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CITATION :

A double blind, randomised placebo controlled trial of

rifampicin with omeprazole in the treatment of human
cutaneous leishmaniasis
D.K. Kochara, Govind Sainia, S.K. Kochara, P. Sirohia, R.A. Bumbb,
R.D. Mehtab, & S.K. Purohitc
aDepartment

of Medicine, bDepartment of Skin and STD, S.P. Medical College, Bikaner;

cDepartment of Preventive Medicine,
Veterinary College, Bikaner, Rajasthan, India

Are the results of this single preventive or therapeutic trial valid ?

Was the assignment of patients
to treatments randomized?
Was the randomization list
concealed?
Was follow-up of patients
sufficiently long and complete?
We all patients analyzed in the
groups to which they were
randomized?
Were patients,clinicians, and
study personnel kept blind to
treatment?
Were the groups trated equally,
apart from the experimental
treatment?
Were the groups similar at the
start of the trial apart from the
experimental therapy?

Yes, at abstract and background page 161

Yes, a double blind, randomised placebo
control study page 161
Yes, at metods and result page 161
Yes, at table 1 page 164

Yes, Double blind (researcher and patient) on

page 161
Yes, at page 162 and flow chart at page 163

No substantial difference in the baseline

characteristic data. Page 161 and 164.

Are the valid results of this randomized trial important?

What is the magnitude of the
treatment effect?

How precise is the estimate of

the treatment effect?

rifampicin and omeprazole is a highly

effective for making disappear parasite which
caused cutaneous leishmaniasis (Leishmania
tropica). Page 161, 163 and 165.
rifampicin and omeprazole is a highly
effective for the management of cutaneous
leishmaniasis, it can looking at cases which
can heal from cutaneous leishmaniasis. At
the end of the study observed that out of 23

patients receiving rifampicin, 16 (69.6%)

cases had complete healing, 3 (13.04%) had
partial healing and4 (17.4%) had no healing
whereas in the placebo group 3 (14.2%)
cases had complete healing, 4 (19.05%) had
partial healing and 14 (66.7%) had no
healing. Page 165 and 161.

Your calculations

CER

14,2%

EER

69,5%

RELATIVE
RISK
REDUCTION
(RRR)
CER-EER
CER

ABSOLUTE
RISK
REDUCTION
(ARR)
CER EER

NUMBER
NEEDED TO
TREAT (NNT)

|14,2%-69,5%|
14,2%
=3,89%

|14,2%-69,5%|

1/55,3%

=55,3%
55%-55,5%

=2
1-2

1/ARR

95%Cl

Can you apply this valid, important evidence about therapy in caring for your
patients?
Do these results apply to our
patients?
Is our patient so different from those
in the study that its results cannot
apply?
Is the treatment feasible in or
setting?
What are our patients potensial
benefits and harms from the
therapy?
Method I : f

Risk of the outcome in our patieny,

relative to patients in the trial
Expressed as a
decimal : ................................
NNT/ F : ...................../
..............= ..................

Method II : 1/(PEER X RRR)

(NNT for patients like ours)

Our patients expected event rate if they
received the control treatment (PEER)
= .....................
1/(PEER X RRR) = 1/...................
= ......................

Are our patients values and

preferences satisfied by regimen and
its consequences?
Do we and our patient have a clear
assesment of their values and
preferences?
Are they met by this regimen and its
consequences