surgical scar in the preauricular region indicative of
auricular tag removal. A pit was present in front of
right tragus (Fig 2a, 2b and 2c). On examination
showed macrostomia approximately 45mm with a
mild deviation of the mandible to the left side and had
mixed dentition with anterior open bite. Patient also
had multiple carious teeth (Fig 3).
His parents were non-consanguineous and there was

no family history of similar defects or any maternal
illness/medication during pregnancy. There was no
evidence of any psychological disability.
Radiological examination: Digital Orthopantamo
graph (OPG) revealed hypoplastic condyle and
coronoid processes with flat glenoid fossa and
articular eminence. Lateral Cephalograph revealed
block vertebrae with C2 and C3. Chest radiograph
showed crowds of ribs on the left side and scoliosis of
vertebral column (Fig 4a, 4b and 4c).
DISCUSSION
Fig 2: a) anterior rotation of the left external helix (b)

preauricular pit and surgical scars (c) accessory tragi
and surgical scar of left lateral facial cleft.
Fig 3: Anterior open bite and macrostomia
Fig 4: (a) Digital OPG showing hypoplastic condyle and

coronoid processes and flattening of glenoid fossa and
articular eminence (b) lateral cephalograph shows
block vertebrae with C2 and C3 (c) Chest radiograph
reveals crowding of ribs on the left side and scoliosis of
vertebral column
Rashmishree et al.,
Majority of this syndrome occur sporadically and

there is a very small chance of familial occurrence.
Although exact etiology of Goldenhar syndrome is
unknown, autosomal recessive or dominant
inheritance has been suggested.6 Multifactorial
inheritance due to interaction of many genes, possibly
in combination with environmental factors such as
chemical exposure can be the etiology. The diagnosis
of Goldenhar syndrome is mainly based on clinical
aspect and associated radiologic findings and
systemic conditions.
Varied clinical features of syndrome
1. Ear: Preauricular skin tags, dysmorphic ear,
conductive hearing loss.
2. Neck: Branchial fistula, webbing, abnormalities
of sternocleidomastoid muscle.
3. Abdominal wall: Divarication of recti, umbilical
hernia, inguinal hernia
4. Eye: Epicanthal folds, upper / lower lid
coloboma, epibulbar dermoids, epiphora,
microopthalmia
5. Face: Hypoplasia of maxillary, zygomatic,
coronoid and condylar process, macrostomia,
mandibular ramus asymmetry.
6. Back: Pilonidal dimple, kyphoscoliosis.
7. Hands / Fingers: Polydactyly, clinodactyly, single
palmar crease.
8. Skeletal: Cervical fusion, hemivertebrae, and
scoliosis.
9. Cardiovascular: Cardiomegaly, ASD, VSD,
TOF.7-10
Our patient had macrostomia (surgically treated), an
accessory tragi on the left side, preauricular pit on the
right side, preauricular skin tags and epibulbar tumors
on both the sides (surgically treated), hypoplasia of
the condyle and coronoid processes with flat glenoid
fossa and articular eminence on the left side, block
vertebrae (C2 and C3), crowding of ribs on the left
side and scoliosis of the vertebral column.
1014
CNS: The frequency of intellectual retardation varies

from 10-25% from a practical standpoint; those
children with encephalocele, severe microphthalmia
or with malformations not traditionally seen in
Goldenhar syndrome have a severe risk of mental
retardation
Prognosis: Prognosis is variable and depends on the
presence and severity of associated cardiovascular,
neurological and other complications. The life span of
children is normal.
In our patient, the prognosis would have been better.
Our patient had undergone plastic surgery for
aesthetic correction. Specialized dental care was
advised for carious teeth and malocclusion. Other
treatment options in GS include grafting to correct the
cheekbones, jaw surgery, eye surgery, ear
reconstruction, staged orthodontics, palatal closure,
speech therapy (cleft palate cases) and hearing aids.
The differential diagnosis includes Treacher Collins
syndrome (TCS) that affects both sides of face
symmetrically and lacks ocular and vertebral
malformations of GS. Pierre Robin syndrome always
consists of cleft palate, micrognathia and
glossoptosis. Moebius syndrome is a nonfamilial
deficient development of cranial muscles consisting
of facial diplegia with bilateral paralysis of the ocular
muscles, particularly those supplied by abducens.
Other birth defects similar to GS are Nager
Acrofacial Dysostosis, Maxillofacial dysostosis,
Townes-Brocks Syndrome and Brachio-oto-renal
syndrome. There is no vaccine available to prevent
GS in the present date.
CONCLUSION
The effect of Goldenhar syndrome is more evident as
the child grows, because of delay in the growth and
development of the affected areas. The lack of
development of the upper and lower jaws can cause
dental malocclusion, which requires surgical and/or
orthodontic corrections. So it requires a
multidisciplinary approach and long-term follow-up
to monitor the growth and development.

REFERENCES
1. Sharma JK. Goldenhar-Gorlins syndrome.
Indian Journal of Otolaryngology and Head and
Neck Surgery. 2006; 58(1).
2. Oski FA, de Angelis CA, Feigin RD, Warshaw
JB. Sndromes comuns com anormalidades
morfolgicas. Princpios e Prtica de Pediatria.
Rio de Janeiro: Guanabara Koogan; 1990; 482.
3. Atherton DJ, Moss C. Naevoid and other
developmental defects. In Burns T, Breathnach S,
Cox N, Griffith C. eds. Rooks Textbook of
Dermatology. Oxford: Blackwell Science. 2004.
4. Muhammad Arif Maanl. Goldenhar syndrome:
case reports with review of literature. Journal of
Pakistan Association of Dermatologists 2008; 18:
53-55
5. Kokavec R. Goldenhar syndrome with various
clinical manifestations. Cleft Palate Craniofac.
2006, 43,628-634.
6. Bayraktar S, Bayraktar ST, Ataoglu E et al.
Goldenhar syndrome associated with multiple
congenital abnormalities. J Trop Pediatr. 2005;
51: 377-9.
7. Gorlin RJ, Pindberg JJ, Cohen MM. Oculoauriculo-vertebral dysplasia. In: Syndromes of
the Head and Neck. A Blackiston Division.
McGraw- Hill Book Co: New York, London and
Johannesberg; 1964. p. 546
8. Goldenhar M. Association malformatives de
Ioeil et de Ioreill en particulier le syndrome
dermoide epibulbaire - appendices-auriculares
fistula auris congenita et ses relations avec la
dysostose mandibulofaciale. J Genet Hum
1952;1: 243-82.
9. Collins ET. Cases with symmetrical congenital
notches in the outer part of each lid and defective
development of the malar bones. Trans
Ophthalmol Soc UK 1900; 20:190.
10. Summit R. Familial Goldenhar Syndrome. Birth
Defects 1969; 5:106-9.
ACKNOWLEDGEMENT
We would like to thank Dr. Kirty Nandimath,
Professor, S D M College of Dental Sciences and
Hospital, Dharwad & also our Parents for their
constant support.
Rashmishree et al.,
1015
DOI: 10.5958/2319-5886.2014.00042.3

&
Health Sciences
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Volume 3 Issue 4
th
Case report
Coden: IJMRHS
Revised: 3rd July 2014
Copyright @2014
ISSN: 2319-5886
TIBIAL TUBEROSITY AVULSION FRACTURE IN AN ADULT- A RARE CASE REPORT

*Aterkar Vaibhav M, Mahajan Uday D, Somani Ashish M
Dept of Orthopedics, Rural Medical College, Pravara Institute of Medical Sciences (DU), Loni, Maharashtra,
India
*Corresponding author email: vaibhavaterkar@gmail.com
ABSTRACT
Tibial tuberosity avulsion fracture in an adult a rare case report. Avulsion of the tibial tuberosity is not an
uncommon entity seen in adolescents. This injury is a very rare event in adults, with only a few cases reported in
literature. Here we present a very rare case of an adult having tibial tuberosity avulsion with fracture femur. We
performed an open reduction and internal fixation of the tibial tubercle using a cortical screw and tension-band
wire. Patient had a good functional recovery after Six weeks of follow up.
Keywords: Tibial Tubercle, Avulsion, Extensor Mechanism, Tension Band Wiring.
INTRODUCTION
Tibial tuberosity avulsion fracture in an adult- a rare
case report. Avulsion of the tibial tuberosity is not an
uncommon entity seen in adolesents1. This injury is a
very rare event in adults, with only a few cases
reported in literature2, 3. Avulsions distally at the tibial
tubercle are rarer in adults, but have been reported in
combination with acute tibial tubercle avulsions
fractures in adolescent athletes4.These are very
uncommon injuries, with only 170 cases reported
since 18535,6.
Osgood- schlatter disease (an osteochondritis of the
tuberosity of the tibia) and associated tibial tubercle
avulsion fractures are common in children with an
open physis due to a relatively weak bone at the bone
tendon interface near the epiphysis. They account for
less than 3% of all physical injuries in children7.
The above mentioned factors do not play a role in
causing such injuries in the adults. Hence, these
injuries are extremely rare in adults, with only case
reports in the literature.
Table1: Classification of tibial tuberosity fracture8, 10:
Ogden Classification (modification of WatsonJones)

Type I
Fracture of the secondary ossification
center near the insertion of the patellar
tendon
Type II
fracture propagates to proximal to the
junction with the primary ossification
center
Type III
Fracture extends posteriorly to cross the
primary ossification center
Type IV
Fracture through the entire proximal
tibial physis
Type V
periosteal avulsion of the extensor
mechanism
from
the
secondary
ossification center
Here we report an exceptional case of a middle aged
man who sustained a Tibial tubercle avulsion
fracture, its natural history in adults, a possible
explanation of the mode of trauma and portrayal of
the surgical practice and a successful post-operative
rehabilitation regime.
1016
Vaibhav et al.,
CASE REPORT
A 34-year-old male had a history of a road traffic
accident due to hit and run by a car, while the patient
was on a motorbike. He presented to us with right
thigh pain and right knee pain with swelling and on
examination she had swelling of right thigh and the
limb being in complete external rotation was
suggestive of a shaft femur fracture. He also had
swelling and ecchymosis anteriorly along the
proximal tibia, particularly over the tibial tuberosity
area. Active extension of his knee was not possible.
assisted exercise were started. Six weeks follow up xray showed satisfactory union of the tubercle
fragment after which active extension was
commenced.
Fig 2: Postoperative x-ray lateral view of left knee and

proximal leg
Fig 1- x-ray lateral view of left knee and proximal leg
Plain roentgenogram of the femur and knee revealed

a mid third shaft femur fracture and an avulsion
fracture of the tibial tuberosity.
He was immobilized with an above knee posterior
splint and skin traction.
Open reduction and internal fixation via an incision
centering directly over the tibial tuberosity was taken.
Our aim to do this was to have an accurate anatomical
reduction of the tuberosity fragment and restoration
of extensor mechanism configuration and function.8
On sharp dissection of the area a small 2x1 cm
tuberosity fragment was found avulsed from the base,
but was attached to the patellar tendon. With the knee
in extension the fragment was reduced back to its
crater and two 1.5 mm k-wires passed through it, and
engaged in the posterior cortex of tibia under direct
guidance of image intensification. A tension band
construct was carried out, thus maintaining the
stability and reduction.
The torn edges of parapatellar retinaculum were
sutured meticulously to the side running periosteum
of tibia to get a watertight closure. The
Intramedullary interlocking nail was done for the
shaft femur fracture.
Patient was immobilized in a long knee brace for four
weeks, after which passive knee exercise and active
Vaibhav et al.,
Fig 3: Postoperative x-ray AP view of left knee and proximal

leg
DISCUSSION
Avulsion fractures of the tibial tuberosity are
uncommon injuries.9 In adolescents this type of
fracture accounts for less than 3% of all epiphyseal
plate injuries.10 Usually such an injury in an adult
would produce a patellar tendon tear. Complications
of tibial tuberosity avulsion: Recurvatum deformity,
Compartment syndrome, Loss of range of motion and
bursitis12, 13
The stresses generated by the active contractions of
the quadriceps muscle are borne by the patellar
tendon attachment at the tibial tuberosity. Failure of
the bone usually occurs at the site of muscle insertion.
Tensile forces also create ligament avulsions. A
ligament avulsion, or an avulsion fracture, occurs
more frequently in children than in adults. Avulsion
fractures occur when tensile strength of the bone is
not sufficient to prevent fractures.
The open physis in adolescence is incapable of
resisting the extreme tensile forces and results in an
1017
avulsion, but these factors are precluded in adults

sustaining a similar trauma. Such injuries can occur
on landing after a fall or a jump which produces a
rapid contraction of the quadriceps mechanism
against a partially flexed knee with the foot planted or
a direct trauma to the knee. But due to associated
shaft femur fracture and ecchymosis over the knee we
conclude, in our case it may be due to direct trauma
to the knee.
The scenario in adults is somewhat different in adults
where repeated stresses in the same enormity and
direction may cause inflammation of the tendon.
Different
modalities of
treatment
include:
Nonoperative long leg cast in extension for 4-6
weeks. Operative modalities: 1) Closed reduction and
percutaneous fixation (using a screw) 2) Open
reduction and internal fixation (using cannulated
screw) 3) Open reduction with arthrotomy and
internal fixation 4) Open reduction and soft tissue
repair.14 Postoperative care: 1) Immobilization with
long leg cast for 4-6 weeks and strict non-weight
bearing. 2) Rehabilitation with a progressive extensor
mechanism strengthening and return to mobilization
no sooner than 3 months.
Here, owing to a very small fragment it was difficult
to pass a cannulated screw through the fragment to
fix it. Hence, two small k-wires of size 1.5 mm have
been passed through the fragment to fix it. These
wires are made bicortical in the posterior cortex of
the tibia. A cortical screw with washer is passed in an
antero-posterior direction. A tension band construct
was made with one loop passing under the patellar
tendon and other through the screw and washer.
The prospective advantage of using a tension-band
wire fixation is early rehabilitation and weightbearing. Cast immobilization for extended periods of
time cause inhibition, deconditioning and quadriceps
muscles wasting. This leads to problems in
rehabilitation at a later stage.
CONCLUSION
Thus, on a concluding note some interesting points
worth mentioning about this case are: The age of the
patient who is middle aged, secondly mode of trauma
is direct fall, associated injury in the form of shaft
femur fracture and our decision to surgically
intervene to give the patient early rehabilitation.
ACKNOWLEDGEMENT
We acknowledge Mr. Vikhe D N (clerk) Dept of
Orthopedics RMC, Loni for his technical assistance.
REFERENCES
1. Legaye J, Lokietek W. Fracture-avulsion of the
tibial tuberosity in adolescents. Acta Orthop Belg
1991;57(2): 199-203
2. Chautems R, Michel J. Bifocal avulsion of the
patellar tendon in an adult. Rev Chir Orthop
Reparatrice Appar Mot 2001; 87(4): 388-91
3. Vella D, Peretti G, Fra F. One case of fracture of the
tibial tuberosity in adult. Chir Organi Mov. 1992;
77(2): 299-301.
4. Nikiforidis PA, Babis GC. Avulsion fractures of the
tibial tuberosity in adolescent athletes treated by
internal fixation and tension band wiring. Knee
Surg Sports Traumatol Arthrosc 2004;12:27176
5. Mounasamy V, Brown TE. Avulsion fracture of the
tibial tuberosity with articular extension in an adult:
a novel method of fixation. Eur J Ortho Traumatol.
2008; 18:157-59
6. Singh R, Sharma A. An avulsion fracture of the
tibial tuberosity with fracture of the tibia in a
hockey player. The Internet Journal of Orthopaedic
Surgery. 2005; 2:2
7. Levi JH, Coleman CR. Fracture of the tibial
tubercle. Am J Sports Med. 1976; 4:254-63
8. Watson JR. Fractures and joint injuries. Williams &
Wilkins, Baltimore. 1995: vol2, 4th edn : 751-800
9. William LH, Charles RH, William DA. Avulsion
fractures of the tibial tubercle. J Bone Joint Surg
Am The Journal Of Bone & Joint Surgery. 1971;
53(8):1579-83
10. Vella D, Peretti G, Fra F. One case of fracture of the
tibial tuberosity in the adult. Chir Organi Mov.
1992; 77:299-301
11. Ogden JA, Tross RB, Murphy MJ: Fractures of the
tibial tuberosity in adolescents. J Bone Joint Surg
1980, 62:205-215
12. Wall JJ. Compartment syndrome as a complication
of the Hauser procedure. J Bone Joint Surg Am
1979;61(2):185191
13. Pape JM, Goulet JA, Hensinger RN. Compartment
syndrome complicating tibial tubercle avulsion.
Clin Orthop RelatRes. 1993;295:20104
14. Polakoff DR, Bucholz RW.JA. Tension band wiring
of displaced tibial tuberosity fractures in
adolescents. ClinOrthop Relat Res. 1986;209:161
65
1018
Vaibhav et al.,
DOI: 10.5958/2319-5886.2014.00043.5

&
Health Sciences
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Volume 3 Issue 4
th
Case report
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 20 July 2014
GARENOXACIN IN UNCOMPLICATED URINARY TRACT INFECTION A CASE STUDY REPORT

Pukar M1, Shah JP2, *HajareA3, Krishnaprasad K3, Bhargava A3
1
Professor, 2Associate Professor, Department of General Surgery, SBKS Medical Institute and Research Centre,
Vadodara
3
Medical Services, Glenmark Pharmaceuticals Ltd., Mumbai
*Corresponding author email:anoophajare@gmail.com
ABSTRACT
Urinary tract infection (UTI) is a global problem which has increased the morbidity and mortality in both men and
women. Strategies which are proposed in the management of UTIs include the use of empirical antibiotics with a
broader spectrum of coverage. Urine specimen culture is of significant importance to evaluate the organism
responsible in the pathogenesis. Garenoxacin, a newer fluoroquinolone with unique structural advantage appears to a
suitable drug in the treatment of UTIs.
Keywords: Urinary tract infection, Garenoxacin, fluoroquinolone, PK/PD, E.coli
INTRODUCTION
A urinary tract infection (UTI) is defined as microbial
infiltration of the otherwise sterile urinary tract and is
one of the most common bacterial infections occurring
worldwide. UTIs include infections of the urethra
(urethritis), bladder (cystitis), ureters (ureteritis), and
kidney (pyelonephritis) 1.
Uncomplicated UTIs are those occurring in healthy
premenopausal, non-pregnant women with no history of
an abnormal urinary tract. These include acute cystitis
and pyelonephritis2. Longer courses of treatment are
often recommended for persons with complicated
urinary tract infections.
CASE REPORT
A female aged 34 years weighing 57 kgs approached a
consultant surgeon at a tertiary care hospital at
Vadodara complaining of burning micturition, difficulty
in urination and increased urinary frequency since 3
days. The patient was well built, well-nourished and
was in a stable condition. She was afebrile and her vital
parameters like pulse rate, respiratory rate and blood
pressure were within the normal limits. There was no

generalized lymphadenopathy. There was no history of
any chronic illnesses like Diabetes mellitus or
tuberculosis. The patients urine specimen was sent to
the microbiology department for urine culture.
Garenoxacin 400 mg OD (200 mg X 2 tablets stat) for 5
days was prescribed to the patient along with a urinary
alkalizing agent. The patient was also advised to
consume plenty of water. She was asked to come back
to the OPD for the follow up. After 2 days the urine
culture reported E. coli. The patient returned to the
OPD on the third day and admitted to the doctor about
the relief of urinary symptoms. After 5 days of therapy
another urine specimen was sent to the microbiology
department. The urine culture report was found to be
negative for E.coli.
DISCUSSION
UTIs are the most frequent bacterial infection seen in
the outpatient setting. 1 in 3 women will develop a UTI
requiring antibiotic treatment by age 24, and 50%
1019
Pukar et al.,
experience at least 1 UTI during their lifetime3 . The

incidence of cystitis is found to be significantly higher
in women than men, which might be the result of
anatomic difference. Among young, healthy women
with cystitis, the infection recurs in 25% of women
within 6 months after the first urinary tract infection,
and recurrence rate increases with more than 1 prior
urinary tract infection. Acute uncomplicated
pyelonephritis is much less common than cystitis
(estimated ratio, 1 case of pyelonephritis to 28 cases of
cystitis) with a peak annual incidence of 25 cases per
10,000 women 15 to 34 years of age2.
Management guidelines:
Aims of treatment4:
There are two predominant aims in the treatment of
both uncomplicated and complicated UTIs
1. Rapid and effective response to therapy and
prevention of recurrence in the individual patient
treated
2. Prevention of emergence of resistance to
chemotherapy in the microbial environment or at
least prevention of further increase of resistance.
Current therapeutics for the treatment of UTI in adults
include: 1. -lactams (like Amoxicillin/Clavulanate,
Ampicillin/Sulbactam, and Cefixime etc.) 2.
Fluoroquinolones (like Norfloxacin, Levofloxacin, and
Ciprofloxacin
etc.)3.
Oxazolidinones
(like
Nitrofurantoin, Linezolid) and 4.Pyrimethamines(like
Trimethoprim/Sulfamethoxazole)
Garenoxacin: Garenoxacin
is
a
novel
desfluoroquinolonethat lacks fluorine at the C-6
position5 but has fluorine incorporated through a C-8
difluoromethyl ether linkage. It has been shown to have
activity against a wide range of clinical isolates. The
activity of garenoxacin has been further assessed
against strains of S. aureus with specific topoisomerase
mutations, and more recently, it has been shown that
garenoxacin has similar potency against both
topoisomerase IV and DNA gyrase (dual-targeting
quinolone)6, thus requiring mutations in both
topoisomerases for resistance to occur. Although
horizontal transfer is a major reason for the spread of
ciprofloxacin-resistant strains, the role of antimicrobial
selection may also play an important role7.In vitro
profile of Garenoxacin against the UTI pathogens7,
8
:Garenoxacin is found to have lower MIC90 values
(Fung Tomc) to the common UTI pathogens. For the
fact that Garenoxacin is excreted in the unchanged form
in the urine it is believed to exert its antibacterial
properties against the UTI pathogens8. For antibacterial

like fluoroquinolone which exhibit concentration
dependent killing, increasing the AUC/MIC ratio would
increase the bactericidal activity. Today AUC/MIC
ratio values of 125-150 h for gram negative and 30-40 h
for gram positive organisms are recommended not only
for the microbiological outcome but also to prevent
resistance9.
Table 1: In-vitro profile of Garenoxacin against
common UTI pathogens
Pathogen
MIC90
AUC/
Cmax/
(g/ml) MIC
MIC
E. coli
0.06
1678.3
123.8
Klebsiellapneumoniae 0.5
201.4
14.9
Proteus mirabilis
1
Enterococcus faecalis 0.5
100.7
201.4
7.4
14.9
Streptococcus agalactiae0.12
839.2
62
MIC90, AUC, MIC, Cmax,

Garenoxacin was also found to be superior in terms of
safety profile. Garenoxacin was found to be well
tolerated by healthy adult subjects at oral doses up to
1,200 mg/day for up to 14 days10. A Post-marketing
surveillance (PMS) study done at Japan by Hori et al.11
in 6,412 patients confirmed the superior tolerability
profile of Garenoxacin.
CONCLUSION
UTI is found to be a common problem worldwide,
especially in reproductive women. Need of the hour is
to start the therapy with an empirical antibiotic with a
broad spectrum of coverage. Garenoxacin with its
superior efficacy and safety profile appears to be a
suitable choice among the currently available
antibiotics for the treatment of UTIs. The excellent
PK/PD profile also adds up to the advantage of
preventing selection of resistant mutants. Convenient
once a day dosing schedule has improved the patient
compliance.
Conflict of interest: Nil.
REFERENCES
1. Barber AE, Norton JP, Spivak AM, Mulvey MA.
Urinary Tract Infections: Current and Emerging
Management
Strategies.
Clinical
Infectious
Diseases. 2013;57 (5): 719-724
1020
Pukar et al.,
2. Hooton TM. Uncomplicated urinary tract infection.

New
England
Journal
of
Medicine.
2012;366(11):1028-37.
3. Dielubanza EJ, Schaeffer AJ. Urinary tract
infections in women. Medical Clinics of North
America. 2011;95(1):27-41.
4. Wagenlehner FME, Naber K. Journal of European
Urology. 2006;Treatment of Bacterial Urinary
Tract
Infections:Presence
and
Future.
J.2006;49(2):235-44.
5. Fung-Tomc JC, Minassian B, Kolek B, Huczko E,
Aleksunes L, Stickle T, et al. Antibacterial
spectrum of a novel des-fluoro (6) quinolone,
BMS-284756.
Antimicrobial
Agents
and
Chemotherapy. 2000;44(12):3351-6.
6. Ince D, Zhang X, Silver LC, Hooper DC. Dual
targeting of DNA gyrase and topoisomerase IV:
target interactions of garenoxacin (BMS-284756,
T-3811ME),
a
new
desfluoroquinolone.
Antimicrobial
agents
and
chemotherapy.
2002;46(11):3370-80.
7. Christiansen K, Bell JM, Turnidge JD, Jones RN.
Antimicrobial activities of garenoxacin (BMS
284756) against Asia-Pacific region clinical isolates
from the SENTRY program, 1999 to 2001.
Antimicrobial
agents
and
chemotherapy.
2004;48(6):2049-55.
8. Takagi H, Tanaka K, Tsuda H, Kobayashi H.
Clinical studies of garenoxacin. International
journal of antimicrobial agents. 2008;32(6):468-74.
9. Liapikou A, Torres A. Current treatment of
community-acquired pneumonia. Expert opinion on
pharmacotherapy. 2013;14(10):1319-32.
10. Gajjar D, Bello A, Ge Z, Christopher L, Grasela D.
Multiple-dose safety and pharmacokinetics of oral
garenoxacin in healthy subjects. Antimicrobial
agents and chemotherapy. 2003;47(7):2256-63.
11. Hori S MN. Survey on the usage results of
Garenoxacin tablets. Post marketing surveillance
report. Japanese Journal of Chemotherapy.
2011;59(5): 495-511.
1021
Pukar et al.,
DOI: 10.5958/2319-5886.2014.00044.7

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Volume 3 Issue 4
th
Case report
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
PELVIC ULTRASOUND DIAGNOSIS OF GIANT VESICAL CALCULUS IN 10 YEAR OLD BOY

*Danfulani M1, Musa MA2, Bashir BM3
1
Department of Radiology, Usmanu Danfodiyo University Teaching Hospital Sokoto, Nigeria.

Department of Anatomy, College of Health Sciences, Usmanu Danfodiyo University, Sokoto, Nigeria.
3
Department of Surgery, Usmanu Danfodiyo University Teaching Hospital, Sokoto, Nigeria.
2
*Corresponding author email : danfulo2005@gmail.com

ABSTRACT
Ultrasonography has a vital role to play in the management of children with urinary tract infection as it helps not
only in assessing the urinary tract, but also in excluding complication that may arise from the diseases such as a
urinary tract stone formation. We report a case of a 10 year old boy with giant vesical calculus to the alert
pediatricians to the likelihood of bladder calculus complicating urinary tract infection in our environment and the
usefulness of imaging modality both in the clinical work-up and the follow up in order to reduce delay in patient
management. It is also presented to alert general practitioners that simple non-invasive and cheap ultrasound has a
role to play in making a diagnosis and management.
Keywords: Giant vesical calculus, Ultrasound, Low resource settings.
INTRODUCTION
Giant bladder calculus is defined as a stone in the
urinary bladder weighing more than 100g.1 Such giant
stones are rare in modern urological practice. Urinary
bladder stone account for about 5% of urinary
calculus,2,3 a giant stone is rare2 and commoner in
males due to higher incidence of lower urinary tract
obstruction.2 This stones are usually mixed stones and
are frequently associated with urinary tract infection
by urea splitting organisms.3 Recognized causes
bladder stones include other urinary system problems
such as Bladder diverticulum, Neurogenic bladder,
urinary tract infection and enlarged prostate in the
elderly. Almost all bladder stones occur in men 4,5 and
bladder stones are much less common than kidney
stones.4,5 Bladder stones may occur when urine in the
bladder is concentrated and materials crystallize..4,5
Bladder stone may also result from foreign objects in
the bladder.4,5 Recognized symptoms of urinary
bladder calculus include dysuria, urine frequency
Danfulani et al.,
haematuria, urine retention, hydronephrosis and renal

failure among others.5 Urinary incontinence can occur
also with bladder stones.5 The techniques of removal
of giant vesical calculus includes open suprapubic
vesicolithotomy which is the treatment of choice,4,5
percutaneous cystolithotomy and cystolitholapaxy.
This relieves obstruction and infection is treated with
antibiotics. We report a case of unusually giant vesical
calculus to alert the pediatricians to the likelihood of
bladder calculus complicated urinary tract infections,
and the usefulness of imaging modality both in the
clinical work-up and the follow-up, in order to reduce
delay in patient management. It is also presented to
alert general practitioners that simple non-invasive,
cheap ultrasound has a role to play in making a
diagnosis and management of bladder calculus.
1022
CASE REPORT
Ten years old school child, presented to Ultrasound
Unit of the Radiology department of Sir Yahya
Memorial Hospital Birnin Kebbi with a referral to do
an abdominopelvic ultrasound scan. He was referred
on account of suspected urinary tract infection which
was recurrent and not responding to conventional
antibiotics. The patient has been treated severally in
the paediatric outpatient department (POPD) with
antibiotics but with no improvement in symptoms. On
abdominopelvic ultrasound a very huge strongly
echogenic curvilinear structure was demonstrated
within the bladder lumen, casting posterior acoustic
shadows and approximately measuring about 3cm x
2.5cm. The surrounding urine noted show mobile
internal echoes signifying superimposed cystitis (fig
1). In addition the kidneys show poor corticomedullary
differentiation with reversal of echotexture but their
sizes are normal, consistent with early renal
parenchymal diseases presumably pyelonephritis (fig
2). Abdominal USS examination concluded that the
patient had a huge vesical calculus and superimposed
cystitis and pyelonephritis (Ascending UTI) and
advised plain pelvic x-ray for further evaluation. The
patient was however yet to do x-ray up to the time the
surgery was done and the bladder stone removed.
Fig.1: Pelvic Sonogram Showing a Huge (giant)

Vesical Stone Casting Posterior Acoustic Shadow
Urine M/C/S (microscopy, culture and sensitivity was

done) which yielded no bacterial growth, microscopy
however, revealed few leucocytes, erythrocytes, oxalate
crystals and casts. Haematologic indices and urea,
electrolytes and creatinine were within normal limits.
Danfulani et al.,
Fig 2: Abdominal Sonogram Showing Poor

Corticomedullary Differentiation and Reversal
Echotexture
DISCUSSION
Huge vesical calculus whether in children or in adults
are extremely rare in modern urologic practice.1 A
huge stone is rare and commoner in males,2 just as it
is in the presented case and is usually due to higher
incidence of lower urinary tract obstruction or urinary
tract infection. No metabolic problems were
discovered in our patient and the precipitating factor
was an underlying urinary tract infection, even
though no isolate of a microorganism was made on
urine culture, this is presumably due to recurrent
antibiotics therapy before presentation. In the
presented case a combination of recurrent urinary
tract infection and dietary (nutritional deficiencies of
Vit. A, Magnesium, Phosphate, Vit. B6 combined
with low protein and high carbohydrate diet) is the
most likely cause of huge calculus.5 This finding
agrees with what was reported by Rahman et al in
Ilorin North-central Nigeria.6 No evidence of
established lower urinary tract obstruction in our
patient that would have caused the formation of such
a huge calculus, similar cases have been reported in
the literature.6,7,8 Surgery is the treatment of choice in
the management of a Giant bladder calculus; most
documented literature reports recommend an open
suprapubic vesicolithotomy as the treatment of
choice.8
CONCLUSION
The report of this case is hoping to alert the
paediatricians and general duty doctors managing
paediatric patients with suspected urinary tract
infection to always request Abdminopelvic scan in
1023
their clinical work-up. This would not only confirm

the diagnosis but would also exclude the
complication of this disease entity such as bladder
calculus that may arise from it.
ACKNOWLEDMENT
We acknowledge the support of Sani Muhammad
Abacha of Ultrasound Unit of Radiology
Department, Sir Yahaya Memorial Hospital, Birnin
Kebbi, Kebbi State.
REFERENCES
1. Becher RM, Tolia BM, Newman HR. Giant
vesical calculus. JAMA 1976;239 (21): 2272
3.
2. Schwartz BF, Stroller ML. The vesical calculus.
Urol Chin N Am 2000; 27 (2):333 46.
3. Aliyu S, Ali N, Ibrahim AG. Giant vesical
calculus. Nigerian journal of medicine; 2013;
22(2): 148 50.
4. Benway BM, Bhayani SM. Lower urinary tract
calculi. In: Wein AJ, ed. Campbell-Walsh
Urology . 10th ed. Philadelphia, Pa: Saunders
Elsevier; 2011:chap 89.
5. Sharma R, Dill CE, Gelman DY. Urinary
bladder calculi. J Energ Med; 2011; 41 (2): 185
186.
6. Rahman GA, Akande AA, Mamuda NA. Giant
vessel calculus: experience with management of
two Nigerians. Mgj Surg Res 2005; 7(1-2): 203
05.
7. Nygaard E, Terjesen T. Giant vesical calculus
and ameria scan. J Urol Nephrol. 1979.10; 88
90.
8. Chen S, Kao Y, Tse S. A giant bladder stone. J
Tua 2003; 14(4): 201 03.
Danfulani et al.,
1024
DOI: 10.5958/2319-5886.2014.00045.9
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th
Volume 3 Issue 4

Case report
Coden: IJMRHS
th
Copyright @2014
ISSN: 2319-5886
THE ABERRANT RENAL VESSEL AT LOWER POLE OF KIDNEY: A CASE REPORT

*Meshram Pritee M1, Khedekar Deepak N1, Hattangdi Shanta S3
1
Assistant Professor, 2Professor & Head, Department of Anatomy, LTMMC & GH, Sion, Mumbai, India
*Corresponding author email: prt_meshram@yahoo.co.in

ABSTRACT
A sound knowledge of the normal and variations in blood supply of kidney is a prerequisite to having a
favourable surgical outcome. Knowledge of the commonly occurring variations assumes even more significance
in the era of diagnostic imaging and minimally invasive surgical approaches. We describe a case of variation of
the renal blood vessel found during the routine dissection. A male cadaver, approximately of 60 years, presented
an aberrant renal artery on the left side. Variation in the number, source, branching and course of the renal arteries
occurs frequently. Any variation in arterial supply is important to clinicians undertaking surgery or other
intervention renal procedures.
Keywords: Renal artery, Aberrant Renal artery, Polar artery.
INTRODUCTION
The renal arteries originate from the abdominal aorta
and
enter
the
renal
hila
to
supply
the kidneys. Traditionally, each kidney receives
irrigation from a single renal artery. However, many
studies report great variability in renal blood supply,
the number of renal arteries and the arrangement of
hilar structures1-5. Here a case is described where; an
aberrant renal artery is seen on the left side. The
aberrant artery took origin from the main left renal
artery. These aberrant arteries account for about 30%
of existence, while 70% owes for the normal type. An
aberrant artery is the artery that supplies the kidney
without entering its hilum6.
CASE REPORT
During the routine dissection in 10% formalin fixed
male cadaver of approximately 60 years in the
Department of Anatomy, Lokmanya Tilak Municipal
Medical College, Sion, Mumbai, the posterior
abdominal wall was dissected. After opening the
abdomen, when the renal vessels were dissected and
Priteet et al.,
traced carefully it was found that there is a single

renal artery on the right side. However, while tracing
the left renal artery it was found that the main renal
artery originated at the level of the lower border of
the L1 vertebra. It was then running horizontally
along with left renal vein towards the hilum of the left
kidney and enters the left kidney. After the origin of
the main artery an aberrant renal artery originated
from the main renal artery (Fig 1) it continued
downward and laterally towards the lower pole of left
kidney. It passed posterior to the lower ole of left
kidney and entered the kidney through its posterior
aspect. No other aberrant renal vessel was found at
the upper pole of the same kidney. No aberrant vessel
was found on the right side. Such variation has great
implications when surgery is indicated, as in renal
transplants, urological and radiological procedures.
DISCUSSION
Normally the renal arteries arise from the abdominal
aorta at the L1-2 vertebral body level, inferior to the
origin of the superior mesenteric artery.
1025
Fig 1: The Aberrant Renal Artery

A: left kidney, B: cut left artery, C: aberrant renal
artery entering lower pole of left kidney
The right renal artery courses inferiorly and passes
posterior to the IVC and the right renal vein to reach
the renal hilum. The left renal artery passes more
horizontally, posterior to the left renal vein to enter
the renal hilum. Both the renal arteries have
anterior and posterior divisions. The anterior and

posterior divisions divide into segmental
branches which then divide into lobar branches.
The lobar arteries successively branch into
interlobar, arcuate and interlobular arteries. The
afferent arterioles, which supply the glomeruli,
originate from the interlobular arteries.
According to Felix7there are nine pairs of lateral
mesonephric arteries arising from the dorsal
aorta. These mesonephric arteries extend from
sixth cervical segment to third lumbar segment.
The cranial arteries disappear and the upper
lumbar arteries form a network called the rete
arteriosum urogenitale that supplies in future the
metanephros. The metanephros in future develops
into adult kidney deriving its blood supply from the
rete arteriosum. Most of the roots forming this
network degenerate only a few roots which form
renal artery persists. Thus the aberrant renal vessel
can considered as persisting segmental arteries. The
presence of the aberrant renal vessel can be
considered as the developmental defect. The studies
by F.T Graves 8has classified these aberrant renal
vessels into three groups
Group 1: arising at the hilum
Group2: arising in the pedicle
Group 3: arising from the aorta.
Priteet et al.,
According to this classification the aberrant vessel in

our case belongs to group 2. Some studies suggest the
presence of aberrant renal vessel at the lower pole in
2 % population9. The aberrant renal arteries
compressing the ureter have been considered to be
etiologic
agents
in
the
production
of
5,9
hydronephrosis . An aberrant inferior polar renal
artery of aortic origin, arching around the renal vein
is described in 7% of cases 10. These arteries were
more common on left side. These arteries were
reported of causing orthostatic proteinuria and
orthostatic hypertension. In our study the lower polar
artery was found on left side but no such arching
around the renal vein found. In Studies by Bakheit
MA1, Motabagani MA multiple anomalies of the
posterior abdominal wall arteries were found in a
single male cadaver aged 50-years2. These anomalies
were accessory renal, a pre-hilar division of the renal,
unilateral origin of the inferior phrenic artery from
the renal and aberrant suprarenal arteries. No such
abnormalities were found in the present study. In the
present study the lower polar artery has been seen
which has a great clinical significance. It has been
seen that failure to restore circulation in such artery
after surgery may lead to segmental ischemia and
necrosis.
CONCLUSION
The precise knowledge of renal vasculature and the
variations in the renal vessels are important for
surgeons, a urologist for vascular reconstructions,
renal endoscopic surgeries and renal transplant
surgeons performing any renal surgeries should have
the proper knowledge of renal vasculature and the
variations. Thus the present study highlights the
presence of the aberrant renal vessel at the lower pole
of the kidney and its clinical significance. As the
number of renal surgical and radiological
interventions increase, a better understanding of the
anatomy of renal arteries and their branches gain
importance.
Conflicting Interest: Nil
REFERENCES
1. Cerny JC, Karsch D. Aberrant renal arteries.
Urology. 1973; 2:623-626.
1026
2. Bakheit MA, Motabagani MA. Anomalies of the

renal, phrenic, suprarenal arteries Saudi Med J.
2004; 25(3): 376-378.
3. Gesase AP. Rare origin of supernumerary renal
vessel supplying lower pole of the left kidney.
Ann Anatomy. 2007; 189 (1):53-58.
4. Satyapal KS, Haffejee AA, Singh B, Ramsaroop
L, Robbs JV, Kalideen JM. Additional renal
arteries: incidence and morphometry. Surg Radiol
Anat. 2001; 23: 3338.
5. Edsman G. Accessory vessels of the kidney and
their diagnosis in hydronephrosis. Actaradiol.
1954; 42: 26.
6. Standring Susan, Ellis H, Healey JC, eds. Grays
Anatomy: The Anatomical Basis of Clinical
Practice.
London,
Elsevier
Churchill
Livingstone Publishers. 2005; 127475.
7. Felix W. The development of the urinogenital
organs. In Keibel and Mall, Human Embryology.
Philadelphia, J. B. Lippincott Company, 1912; 2:
752.
8. Graves FT. The aberrant renal artery. J Anat.
1956; 90(l): 55358.
9. Sanford HL. Anomalous renal vessels associated
with ureteral obstruction and hydronephrosis .Tr.
Am. A Genito-Urin.Surgeons. 1926;19:105
10. Hilel Nathan. Observations on Aberrant Renal
Arteries Curving Around and Compressing the
Renal Vein Possible Relationship to Orthostatic
Proteinuria and to Orthostatic Hypertension.
Journal of the American Heart Association. 1958;
18:1131-34.
Priteet et al.,
1027
DOI: 10.5958/2319-5886.2014.00046.0

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Health Sciences
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Volume 3 Issue 4
Coden: IJMRHS
nd
Revised: 5thAug 2014
Case report
Copyright @2014
ISSN: 2319-5886
SPONTANEOUS BILATERAL RUPTURED AND UNRUPTURED TUBAL ECTOPIC PREGNANCIES:

A CASE REPORT AND LITERATURE REVIEW FROM NIGER DELTA NIGERIA
*Ekine A A1, Udoye EP2
1
Department of Obstetrics and Gynaecology, Niger Delta University Teaching Hospital, Okolobiri, Bayelsa State,
Nigeria.
2
Department of Anatomical Pathology, Niger Delta University Teaching Hospital, Okolobiri, Bayelsa State,
Nigeria.
*Corresponding author email:adokin1960@gmail.com
ABSTRACT
Historically ectopic pregnancy and it`s complications account for the most leading cause of first trimester
maternal deaths in the world. Bilateral tubal pregnancies in the absence of a preceding induction of ovulation (or
tubal manipulation for assisted conception) are very rare occurrences and are associated with high potentials for
causing maternal mortality. We herein report an uncommon mode of presentation of an ectopic pregnancy in a
multi-parous woman, with a spontaneous bilateral tubal pregnancy. The Patient presented in shock, which was
caused by a ruptured right ampullary tubal ectopic pregnancy with massive haemoperitoneum. During a life
saving emergency exploratory laparotomy which showed a ruptured right ectopic pregnancy, an enlarged unruptured left ampullary mass highly suspicious of ectopic pregnancy was also removed. Both tubal pathologies
were confirmed as ectopic gestations histopathologically. This case underscores the variety of such occurrences, a
high index of suspicion, judicious intra-operative inspection of the contra lateral tube and histopathological
evaluation of the specimens.
Keywords: Bilateral, Tubal, Ectopic, Pregnancy, Complications
INTRODUCTION
Ectopic pregnancy has been found to be on the
increase in the past three decades and this pattern has
not reversed currently, even in our centre. While first
trimester maternal mortality as a direct or indirect
result of ectopic pregnancy had been on the decline,
the incidence and prevalence of ectopic pregnancy is
on the rise1. Bilateral ectopic pregnancy is a very
unique form of twin pregnancy, more commonly seen
in assisted reproductive technique, than occurring
spontaneously2,3. According to medical literatures,
approximately 250 cases have been reported, though
the actual incidence is unknown and cannot be
determined currently2. However a gross estimation of

between 1 in 750 and 1 in 1,580 ectopic pregnancies
and also 1 in every 200,000 live births is mentioned
in most medical literatures1,4-7. Other reports have
shown spontaneous bilateral pregnancy to be higher
in native Africans, possibly due to the higher
prevalence of twin pregnancy and pelvic
inflammatory diseases, resulting in incidence rate of
about 1 in 51 ectopic pregnancies.6,7
Twin
pregnancies can occur in many ways; like bilateral
tubal pregnancy of the same gestational age or
different ages with both aborting or one aborting
Ekine et al.,
1028
while the other is developing. The involvement of the

tube could be unilateral twin ectopic but neighboring
structures like the broad ligament, ovary or
abdominal structures can be involved6. The bilateral
tubal twin pregnancy is the rarest form of extra
uterine pregnancy 1. Twin pregnancies in the same
tube and heterotopic pregnancies are notably more
common after assisted reproductive technique (ART),
tubal surgeries, hormonal manipulations for multiple
ovulations.8-11. Some of the risk factors associated
with the ectopic pregnancy include, pelvic
inflammatory diseases, intrauterine contraceptives
device usage, tubal surgeries, and assisted
reproductive techniques1,3,4,7,11,12. Diagnosis of
bilateral tubal ectopic pregnancies is not easy as they
are not always suspected, even ultrasound has its
limitations and that is the reason why bilateral ectopic
pregnancy is mostly encountered unsuspected at
laparotomy. Though in many cases conservation of
fertility is an important issue, bilateral salpingectomy
is often required in some given circumstances.
However, efforts should always be made to see the
integrity of contra lateral adnexa if attainable. We
herein report the first documented case of
spontaneous simultaneous bilateral tubal pregnancy
in the Niger Delta region occurring in a multipara
which was managed by bilateral salpingectomy.
A housewife with primary level of education aged 37

years, gravida 5, para 4 + 0, four alive (three boys and
one girl), presented at the Accident and Emergency
Department with a four-day history of abdominal
pain, a day history of vaginal bleeding, and an
episode of fainting attack. Her last menstrual period
was on 29-11-2013. She was apparently well for a
period of approximately 12 weeks of amenorrhea,
after which she experienced lower abdominal pains,
which were insidious in onset, initially pronounced in
the right supraumblical region of the abdomen, and
later became generalized, colicky in nature with no
known aggravating or relieving factors. The pain had
persisted for 3 days and so on the fourth day she went
for an "abdominal massage" by a native therapist, a
common practice in this part of our country, Nigeria.
On completion of the native therapy, the woman
started having vaginal bleeding. During this long
period of amenorrhea, she never sought medical
attention nor did a pregnancy test. Initially the
vaginal bleeding was scanty, but later it became

heavier, necessitating the use of four fully soaked
pads with clots. There was no passage of fleshy
materials or grape like vesicles, but she afterwards
complained of headache, dizziness, and later
slumped.
She was sexually active, but never used any form of
contraceptives. There was no past history of
termination of pregnancy, sexually transmitted
disease or use of fertility enhancing drugs. Also, there
was no family history of twining or history of tubal
surgeries. The patient has four children, three boys
and a girl.
At presentation, she was in respiratory distress and in
shock. Her vital signs were Pulse 110beats/minute,
Blood pressure70/40 mmHg, respiratory rate of 38
circles per minute. She was extremely pale, but not
jaundiced. Her chest was clinically clear. Abdomen
was distended with generalized tenderness and did
not move with respiration. Abdominal paracentesis
done yielded non-clotting blood. On gentle speculum
vaginal examination, the vulva was bloodstained, the
cervix looked healthy and there was no significant
bleeding through the cervical OS but the posterior
fornix was bulging. Bimanual examination was
excluded due to the overwhelming evidence of
massive haemoperitoneum. Urgent urinary pregnancy
test was positive. Pelvic ultrasound scan was not done
because of lack personnel at the time, but with the
presence of blood in the peritoneum a suspicion of
ruptured ectopic pregnancy was strong. The urgent
packed cell volume (PCV) done was 14% and initial
diagnosis of ruptured ectopic pregnancy in
hemorrhagic shock was made. The patients relatives
were counseled on immediate surgical intervention to
avoid any consequence adverse outcome since she
was not capable of taking any proper decision at that
moment. Though she was not quite stable and fit for
surgery, a decision for surgical intervention had to be
made to avoid imminent fatal incidence.
Immediate resuscitation with intravenous fluids,
plasma expanders and blood transfusion was
commenced and continued in the emergency
explorative laparatomy that was done for her via a
midline sub-umbilical incision. Intra-operative
findings revealed haemoperitoneum of more than two
liters with severe intra-abdominal pelvic adhesions.
Right ampullary ruptured ectopic pregnancy was
confirmed and salpingectomy was done. Close
Ekine et al.,
1029
CASE REPORT
inspection of the other organs revealed a distended

and unruptured left tube ampullary region measuring
about 9 cm by 6 cm. Subsequently, salpingectomy
was also done for the left tube, followed by
adhesiolysis. The haemoperitoneum was evacuated
and warm saline peritoneal lavage was done before
closing up. She was transfused with 3units of blood
intraoperatively.
Combined
broad
spectrum
antibiotics was commenced immediate postoperative
due to the massive adhesions seen during the surgery,
though from the patient`s history there was no
information about previous pelvic inflammatory
diseases (PID). The immediate postoperative period
was uneventful. The pack cell volume done on the
second day post operation was 19% so she had a
further transfusion of two units of blood. She was
commenced on graded oral sips second day post
operation. Sutures were removed on day seven post
operation and wound healing was good. A repeat
pack cell volume done was 28% and she was
discharged home on heamatinics. Before discharge
the patient was counseled on the likelihood of future
reproductive impairment and the role of IVF and
adoption as possible options, if the patient desires
more children. The specimen of both fallopian tubes,
a haemorrhagic mass from right fallopian tube and
omentum were sent for histopathological evaluation.
Fig1: Kidney dish containing enlarged right and

left fallopian tubes with a large haemorrhagic
mass from the ruptured right tube and omental
tissue from adhesiolysis.
Fig 2: Enlarged right ruptured fallopian tube with

a haemorrhagic mass attached to it.
Ekine et al.,
Fig 3: Cut surface of ruptured right Fallopian

tube showing intratubal haemorrhage.
Fig 4: Cut surface of haemorrhagic mass attached

to the ruptured right fallopian tube showing blood
clots with islands of solid tissue.
Fig 5: Dilated left unruptured tube with omental

tissue.
Fig 6: Cut surface of left fallopian tube showing

intratubal haemorrhage.
1030
The histopathological report confirmed bilateral tubal

ectopic gestations based on the presences of chorionic
villi and decidua in both tubes.
Fig 10: Histologic section from the omental tissue

showing focal haemorrhage and dense infiltration
of adipose tissue by lymphocytes. H&E x 100
Fig 7: Histologic section from right fallopian tube
showing dilated lumen containing haemorrhage,
decidua and chorionic villi. H&E x 100
At follow up four weeks later her clinical state was

fine, and PCV was 31%. As at the last follow up visit
three months after discharge, she has been well with
no complains. The patient gave permission to report
the case with pictures, anonymously.
DISCUSSION
Fig 8: Histologic section of the haemorrhagic mass

from the right ruptured fallopian tube showing
haemorrhagic
necrosis
with
degenerating
chorionic villi and decidua. H&E x 100
Fig 9: Histologic section from the left fallopian

tube showing dilated lumen containing blood clot
within which are chorionic villi. H&E x 100
Ekine et al.,
The incidence of bilateral ectopic pregnancy is now

known to vary between 1 in 725 to 1 in 1580 of all
ectopic pregnancies and estimated to occur in about 1
in 200,000 pregnancies.4 Bilateral tubal pregnancy in
the absence of ovulation induction or ART represents
the rarest type of ectopic pregnancies and twin
pregnancy in the same tube is of higher frequency
than bilateral tubal type.2 The index case was a
simultaneous bilateral ectopic pregnancies, hence
represents an exceedingly rare form of ectopic
gestation. Only a few cases of simultaneous bilateral
pregnancy have been published, about 250 cases, of
which many occurred following assisted reproductive
treatment. 2 Our case was not only a very rare form,
but was spontaneous. Norris' criteria of 19538 for a
diagnosis of simultaneous bilateral tubal pregnancy
required that the chorionic villi in each tube should be
sufficient for diagnosis, which is a modification of
1939 criteria by Fishback13, which suggested the
presence of fetuses or any portion of the fetuses along
with placenta material for such diagnosis. Our case
satisfied Norris' criteria as indicated by the
histopathological report and hence, was confirmed
bilateral tubal ectopic pregnancies.
A high index of suspicion and careful examination of
the contra lateral tube are necessary for diagnosis of
bilateral ectopic pregnancy intra-operatively11,14,15.
1031
This is more so as the preoperative diagnosis with

ultrasound scan is unreliable 16,17, with only very few
reported cases diagnosed by preoperative ultrasound
scanning2. Our patient was diagnosed intraoperatively in line with the fact that preoperative
diagnosis is uncommon.
The index case was spontaneous as she was not
known to be on fertility enhancing medication or to
be undergoing assisted reproduction therapies which
are known risk factors for bilateral ectopic
pregnancy18. Also, she had no family history of twin
pregnancy, nor was she of the ethnic groups that are
prone to twining in Nigeria19,20, as such are further
risk factors for bilateral ectopic pregnancy. However,
she had extensive pelvic adhesions which were most
probably as a result of chronic pelvic inflammatory
disease, a notable risk factor for ectopic pregnancy. 1,4
Whether bilateral ectopic pregnancy occurred
spontaneously or occurred on a background of
ovulation induction or is induced by assisted
reproductive techniques, the hallmarks of good
management including detailed ultrasound scanning
(especially when presentation is not acute or life
threatening), judicious intra-operative inspection of
the contra lateral tubes, histopathological examination
of the specimens and appropriate patient counseling,
among others will ensure best practices. Our case
presented in shock for which positive peritoneal tap
of non-clotting blood and a history of amenorrhea of
12 weeks was sufficient to commence a life-saving
intervention. However, other factors were duly
observed.
Researchers from eastern Nigeria have stated a
preference to salpingostomy when the tubes are intact
as that gives the patient hope of future fertility and
helps to prevent family disintegration associated with
childlessness.21,22 It has also been observed that for
unknown reasons many women fail to become
pregnant even after successful reconstructive tubal
surgery.22,23 Documented evidence also showed that
recurrent ectopic pregnancies occur in 6-16% of
women with a previous history of ectopic18 Therefore
salpingostomy option in the management of ectopic
pregnancy should be left for cases that strictly merit it
after weighing all the risk against the hope of future
fertility for the childless. This implies a sound clinical
judgment considering the parity of the patient, marital
status, reproductive aspirations, condition at
presentation, findings on physical examination, the
Ekine et al.,
experience of the surgical team and the available

resources.24 Our case was a para 4, four alive with
good sex ratio, who presented in shock from
suspected ruptured ectopic post traditional abdominal
massage and was diagnosed of bilateral tubal ectopic
pregnancy intra operatively during a life-saving
surgical intervention, in which salpingectomy was
done for the unruptured tube based on sound clinical
judgment.
The principles of treatment of unilateral ectopic
gestations can be applied in simultaneous bilateral
ectopic pregnancy, since no separate guideline for
treatment has been developed due to the rarity of such
cases. 25 Apart from laparoscopy being the choice
treatment of elective management of ectopic
pregnancy, it can be used to examine the contra
lateral tube and to diagnose and manage bilateral
ectopic pregnancy as in the case of Sommer et al 1,26
Takeuchi et al reported the first case of laparoscopic
treatment of bilateral tubal pregnancy in 199527.
Currently, reports of primary medical treatment of
bilateral tubal ectopic pregnancy with methotrexate
are lacking, though since the diagnosis of this
condition is usually intra-operative, it may be
possible that there would have been such cases in
which clinicians were unaware that their medical
treatment for unilateral unruptured tubal ectopic
pregnancy had resulted in successful management of
exiting unruptured pregnancy in the contra lateral
tubes.1
CONCLUSION
High index of suspicion and meticulous examination
of both tubes and adnexa even in the presence of
significant pelvic adhesions coupled with a holistic
approach in clinical judgment for possible surgical
intervention are of great importance in the detection
and treatment of bilateral tubal pregnancy.
ACKNOWLEDGMENT
We duly sought for and obtained permission from the
patient to publish this report with pictures
anonymously. Ethical approval was also granted by
the ethics committee of our hospital to report case.
REFERENCES
1. Andrews J, Farrell S. Spontaneous bilateral tubal
pregnancies: a case report. J Obstet Gynecol
1032
Can 2008; 30:51-54.

2. Martinez J, Cabistany AC, Gonzalez M, Gil O,
Farrer M, Romero JA. Bilateral simultaneous
ectopic pregnancy. South Med J 2009; 102:10551057.
3. Rizk B, Morcos S, Avery S, Elder K, Brinsden P,
Mason B, et al. Rare ectopic pregnancies after in
vitro fertilization: one unilateral and four bilateral
tubal pregnancies. Hum Reprod 1990; 5:10251028.
4. Adair CD, Benrubi GI, Sanchez-Ramos L,
Rhatigan R. Bilateral tubal ectopic pregnancies
after bilateral partial salpingectomy: a case
report. J Reprod Med 1994; 39:131-133.
5. Al-Quraan GA, Al-Taani MI, Nusair BM, ElMasri A, Arafat MR, Khateeb MM. Spontaneous
ruptured and intact bilateral tubal ectopic
pregnancy. a case report. East Mediterr Health J
2007; 13:972-974.
6. Kansaria J, Chauhan A, Mayadeo N. An unusual
case of bilateral tubal ectopic pregnancy
[Internet]. Bombay Hosp J 2002; 44. Available
from:http://www.bhj.org/journal/2002_4401_jan/
case_
7. Jignesh Kansaria, Anahita C, Niranjan M. An
unusual case of Bilateral tubal ectopic Pregnancy.
J Reprod Med 2005; 50(3): 222-224.
8. Norris S; Bilateral simultaneous tubal
pregnancy.CAN Med Assoc J 1953:68:379-381
9. Fox ET,Mevs FF. Simultaneous bilateral tubal
pregnancies, report of 2 cases. Obstet Gynecol
1963; 21:499-501.
10. Sebastiano C, Vincenzo C, Pietro G. Bilateral
tubal pregnancy following in vitro fertilization
and embryo transfer. Eur J Obstet Gynecol Rep
Bio 2003; 110(2): 237-239.
11. Marpeau O, Barranger F, Cortez A, Uzan
S.Bilateral tubal pregnancy after natural
conception: a case report. J Reprod Med 2005;
50:222-224.
12. Shetty JP, Shetty B, Rao C, Makannavar JH, A
rare case of bilateral tubal pregnancy J Indian
Med Assoc. 2011; 109(7):506-7.
13. Fishback HR. Bilateral simultaneous ectopic
pregnancy. Am J Obstet Gynecol 1939; 37:1035.
14. Edelstein MC, Morgan MA. Bilateral
simultaneous tubal pregnancy: case report and
Ekine et al.,
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
review of literature Obstet Gynecol Surv 1989;

44: 250-252
Ryan MT, Saldana B. Bilateral ectopic
pregnancy: a tale of caution. Acad Emerg Med
2000; 7:1160-1163.
De Graaf FL, Demetroulis C. Bilateral tubal
ectopic pregnancy: diagnostic pitfalls BrJ clin
Pract 1997; 51: 56-58
Hugues J, Olszewska B, Dauvergne P, Bulwa S,
Cedrin-Durnerin I. Two-step diagnosis of
bilateral ectopic pregnancy after in vitro
fertilization .J Assist Reprod Genet 1995; 12:
460-462
Jurkovic D. Ectopic pregnancy. In: Edmonds DK,
editor. Dewhursts Textbook of Obstetrics and
Gynaecology.7th ed. Massachusetts: Blackwell
Publishing; 2007. p.106-16.
Onuigbo IB, Eze JN, Okafor II. Twin proneness
associated with two extraordinary cases of
coexistence of bilateral tubal pregnancies. J Coll
Med 2007;12:5-7
Azubike JC. Multiple births in Igbo women. Br J
Obstet Gynaecol 1982; 89:77-9.
Egwuatu VE, Ozumba BC. Unexpectedly low
ratio and falling incidence of ectopic pregnancy
in Enugu, Nigeria. 1978-1981.Int.J.Fertil 1987;
32:113-21
Eze JN. Successful intrauterine pregnancy
following salpingostomy: Case report Niger J
Med 2008; 17: 360-362.
Schenker JG, Evron S. New concepts in the
surgical management of tubal pregnancy and the
consequent postoperative results. Fertil Steril
1983; 40:709-723
Eze JN, Obuna JA, Ejikeme BN, Bilateral tubal
pregnancies; A report of two cases, in Enugu,
Nigeria: Ann of African medicine 2012; 11:112115.
Kelly AJ, Sowter NC, Trinder J. The
management of tubal pregnancy London: RCOG
Press; 2004.
Sommer EM, Reisenberg K, Bogner G, Nagele F.
Laparoscopic management of an unrecognized
spontaneous bilateral tubal pregnancy. Acta
Obstet Gynecol Scand 2002; 81(4): 366-68.
Takeuchi K, Kitagaki S, Koketsu I. Bilateral
tubal pregnancy treated with laparoscopy. Int J
Gynecol Obstet 1995; 51:259-60.
1033
DOI: 10.5958/2319-5886.2014.00047.2

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th
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SPONTANEOUS FUNDAL UTERINE RUPTURE IN A GRANDMULTIPARA; AN UNUSUAL SITE OF

RUPTURE
*Adoke AU1, Ukwu AE1,Shehu CE,1 Burodo A1, Singh S1
1
Department of Obstetrics and Gynecology, Usmanu Danfodiyo University Teaching Hospital (UDUTH), PMB
2370, Sokoto, Sokoto State, Nigeria
*Corresponding author email: aadoke@yahoo.com
ABSTRACT
Uterine rupture is an obstetric emergency and a catastrophe with attendant maternal and fetal morbidity and
mortality. It is not uncommon in unscarred uterus, but commonly occurs in uterus with one or more previous scar.
We present a case of rupture of the fundus of the uterus in a multipara at 34 weeks with previous history of
repeated episode of retained placenta that was manually removed. Repeated manual removal of retained placenta
may have resulted in infection, scarring and weakness of the uterine wall. This could predispose the patient to
uterine rupture as the pregnancy advances.
Keyword: Fundus, Placenta, Scarring
INTRODUCTION
Uterine rupture is an obstetric catastrophe often
complicated
with maternal
and
fetal
1,2,3
morbidity and mortality.
It is a major cause of
direct maternal death encountered mostly in
developing countries and an index of poor obstetric
care in a woman's reproductive career. With
worsening economic conditions, rising caesarean
section rates, as well as a version for operative
delivery, uterine rupture will continue to confront us
in our daily clinical practice.
The incidence varies world over and tends to be
higher in low resource settings like ours and very low
in developed countries. Reported incidences
averaging less than 0.4 in developed and is between
2.4 to 8.9 per 1000 deliveries in the low resource
setting.4-7 However, findings from other parts of
Nigeria were quite a departure with values as high as
13 per 1000 deliveries reported8. In the USA, more
than 85% are traumatic or happen in a scarred uterus6.
In low resource settings like ours particularly in
Adoke et al.,
Africa and Sub-Saharan Africa, ruptures are mainly

spontaneous and occur in uterus as a complication of
labor. The major antecedent factors are poverty,
ignorance, illiteracy, traditional practices, high parity,
a lack of antenatal care, unsupervised delivery, poor
infrastructure, delivery outside of a health institution,
cephalo-pelvic disproportion and the injudicious use
ofoxytocics9. Also, uterine rupture due to excessive
fundal pressure in an unbooked primigravida has
been reported.10 Similarly, cases due overzealous
oxytocin infusion11 and attempted external cephalic
version have also been reported. 12
CASE REPORT
We present a 30yr old unbooked G5P4+1A3 at 34
weeks gestation. She was admitted on account of
three days history of sudden spontaneous profuse
bleeding per vagina and abdominal pain. Bleeding
was bright red with passage of blood clot; however
quantity reduced two days later and stopped on the
1034
third day. She had no history of bleeding in early

pregnancy. Her last three deliveries were complicated
by retained placenta which was manually removed at
a peripheral centre. She had no history of labor pains
or drainage of liquor. There was no history of trauma
or surgical procedure in the past. Abdominal pain was
sharp initially then generalized dull achy in nature.
She had stopped perceiving fetal movement which
prompted her to report to an ultrasound centre three
days after onset of her problems. The result of
ultrasound showed an intrauterine fetal death at 32
weeks gestation. She was fully conscious, pale, but
not in painful distress. Her pulse rate was 100 beats
per minute, blood pressure - 130/70mmHg.
Examination revealed irregularly enlarged abdomen,
mildly tender, symphysio-fundal height was
35cm.The fetal parts were easily felt just beneath the
anterior abdominal wall. The lie and presentation
were difficult to ascertain. Fetal heart sound was
absent. The cervix was posterior, 2cm long and
cervical OS admit a tip of a finger. She had
emergency laparotomy with the finding of a fresh
stillborn fetus extruded through the fundus of the
uterus and floating inside the peritoneal cavity. The
uterus was well involuted about 16 week size with
complete disruption of the fundus. There was no
active bleeding. Hemoperitoneum was about 1.2L of
blood. A subtotal hysterectomy was performed. She
had a smooth postoperative recovery period and was
discharged home on the seventh day. Figures 1&2
summarize
the
intra-operative
finding.
Fig 1: Shows a fresh stillbirth fetus

DISCUSSION
The incidence of ruptured uterus remains high in
Africa compared to Europe. In Nigeria higher values
have been recorded particularly in the north. The age
and parity distribution of this patient is similar to that

found in other studies with ruptured uterus.
Fig 2: Show site of uterine rupture at the fundus

of the uterus. The wound edges are covered with
clots and necrotic tissues with no active bleeding
Patients with a ruptured uterus tend to be multiparous
and of advanced maternal age as was the case in this
index patient. The most likely predisposing factor in
this case was ignorance, illiteracy, high parity,
previous unsupervised home delivery and repeated
manual removal of placenta. Vaginal bleeding,
abdominal pain/tenderness and shock are the common
clinical features seen in ruptured uterus. These
features were also seen in this patient, however, she
was not in shock about two days after onset of
symptoms. The fetus was extruded through the
fundus of the uterus and there was minimal bleeding
from the edges of rupture. The wound edges were
covered with necrotic organized sloughs with no
evidence of bleeding vessel. These are a departure
from the usual severe massive hemorrhage that is
usually seen in cases of uterine rupture. Perhaps
fibrosis at the fundus from repeated manual removal
of placenta could have accounted for these, since
fibrosed tissues have poor blood supply. Reports have
shown that unscarred uterus constituted a large
number of uteri that ruptured spontaneously, which is
in tandem with findings in other studies13. Fetal
malpresentation, obstructed labor, oxytocin abuse and
multiparity were commonly associated factors14. The
anterior wall of the uterus was the commonest site
affected and tubal ligation was the surgical procedure
in 36% of cases3. In this patient the possible
mechanism of rupture was likely due to repeated
retained placenta and manual removal of placenta.
This could have resulted in repeated injury, infection
and inadvertently weakness of the uterine wall with
1035
Adoke et al.,
resultant exuberant scar tissue formation. Therefore,

we postulate that in this case the fundus of the uterus
was the site of rupture presumably due to stretching
of the scarred fundus by the fetus. These would have
likely lead to thinning of the scar and subsequent
rupture of the fundus.
CONCLUSION
Uterine rupture may occur unnoticed, particularly in
unscarred uterus. Patients with repeated episodes of
retained placenta who had manual removal are likely
to have a spontaneous uterine rupture. High index of
suspicion should be entertained in this group of
patients.
ACKNOWLEDGEMENT: Many thanks to the
Feto-maternal team at UDUTH and all those involved
in the care of this patient.
REFERENCES
1. Groen GP. Uterine rupture in rural Nigeria.
Review of 144 cases. Obst. Gynaecol. 1974;
44(5): 682-7.
2. Ahmed Y, Shehu CE, Nwobodo EI, Ekele BA.
Reducing maternal mortality from ruptured
uterus--the Sokoto initiative. Afr J Med Sci.
2004; 33(2):135-8.
3. Robert AO, Ekele BA. Rupture uterus: Halting
the scourge. Trop J Obstet Gynaecol 2002; 19:1 3.
4. Konje JC, Odukoya OA, Ladipo OA. Ruptured
uterus in Ibadan. A 12 year review. Int. J. Obstet.
Gynaecol. 1990;32: 207-13.
5. Johanson R. Obstetric Procedures. In: Edmonds
DK, (ed.). Dewhurst's Textbook of Obstetrics and
Gynecology for Postgraduates. 6th ed. Blackwell
Scientific Publications, London. 1999;323-24.
6. Agboola A. Rupture of the uterus. Nig. Med. J
1977; 12: 19-21.
7. Ola ER, Olamijulo JA. Rupture of uterus at the
Lagos University Teaching Hospital, Lagos,
Nigeria. West African Journal of Medicine. 1998;
17(3): 188-93.
8. Ekele BA, Audu LR, Muyibi S. Uterine Rupture

in Sokoto, Northern Nigeria - Are We Winning?
Afr. J. Med. Sci.2000; 29 (3-4): 191-93.
9. Aboyeji AP, Ijaiya MD, Yahaya UR. Ruptured
uterus: a study of 100 consecutive cases in Ilorin,
Nigeria. J Obstet Gynaecol Res. 2001; 27(6):3418.
10. Nnadi D, Nwobodo E, Ukwu A, Airede L.
Uterine rupture in a primigravida: A case report.
Sahel Med J 2006;9:71-3.
11. Orji EO, Dayo AA, Malomo OO. Rupture of the
pregnant uterus in an unbooked Primigravida: A
case report. Trop J Obstet Gynaecol 2002;19:4950.
12. Ibekwe PC. Rupture uterus in a primigravida: A
case report. Trop J Obstet Gynaecol 2002; 19:478.
13. Faleyimu BL, Makinde OO. Rupture of the
gravid uterus in Ile-Ife, Nigeria. Tropical Doctor.
1990;20:188-89.
14. Lawson JB. Sequelae of obstructed labor. In:
Lawson JB, Stewards DB. Editors. Obstetrics and
Gynecology in the tropics and developing
countries. Edward Arnold Publishing Ltd.
London, 1967. 203-18.
1036
Adoke et al.,
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th
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A CASE OF PROGERIA SYNDROME TREATED AS VIP PATIENT

*Seema Mahant1, Mahant PD2, C.M. Reddy3
1
Professor & Head, Department of Medicine, PCMS & RC, Bhopal, India
2
3
Head, Dept. of Radiodiagnosis, RKDF Medical College, Bhopal, M.P., India

Asstistant Professor, Dept of Paediatrics, Chirayu Medical College, Bhopal, M.P., India
*Corresponding author email: pdmahant@gmail.com

ABSTRACT
Progeria is rare autosomal recessive genetic disease with an incidence of about one in eight million. He was 16
years old boy lying on the couch. He was short stature thin with minimal subcutaneous tissue, skin was thin and
fragile with loss of hair over scalp, eyebrows and eyelashes, and his face was dismorphic with prominent eyes,
beaked nose, small jaw and large cranium with visible veins over it. His voice was thin and high pitched. Overall,
this gives them an extremely aged nearly 70 -80 years old man look. The patient was a known case of progeria
syndrome and he was treated as a VIP patient by all faculty members and staff, though he belongs low
socioeconomic status, no political issue with them. But still he was a VIP.
Keywords: Progeria, VIP patient, old man look (accelerated aging).
INTRODUCTION
CASE REPORT
I am Dr. Seema mahant want to share a very
interesting case experience. One day when I entered
in the ward, I saw everyone was excited and running

in one direction, I thought some VIP patient get
admitted thats by everyone was thrilled. Eagerly I
also went in the same direction. When I saw the
patient I get surprised, he was 16 years old boy lying
on the couch. He was short stature thin with minimal
subcutaneous tissue. His skin was thin and fragile
with loss of hair over scalp, eyebrows and eyelashes.
His face was dismorphic with prominent eyes, beaked
nose, small jaw and large cranium with visible veins
over it. When I asked his name, his voice was thin
and high pitched. Overall, this gives them an
extremely aged nearly 70 -80 years old man look. He
was very kind and cooperative. For this man his life
is very fast days are becoming months, months
become years and years became decades. He was a
school going boy studying in 7th class and good in
study. He is very friendly. On asking the complain
patient told he have a cough and fever for 5 days. On
Seema Mahante et al..,
Progeria is rare autosomal recessive genetic disease

with an incidence of about one in eight million. 1
Prominent characteristic feature is accelerated aging.
The classic type of progeria, is Hutchinson-Gilford
Progeria Syndrome (HGPS), named for the two
doctors who first described it.2 The cause of Progeria
is a mutation in the gene that encodes the protein
Lamin-A..3 Clinical presentation usually slow growth,
slow weight gain, failure to thrive, with poor, very
slow weight gain over time, loss of body fat and hair,
aged-looking skin in spite of no abnormalities of
growth hormone, parathyroid hormone, and adrenal
hormones. Most of the patients die from
complications of atherosclerosis, such as heart attack
or stroke.4 No definitive therapy is available.2
1037
examination-patient was conscious oriented and well

cooperative, he has mild fever, pulse 92 bpm, BP was
170/100 mmHg, respiratory rate was 30 per min. with
minimal crepitition on Rt. lower chest.
Biochemical investigations were normal except for
increased serum cholesterol. X-ray chest shows Rt.
Lower pneumonitis with mild cardiomegaly. ECG
shows-LVH with poor progression of R wave V1-V6.
Echocardiography reveals- LVH with Gr. II diastolic
dysfunction and poor LV function LVEF-40%.
Treatment started with antibiotics, antihypertensive,
lipid lowering drugs, antiplatelets and antianginal
drugs. The patient was discharged after 7 days.
In this syndrome, the rate of ageing is accelerated up

to seven times that of normal. The average life span is
13 years (range 7-27 year). The death is mainly due
to cardiovascular complications like myocardial
infarction or congestive heart failure. Till date, no
definitive therapy is available and the patient is
generally treated conservatively. 4, 5
DISCUSSION
Progeria is a debilitating, rare illness anda genetic
disorderr with just 45 odd cases in the world and is
characterized by features of premature aging.1 The
probable cause is a mutation in the Lamin located in
the nuclear matrix. An increase in the blood
hyaluronic acid levels is responsible for
sclerodermatous
changes
and
cardiovascular
2.
abnormalities The classic type of progeria is
Hutchinson-Gilford Progeria Syndrome (HGPS),
named for the two doctors. Specific features of HGPS
include- progressive heart disease, severe failure to
thrive, with poor, very slow weight gain, over time,
loss of body fat and hair aged-looking skin hearing
loss stiff, painful joints, especially in the hips and
feet, limiting range of motion hip dislocation bone
rigidity and loss of bone mineral density, dry eyes,
sometimes leading to irritation and clouding dental
and gum disease.3 Radiography of the skull shows
craniofacial disproportion, delayed and abnormal
dentition. Urine test results excessive excretion of the
glycos
aminoglycan,
hyaluronic
acid.5
Fig 1: Slowed growth, with below-average height

and weight, accelerated aging, prematurely old.
Seema Mahante et al..,
Fig 2: Showing Narrowed face, small lower jaw, thin

lips and beaked nose, Head dis- proportionately large
for face, Prominent eyes and incomplete closure of
the eyelids, Hair loss, including eyelashes and
eyebrows, thinning, spotty, wrinkled skin, Visible
veins.
CONCLUSION
In our clinical practice, we see many patients daily,
but few of them we cannot forget. Here I shared an
interesting presentation of a rare disease Progeria.
Right now the patient is not with us, but his memories
will remain forever.
ACKNOWLEDGMENT
I am very grateful to Prof. Dr.U.B.Shah, Dean RKDF
medical college for his help and interest in research
and publication..
Conflict of interest-: Nil
REFERENCES
1. Brown WT. Progeria: A human disease model of
accelerated aging. Am J Clin Nutr. 1992; 55:
1222S224S.
2. De Busk FL. The Hutchinson-Gilford progeria
syndrome: Report of 4 cases and review of the
literature. J Pediatr. 1972; 80:69724.
3. Zebrower M, Kieras FJ, Brown WT. Urinary
hyaluronic acid elevation in Hutchinson-Guilford
progeria syndrome. Mech Ageing Dev. 1986;
35:3946.
4. Sarkar PK, Shinton RA. Hutchinson-Guilford
progeria syndrome. Postgrad Med J. 2001; 77:312
7
5. Guilford H. Progeria: a form of senilism.
Practitioner 1904; 73:18817.
1038
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Case report
BENIGN OCCIPITAL EPILEPSY OF CHILDHOOD: PANAYIOTOPOULOS SYNDROME IN A 3

YEAR OLD CHILD
Menon Narayanankutty Sunilkumar *, Vadakut Krishnan Parvathy
Department of Pediatrics, Amala Institute of Medical Sciences, Amala Nagar, Thrissur, Kerala, India
*Corresponding author email:sunilsree99@gmail.com
ABSTRACT
Panayiotopoulos syndrome (PS) is a relatively frequent and benign epileptic syndrome seen in children in the age
group of 3-6 years and is characterised by predominantly autonomic symptoms and/or simple motor focal seizures
followed or not by impairment of consciousness. Although multifocal spikes with high amplitude sharp-slow
wave complexes at various locations can be present in the EEG, interictal electroencephalogram (EEG) in
children with this particular type of epilepsy characteristically shows occipital spikes. This syndrome has known
to be a masquerader and can imitate gastroenteritis, encephalitis, syncope, migraine, sleep disorders or metabolic
diseases. In the absence of thorough knowledge of types of benign epilepsy syndromes and their various clinical
presentations, epilepsy such as PS can be easily missed. The peculiar aspects of this type of epilepsy in children
should be known not only by paediatricians but also by general doctors because a correct diagnosis would avoid
aggressive interventions and concerns on account of its benign outcome. In this case study, we report a case of PS
in a 3 year old child.
Keywords: Benign occipital epilepsy, Panayiotopoulos syndrome, Autonomic symptoms, Emesis, EEG
INTRODUCTION
The International League Against Epilepsy in their
expert consensus has given due importance for the
various benign childhood seizures which have good
prognosis.1 PS is a common idiopathic childhoodspecific seizure disorder formally recognized by the
league and is included in the category of benign
epilepsy syndromes and is recognized worldwide for
its autonomic presentations.2,3 This early-onset benign
childhood
seizures
was
described
by
4
Panayiotopoulos.
It has been defined by
Panayiotopoulos as consisting of brief, infrequent
attacks or prolonged status epilepticus and
characterized by ictal deviation of the eyes and/or
head and vomiting, occurring in children usually

between the ages of 3 and 7 years. 5
Seizures are usually followed by postictal headache
and are often associated with interictal occipital
rhythmic paroxysmal EEG activity that appears only
after eye closure.5The PS has excellent prognosis and
parents can be definitely reassured about its benign
course.4,6- 9 The risk of developing seizure disorder in
later life is negligible. 6 Detection of occipital
epilepsy at very early stage is needed to successfully
treat this condition and allay the fears of the parents
and care givers of these children with PS. In this case
report, we discuss about the occipital epilepsy in a 3
year old girl child.
1039
Menon et al.,
CASE REPORT
A 3-year-old girl, only sibling from a poor
socioeconomic family of a non-consanguineous
couple, presented in the out-patient with complaints
of becoming limp after sudden episode of vomiting,
followed by up rolling of eyes, stiffening of the both
upper limbs and lower limbs and a brief period of
drowsiness. The child was happily playing in the
house about half an hour back. There was no
associated fever, trauma, ear discharge, no common
paediatric illnesses like diarrhea, dysuria, cough,
running nose, wheezing and throat pain.
A detailed history was taken. The child was born of
non-consanguineous parents, full term normal vaginal
delivery, with a birth weight of 2.215 kg. She was
immunized to date and had normal milestones of
development. The history revealed that she had
similar episodes of vomiting especially getting up
from sleep and having deviation of eyes to one side,
becoming limp and followed by drowsiness for few
minutes in the past from the age of 1 years old.
Overall she had 5-6 such episodes and 3 times she
had these episodes when she was sleeping. There was
no associated fever during these episodes. Two times
she had stiffening of all the limbs with deviation of
eyes to one side, and followed by drowsiness. There
was no focal type of seizures in this child. The
parents attributed these to indigestion and gave home
remedies as always there was vomiting and tiredness
following the episodes. The child then used to play
around normally. One month back the child was seen
by a local doctor who advised EEG and it was done
which was reported as normal and parents were
advised follow up.
The child on admission was tired, but was conscious.
On examination, she was afebrile, signs of meningeal
irritation were absent, central nervous system
examination was normal, neurocutaneous markers
were absent, fundus examination was normal. Other
systemic examinations were normal. Laboratory
investigations showed hemoglobin (11.7 g/dl) with
low indices, total leucocyte count (11,550/cumm),
neutrophils (75%), lymphocytes (22%), platelets
(210000/l), ESR (35mm at1 hr), serum calcium (10
mg%), SGPT (28 U/l), serum electrolytes levels were
normal.EEG was done (Figure- 1A and B) and
reported as symmetrically distributed normal sleep
Menon et al.,
activities, with activation of rare sharp wave

discharges arising from the left occipital region. An
awake record could not be obtained. The diagnosis of
PS was made based on the clinical history and EEG
which showed the predominantly occipital spikes.
(Fig 1) She was started on carbamazepine with
increasing the dose schedule to her required weight.
The child did not have any allergic reaction to the
drug and did not progress to autonomic instability.
She and her parents were given excellent emotional
and pschycological supportive care.
After completion of 5 days of observation for her
symptoms and any allergy to the she was discharged
on day 6 with improvement in clinical conditions on
multivitamins, hematinics and deworming drugs with
an advice to follow-up .
Fig1: A and B): EEG of the child showing the
occipital spikes (arrow heads).
DISCUSSION
PS described by Panayiotopoulos4 is a common
autonomic childhood epileptic syndrome with a
significant clinical, pathophysiological characteristics
and is multifocal.10 PS is now formally recognized as
a distinct clinical entity within the spectrum of benign
focal epilepsies of childhood.11 PS affects 13% of
children aged 3 to 6 years who have had 1 or more
afebrile seizures and 6% of such children are in the 1to 15-year age group.6,7,12 Autonomic epileptic
seizures and autonomic status epilepticus are the
cardinal
manifestations
of
Panayiotopoulos
syndrome.12. The main aspect of PS is that
irrespective of their location at onset, there is
activation of autonomic disturbances and emesis, to
1040
which children are particularly vulnerable. These

symptoms and pattern of autonomic seizures and
autonomic status epilepticus in PS do not occur in
adults and are very specific to childhood. 12
PS is often confused with occipital epilepsy and
acute non-epileptic disorders such as encephalitis,
syncope, cyclic vomiting or atypical migraine even
with
characteristic
clinical
and
EEG
13
manifestations. The clinical and EEG features of PS
is due to a maturation-related diffuse cortical
hyperexcitability. 4,6 This diffuse epileptogenicity
which may be unequally distributed, is predominating
in one area of the brain, and is often posterior. The
explanation for the characteristic involvement of
emetic and the autonomic systems may be attributed
to epileptic discharges which are generated at various
cortical locations and this in turn influence the
childrens vulnerable emetic centers and the
hypothalamus.4,6The diagnosis is based entirely on
clinical presentation and EEG.12
PS has some of the key clinical features which are
often present as single, focal seizures with an unusual
constellation of autonomic, mainly emetic,
symptoms, associated behavioral changes, and
sometimes seizure like clinical manifestations such
as unilateral deviation of the eyes and convulsions.
3,4,7,8,9,13
The emetic triad in PS (nausea, retching,
vomiting) culminates in vomiting in 74% of the
seizures; in others, only nausea or retching occurs,
and in a few, vomiting may not be present. Other
autonomic manifestations include pallor, mydriasis or
miosis, flushing or cyanosis thermoregulatory and
cardiorespiratory alterations. Frequently incontinence
of urine and/or feces, hypersalivation, cephalic
sensations, and modifications of intestinal motility
are also seen.9 Half of the convulsions end with
hemiconvulsions or generalized convulsions. Two
thirds occur during sleep as was seen in our child for
about three times. Autonomic status epilepticus
enveals then. The seizures usually last for 515 min,
but half of them are prolonged, sometimes for hours,
constituting autonomic status epilepticus. The patient
recovers within a few hours. Even after the most
severe seizures episodes and status.12
An electroencephalogram is the only investigation
with abnormal results, usually showing multiple
spikes in various brains locations.12 Multifocal spikes
that predominate in the posterior regions characterize
the EEG. 6The EEG variability in our child of 3 years

is showing the characteristic occipital spikes from the
left occipital region. The EEG done 5 months back
was normal in our child. PS is the second most
frequent benign syndrome of childhood after rolandic
epilepsy, which primarily affects 15% of children at a
peak onset at age 79 years. 1 Another epileptic
syndrome categorized with PS and rolandic epilepsy
is the Gastaut type childhood occipital epilepsy2,
manifesting with frequent and brief visual seizures.
However, this is rare, of uncertain prognosis, and
markedly different from PS, despite common
interictal EEG manifestations of occipitalspikes.6
Occipital spikes in non-epileptic children with
defective vision, occipital slow spike-and-wave found
in some patients with the Lennox-Gastaut syndrome,
focal epilepsy due to occipital lesions, seizures
originating in the temporal lobe secondary to an
occipital abnormality, and complicated or basilar
migraine must be considered in the differential
diagnosis.5
There are typical and atypical case of PS.15,17,18 Lada
et al 15 conducted a retrospective study of 43 patients
with PS who were seizure free >2 years. In their
analysis girls predominated, as in our child was a girl.
The first seizure was seen in 5 years of age. 86% had
emesis as the symptom with the seizures. Seizures
during sleep (84%) were more common than those in
wakefulness. EEG showed occipital spikes in more
than 50% of patients. Prognosis was excellent and
80% children have been free of seizures for 2 years
as is in a typical case of PS.15 Deerliyurt et al16 did a
case series study of patients with PS and postulated
that PS is associated with high rates of febrile
convulsions.
Afebrile
convulsions/epilepsy,
migraine, and breath-holding spells in the patients
and families suggested the importance of genetic
factors 17. Febrile seizures are to be considered in the
differential diagnosis because the recovery of
consciousness from seizure is fast and control of the
seizure is paramount, uncomplicated usually.18
Ferrieet al. 17 postulated an atypical evolution of PS
in a case report.
The management of PS is not complicated. Education
and knowledge about PS is the cornerstone of
management. Control of the seizure is paramount.
Prophylactic treatment with antiepileptic medication
may not be needed for most patients. The emphasis is
1041
Menon et al.,
on treatment of possible fever and mainly of the

underlying illness. One third (30%) of the seizures
are relatively brief and self-limited. They subside
spontaneously within 210min. The other two thirds
(70%) have long-lasting seizures (>10 min) or status
epilepticus (>30 min to hours). These should be
appropriately and vigorously treated as for status
epilepticus.19,20 Parents of children with recurrent
seizures should be advised to place the child on its
side or stomach on a protected surface and administer
a preparation of intravenous rectal benzodiazepine
(BZD). In an emergency facility, the childs airway
should be kept clear, oxygenation maintained, and
intravenous or rectal antiepileptic drug (AED) given
to halt the seizures. A BZD is probably the first
choice. The great majority with PS do not need AED
treatment even if they have lengthy seizures or have
more than two recurrences. There is no increased risk
of subsequent epilepsy or neurologic deficit. If a child
has multiple recurrences (only about 5% exceed 10
seizures) and if the parents too worried prophylaxis
can be given. Continuous prophylaxis consists of
daily medication with any AED with proven efficacy
in partial seizures. Although, there is no evidence of
superiority among monotherapy with phenobarbitone,
carbamazepine (CBZ), sodium valproate or no
treatment in PS, most authors prefer CBZ. 14 Our
child was started on oxcarbazepine, a structural
derivative of CBZ with no side effects since last 1
month. Autonomic status epilepticus in the acute
stage needs thorough evaluation; aggressive treatment
may cause iatrogenic complications including
cardiorespiratory arrest.12 The adverse reactions of the
antiepileptic drugs such as severe allergic reactions,
abnormal liver function tests and idiosyncratic
reaction should be kept in mind and monitored.14
The prognosis of PS is excellent 4,6-9 The lengthy
seizures and status do not have any adverse
prognostic significance, and the risk of developing
epilepsy in adult life is probably no more than that of
the general population.6 One third of patients (27%)
have a single seizure only, and another half (47%)
have two to five seizures. Only 5% have >10
seizures, but outcome is again favorable. Remission
usually occurs within 1 to 2 years from onset.6
PS is a common cause of epilepsy in children and a

knowledgeable doctor does not miss it. Physician
education of PS and recent guidelines on epilepsy
management is vital in detecting PS at very early
stage, so further lifesaving interventions can be done
and prevent delay in the treatment administration.
Multiple antiepileptic drugs use is required in only in
a small proportion of patients. Seizures in PS, like
febrile convulsions, despite their excellent prognosis,
are a frightening experience for the in experienced
parents, who often think that their child is dead or
dying. Parents of young children should have general
information by the family doctor regarding PS.
Parental education and a supportive group comprising
the paediatrician, neurologist, nursing staff and the
social worker can help and reassure these distort
parents as was done in our child who is doing fine
with no recurrence in the last 1 month.
ACKNOWLEDGEMENT
The authors acknowledge the help of Dr Ajith TA,
Professor of Biochemistry, Amala Institute of
Medical Sciences, Amala Nagar, Thrissur, Kerala
during the preparation of the manuscript.
REFERENCES
1. Commission on Classification and Terminology
of the International League Against Epilepsy.
Proposal for revised classification of epilepsies
and epileptic syndromes. Epilepsia 1989;30:389
99.
2. Engel J Jr. A proposed diagnostic scheme for
people with epileptic seizures and with epilepsy:
Report of the ILAE Task Force on Classification
and Terminology. Epilepsia 2001;42:796803.
3. Berg AT, Panayiotopoulos CP. Diversity in
epilepsy and a newly recognized benign
childhood syndrome [Editorial]. Neurology
2000;55:10734.
4. Panayiotopoulos CP. Panayiotopoulos syndrome.
Lancet 2001;358:689.
5. Andermann F, ZifkinB.The benign occipital
epilepsies of childhood: an overview of the
idiopathic syndromes and of the relationship to
migraine. Epilepsia. 1998;39:S9-23.
CONCLUSION
1042
Menon et al.,
6. Panayiotopoulos CP. Panayiotopoulos syndrome:

a common and benign childhood epileptic
syndrome. London: John Libbey, 2002.
7. Panayiotopoulos CP. Vomiting as an ictal
manifestation of epileptic seizures and
syndromes. J Neurol Neurosurg Psychiatry
1988;51:1448-51
8. Caraballo R, Cersosimo R, Medina C, Fejerman
N. Panayiotopoulos-type benign childhood
occipital epilepsy: a prospective study.
Neurology 2000;55:1096100.
9. Kivity S, Ephraim T, Weitz R, Tamir A.
Childhood epilepsy with occipital paroxysms:
clinical
variants in 134 patients. Epilepsia
2000;41:152233.
10. Guerrini R, PellacaniS. Benign childhood focal
epilepsies. Epilepsia. 2012;53::9-18.
11. Koutroumanidis M. Panayiotopoulos syndrome:
an important electroclinical example of benign
childhood
system
epilepsy.
Epilepsia
2007;48:1044-53.
12. Covanis A. Panayiotopoulos syndrome: a benign
childhood autonomic epilepsy frequently
imitating encephalitis, syncope, migraine, sleep
disorder, or gastroenteritis. Pediatrics. 2006
;118:e1237-43.
13. Michael
M, Tsatsou K, Ferrie
CD.
Panayiotopoulos syndrome: an important
childhood autonomic epilepsy to be differentiated
from occipital epilepsy and acute non-epileptic
disorders. Brain Dev. 2010;32:4-9.
14. Ferrie CD, Beaumanoir A, Guerrini R, Kivity S,
Vigevano F, Takaishi Y Early-onset benign
occipital seizure susceptibility syndrome.
Epilepsia1997;38:28593.
15. Lada C, Skiadas K, Theodorou V, Loli N,
Covanis A. A study of 43 patients with
panayiotopoulos syndrome, a common and
benign childhood seizure susceptibility.Epilepsia.
2003;44:81-8.
16. Deerliyurt A, Teber S, Bekta O, Senkon G.
Panayiotopoulos syndrome: A case series from
Turkey. Epilepsy Behav. 2014;36:24-32.
17. Ferrie CD, Koutroumanidis M, Rowlinson S,
Sanders S, Panayiotopoulos CP. Atypical
evolution of Panayiotopoulos syndrome: a case
report. Epileptic Disord. 2002;4:35-42.
18. Knudsen FU. Febrile seizures: treatment and

prognosis. Epilepsia.2000;41:29.
19. American Academy of Pediatrics. Practice
parameter: the neuro diagnostic evaluation of the
child with a first simple febrile seizure:
Provisional Committee on Quality Improvement,
Subcommittee on Febrile Seizures. Pediatrics
1996;97:76972.
20. Mitchell WG. Status epilepticus and acute
repetitive seizures in children, adolescents, and
young adults: etiology, outcome, and treatment.
Epilepsia.1996;37:S7480.
1043
Menon et al.,
DOI: 10.5958/2319-5886.2014.00050.2

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Health Sciences
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Volume 3 Issue 4
th
Case report
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
nd
Revised: 22 Aug 2014
MEGALOURETHRA: A CASE REPORT

*Aditya Pratap Singh1, Javed Salam Ansari1, Arvind Shukla2, Aadil Farooq1, Veenita Chaturvedi2, Morya DP1
1
M.ch. (Resident), 2Professor Department of Pediatric surgery, S.M.S. Medical College, Jaipur
*Corresponding author email: dr.adisms@gmail.com

ABSTRACT
Congenital megalourethra is a rare mesenchymal anamoly of the male urethra. It is defined as dilation of the
anterior urethra due to absence of development or deficiency of erectile tissue of the penis. It leads to deformity of
the penis (scaphoid megalourethra) or impotence (fusiform megalourethra) and also renal insufficiency and
pulmonary hypoplasia. The associated anomalies are often life threatening and influence the management and
prognosis. We present here a report of a case of megalourethra.
Keywords: Congenital, Fusiform, Megalourethra, Scaphoid.
INTRODUCTION
Megalourethra is a congenital disorder, characterized
by dilatation as a whole or a part of urethra with a
specific penile ventral deformity known as the
pelican bag. It is a rare form of functional lower
urinary tract obstruction.1 Maternal diabetes and
associated VACTERAL syndrome are implicated.2,3
It is of two type scaphoid and fusiform. A meticulous
surgery is needed to restore the original shape and
function.
anomalies and proved devoid of any association and

syndrome. Routine investigation was done, those
were in normal level except renal function test which
were deranged. Blood urea 87mg/dl and serum
creatinine 1.67mg/dl and potassium 5.7 mEq/lit.
USG
abdomen
suggestive
of
bilateral
hydroureteronephrosis, dilated PCS, cystitis with
megalourethra. (fig 2).
CASE REPORT
An eight month male child parent complaining of
penile deformity without derangement of stream
admitted in our institute. On local examination the
ventral penile surface was markedly dilated and
redundant. Penoscrotal angle was reduced. Urethral
meatus was normal. It was fusiform megalourethra.
(fig 1) Examination revealed normal genitalia with
normally descended testis and scrotum. The urinary
stream was normal except for a terminal dribbling.
There was no relevant family history or antenatal
history. Patient was screened for other congenital
Fig 1: Pre Operative megalourethra photo
1044
Aditya Pratap Singh et al.,
MCU revealed urethra dilated with no reflux seen.

(fig 3) Because of deranged renal function so planned
to open the urethra. (fig 4) A urethral fistula that
resulted was later planned for repair.(fig 5)
Fig 5: Photo shows ventral urethral fistula

DISCUSSION
Fig 2: USG shows megalourethra
Fig 3: Micturiting cystourethrography showing

dilated urethra
Fig 4: Intraoperative photo showing ventral

created fistula and anterior opening of urethra
Megalourethra results from deficiency of the

mesodermal tissues of the phallus due to defective
migration, differentiation or development of the
erectile tissue.3
There are two varieties of congenital megalourethrascaphoid and fusiform. In the fusiform the corpus
spongiosum is maldeveloped in the anterior urethra
leads bulging of ventral urethra where as in scaphoid
both spongiosum and cavernosum maldeveloped or
deficient causing circumferential expansion of
urethra. Intermediate form has been reported.4
Fusiform type is more common. The fusiform variety
is more serious than scaffold type and is associated
with more serious anomalies and carries a poor
prognosis. 5
This anomaly can be associated with other urinary
tract anomalies including dysplastic kidneys,
vesicoureteric reflux, undescended testis, Prune belly
syndrome, megaureter, hypospadias, posterior
urethral valve and other system abnormalities5
including Vacteral.
The fusiform variety has a higher incidence of
oligohydromnios, pulmonary hypoplasia. As a result
of oligohydromnios which can result in neonatal
death and chronic progressive renal failure that can
result in end stage renal disease.2
The management is classically the Nesbit repair. The
timing and method of reconstruction in patients with
congenital megalourethra are dictated by the
anatomical construction of the phallus and the health
of the child. In those patients who survive the
immediate neonatal period, reconstruction of the
phallus can be undertaken. Nesbit described after a
1045
circumcising incision and degloving of the penis. He

performed a longitudinal reduction urethroplasty on a
catheter. Some have advocated urethral placation,
However the rarity of the defect precludes any
generalization with regards to surgical management.
Each case must be considered individually.4
It has been suggested that sac like dilatation of distal
urethra cause proximal obstruction with resultant
dilatation of upper urinary tract. The urinary tract
return to normal after correction of megalourthra.
Detailed investigation of the upper and lower urinary
tract should be carried out at the earliest to detect
anomalies and to treat them early to reduce morbidity
and mortality.
CONCLUSION
The prognosis of isolated scaphoid megalourethra is
very good. The operation is simple and successful.
On the other hand, the fusiform type is difficult to
treat. Early diagnosis and management affords a long
lasting cure to the patients.
REFERENCES
1. Amsalem H, Fitzgerald B, Keating S, Ryan G,
Keunen J, PippiSalle JL, et al. Congenital
Megalourethra: Prenatal Diagnosis and Postnatal
Autopsy Findings. Report on 10 cases.
Ultrasound Obstet Gynecol 2011; 37 (6): 67883
2. Ardiet E, Houfflin-Debarge V, Besson R, Subtil
D, Puech F. Prenatal diagnosis of congenital
megalourethra associated with VACTERL
sequence in Twin pregnancy: favorable post-natal
outcome. Ultrasound Obstet Gynecol 2003; 21:
619-20.
3. Stephens FD, Fortune DW. Pathogenesis of
Megalourethra. J Urol 1993; 149(6): 1512-16.
4. Jones EA. Freedman Al, Ehrlich RM.
Megalourethra and urethraldiverticula. Urol Clin
North Am 2002; 29 (2): 34148.
5. Sharma AK, Shekhawat NS, Agarwal R,
Upadhyay A, Mendoza WX, Harjai MM.
Megalourethra: a report of four cases and review
of the literature. Pediatr. Surg. Int.1997; 12: 45860
1046
DOI: 10.5958/2319-5886.2014.00051.4

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Volume 3 Issue 4
Coden: IJMRHS
st
Revised: 1st Sep 2014
Copyright @2014
ISSN: 2319-5886
Case report
PONTIAC FEVER ASSOCIATED WITH ERYTHEMA NODOSUM
*
Hilal Bektas Uysal1, Hulki Meltem Snmez2, Sertan Bulut3, Murat Telli4
Assistant Professor, 2Professor Department of Internal Medicine, Adnan Menderes University School of
Medicine, Aytepemevkii Merkez/ Aydin 09100, Turkey
3
Doctor in Pulmoner Diseases Department, Adnan Menderes University School of Medicine, Aytepemevkii
Merkez/ Aydin 09100, Turkey
4
Assistance Professor in Department of Microbiology, Adnan Menderes University School of Medicine,
Aytepemevkii Merkez/ Aydin 09100, Turkey
*Corresponding author email: hilalbektasuysal@yahoo.com
ABSTRACT
Legionellae are gram-negative bacteria found in clean water sources worldwide. Infection with Legionella
species presents as two distinct clinical forms; Legionnaires' Disease; characterized by pneumonia and Pontiac
Fever; a flu-like illness, characterised by a high attack rate and absence of fatal complications. Cutaneous
manifestations are very uncommon during Legionella infections. To our knowledge; only nine cases of
legionellosis, presenting with skin rash have been reported in the literature. The striking point is, only two men in
this nine cases of Legionella infections, had had Pontiac Fever. Here we present the third case of skin rash
associated with Pontiac fever, reported in the literature to date.
Keywords: Pontiac Fever, Erythema Nodosum, Legionella
INTRODUCTION
Legionellae are gram-negative bacteria found in clean
water sources worldwide. Water is the major
reservoir of Legionella species.1 Most aerosolized
sources of bacterial-contaminated warm water,
including whirlpool spas, warm spring pools, garden
watering systems, decorative fountains, cooling
towers, and industrial cleaning systems that use highpressure water, have been linked to outbreaks of
legionellosis.2,3
Infection with Legionella species presents as two
distinct clinical forms; Legionnaires' Disease (LD), a
multisystem illness characterized by pneumonia and
Pontiac Fever (PF), a self-limiting flu-like illness.4 It
is not known why these two different clinical forms
occur, but organism inoculation, transmission modes ,
and host factors seems to be important.5
Uysal et al.,
Pontiac fever, occurs after exposure to aerosols of

water colonized with Legionella species. Disease
mainly diagnosed in outbreaks, rarely seen
simultaneously.6 The first outbreak has been reported
in the United States in 1967 in Pontiac, Michigan,
that resulted from the contamination of the central
air-conditioning system from an evaporating
condenser. PF takes its name from this outbreak.7
LD, is characterized by an acute severe pneumonia
with an average incubation time of 2 to 10 days, and
a low attack rate (0.1 to 5%) in general population.
PF, is the milder form characterised by a short
incubation time of 30-90 h, nearly 70-90% of high
attack rates8 and absence of fatal or long term
complications9 . Patients with PF have influenza like
symptoms. After a typical asymptomatic interval of
1248 h after exposure; fever, chills, headache,
1047
myalgia, arthralgia, malaise, sore troat, nonproductive

cough, abdominal pain, nausea occurs in most of the
cases.7-9 There is no evidence of pneumonia on chest
radiography or physical examination of the patients.
Slight leukocytosis with neutrophilic predominance
may sometimes be detected.10
Multisystemic extrapulmonary involvement is
observed during Legionella infections, however,
cutaneous manifestations is very uncommon. Only a
few cases of cutaneous involvement have been
described to date, according to our present
knowledge. Here we are reporting a Pontiac Fever
case, associated with ertythema nodosum.
CASE REPORT
A 39 year old woman with no underlying disease,
was admitted to our clinic with malaise, nonproductive cough, sore throat, hoarseness, myalgia,
arthralgia and fever for 3 days followed by warm,
painful, erythematous, non-pruriginous nodules on
bilateral pretibial areas and swelling of the right
ankle.
She did not use alcohol or tobacco. She was living in
a farm and working in the garden care and in the care
of farm animals. She had not travelled recently and
any one of the household had had an upper
respiratory infection within the preceding week.
Upon admission she had a body temperature of 37.5
C, blood pressure of 110/60 mmHg and a pulse rate
of 93 per minute. On physical examination, she had
pale skin and mucous membranes, apical systolic
murmur, unremarkable respiratory system and
abdominal examinations. Arthritis identified on the
right ankle with swelling and pain. She had red
coloured, rounded, approximately 1cm in diameter,
maculer, painful lesions on bilateral forearms and
bilateral pretibial rounded, slightly raised,
nonulcerative, painful, warm, red nodules compatible
with erythema nodosum (Fig-1, Fig-2)
Fig1: In a PF patient the cutaneous involvement of legs

with erythema nodosum
Uysal et al.,
Fig- 2: In a PF patient the cutaneous involvement

of forearms.
Laboratory work-up demonstrated dimorphic anemia
of both iron and vitamin B12 deficiency. Her blood
test results showed the following: white blood cell
count at 9,97x 103/L with remarkable neutrophilia (
82,4%), mild hyponatraemia at 135 mmol/L (normal
range
136-145
mmol/L),
an
erythrocyte
sedimentation rate during the first hour 64 mm
(normal < 20 mm) and C-reactive protein rate at 65,3
mg/L (Normal range 0-6 mg/L). Chest X-ray was
unremarkable.
Erythema nodosum has been associated with a wide
spectrum of infections, drugs and systemic diseases,
and may also be idiopathic. To consider all possible
etiologies of erythema nodosum a few
tests
conducted. Throat swab, nasopharingeal swab, urine
cultures were negative. Antistreptolysin-O (ASO)
titer was in normal range. PPD skin test for
tuberculosis was 7 mm (negative for active infection
in Turkey). Contrast enhanced chest CT scan was
unremarkable. Pathergy test for Behcet disease was
negative. Anti-ds DNA, anti-nuclear antibody and
rheumatoid factor were all negative. There was no
clinical or laboratory alarm sign for malignancy. The
multiplex RT-PCR assay of nasopharingeal swab for
bacteria was positive for Legionella spp. Multiplex
RT-PCR assay of nasopharingeal swab for viruses
was negative. Legionella Urine Antigen Test (UAT)
was negative.
Immediately, bed rest, elevation of the legs and
supportive therapy started. For pain management oral
indomethacin 25 mg, twice a day started.
Two days after the admission, malaise, nonproductive cough, sore troat, hoarseness and myalgia
disappeared. Arthritis on the right ankle regressed and
erythema nodosum nodules evolved from bright red
to a brownish yellow discoloration resembling bruises
on the fifth day of admission.
1048
The patient became asymptomatic on the ninth day of

hospital admission, laboratory examination results
were all normal except the persisting increased
erythrocyte sedimentation rate (43 mm/h). She
discharged with a control plan after 3 weeks .
DISCUSSION
Cutaneous involvement during legionella infections is
very rare, and to our knowledge; only nine cases of
legionellosis, presenting with skin rash have been
reported in the literature 11-15 .The striking point is,
only two men in this nine cases of Legionella
diseases, had had PF.16 Here we present the third
case of skin rash associated with PF.
The pathogenesis of skin involvement in the progress
of PF is unknown. It was considered to be mediated
either by a toxin produced by the organism or by an
immunological reaction formed by the host to the
bacteria,
or
other
unidentified
additional
13,16
mechanisms.
The clinical diagnosis of PF is usually very difficult
in most patients because of its nonspecific
presentation. Thus, the door to successful diagnosis
is, making proper microbiological tests. Serologic
and urinary antigen tests (UAT) are the most useful
routine tests for the diagnosis of PF.
Approximately 50% of the 48 species of Legionella
and 70 distinct serogroups identified have been
associated with human disease. Validated serologic
testing fort he majority of the 70 serogroups have not
been fully developed, only Legionella pneumophilia
serogroup 1 (LP1) can be reliably assayed by urinary
antigen tests.17 Nonpneumophilia causes of the
disease are particularly difficult to diagnose. The
sensitivity of UAT is, proportionally increased with
the clinical severity of the disease4. Thus, patients
with PF may have been undiagnosed because of the
milder clinical course, if only UAT were used.
Previous studies about UATs in PF are very limited18.
This may be because these tests were primarily used
for diagnosis of hospitalised patients. Thus, the
validity of these laboratory tests for patients with
mild clinical illness and not demanding hospital
admission, is not clear. In our case the negative result
of UAT, demonstrates the cause of the PF is, an
another species, or serogroup of Legionella, rather
than LP1.
There is no agreed-upon definition of Pontiac fever.
The diagnosis is usually made on the basis of
epidemiologic,
clinical,
laboratory,
and
environmental microbiology findings. Because of its
benign course and the absence of specific findings,
the occurrence of PF is often undiagnosed. Although,
the disease is self-limiting and patients recover
without treatment, the diagnosis is very important.
CONCLUSION
The diagnosis of PF is a marker of patients
environmental contamination by Legionella and
thereby should be a sign for taking all prevention
measures.
The case reported here demonstrates the importance
of using additional diagnostic methods (RT-PCR),
besides the fast and easy to perform urinary antigen
tests, to obtain a more accurate diagnosis, if
suspected. Furthermore, this case shows that PF can
be associated with cutaneous involvement.
Conflict of Interest :Nil
REFERENCES
1. Fliermans CB, Cherry WB, Orrison LH,
2.
3.
4.
5.
6.
Smith SJ, Tison DL, Pope HD. Ecological

distribution of Legionella pneumophila.
Appl. Environ. Microbiol.1981; 41:916.
Fraser DW, Deubner DC, Hill DL, Gilliam
DK. Non pneumonic, short-incubation-period
legionellosis (Pontiac fever) in men who
cleaned a steam turbine condenser. Science
1979; 205:6901
Jones TF, Benson RF, Brown EW, Rowland
JR, Crosier SC, Schaffner W. Epidemiologic
investigation of a restaurant-associated
outbreak of Pontiac fever. Clin Infect Dis
2003; 371:2927
Diederen B. Legionella species and
Legionnaires Disease, Journal of Infection.
2008; 56:1-12
Mandell GL, Bennett JE, Dolin R Eds,
Principles and Practice of Infectious
Diseases, 4th edition, Churchill Livingstone,
1995: 2087.
Fenstersheib M, Miller M, Diggins C.
Outbreak of Pontiac fever due to Legionella
anisa. Lancet 1990; 336:3537
1049
Uysal et al.,
7. Glick TH, Gregg MB, Berman B, Mallison
18. Edelstein PH. Urine antigen tests positive for
G, Rhodes WW Jr, Kassanoff I. Pontiac

fever: an epidemic of unknown etiology in a
health
department.I.
Clinical
and
epidemiologic aspects. Am J Epidemiol
1978; 107:14960
Pancer K, Stypulkowska-Misiurewicz H:
Pontiac Fever non-pneumonic legionellosis.
Przegl Epidemiol 2003; 576:7-12
Fields BS, Haupt T, Davis JP, Arduino MJ,
Miller HP, Butler JC: Pontiac fever due to
Legionella micdadei from whirlpool Spa:
possible role of bacterial endotoxin. J Infect
Dis 2001; 184:1289-92
Luttichau HR, Vinther C, Uldum SA. An
outbreak of Pontiac fever among children
following use of a whirlpool. Clin Infect
Dis.1998; 26: 1374-78
Randall TW, Naidoo P, Newton KA.
Legionnaires disease in Port Elisabeth. S Af
Med J 1980; 581:7-23.
Helms CM, Johnson W, Donaldson MF.
Pretibial rash in Legionella pneumophila
pneumonia. JAMA 1981; 2451:758-59
Allen TP, Fried JS, Wiegmann TB.
Legionnaires disease associated with rash
and renal failure. Arch Intern Med 1985;
145:729-30
Calza L, Briganti E, Casolari S.
Legionnaires disease associated with
macular rash: two cases. Acta Derm Venereol
2005; 85:342-44
Ziemer M , Ebert K, Schreiber G, Voigt R.
Exanthema
in
Legionnaires
disease
mimicking a severe cutaneous drug reaction.
Clin Exp Derm 2009; 34:72-74
Spitalny KC, Vogt RL, Witherell LE.
National survey on outbreaks associated with
whirlpool spas. Am J Public Health 1984; 74:
725-6
Fields BS, Benson RF, Besser RE.
Legionella and Legionnaires disease: 25
years of investigation. Clin Microbial Rev
2002; 15:506-26
Pontiac fever: implications for diagnosisand

pathogenesis. Clin. Infect. Diseases 2002;
44:229-31
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
1050
Uysal et al.,
DOI: 10.5958/2319-5886.2014.00052.6

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Health Sciences
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Volume 3 Issue 4
Received: 14thAug 2014
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
Case report
ORAL SUBMUCOUS FIBROSIS: A SIMPLE APPROACH FOR INTUBATION
*Rachana N D1, Sandhya K2
1
Senior Resident, 2Associate Professor, Department of Anaesthesiology, Super speciality Hospital, Bangalore
Medical College and Research Institute, Bangalore.
*Corresponding author email: rachanakiran84@gmail.com
ABSTRACT
When encountered with an anticipated difficult airway, we should be vigilant in our anaesthetic techniques and be
prepared with an appropriate plan for airway securing. In OSMF cases fiberoptic being the gold standard,
tracheostomy is the next choice in awake state. These procedures cause discomfort to the patient and scarring.
This case report discusses the anaesthetic management of 32 yr old with OSMF for release and SSG where
instead, local release of fibrotic bands under sedation and local anaesthesia facilitated direct laryngoscopy and
thus airway securement. Thus this method avoids the discomfort associated with the above mentioned techniques
and also can be done in circumstances of the non availability of fiberoptic.
Keywords Airway management, Direct laryngoscopy, Local release, OSMF
INTRODUCTION
Oral submucous fibrosis is a premalignant lesion of the
buccal mucosa usually caused by chewing betel nut. It
is characterised by the slowly progressive development
of fibrous bands beneath the oral mucosa with
secondary mucosal atrophy. It is widely accepted to be
a collagen disease of insidious onset associated with
chronic local irritation which will lead to limited
opening of the oral cavity or inability to open the mouth
due to which a patient can neither consume normal diet
nor maintain good oral hygeine1. OSMF causes
difficulty in laryngoscopy and intubation of the
trachea1,2. Patients with OSMF require anaesthesia for
trismus correction, resection or reconstructive surgery.
OSMF it can cause difficulty in laryngoscopy and
intubation or by causing trismus. In any ways OSMF
patients have difficult airway. Here we present a case of
OSMF successfully managed at BMCRI-SSH hospital
with a direct laryngoscopy in case of non availability of
fiberoptic.
CASE REPORT
Rachna et al.,
A 32 yr old man, weighing 70 kgs, presented with a

complaint of progressive inability to open the mouth
since 6 yrs. He gave history of constant irritation of
buccal mucosa due to his teeth and cheek bite unlike the
usual history of chewing betel nut.
Past medical history was insignificant. Examination of
the airway revealed a mouth opening of 1cm, thick
fibrotic bands were palpable intra orally extending up to
pterygomandibular raphe region and the inter incisor
distance was 1cm. Complete intra oral and airway
examination was not possible due to restricted mouth
opening. A diagnosis of OSMF was made based on the
history and the examination findings. He was
subsequently posted for Resection of fibrotic bands and
SSG. Since our institute did not have a fiberoptic
Bronchoscope, a plan for release of fibrotic bands under
local anaesthesia and then direct laryngoscopy was
made failing which tracheotomy would be considered.
The patient was explained about the procedure and
1051
written informed consent was obtained for local release

followed by intubation or tracheotomy. The patient was
pre medicated on the previous night with Tab
Alprazolam 0.5 mg for anxiolysis. On the day of
surgery difficult airway cart was kept ready including
that for emergency tracheotomy. In the operation
theatre monitors were connected for continuous
recording of heart rate, oxygen saturation,
electrocardiogram, end tidal CO2 and non invasive
blood pressures.
IV Glycopyrrolate 0.2 mg was given intramuscularly as
antisialogogue. A bolus of Inj Dexmedetomedine 1/kg
was given over 10 mins and infusion was continued
intraoperatively at the rate of 0.5g/kg (11). 20 ml of
2 xylocaine with adrenaline was infiltrated into the
bands. After 10 mins perioral fibrotic bands were
released and mouth opening improved by 1cm. For
induction of anaesthesia IV fentanyl 2g/kg,
thiopentone 5mg/kg and succinylcholine 1.5mg/kg were
used. On direct laryngoscopy Cormack-Lehanne
grading was found to be 3. Patient was intubated with
8.0 cuffed encotracheal tube, ventilation checked and
tube secured. Intraoperatively patient was maintained
with Inj.Vecuronium and a mixture of Oxygen, Air and
Isoflurane with stable intraoperative vitals throughout
the surgical procedure. The fibrous bands were
thoroughly released and split skin grafting was done. At
the end of the procedure mouth opening was 2.5 cm.
Muscle relaxation was reversed with Inj Neostigmine
0.05mg/kg and Glycopyrrolate 20 /kg and was
extubated uneventfully.
trismus 3,4
Fig 2: Postoperative mouth opening
OSMF is a chronic condition of insidious onset that

may affect any part of the oral cavity and sometimes
pharynx, leading to stiffness of the oral mucosa causing
OSMF typically affects the buccal mucosa, lips, retro

molar areas, soft palate and occasionally pharynx and
the oesophagus. The disease begins with glossitis,
stomatitis and vesicle formation. Early lesions appear as
a blanching of the mucosa, imparting a mottled, marble
like appearance, whereas later lesions demonstrate
palpable fibrous bands that render the mucosa pale,
thick and stiff. Mobility of the tongue may be
decreased. The faucillar pillars may become thick and
short. Sometimes the condition spreads to the pharynx
and down to the pyriform fossae. In severe cases, the
patient may have difficulty in chewing, swallowing and
speaking.
Difficult airway is commonly seen in OSMF. The
airway should be assessed thoroughly and
anaesthesiologists should be prepared for difficult
airway. The resulting trismus and IID has been used to
classify patients into mild (IID >20 mm) and severe
(IID <15mm) OSMF 5. This classification may be
misleading for anaesthesiologists, as IID of at least 30
mm is required for direct laryngoscopy 6 and patients
with mild OSMF may still be difficult to intubate.
The easiest and quick assessment of airway can be done
with 1-2-3 rule. 1- Adequate mobility of TMJ can be
assessed by the ability to insinuate one finger into the
TMJ space in front of the tragus during opening and
closing the mouth. 2- Adequate space between the jaws
for introduction of a laryngoscope blade, facilitating
exposure of the glottis and passage of the endotracheal
tube can be assessed by the presence of at least 2cm of
interincisal distance. 3- Thyromental distance of more
than 3 finger breadth measured between the thyroid
notch and the symphysis menti is used to evaluate the
space available for displacement of the tongue during
laryngoscopy and intubation 7.
Rachna et al.,
Fig 1: Preoperative mouth opening

DISCUSSION
1052
Preliminary laryngoscopy under anaesthesia is useful

but should be reserved for patients with adequate mouth
opening. Airway management mainly depends on
expertise and available equipments8. Blind nasal,
retrograde intubation, tracheostomy are the other
choices with fiberoptic being the technique of choice9.
Allen and Osman reported a case of OSMF in
anaesthetic literature in which elective fiberoptic
intubation was done10. This needs adequate
preoperative preparation along with counselling of the
patient. Tracheostomy is an alternative technique
preferred and this is associated with complications like
hemorrhage,
subcutaneous
emphysema,
pneumomediastinium,
pneumothorax,
recurrent
laryngeal nerve damage, infection, and stenosis and
scarring. Here we have discussed intubating the patient
with local release of fibrotic bands which will improve
the mouth opening to a certain extent and thus avoiding
the discomfort associated with awake fiberoptic
intubation and the scarring and other complications of
tracheostomy
Dexmedetomidine has analgesic, anxiolytic and
antisialogogue properties 12, 13 .It does not depress
respiration and Spo2 remains within normal limits if
DEX is used in the dose range of 0.2to0.7g/kg/hr
13
.We typically use 0.5g/kg/hr because it is a midrange dose for conscious intubation.
1. Stone DJ, Gal TJ. Airway management. In: Miller

RD, ed. Anesthesia, 5th Ed. Philadelphia: Churchill
Livingstone, 2000: 1414 51.
2. Maharjan R, Jain K, Batra YK. Submucous fibrosis

secondary to chewing of quids: another cause of
unanticipated difficult intubation. Can J Anaesth.
2002; 49: 309 11
3. Schwartz J. Atrophia Idiopathica (tropica) mucosae
oris. Demonstrated at the Eleventh International
Dental Congress, London, 1952 (cited by Sirsat
&Khanolkar). Ind. j. med. Sci., 1962, 16: 189
4. Caniff JP, Harvey W, Harris M. Oral submucous
fibrosis: its pathogenesis and management.
BeDentJ1986; 160(12):429-34
5. Merchant AT, Haider SM, Firkee FF. Increased
severity of oral submucous fibrosis in young
Pakistani men. Br J Oral Maxillofacial Surg 1997;
35:2847.
6. Stone DJ, Gal TJ. Airway management. In: Miller
RD, ed. Anesthesia, 5th ed. Philadelphia: Churchill
Livingstone, 2000:141451.
7. Venkateswaran Ramkumar. Preparation of the
patient and airway for awake intubation. Indian J
Anaesth 2011; 55:442-7
8. Practice Guidelines for Management of the
Difficult Airway. A report by the ASA Force on
Management
of
the
Difficult
Airway.
Anesthesiology 1993; 78:59702.
9. Caplan RA, Benumof JL, Berry FA, et al. Practice
guidelines for management of the difficult airway.
A report by the American Society of
Anaesthesiologists Task Force on management of
the difficult airway. Anesthesiology1993; 78:59702
10. Allen PW, Osman HG. Submucous fibrosis
(Letter). Anaesthesia 1988; 43:809-10
11. Sergio D, Bergese MD, Babak Khabiri DO,
William Roberts MD, Michael B, Howie MD,
Thomas D, Mc Sweeney BS, Mark A. Gerhardt
MD, PhD Dexmedetomidine for conscious sedation
in difficult awake fiberoptic intubation cases.
Journal of Clinical Anesthesia 2007; 19:141-44.
12. Jaakola ML, AliMelkkila T, Kanto J, Kallio A,
Scheinin H, Scheinin M. Dexmedetomidine reduces
intraocular pressure, intubation responses and
anaesthetic requirements in patients undergoing
ophthalmic surgery. BrJAnaesth1992; 68:570-5.
13. Hogue CW Jr, Talke P, Stein PK, Richardson C,
Domitrovich PP, Sessler DI. Autonomic nervous
system responses during sedative infusions of
dexmedetomidine.Anesthesiology2002;97:59
Rachna et al.,
CONCLUSION
The characteristic feature of OSMF is extremely
restricted mouth opening and distortion of airway
rendering difficult intubation. Airway securing by the
awake fiberoptic intubation may be the ideal method
but in the situations of non availability of fiberoptic and
to avoid the discomfort of awake intubation this method
of local release of bands and direct laryngoscopy can be
considered. Thus, this method abolishes the discomfort
of awake intubation, tracheostomy scarring and is also
cost effective.
Limitation: Though the above meathod was successful
in our patient the same may not be reproducable in
similar clinical presentations.
Conflict of Interest: None
REFERENCES
1053
DOI: 10.5958/2319-5886.2014.00053.8

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th
Case report
Copyright @2014
ISSN: 2319-5886
HIBERNOMA AT UNUSUAL LOCATION: DIAGNOSIS ON FINE NEEDLE ASPIRATION CYTOLOGY &

LITERATURE REVIEW
*Gupta Shruti, Poflee Sandhya, Pande Nandu, Umap Pradeep, Shrivastava Alok
Department of Pathology, Indira Gandhi Government Medical College, Nagpur, Maharashtra, India
*Corresponding author email: drshrutimlb@gmail.com
ABSTRACT
Hibernoma is a rare benign neoplasm that shows differentiation towards brown fat. Most hibernomas occur in
sites where brown fat persists beyond fetal life, however, they have been known to occur at many uncommon
locations. We present a case of 45 year old female with history of painless, slow growing mass in the pubic region
for last seven years, initially diagnosed as hibernoma on fine needle aspiration cytology. The diagnosis was later
confirmed on histopathologic examination. The preoperative diagnosis of hibernoma can be difficult because its
clinical, radiological & cytological features may overlap with those of other benign & malignant lipomatous
tumours.
Keywords: Hibernoma, Brown fat, Fine needle aspiration cytology diagnosis
INTRODUCTION
Hibernoma is a benign soft tissue tumour derived
from brown fat and is of significantly rare occurrence
as compared to lipoma that is a benign soft tissue
tumour derived from white or adult fat. The
cytological features of hibernoma on fine needle
aspiration cytology (FNAC) are characteristic and can
be useful in the preoperative investigation of
lipomatous tumors.1 Despite of its characteristic
appearance in cytology smears, reports on cytological
diagnosis of hibernoma are few & far between.2 The
cytological features of Hibernoma are highlighted and
its differential diagnosis from other lipomatous
tumors is discussed.
CASE REPORT
A 45 year old female was referred for FNAC from
surgery OPD with a history of painless, slow growing
mass in the pubic region since last seven years. The
patient denied any other significant complaints or
Shruti et al.,
constitutional symptoms. She had a healthy

surgical Pfannenstiel incision scar mark owing to
abdominal hysterectomy done nine years back for
dysfunctional uterine bleeding.
On local examination, a 23 cm well defined, firm,
non tender swelling, mobile in all directions, located
in the superficial subcutaneous plane with no
overlying skin changes was palpable. (Fig. 1(a)).
Clinical suspicion was of a desmoid tumor or
fibroma.
Ultrasonography was suggestive of a soft tissue
tumour with increased vascularity. FNAC was
performed using a 23" gauge needle, which yielded
oily aspirate. Smears were moderately cellular and
showed cells of variable sizes and large cells having
abundant multivacuolated cytoplasm and centrally
placed nuclei in a fatty background (Fig. 1(b)). Some
cells have granular eosinophillic cytoplasm. In
multivacuolated cells, the nuclei were small and
round and did not show indentation, differentiating
1054
these cells from lipoblasts (Fig. 2(a)). Taking into

consideration the known comparable histologic
features, a cytodiagnosis of "Benign Adipose tissue
tumour" consistent with "Hibernoma" was made.
Excision of the lesion was done. The histological
sample consisted of a soft yellow, brownish
encapsulated tumour mass measuring 3 3 cm and
yellow brown cut surface. (Fig 2(b))
H&E stained sections showed a distinct lobular
pattern. The tumour mass was composed of round
cells that showed distinct cellular membrane and
granular eosinophilic cytoplasm with centrally placed
nuclei.
Some
cells
showed
distinctive
multivacuolated cytoplasm and small round nuclei
without indentation. These cells were admixed with
large mature adipocytes with eccentric flattened
nuclei. The cellular features appreciated in the
cytology smears were comparable to those seen in
histopathology sections. fig 3(a) and (b).
The cytological diagnosis of hibernoma was thus
confirmed on histopathology.
Fig 3: Comparable features of Hibernoma

cytological smear (a) & histological section (b).
H& E (400X)
DISCUSSION
Fig 2: (a) Cytology smears showing cells with

multivacuolated cytoplasm. MGG ( 400X). Inset
showing typical "Mulberry cell". (b) Surgical
specimen of the tumour mass.
Hibernoma is a rare benign adipose tissue tumour

which shows differentiation towards brown fat.
In 1906, Merkel described the first brown fat tumour
as a pseudolipoma of the breast and the term
hibernoma was coined in 1914 by Gery, due to
morphological resemblance of the tumour to the
brown fat of hibernating mammals. 1
It is suggested that hibernomas represent altered
programming of neoplastic fat cells towards brown
fat differentiation.2 Clinically, hibernomas are usually
painless soft tissue masses that arise in adults with
peak incidence in the third decade and slight male
preponderance. Tumour size can range from 1 to 24
cm diameter with an average of 9.3 cm. It often
produces symptoms due to compression of adjacent
structures.3
The most common site of hibernoma is subcutaneous
tissue of the back, especially interscapular area. Other
frequent locations include the neck, axilla, thigh, and
intrathoracic area. They have been reported at
uncommon sites including the scalp, buttock,
popliteal fossa and scrotum, and intracranially,
intraspinally and periureterically. Hibernomas that
arise at unusual sites may dictate the clinical course.4
Literature also mentions case reports of hibernomas
in paraglottic, cervical region and mediastinum1,5,6.
When hibernomas occur at an unusual location, it
cannot be differentiated from other tumours that
occur commonly at the site on the basis of clinical
and radiological findings as the case described here.
Routine radiography may demonstrate a faint softtissue mass or swelling. Ultrasonography shows a
Shruti et al.,
1055
Figure :(a) Subcutaneous swelling in left pubic

region, (b) Cytology smear showing cells of
variable sizes in a fatty background. H & E (400X)
hyperechoic mass, and hypervascularity with

enlarged vessels may be noted on Doppler imaging.7
Cytology smears reveal clusters of uniform, round
cells with well-defined borders as well as occasional
single cells. The cell cytoplasm is filled with small,
uniform fat globules that appear as empty vacuoles in
cytology smears. Occasionally, the tumour cells
display finely granular cytoplasm. The nuclei are
centrally placed with smooth contours, evenly
distributed chromatin, and small nucleoli. A delicate
network of capillaries frequently surrounds the cells.8
On gross examination, hibernoma is usually well
defined, soft and mobile. Its colour varies from tan to
red, brown, largely depending on the relative amount
of intracellular lipid.
Microscopically, in tissue sections the tumour cells
appear round or polygonal and are closely opposed to
one another within the lobules. Three principal types
of cells in varying proportions can be recognized- (a)
a small cell with granular, eosinophilic cytoplasm and
with or without, multiple small lipid droplets, distinct
cellular membrane and centrally placed nucleus (b) a
larger, multivacuolated fat cell with scanty granular,
eosinophilic cytoplasm that shows the presence of
multiple small oil-red O-positive lipid droplets and
central nucleus. This cell is known as a mulberry cell
and (c) a still larger, univacuolated fat cell with
peripherally placed nucleus. Cells of the three
principal types, with transitional forms, usually are
dispersed randomly throughout the lobules. In most
tumours,
multivacuolated
mulberry
cells
predominate. 9
Four morphologic variants of hibernoma have been
identified: typical, myxoid, spindle cell, and lipomalike. Typical hibernoma, that is the most common
type, includes eosinophilic cell, pale vacuolated cell,
and mixed cells based on the quality of the cytoplasm
of hibernoma cells. The myxoid variant contains a
loose basophilic matrix. Spindle cell hibernoma
presents features of spindle cell lipoma and
hibernoma; all occurring in the neck or scalp. The
lipoma-like variant contains only scattered hibernoma
cells.10The case presented here belongs to 'the typical
hibernoma' variety.
Cytological features of hibernoma are characterstic &
are comparable to its histologic features; however
studies describing cytological features of hibernoma
are sparse other than case series by Maria et al.11 The
Shruti et al.,
authors have emphasised that differentiating

hibernoma from other lipomatous tumours is difficult
at times due to overlap between clinical, radiographic
& cytological features. Immunohistochemically, 85%
of these tumours are positive for S-100 protein.3
However, immunohistochemistry and special stains
are not useful in differentiating hibernoma from other
benign and malignant lipomatous tumours.
Preoperative differential diagnosis of hibernoma from
various types of liposarcomas is important as it may
affect patient management. While liposarcoma needs
excisions with wide margins, hibernomas can be
excised marginally.
The primary difference on cytology is between the
brown fat-like cells of hibernoma and the lipoblasts
of liposarcoma. The Hibernoma cell has abundant
cytoplasm that contains multiple, small fat vacuoles
& a uniform central nucleus with evenly distributed
chromatin. An additional distinguishing feature of
hibernoma is the presence of delicate capillaries
surrounding individual hibernoma cells.11 We did not
observe this feature in any of the cytology smears
from the aspiration of abdominal wall swelling
described here. Lipoblasts of well differentiated
liposarcoma may be uni or multi vacuolated and vary
in size & shape. They have a comparatively larger,
hyperchromatic nuclei indented by cytoplasmic fat
vacuoles. Myxoid liposarcoma in addition will have
prominent myxoid background and rich capillary
network. Nuclear atypia is prominent in Round cell
liposarcoma.
Distinguishing hibernoma from lipoma with
regressive changes is difficult, but not so significant
clinically, both being benign tumours.
Adult rhabdomyoma and granular cell tumours are
readily distinguished from hibernoma by the
complete absence of lipid vacuoles in the cytoplasm
and lack of delicate vasculature.
Lipoblastoma, another benign lipomatous tumour is
clearly distinguished clinically because of different
ages of presentation and sites of occurrence. On
cytology, it is more likely to be confused with
liposarcoma.
The ultrastructural features of hibernoma include
multivacuolated and univacuolated cells containing
variable numbers of lipid vacuoles, abundant
moderately
pleomorphic
mitochondria
with
transverse cristae, lysosomes, lipofuscin granules,
1056
pinocytotic vesicles, well formed basal lamina, and

prominent subplasmalemmal condensations.12
Cytogenetic analyses of hibernomas have consistently
revealed rearrangements of chromosome bands
11q132113 Latest studies suggest that concomitant
deletions of tumour suppressor genes MEN1 and AIP
are essential for the pathogenesis of the brown fat
tumour hibernoma. 14 Hibernomas are also found to
be characterized by Homozygous Deletions in the
Multiple Endocrine Neoplasia Type I Region.15, 16
Local excision is the treatment of choice for
hibernoma. Aggressive behaviour or local recurrences
are not reported. 2
CONCLUSION
A reliable preoperative diagnosis of hibernoma can
be made based on the combination of
clinicoradiographic findings and characteristic
cytologic
features,
provided
the
reporting
cytopathologists is aware of the differential
diagnoses.
ACKNOWLEDGEMENT
Dr. (Mrs.) A.V. Shrikhande, Professor & Head,
Department of Pathology, Indira Gandhi Govt.
Medical College, Nagpur.
REFERENCES
1. Minni, Barbaro, Vitolo, Filipo. Hibernoma of The
Para-Glottic Space: An Unusual Tumour Of The
Larynx. Acta Otorhinolaryngologica italic 2008;
28:141-43.
2. Sheth A, Terzic M, Arsenovic N. Vulvar
hibernoma.Indian
J
Pathol
Microbial
2011;54:817-8.
3. Furlong MA, Fanburg-Smith JC, Miettinen M.
The morphologic spectrum of
hibernoma: a
clinicopathologic study of 170 cases. Am J Surg
Pathol 2001; 25: 809-14.
4. Mustafa Kosem, Metin Karakok, Hibernoma: A
Case Report & Discussion of a Rare Tumor, Turk
J Med Sci 2001; 25: 175-76.
5. Khalid Khattala, &, Aziz Elmadi, Hanane
Bouamama,
Mohamed
Rami,
Youssef
Bouabdallah. Cervical hibernoma in a two year
old boy. Pan African Medical Journal.2013
16:27.
Shruti et al.,
6. Baldi, Santini, Mellone, Esposito, A M Groeger,

M Caputi, F Baldi. Mediastinal hibernoma: a case
report. J Clin Pathol 2004; 57:99394.
7. Balaguera, Isabel, L Aquiriano, Morales,
Orellana, Hernndez. Axillary Hibernoma: An
Unusual Benign Soft-Tissue Tumor. The Internet
Journal of Surgery. 2009; 22: 1.
8. Oscar Lin & Maureen F Zakowski. Cytology of
Soft Tissue, Bone, & Skin. In: Marluce Bibbo,
David
Wilbur
(3rded.),
Comprehensive
Cytopathology, Elsevier, 2008, 473-74.
9. Tumors with Fatty, Muscular, Osseous, and/or
Cartilaginous Differentiation. In: Elder (10th ed.)
Lever's Histopathology of the Skin, Lippincott
Williams & Wilkins, 2009, 1068-70.
10. Benign Lipomatous tumors. In: Weiss &
Goldblum (5th ed.), Soft Tissue Tumors, Elsevier,
2008, 466-70.
11. Maria M. Lemos, Lars-Gunnar Kindblom, Jeanne
M. Meis-Kindblom, Fabrizio Remotti, Walter
Ryd, Bjo rn Gunterberg, Helena Willen. FineNeedle Aspiration Characteristics of Hibernoma.
Cancer (Cancer Cytopathol) 2001; 93: 20610.
12. Thomas A. Seemayer, Juergen Knaack, Nai-San
Wang, M. Nisar Ahmed, On ultrastructure of
hibernoma.Cancer;1975;36:1785-93
13. Mertens F, Rydholm A, Brosjo O, Willen H,
Mitelman F, Mandahl N. Hibernomas are
characterized by rearrangements of chromosome
bands 11q1321. Int J Cancer. 1994; 58: 50305.
14. Karolin H. Norda, Linda Magnussona,
Margareth Isakssona, Jenny Nilssona, Henrik
Lilljebjrna, Henryk A. Domanskib, Lars-Gunnar
Kindblom, Nils Mandahla, and Fredrik Mertensa,
Concomitant deletions of tumor suppressor genes
MEN1 and AIP are essential for the pathogenesis
of the brown fat tumor hibernoma, PNAS
2010;107:49.
15. David Gisselsson, Mattias Hoglund, Fredrik
Mertens, Paola Dal Cin,
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Hibernomas are Characterized by Homozygous
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16. Contributions of Cytogenetics and Molecular
Cytogenetics to the Diagnosis of Adipocytic
Tumors, Jun Nishio ,Journal of Biomedicine and
Biotechnology,2011:: Article ID 524067
1057
DOI: 10.5958/2319-5886.2014.00054.x

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Volume 3 Issue 4
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Case report
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th
NEW INSIGHTS IN TO SYSTEMIC AMYLOIDOSIS: PRIMARY AMYLOIDOSIS ASSOCIATED

WITH TUBERCULAR LYMPHADENITIS
*Shivraj Meena1, Nirmal Ghati2, Rita Sood3, Naval Kishore Vikram4
1
Senior Resident, 2 Junior Resident, 3Professor, 4Additional Professor, Department of Medicine, All India
Institute of Medical Sciences, New Delhi, India
*Corresponding author email: shivraj.aiims@gmail.com
ABSTRACT
Tuberculosis is generally followed by secondary amyloidosis. The association of primary systemic amyloidosis
with tuberculosis is very rare. There is only one case thus far reported in literature. We report such a rare case of
primary amyloidosis with tuberculous lymphadenopathy. A 45 year old woman presented at the medicine
department of all India institute of medical sciences , New Delhi with on & off erythematous rashes over both
eyes for 1 year; low grade fever, fatigue and significant weight loss for 4 months, dysphagia for solid food since 1
month. Main finding on examination were pallor, macroglossia, bilateral periorbital erythematous rashes (racoon
eyes), hepatomegaly & cardiomegaly. She had raised serum alkaline phosphatase level. Chest x-ray revealed
cardiomegaly. USG abdomen revealed multiple retroperitoneal mesenteric lymph nodes and hepatomegaly. USG
guided FNAC from mesenteric lymph node showed acid fast bacillus. Histological examination of liver biopsy
showed amyloid deposition on congo red stain. Patient was treated with DOTS category I ATT with Bortezomib
and Dexamethasone based weekly chemotherapy.
Keywords: Amyloidosis, Tubercular lymphdenopathy, Bortezomib
INTRODUCTION
The term amyloid was introduced in 1854 by the
German physician scientist Rudolph Virchow
(reviewed by Cohen, 1986).1 Rudolf Virchow first
described amyloidosis as an extracellular deposition
of carbohydrate. What we know now is that there is
an extracellular deposition of proteinaceous material
which, when stained with Congo red gives apple
green birefringence under polarized light. In 1838,
Mathias Schleiden, a German botanist, coined the
term amyloid for the amylaceous constituents of
plants. In 1854, Rudolf Virchow adopted the term to
describe abnormal extra-cellular material that he
encountered in the liver during autopsy.2 Divry and
associates3 recognized that the amyloid deposits
showed apple-green birefringence when specimens
stained with Congo red were viewed under polarized
light. This observation remains the sine qua non of

the diagnosis of amyloidosis. We report a case of
uncommon association of primary AL amyloidosis
with a common disease.
CASE REPORT
A 45 year old woman presented with on & off
erythematous rashes over both eyes for 1 year; low
grade fever, fatigue and significant weight loss for 4
months, dysphagia for solid food since 1 month;
intermittent spasmodic pain at umbilical region since
20days. Her BP was 100/70 mm/Hg, PR: 102/ min,
RR:22/ min. She had pallor, macroglossia (figure1),
petechial rashes over right arm & bilateral periorbital
erythematous rashes (racoon eyes). On abdomen,
1058
Shivraj et al.,
tenderness at right hypochondrium and enlarged firm

tender liver (24 cm) were present. CVS examination
revealed cardiomegaly only.
Fig 1: Showed macroglossia

Blood test showed Hb: 11.4g/dl, WBC: 14300/cu
mm, Platelet: 561000/ul, ESR: 05mm/hr. She had
isolated raised ALP: 840 IU/L) level. Urine routine
microscopy and 24 hr. urinary protein were normal.
Chest x-ray revealed cardiomegaly. Her ECG
revealed low voltage QRS complex in the limb leads
with poor progression of R wave in precordial leads.
As a suspected case of infection - HIV, hepatitis viral
markers, blood & urine gram stain culture done were
negative. Though toxic granules containing
neutrophils were present, no atypical malignant cells
in the blood. Lactate dehydrogenase level was
normal. Serum & urine protein electrophoresis
showed no M band, but elevated lambda light chain
level (=152. 53 mg/L) in serum free light chain
assay. kappa & lambda light chain ratio was low
(k:=0.06). Total protein & albumin globulin ratio
were normal.
USG abdomen revealed multiple retroperitoneal
mesenteric lymph nodes, hepatomegaly, mild ascites
and bilateral mild pleural effusion. Contrast enhanced
computed tomography (CECT) of chest and abdomen
confirmed the USG finding. USG guided Fine needle
Aspiration Cytology (FNAC) from mesenteric lymph
node showed Acid Fast Bacilli (AFB). Bone marrow
biopsy showed 7% mature plasma cells, but it was
negative for lymphoma deposits or amyloids.
Abdominal fat pad biopsy was equivocal for
amyloidosis. Subsequently liver biopsy was done and
histopathologicaly revealed amyloid deposition
(figure II). Immunohistochemistry of liver biopsy
showed predominant lambda light chain deposition
around blood vessels in the background of
nonspecific lambda and kappa light chain deposition

in the sinusoids.
Fig 2: A Section of the liver stained with congo red

reveals pink-red deposits of amyloid (arrow) along
with sinusoids. (40x).
As the patient had progressive dysphagia, barium
swallow was showed sluggish peristalsis with tertiary
contraction in thoracic oesophagus but subsequent
upper G.I. endoscopy was normal. Autonomic
function tests revealed severe dysfunction, but the
nerve conduction test was normal. Echocardiography
showed
bi-ventricular
hypertrophy,
bi-atrial
enlargement, thickened IVS and posterior wall,
granular sparkling of myocardium, severe left
ventricular dysfunction (EF 27%) & mild pericardial
effusion. Subsequent Holters study and BNP level
were normal.
Based on the above, a final diagnosis of primary
Amyloid Light-chain (AL) amyloidosis with
abdominal Koch was made. For tuberculosis,
category I anti tubercular treatment (ATT) and for
amyloidosis, Bortezomib and Dexamethasone based
weekly chemotherapy started. Though her symptoms
improved temporarily in the form of decreased
dizziness, fatigue, but after the third chemotherapy,
she developed decompensated chronic heart failure
(CHF) followed by diarrhoea. Appropriate treatment
started & Bortezomib based chemotherapy withheld
in the fear of drug induced diarrhoea. Later she
started having direct hyperbilirubinemia with
leucocytosis. ATT modified & broad spectrum
antibiotics started as all the investigations to localize
the infection were negative. Because of deranged
LFT, Bortezomib chemotherapy stopped and
Cyclophosphamide & Dexamethasone based weekly
chemotherapy started. But the patients condition
deteriorated rapidly and she died of septic shock with
aspiration pneumonia after 4 weeks.
1059
Shivraj et al.,
DISCUSSION
Amyloidosis is a heterogeneous group of diseases
associated with the common pathological process of
extracellular protein deposition in various organs,
leading to organ dysfunction and death.
Inspite of the fact that hepatic involvement in
systemic amyloidosis is common histologically
occurring in 60-100% of liver specimens4 clinically
apparent liver disease is infrequent. The patient had
markedly elevated serum alkaline phosphatase which
suggests an early phase of intrahepatic cholestasis.
Jaundice is usually a terminal feature and most
probably would have appeared if the patient had lived
long enough. Intrahepatic cholestasis secondary to
amyloidosis has been reported by several other
workers.5,6 Other parameters of liver function which
reflect the integrity of the hepatic parenchymal cells,
such as bilirubin level, serum albumin and
prothrombin time were normal because hepatic
amyloidosis is primarily an infiltrative disorder.
Tuberculosis is generally followed by secondary
amyloidosis. The association of primary systemic
amyloidosis with tuberculosis is very rare. Only one
case thus far reported in literature.7 Diagnosis of
tuberculosis in presence of systemic amyloidosis can
be challenging as Amyloid material in a lymph node
can masquerade as caseous necrosis in cytology.8 Our
patient had AFB in the abdominal lymph nodes which
regressed completely with ATT. The present case
outlines the challenges in management of atypical
cases where liver involvement with amyloid and use
of potentially hepatotoxic drugs was required for the
treatment of the patient.
There was no identifiable chronic inflammatory,
infective or neoplastic disorder to account for
amyloid deposition. Serum protein electrophoresis
did not show abnormal band. There was no bencejones protein in urine and bone marrow examination,
did not show expansion of plasma cell. This suggests
that the amyloidosis is most likely to be primary, but
unrelated to any overt immunocyte dyscrasia.
Our patient had primary amyloidosis with Liver,
Cardiac, ANS and GIT involvement with abdominal
tuberculous lymphadenopathy. Bortezomib with
dexamethasone is a proven therapy for primary
amyloidosis.9 Our patient was started on this
treatment. Since she developed side effects, therapy
was changed to cyclophosphamide.

succumbed to her disease.
But
she
CONCLUSION
We conclude that tuberculosis is generally followed
by secondary amyloidosis. The association of primary
systemic amyloidosis with tuberculosis is very rare,
but in this case we can also think that primary
systemic amyloidosis can be associated with
tuberculosis.
ACKNOWLEDGMENT
This work was done in the department of medicine at
AIIMS, Hospital without any additional financial
support. Authors thanks to all participants in this
study. They are also grateful to Dr A B Dey for their
advice to patient care and management.
Conflict of interest: The authors declare no conflict
of interest.
REFRENCES
1
2
Jean DS, Alan SC. History of the Amyloid Fibril.

Journal of Structural Biology. 2000;130:8898.
Virchow VR. Ueber einem Gehirn and
Rueckenmark des Menschen auf gefundene
Substanz mit chemischen reaction der Cellulose.
Virchows Arh Pathol Anat.1854;6:135-8.
Divry P, Florkin M. Sur les prorietes optiques de
lamyloide. CR Seances Soc Biol.1927;97:180810.
Gertz MA, Kyle RA. hepatic amyloidosis clinical
appraisal
in
77
patients.
Hepatology.
1997;25:118-21
Mc Donald P, Usborne C, Playfer JRA. Case of
intrahepatic choestasis due to amyloidosis. Int. J.
Clin. Pract. 1988;52:201-02
Gornka MK, Bhasin DK, Vasisth RK,Dhawan S.
Hepatic amyloidosis presenting with severe
intraheptic cholestasis. J. Clin Gastroenterol.
1996;23:134-36
Fekih L, Boussoffara L, Fenniche S, Hassene H.
Enigmatic evolution of an association of
pulmonary tuberculosis and amyloidosis. Rev
Mal Respir. 2011;28(5):691-5
Sharma N, Sharma S, Bindra R. Plasmacytoma
with amyloidosis masquerding as tuberculosis on
cytology. J Cytol. 2009;26:161-3
Kastritis E, Anagnostopoulos A.Treatment of
light chain (AL) amyloidosis with the
combination of bortezomib and dexamethasone.
Haematologica. 2007;92(10):1351-58
1060
Shivraj et al.,
DOI: 10.5958/2319-5886.2014.00055.1

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Case report
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ISSN: 2319-5886
PRESENTATION OF EWINGS SARCOMA IN UNLIKELY AGE GROUP AT UNUSUAL LOCATION

Prasad DV1, Sanjay Mulay2, Krishna Badgire 3, *Abhinav S.Jadhav4, Deepak Datrange4, Arun alex4
1
Professor, 2Officiating Professor, 3Assistant Professor, 4Resident, Department of Orthopedics, Rural Medical
College, Loni, Ahmednagar, Maharashtra
Corresponding author email: dr.ratz21@gmail.com
ABSTRACT
Ewings sarcoma is a highly malignant, round cell neoplasm of uncertain origin. It is the sixth most common
malignant tumour of bone. It must be distinguished from chronic osteomyelitis and other malignant round cell
tumours like lymphoma, metastatic neuroblastoma and small cell osteosarcoma. Most patients are between 10 to
25years old; rarely, patients are younger than age 5 years and older than age 40 years. We report a 55 years
female who presented with swelling over right shoulder with pain and inability to move right shoulder later
diagnosed as Ewings sarcoma of proximal part of humerus right side. The earlier diagnosis at this age may help
in better management of the condition and prevent further complications and have a better prognosis.
Keywords: Ewings sarcoma, Primitive neuroectodermal tumour (PNET), Ewing family of tumours (EFT),
Round cell tumour.
INTRODUCTION
Ewings sarcoma is a highly malignant, round cell
neoplasm of uncertain origin. It is the sixth most
common malignant tumour of bone 1. Most patients
are between 10 to 25years old; rarely, patients are
younger than age 5 years and older than age 40 years
1
. In 1918, a tumour composed of small round cells
with rosettes in ulnar nerve was described by Arthur
P Stout 2, later on it became known as Primitive
neuroectodermal tumour (PNET). James Ewing
described a tumour of diaphysis of long bones
composed of undifferentiated cells and the tumour
was radiosensitive 3. Earlier Ewings sarcoma (ES) &
PNET were described as two separate entities, but in
1975 Angervall and Enzinger described extraskeletal
tumour resembling to ES 4 and Jaffe et al. Wrote an
article on the neuroectodermal tumour of bone in
1984 5. Now it is known that ES and PNET have
similar translocations and are the two ends of the
histological spectrum of Ewings family of tumours
(EFT). Analysis of molecular techniques not only

provided better understanding of biology, but also
help in developing better techniques in diagnosis and
prospective potential treatment. The present report is
about a rare presentation of Ewings sarcoma in a 55
years old female who presented with swelling over
right shoulder with severe pain and inability to move
right shoulder.
CASE REPORT
A55 years old female, housewife, was presented with
progressive swelling over right shoulder and
difficulty in shoulder movements. Swelling was
accompanied with severe pain which increased
gradually over a period of 6 months.
On examination, she was an average built female
with swelling over right shoulder and upper part of
right arm. Swelling was of 25x20cm size. It was a
1061
Prasad et al.,
solitary swelling with local rise of temperature over

swelling. Swelling was tender and variable in
consistency. It was a non-mobile swelling. Redness
and prominent superficial veins were visible over
swelling over right shoulder and upper part of arm
(Fig.1). Her haemoglobin levels were decreased and
she had an elevated erythrocyte sedimentation rate
(ESR). Her renal function tests and liver function
tests were towards the lower normal range.
X-ray right shoulder with arm shows round lytic
lesion in head and upper part of humerus (Fig.2).
MRI of right shoulder joint was suggestive of a
8.7x6.7x6.5 cm well defined, lobulated, expansile,
lytic, lesion involving head and proximal shaft of
right humerus, causing thinning and erosion of the
cortex with breach at few places and narrow zone of
transition, adjacent soft tissue extensions with edema
and moderate right shoulder joint effusion. These
findings are suggestive of neoplastic mass involving
proximal humerus with pathological fractures (Fig. 3)
Histopathology report shows sheets of small round
cells with hyperchromatic nuclei, condensed
chromatin and scanty eosinophilic cytoplasm with
vaculisations with unremarkable bony trabeculae
(Fig.4). Immuno-histochemistry is suggestive of
Vimentin, CD99, S 100 positive and AE1/AE3
focally positive. Cytology report was suggestive of
cytomorphological features positive for malignancy.
Fig 3: MRI right shoulder - T1W,T2W and STIR

images showing expansile, lobulated, lytic lesion
involving head and proximal part of humerus.
Fig 1: Clinical photograph of a patient showing

right shoulder swelling.
Fig 4: Microscopic picture (40X) showing sheets of

small round cells with hyperchromatic nuclei
(arrow), condensed chromatin and scanty
eosinophilic cytoplasm.
Fig 2:X-ray right shoulder showing round lytic

area in upper end of humerus.
1062
Prasad et al.,
DISCUSSION
Epidemiology: EFT comprises 5 to 10 % of total
bone tumour and is the 2nd most common tumour of
childhood 6. It occurs predominantly in young adults
and children and shows a slight predilection for males
7
.75% cases are seen between 10 to 25 years age of
life. Youngest case reported so far was of 4.5 months
old 8 and oldest case reported was 61 years old.
Infancy cases are to be differentiated from metastatic
neurofibroma. Sites: At 55% long bones it is usually
diaphyseal lesion but also metaphyseodiaphyseal
lesion can be seen. Flat bone (pelvis and ribs)
involvement can also be seen. Less common sites of
occurrence are skull, vertebra and scapula.
Presentation of Ewings sarcoma: Pain, Swelling
and fever are the presenting symptoms. X-ray shows
permeative pattern of bone involvement (boundary
between uninvolved bone and area of bone
destruction and bone is broad, vague &
imperceptible). All types of periosteal reactions seen
like an onion peel, moth eaten, honeycombed, fine
and reticulated 1.
Biopsy: Ideally core biopsy is done, if repeated
attempts of core biopsy fail open biopsy is done.
FNAC not recommended in case of Ewings sarcoma.
Frozen section studies opted in selected cases only as
freezing of tissue distorts the morphology. Fixation of
tissue is done in 10% formalin. Inadequate fixation
leads to loss of antigen, so inconclusive results of
immunohistochemistry and also causes autolysis and
degeneration of DNA thus making molecular analysis
difficult. Ratio of specimen to formalin is 1:10.
Histology: It is prototype of small round cell tumour
growth. It shows sheets of small cells with increased
nuclear to cytoplasm ratio. Cytoplasm is scanty,
eosinophilic, and detected by periodic acid Schiff
(PAS), contains glycogen and diastase degradable.
Occasional rosette formation is seen and frequently
undergoes necrosis and residual viable cells show
perithetiomatous or perivascular distribution. EFT
tumour cells can be large with irregular nuclear
membrane and prominent nucleoli 9. EFT cells show
membrane expression of CD99 /MIC 2 on
immunohistochemistry 10. Antibody against FLI-1 is
seen in the nucleus of tumour cells, which is specific
for the diagnosis of EFT 11. Tumour cells may show
neuron specific enolase (NSE), synaptophysin and s100 protein 12.
Family of EFT includes -1) non hodgkins lymphoma

2)rhabdomyosarcoma 3) synovial sarcoma
4)mesenchymal chondrosarcoma 5)desmoplastic
small round cell tumor (DSRCT) 6)retinoblastoma.
False positive cd99 screening is seen in other cases as
well, hence CD99, FLI1 and NSE to be positive for
diagnosis of EFT/PNET.
Molecular genetics: Translocation t (11:22)
(q24:q22) is seen in 85 % cases. Fusion of EWS gene
on 22q12 with FLI-1 on 11q24 results in chimeric
fusion transcript EWS-FLI1 13. EWS-FLI1 induces
insulin like growth factor (IGF-1). Phospholipase D2
(PLD2) and Protein tyrosine phosphatase 1 (PTPL1)
are expressed in increased levels. Thus tumour cells
escape from apoptosis and growth inhibition.
Therapeutic targets: EWS-FLI1 fusion is to be
targeted and split. Monoclonal antibodies against IGF
-1 are being tried as it is associated with EFT
growth14 and PLD 2, PTPL1 are other conceivable
candidates as both are highly expressed in EFT 15.
Chemotherapy in ES: There is no universally
accepted staging. American joint committee on
cancer (AJCC) suggests that primary bone or extra
skeletal Ewings sarcoma may be included with their
respective bone or soft-tissue sarcoma staging (STS)
systems16. Although AJCC staging includes
metastatic disease and tumour size greater or less than
8 cm; nodal status and grade are irrelevant for ES
because it rarely spreads by lymph nodes and by
definition of the ES is high grade tumour 16. Presence
or absence of metastasis at the time of diagnosis is
used as the main tool for planning the treatment
strategy16.
Prognostic factors: 1) tumour site and size 2) age
and gender 3) serum LDH levels
ES in distal extremity have better prognosis than
proximal extremity. ES in a central location (pelvis)
have worse prognosis17,18,19. Tumour volume <100200ml-small tumour has better prognosis and tumour
volume >100-200ml- large tumour has a bad
prognosis. Girls have better prognosis than boys 19.
Increased serum LDH levels at time of diagnosis with
large tumours with metastatic disease has a worse
prognosis. Metastasis in lungs alone have prognosis
better than metastasis in extra-pulmonary sites.
Patient with minimal tumour or no residual tumour
after preoperative chemotherapy incline towards
better prognosis.
1063
Prasad et al.,
Evolution of chemotherapy: Adjuvant therapy:

Vincristine + Actinomycin D + Cyclophosphamide
(VAC).
Intergroup Ewings sarcoma study (IESS): VAC +
doxorubicin. IESS trial II demonstrated that
intermittent high doses of VAC + doxorubicin was
better than continuous moderate dose therapy with
this agents 20.VAC+ doxorubicin alternating with
Ifosfamide and Eloposide (IE) has better prognosis.
There is no role of dose intensification.
Current trend: Alternating cycles of VAC IE every
3 weeks21 to 48 weeks with local control at 9-12
weeks is to be administered. There is no role of dose
compression (decrease in duration of cycles). There is
some role of stem cell in preliminary stages of
management.
Local therapy: Surgical resection with or without
limb salvage followed by Radiotherapy and then
chemotherapy is given.
5.
6.
7.
8.
9.
CONCLUSION
Chemotherapy remains the backbone of the treatment
for Ewings sarcoma, local treatment with surgery
&/or radiotherapy has an important role in the
management of ES. The outcome of management is
better in localized ES as compared to the elusive
outcome in metastatic disease or local recurrence.
This case is presented in view of rarity to increase
suspicion index for the presence of Ewings sarcoma.
Early detection of Ewings sarcoma as chemotherapy
and radiotherapy can limit further damage and
progression of the disease can be done.
10.
11.
12.
ACKNOWLEDGEMENT: Nil
Conflict of Interest: None
13.
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M, Bertoni F. Prognostic factors in nonmetastatic Ewings sarcoma tumor of bone: An
analysis of 579 patients treated at a single at a
single institution with adjuvant or neo-adjuvant
chemotherapy between 1972 and 1998.Acta
oncol 2006; 45:469-75.
Burgert EO Jr, Nesbit ME , Garnsey LA , Gehan
EA, Herrmann J, Vietti TJ, et al. Multimodal
therapy for management of non-pelvic , localized
Ewings sarcoma of bone :intergroup study IESSII. J Clin Oncol 1990; 8:1514-24.
Granowetter L, Womer R, Devidas M, Karlio M,
Wang C, Bernstein M, et al. Dose intensified
compared with standard chemotherapy for nonmetastatic Ewings sarcoma family of tumors: a
childrens oncology group study. J clin Oncol
2009; 27:2536-41.
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DOI: 10.5958/2319-5886.2014.00056.3

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ISSN: 2319-5886
th
Case Report
IS SUSTAINED NATURAL APOPHYSEAL GLIDES COMBINED WITH CONVENTIONAL

PHYSIOTHERAPY EFFECTIVE FOR PATIENTS WITH FACET JOINT SYNDROME? A CASE
SERIES
Deepak B. Anap1, Subhash Khatri2, Zambare BR.3
1
Associate Professor & Ph.D Scholar, PDVVPFs, College of Physiotherapy, Vilad, Ahmednagar, Maharashtra
Professor & Principal, Pravara Institute of Medical Sciences, College of Physiotherapy, Loni, Ahmednagar
3
Professor & HOD, Dept. of Anatomy, PDVVPFs, Medical College, Vilad, Ahmednagar, Maharashtra
2
ABSTRACT
Background: Chronic back pain has been the nemesis of the human race since the time they evolved and began
walking on their two legs; leaving aside the 4 limb locomotion of their predecessors. Varied are the causes of low
back ache and facet joint syndrome is one amongst them. Hence this study was undertaken to find out the
effectiveness of SNAGS and conventional physiotherapy in patients with lumbar facet joint syndrome. Purpose:
To describe the management and outcomes of 4 patients with lumbar facet joint syndrome treated with Sustained
Natural apophyseal glides (SNAGs), Therapeutic Ultrasound and lumbar stabilization exercises. Study Design :
A case series of consecutive patients with Lumbar facet syndrome Case Description: Four consecutive patients
(mean age 52 years) who presented with lumbar facet syndrome were treated with two weeks protocol which
included Sustained Natural apophyseal glides, Therapeutic Ultrasound (Cont. 1-MHz , 2.0-W/cm2, 10min) and
lumbar stabilization exercises. Follow up was taken 1 week after the end of active intervention. All patients
completed Visual analogue Scale (VAS), Modified Oswestery Disability Questionnaire (MODQ), Sorensen Test
hold Timing and spinal Range of motion on initial assessment, immediately at the end of active intervention (2
weeks) and at the end of follow up. Outcome: All four patients showed the mean percentage change in score of
VAS 49.87 %, MODQ 61.14 %, Sorensen test scores 19.63 %, Flexion range 9.21 % and extend range 17.07 % at
the end of follow up. Conclusion: All four patients with Lumbar facet joint syndrome treated with sustained
natural apophyseal glides (SNAGS), Therapeutic Ultrasound and lumbar stabilisation exercises exhibited reduced
pain, reduced disability, improved endurance of back muscles and range of motion at the time follow-up.
Key words: Facet syndrome, Sustained Natural Apophyseal Glides
INTRODUCTION
The lumbosacral Facet joint is reported to be the
source of pain in 15-40% of patients with chronic
Low Back Pain (LBP). The first discussion of the
facet joint as a source of LBP was by Goldwaith in
1911.1 In 1927, Putti illustrated osteoarthritic changes
of Facet joints in 75 cadavers of persons older than 40
years.2 In 1933, Ghormley coined the term facet
syndrome suggesting that hypertrophic changes
secondary to osteoarthritis of the zygapophyseal

processes led to lumbar nerve root entrapment, which
caused LBP.3
In addition to causing localized spinal pain, facet
joints may refer pain to adjacent structures. Pain
referral patterns of facet joints have been well
described4-7. Cervical facet joint pain may radiate to
the neck, head and shoulders and lumbar facet joint
1066
Deepak et al.,
pain may refer to the back, buttocks and proximal

lower extremities.
Physiotherapy treatments including land-based lower
back mobility exercise and soft tissue massage may
be of benefit during this time to improve the longer
term outcomes of patients with chronic low back pain
and facet joint pain.8
Mulligan's mobilization-with movement (MWM)
treatment techniques are gaining increasing
popularity for use in musculoskeletal conditions,
such as low back pain (LBP) and other disorders9.
One of the most important MWM techniques is
described as the SNAG, pioneered by Brian
Mulligan10. SNAG is an acronym for "sustained
natural apophyseal glide" with the technique
described as involving the application of an accessory
passive glide to the lumbar vertebrae while the patient
simultaneously performs an active movement11.
The direction of the glide is argued to be along the
plane of the facet joints and the technique is
performed in a weight-bearing position (i.e.sitting,
standing). Among the SNAG's basic principles of
clinical management is an immediate reduction or
cessation of pain and an increase in range of motion
(ROM).10-11
A number of investigators have cited evidence that
supports the use of stabilization exercises for
enhancing spinal stability.12 The local muscles are
said to be crucial in this mechanism. This may be
because of their contribution to maintaining the
position of the spine and their ability to improve
trunk endurance. Core stability training is frequently
used to improve spinal stability. It has been used for
many years in physical therapy and has become
popular in fitness settings13.It has been speculated that
this method of training improves spinal stability and
may assist in decreasing the risk of back pain.
Till date, no studies in physiotherapy have assessed
efficacy of Sustained natural apophyseal glides
treatment of lumbar facet joint syndrome. The aim of
the case series, therefore, to describe the management
and outcomes of 4 patients with lumbar facet joint
syndrome treated with Sustained Natural apophyseal
glides (SNAGs), Ultrasound and lumbar stabilization
exercises.
CASE SERIES
Four consecutive patients, referred to physiotherapy
outpatient department of with a diagnosis of lumbar
facet joint syndrome were screened for the eligibility
criteria in this case series. All participants satisfied
the inclusion criteria i.e Participants diagnosed with
facetal arthropathy on MRI, localised unilateral
lumbar pain, replication or aggravation of pain by
unilateral pressure over the facet joint, Pain eased in
flexion, Pain in extension, lateral flexion or rotation
to the ipsilateral side. Exclusion criteria for the study
was history of Spinal Surgery, trauma to the spine,
and manipulation under anaesthesia, Metabolic
Disorders Osteoporosis and Spinal Tumours. This
study was approved by the Institutional Ethical
Committee of PIMS, Loni. Each subject signed
written informed consent before intervention.
Outcome Measures:
Modified Oswestry Low Back Disability
Questionnaire: The questionnaire consists of 10
items addressing different aspects of function. Each
item is scored from 0 to 5. Total Score was converted
in percentage, scores range from 0-100% with lower
scores meaning less disability.14
Pain :The pain VAS consisted of a 10 cm horizontal
line anchored at one end by the words no pain' and at
the other end by the words 'worst pain'. 15
Back Endurance Testing: Sorensen Test: BieringSorensen described this method of testing isometric
back endurance; it measures how long (to a maximum
of 240 seconds) the subject can keep the unsupported
trunk (from the upper border of the iliac crest)
horizontal while prone on an examination table.
Published studies demonstrate that the test assesses
the endurance of all the Muscles involved in
extension of the trunk, which include not only the
paraspinal muscles, but notably the multidus
muscle. 16
Spinal Range of Motion: Modified Schobers Test :
Macrae and Wright17 modified the original Schober
method by marking a point 5 cm below and 10 cm
superior to the lumbosacral junction. When the
patient moves into full lumbar flexion, the increase in
distance between the marks gives an estimate of
spinal flexion ROM.
Intervention: All patients in this case series attended
physiotherapy 5 times weekly for a period of 2
weeks. Each treatment session lasted for a total of 30
1067
Deepak et al.,
minutes. During the sessions, patients received

Extension range of motion at 3rd weeks (Follow up
Therapeutic ultrasound around affected area,
visit) after the initial examination.
Mulligans Sustained Natural Apophyseal glides and
spinal stabilization exercises. After 2 weeks of active
intervention subjects were allowed to continue
stabilization exercises at home for 1 week until the
follow up visit.
SNAGs Technique: The Mulligans SNAG was
applied on affected lumbar motion segment by
therapist. SNAGs were performed from a comfortable
sitting position in a plinth, while participants
performed an active flexion 6 times. A belt was used,
as advised by Mulligan (1999). Following palpation
of the spinous process (to be mobilised), the force
was applied in a parallel direction to the lumbar facet
Fig 1: Patient Receiving SNAGs Technique
joints, via the ulnar styloid process of the therapist to
Analysis:
Pre-and post treatment scores were
the skin over the relevant spinal level. A total of 3
converted to a change score by formula: Change
sets of mobilisation, in accordance with Mulligans
score= Pretreatment score-Post treatment score 100
rule of three were administered with a one min break
/ Pre treatment score
between sets. (Fig 1)
Follow-up Measurements: All patients completed
the MODQ, VAS, Sorens test Score and Flexion
Table 1: Pre & Post comparsion of VAS, MODQ, Soresens Test score
Case VAS
%
MODQ
%
Sorensens Test Score
% change
change
change
Pre
Post
Pre
Post
Pre
Post
1
8
3.4
57.5
36
14
61.11
75
90
20
2
7
4.5
35.71
34
12
64.70
77
89
15.58
3
8
4
50
32
12
62.5
75
91
21.33
4
8
3.5
56.25
32
14
56.25
74
90
21.62
Outcome:VISUAL
All four
patients
showed
the
mean
percentage
change
in
score
of
VAS
49.87%,
MODQ 61.14%,
ANALOGUE SCALE
Sorensen test score 19.63% , Flexion range 9.21 % and extension range 17.07 % at the end of follow up. (Table 1)
VAS
8
7
6
5
4
3
2
1
0
VAS PRE
VAS POST
1
PATIENT
Fig 2: Visual analogue scale
Fig 3: Spinal range of motion
1068
Deepak et al.,
SORENSEN'S TEST HOLD TIME
100
80
HOLD TIME PRE
60
HOLD TIME(SEC)
40
20
HOLD TIME
POST
PATIENT
MODQ
SCORE
Fig 4: Sorensens test holds time
40
30
MODQ SCORE
20
MODQ PRE
10
0
MODQ POST
1
PATIENT
Fig 5: MODQ Score

DISCUSSION
The purpose of this case series was to describe the

outcomes in four patients with Lumbar facet joint
syndrome using SNAGs, Therapeutic Ultrasound and
spinal Stabilisation exercises. Although a cause-andeffect relationship cannot be inferred from a case
series, our results suggest that this particular
treatment approach may be beneficial in improving
the outcomes in patients with lumbar facet syndrome.
All four patients showed improvement in pain
(49.87%) at the end of follow-up (Fig 2). The
mechanism by which this MWM exerts its
ameliorative effects in clinical practice remains
somewhat of an enigma; however biomechanical and
neurophysiological mechanisms may be involved18-19.
Biomechanically it was proposed that MWM may
address joint partner bone alignment18 and positional
faults25.Potential neurophysiological mechanisms
include changes in descending pain inhibitory
systems and, and changes in central pain-processing
mechanisms20.
Our case series results showed improvement in
flexion and extension range of motion (Fig 3) which
in accordance with study by Kostantinou et al27
investigated the immediate effects of MWM's in

ROM and pain levels in 26 LBP patients with pain
and flexion ROM limitations. Results of their study
indicated that 73% of the intervention condition and
35% of the placebo condition had improvements in
flexion-extension ROM (as measured with an
inclinometer) and/or pain scores. According to
Mulligan (1999) applying a SNAG may reposition
the superior vertebra. Mulligans original theory for
the effectiveness of a technique is based on concepts
related to Positional Faults that occur secondary to
injury and lead to malt racking of the joint resulting
in symptoms such as pain, stiffness and weakness.
The cause of positional faults has been suggested to
be due to changes in shape of articular surfaces,
thickness of cartilage, orientation of fibers of
ligaments and capsule, or the direction and pull of
muscles and tendons. Mulligans technique correct
this by repositioning the joint causing it to track
normally.21-22
The MWM was largely conducted in a weightbearing position and patients received simultaneous
feedback of painless joint movements. This feedback
might modulate psychological features such as fear of
movements, resulting in an increased activity level. 23
In present case series improvement (Mean 19.63%)
was seen at hold time in Sorensens test (fig 4) at the
end of follow up. Decreased trunk strength and
endurance associated with a cyclical pattern of
deconditioning through pain, avoidance and inactivity
have been noted as defining characteristics in LBP
(Biering-Srensen, 1984; Mayer and Gatchel, 1988).
In addition to improvement in Range of motion and
reduction in pain, MWM in a weight-bearing position
requires muscle activity, which might have resulted in
improved motor performance and increase in strength
of core muscles when applied along with core
stabilisation exercises. Lumbopelvic stabilization
approach seems to be useful for the management of
low back pain. Based on a solid biomechanical model
(Panjabis hypotheses), it has demonstrated positive
effects over pain and return to activity, but it is not
clear the optimal type of exercise, duration or number
of repetitions, among other variables. Exercises
designed to improve spinal stabilization have gained
popularity in the conservative treatment of patients
with LBP; however, the evidence for the
effectiveness of this approach is sparse and
equivocal.24 Improvements in pain intensity and
1069
Deepak et al.,
functional disability were also demonstrated in from

results of our study ( Fig 5) which are in according to
previous studies including groups of patients with
low back pain suffering from a spondylolisis or a
spondylolisthesis25and a significant decrease of
symptoms in people with hypermobility.26
CONCLUSION
In this case series, all four patients with Lumbar facet
joint syndrome treated with sustained natural
apophyseal glides (SNAGS), Therapeutic Ultrasound
and lumbar stabilisation exercises exhibited reduced
pain, reduced disability, improved endurance of back
muscles and range of motion at the time follow-up.
This report allows for initial hypothesis development
that this approach may have clinical merit.
Limitations of the study: Limitations of this report
are inherent to its case series design. Without a
comparison group, we cannot determine if similar
improvements would have occurred had these
patients received a different treatment approach or no
treatment at all. Future research in the form of
randomized clinical trials should be conducted to
investigate the effectiveness of this treatment
approach in lumbar facet syndrome patients.
6.
7.
8.
9.
10.
11.
ACKNOWLEDGEMENT
Authors are thankful to Department of Orthopaedics
and Department of Radiodiagnosis
Conflict of Interest: The authors report no conflict
of interest
12.
13.
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Ghormley RK. Low back pain with special
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McRae DL. Asymptomatic intervertebral disc
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Chambers H. Physiotherapy and lumbar facet
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O'Brien T, Vicenzino B: A study of the effects of
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Radebold A, Cholwicki J, Pasnjabi MM. Muscle
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Osullivan PB, GDM. Phyty, Twomey LT,
Allison GT. Evaluation of specific stabilizing
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with radiologic diagnosis of spondylolysis or
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Stratford P, Levy D, Gowland C, Evaluative
properties of measures used to assess patients
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Physiotherapy Canada 1993;45:160-64
Demoulin C, Vanderthommen M, Duysens C,
Crielaard JM., Spinal muscle evaluation using the
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Joint Bone Spine. 2006;73(1):43-50.
Macrae IF, Wright V. Measurement of
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18. Mulligan BR: Manual Therapy: "Nags", "Snags"

"Mwms". 4th edition. New Zealand: Wellington;
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19. Wilson E: The Mulligan concept: NAGS,
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Naloxone fails to antagonize initial hypoalgesic
effect of a manual therapy treatment for lateral
epicondylalgia. Journal of Manipulative and
Physiological Therapeutics 2004;27: 180185
21. Wilson . The Mulligan concept: NAGS, SNAGS
and mobilizations with movement. Journal of
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81-89
22. Mulligan BR. Manual Therapy NAGS SNAGS
MWMS etc.. Plane View services Ltd. New
Zealand. 2006, 5th Revised Edition
23. Vicenzino B, Hall T, Hing W, Rivett D. A new
proposed model of the mechanisms of action of
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Hall T, Hing W, and Rivett D (eds) Mobilisation
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24. Bendebba M, Torgerson WS, Long DM. Avali
dated, practical classication procedure for many
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25. O'Sullivan PB. Lumbar segmental instability:
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26. Fritz JM, Whitman JM, Childs JD. Lumbar spine
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27. Konstantinou K, Foster N, Rushton A, Baxter D,
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DOI: 10.5958/2319-5886.2014.00057.5

&
Health Sciences
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Volume 3 Issue 4
th
Coden: IJMRHS
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ISSN: 2319-5886
th
Case Report
A CASE REPORT OF CARDIOTOXICITY DUE TO HOMEOPATHIC DRUG OVERDOSE

MilindChandurkar1,Girish Patrike2, NitinChauhan2, SanketMulay2, Manoj Vethekar2, JaweedAkhtar2, Mallikarjun
Reddy2
1
Professor and Head, 2PG Resident, Department of Medicine, Rural Medical College of PIMS (DU), Loni,
Ahmednagar, Maharashtra
*Corresponding author email: drmilindch@gmail.com
ABSTRACT
Aconite is one of the most toxic plants. Aconitine and related alkaloids found in the Aconitum species are highly
toxic cardiotoxins and neurotoxins. Severe aconite poisoning can occur after accidental ingestion of the wild plant
or consumption of an herbal decoction made from aconite roots. The toxic components of Aconitum as aconitine
and related alkaloids cause cardiotoxicity, neurotoxicity and gastrointestinal toxicity through their actions on
sodium channels. Cardiac manifestations include hypotension and ventricular tachyarrhythmias. Ventricular
tachyarrhythmias and refractory cardiovascular collapse, such as in the case of this patient account for lifethreatening toxicities in severe aconite poisoning. In general, vagal slowing is seen in 10 to 20% of fatal
intoxications. If higher concentrations are present, supraventricular tachycardia, ventricular tachycardia, torsades
de pointes, and other conduction disturbances may be seen. Ventricular fibrillation may be seen, and is often the
cause of death. Available clinical evidence suggests that drugs like amiodarone and flecainide are reasonable firstline treatment.
Keywords: Aconite, cardiotoxicity, Neurotoxicity, Ventricular tachyarrythmias.
INTRODUCTION
Aconite has long been used in the traditional
medicine of Asia (India, China) Aconitum ferox
(Vatsanabha) is one of the deadliest poisons in
Ayurveda. It is categorized in Mahavishavarg in all
Ayurvedic texts1.In Asia most aconite poisoning
cases are related to the use of Aconitum rootstocks in
traditional medicine2. Extracts of the plant are also
used in homeopathy to decrease fever, as cardiac
depressant, and to treat neuralgia3. There were over
600 reported cases of poisoning in China alone up to
2006, and in Hong Kong It was estimated that 75% of
Chinese herbal medicine related hospital admissions
were related to aconite toxicity4. In this article we
report a case of aconite induced cardiotoxicity that

was managed in our hospital.
CASE REPORT
A 35 yrs old female brought by relatives with
presenting complaints of nausea, epigastric pain and
severe vomiting since morning on the day of
admission.. She was referred from surgery OPD as
her pulse was rapid and irregularly irregular. Patient
advised medicine reference for tachycardia and
irregular pulse. On examination, Pulse was 150/min,
low volume, irregularly irregular. Blood pressure was
80 systolic mm of Hg. On auscultation S1, S2 heard.
No cardiac murmur. ECG suggestive of Bidirectional
1072
Chandurkar et al.,
ventricular tachycardia(Fig 2). 2DECHO screening

done in OPD there was normal. Patient admitted in
Intensive care unit. Emergency cardioversion was
done with 360 J for ventricular tachycardia but it
didnt revert. Inj. Amidarone 300 mg. iv. bolus was
given and sinus rhythm was achieved(Fig 3). patient
was then put oni.v.Amidarone1gm infusion for 24
hrs. Hypotension responded to fluid therapy and
supportive care. However, patient had intractable
vomiting for 3 days, which was treated with inj
Ondansetron 4 mg and i.v. fluids for dehydration.
Detailed history given by patient suggestive of
consumption of Mother Tincture (Aconite Radice
Preparation) about two teaspoonful for pain abdomen
and gall stones, and followed by above symptoms
after 1-2 hour of consumption. (Bottle presented by
the patient)(Fig 1b) prescribed by homeopathic
doctor. The patient was not advised regarding
frequency, quantity and dilution of the drug.
Patient responded to intravenous antiarrhythmic drug
(Inj. Amidarone). But intermittent multiple
ventricular ectopics were observed till next day. Fluid
resuscitation was done and hemodynamic stability
maintained with supportive care.
Fig 1: a) Aconitum Plant b) Mother Tincture

presented by Patient
Fig 2: ECG on admission suggestive of Bidirectional ventricular tachycardia
Fig 3: ECG on discharge Normal Sinus Rhythm

Other routine laboratory investigations (LFT, RFT,
and Chest X-Ray) are within normal limit. Patient
treated successfully and discharged on 5th day.
DISCUSSION
Homeopathy has a holistic approach to healing, with
as its central tenet that like cures like. Established
in 1796 by the German physician Samuel Christian
Hahnemann, it treats patients with heavily diluted
preparations of substances which in their undiluted
form are thought to cause effects similar to the
symptoms presented. Homeopathic medicines are in
general considered to be safe when administered
appropriately, toxicological aspects should not be
neglected, especially when using lower dilutions of
unsafe starting material5.
Aconite is a well known toxic plant of the genus
Aconitum in the Ranunculaceae family. Aconite
related alkaloids such as aconitines, benzoylaconines
and aconines, and the aconitines (aconitine,
hypaconitine, jesaconitine and mesaconitine) are the
causative agents of Aconite poisoning6. Aconitum
alkaloids are the active ingredients and the source of
toxicity. The amount and type of aconitum alkaloids
are the main factors determining the severity of
intoxication. For the same plant, the level of active
ingredient is affected by the time of harvest and
method of processing. The tuberous roots of genus
Aconitum are commonly applied for various diseases.
These tubers of Aconitum are used in the herbal
medicines only after processing7. Soaking and boiling
during processing or decoction preparation will
hydrolyze aconite alkaloids into less toxic and nontoxic derivatives8,9. The detoxification induced a
change in the structure of aconitine making it less
cardio-toxic10. However, the use of a larger than
recommended dose and inadequate processing
increases the risk of poisoning.
1073
Chandurkar et al.,
Typical
manifestations
of
poisoning
are
gastrointestinal, neurological, and cardiovascular,
with malignant ventriculararrhythmias11. The
neurological features could be sensory symptoms like
tingling or numbness or motor like weakness in one
or all limbs. The cardiovascular manifestations are
chest pain, shock and palpitations due to various
ventricular and supraventricular tachycardias. The
gastrointestinal features are similar to any other toxin
like nausea, vomiting, pain in abdomen and
diarrhoea. Death occurs usually due to refractory
ventricular tachycardia or ventricular asystole. The
reported overall in-hospital mortality is 5.5%.
Aconitine
can
also
cause
BiVentricular
12
Tachycardia .
The toxic effects on heart and nervous system of
aconitine and similar alkaloids are due to action on
voltage sensitive sodium channels of above tissues.
Aconitine binds to the open state of the voltagesensitive sodium channel and inhibits its inactivation.
Aconitine will induce arrhythmias after the fiber has
been completely repolarised. This arrhythmia is
generally facilitated in the presence of high Cat +
solution, yet the aconitine-induced arrhythmia occurs
even in the presence of low Ca++ solutions. Thus
intracellular Na+ loading plays an important role in
the aconitine-induced delayed afterdepolarization and
transient inward currents in low Ca++ solution. The
consequent prolonged inward current of the sodium
channel leads to intracellular accumulation of Na+
and activates the NaCa exchanger, causing Ca2+
overload and delayed afterdepolarization. Several
reports suggest that delayed after depolarization has
an
important
role
in
triggering
and
maintainingBiVentricular Tachycardia12.
Management of aconite poisoning is supportive,
including immediate attention to the vital functions
and close monitoring of blood pressure and cardiac
rhythm. Extensive vomiting and diarrhoeamayrequire
that fluid and electrolytes be monitored and replaced
as necessary. Inotropic therapy is required if
hypotension persists. Ventricular arrythmias caused
by aconite toxicity are refractory to both electrical
and chemical cardioversion. In such cases it is
important to maintain basic life support and early use
of cardiopulmonary bypass. Antiarrythmics like
Amiodarone and Flecainide are reasonable first-line
drugs as per presently available evidence.13
CONCLUSION
This case report emphasises the importance that there
may be many more cases of acute aconite toxicity
which must be going unnoticed due to consumption
of toxin in inappropriate dilution, form or as herbal
drug. Homoeopathy is the method of treating an
ailment caused by injurious toxic substances with the
same or similar substances given in an extremely
diluted form. It is absolutely essential that the poison
of the like thereof be diluted to the extent that it
causes no harm to the body. One should advise
patients regarding quantity and dilution of the drug
while prescribing homeopathic medication.
Detailed history, clinical examination, early
management of ventricular tachycardia and
supportive intensive care management in case of
aconite induced cardiotoxicity help to treat patients
successfully.
Acknowledgement: The Authors do not report any
conflict of interest regarding this work.
REFERENCES
1. Anjali
Sheokand,
AnitaSharma
UK.
GothechaVatsanabha (AconitumFerox): From
VishaTo
Amrita.
International
Journal
OfAyurvedic
And
Herbal
Medicine.
2012;2(3):423-26
2. Poon WT, Lai CK, Chingetal CK. Aconite
poisoning in camouflage. Hong Kong Med. J.
2006;12(6):45659
3. Chan, CPand Au, CKH. Three Cases of Aconite
Root Poisoning Due to Bikhamaina Hong Kong
Nepalese Family; Hong Kong Journal of
Emerg.Med.2010;17(2):158-62.
4. Imazio M, Belli R, Pomari F, Cecchi E, Chinaglia
A, Gaschino G, etal., Malignant Ventricular
Arrhythmias
due
to
AconitumnapellusSeeds.Circulation.2000;102:29
07-08
5. Paudel R, Palaian S, Ravi Shankar P, Paudel B,
Bhattarai S. Aconite Poisoning: A Clinical
Review Of The First Four Cases From Nepal.
Journal of Clinical and Diagnostic Research.
2008; 2:651-55.
6. Fujita Y, Terui K, Fujita M. Five cases of aconite
poisoning: toxic kinetics of aconitines. J Anal
Toxicol. 2007;31:13237
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Chandurkar et al.,
7. SajanlShyaula. Phytochemicals, Traditional Uses

and Processing of Aconitum Species in Nepal.
Nepal Journal of Science and Technology.
2011;12:171-78
8. Namyata
Y
Pathak,
AshwinikumarRaut,
AshokBVaidya.
Comprehensive
Ayurvedic
Therapeutics: Current relevance of multi-modal
interventions. Ayurveda Foundation, Kasturba
Health Society. 2009
9. Chan TY. Aconite poisoning. ClinToxicol
(Phila).2009;47(4):279-85
10. Takeshi Kitamura, Seiji Fukamizu, RintaroHojo,
Takekuni Hayashi, Kota Komiyama, Yasuhiro
Tanabe, Tamotsu Tejima, et al., Various
morphologies of bidirectional ventricular
tachycardia caused by aconite Torikabuto
poisoning. Journal of Cardiology Cases.
2013;7(2):42-44
11. Sawanobori T, Hirano Y, Hiraoka M. Aconitineinduced delayed after depolarization in frog
atrium and guinea pig papillary muscles in the
presence of low concentrations of Ca2+. Jpn J
Physiol. 1987;37:5979
12. World Health Organization.Safety issues in the
preparation of homeopathic medicines; 2009: 1-5
13. Imtiaz Ahmad Chaudhary. Homoeopathy (Like
cures like) English Translation from Urdu, Islam
International Publications Ltd.2005;3
1075
Chandurkar et al.,
DOI: 10.5958/2319-5886.2014.00058.7

&
Health Sciences
www.ijmrhs.com
Volume 3 Issue 4
th
Coden: IJMRHS
Copyright @2014
ISSN: 2319-5886
th
Revised: 8 Sep 2014
Case report
RARE PRESENTATION OF PITUITARY ADENOMA WITH OPHTHALMOPLEGIA
Neeta Misra1, *Mohammad Farooqui2, Somen Misra3
1
Professor 2Post-graduate Student, 3Professor Department of Ophthalmology, Pravara Institute of Medical

Sciences, Loni, Ahmednagar, Maharashtra
*Corresponding author email: drmsfarooqui@yahoo.com
ABSTRACT
Pituitary Adenomas are benign intracellular tumours accounting for 10% to 15% of all intracranial neoplasms.
They usually affect the adult population between the fourth and sixth decades of life. The prevalence of Pituitary
Macro adenomas, with a diameter of more than 1cm, is estimated to be only about 0.2%. Pituitary
macroadenomas can be either functioning or non-functioning depending upon the endocrinological status of the
patient. Non functioning Pituitary macroadenoma extending laterally into the cavernous sinus resulting in ocular
motor palsies is uncommon. Rarely is it the presenting sign. We report a case of Pituitary Macroadenoma
presenting with left sided Ptosis and complete Ophthalmoplegia due to extension into the ipsilateral cavernous
sinus.
Keywords: Pituitary Adenoma, Ophthalmoplegia, Pituitary gland, Cavernous Sinus
INTRODUCTION
Pituitary adenomas are benign tumours which arise
within the anterior lobe of the pituitary gland in the
sellaturcica. Pituitary adenomas can be classified by
different methods, including size, hormonal activity,
and histologic staining pattern. Tumours more than 1
cm are called macroadenomas and less than 1cm are
called microadenomas1, 2.
Macroadenomas are
relatively rare with a prevalence reported to be0. 2%.
3
Clinical symptoms depend on whether the tumour is
secreting or non-secreting. Non secreting (non
functioning) adenomas accounting for 25% to 35% of
pituitary adenomas, are hormonally inactive, and are
the most common form of macroadenomas4. Pituitary
macroadenomas can present with mass effect, causing
pressure
on
the
adjoining
structures
or
endocrinological disturbances. Mass effect causes
headache, decrease in visual acuity, hypopituitarism
and visual field defects associated with compression
of the optic chiasma5,6. In fact, pituitary adenomas are
the most common cause of Optic chiasmal
Neeta et al.,
compression7,8. Rarely 6-10% of macroadenomas

extend laterally into the cavernous sinus and result in
3rd, 4th and 6th cranial nerve palsies. We report a case
of Pituitary Adenoma presenting with left sided
Ptosis and complete Ophthalmoplegia due to
extension into the ipsilateral cavernous sinus.
CASE REPORT
A 70 year old male presented to the ophthalmology
department with complaints of acute onset drooping
of left eyelid, severe throbbing retro orbital pain and
3 episodes of vomiting which was non projectile
since 2 days. Patient had unilateral, left sided, dull
headache since the last 1 month. There was no history
of fever, giddiness, convulsions, weakness in any
limb, blurring of vision or ataxia. Patient was not a
known case of hypertension or diabetes. On
examination, he was conscious, oriented, with blood
pressure of 142/70 mm of Hg and pulse of 72/min.
1076
Physical examination revealed a thin built, adequately

nourished male. Ophthalmological examination
showed BCVA of 6/12 and 6/18 in the right and
left eye respectively. There was a complete aptosis
on the left side. Retraction of left upper lid revealed
mild proptosis and total ophthalmoplegia with
marked restriction of ocular movements in all
directions of gaze. (Fig 1) The left pupil was semi
dilated with absent direct and consensual light reflex.
Slit lamp examination of both eyes showed early
nuclear cataractous changes in both eyes but was
otherwise normal. Fundus examination of both eyes
was within normal limits. The rest of the neurological
examination, including other cranial nerves was
essentially normal.
Fig 3: Plain X-ray skull (lateral view) revealed widened

sella with thinning and erosion of floor of sella
Fig 1: Ocular movements in all directions
Fig 4: MRI Brain and Orbit
Fig 2: Directions of gaze

Perimetry revealed classical Bitemporal hemianopia
(Fig 2). Plain X-ray skull (lateral view) revealed
widened sella with thinning and erosion of floor of
sella (Fig 3).
Neeta et al.,
MRI Brain and Orbit (plain and contrast) revealed

2.102.051.73 cm sized, mildly enhancing, round to
oval, well defined mass in sellar and suprasellar
region which also showed extension into the left
cavernous sinus (Fig 4). The supra-sellar cistern was
obliterated & optic chiasma pushed upward.
Diagnosis of Pituitary Macroadenoma, extending into
the left cavernous sinus was made.
In view of this finding of cavernous sinus extension,
patient was referred to a neurosurgeon for
management.
1077
DISCUSSION
Pituitary adenomas are benign tumours which arise
within the anterior lobe (adenohypophysis) of the
gland in the sellaturcica. They account for 10-15% of
all intracranial neoplasmsm1. With regard to size,
pituitary adenomas have been classified as
Macroadenomas (10mm) and Microadenomas (<10
mm). Macro adenomas are rare and constitute only
0.2% of all pituitary adenomas. Adenomas can also
be differentiated as Functional or Non functional
tumours based on their hormonal activity in vivo as
determined by immunohistochemistry and electron
microscopy. Pituitary adenomas can further be
divided by their staining pattern on histology as
eosinophilic, basophilic and chromophobes (which
are very often nonfunctioning adenomas).
Most pituitary adenomas are soft, well-circumscribed
lesions that are confined to the sellaturcica.
Expansion may lead to bony erosion of the anterior
clinoid processes and sellaturcica9. Macroadenomas
may be secreting or non secreting adenomas.
Functioning
adenomas secrete hormones and
manifest with many endocrine syndromes hence these
tumours present earlier and are of smaller size and
confined to the gland. Non secreting adenomas
present very late and symptoms appear due to mass
effect i.e they grow large in size and compress the
adjacent structures by suprasellar extension and optic
chiasma involvement leading to visual disturbances.
Very rarely non secreting adenomas extend laterally
into the cavernous sinuses, resulting in 3rd, 4th and 6th
cranial
nerve
palsies
leading
to
total
Ophthalmoplegia. It has been observed in a large
series by Kim SH, et al (2007) that out of 1000
patients of pituitary adenomas only 59 patients had a
lateral extension into the cavernous sinus10, making it
a very rare complication of pituitary adenomas.
Indications for surgery are severe neuro-ophthalmic
signs such as severely reduced visual acuity, severe
and persistent or deteriorating visual field defects, or
deteriorating level of consciousness.
hemodynamically unstable patients. Surgical

intervention is offered to patients with severe neuroophthalmic signs.
Conflict of interest & financial support: Nil
REFERENCES
1. Kumar V, Abbas AK, Fausto N. Robbins and
Cotran Pathologic Basis of Disease, 7th
Ed. Elsevier; 2005:1156-64
2. Ezzat S, Asa SL, Couldwell WT, Barr CE, Dodge
WE, Vance ML, McCutcheon IE. The Prevalence
of Pituitary Adenomas: A Systematic
Review. Cancer. 2004;101(3):613-9.
3. Dekkers OM, Pereira AM, Romijn JA. Treatment
and follow pof clinically nonfunctioning pituitary
macroadenomas. J Clin Endocrinol Metab 2008;
93(10):3717-26.
4. Colao A, Di Somma C, Pivonello R, Faggiano A,
Lombardi G, Savastano S. Medical therapy for
clinically non-functioning pituitary adenomas.
EndocrRelat Cancer 2008 Dec;15(4):905-15.
5. Platta CS, Mackay C, Welsh JS. Pituitary
adenoma: a radiotherapeutic perspective. Am J
Clin Oncol. 2010;33(4):408-19.
6. Dekkers OM, Pereira AM, Romijn JA. Treatment
and follow-up of clinically nonfunctioning
pituitary macroadenomas. J Clin Endocrinol
Metab 2008;93(10):3717-26.
7. Neuro-Ophthalmology. Basic and Clinical
Science Course, Section 5. American Academy
of Ophthalmology; 2010:159-65.
8. Yanoff M, Duker JS. Optic chiasm, Parasellar
region, and Pituitary fossa.Ophthalmology, 3rd
Ed. Elsevier; 2009:986-94.
9. Kumar V, Abbas AK,Fausto N. Robbins and
Cotran Pathologic Basis of Disease, 7th Ed.
Elsevier; 2005:1156-64
10. Kim SH, Lee KC, Kim SH. Cranial nerve palsies
accompanying pituitary tumour. J Clin
Neuroscience. 2007;14(12): 1158-62
CONCLUSION
Total Ophthalmoplegia due to lateral extension into
the cavernous sinus is an extremely rare complication
of pituitary adenomas. Timely diagnosis by imaging
studies can help decrease the morbidity and mortality.
Conservative management with steroids is given to
Neeta et al.,
1078

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DOI: 10.5958/2319-5886.2014.00001.

International Journal of Medical Research

EFFECTIVENESS OF RESISTED ABDOMINAL EXERCISE VERSUS RESISTED DIAPHRAGMATIC

*Sathish Gopaladhas1, Anilkumar Panigrahy2, Elanchezhian Chinnavan3, Rishikesavan Ragupathy4

Professor, White Memorial College of Physiotherapy, Tamil Nadu, India

*Corresponding author email: gdssathish@gmail.com

lactic acid, but is transported to the mitochondria,

Int J Med Res Health Sci. 2014;3(4):785-789

exercise module, training state and muscle power2.

On the contrary the abdominal muscles are probably

Int J Med Res Health Sci. 2014;3(4):785-789

exercise. Pre test values of step test, endurance levels

Each session lasted for 30 minutes per day for six

test which is measured in minutes 13. Abdominal curls

Paired t-test was done to compare the pretest and

99.99%significance of the result. Subjects from the

who underwent resisted diaphragmatic exercise

Int J Med Res Health Sci. 2014;3(4):785-789

6. Hedrick, Allen MA. Training the Trunk for

Int J Med Res Health Sci. 2014;3(4):785-789

International Journal of Medical Research

EFFECT OF SLOW RHYTHMIC VOLUNTARY BREATHING PATTERN ON ISOMETRIC HANDGRIP

*Rajajeyakumar M1, Janitha A2, Madanmohan3, BalachanderJ4

*Corresponding author email:rajakumar60@gmail.com

influenced by several factors, including age; gender;

strength is an important test to evaluate physical

Int J Med Res Health Sci. 2014;3(4):790-796

seconds. ECG was examined for artifacts and

Int J Med Res Health Sci. 2014;3(4):790-796

In contrast, BMI values were in the males

initial value of 119.32 2.93 to 111.75 2.95, the

Int J Med Res Health Sci. 2014;3(4):790-796

Table 4: Parameters of group II (Savitri female)

attained statistical significance at the beginning and

Int J Med Res Health Sci. 2014;3(4):790-796

pranayama increases frequency and duration of

grip strength is associated with bone mineral density,

Int J Med Res Health Sci. 2014;3(4):790-796

consumption during exercise in patients with

adults.Int. Res J Pharm. App Sci., 2013; 3(5):

Int J Med Res Health Sci. 2014;3(4):790-796

International Journal of Medical Research

PREVALENCE, CHARACTERIZATION AND CLINICAL SIGNIFICANCE OF KLEBSIELLA

Sarita Nayak1, Suman Singh2, Soeb Jankhwala3, Riddhi Pradhan4

associated with human infections.1,2 Antibiotic

Int J Med Res Health Sci. 2014;3(4):797-803

can then transfer the genetic information in a

antimicrobial sensitivity was performed using

Int J Med Res Health Sci. 2014;3(4):797-803

During the study period of a year, a total of 5455

Table2: Distribution of Ertapenem

Klebsiella pneumoniae was isolated i.e. 11/102

Data like age, sex, date of admission, date of culture

The prevalence of ertapenem resistance is 30.4%.

were ertapenem sensitive, 31% died or worsened.

samples. Out of these six were isolated from pus

Ertapenem resistance Ertapenem Sensitive

Odds ratio (C.I)

Surgery in last 30 days 9 (34.6%) 22(28.9%) 17 (65.4%)

0.58750 1.299 (0.5036-3.353)

14 (46.7%) 17 (23.6%) 16 (53.3%)

14 (43.8%) 17 (24.3%) 18 (56.3%) 53 (75.7%) 0.04735 2.425 (0.9991-5.885)

Ward stay (days)

Globally ertapenem resistance in Klebsiella