Cocrane Ingles

Interventions for dysphagia and nutritional support in acute
and subacute stroke (Review)

Geeganage C, Beavan J, Ellender S, Bath PMW
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2012, Issue 10
http://www.thecochranelibrary.com
Interventions for dysphagia and nutritional support in acute and subacute stroke (Review)
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
T A B L E O F C O N T E N T S
1 HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
14 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15 AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
27 CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
92 DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 Swallowing therapy, Outcome 1 Case fatality at end of trial. . . . . . . . . . . 95
Analysis 1.2. Comparison 1 Swallowing therapy, Outcome 2 Death or dependency at end of trial. . . . . . . . 97
Analysis 1.3. Comparison 1 Swallowing therapy, Outcome 3 Institutionalisation. . . . . . . . . . . . . . 97
Analysis 1.4. Comparison 1 Swallowing therapy, Outcome 4 Length of stay (days). . . . . . . . . . . . . 98
Analysis 1.5. Comparison 1 Swallowing therapy, Outcome 5 Chest infection or pneumonia. . . . . . . . . . 99
Analysis 1.6. Comparison 1 Swallowing therapy, Outcome 6 Dysphagia at end of trial. . . . . . . . . . . . 100
Analysis 1.7. Comparison 1 Swallowing therapy, Outcome 7 Pharyngeal transit time (seconds). . . . . . . . . 102
Analysis 1.8. Comparison 1 Swallowing therapy, Outcome 8 Swallow score. . . . . . . . . . . . . . . 103
Analysis 1.9. Comparison 1 Swallowing therapy, Outcome 9 Nutritional (albumin). . . . . . . . . . . . . 104
Analysis 2.1. Comparison 2 Route of feeding, Outcome 1 Case fatality at end of trial. . . . . . . . . . . . 105
Analysis 2.2. Comparison 2 Route of feeding, Outcome 2 Death or dependency at end of trial. . . . . . . . . 106
Analysis 2.3. Comparison 2 Route of feeding, Outcome 3 Institutionalisation. . . . . . . . . . . . . . . 107
Analysis 2.4. Comparison 2 Route of feeding, Outcome 4 Length of stay in hospital (days). . . . . . . . . . 108
Analysis 2.5. Comparison 2 Route of feeding, Outcome 5 Pressure sores. . . . . . . . . . . . . . . . 109
Analysis 2.6. Comparison 2 Route of feeding, Outcome 6 Chest infection or pneumonia. . . . . . . . . . . 110
Analysis 2.7. Comparison 2 Route of feeding, Outcome 7 Dysphagia at end of trial. . . . . . . . . . . . . 111
Analysis 2.8. Comparison 2 Route of feeding, Outcome 8 Treatment failure. . . . . . . . . . . . . . . 112
Analysis 2.9. Comparison 2 Route of feeding, Outcome 9 Gastrointestinal bleeding. . . . . . . . . . . . 113
Analysis 2.10. Comparison 2 Route of feeding, Outcome 10 Feed delivery (%). . . . . . . . . . . . . . 114
Analysis 2.11. Comparison 2 Route of feeding, Outcome 11 Weight at end of trial (last value carried forward) (kg). . 115
Analysis 2.12. Comparison 2 Route of feeding, Outcome 12 Mid-arm circumference (last value carried forward) (cm). 116
Analysis 2.13. Comparison 2 Route of feeding, Outcome 13 Albumin (last value carried forward) (g/L). . . . . . 117
Analysis 3.1. Comparison 3 Timing of feeding, Outcome 1 Case fatality at end of trial. . . . . . . . . . . . 118
Analysis 3.2. Comparison 3 Timing of feeding, Outcome 2 Death or disabled at end of trial. . . . . . . . . . 118
Analysis 3.3. Comparison 3 Timing of feeding, Outcome 3 Institutionalisation. . . . . . . . . . . . . . 119
Analysis 4.1. Comparison 4 Fluid supplementation, Outcome 1 Time to resolution of dysphagia (days). . . . . . 120
Analysis 5.1. Comparison 5 Nutritional supplementation, Outcome 1 Case fatality at end of trial. . . . . . . . 121
Analysis 5.2. Comparison 5 Nutritional supplementation, Outcome 2 Death or dependency at end of trial. . . . . 122
Analysis 5.3. Comparison 5 Nutritional supplementation, Outcome 3 Institutionalisation. . . . . . . . . . 122
Analysis 5.4. Comparison 5 Nutritional supplementation, Outcome 4 Length of stay in hospital (days). . . . . . 123
Analysis 5.5. Comparison 5 Nutritional supplementation, Outcome 5 Pressure sores. . . . . . . . . . . . 124
Analysis 5.6. Comparison 5 Nutritional supplementation, Outcome 6 Energy intake (kcal/day). . . . . . . . 125
Analysis 5.7. Comparison 5 Nutritional supplementation, Outcome 7 Protein intake (g/day). . . . . . . . . 126
Analysis 5.8. Comparison 5 Nutritional supplementation, Outcome 8 Albumin (last value carried forward). . . . 127
127 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
128 WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
i Interventions for dysphagia and nutritional support in acute and subacute stroke (Review)
129 HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
129 CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
129 DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
129 SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
130 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
130 INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ii Interventions for dysphagia and nutritional support in acute and subacute stroke (Review)
[Intervention Review]
Interventions for dysphagia and nutritional support in acute
and subacute stroke
Chamila Geeganage
1
, Jessica Beavan
2
, Sharon Ellender
3
, Philip MW Bath
3
1
Clinical Pharmacology and Pharmacy, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
2
Department of Stroke
Medicine, Royal Derby Hospital, Derby, UK.
3
Division of Stroke Medicine, University of Nottingham, Nottingham, UK
Contact address: Philip MW Bath, Division of Stroke Medicine, University of Nottingham, Nottingham, NG5 1PB, UK.
philip.bath@nottingham.ac.uk.
Editorial group: Cochrane Stroke Group.
Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 10, 2012.
Review content assessed as up-to-date: 14 March 2012.
Citation: Geeganage C, Beavan J, Ellender S, Bath PMW. Interventions for dysphagia and nutritional support in acute and subacute
stroke. Cochrane Database of Systematic Reviews 2012, Issue 10. Art. No.: CD000323. DOI: 10.1002/14651858.CD000323.pub2.
A B S T R A C T
Background
Dysphagia (swallowing problems) are common after stroke and can cause chest infection and malnutrition. Dysphagic, and malnour-
ished, stroke patients have a poorer outcome.
Objectives
To assess the effectiveness of interventions for the treatment of dysphagia (swallowing therapy), and nutritional and uid supplemen-
tation, in patients with acute and subacute (within six months from onset) stroke.
Search methods
We searched the Cochrane Stroke Group Trials Register (February 2012), MEDLINE (1966 to July 2011), EMBASE (1980 to July
2011), CINAHL (1982 to July 2011) and Conference Proceedings Citation Index- Science (CPCI-S) (1990 to July 2011). We also
searched the reference lists of relevant trials and review articles, searched Current Controlled Trials and contacted researchers (July
2011). For the previous version of this review we contacted the Royal College of Speech and Language Therapists and equipment
manufacturers.
Selection criteria
Randomised controlled trials (RCTs) in dysphagic stroke patients, and nutritional supplementation in all stroke patients, where the
stroke occurred within six months of enrolment.
Data collection and analysis
Two reviewauthors independently applied the inclusion criteria, assessed trial quality, and extracted data, and resolved any disagreements
through discussion with a third review author. We used random-effects models to calculate odds ratios (OR), 95% condence intervals
(95% CI), and mean differences (MD). The primary outcome was functional outcome (death or dependency, or death or disability)
at the end of the trial.
1 Interventions for dysphagia and nutritional support in acute and subacute stroke (Review)
Main results
We included 33 studies involving 6779 participants.
Swallowing therapy: acupuncture, drug therapy, neuromuscular electrical stimulation, pharyngeal electrical stimulation, physical stim-
ulation (thermal, tactile), transcranial direct current stimulation, and transcranial magnetic stimulation each had no signicant effect
on case fatality or combined death or dependency. Dysphagia at end-of-trial was reduced by acupuncture (number of studies (t) = 4,
numbers of participants (n) = 256; OR 0.24; 95% CI 0.13 to 0.46; P < 0.0001; I
2
= 0%) and behavioural interventions (t = 5; n = 423;
OR 0.52; 95% CI 0.30 to 0.88; P = 0.01; I
2
= 22%). Route of feeding: percutaneous endoscopic gastrostomy (PEG) and nasogastric
tube (NGT) feeding did not differ for case fatality or the composite outcome of death or dependency, but PEG was associated with
fewer treatment failures (t = 3; n = 72; OR 0.09; 95% CI 0.01 to 0.51; P = 0.007; I
2
= 0%) and gastrointestinal bleeding (t = 1; n = 321;
OR 0.25; 95% CI 0.09 to 0.69; P = 0.007), and higher feed delivery (t = 1; n = 30; MD 22.00; 95% CI 16.15 to 27.85; P < 0.00001)
and albumin concentration (t = 3; n = 63; MD 4.92 g/L; 95% CI 0.19 to 9.65; P = 0.04; I
2
= 58%). Although looped NGT versus
conventional NGT feeding did not differ for end-of-trial case fatality or death or dependency, feed delivery was higher with looped
NGT (t = 1; n = 104; MD 18.00%; 95% CI 6.66 to 29.34; P = 0.002). Timing of feeding: there was no difference for case fatality, or
death or dependency, with early feeding as compared to late feeding. Fluid supplementation: there was no difference for case fatality,
or death or dependency, with uid supplementation. Nutritional supplementation: there was no difference for case fatality, or death
or dependency, with nutritional supplementation. However, nutritional supplementation was associated with reduced pressure sores (t
= 2; n = 4125; OR 0.56; 95% CI 0.32 to 0.96; P = 0.03; I
2
= 0%), and, by denition, increased energy intake (t = 3; n = 174; MD
430.18 kcal/day; 95% CI 141.61 to 718.75; P = 0.003; I
2
= 91%) and protein intake (t = 3; n = 174; MD 17.28 g/day; 95% CI 1.99
to 32.56; P = 0.03; I
2
= 92%).
Authors conclusions
There remains insufcient data on the effect of swallowing therapy, feeding, and nutritional and uid supplementation on functional
outcome and death in dysphagic patients with acute or subacute stroke. Behavioural interventions and acupuncture reduced dysphagia,
and pharyngeal electrical stimulation reduced pharyngeal transit time. Compared with NGT feeding, PEG reduced treatment failures
and gastrointestinal bleeding, and had higher feed delivery and albumin concentration. Nutritional supplementation was associated
with reduced pressure sores, and increased energy and protein intake.
P L A I N L A N G U A G E S U M M A R Y
Interventions for problems with swallowing and poor nutrition in patients who have had a recent stroke
Stroke is often complicated by problems with swallowing (dysphagia) and poor nutrition. Normal oral feeding in those with swallowing
problems may lead to pneumonia and an increased risk of death. Therapies to improve swallowing are designed to accelerate recovery
of swallowing function and reduce the risk of developing pneumonia. We reviewed 33 studies involving 6779 patients (the average
age of patients across the studies was 71 years). There was some evidence that acupuncture and behavioural interventions may reduce
dysphagia but the roles of drug therapy, neuromuscular electrical stimulation, pharyngeal electrical stimulation, physical stimulation,
transcranial direct current stimulation, and transcranial magnetic stimulation remain unclear. Liquid food may be given directly into
the stomach through feeding tubes, either via the gullet, using a nasogastric tube (NGT), or directly into the stomach via a percutaneous
endoscopic gastrostomy (PEG) tube. Starting tube feeding (with either NGT or PEG) early after stroke may reduce death although
the information available remains inconclusive. If longer-term feeding is required PEG feeding provides better nutrition and is more
secure than a NG tube. The available trial evidence does not support the routine use of protein and energy supplements in acute stroke
patients who are able to take food by mouth; supplements may show benet in those who have signs of malnutrition, for example
through reducing pressure sores.
B A C K G R O U N D
Description of the condition
Dysphagia after stroke is common, affecting 27% to 64% of pa-
tients (Gordon 1987; Wolfe 1993; Odderson 1995; Smithard
1996; Mann 2000; Singh 2006a). Half of these patients will re-
cover within two weeks; some will die and others will require long-
term feeding with signicant impairment of function, recovery,
and quality of life (Barer 1989; Smithard 1997; Mann 1999; Perry
2004). Complications of dysphagia include aspiration leading to
chest infection and pneumonia, malnutrition, inability to rehabil-
itate, increased risk of infection, prolonged length of stay in hos-
pital, and an increased risk of death (Smithard 1993; Odderson
1995; Finestone 1996; Smithard 1996; Sharma 2001; Martino
2005). Dysphagia improves spontaneously inmany stroke patients
although at one month after stroke 15%of patients still have swal-
lowing problems (Smithard 1993). The early identication and
management of dysphagia has been shown to reduce pneumonia
rates (Odderson 1995; Ramsey 2003; Hinchey 2005).
Under-nutrition is common in stroke patients at the time of their
admission (8% to 28%) and worsens during their hospital stay
(Axelsson 1989; Gariballa 1998; FOOD2003; Crary 2006). Mal-
nutrition is associated with increased mortality, length of hospital
stay (thereby increasing costs), inability to rehabilitate, and poor
functional status (Smithard 1993; Finestone 1996; Gariballa 1998;
Correia 2003; FOOD 2003). Whether and how food should be
supplemented in stroke patients remains unclear.
Under-nutrition and dysphagia after a stroke are risk factors for
poor clinical outcomes. Therefore, treatment of these conditions
may be benecial.
Description of the intervention
Interventions for treating dysphagia are often administered by
speech and language therapists (SLTs). These interventions involve
the modication of uid and food consistencies, postural tech-
niques, swallowing exercises, and stimulation of oral and pharyn-
geal structures (Lazarra 1986; Logemann 1991; Logemann 1993).
Local stimulation techniques include thermal and electrical stim-
ulation. Transcranial direct current stimulation (TDCS) and tran-
scranial magnetic stimulation (TMS) are also under investigation
(Power 2004; Hamdy 2006). Acupuncture techniques are used
routinely in some countries.
A number of types of pharmacological agents (capsaicin, black
pepper oil, cabergoline, angiotensin-converting enzyme (ACE)
inhibitors, and nifedipine) have also been studied in patients
(Ebihara 1993; Arai 1998; Arai 2003; Ebihira 2004; Ebihira 2005;
Ebihara 2006), mostly with chronic or mixed aetiology dysphagia.
The nutritional intake of patients with dysphagia may be man-
aged by using modied diet consistencies or tube feedings. For
the latter, tube feedings can be inserted in the nose and positioned
in the stomach (nasogastric tube (NGT)), jejunum (nasojejunal
tube (NJT)) or surgically placed in the stomach (percutaneous en-
doscopic gastrostomy (PEG)), radiologically inserted gastrostomy
(RIG) tube feeding, or parenteral (intravenous (iv)) feeding. Inser-
tion of an NGT is relatively easy, but requires training and aware-
ness of the risks, which, although low (OMahony 1995), have
been highlighted by safety alerts from the UK National Patient
Safety Agency (NPSA 2005). Many patients nd NGTs uncom-
fortable, have poor understanding secondary to their stroke, and
repeatedly pull out the tube resulting in interruption of feeding
and subsequent worsening of their nutritional state. PEGinsertion
is an invasive procedure and can be complicated by bleeding, local
infection, peritonitis, perforation, and aspiration leading to pneu-
monia and increased mortality in older stroke patients (Wanklyn
1995; NCEPOD 2004). PEG is more acceptable and less irritat-
ing to patients and is superior in delivery of feed and maintaining
nutritional status in long-term dysphagic patients with traumatic
brain damage and stroke (Wicks 1992; Norton 1996; Erdil 2005).
Radiologically inserted equivalents such as RIG are available, but
are less commonly used. It remains unclear whether PEG is supe-
rior to NGT in patients with acute stroke, the ideal time to start
feeding following stroke onset, and after what time period PEG
tubes are best inserted. The role of methods such as mittens for re-
straint, nasal bridles for holding NGT in place, and NJTs remains
unclear. Intravenous feeding of dysphagic patients is generally not
used unless there is enteral failure because of high complication
rates through infection and thromboembolism.
How the intervention might work
These physical and pharmacological techniques may help recovery
of dysphagia following stroke. In addition, they might hasten the
natural recovery process. However, the improvement in swallow-
ing and other measures could simply be because of the natural re-
covery process. Similarly, feeding, uid, or nutritional supplemen-
tation may enhance stroke recovery or may accelerate the natural
recovery process or improvements may only be because of natural
recovery.
Why it is important to do this review
It remains unclear whether patients managed by these physical
and pharmacological techniques fare better than those receiving
no therapy. Improvements may be because of the natural recovery
of swallowing function, acute stroke treatment, and stroke unit
rehabilitation rather than just because of the dysphagia-targeted
therapy.
This reviewaimedtoassess the effectiveness of interventions for the
treatment of dysphagia (swallowing therapy), and nutritional and
uid supplementation, in patients with acute or subacute stroke.
O B J E C T I V E S
To determine:
1. if swallowing therapy improves clinical outcome;
2. the optimal administration (route, timing) of feeding and
uid administration;
3. if food supplementation improves clinical outcome.
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised controlled trials involving patients with acute or sub-
acute stroke comparing the following.
In participants with dysphagia
Swallowing therapy
Acupuncture versus no acupuncture or routine acupuncture
or sham acupuncture.
Behavioural interventions: swallowing exercises, dietary
modication, positioning versus limited or usual or no treatment.
Drug intervention versus none or placebo.
Neuromuscular electrical stimulation (NMES) versus none
or sham stimulation.
Pharyngeal electrical stimulation (PES) versus none or
sham stimulation.
Physical stimulation: thermal, tactile versus limited, or
usual or no treatment.
TDCS versus none or sham stimulation.
TMS versus none or sham stimulation.
Comparisons of different strategies: NMES versus
behavioural interventions.
Route of feeding
Parenteral versus enteral feeding.
PEG versus NGT.
NJT versus NGT.
NGT with loop versus NGT.
Timing of feeding
Early versus late.
Fluid supplementation
Subcutaneous (sc) versus iv.
Thickened versus non-thickened uids.
In participants without dysphagia
Nutritional supplementation
Supplementation versus no supplementation in non-
dysphagic patients.
We excluded trials if they used a cross-over design, recruited pa-
tients after six months of stroke onset, or if they involved a large
proportion of patients with non-stroke causes of dysphagia.
Types of participants
Denitions
Acute or subacute stroke
Participants recruited with a clinical diagnosis of stroke within six
months of onset.
Stroke type
Ischaemic or haemorrhagic.
Early feeding
Within seven days of stroke onset.
Dysphagia
Diagnosed clinically (water swallow tests, modied diet and uid
assessments, swallowing test scores) by a range of clinicians, or
using videouoroscopy, or using exible endoscopic evaluation of
swallowing (FEES).
Malnutrition or under-nutrition
Subjective assessment based onbody mass index (BMI), Demiquet
index (a ratio to determine body mass in relation to skeletal size;
used as an alternative to BMI, where measurement of height is
difcult, and also in older people, where BMI is less reliable),
nutritional risk score, anthropometric measures, and biochemical
measures.
Types of interventions
Swallowing therapy for dysphagia
Acupuncture.
Behavioural interventions: swallowing exercises/therapy and
dietary modication.
Drug therapy.
NMES.
PES.
Physical stimulation (thermal, tactile).
TDCS.
TMS.
Feeding and uids
Route of feeding: NGT, NJT, PEG, RIG, iv, sc.
Timing of feeding.
Fluid supplementation.
Nutritional supplementation: providing protein and calorie
supplements.
Types of outcome measures
Where available we obtained Information on the following out-
come measures for each trial.
Primary outcomes
Functional outcome: death or dependency, or death or disability,
at the end of the trial (we dened disability and dependency as a
Barthel Index of 0 to 55 or Rankin score of 3 to 5).
Secondary outcomes
1. Case fatality at the end of the trial.
2. Neurological deterioration as measured by a stroke
impairment scale (e.g. National Institutes of Health Stroke Scale,
Scandinavian Stroke Scale) within four weeks.
3. Late disability or dependency at the end of the trial.
4. Proportion with dysphagia at the end of the trial.
5. Improvement in dysphagia: videouoroscopy, pharyngeal
transit time, swallowing time, normal water swallow test,
improvement in swallow function scales, functional oral intake
scale (FOIS), Watian swallow scale, return to normal diet and
uids.
6. Aspiration: clinical, videouoroscopy.
7. Pneumonia: clinical, radiologically.
8. Gastrointestinal bleeding.
9. Feeding tube failures: withdrawal of tube feeding.
10. Nutritional measures: weight, albumin, mid-arm
circumference (MAC).
11. Length of hospital stay.
12. Pressure sores.
13. Institutionalisation: discharge destination, residential or
nursing home or extended care facility.
14. Quality of life: for example Short Form-36 (SF-36),
EuroQol.
15. Food intake: calories or volume of feed.
Search methods for identication of studies
See the Specializedregister sectioninthe Cochrane Stroke Group
module. We searched for trials in all languages and arranged trans-
lation of relevant trials published in languages other than English.
Electronic searches
We searched the Cochrane Stroke Group Trials Register (last
searched in February 2012), MEDLINE (1966 to July 2011)
(Appendix 1), EMBASE (1980 to July 2011) (Appendix 2),
CINAHL (1982 to July 2011) (Appendix 3), and Conference Pro-
ceedings Citation Index-Science (CPCI-S) (1990 to July 2011).
Searching other resources
In an effort to identify further published, unpublished, and ongo-
ing trials, we:
1. searched the reference lists of relevant trials, review articles,
and our own reference lists;
2. contacted researchers;
3. searched the ongoing trials register Current Controlled
Trials (www.controlled-trials.com/) (July 2011).
For the previous version of this review we contacted the Royal
College of Speech and Language Therapists Special Interest Group
for adult-acquired dysphagia, and companies who manufacture
PEG- or NGT-related equipment.
Data collection and analysis
Selection of studies
For this update two review authors (CG and JB) scanned the ti-
tles and abstracts of the records identied from the searches of
the electronic bibliographic databases and excluded obviously ir-
relevant articles. We then obtained the full text of the remaining
studies and the same two review authors selected relevant trials
based on the review inclusion criteria. These two review authors
resolved any disagreements through discussion and consultation
with a third review author (PB) if necessary.
Randomised controlled trials in acute or subacute (less than six
months) stroke of:
1. interventions for dysphagia;
2. feeding strategies and timing;
3. uid supplementation; and
4. effects of nutritional supplementation.
Data extraction and management
For this updated review, two review authors (CG and JB) assessed
new trials, extracted data using a predened proforma, and re-
solved disagreements through discussion and consultation with
a third review author (PB). We sought additional information,
where necessary, from the principal investigators of trials that ap-
peared to meet the inclusion criteria.
Assessment of risk of bias in included studies
We assessed risk of bias in the included trials using the Risk of
bias tool as recommended inthe Cochrane Handbook for Systematic
Reviews of Interventions (Higgins 2011). The assessment included:
sequence generation, allocation concealment, blinding of partici-
pants and personnel, blinding of outcome assessment, incomplete
outcome data, selective outcome reporting, and other issues.
Measures of treatment effect
We calculated weighted estimate of the typical treatment effect
across trials using the odds ratio (OR) and 95% condence in-
tervals (CIs) for binary data and mean difference (MD) and 95%
CIs for continuous data and used Review Manager 5.1 (RevMan
2011). We calculated ORs using the Mantel-Haenszel method and
MDs using the inverse variance method.
Unit of analysis issues
Where outcome measures included different scores we converted
these to grades in the same direction of desirability and analysed
them using MDs. Three studies compared graduations of therapy
(Yuan 2003; Carnaby 2006; Jing 2007). In these cases we divided
the middle intensity group in two, and analysed the study data by
comparing high intensity with mediumintensity, and mediumin-
tensity with low intensity or no treatment. When a trial compared
more than one active treatment with a common control group,
we divided the control group patients equally between treatment
groups to prevent control patients being counted more than once
and thereby articially narrowing the CIs.
Dealing with missing data
If trial publication did not provide relevant data we contacted the
principle investigator in an effort to obtain the missing data. If
they did not respond, then we excluded the trial fromthe analyses.
Assessment of heterogeneity
We used random-effects models as we anticipated that the trials
would be heterogeneous in design, including different types of
patients and interventions. We assessed heterogeneity by looking
at the forest plots to see how CIs overlapped (non-overlapping
studies are likely to exhibit statistical heterogeneity) and by the I
2
statistic (Higgins 2011).
Assessment of reporting biases
We assessed trials for selective outcome reporting and the as-
sessment of each trial is reported in the Risk of bias table
(Characteristics of included studies).
Data synthesis
We obtained data on randomisation, blinding, the number of pa-
tients randomised, time of treatment from stroke, type of dyspha-
gia therapy, patient withdrawals and losses to follow-up, and rele-
vant outcomes (Types of outcome measures).
Subgroup analysis and investigation of heterogeneity
For eachoutcome we analyseddifferent swallowing andnutritional
interventions as different subgroups. We assessed heterogeneity
by looking at the forest plots to see how well the CIs of trials in
each subgroup overlapped (if studies did not overlap at all then it
was likely to have more variation between the study results than
expected by chance) and by the I
2
statistic.
Sensitivity analysis
We did not perform any sensitivity analyses because of the small
number of trials.
R E S U L T S
Description of studies
See: Characteristics of included studies; Characteristics of
excluded studies; Characteristics of studies awaiting classication;
Characteristics of ongoing studies.
We identied 195 studies. Of these, 15 studies are ongoing and we
excluded 108 studies mainly because they have compared two ac-
tive treatments without a control, the trials were not randomised,
or no relevant outcome data were present (Characteristics of
excluded studies). A further 38 studies are awaiting assessment be-
cause we are in the process of retrieving full-text articles of these
publications (Studies awaiting classication).
Results of the search
The database searches identied 975 references. A further 21 ref-
erences were identied through other sources (Figure 1). We as-
sessed 156 full-text articles for eligibility and we are in the process
of retrieving a further 38 full-text articles (Figure 1). The present
analyses included 33 studies involving 6779 patients (Included
studies). The mean age across the included studies was 71 years.
Figure 1. Study ow diagram.* Further 38 studies are awaiting assessment.
Included studies
We included 18 studies involving 967 patients. The trials looked
at various forms of swallowing therapy after stroke.
Acupuncture
We included ve acupuncture studies involving 321 patients (Liu
2000; Wei 2005; Bai 2007a; Bai 2007b; Huang 2010).
Behavioural interventions
Five studies tested behavioural interventions in 423 patients (Yuan
2003a; Yuan 2003b; Song 2004; Carnaby 2006a; Carnaby 2006b).
Behavioural interventions consisted of swallowing exercises, envi-
ronmental modications such as upright positioning for feeding,
safe swallowing advice, and appropriate dietary modications.
Drug therapy
We included two studies with a total of 75 patients (Perez 1997;
Gosney 2006). Drug interventions included nifedipine (17 pa-
tients) (Perez 1997) and an antibacterial oral gel in 58 dysphagic
stroke patients (from a larger sample of 203 stroke patients)
(Gosney 2006).
Neuromuscular electrical stimulation
One study assessed NMES in 22 patients (Lim 2009).
Pharyngeal electrical stimulation
PES was assessed in one study involving 28 patients (Jayasekeran
2010).
Physical stimulation (thermal, tactile)
Two studies assessed physical stimulation (thermal or tactile) in
35 patients with dysphagia (Bath 1997; Power 2006).
Transcranial direct current stimulation
One study involving 14 patients assessed TDCS (Kumar 2011).
Transcranial magnetic stimulation
One study assessed TMS in 26 patients (Khedr 2009).
Feeding and uids
Route of feeding
Five studies (455 patients) compared PEG with NGT feeding
(Norton 1996; Bath 1997; PEGASUS 2004; FOOD 3 2005;
Hamidon 2006). One study (104 patients) compared looped
NGT versus conventional NGT (Beavan 2010). The studies
ranged in size from 19 patients (single site) (Bath 1997) to 321
patients (47 sites) (FOOD 3 2005). Patients were recruited at be-
tween four and 30 days post stroke (Characteristics of included
studies). We excludedseveral trials because of study design: chronic
stroke, method of randomisation, low proportion of stroke pa-
tients, or lack of data (Characteristics of excluded studies). There
were no trials on the use of RIG tubes or parenteral nutrition in
stroke alone.
Timing of feeding
A second component within the FOOD(Feed Or Ordinary Diet)
family of trials compared earlier (within seven days) versus later
feeding in 859 patients from 83 sites (FOOD 2 2005). We found
no other RCTs assessing timing of feeding in acute stroke.
One study (20 participants) compared administering free water
and thickened uids with thickened uids alone in patients known
to aspirate thin uids (Garon 1997).
Eight studies involving 4391 non-dysphagic patients assessed the
effect of nutritional supplementation (Gariballa 1998; FOOD
1 2005; Aquilani 2008; Rabadi 2008; Nutristroke 2009a;
Nutristroke 2009b; Nutristroke 2009c; Ha 2010). One study in-
cluded 42 patients with impaired nutritional status (Gariballa
1998). The third component within the FOOD family of trials
assessed protein-calorie supplementation in 4023 patients from
125 centres (FOOD 1 2005). Three studies assessed antioxidants
and n3-fatty-acid supplementation in 52 post-stroke patients
(Nutristroke 2009a; Nutristroke 2009b; Nutristroke 2009c). An-
other study assessed intensive nutritional supplementation in 102
under-nourished post-stroke patients (Rabadi 2008). The seventh
study assessed protein-calorie supplementation in 48 post-stroke
patients (Aquilani 2008). The nal study assessed the effects of
individualised nutritional supplementation in 124 post-stroke pa-
tients aged over 65 years (Ha 2010). We excluded a further 12
studies (Characteristics of excluded studies).
Excluded studies
We excluded a further 108 studies, mainly because there was no
control group, the trial was not randomised, or no relevant out-
come data were available (Characteristics of excluded studies).
Risk of bias in included studies
We assessedkey sources of bias as follows. Risk of bias across studies
is summarised in Figure 2.
Figure 2. Risk of bias graph: review authors judgements about each Risk of bias item presented as
percentages across all included studies.
Allocation
Thirteenstudies involved randomisationby computer, thereby en-
suring concealment of allocation (Bath 1997; Garon 1997; Perez
1997; FOOD 1 2005; FOOD 2 2005; FOOD 3 2005; Carnaby
2006; Gosney 2006; Hamidon 2006; Aquilani 2008; Beavan
2010; Ha 2010; Jayasekeran 2010). Randomisation occurred us-
ing randomnumbers tables in two studies (Song 2004; Jing 2007);
block randomisation by telephone in one study (Gariballa 1998);
sealed opaque envelope containing block randomisation of 10 pa-
tients in one study (Rabadi 2008); and using a specic list in
three studies (Nutristroke 2009a; Nutristroke 2009b; Nutristroke
2009c). Randomisation procedures were unclear in 10 studies
(Norton 1996; Liu 2000; Yuan 2003; PEGASUS 2004; Wei 2005;
Power 2006; Khedr 2009; Lim2009; Huang 2010; Kumar 2011).
Baseline prognostic factors were similar between intervention
and control groups in 17 studies (Garon 1997; Perez 1997;
Gariballa 1998; PEGASUS 2004; FOOD1 2005; FOOD2 2005;
FOOD 3 2005; Carnaby 2006a; Carnaby 2006b; Aquilani 2008;
Rabadi 2008; Khedr 2009; Nutristroke 2009a; Nutristroke 2009b;
Nutristroke 2009c; Beavan 2010; Ha 2010); matching in the
other 16 studies was unclear (Norton 1996; Bath 1997; Liu 2000;
Yuan 2003a; Yuan 2003b; Song 2004; Wei 2005; Gosney 2006;
Hamidon 2006; Power 2006; Bai 2007a; Bai 2007b; Lim 2009;
Huang 2010; Jayasekeran 2010; Kumar 2011).
Blinding
Seven studies were double blind (Perez 1997; Aquilani 2008;
Rabadi 2008; Nutristroke 2009a; Nutristroke 2009b; Nutristroke
2009c; Kumar 2011). One study was single blind (Power 2006).
Outcomes were assessed in a blinded fashion in eight studies (
Perez 1997; FOOD 1 2005; FOOD 2 2005; FOOD 3 2005;
Wei 2005; Carnaby 2006; Khedr 2009; Jayasekeran 2010) and
unblinded ineight studies (Norton 1996; Bath 1997; Garon1997;
Gosney 2006; Hamidon 2006; Bai 2007a; Bai 2007b; Beavan
2010); outcome blinding was unclear in nine studies (Gariballa
1998; Liu 2000; Yuan 2003a; Yuan 2003b; PEGASUS 2004; Song
2004; Lim 2009; Ha 2010; Huang 2010).
Incomplete outcome data
Two studies reported no loss of patients during follow-up, 15 stud-
ies reported loss of patients during follow-up, and loss of patients
during follow up was unclear in the remaining studies (Included
studies).
Selective reporting
Twenty-three studies reported complete data; inanother 10 studies
it was unclear whether reported data were complete.
Other potential sources of bias
The three acupuncture studies (Liu 2000; Wei 2005; Jing 2007)
and two of the swallowing studies (Yuan 2003; Song 2004) were
assessed from translations of the original text. Translations from
Chinese to English were performed by native Chinese speakers.
Effects of interventions
Acupuncture
Dysphagia at the end of the trial
Data fromfour studies showed a reduction in dysphagia by end of
trial (t = 4; n = 256; OR 0.24; 95% CI 0.13 to 0.46; P < 0.0001)
(Analysis 1.6).
Swallow score
There was no difference in swallow scores between treatment and
control groups. However, signicant heterogeneity was noted (t
= 3; n = 256; MD -0.41; 95% CI -1.53 to 0.72; I
2
= 91%; P <
0.0001) for swallow scores in acupuncture studies (Analysis 1.8).
Data on other outcomes were not available.
Behavioural interventions
Behavioural interventions signicantly reduced dysphagia by end
of trial (t = 5; n = 423; OR 0.52; 95% CI 0.30 to 0.88; I
2
= 22%;
P = 0.01) (Analysis 1.6).
Length of stay
A non-signicant reduction in length of stay was noted (t = 4; n
= 370; MD -2.70; 95% CI -5.68 to 0.28; I
2
= 19%; P = 0.08)
(Analysis 1.4).
Chest infection or pneumonia
A non-signicant reduction in chest infection/pneumonia was
noted (t = 5; n = 423; OR 0.50; 95% CI 0.24 to 1.04; I
2
= 34%;
P = 0.06) (Analysis 1.5).
Case fatality at the end of trial
No effects were apparent on case fatality (t = 2; n = 306; OR 0.83;
95% CI 0.46 to 1.51) (Analysis 1.1).
Death or dependency at the end of trial
No effects were apparent on death or dependency (t = 2; n = 306;
OR 1.05; 95% CI 0.63 to 1.75) (Analysis 1.2).
Institutionalisation
No effects were apparent on institutionalisation (t = 2; n = 306;
OR 0.76; 95% CI 0.39 to 1.48) (Analysis 1.3).
Nutrition (albumin)
No effects were apparent on blood albumin concentration (t = 2;
n = 64; MD 0.20; 95% CI -4.77 to 5.17) (Analysis 1.9).
Drug therapy
Drug therapy was not associated with differences in case fatality
(t = 1; n = 17; OR 1.14; 95% CI 0.06 to 21.87) (Analysis 1.1).
No effect on chest infection or pneumonia (t = 1; n = 58; OR
0.19; 95% CI 0.02 to 1.67) (Analysis 1.5).
No effect on dysphagia at end of trial (t = 1; n = 17; OR 0.48;
95% CI 0.07 to 3.35) (Analysis 1.6).
Pharyngeal transit time (seconds)
No effect on pharyngeal transit time (t = 1; n = 17; MD -0.21;
95% CI -0.91 to 0.49) (Analysis 1.7).
Neuromuscular electrical stimulation
NES did not alter dysphagia at the end of one small trial (t = 1; n
= 22; OR 0.43; 95% CI 0.07 to 2.50) (Analysis 1.6).
Pharyngeal electrical stimulation
PES signicantly reduced pharyngeal transit time (t = 1; n = 28;
MD -0.15; 95% CI -0.51 to 0.20) (Analysis 1.7).
PES did not alter case fatality at end of trial (t = 1; n = 18; OR
4.31; 95% CI 0.19 to 98.51) (Analysis 1.1).
0.43; 95% CI 0.06 to 3.09) (Analysis 1.5).
Physical stimulation (thermal, tactile)
Inone small trial, physical stimulationhad no effect oncase fatality
(t = 1; n = 19; OR 1.05; 95% CI 0.16, to 6.92) (Analysis 1.1).
No effect on dysphagia at the end of trial (t = 1; n = 7; OR 0.33;
95% CI 0.01 to 11.34) (Analysis 1.6).
One small study reduced pharyngeal transit time (t = 1; n = 28;
MD -0.19; 95% CI -0.34 to -0.04) (Analysis 1.7).
Swallow score
No effect on swallow score (t = 1; n = 28; MD 1.40; 95% CI -
2.58 to 5.38) (Analysis 1.8).
Transcranial direct current stimulation
TDCS did not alter dysphagia at the end of one small trial (t = 1;
n = 14; OR 0.29; 95% CI 0.01 to 8.39) (Analysis 1.6).
Swallow score
No effect on swallow score (t = 1; n = 14; MD 1.00; 95% CI -
0.50 to 2.50) (Analysis 1.8).
Transcranial magnetic stimulation
TMS did not alter case fatality at the end of one small trial (t = 1;
Feeding and uids
Percutaneous endoscopic gastrostomy versus nasogastric
tube feeding
Data were available for ve studies (Norton 1996; Bath 1997;
PEGASUS 2004; FOOD 3 2005; Hamidon 2006).
Treatment failures
PEG was associated with fewer treatment failures (t = 3; n = 72;
OR 0.09; 95% CI 0.01 to 0.51; P = 0.007; I
2
= 0%) (Analysis
2.8).
Gastrointestinal bleeding
PEG was associated with fewer gastrointestinal bleeding events (t
= 1; n = 321; OR 0.25; 95% CI 0.09 to 0.69; P = 0.007) (Analysis
2.9).
Feed delivery (%)
PEG was associated with higher feed delivery (t = 1; n = 30; MD
22.00; 95% CI 16.15 to 27.85; P < 0.00001) (Analysis 2.10).
Albumin (g/L)
PEGwas associated with higher albumin (t = 3; n = 63; MD 4.92;
95% CI 0.19 to 9.65; P = 0.04; I
2
= 58%) (Analysis 2.13).
Mid-arm circumference (cm)
PEG was also associated with a trend to a higher MAC (t = 3; n =
58; MD 2.29; 95% CI -0.30 to 4.89; P = 0.08; I
2
= 0%) (Analysis
2.12).
Pressure sores
PEG was associated with fewer pressure sores (t = 1; n = 321; OR
3.10; 95% CI 0.98 to 9.83; P = 0.05) (Analysis 2.5).
PEG and NGT feeding did not differ for end-of-trial case fatality
(t = 5; n = 455; OR 0.81; 95% CI 0.42 to 1.56) (Analysis 2.1).
No effect on death or dependency (t = 3; n = 400; OR 0.80; 95%
CI 0.12 to 5.55) (Analysis 2.2).
No effect on institutionalisation (t = 2; n = 364; OR 0.62; 95%
CI 0.15 to 2.57) (Analysis 2.3).
Length of stay in hospital (days)
No effect on length of stay in hospital (t = 2; n = 384; MD 14.32;
95% CI -12.04 to 40.68) (Analysis 2.4).
No effect on chest infection/pneumonia rates (t = 2; n = 93; OR
0.65; 95% CI 0.23 to 1.86) (Analysis 2.6).
Dysphagia at end of trial
No effect on dysphagia at end of trial (t = 2; n = 66; OR 0.76;
95% CI 0.05 to 11.77) (Analysis 2.7).
Weight at end of trial (kg)
No effect on weight at end of trial (t = 2; n = 34; MD 4.08; 95%
CI -4.32 to 12.48) (Analysis 2.11).
Looped nasogastric tube versus conventional nasogastric
tube
One small study compared looped NGT with conventional NGT
feeding (Beavan 2010).
Feed delivery (%)
Feed delivery was signicantly higher in the looped NGT group
than conventional NGT group (t = 1; n = 104; MD 18.00; 95%
CI 6.66 to 29.34; P = 0.002) (Analysis 2.10).
Looped NGTversus conventional NGT feeding did not differ for
end-of-trial case fatality (t = 1; n = 104; OR 0.60; 95% CI 0.27
to 1.33) (Analysis 2.1).
No effect on death or dependency (t = 1; n = 104; OR 0.52; 95%
CI 0.18 to 1.57) (Analysis 2.2).
No effect on institutionalisation (t = 1; n = 104; OR 1.73; 95%
CI 0.78 to 3.81) (Analysis 2.3).
95% CI -8.48 to 22.48) (Analysis 2.4).
Pressure sores
No effect on pressure sores (t = 1; n = 104; OR 1.04; 95% CI 0.28
to 3.84) (Analysis 2.5).
0.84; 95% CI 0.39 to 1.84) (Analysis 2.6).
Treatment failure
No effect on treatment failure (t = 1; n = 104; OR 1.67; 95% CI
0.64 to 4.34) (Analysis 2.8).
Gastrointestinal bleeding
No effect on gastrointestinal bleeding (t = 1; n = 104; OR 1.63;
95% CI 0.43 to 6.17) (Analysis 2.9).
Timing of feeding
One medium-sized study compared starting feeding earlier (less
than one week) or later (FOOD 2 2005). Feeding commenced
earlier rather than later was associated with a tendency to a lower
end-of trial case-fatality (t = 1; n = 859; OR 0.79; 95% CI 0.61
to 1.04; P = 0.09) (Analysis 3.1). The timing of feeding did not
differ for death or disability (t = 1; n = 859; OR 0.94; 95% CI
0.68 to 1.31) (Analysis 3.2) or rate of institutionalisation (t = 1;
Data were only available fromone small study (Garon1997). Fluid
supplementation did not alter the time to resolution of dysphagia
(t = 1; n = 20; MD -8.10; 95% CI -20.84 to 4.64) (Analysis 4.1).
No episodes of pneumonia were reported.
Data were available for eight studies involving 4391 patients (
Gariballa 1998; FOOD 1 2005; Aquilani 2008; Rabadi 2008;
Nutristroke 2009a; Nutristroke 2009b; Nutristroke 2009c; Ha
2010).
Pressure sores
Nutritional supplementation was associated with reduced pressure
sores (t = 2; n = 4125; OR 0.56; 95% CI 0.32 to 0.96; P = 0.03;
I
2
= 0%) (Analysis 5.5).
Energy intake (kcal/day)
Energy intake was increased (t = 3; n = 174; MD 430.18; 95% CI
141.61 to 718.75; P = 0.003; I
2
= 91%) (Analysis 5.6).
Protein intake (g/day)
Protein intake was increased (t = 3; n = 174; MD 17.28; 95% CI
1.99 to 32.56; P = 0.03; I
2
= 92%) (Analysis 5.7).
A non-signicant reduction in case fatality was noted (t = 7; n
= 4343; OR 0.58; 95% CI 0.28 to 1.21; P = 0.14; I
2
= 38%)
(Analysis 5.1).
A non-signicant reduction in institutionalisation was noted (t =
1; n = 102; OR 0.48; 95% CI 0.22 to 1.07) (Analysis 5.3).
No effect on death or dependency (t = 1; n = 4023; OR1.06; 95%
CI 0.94 to 1.20) (Analysis 5.2).
95% CI -0.81 to 3.60) (Analysis 5.4).
Albumin (g/L)
No effect on albumin concentration (t = 2; n = 144; MD 0.29;
95% CI -0.65 to 1.24) (Analysis 5.8).
D I S C U S S I O N
We identied33studies that assessedfeeding andswallowing treat-
ment strategies in stroke patients. A further 14 studies are ongoing
(Characteristics of ongoing studies).
Eighteen completed studies assessed the effect of swallowing ther-
apy in patients with post-stroke dysphagia. A variety of stimula-
tory techniques have been tested - acupuncture, behavioural ther-
apy, drug therapy, NMES, PES, physical stimulation, TDCS, and
TMS. None of the techniques showed, individually, signicant ef-
fects on functional outcome (primary outcome) or case fatality, al-
beit each based onlimited data. Both acupuncture and behavioural
interventions signicantly reduced dysphagia at the end of trial. In
the absence of signicant effects on the primary outcome, signi-
cant ndings in secondary and explanatory outcomes may reect
chance (e.g. owing to multiple comparisons) and further trials are
needed to test these observations.
Limited evidence from ve studies suggested that there might be
a trend towards a lower death rate with PEG as compared with
NGTfeeding, although the results were heterogeneous and largely
reected the results from one study (Norton 1996) where timings
for NG feeding were much later than current practice. PEG feed-
ing appeared to improve overall delivery of feed.
The data related to timing of feeding suggested that enteral nutri-
tion should be commenced earlier (within seven days) rather than
later (FOOD 2 2005).
Nutritional supplementation involving seven studies was associ-
ated with a non-signicant reduction in case fatality although,
again, considerable heterogeneity existed. Pressure sores were sig-
nicantly lower with nutritional supplementation. However there
was no effect on death or dependency, length of stay in hospi-
tal, or albumin concentration. Albumin is a poor marker of nu-
tritional status and more closely relates to sepsis, severe illness,
and inammatory conditions. Several studies assessing nutritional
supplementation have provided data on albumin levels and it was
the main reason for adding this biochemical indicator into the
present version of this review. Studies included post-stroke pa-
tients irrespective of their swallowing status and had variable base-
line nutritional status. Of four studies, the rst recruited under-
weight stroke patients (Rabadi 2008), the second recruited older
(over 65 years) stroke patients (Ha 2010), the third trial recruited a
small number of under-nourished patients (FOOD 1 2005), and
the fourth recruited patients only with under-nutrition (Gariballa
1998).
No studies reported data on food intake using calories or volume
of feed. This measurement would be useful concordance with the
reported energy intake (kcals/day) consumption measures that are
already reported in this review, especially during transition from
non-oral feeding routes to oral dietary consumption (liquids or
thickened liquids) of high-calorie supplements.
Results of the present analysis were subject to several caveats. First,
we excluded 108 studies from the analysis. One common rea-
son for exclusion was that studies compared two active treatments
without having a control or placebo. Therefore, we would encour-
age trialists to design a control or placebo group for future trials.
Lack of uniformity in outcome measures and lack of data on clin-
ical outcomes, such as dependency, mortality, institutionalisation,
and chest infections, has led us to exclude many trials. These tri-
als have used various swallowing assessment techniques, cortical
excitability techniques, and videouoroscopic measurements. In
future, trialists should be encouraged to report clinical outcomes.
Second, a further 38 studies are awaiting assessment and we ac-
knowledge that this is a signicant number of publications that
may have the potential to affect the results of the review. We will
seek full-text articles for these studies and we will add them to
the review as soon as possible. Third, with regard to acupuncture,
data from the three studies may have been confounded owing to
the use of routine acupuncture or a different type of acupunc-
ture as control, variation in the delivery of therapy, and the risk of
language bias since the majority of acupuncture literature is only
available in full in Chinese language journals. Fourth, the risk of
bias assessments were completed for newly added studies in this
update; however, these were incomplete for some studies that were
already in the review, mainly because the publications did not pro-
vide the relevant information.
In addition, the present analysis included studies up to six months
from stroke onset. However, in future, it may be useful to analyse
acute and rehabilitation studies separately.
Ongoing trials should add substantially to the existing data
(Characteristics of ongoing studies).
A U T H O R S C O N C L U S I O N S
Implications for practice
Acupuncture and behavioural therapy (as provided by SLTs) may
reduce dysphagia, although the components of each that are ef-
fective remain unclear. In the short term, the available evidence
suggests that survival may be better if feeding is started earlier, and
there is no clear advantage of PEG over NG feeding. For those
patients who require long-term nutritional support (feeding be-
yond six months) PEG feeding results in fewer treatment failures
and gastrointestinal bleeding and better feed delivery. Finally, nu-
tritional supplements do not appear to be of value to the majority
of patients except for those who are admitted malnourished or
possibly in those who are at particular risk of malnourishment.
Implications for research
Further research is needed to discover which components of swal-
lowing therapy, including acupuncture, are benecial. Research
studies into dysphagia and under-nutrition need to ensure that
standardised outcome measures are used to allow comparison of
trials. However, measuring nutritional status is difcult and there
are no indicators validated in the stroke population. Reporting of
proportions of patients who develop pneumonia or have signs of
aspiration should be an important outcome measure in all dys-
phagia and feeding-related trials. Few studies (FOOD 1 2005;
FOOD2 2005; FOOD3 2005) assessed quality of life, which has
relevance when balancing the risks and benets of interventions in
severely disabled stroke survivors. In addition, several studies have
compared active treatments without a control group and were ex-
cluded fromthis review. For future studies we recommend trialists
include a control or placebo group.
A number of studies assessing interventions for dysphagia and
nutritional support are ongoing and these will add further infor-
mation on this important research question (Characteristics of
ongoing studies). A number of studies of mixed groups of chronic
dysphagia have been done or are ongoing: a systematic review of
these studies may inform the management of acute and subacute
dysphagia post stroke.
A C K N O W L E D G E M E N T S
We thank Ms JeanKerr and Ms Morwenna Collins (SLTs) for their
help with the early stages of the rst version of the review, and
Cameron Sellars and David Smithard for their involvement in the
completion of the rst version (through searches, interpretation
of data, and writing the review). We thank the Cochrane Stroke
Group for helping identify trials, and their editors and external
assessor for comments on the review. Several trialists and other
interested healthcare staff reviewed the draft of the rst version
and made comments - we thank each of them: CGMI Baeten
(Netherlands), MS Dennis (UK), BR Garon (USA), GJ Hankey
(Australia), GKT Holmes (UK), PR Mills (UK), B Norton (UK),
C Ormiston (USA), J Rosenbek (USA), and G Vanhooren (Bel-
gium). We also thank D Luo and G Lan who translated ve of the
papers from Chinese into English. Finally, we are grateful to the
funding bodies that supported this research. Naturally any mis-
takes are our own. We would be very grateful to be informed of
any other related completed or ongoing trials that are not listed in
the review.
R E F E R E N C E S
References to studies included in this review
Aquilani 2008 {published data only}
Aquilani R, Scocchi M, Boschi F, Viglio S, Iadarola P,
Pastoris O, et al.Effect of calorie-protein supplementation
on the cognitive recovery of patients with subacute stroke.
Nutritional Neuroscience 2008;11(5):23540.
Bai 2007a {published data only}
Bai J, Li B, Wang Z, Gao W, Wang L. The role of different
needling manipulation in adjusting swallow period obstacle
of dysphagia after stroke. Zhongguo Zhenjiu 2007;27(1):
357.
Bai 2007b {published data only}
Bai J, Li B, Wang Z, Gao W, Wang L. The role of different
needling manipulation in adjusting swallow period obstacle
of dysphagia after stroke. Zhongguo Zhenjui 2007;27(1):
357.
Bath 1997 {unpublished data only}
Bath PMW, Kerr J, Collins M. Factorial trial of swallowing
versus conventional therapy, and PEG versus nasogastric
tube feeding, in dysphagic patients with recent stroke.
Unpublished 1997.
Beavan 2010 {published data only}
Beavan J, Conroy SP, Harwood R, Gladman JR, Leonardi-
Bee J, Sach T, et al.Does looped nasogastric tube feeding
improve nutritional delivery for patients with dysphagia
after acute stroke? A randomised controlled trial. Age and
Ageing 2010;39(5):62430.
Carnaby 2006a {published and unpublished data}
Carnaby G, Hankey GJ, Pizzi J. Behavioural intervention

for dysphagia in acute stroke: a randomised controlled trial.
Lancet Neurology 2006;5:317.
Mann G, Baxter K, Hankey G, Davis B, Stewart-Wynne E.
Treatment for swallowing disorders following acute stroke:
a randomised controlled trial. Stroke Society of Australia
Annual Scientic Meeting. 1997.
Mann G, Hankey G, Davis B, Stewart-Wynne E.
Swallowing therapy after acute stroke study (STAASS):
where are we now?. Journal of Clinical Neuroscience 1999;6
(3):281.
Carnaby 2006b {published data only}
Carnaby G, Hankey GJ, Pizzi J. Behavioural interventions
FOOD 1 2005 {published and unpublished data}
Dennis M. FOOD trial (Feed Or Ordinary Diet): a
multicentre trial to evaluate various feeding policies in
patients admitted to hospital with a recent stroke. Stroke
1998;29:551.
Hankey GJ, Dennis MS. Food (Feed Or Ordinary Diet):
a family of three randomised trials evaluating feeding
policies for patients admitted to hospital with a recent
stroke. Journal of Clinical Neuroscience 2002;9(4):483.
Ricci S. International Stroke Trials Collaboration: FOOD
Trial (Feed Or Ordinary Diet). Revista Medica 1999;5(4):
1912.
Signorini DF, on behalf of the International Stroke Trials
Collaboration - FOOD. Advantages of an inclusive trial:
the FOOD pilot experience. Cerebrovascular Diseases 1998;
8 Suppl 4:83.
The FOOD trial collaboration. Routine oral nutritional

supplementation for stroke patients in hospital. Lancet
2005;365:75563.
The International Stroke Trials Collaboration. FOOD Trial
(Feed Or Ordinary Diet). Protocol.
1998;29:551.
1912.
8 Suppl 4:83.
The FOOD Trial Collaboration. Effect of timing and

method of enteral tube feeding for dysphagic stroke patients
(FOOD): a multicentre randomised controlled trial. Lancet
2005;365:76472.
1998;29:551.
1912.
8 Suppl 4:83.
The FOOD Trial Collaboration. Effect of timing and

method of enteral tube feeding for dysphagic stroke patients
(FOOD): a multicentre randomised controlled trial. Lancet
2005;365:76472.
Gariballa 1998 {published data only}
Gariballa SE, Parker SG, Castledon CM. A randomised

controlled trial of nutritional supplementation after stroke.
Age and Ageing 1998;27 Suppl I:66.
Gariballa SE, Parker SG, Taub N, Castleden M. A
randomized, controlled, single blind trial of nutritional
supplementation after acute stroke. Journal of Parenteral
and Enteral Nutrition 1998;22(5):31519.
Garon 1997 {published and unpublished data}
Garon BR, Engle M, Ormiston C. A randomized control
study to determine the effects of unlimited oral intake of
water in patients with identied aspiration. Journal of
Neurological Rehabilitation 1997;11:13948.
Gosney 2006 {published data only}
Gosney M, Martin MV, Wright AE. The role of the selective
decontamination of the digestive tract in acute stroke. Age
and Ageing 2006;35:427.
Ha 2010 {published data only}
Ha L, Hauge T, Spenning AB, Iversen PO. Individual,
nutritional support prevents undernutrition, increases
muscle strength and improves QoL among elderly at
nutritional risk hospitalized for acute stroke: a randomized,
controlled trial. Clinical Nutrition 2010;29(5):56773.
Hamidon 2006 {published data only}
Hamidon BB, Abdullah SA, Zawawi MF, Sukumar N,
Raymond AA. A prospective comparison of percutaneous
endoscopic gastrostomy and nasogastric tube feeding in
patients with acute dysphagic stroke. Medical Journal of
Malaysia 2006;61(1):5966.
Huang 2010 {published data only}
Huang Z, Huang F, Yan HX, Min Y, Gao Y, Tan BD,
et al.Dysphagia after stroke treated with acupuncture
or electric stimulation: a randomized controlled trial.
Zhongguo Zhen Jiu 2010;30(12):96973.
Jayasekeran 2010 {published data only}
Jayasekeran V, Singh S, Tyrrell P, Michou E, Jefferson S,
Mistry S, et al.Adjunctive functional pharyngeal electrical
stimulation reverses swallowing disability after brain lesions.
Gastroenterology 2010;138(5):173746.
Khedr 2009 {published data only}
Khedr EM, Abo-Elfetoh N, Rothwell JC. Treatment of
post-stroke dysphagia with repetitive transcranial magnetic
stimulation. Acta Neurologica Scandinavica 2009;119(3):
15561.
Kumar 2011 {published data only}
Kumar S, Wagner CW, Frayne C, Zhu L, Selim M, Feng
W, et al.Noninvasive brain stimulation may improve
stroke-related dysphagia: a pilot study. Stroke 2011;42(4):
103540.
Lim 2009 {published data only}
Lim KB, Lee HJ, Lim SS, Choi YI. Neuromuscular
electrical and thermal-tactile stimulation for dysphagia
caused by stroke: a randomized controlled trial. Journal of
Rehabilitation Medicine 2009;41(3):1748.
Liu 2000 {published data only}
Liu L. Acupuncture treatment of bulbar palsy - a report of
54 cases. Journal of Traditional Chinese Medicine 2000;20
(1):302.
Norton 1996 {published data only}
Norton B, Holmes GKT. Percutaneous endoscopic
gastrostomy feeding after acute dysphagic stroke. BMJ
1996;312:9734.
Norton B, Homer-Ward M, Donnelly MT, Long RG,
Holmes GKT. A randomised comparison of percutaneous
endoscopic gastrostomy feeding and nasogastric tube
feeding following acute dysphagic stroke. Gut 1994;35
Suppl 5:S6.
Norton B, Homer-Ward M, Donnelly MT, Long RG,

Homes GKT. A randomised prospective comparison of
percutaneous endoscopic gastrostomy and nasogastric tube
feeding after acute dysphagic stroke. BMJ 1996;312:136.
Norton B, Long RG, Holmes GKT. Tube feedings and le
drawers. Gastroenterology 1996;111:8289.
Sanders H, Newall S, Norton B, Holmes GTK. Gastrostomy
feeding in the elderly after acute dysphagic stroke. Journal
of Nutrition Health and Aging 2000;4(1):5860.
Nutristroke 2009a {published data only}
Garbagnati F, Cairella G, De Martino A, Multari M,
Scognamiglio U, Venturiero V, et al.Is antioxidant and n-
3 supplementation able to improve functional status in
poststroke patients? Results from the Nutristroke Trial.
Cerebrovascular Diseases 2009;27(4):37583.
Nutristroke 2009b {published data only}
Nutristroke 2009c {published data only}
PEGASUS 2004 {unpublished data only}
Barer D. PEGASUS - Percutaneous Endoscopic
Gastrostomy After Stroke. Nutritional support for stroke
patients with dysphagia: a randomised controlled trial.
Outline protocol and unpublished data.
Perez 1997 {published and unpublished data}
Perez I, Smithard DG, Davies H, Kalra L. Pharmacological

treatment of dysphagia in stroke. Dysphagia 1998;13:126.
Smithard D, Perez I, Kalra L. Pharmacological treatment of
dysphagia in stroke. Age and Ageing 1997;26 Suppl 1:40.
Smithard D, Perez I, Kalra L. Pharmacological treatment of
dysphagia in stroke. Cerebrovascular Diseases 1997;7 Suppl
4:36.
Power 2006 {published data only}
Power ML, Fraser DH, Hobson A, Singh S, Tyrell P,
Nicholson DA, et al.Evaluating oral stimulation as a
treatment for dysphagia after stroke. Dysphagia 2006;21(1):
4955.
Rabadi 2008 {published data only}
Rabadi MH, Coar PL, Lukin M, Lesser M, Blass JP.
Intensive nutritional supplements can improve outcomes in
stroke rehabilitation. Neurology 2008;71(23):185661.
Song 2004 {published data only}
Song QL. Swallowing and ingesting training and nursing
in patients with swallowing disorders after stroke. Chinese
Journal of Clinical Rehabilitation 2004;8(19):37223.
Wei 2005 {published data only}
Wei LL. Effect of shuiti acupoint injection with stellate
ganglion block on swallow dysfunction after stroke. Chinese
Yuan 2003a {published data only}
Yuan ZH, Huang LL, Chen ZL. Coagulant and enteral
nutrition agents in the rehabilitation of deglutition disorders
for patients with acute stroke. Chinese Journal of Clinical
Rehabilitation 2003;7(28):38345.
Yuan 2003b {published data only}
Yuan MZ, Huang LR, Chen ZL. Coagulant and enteral
nutrition agent in the rehabilitation of deglutition disorders
References to studies excluded from this review
Akamatsu 2009 {published data only}
Akamatsu C, Ebihara T, Ishizuka S, Fujii M, Seki K, Arai
H, et al.Improvement of swallowing reex after electrical
stimulation to lower leg acupoints in patients after stroke.
Journal of the American Geriatric Society 2009;57(10):
195960.
Akkersdijk 1995 {published data only}
Akkersdijk WL, van Bergeijk JD, van Egmond T, Mulder
CJJ, van Berge Henegouwen GP, van der Werken C, et
al.Percutaneous endoscopic gastrostomy (PEG): comparison
of push and pull methods and evaluation of antibiotic
prophylaxis. Endoscopy 1995;27:3136.
Arai 1998 {published data only}
Arai T, Yasuda Y, Takaya T, Toshima S, Kashiki Y, Yoshimi
N, et al.ACE inhibitors and symptomless dysphagia. Lancet
1998;352:1156.
Arai T, Yasuda Y, Takaya T, Toshima S, Kashiki Y, Yoshimii
N, et al.Angiotensin-converting enzyme inhibitors,
angiotensin II receptor antagonists, and symptomless
dysphagia. Chest 2000;117(6):181920.
Arai T, Ekizawa K. Cabergoline and silent aspiration
in elderly patients with stroke. Journal of the American
Geriatrics Society 2003;51(12):1815.
Baek 1997 {published data only}
Baek S-S, Park S-B, Lee S-G, Lee K-M, Kim S-H. The effect
of neck posture in swallowing of stroke patients. Journal
of Korean Academy of Rehabilitation Medicine 1997;21(1):
812.
Baeten 1992 {published data only}
Baeten C, Hoefnagels J. Feeding via nasogastric tube or
percutaneous endoscopic gastrostomy. A comparison.
Scandinavian Journal of Gastroenterology 1992;27 Suppl
194:958.
Bourdel-Marchasson 2000 {published data only}
Bourdel-Marchasson I, Barateau M, Rondeau V, Dequae-
Merchadou L, Salles-Montaudon N, Emeriau J-P, et
al.A multi-center trial of the effects of oral nutritional
supplementation in critically ill older inpatients. Nutrition
2000;16:15.
Brownsell 2000 {published data only}
Brownsell MD, Mealey PJ, Watkins CL, Jack CIA, Leathley
MJ. A feasibility study of differing methods of parenteral
hydration post-stroke. Consensus Conference on Stroke
Treatment and Service Delivery. Edinburgh: Royal College
of Physicians, 2000:41.
Blow 2008 {published data only}
Blow M, Speyer R, Baijens L, Woisard V, Ekberg O.
Neuromuscular electrical stimulation (NMES) in stroke
patients with oral and pharyngeal dysfunction. Dysphagia
2008;23(3):3029.
Challiner 1994 {published data only}
Challiner Y, Hayward M, Al-Jubouri M, Julious S. Is
subcutaneous rehydration as effective as intravenous in
elderly stroke patients?. Age Ageing 1992;21 Suppl 1:17.
Challiner YC, Jarrett D, Hayward MJ, Al-Jubouri MA,

Julious SA. A comparison of intravenous and subcutaneous
hydration in elderly acute stroke patients. Postgraduate
Medical Journal 1994;70:1957.
Chaudhuri 2006 {published data only}
Chaudhuri G, Brady S, Caldwell R. Electric stimulation for
dysphagia owing stroke: pilot data. Archives of Physical
Medicine and Rehabilitation 2006;87(11):e51.
Chen 2002 {published data only}
Chen F, Zhang X. Tongue acupuncture therapy plus ice
stimulation for treating 50 cases of dysphagia at the acute
stage of sanguineous apoplexy Henan Traditional Chinese
Medicine. Henan Zhong Yi 2002;22(2):59.
Chen Y, Li SY, Wang Y. The impression on the deglutition
disorders due to pseudobulbar palsy treated with
electroacupuncture integrated rehabilitation. Chinese
Chon 2000 {published data only}
Chon JS, Chun S, Kim D-A, Ohn SH, Cho SR, Seo JH,
et al.Effect on diarrhea of dietary soluble ber added to
nasogastric tube-fed formulas in stroke or traumatic brain
injury patients. Journal of Korean Academy of Rehabilitation
Medicine 2000;24(5):8706.
Choudhry 1996 {published data only}
Choudhry U, Barde CJ, Markert R, Gopalswamy N.
Percutaneous endoscopic gastrostomy: a randomized
prospective comparison of early and delayed feeding.
Gastrointestinal Endoscopy 1996;44(2):1647.
Chunhe 1998 {published data only}
Chunhe W, Siqi D, Hualan L, Zhaosheng D. 120 cases of
pseudobulbar paralysis treated by needling Lianquan and
Chize. Journal Traditional Chinese Medicine 1998;18(2):
968.
Cobb 1982 {published data only}
Cobb LM, Cartmill AM, Barry M, Gilsdorf RB. A tube for
enteral nutrition of patients with aphagopraxia and patients
with ventilator assistance. Surgery Gynecology and Obstetrics
1982;155:814.
Cola 2010 {published data only}
Cola PC, Gatto AR, Silva RG, Spadotto AA, Schelp
AO, Henry MACA. The inuence of sour taste and cold
temperature in pharyngeal transit duration in patients with
stroke. Arquivos de Gastroenterologia 2010;47(1):1821.
Davalos 1994 {published data only}
Davalos A. Trial of diet in stroke: high versus low glucose
nasogastric feeding. Unpublished.
deAguilar-Nascimento 2011 {published data only}
de Aguilar-Nascimento JE, Prado Silveira BR, Dock-
Nascimento DB. Early enteral nutrition with whey protein
or casein in elderly patients with acute ischemic stroke:
a double-blind randomised trial. Nutrition 2011;27(4):
4404.
DePippo 1994 {published data only}
DePippo KL, Holas MA, Reding MJ. Dysphagia therapy
following stroke: a controlled trial (abstract). Neurology
1993;43:A2345.
DePippo KL, Holas MA, Reding MJ, Lesser ML, Mandel
FS. Dysphagia therapy following stroke: a controlled trial.
Neurology 1992;42:249.
DePippo KL, Holas MA, Reding MJ, Mandel FS, Lesser

ML. Dysphagia therapy following stroke: a controlled trial.
Neurology 1994;44:165560.
Diboune 1993 {published data only}
Diboune M, Ferard G, Ingenbleek Y, Bourguignat A,
Spielmann D, Scheppler-Roupert C, et al.Soybean oil,
blackcurrant seed oil, medium-chain triglycerides, and
plasma phospholipid fatty acids of stressed patients.
Nutrition 1993;9(4):3449. [: 4658]
Diniz 2009 {published data only}
Diniz PB, Vanin G, Xavier R, Parente MA. Reduced
incidence of aspiration with spoon-thick consistency in
stroke patients. Nutrition in Clinical Practice 2009;24(3):
4148.
Duncan 1996 {published data only}
Duncan HD, Bray MJ, Kapadia SA, Bowling TE, Cole
SJ, Gabe SM, et al.Prospective randomized comparison
of two different sized percutaneous endoscopically placed
gastrostomy tubes. Clinical Nutrition 1996;15:31720.
Ebihara 1993 {published data only}
Ebihara T, Sekizawa K, Nakazaqa H, Sasaki H. Capsaicin
and swallowing reex. Lancet 1993;341:432.
Ebihara 2006 {published data only}
Ebihara T, Ebihara S, Maruyama M, Kobayashi M, Itou A,
Arai H, et al.A randomised trial of olfactory stimulation
using black pepper oil in older people with swallowing
dysfunction. Journal of the American Geriatrics Society 2006;
54(9):14016.
Ebihira 2004 {published data only}
Ebihara T, Takahasi H, Ebihira S, Okazaki T, Sasaki T,
Wabanto A, et al.Theophylline improved swallowing reex
in elderly nursing home patients. Jourmal of the American
Ebihira 2005 {published data only}
Ebihara T, Takahashi H, Ebihara S, Okazaki T, Sasaki T,
Watando A. Capsaicin Trouche for swallowing dysfunction
in older people. Journal of American Geriatrics Society 2005;
53:8248.
EVATT 2005 {published data only}
Hofman Z. Evaluation of gastrointestinal tolerance of a new
thickening powder in patients with dysphagia (# NTR555).
Nederlands Trial Register, 2005. www.trialregister.nl/
trialreg/admin/rctview.asp?TC=555 (accessed 30 August
2012).
Fraser 2002 {published data only}
Fraser C, Power M, Hamdy S, Rothwell J, Hobday D,
Hollander I, et al.Driving plasticity in human adult motor
cortex is associated with improved motor function after
brain injury. Neuron 2002;34(5):83140.
Freed 1996 {published data only}
Freed M, Christian MO, Beytas EM, Tucker H, Kotton B.
Electrical stimulation of the neck: a new effective treatment
for dysphagia. Dysphagia 1996;11:159.
Freed 2001 {published data only}
Freed ML, Freed L, Chatburn RL, Christian M. Electrical
stimulation for swallowing disorders caused by stroke.
Respiratory Care 2001;46(5):46674.
Gallas 2010 {published data only}
Gallas S, Marie JP, Leroi AM, Verin E. Sensory
transcutaneous electrical stimulation improves post-stroke
dysphagic patients. Dysphagia 2010;25(4):2917.
Gandol 2007 {published data only}
Gandol M, Farina S, Gambarin M, Camin M, Fiaschi A,
Tinazzi M, et al.Early rehabilitative treatment of dysphagia
in patients affected by stroke. A case-controlled study.
Proceedings of the Italian Stroke Forum; 2007 Feb 15-16;
Florence, Italy. 2007.
Gossner 1999 {published data only}
Gossner L, Keymling J, Hahn EG, Ell C. Antibiotic
prophylaxis in percutaneous endoscopic gastrostomy (PEG):
a prospective randomized clinical trial. Endoscopy 1999;31
(2):11924. [: 7038]
Goulding 2000 {published data only}
Goulding R, Bakheit AMO. Evaluation of the benets of
monitoring uid thickness in the dietary management of
dysphagic stroke patients. Clinical Rehabilitation 2000;14:
11924.
Ha 2003 {published data only}
Ha L, Hauge T. Percutaneous endoscopic gastrostomy
(PEG) for enteral nutrition in patients with stroke.
Scandinavian Journal of Gastroenterology 2003;38(9):9626.
Hersio 1990 {published data only}
Hersio K, Vapalahti M, Kari A, Takala J, Hernesniemi J,
Tapaninaho A, et al.Impaired utilization of exogenous
amino acids after surgery for subarachnoid haemorrhage.
Acta Neurochirurgica 1990;106:137.
Honda 1990 {published data only}
Honda H, Fukuo Y, Kobayashi Y, Iwasaki M, Terashi A, Seta
K, et al.The trial of the rich-proteined tube alimentation in
the patients with cerebrovascular accident. Stroke 1990;21
(8 Suppl I):I38.
Horiuchi 2008 {published data only}
Horiuchi A, Nakayama Y, Tanaka N, Fujii H, Kajiyama
M. Prospective randomized trial comparing the direct
method using a 24 Fr bumper-button-type device with
the pull method for percutaneous endoscopic gastrostomy.
Endoscopy 2008;40(9):7226.
Huang 2006 {published data only}
Huang, JY, Zhang, DY, Yao, Y, Xia, QX, Fan, QQ. Training
in swallowing prevents aspiration pneumonia in stroke
patients with dysphagia. Journal of International Medical
Research 2006;34:3036.
Huckabee 2006 {published data only}
Huckabee NL, Steele CM. An analysis of lingual
contribution to submental surface electromyographic
measures and pharyngeal pressure during effortful swallow.
Archives of Physical and Medical Rehabilitation 2006;87(8):
106772.
Iizuka 2005 {published data only}
Iizuka M, Reding M. Use of percutaneous endoscopic
gastrostomy feeding tubes and functional recovery in stroke
rehabilitation: a case-matched controlled study. Archives of
Physical Medicine and Rehabilitation 2005;86(5):104952.
Iwasaki 1999 {published data only}
Iwasaki K, Wang Q, Nakagawa T, Suzuki T, Sasaki H. The
traditional Chinese medicine Banxia Houpo Tang improves
swallowing reex. Phytomedicine 1999;6(2):1036.
Kang 2010 {published data only}
Kang Y, Lee HS, Paik NJ, Kim WS, Yang M. Evaluation
of enteral formulas for nutrition, health, and quality of
life among stroke patients. Nutrition Research and Practice
2010;4(5):3939.
Kee 2006 {published data only}
Kee K, Brooks W, Dhami R, Bhalla A. Evaluating the use
of hand mittens in post stroke patients who do not tolerate
naso-gastric feeding. UK Stroke Forum Abstract Book.
2006; Vol. Poster No 39:44.
Kiger 2006 {published data only}
Kiger M, Brown C, Watkins L. Dysphagia management:
an analysis of patients outcomes using VitalStim therapy
compared to traditional swallow therapy. Dysphagia 2006;
21(4):24353.
Kim 2007 {published data only}
Kim MH, Kim MY. The effects of swallowing with
oropharyngeal sensory stimulation in nasogastric tube
insertion in stroke patients. Taehan Kanho Hakhoe Chi
2007;37(4):55867.
Kim 2010 {published data only}
Kim H-G, Oh B-M, Yoon S-J, Han T-R. Inuence of
commercially available food thickeners on the swallowing
function of patients with dysphagia. International Journal of
Stroke 2010;5 Suppl 2:293.
Kobayashi 1996 {published data only}
Kobayashi H, Nakagawa T, Sekizawa K, Arai H, Sasaki H.
Levodopa and swallowing reex. Lancet 1996;348:13201.
Kuhlemeier 2001 {published data only}
Kuhlemeier KV, Palmer JB, Rosenberg D. Effect of liquid
bolus consistency and delivery method on aspiration and
pharyngeal retention in dysphagia patients. Dysphagia
2001;16:11922.
Lien 2001 {published data only}
Lien HC, Chang CS, Yeh HZ, Poon SK, Yang SS, Chen
GH. The effect of jejunal meal feeding on gastroesophageal
reux. Scandinavian Journal of Gastroenterology 2001;36(4):
3436.
Logemann 2009 {published data only}
Logemann JA, Rademaker A, Pauloski BR, Kelly A,
Stangl-McBreen C, Antinoja J, et al.A randomized study
comparing the Shaker exercise with traditional therapy: a
preliminary study. Dysphagia 2009;24(4):40311.
Lopez 2000 {published data only}
Ferero Lopez MI, Grau Santana P, Espuig Bulto D,
Talaero Bolinches C, Botella Trelis JJ. Assessment of the
dietary intake of elderly patients institutionalized with
dysphagia [Valoracion de la ingesta en pacientes ancianos
institucionalizados con disfagia]. Nutricion Hospitalaria
2000;XV(2):7983. [: 6419]
Ludlow 2006 {published data only}
Ludlow CL. A comparison of an implanted neuroprosthesis
with sensory training for improving airway protection in
chronic dysphagia. Stroke Trials Registry, Internet Stroke
Center, www.strokecenter.org/trials (accessed 30 August
2012).
Ludlow 2007 {published data only}
Ludlow C, Humbert I, Saxon K, Poletto C, Sonies B,
Crujido L. Effects of surface electrical stimulation both at
rest and during swallowing in chronic pharyngeal dysphagia.
Dysphagia 2007;22:110.
Macqueen 2003 {published data only}
Macqueen CE, Taubert S, Cotter D, Stevens S, Frost GS.
Which commercial thickening agent do patients prefer?.
Dysphagia 2003;18:4652. [: 7420]
McCormick 2008 {published data only}
McCormick SE, Stafford KM, Saqib G, Chronin DN,
Power D. The efcacy of pre-thickened uids on total uid
and nutrient consumption among extended care residents
requiring thickened uids due to risk of aspiration. Age and
Ageing 2008;37:7145.
Mepani 2009 {published data only}
Mepani R, Antonik S, Massey B, Kern M, Logemann J,
Pauloski B, et al.Augmentation of deglutitive thyrohyoid
muscle shortening by the Shaker Exercise. Dysphagia 2009;
24:2631.
Michou 2010 {published data only}
Michou E, Mistry S, Jefferson S, Singh S, Hamdy SA.
Preliminary study of neurostimulation based interventions
in the treatment of chronic dysphagia post stroke. GUT
2010;59(1):A27.
Michou E, Mistry S, Jefferson S, Singh S, Rothwell

J, Hamdy S. Addressing oropharyngeal dysphagia post
stroke with neurostimulation interventions: a pilot study.
International Journal of Stroke 2010;5 Suppl 3:612.
Michou 2011 {published data only}
Michou E, Mistry S, Jefferson S, Singh S, Rothwell J,
Tyrrell P, et al.Neurostimulation techniques benet stroke
patients with chronic oropharyngeal dysphagia: preliminary
results from a randomised controlled study. Cerebrovascular
Diseases 2011;31(Suppl 2):58.
Nakagawa 1999 {published data only}
Nakagawa T, Wada H, Sekizawa K, Arai H, Sasaki H.

Amantadine and pneumonia. Lancet 1999;353:1157.
Sekizawa K, Yanai M, Yamaya M, Arai H, Sasaki H.
Amantadine and pneumonia in elderly stroke patients.
Lancet 1999;353:2156.
Nakayama 1998 {published data only}
Nakayama K, Sekizawa K, Sasaki H. ACE inhibitor and
swallowing reex. Chest 1998;113(5):1425.
NINDS 2006a {published data only}
NINDS. Volitional swallowing in stroke patients with
chronic dysphagia, 2006. clinicaltrials.gov/ct2/show/
NCT00306501 (accessed 30 August 2012).
NINDS 2007a {published data only}
NINDS. A comparison of an implanted neuroprosthesis
with sensory training for improving airway protection
in chronic dysphagia, 2007. clinicaltrials.gov/ct2/show/
NCT00376506 (accessed 30 August 2012).
Nishiyama 2010 {published data only}
Nishiyama Y, Abe A, Ueda M, Katsura K, Katayama Y.
Nicergoline increases serum substance P levels in patients
with an ischaemic stroke. Cerebrovascular Diseases 2010;29
(2):1948.
Nyswonger 1992 {published data only}
Nyswonger GD, Helmchen RH. Early enteral nutrition
and length of stay in stroke patients. Journal of Neuroscience
Nursing 1992;24:2203.
Oommen 2011 {published data only}
Oommen ER, Kim Y, McCullough G. Stage transition and
laryngeal closure in poststroke patients with dysphagia.
Dysphagia 2011;26(3):31823.
Panos 1994 {published data only}
Panos MZ, Reilly H, Moran A, Reilly T, Wallis PJW, Wears
R, et al.Percutaneous endoscopic gastrostomy in a general
hospital: prospective evaluation of indications, outcome,
and randomised comparison of two tube designs. Gut 1994;
35:15516.
Park 1992 {published and unpublished data}
Park RHR, Allison MC, Lang J, Spence E, Morris AJ,
Danesh BJZ, et al.Randomised comparison of percutaneous
endoscopic gastrostomy and nasogastric tube feeding in
patients with persisting neurological dysphagia. BMJ 1992;
304:14069.
Park 1997 {published data only}
Park CL, ONeill PA, Martin DF. A pilot exploratory study
of oral electrical stimulation on swallow function following
stroke: an innovative technique. Dysphagia 1997;12:1616.
Park J, White AR, James MA, Halsley AG, Johnson
P, Chambers J, et al.Acupuncture for subacute stroke
rehabilitation. A sham controlled subject and assessor blind
randomised trial. Archives of Internal Medicine 2005;165:
202631.
Park T, Kim Y, Ko DH, McCullough G. Initiation and
duration of laryngeal closure during the pharyngeal swallow
in post-stroke patients. Dysphagia 2010;25(3):17782.
Permsirivanich 2009 {published data only}
Permsirivanich W, Tipchatyotin S, Wongchai M,
Leelamanit V, Setthawatcharawanich S, Sathirapanya P,
et al.Comparing the effects of rehabilitation swallowing
therapy vs. neuromuscular electrical stimulation therapy
among stroke patients with persistent pharyngeal dysphagia:
a randomized controlled study. Journal of the Medical
Association of Thailand 2009;92(2):25965.
Pohl 2009 {published data only}
Pohl M, Mayr P, Mertl-Roetzer M, Lauster F, Haslbeck M,
Hipper B, et al.Glycemic control in patients with type 2
diabetes mellitus with a disease-specic enteral formula:
stage II of a randomized, controlled multicenter trial.
Journal of Parenteral and Enteral Nutrition 2009;33(1):
3749.
Power 1997 {published data only}
Power M, Hamdy S, Nicholson D, Aziz O, Tallis RC,
Thompson DG. Effects of liquid consistency on pharyngeal
efciency in stroke patients with and without dysphagia.
Dysphagia 1997;12(2):108.
Pownall 2008 {published data only}
Pownall S, Enderby P, Hendra T, Marshall M. Are thickened
uids worth the trouble? A pilot RCT of dysphagia
management. Proceedings of the 3rd UK Stroke Forum
Conference. Harrogate, UK: The Stroke Association, 2008:
867.
Robbins 2007 {published data only}
Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL,
Gentry LR, et al.The effects of lingual exercise in stroke
patients with dysphagia. Archives of Physical and Medical
Rehabilitation 2007;88:1508.
Robinson 1995 {published data only}
Robinson TG, Potter JF. Postprandial and orthostatic
cardiovascular changes after acute stroke. Stroke 1995;26
(10):18116. [: 2356]
Rosenbek 1991 {published data only}
Rosenbek JC, Robbins J, Fishback B, Levine RL. Effects
of thermal application on dysphagia after stroke. Journal
Speech and Hearing Research 1991;34:125768.
Rosenbek JC. Effects of thermal stimulation on dysphagia
after stroke. Journal of Rehabilitation Research and
Development 1990;28(1):151.
Rosenbek JC, Roecker EB, Wood JL, Robbins J. Thermal

application reduces the duration of stage transition in
dysphagia after stroke. Dysphagia 1996;11:22533.
Rosenbek JC, Robbins JA, Willford WO, Kirk G, Schiltz A,
Sowell TW, et al.Comparing treatment intensities of tactile-
thermal application. Dysphagia 1998;13:19.
Roy 2005 {published data only}
Roy PM, Person B, Souday V, Kerkeni N, Dib N, Asfar P.
Percutaneous radiologic gastrostomy versus nasogastric tube
in critically ill patients. Clinical Nutrition 2005;24:3215.
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Indicates the major publication for the study

C H A R A C T E R I S T I C S O F S T U D I E S
Characteristics of included studies [ordered by study ID]
Aquilani 2008
Methods Computerised randomisation
Double blind
Baseline prognostic factors balanced between treatment groups
Participants 1 centre in Italy
48 patients
Mean age 72 years
Interventions Rx: calorie-protein supplementation (n = 24)
C: routine care (n = 24)
For 21 days
Outcomes Anthropometric and nutritional variables
Cognitive function
Notes Exclusions: aphasic patients, chronic renal failure, diabetes on hypoglycaemic therapy
Risk of bias
Bias Authors judgement Support for judgement
Random sequence generation (selection
bias)
Low risk Randomisation list derived through ran-
dom generator procedure using SAS soft-
ware
Allocation concealment (selection bias) Low risk Computerised randomisation
Randomisation list identied the blinded
treatments as A or B
Blinding (performance bias and detection
bias)
All outcomes
Low risk As above
Blinding of participants and personnel
(performance bias)
All outcomes
Low risk Double-blind
Blinding of outcome assessment (detection
bias)
All outcomes
Low risk Outcome assessor was blinded to the sup-
plementation
Incomplete outcome data (attrition bias)
All outcomes
Low risk
Aquilani 2008 (Continued)
Selective reporting (reporting bias) Low risk
Bai 2007a
Methods Random numbers table
Outcomes not blinded
(medium- versus low-intensity data set)
Participants 1 centre in China
111 patients within 2 weeks of stroke
Baseline characteristics similar
No cross-overs or drop-outs identied
Dysphagia dened by Watian swallow test
Interventions A1: shallow needling (control) (n = 35) = low intensity
A2: single deep needling (n = 18) = medium intensity
B: deep multi-needling
Outcomes Watian drinking test grade
Return to normal diet
Notes Exclusions: needle phobia, infection risk, dementia, inability to co-operate with treat-
ment
Risk of bias
bias)
High risk Randomisationusing a randomnumber ta-
ble
Allocation concealment (selection bias) Unclear risk Unclear
bias)
All outcomes
Unclear risk Unclear
(performance bias)
All outcomes
bias)
All outcomes
High risk Outcomes not blinded
All outcomes
Bai 2007a (Continued)
Selective reporting (reporting bias) Unclear risk Unclear
Other bias Unclear risk Unclear
Bai 2007b
Methods (High versus medium dataset)
Participants As data set 1
Interventions A1: shallow needling (control)
A2: single deep needling (n = 17) = medium intensity
B: deep multi-needling (n = 40) = high intensity
Outcomes As data set 1
Notes -
Risk of bias
bias)
High risk Randomisation using a random number table
bias)
All outcomes
(performance bias)
All outcomes
bias)
All outcomes
High risk Outcomes not blinded
All outcomes
Bath 1997
Methods Computerised randomisation by minimisation
Unblinded outcome assessment
Analysis by ITT
Cross-overs: 3 NGT to PEG, 0 PEG to NGT
Balancing of baseline prognostic factors between treatment groups unclear
Participants 1 centre in UK
19 patients: 8 male
Mean age 77 (SD 11) years
13 ischaemic stroke, 6 haemorrhagic stroke
100% CT
Enrolment within 2 weeks of stroke onset
Interventions Factorial trial: PEG versus NGT; intensive versus conservative swallowing therapy
PEG:NGT: up to 3 NGTs
Intensive swallowing therapy: as for conservative, plus voluntary control (tongue-hold-
ing), sensory stimulation (tactile, oromotor exercises, swallow practice)
Conservative swallowing therapy: review, advice regarding feeding route, postural/dietary
modication, safe swallowing methods
Outcomes Primary outcomes: resumption of safe feeding at 12 weeks, weight loss < 5% at 6 weeks,
discharge by 6 weeks
Secondary outcomes: impairment, disability, handicap, quality of life, tube failures, chest
infection, oropharyngeal delay time (by videouoroscopy) at 4 weeks
Notes Exclusions: oro-gastrointestinal disease, concurrent severe illness, coagulopathy, pre-mor-
bid dependency, severe dementia, psychiatric illness
Follow-up: 3 months
Risk of bias
bias)
Low risk Computerised randomisation by minimi-
sation
Allocation concealment (selection bias) Low risk As above
bias)
All outcomes
High risk Unblinded outcome assessment
Beavan 2010
Methods Computer-based randomisation
Allocation sequence was concealed from researchers and participants
Outcome measurements and the intervention were not blinded to group allocation
Analysis by ITT
Participants 4 centres in UK
104 patients with acute stroke (stroke onset to randomisation median 4 days; IQR 3 to
6 days)
Mean age 80 years
Interventions Rx: NGT + nasal loop (n = 51)
C: NGT + conventional adhesive dressing (n = 53)
Outcomes Primary outcome: proportion of prescribed feed and uids delivered via NGT over 2
weeks after randomisation
Secondary outcome measures at 2 weeks: mean volume of feed and uids delivered,
proportion of participants not receiving any NGTfeed, supplementary parenteral uids,
number of NGT insertions, number of chest X-rays to check NGT position, change in
weight, treatment failure, adverse events, and tolerability
Secondary outcome measures at 3 months: mortality, length of hospital stay, PEG use,
residential status, and Barthel Index
Notes Exclusions: contraindications to NGTfeeding, NGThad been established for more than
7 days elsewhere
Risk of bias
bias)
Low risk Randomisation was based on a computer-
generated pseudo-random list using ran-
dom permutated blocks of randomly vary-
ing size and stratied by site and stroke
severity
Allocation concealment (selection bias) Low risk Recruits were consecutively randomised,
and the allocation sequence was concealed
from researchers and participants until the
end of the trial once all analyses were com-
plete
bias)
All outcomes
High risk Outcome measurements and the interven-
tion were not blinded to group allocation,
owing to the nature of the intervention and
concurrent data collection
Beavan 2010 (Continued)
(performance bias)
All outcomes
High risk As above
Data were analysed independently by the
study statistician, who was blinded to
group allocation
bias)
All outcomes
High risk As above
All outcomes
Low risk
Carnaby 2006a
Blinded outcome assessments by SLT
ITT
(Medium- versus low-intensity data set)
Participants 1 centre in Australia
306 patients, baseline characteristics similar
Enrolment within 2 weeks of stroke onset: mean/median 2 days, range 0 to 12 days
Clinical and videouoroscopic evidence of dysphagia
Interventions Rx 1: standardised high-intensity swallowing therapy (n = 102)
Rx 2: standardised low-intensity swallowing therapy (n = 102); medium = 51
C: usual care. Low = 102
Treatment for up to 1 month
Outcomes Outcomes: time to return to normal diet; aspiration pneumonia; dysphagia (PHAD
score < 85)
Notes Trial completed and published 2006
Exclusions: previous swallowing therapy, head and neck surgery, inability to consent
Follow-up: 6 months
Risk of bias
bias)
Low risk The treatment allocation was based on a
computer-generated random numbers list
generated with the SPSS statistical package
Carnaby 2006a (Continued)
Allocation concealment (selection bias) Low risk The randomisation schedule was held in
the trial ofce, remote from the study en-
vironment; assignment to 1 of 3 treatment
options by giving a telephone
Call to the trial ofce was done by the study
speech pathologist
bias)
All outcomes
High risk All people involved in the study were un-
aware of the treatment allocation, apart
from the patients and the study speech
pathologist who treated the patients
Assigned to the high-intensity and low-in-
tensity groups
(performance bias)
All outcomes
High risk As above
bias)
All outcomes
Low risk Outcome was assessed by an independent
speech pathologist, who was unaware of
the treatment allocation, every month for
6 months after randomisation
All outcomes
Low risk 3 patients were lost to follow-up before the
6-month analysis
Carnaby 2006b
Methods (High vs. medium data set)
Interventions High = 102 (high intensity)
Medium = 51 (low intensity)
Notes -
Risk of bias
bias)
Low risk The treatment allocation was based on a computer-gen-
erated random numbers list generated with the SPSS sta-
tistical package
Carnaby 2006b (Continued)
Allocation concealment (selection bias) Low risk The randomisation schedule was held in the trial ofce,
remote from the study environment; assignment to 1 of
3 treatment options by giving a telephone
Call tothe trial ofce was done by the study speechpathol-
ogist
bias)
All outcomes
High risk All people involved in the study were unaware of the treat-
ment allocation, apart from the patients and the study
speech pathologist who treated the patients
Assigned to the high-intensity and low-intensity groups
(performance bias)
All outcomes
High risk As above
bias)
All outcomes
Low risk Outcome was assessed by an independent speech pathol-
ogist, who was unaware of the treatment allocation, every
month for 6 months after randomisation
All outcomes
Low risk 3 patients were lost to follow-up before the 6-month anal-
ysis
FOOD 1 2005
Blinded outcome assessment by post or telephone
Cross-overs: 3 normal diet to supplement, 48 supplement to normal diet, 79 did not
receive allocated supplements
Participants 125 centres in 15 countries
4023 non-dysphagic patients: 2149 male
Stroke 99%
Enrolment within 30 days of stroke onset
Interventions Rx: protein (22.5 g per day) energy (540 kcal) supplements + normal hospital diet (n =
2011)
C: normal hospital diet (n = 2001)
Outcomes Primary outcomes: dead or dependent (mRS 3 to 6); death at 6 months
Secondary outcomes: place of residence, EURO-QoL, treatment compliance, length of
hospital stay, discharge destination
FOOD 1 2005 (Continued)
Notes Exclusions: dysphagia, SAH
Follow-up: 6 months
Risk of bias
bias)
Low risk Used a computer-generated minimisation
algorithm
Allocation concealment (selection bias) Low risk The randomisationsystems were housedon
a secure server with access permitted, via a
password, only to those members of the co-
ordinating teamwho had been fully trained
how to use the systems
Participating centres were issued with codes
in order for them to access the randomisa-
tion services
bias)
All outcomes
High risk FOOD was an open trial, with both the
randomising person and the patient being
aware of the treatment allocation
The only blinded assessment was the 6-
month follow-up
(performance bias)
All outcomes
High risk As above
bias)
All outcomes
Low risk As above
All outcomes
Low risk 11 lost to follow-up
FOOD 2 2005
Methods Computerised randomisation by minimisation (age, country, predicted poor outcome)
Cross-overs: 58 avoid to early group, 60 did not receive early tube
859 dysphagic patients: 394 male
Stroke 99.5%
Interventions Rx: early (within 7 days) enteral feeding (n = 429)
C: later (after 7 days) enteral feeding (n = 430)
hospital stay, discharge destination, treatment complications
Notes Exclusions: SAH
Follow-up: 6 months
Risk of bias
bias)
algorithm
tion services
bias)
All outcomes
month follow-up
(performance bias)
All outcomes
High risk As above
bias)
All outcomes
Low risk As above
All outcomes
FOOD 3 2005
Cross-overs: 13 in NGT group received early PEG, 23 allocated to PEG received NGT
321 dysphagic patients: 144 male
Stroke 100%
Interventions Rx: PEG feeding (within 3 days of enrolment) (n = 162)
C: NGT (n = 159)
hospital stay, discharge destination, treatment complications
Notes Exclusions: SAH
Follow-up: 6 months
Risk of bias
bias)
algorithm
tion services
bias)
All outcomes
month follow-up
(performance bias)
All outcomes
High risk As above
bias)
All outcomes
Low risk As above
All outcomes
Low risk None lost to follow-up
Gariballa 1998
Methods Method of randomisation: block randomisation by telephone, concealment unclear
Blinding of nutritional outcome measurement only
Analysis by ITT unclear
Cross-overs unclear
Baseline factors balanced
42 non-dysphagic patients with impaired nutritional status (dened as MAC and TSF
1 SD below the mean expected)
Mean age 78 years in intervention and 80 years in control group
All ischaemic stroke
Enrolment within 1 week of stroke onset
Interventions Rx: daily enteral sip feeding and usual hospital food, treatment for 4 weeks (n = 21)
C: usual hospital food (n = 21)
Outcomes Primary outcomes: energy intake and nutritional status (weight, TSF, MAC, albumin,
transferrin, and iron)
Secondary outcomes: 3-month case fatality
Notes Exclusions: dysphagia, normal nutritional status, haemorrhagic stroke, active gastroin-
testinal disease, renal or liver failure, heart failure, sepsis, or malignancy
Follow-up: 3 months
Risk of bias
bias)
Low risk Block randomisation by telephone
Allocation concealment (selection bias) Unclear risk Concealment unclear
bias)
All outcomes
High risk Single blind
Blinding of nutritional outcome measure-
ment only
Gariballa 1998 (Continued)
(performance bias)
All outcomes
High risk Study participants and nurses were aware
of the group to which they were allocated
bias)
All outcomes
Low risk As above
All outcomes
Low risk 4 lost to follow-up immediately after ran-
domisation owing to early discharge as a
result of complete recovery
Garon 1997
Outcomes assessed unblinded
Analysis by ITT
No cross-overs, exclusions post-randomisation, or losses to follow-up
Participants 1 centre in USA
20 patients with documented aspiration of thin uids only: 14 male, 6 female
Mean age 76.8 years
Stroke types unclear
Enrolment within 3 weeks of stroke onset: mean 12.8 days, range 4 to 19 days
Interventions Rx: thickened uids and free water (n = 10)
C: thickened uids only (n = 10)
Treatment until aspiration resolved (7 to 64 days)
Outcomes Outcomes: development of pneumonia, dehydration, and satisfaction
Time to resolution of aspiration to thin uids
Notes Exclusions: aspiration to thickened uids
Follow-up: 30 days beyond resolution of aspiration
Risk of bias
bias)
Low risk Computerised randomisation
Allocation concealment (selection bias) Unclear risk Concealment unclear
Garon 1997 (Continued)
bias)
All outcomes
(performance bias)
All outcomes
bias)
All outcomes
Unclear risk Outcomes assessed unblinded
All outcomes
Low risk No losses to follow-up
Gosney 2006
Methods Computer-generated random numbers by research pharmacist, placebo-controlled dou-
ble blind. Outcomes unblinded
Participants 3 centres in the UK
203 patients
100% stroke
58 with dysphagia, baseline characteristics similar
Interventions Rx: selective decontamination of digestive tract with antibacterial oral gel for 3 weeks (n
= 25)
C: placebo (n = 33)
Outcomes Pneumonia rates
Colonisation with anaerobic gram negative
Bacteria
Barthel Index
SSS
Notes Exclusions: on antibiotics, steroids, or previous stroke
Risk of bias
bias)
Low risk Computer-generated random numbers
Gosney 2006 (Continued)
bias)
All outcomes
Low risk Double blind
(performance bias)
All outcomes
bias)
All outcomes
High risk Outcomes unblinded
All outcomes
High risk Of the 203 patients, 20 died during their
hospitalisation, 19 withdrew and full fol-
low-up was obtained for the remaining 164
Ha 2010
Methods Computer-based randomisation
Blinding unknown
Baseline prognostic factors were balanced between treatment groups
Participants 1 centre in Norway
170 patients < 3 days of acute stroke
5 excluded after randomisation, 41 lost to follow-up (22 died, 19 refused to participate
in follow-up)
Mean age 79 years
Interventions Rx: individualised nutritional treatment (n = 58)
C: routine care (n = 66)
Outcomes Primary: percentage of patients with weight loss > 5%
Secondary: quality of life, hand grip strength, length of hospital stay
Notes Exclusions: stroke diagnosis unclear, critically ill, severe dementia, could not be weighed,
planned discharge < 24 hours after the rst visit by trial assessor
Risk of bias
bias)
Low risk The sequence of treatment allocation was
prepared from a computer-generated ran-
domisation list by a person not involved in
patient assessments
Ha 2010 (Continued)
Allocation concealment (selection bias) Low risk Patients randomised to individualised, nu-
tritional treatment or to routine care in
blocks of 20 patients using sequentially
numbered, non-transparent envelopes con-
taining the treatment allocation informa-
tion
bias)
All outcomes
Unclear risk Blinding unknown
(performance bias)
All outcomes
bias)
All outcomes
All outcomes
High risk 41 lost to follow-up (22 died, 19 refused to
participate in follow-up)
Hamidon 2006
Methods Computer block randomisation, no cross-overs
Unblinded outcome measures
Participants 1 centre in Malaysia
23 patients within 7 days of acute stroke
Dysphagia dened by water swallow test
Interventions Rx: PEG (n = 10)
C: NGT (n = 13)
Outcomes Case fatality, nutritional measures (TSF, MAC, albumin)
Tube failures (blockage or removal)
Notes Exclusions: unclear
Risk of bias
bias)
Low risk Computer block randomisation
Hamidon 2006 (Continued)
bias)
All outcomes
(performance bias)
All outcomes
bias)
All outcomes
High risk Unblinded outcome measures
All outcomes
Huang 2010
Methods Method of randomisation unknown
Blinding unknown
97 patients with post-stroke dysphagia
Interventions Group 1: electric stimulation (n = 35)
Group 2: rehabilitation training group (n = 30)
Group 3: acupuncture (n = 32)
Outcomes Swallowing function
Notes -
Risk of bias
bias)
Unclear risk Method of randomisation unknown
bias)
All outcomes
Huang 2010 (Continued)
(performance bias)
All outcomes
Unclear risk As above
bias)
All outcomes
Unclear risk As above
All outcomes
Jayasekeran 2010
Blinded outcome measures
Balancing of prognostic baseline factors between treatment groups unclear
28 patients with acute anterior circulation cerebral infarct or haemorrhage (< 3 weeks)
Mean age 75 years
Interventions Rx: bedside pharyngeal electrical stimulation
C: sham stimulation
Duration: once daily for 3 consecutive days
Outcomes Airway aspiration at 2 weeks post intervention
Notes Exclusion: dementia, pacemaker or implantable cardiac debrillator, severe receptive
aphasia, unstable cardiopulmonary status, distorted oropharyngeal anatomy (e.g.
pharyngeal pouch), brain-stem stroke, and dysphagia resulting from conditions other
than hemispheric stroke
Risk of bias
bias)
Low risk Computerised randomisation by minimi-
sation
bias)
All outcomes
Jayasekeran 2010 (Continued)
(performance bias)
All outcomes
bias)
All outcomes
Low risk Blinded outcome measures
All outcomes
High risk 3 lost to follow-up
Khedr 2009
Methods Method of randomisation unclear: patients were assigned randomly to receive real or
sham repetitive transcranial magnetic stimulation using closed envelopes
Blinded outcome assessment
Allocation sequence was concealed from participants
Participants 1 centre in Egypt
26 patients between the 5th and 10th days post stroke (monohemispheric)
Mean age 56 years
Interventions Rx: repetitive transcranial magnetic stimulation of the affected motor cortex (n = 14)
C: sham stimulation (n = 12)
Outcomes Primary outcome: score on the dysphagia rating scale
Secondary outcomes: motor power of hand grip, Barthel Index, measures of oesophageal
motor evoked potentials from both hemispheres before and 1 month after sessions
Notes Exclusion: head injury or neurological disease other than stroke, unstable cardiac dys-
rhythmia, fever, infection, hyperglycaemia, and prior administration of tranquilliser
Risk of bias
bias)
Unclear risk Method of randomisation unclear
Allocation concealment (selection bias) Low risk Allocation sequence was concealed from
participants
bias)
All outcomes
Low risk As above
Khedr 2009 (Continued)
(performance bias)
All outcomes
Low risk Patients were informedof whichgroupthey
had been allocated at the end of the last
assessment
bias)
All outcomes
Low risk Blinded outcome assessment
All outcomes
Low risk All patients apart from 1 in the sham treat-
ment group who died completed the trial
and follow-up periods
Kumar 2011
Methods Randomisation using simple randomisation
Double blind
Participants 1 centre in USA
14 patients with subacute (24 to 168 hours) unilateral hemispheric infarction
Mean age 75 years
Interventions Rx: anodal transcranial direct current stimulation
C: sham stimulation
For 5 consecutive days
Outcomes Swallowing impairment using dysphagia outcome and severity scale
Notes Exclusions: patients with difculty following instructions because of obtundation or cog-
nitive impairment, pre-existing swallowing problems, other contraindications to tran-
scranial direct current stimulation
Risk of bias
bias)
Unclear risk Randomisation using simple randomisa-
tion
Allocation concealment (selection bias) Unclear risk As above
bias)
All outcomes
Kumar 2011 (Continued)
(performance bias)
All outcomes
bias)
All outcomes
All outcomes
Lim 2009
Methods Method of randomisation unclear: participants were divided into 2 groups according to
the order of enrolment
Blinding of outcomes unclear
Participants 1 centre in Korea
22 patients with CT or MRI conrmed stroke < 6 months from onset
Mean age 64 years
Interventions Rx: neuromuscular electrical stimulation + thermal-tactile stimulation (n = 13)
C: thermal-tactile stimulation (n = 9)
Outcomes Outcomes: swallow function, scoring system, penetration-aspiration scale and pharyn-
geal transit time
Notes Exclusions: inability to receive the treatment for 1 hour, neurological disease other than
stroke, combined behavioural disorder that interfered with administration of therapy,
current illness or upper gastrointestinal disease, inability togive informedconsent because
of cognitive impairment or receptive aphasia
Risk of bias
bias)
Unclear risk Method of randomisation unclear. Partici-
pants were divided into 2 groups according
to the order of enrolment
Allocation concealment (selection bias) Unclear risk As above
Lim 2009 (Continued)
bias)
All outcomes
Unclear risk No details available
(performance bias)
All outcomes
bias)
All outcomes
All outcomes
High risk 36 enrolled to the study. Only 28 patients
completed the study (16 in the experimen-
tal group and 12 in the control group)
Liu 2000
Methods Method of randomisation unclear
Blinding of outcomes unclear
84 patients with bulbar palsy and CT/MRI documented stroke: male 54, female 30
Age 50 to 78 years
Infarct 56, haemorrhage 28
Enrolment within 2 months of stroke onset
Interventions Rx: acupuncture - Tiantu (CV 22), Lieque (LU 7), Zhaohai (KI 6) - once daily for 10
days (n = 54)
C: (n = 30)
Outcomes Outcome: bulbar function (phonation, swallowing, cough reex)
Timing unclear
Notes Exclusions: not given
Risk of bias
bias)
Liu 2000 (Continued)
bias)
All outcomes
Unclear risk Blinding unclear
(performance bias)
All outcomes
bias)
All outcomes
All outcomes
Norton 1996
Methods Method of randomisation unclear: patients were randomly allocated using closed en-
velopes
Outcome assessments unblinded
Analysis by ITT
No cross-overs, exclusions post-randomisation, or losses to follow-up
Balancing of baseline prognostic factors for treatment groups unclear
30 participants: 11 male
Mean age 77 years
Stroke types not given; CT performed in 25 patients
Enrolment 14 ( 3) days post-admission
All patients were unconscious at admission with a dense hemiplegia
Dysphagia assessed by absence of normal gag reex or inability to swallow 50 mL of
sterile water without choking
Interventions PEG tube (12 French gauge Fresenius or 24 French gauge Wilson Cook) inserted using
percutaneous approach with pull-through. Antibiotic (cefuroxime 750 mg iv) given
prophylactically; sedation with 5 to 10 mg diazepam (n = 16)
NGT (Flocare 500); all patients got standard enteral feed (Nutrison); feed delivered via
Flowcare 500 at 50 mL/hour for rst 24 hours increased to 100 mL/hour; patients fed
in a semi-recumbent position for 6 weeks (n = 14)
Outcomes Case fatality at 6 weeks
Amount of feed administered
Change in nutritional status (MAC, serum albumin, TSF, weight change)
Treatment failure
Length of hospital stay
Number of times tube inserted
Norton 1996 (Continued)
Notes Exclusions: previous history of gastrointestinal disease, unt for endoscopy or iv sedation
Follow-up: 6 weeks
Risk of bias
bias)
Unclear risk Patients were randomly allocated using
closed envelopes
bias)
All outcomes
(performance bias)
All outcomes
bias)
All outcomes
High risk Outcome assessments unblinded
All outcomes
Nutristroke 2009a
Methods Method of randomisation: using a specic list
Double blind
20 patients lost to follow-up
Participants 72 patients, < 60 days from ictus
Interventions Rx: Nutristroke diet + antioxidants (n = 16)
C: Nutristroke diet + placebo (n = 18)
For 12 months
Mean age 65 years
Outcomes Anthropometric measures, neurological/functional status
Notes Exclusions: > 60 days fromictus, haemorrhagic lesions, other chronic disabling patholo-
gies, inability or refusal to give consent
Nutristroke 2009a (Continued)
Risk of bias
bias)
Unclear risk Randomised using a specic list
bias)
All outcomes
Low risk No patient, research assistant, investigator
or any other medical or nursing staff could
distinguish the placebo from the supple-
ments during the study
(performance bias)
All outcomes
Low risk As above
bias)
All outcomes
Low risk As above
All outcomes
High risk 20 drop-outs (27.2%) with 4 deaths (3
males, 1 female) formcardiovascular events
Nutristroke 2009b
Methods -
Participants -
Interventions Rx: Nutristroke diet + n3 fatty acid (n = 20)
Mean age 61 years
Outcomes -
Notes -
Risk of bias
bias)
Nutristroke 2009b (Continued)
bias)
All outcomes
Low risk No patient, research assistant, investigator, or any other medical
or nursing staff could distinguish the placebo from the supple-
(performance bias)
All outcomes
Low risk As above
bias)
All outcomes
Low risk As above
All outcomes
High risk 20 drop-outs (27.2%) with 4 deaths (3 males, 1 female) from
cardiovascular events
Nutristroke 2009c
Methods -
Participants -
Interventions Rx: Nutristroke diet + antioxidants + n3 fatty acid (n = 18)
Mean age 66 years
Outcomes -
Notes -
Risk of bias
bias)
bias)
All outcomes
Low risk No patient, research assistant, investigator, or any other medical
or nursing staff could distinguish the placebo from the supple-
(performance bias)
All outcomes
Low risk As above
bias)
All outcomes
Low risk As above
Nutristroke 2009c (Continued)
All outcomes
High risk 20 drop-outs (27.2%) with 4 deaths (3 males, 1 female) from
cardiovascular events
PEGASUS 2004
Outcome assessment blinding unclear
Cross-overs not given
63 dysphagic patients: gender ratio unclear
Enrolled at 5 to 7 days post stroke
Interventions Rx: PEG within 10 days of stroke (n = 32)
C: no PEG for at least 15 days post stroke (n = 31)
Outcomes Primary outcome: unclear
Secondary outcomes: changes in anthropometric (MAC, TSF, BMI), haematological,
and biochemical measures (haemoglobin and serum albumin); dependency; activities of
daily living; chest infection
Notes Exclusions: none given
Follow-up: days 7 and 21 and at discharge
Risk of bias
bias)
bias)
All outcomes
(performance bias)
All outcomes
bias)
All outcomes
PEGASUS 2004 (Continued)
All outcomes
Perez 1997
Triple-blind trial; outcomes assessed by blinded therapist
Analysis by ITT
No cross-overs or losses to follow-up
1 participant withdrawn with heart failure (nifedipine group)
17 patients; 8 male
All rst ischaemic stroke
100% CT
Enrolment 2 weeks after stroke
Interventions Rx: nifedipine (LA 30 mg orally daily, Bayer UK) (n = 8)
Pl: matching tablet; treatment for 4 weeks (n = 9)
Outcomes Primary outcome: clinical improvement in swallowing
Other outcomes: incidence of silent aspiration, pharyngeal transit time and response
duration, swallowing delay (all assessed by videouoroscopy), death
Notes Exclusions: unable to sit, high clinical risk of aspiration, receptive dysphasia, cognitive
impairment, pre-stroke dysphagia, existing neurological or psychiatric disease, current
treatment with calcium channel blockers or aminophylline
Follow-up: 4 weeks. 1 patient withdrawn with heart failure
Risk of bias
bias)
Low risk Computerised randomisation
bias)
All outcomes
Low risk Triple-blind trial
(performance bias)
All outcomes
Low risk Triple-blind trial
Perez 1997 (Continued)
bias)
All outcomes
Low risk Outcomes assessed by blinded therapist
All outcomes
Low risk 1 participant withdrawn with heart failure
(nifedipine group)
No cross-overs
Power 2006
CT scans were analysed by a neuroradiologist who was blinded to the patients clinical
presentation and videouoroscopic swallowing status
Baseline data unclear
16 patients
Interventions Rx: actual electrical stimulation following threshold setting exercise
C: single episode of sham electrical stimulation following threshold setting exercise
Outcomes Changes on videouoroscopy 60 minutes post intervention
Notes Exclusions: prior dysphagia, intercurrent illness, other neurological disease
Risk of bias
bias)
bias)
All outcomes
(performance bias)
All outcomes
bias)
All outcomes
Power 2006 (Continued)
All outcomes
Rabadi 2008
Methods Method of randomisation: sealed opaque envelope block randomisation of 10 patients
Double blind
Participants 1 centre in US < 4 weeks of stroke
Mean age 74 years
Interventions Rx: intensive nutritional supplementation (n = 51)
C: routine nutritional supplementation (n = 51)
Outcomes Primary: change in total score on the FIM
Secondary: FIM motor and cognitive subscores, length of stay, 2-minute and 6-minute
timed walk tests measured at admission and on discharge and discharge disposition
Notes Exclusions: prior history of alcohol abuse, renal and liver disease, malabsorption, medi-
cally unstable or demented, terminally ill, participating any other therapeutic trial
Risk of bias
bias)
Low risk Identical sealed opaque envelope contain-
ing block randomisation of 10 patients
bias)
All outcomes
(performance bias)
All outcomes
Low risk As above
bias)
All outcomes
Low risk As above
All outcomes
Rabadi 2008 (Continued)
Song 2004
Methods Method of randomisation: random numbers table
Allocation method and concealment unclear
53 patients; 46 male
All dysphagia identied by water swallow test
Baseline characteristics reported as similar
Interventions Rx: nurse-led swallowing exercises, oral stimulation and oral care (n = 29)
C (n = 24)
Follow-up: 1 month
Outcomes Primary and secondary outcomes not dened
Resolution of dysphagia by water swallow test and dietary ability, pneumonia rates
Notes Exclusions and whether ITT not stated
Risk of bias
bias)
bias)
All outcomes
(performance bias)
All outcomes
bias)
All outcomes
All outcomes
Wei 2005
Outcomes blinded
68 patients, timing post stroke unclear, but suggest acute
Dysphagia dened by water swallow test
Interventions Rx: Shuiti acupoint injection with stellate ganglion block for 40 days of treatment (n =
32)
C: received standard medical care which included some acupuncture (n = 33)
Outcomes Resolution of dysphagia: water swallow test score
Barthel Index
Chinese Neurological Score
Fugyl-Meyer
Notes Exclusions: needle phobia, organ failure, head and neck tumours
Exclusions and drop-outs accounted for but not analysed by ITT
Risk of bias
bias)
bias)
All outcomes
(performance bias)
All outcomes
bias)
All outcomes
Low risk Outcomes blinded
All outcomes
Yuan 2003a
Blinding unclear
(Medium- versus low-intensity data set)
64 patients, timing unclear
All dysphagia as dened by Watian swallow test
Interventions R1: enteral nutrition agent with thickener and swallowing therapy (high data set = 18)
R2: traditional liquid diet and swallowing therapy (n = 22) (medium data set = 11)*
C: liquid diet only and no swallowing therapy (n = 24) (low data set = 24)*
(R1 and R2 had NGTs for an uncertain amount of time)
*Compared in data set 1
Outcomes Length of stay, pneumonia rates, nutritional measures, resolution of dysphagia (Swallow
test grade)
Notes Exclusions: terminal illness, organ failure
Unclear if any blinding of interventions or outcomes occurred
Risk of bias
bias)
bias)
All outcomes
(performance bias)
All outcomes
bias)
All outcomes
All outcomes
Yuan 2003b
Methods (High versus medium data set)
Interventions High intensity (n = 18)
Medium intensity (n = 11)
Notes -
Risk of bias
bias)
bias)
All outcomes
(performance bias)
All outcomes
bias)
All outcomes
All outcomes
BMI: body mass index
C: control group
CT: computer tomography
FIM: Functional Independence Measure
ITT: intention-to-treat analysis
IQR: interquartile range
iv: intravenous
MAC: mid-upper arm circumference
MD: mean difference
MRI: magnetic resonance imaging
mRS: modied Rankin Score
NGT: nasogastric tube
OR: odds ratio
PEG: percutaneous endoscopic gastrostomy
PHAD: Paramatta Hospitals Assessment for Dysphagia score
Pl: placebo group
Rx: treatment group
SAH: subarachnoid haemorrhage
SD: standard deviation
SLT: speech and language therapist (speech pathologist)
SSS: Scandinavian Stroke Scale
TSF: triceps skinfold
VF: videouoroscopy
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Akamatsu 2009 RCT assessing transcutaneous electrical stimulation versus control
12 patients with chronic stroke and episodes of choking while eating or drinking
Outcome: latency time in swallowing reex
Excluded: no outcome data
Akkersdijk 1995 RCTassessing PEGinsertionmethods and antibiotic prophylaxis indysphagic patients, oropharyngeal
carcinoma (n = 56, 56%), neurogenic (n = 32, 32%), other (n = 12, 12%)
Group 1: Pull PEG and antibiotic prophylaxis
Group 2: Pull PEG
Group 3: Push PEG
Outcome: total complication rate
Excluded: dysphagia of mixed aetiology (stroke % unknown)
Arai 1998 CCT assessing ACE inhibitors in dysphagic and non-dysphagic stroke patients
Outcomes: aspiration (technetium scanning), biochemistry (substance P)
Excluded: (1) not RCT; (2) patients > 3 months post stroke
Arai 2000 Non-RCT comparing imidapril with losartan 53 patients with hypertension, symptomless dysphagia,
and history of stroke
Outcome: serum substance P level
Excluded: (1) non-RCT; (2) comparing 2 active treatments; (3) no outcome data
Arai 2003 RCT
Group 1: cabergoline (n = 13)
Group 2: amantadine (n = 14)
Group 3 : ACE inhibitor (n = 12)
Group 4: Control
Excluded: (1) > 3 months post stroke; (2) denition of aspiration non-standard; (3) randomisation
unclear; (4) insufcient information
(Continued)
Baek 1997 Study comparing effect of neck posture on swallowing latency in stroke patients and controls
Outcome: onset latency of swallowing
Excluded: (1) not RCT; (2) comparison of stroke and control participants
Baeten 1992 RCT comparing PEG and NGT feeding in 90 dysphagic patients with neurological problems (n =
42, 47%), ear nose and throat disease (n = 39, 43%) or post-surgery (n = 9, 10%)
Outcomes: time for insertion, length of enteral feeding, tubes used, complications, convenience
Excluded: (1) dysphagia of mixed aetiology (stroke % unknown)
Bourdel-Marchasson 2000 Cluster RCT assessing effect of oral supplements (400 kcal per day) on pressure ulcers
Outcomes: pressure ulcers, serum albumin
Excluded: (!) most patients not stroke (< 25%); (2) randomised by wards (cluster), not patients
Brownsell 2000 RCT assessing hydration routes in 17 dysphagic stroke patients
Group 1: slow subcutaneous uids (n = 6)
Group 2: bolus subcutaneous uids (n = 6)
Group 3: intravenous uids (n = 5)
Outcomes: mean volume infused, hydration status, weight change, infection
Excluded: (1) outcome measures not relevant to this review
Blow 2008 RCT assessing neuromuscular electrical stimulation versus traditional swallowing therapy in 25 stroke
patients with dysphagia
Outcomes: videoradiographic swallowing evaluation, nutritional status, oral motor function test, and
a visual analogue scale (VAS) for self-evaluation of complaints
Excluded: (1) no outcome data
Challiner 1994 RCT assessing hydration routes in 34 elderly acute stroke patients with either impaired consciousness
or dysphagia
Group 1: subcutaneous uids (n = 17)
Group 2: intravenous uids (n = 17)
2 litres of dextrose-saline/day given for 3 days
No difference in serum osmolality; subcutaneous hydration cheaper
Excluded: (1) outcome measures not relevant to this review
Chaudhuri 2006 RCT assessing effectiveness of electric stimulation versus traditional dysphagia therapy in patients
with acute stroke (< 6 weeks)
Outcomes: The American Speech Language Hearing Association National outcome measurement
system swallowing level
Chen 2002 RCT assessing tongue acupuncture + ice massage + general medical treatment (n = 50) versus general
medical treatment (n = 46) in acute dysphagic stroke patients
Outcome: dysphagia recovery assessed using videouoroscopy
Excluded: (1)unable to obtain data
Chen 2003 RCT assessing electroacupuncture + rehabilitation (n = 34) versus rehabilitation alone (n = 34) in
dysphagia patients with pseudobulbar palsy including stroke
Treated for 10 days
Outcome: dysphagia recovery after stroke
(Continued)
Chon 2000 RCT assessing feed bre content on diarrhoea severity and frequency
Group 1: no bre (n = 15)
Group 2: moderate bre (3.5 g/L) (n = 15)
Group 3: high bre (7 g/L) (n = 15)
Excluded: (1) mixed group of stroke and brain injury patients; (2) no relevant outcomes
Choudhry 1996 RCT assessing timing of feeding: 3 hours (n = 21) versus 24 hours (n = 20) - following insertion of
PEG tube in 41 dysphagic patients (stroke n = 17) requiring PEG
Outcomes: death, fever, infection, residual volume
Excluded: (1) most patients not stroke
Chunhe 1998 Case control study assessing acupuncture at Lianquan (Ren 23) and Chize (Lu 5) in 150 patients with
stroke causing pseudo bulbar palsy
Outcome: resolution of dysphagia
Excluded: (1) not RCT
Cobb 1982 Quasi-RCT (alternate assignment) comparing 2 nasogastric tubes in 41 dysphagic patients on a
ventilator (n = 28, 68%) or with stroke or head injury (n = 13, 32%)
Group 1: Cartmill NGT, 6 French gauge
Group 2: Dobbhoff NGT, 8 French gauge
Outcomes: ease of placement, passage of NGT beyond ligament of Treitz by 48 hours, tube blockage
Excluded: (1) dysphagia of mixed aetiology (stroke < 32%); (2) outcomes not relevant
Cola 2010 Observational study to determine the effect of sour and cold food in the pharyngeal transit times of
30 patients with stroke
Outcome: pharyngeal transit time using a videouoroscopy swallow test
Excluded: (1) non1RCT
Davalos 1994 Unpublished study comparing high versus lowglucose in NGTfeeding in 70 dysphagic stroke patients
No further information on trial design, protocol, patients, interventions, outcomes
deAguilar-Nascimento 2011 RCT comparing early NGT feeding with a standard formula containing hydrolyzed casein versus a
formula containing hydrolyzed whey protein in 31 acute (< 48 hours) ischaemic stroke patients
Outcome: changes in the serum levels of glutathione peroxidase, C-reactive protein, and interleukin
6
Excluded: (1) treatment is confounded, i.e. 2 active groups and no control
DePippo 1994 RCT comparing 3 active interventions in 115 dysphagic stroke patients taught compensatory swal-
lowing techniques
Group 1: patient/family choice of diet and food consistency (n = 38)
Group 2: therapist prescribed diet and food consistency (n = 38)
Group 3: therapist prescribed diet and food consistency, with daily reinforcement of compensatory
swallowing techniques (n = 39)
Outcomes: pneumonia, dehydration, caloric-nitrogen decit, death
Excluded: (1) 3 active treatment groups with no control group (confounded)
(Continued)
Diboune 1993 RCT comparing 3 enteral diets differing only in lipid composition in 36 dysphagic patients with head
injury (n = 15), stroke (n = 13) or other neurological problems (n = 8)
Group 1: soybean oil
Group 2: soybean oil and medium-chain triglycerides
Group 3: soybean oil, medium-chain triglycerides and blackcurrant seed oil
Outcomes: plasma phosphatidylcholine and fatty acid composition
Excluded: (1) most patients not stroke; (2) feed composition not relevant to review
Diniz 2009 Crossover RCT comparing liquid and spoon-thick (pudding-like) feeds in 61 inpatients diagnosed
with stroke
Outcome: aspiration using nasoendoscopy
Excluded: (1) compared 2 active treatments; (2) no relevant outcome data
Duncan 1996 RCT comparing PEG tube size in 52 dysphagic patients (83% stroke)
Group 1: PEG tube, 12 French gauge
Outcomes: mortality, infection, leakage, tube blockage
Excluded: (1) dysphagia of mixed aetiology (stroke 83%); (2) intervention (tube size) not relevant to
this review
Ebihara 1993 RCT assessing dose response relationship of capsaicin (1E-9-1E-6 mol/L) on swallowing reex in 20
patients with stroke or vascular dementia
Outcomes: swallowing latency
Excluded: (1) patients did not have dysphagia
Ebihara 2006 RCT
Group 1: black pepper oil (n = 35)
Group 2: lavender oil (n = 35)
Group 3: water (n = 35)
Excluded: (1) nursing home residents (not acute); (2) outcomes: swallowing time, cerebral blood ow,
substance P; (3) denition and degree of dysphagia unclear; (4) not all stroke; (5) > 3 months post
stroke
Ebihira 2004 RCT
Group 1: theophylline 200 mg od
Group 2: placebo
N = 85 with mild to moderate dysphagia (denition unclear)
Outcome: latency of swallow
Excluded: (1) nursing home residents (not acute), proportion of stroke patients not stated; (2) > 3
months post stroke
Ebihira 2005 RCT
Group1: capsaicin troche 1.5 mcg (n = 34)
Group 2: placebo (blinded) (n = 33) for 4 weeks
Excluded: (1) predominantly stroke (%not stated) nursing home dependent residents; (2) denition
of dysphagia unclear; (3) > 3 months post stroke; (4) outcomes: latency of swallow not of interest to
review
(Continued)
EVATT 2005 RCT including 50 patients with dysphagia following stroke
Evaluation of gastrointestinal tolerance of a new thickening powder versus current thickening powder
Outcome: GI symptoms (measurements: stool frequency and consistency, GI symptoms and food and
uid intake)
Excluded: 2 active treatment groups with no control group (confounded)
Fraser 2002 RCT including 16 acute stroke (< 4 days from ictus) patients with dysphagia
Transcranial magnetic stimulation versus none
Outcome: pharyngeal electromyographic responses
Freed 1996 CCT comparing 3 active interventions in 112 patients with aspiration
Group 1: electrical stimulation
Group 2: thermal stimulation
Group 3: both - failed thermal stimulation followed by electrical stimulation
Outcome: regain oral intake
Excluded: (1) dysphagia of mixed aetiology (stroke ?%); (2) not RCT; (3) 2 active treatment groups
with no control group (confounded)
Freed 2001 Quasi-RCT (alternate assignment) comparing electrical stimulation with thermal-tactile stimulation
in 110 dysphagic stroke patients
Outcome: swallow score
Excluded: (1) 2 active treatment groups with no control group (confounded)
Gallas 2010 Non-RCT transcutaneous electrical stimulation applied submentally to 11 patients with recent
oropharyngeal dysphagia (> 8 weeks) induced by a hemispheric (n = 7) or brainstem (n = 4) stroke,
with pharyngeal residue and/or laryngeal aspiration diagnosed by videouoroscopy
Outcome: dysphagia handicap index questionnaire, videouoroscopy, and cortical mapping of pha-
ryngeal muscles
Excluded: (1) no control group
Gandol 2007 A case-controlled study of early rehabilitation treatment (5 days/week for 2 weeks) in acute dysphagic
stroke patients
Excluded: (1) non-RCT
Gossner 1999 RCT assessing 2 antibiotic regimes with control in 347 patients with cancer or neurological disorders
Outcome: peristomal wound infection (size, number)
Excluded: (1) most patients not stroke; (2) no relevant outcomes
Goulding 2000 RCT assessing methods for preparing thickened uids in 46 dysphagic stroke patients
Group 1: uids thickened using a viscometer
Group 2: uids thickened subjectively
Outcomes: aspiration, viscosity of thickened uids
Excluded: (1) no outcomes
Ha 2003 Non-RCT assessing the use of PEG for enteral nutrition in patients admitted for stroke
Control: patients with other diseases
(Continued)
Hersio 1990 RCT assessing amino acid regimes versus control in 69 patients with SAH requiring post-operative
parenteral nutrition
Outcome: nitrogen balance
Excluded: (1) no relevant outcomes
Honda 1990 Study assessing feed protein content in 39 dysphagic tube-fed stroke patients
Outcomes: biochemistry, haematology
Excluded: (1) insufcient information on trial design, protocol
Horiuchi 2008 RCT comparing the direct method using a 24 Fr bumper-button-type device with the pull method
for percutaneous endoscopic gastrostomy in 140 patients with stroke and other CNS disorders
Outcome: rate of peristomal infections
Excluded: (1) time since stroke onset to randomisation not provided for stroke patients
Huang 2006 Study of 96 consecutive patients within 24 hours of acute stroke
Before and after study of swallowing exercises delivered by trained nurse
Huckabee 2006 Pharyngeal electrical stimulation
Excluded: (1) healthy volunteers; (2) not RCT
Iizuka 2005 Retrospective case-matched controlled study in 193 stroke patients with a PEG tube and matched
193 controls
Outcome: length of rehabilitation hospital stay, improvement in FIM scores, FIM efciency score,
need for transfer back to acute care hospital, diagnosis for which transfer was required, nal discharge
destination, and survival status
Iwasaki 1999 CCT assessing Banxia Houpo Tang in 32 patients with previous ischaemic stroke and pneumonia
Group 1: Banxia Houpo Tang 1.5 g thrice daily before meals for 4 weeks
Group 2: placebo - lactose 1.5 g thrice daily before meals for 4 weeks
Outcomes: swallowing reex latency (EMG), saliva (substance P)
Excluded: (1) not RCT; (2) study not acute/subacute
Kang 2010 RCT comparing 2 different commercial enteral formulas in 12 acute ( 3 months) stroke patients
Outcome: nutritional biomarkers and an oxidative stress biomarker, malondialdehyde (MDA), quality
of life
Excluded: (1) comparison between 2 active treatments, no control group
Kee 2006 Case control study
Intervention : use of mittens
Outcomes: pneumonia, number of NGTs, CXRs, feed delivered, weight change
Kiger 2006 Case control group
Group 1: deep pharyngeal stimulation and VitalStim
Group 2: control
Excluded: (1) not randomised; (2) not all stroke
(Continued)
Kim 2007 Non-RCT assessing the effects of swallowing with oropharyngeal sensory stimulation in nasogastric
tube insertion in 32 stroke patients
Outcome: oro-pharyngeal swallowing function score
Kim 2010 RCT comparing 2 food thickeners on swallowing function in 51 patients with stroke
Outcome: changes of videouoroscopic swallowing study clinical score
Excluded: (1) no time since stroke onset; (2) comparing 2 treatments, no control group; (3) no
outcome data
Kobayashi 1996 Randomised crossover trial assessing levodopa in 27 patients with basal ganglia infarction and 20
healthy volunteers
Outcomes: swallowing latency
Excluded: (1) crossover trial; (2) outcomes (swallowing latency) not relevant to this review; (3) < 50%
stroke
Kuhlemeier 2001 Non-randomised crossover study assessing uid consistency (thin, thick, ultra-thick) and delivery
method (teaspoon, cup) in 190 dysphagic patients
Outcomes: aspiration on videouoroscopy
Excluded: (!) not RCT; (2) dysphagia of mixed aetiology (stroke 61%)
Lien 2001 Crossover trial comparing liquid meal versus saline on gastro-oesophageal reux in 15 PEG gastroje-
junal tube-fed stroke patients (9 with, 6 without oesophagitis)
Outcomes: Oesophageal pH
Excluded: (1) crossover trial; (2) outcomes not relevant to this review
Logemann 2009 RCT assessing either traditional swallowing therapy or the Shaker exercise in patients with prolonged
oropharyngeal dysphagia and aspiration
Outcomes: occurrence of aspiration (preswallow, intraswallow, postswallow) at the 6-week follow-up
period, occurrence of residue in the oral cavity, valleculae, or pyriform sinuses and the Performance
Status Scale for Diet
Excluded: (1) head and neck cancer and stroke; (2) no outcome data
Lopez 2000 RCT assessing liquid diets (thickener, gelatinised water) in 16 dysphagic patients with stroke
Outcomes: intake
Excluded: (1) confounded with no control group
Ludlow 2006 Implanted neuroprosthesis (neuro control implantable receiver-stimulator) to stimulate the laryngeal
nerve versus sensory training in dysphagic patients including stroke > 6 months post onset
Excluded: (1) no control group, 2 active groups compared; (2) no outcome data
Ludlow 2007 Observational
N = 21 dysphagic patients
Intervention: electrical stimulation
Excluded: (1) proportion of stroke unclear; (2) chronic dysphagic patients; (3) not RCT
Macqueen 2003 Crossover trial assessing thickening agents in 8 dysphagic patients (stroke n = 6) and 13 volunteers
Outcome: palatability (visual analogue scale)
Excluded: (1) no relevant outcomes; (2) most participants non-stroke; (3) not RCT
(Continued)
McCormick 2008 RCT comparing pre-thickened, standarised consistency uids for 6 weeks versus uids thickened at
the bedside using modied maize starch for 6 weeks in 11 dysphagic patients in residential care
Outcomes: Barthel Index, Mini Mental State Examination
Excluded: (1) no control group, 2 active interventions
Mepani 2009 RCTcomparing traditional swallowing therapy versus Shaker Exercise in6 stroke and 5 cancer patients
Outcome: deglutitive thyrohyoid shortening before and after completion of assigned therapy regimen
Excluded: (1) no time of onset for stroke patients; (2) no separate results for stroke (3) no outcome
data
Michou 2010 RCT comparing transcranial magnetic stimulation versus sham stimulation 12 stoke patients with
dysphagia
Outcome: pharyngeal electromyographic responses
Michou 2011 RCT comparing transcranial magnetic stimulation versus pharyngeal electrical stimulation versus
paired associative stimulation versus sham stimulation in 14 dysphagic stroke patients
Outcome: videouoroscopic swallowing assessments
Nakagawa 1999 RCT comparing amantadine (100 mg daily) versus control in 185 ischaemic stroke patients
Outcome: pneumonia
Excluded: (1) patients > 3 months of stroke onset
Nakayama 1998 RCT comparing 5 mg imidapril or placebo in randomised, double-blind, crossover design. Patients
were normotensive patients had at least one episode of aspiration and healthy volunteers
Outcome: swallowing reex
NINDS 2006a Non-RCT comparing several techniques designed to improve the ability to swallow in stroke patients
with chronic dysphagia with healthy volunteers
Outcome: swallowing safety
NINDS 2007a RCT assessing intramuscular stimulation device implanted in the neck versus vibrotactile stimulation
of the throat in 20 patients with dysphagia secondary to stroke or chronic neurological disease
Outcome: swallowing safety for 10 mL of thin liquid and 5 mL of pudding with and without stimu-
lation
Excluded: (1) comparing 2 active treatments no control (confounded)
Nishiyama 2010 RCT comparing nicergoline (15 mg tds) versus control in 50 ischaemic stroke patients
Outcome: substance P level
Nyswonger 1992 Retrospective case control study assessing timing of feeding (< 72 hours versus > 72 hours of admission)
in 52 dysphagic stroke patients
Outcome: length of stay
(Continued)
Oommen 2011 Non-RCT assessing effects of changes in bolus consistency involving 60 stroke patients and 20 healthy
non-neurologically impaired patients
Outcomes: stage transition duration and laryngeal closure duration
Excluded: (1) non-RCT; (2) no outcome data
Panos 1994 RCT assessing PEG tube size in 56 dysphagic patients (51% stroke)
Outcomes: time for insertion, infection (including aspiration pneumonia), leakage, tube blockage,
tube fracture, ease of removal, death, anthropometric measures
Excluded: (1) dysphagia of mixed aetiology (stroke 51%); (2) intervention (tube size) not relevant to
this review
Park 1992 RCT comparing PEG with NGT feeding in 40 dysphagic patients
Outcomes: treatment failure, tube removal, tube blockage, patient refusal
Excluded: (1) dysphagia of mixed aetiology (cerebrovascular disease 45%); (2) only 5 of these were
enrolled within 2 months of stroke onset; (3) individual patient data unavailable so not possible to
analyse subgroup of appropriate patients
Park 1997 Single case study assessing oral (palatal) electrical stimulation in 4 stroke patients with chronic dys-
phagia
Outcomes: swallow function, transit time
Excluded: (1) not RCT; (2) non-acute patients
Park 2005 RCT
Group1: acupuncture (n = 56)
Group 2: sham acupuncture (n = 60)
All stroke
Excluded: (1) small number of dysphagic patients (13%); (2) intervention not targeted at dysphagia
Park 2010 Non-RCT measuring initiation of laryngeal closure and laryngeal closure duration in 3 groups of
patients: (1) 10 stroke patients who aspirated before and during the swallow, (2) 10 stroke patients
who did not aspirate, and (3) 10 normal control patients
Outcome: initiation of laryngeal closure and laryngeal closure duration
Permsirivanich 2009 RCT
Group 1: neuromuscular electrical stimulation (n = 12)
Group 2: rehabilitation swallowing therapy (n = 11)
All stroke
Excluded: (1) counfounded, i.e. comparison of 2 active treatments
Pohl 2009 RCT assessing disease specic enteral formula versus standard formula in 105 patients with type 2
diabetes mellitus and neurological dysphagia
Outcome: total insulin requirements, fasting glucose, afternoon blood glucose, HbA1C and safety
criteria
Excluded: (1) time since stroke onset to randomisation unclear
(Continued)
Power 1997 Non-randomised crossover study assessing uid consistency (thin, thick) and volume (5 ml, 10 ml,
cup) in 21 dysphagic stroke patients
Outcomes: functional swallow, aspiration on videouoroscopy
Pownall 2008 RCT assessing thickened uids versus postural and/or swallowing strategies in 50 patients with post-
stroke dysphagia: a further group of patients who were not dysphagic for liquids and who were given
normal uids compared with the RCT
Outcome: development of chest infection and dehydration
Excluded: (1) no control group, 2 interventional groups were compared in the RCT
Robbins 2007 Before and after intervention study
6 acute stroke patients
4 patients > 3 months post stroke
Intervention: lingual exercise programme
Excluded: (1) non-RCT; (2) stroke > 3 months
Robinson 1995 Crossover trial assessing oral energy load (glucose or xylose) in 9 patients with stroke and 8 matched
control participants
Outcomes: blood pressure, heart rate, forearm vascular resistance
Excluded: (1) no relevant outcomes; (2) crossover trial; (3) not dysphagic patients
Rosenbek 1991 Randomised crossover trial assessing thermal stimulation in 7 male dysphagic patients with multiple
previous strokes
Outcome: duration of stage transition
Excluded: (1) crossover trial; (2) most patients recruited > 3 months after stroke onset; (3) randomi-
sation status unclear
Rosenbek 1996 Randomised crossover trial assessing thermal stimulation in 23 dysphagic patients with multiple
previous strokes
Outcome: duration of stage transition, total swallow duration
Excluded: (1) crossover trial; (2) 14 patients recruited > 3 months after stroke onset
Rosenbek 1998 Dose comparison RCT of thermal stimulation (150, 300, 450, 600 trials per week) in 45 dysphagic
stroke patients recruited within 12 weeks
Outcome: number of trials delivered, treatment time, duration of stage transition, aspiration (pene-
tration-aspiration scale)
Excluded: (1) no control group
Roy 2005 Nasogastric tube versus percutaneous radiologic gastrostomy in critically ill patients admitted to
intensive care unit and requiring gastric tubing
Excluded: (1) no control, 2 active treatments; (2) no data for stroke patients
Sanz-Paris 1999 RCT comparing enteral formulae - rich in monounsaturated fatty acid versus rich in carbohydrates -
in 15 diabetic dysphagic stroke patients
Outcomes: ketones at 7, 14 and 21 days
Excluded: (1) no relevant outcomes; (2) time of stroke uncertain
(Continued)
Schneider 2006 Multi bre enriched formula for 2 weeks versus bre-free formula in dysphagic patients on long-term
enteral nutrition
Outcome: faecal short-chain fatty acids and microbiota
Excluded: (1) no control group, confounded trial
Seki 2005 Randomised trial
Group 1: acupuncture (n = 18)
Group 2: no intervention (n = 14)
Exclude: (1) incomplete outcome data; (2) time from stroke unclear; (3) insufcient data available at
time of review
Sekizawa 1998 Case control study assessing ACE inhibitors in stroke patients
Outcomes: pneumonia
Excluded: (1) not RCT; (2) patients > 3 months post stroke
Shaker 2002a RCT comparing head-raising exercise with sham exercise in 27 dysphagic patients
Outcomes: upper oesophageal sphincter function, functional swallow status
Excluded: (1) dysphagia of mixed aetiology (cerebrovascular disease 56%); (2) most patients recruited >
3 months after stroke onset; (3) individual patient data unavailable so not possible to analyse subgroup
of appropriate patients
Smith 2007 RCT comparing NGT and NJT feeding in patients with dysphagia following stroke
Excluded: (1) unable to obtain data
Stahlman 2001 Crossover trial comparing pureed and moulded peaches in 15 dysphagic patients (stroke n = 10) and
15 normal volunteers
Outcome: taste perception
Excluded: (1) no relevant outcomes; (2) crossover trial
Suchner 1996 RCT comparing enteral with parenteral nutrition in 49 tube fed patients post-neurosurgery
Outcomes: biochemistry, energy supply, Glasgow Coma Scale
Excluded: (1) dysphagia of mixed aetiology (intracerebral haemorrhage 6%)
Sukthankar 1994 RCT assessing swallowing therapy (biofeedback) in 9 patients with dysphagia secondary to stroke or
head injury
Group 1: regular therapy (n = 4)
Group 2: regular therapy and oral exercises (n = 2)
Group 3: regular therapy and oral exercises with visual and audio biofeedback (n = 3)
Excluded: (1) dysphagia of mixed aetiology; (2) outcome measures (tongue and lip motor force) not
relevant to this review
Suojaranta 1996 RCT amino acid compositions in 30 patients 12 hours post-surgery for SAH
Outcome: release of amino acids
Excluded: (1) no relevant outcomes
Taylor 2006 3 meals per day (regular menu and portions) versus 5 meals of same energy content in elderly residents
of an extended care facility suffering from dysphagia
Outcome: effect on energy intake
Excluded: (1) confounded, no control group, no data for stroke patients
(Continued)
Teramoto 2008 RCT assessing swallowing function using cilostazol versus placebo in 48 patients with dysphagia
secondary to stroke
Outcom: swallowing function
Excluded: (1) onset of stroke to randomisation 1 to 6 months; (2) crossover study no access to data
on the rst phase
Ueda 2004 21 patients
Group 1: functional swallowing training (n = 11)
Group 2: oral care (n = 11) in nursing home residents (% stroke unknown) who are tube fed
Excluded: (1) < 50% stroke; (2) non-acute; (3) randomisation unclear
van den Hazel 2000 RCT assessing PEG tube composition in 106 patients with mixed indications for tube feeding
Group 1: polyurethane PEG tube, 15 French gauge
Group 2: silicone PEG tube, 16 French gauge
Outcomes: complications, tube complication-free survival, tube failure
Excluded: (1) dysphagia of mixed aetiology (stroke 21%); (2) outcomes not relevant
Varma 2006 Group 1: motor control programme (n = 30)
Group 2: home exercise programme (n = 30)
Randomisation method unclear
Excluded: (1) insufcient data; (2) timing: > 3 months post stroke; (3) outcome methods unclear
Verin 2009 Non-RCTassessing repetitive transcranial magnetic stimulation in patients with post stroke dysphagia
Outcomes: dysphagia handicap index and videouoroscopy
Excluded: (1) non-RCT; (2) no control group
Verin 2011 Non-RCT assessing submental sensitive transcutaneous electrical stimulation in 13 patients with
neurogenic oropharyngeal dysphagia
Outcomes: swallowing function using a standardised videouoroscopic barium swallow
Excluded: (1) non-RCT; (2) no control group
Whelan 2001 RCT assessing uid consistency in 24 dysphagic acute stroke patients
Group 1: pre-thickened uids
Group 2: powder-thickened uids
Outcomes: uid intake, hydration status (biochemistry), infection
Excluded: (1) 2 active interventions compared (confounded)
Wimbury 1990 Non-randomised assessment of speech and language therapy referrals for assessment of speech and
swallowing in elderly patients, 40% of whom had a stroke
Group 1: 2 wards who lled in a questionnaire relating to speech and swallowing problems in 162
admissions
Group 2: 2 wards who did not ll in a questionnaire in 233 admissions
Outcome: referral rate to speech and language therapy service
Excluded: (1) not RCT; (2) dysphagia of mixed aetiology (stroke 40%)
Yang 2002 Non-RCT of acupuncture and sublingual blood letting
Excluded: (1) timing unclear; (2) no control group (confounding); (3) not RCT
(Continued)
Yumin 2004 Randomisation unclear, timing unclear
Group 1: scalp + sublingual needling (n = 44)
Group 2: scalp acupuncture (n = 38)
Excluded: (1) both groups received scalp acupuncture and different forms of needling (not clear which
being evaluated); (2) timing: > 6 months post stroke; (3) baseline swallowing function unclear; (4)
how swallowing outcomes were assessed unclear
Zarling 1994 Crossover trial assessing bre supplementation in dysphagic stroke patients
Group 1: Ultracal (contains 14.4 g/L of bre)
Group 2: Isocal HN
Outcomes: bowel movements, faecal weight, intestinal transit time
Excluded: (1) patients recruited after 3 months; (2) interventions not relevant to this review; (3)
outcomes not relevant to this review
Zhang 2011 RCT comparing different depth of Chonggu (EX-HN 27) by electroacupuncture in patients of
dysphagia after stroke
Chonggu (EX-HN 27) deep insertion group (n = 99)
Chonggu (EX-HN 27) shallow insertion group (n = 94)
Traditional acupuncture group (n = 90)
Outcomes: Kubotas Water Drinking Test Scale, standard swallowing function scale and TCM Scale
of Dysphagia After Stroke
Zhou 2006 High proteinenteral nutritionformula versus standard enteral nutritionformula for 14 days inpatients
with severe stroke
Outcome: survival, hypoalbumenia
Excluded: (1) no control group confounded trial; (2) unable to obtain data
ACE: angiotensin converting enzyme
CCT: controlled clinical trial
CXR: chest x-ray
FIM: Functional Independence Measure
GI: gastrointestinal
NJT: nasojejunal tube
RCT: randomised controlled trial
SAH: subarachnoid haemorrhage
TCM: traditional Chinese medicine
Characteristics of studies awaiting assessment [ordered by study ID]
Ayada 2006
Methods RCT
Participants Patients with dysphagia owing to neurological diseases
Interventions PEG using transnasal endoscopy or transoral endoscope
Outcomes Safety, pain, stress
Notes In the process of retrieving full-text article
Baek 2008
Methods RCT
Participants Dysphagic patients
Interventions NGT versus control
Bai 2007
Methods RCT
Participants Dysphagic stroke patients
Interventions Shallow versus deep versus deep multi-needling
BourdelMarchasson 2000
Methods RCT
Participants Elderly critically ill inpatients at risk of pressure ulcer development
Interventions Nutritional supplements versus control
Outcomes Not available in the study summary
BourdelMarchasson 2000 (Continued)
Carnaby-Mann 2005
Methods RCT comparing of 2 medication delivery systems
Interventions Rapitab orally disintegrating pill versus conventional pill
Outcomes Swallow effort, airway compromise and patient preference
Chen 2005
Methods RCT
Participants Acute dysphagic stroke patients
Interventions Early interventiontoimprove swallowing including altering shape of food, posture, nasal feeding, throat swab training,
and electroacupuncture versus control
Cheng 2005
Methods RCT
Participants Ischaemic stroke patients with pseudobulbar palsy
Interventions Early throat muscle training versus control
Outcomes Effects on vertebral and basilar artery blood ow
Ciocon 1992
Methods RCT
Participants Elderly patients (mostly dysphagic stroke patients)
Interventions Intermittent versus continuous NGT feeding
Doyle 2006
Methods RCT
Participants Dysphagic nursing home residents
Interventions 200 g (8 oz) versus 100 g (4 oz) servings of thickened drinks
Outcomes Effect on food consumption and hydration potential
Elmstahl 1987
Methods RCT
Participants Long-term geriatric inpatients (including stroke)
Interventions Comparison of 3 dietary supplements
Outcomes Effect on dietary intake, anthropometric variables and biochemical analyses
Germain 2006
Methods RCT
Participants Frail elderly nursing home patients (including stroke)
Interventions Reformed foods and thickened beverages versus traditional food
Outcomes Effect on dietary intake and weight
Groher 1987
Methods RCT
Participants Patients with pseudobulbar dysphagia
Interventions Pureed diet with thin liquids versus soft mechanical diet with thickened liquid
Outcomes Incidence of aspiration pneumonia
Han 2004
Methods RCT
Participants Acute stroke patients with dysphagia and dysarthria
Interventions Scalp and neck acupuncture + electroacupuncture versus control
Horiuchi 2006
Methods RCT
Participants Patients with dysphagia
Interventions PEGplacement by single physician using endoscope holder versus PEGplacement by 2 physicians using conventional
pull method
Jefferson 2008
Methods RCT
Participants Chronic dysphagic stroke patients
Interventions Repetitive transcranial magnetic stimulation versus sham stimulation over the unaffected pharyngeal motor cortex
Outcomes Measurements of cortico-pharyngeal excitability
Kostadima 2005
Methods RCT
Participants Mechanically ventilated stroke and head injury patients
Interventions Percutaneous gastrostomy versus NGT
Outcomes Ventilator-associated pneumonia
Lin 2003
Methods RCT
Participants Stroke patients with dysphagia
Interventions Structured swallowing training programme versus no training
Liu 2004
Methods RCT
Participants Stroke patients with pseudobulbar paralysis
Interventions Scalp acupuncture + sublingual needling versus scalp acupuncture + control needling
Lu 2005
Methods RCT
Participants Patients with stroke
Interventions Continuous versus intermittent nasogastric feeding
Outcomes Gastrointestinal haemorrhage
Maetani 2005
Methods RCT
Interventions Peg placement with or without an over tube
Outcomes Peristomal infection
Natarajan 2007
Methods Randomised cross-over study
Interventions Clear uid (10 mL tap water) versus thickened uid (10 mL tap water with a scoop of Nutilis thickener)
Outcomes Aspiration and oxygen saturation
Nowicki 2003
Methods RCT
Interventions Manual + electro-acupuncture (6 to 8 treatments 2 to 3 times per week for 3 weeks) versus control
Ouyang 2003
Methods RCT
Participants Patients with severe cerebral infarction
Interventions Modied enteral nutrition versus traditional nutrition
Outcomes Nutritional status and gut function
Pohl 2005
Methods RCT
Participants Tube-fed type II diabetic patients with neurological dysphagia (primarily stroke)
Interventions Comparison of 2 enteral feeding formulae (low carbohydrates + high monounsaturated fatty acids (Diben) versus
standard formula)
Outcomes Glycaemic control
Reidnauer 2006
Methods RCT
Participants Post stroke patients with dysphagia
Interventions Vital stimulation (and electrotherapy intervention) versus traditional treatment
Singh 2006
Methods RCT
Participants Acute dysphagic stroke patients
Interventions Pharyngeal electrical stimulation versus no treatment
Outcomes Aspiration scores at 2 weeks
Steidl 2002
Methods RCT
Participants Hemiplegic stroke patients
Interventions Carnitine versus placebo
Stiegmann 1990
Methods RCT
Participants Patients referred for placement of feeding gastrostomy (majority neurological)
Interventions Operative gastrostomy versus PEG
Sun 2008
Methods RCT
Participants Patients with dysphagia after stroke
Interventions Acupuncture at Lianquan, Yamen and Tian Zhu acupoints versus VitalStim therapy
Tajiri 2008
Methods RCT
Participants Acute stroke patients needing gastrointestinal tube feeding
Interventions Tube feeding by immunonutrition-oriented or protein-oriented food
Outcomes Short-term clinical outcomes
Toyama 2007
Methods RCT
Participants Dysphagic patients (including stroke)
Interventions Extra-corporeal PEG versus pull method PEG
Wang 2000
Methods RCT
Participants Acute haemorrhage stroke patients
Interventions Continuous parenteral nutrition for 7 days versus glucose control
Xue 2004
Methods RCT
Participants Patients with post-stroke dysphagia
Interventions Early rehabilitation + acupuncture versus control
Yang 2008
Methods RCT
Participants Post stroke dysphagic patients
Interventions FES 40 minutes/day versus FES 40 minutes twice daily
Zhang 2007
Methods RCT
Participants Dysphagic stroke patients with poor elevation of the larynx
Interventions Comparison of 2 methods of larynx elevation (15 minutes, 5 x day for 4 weeks)
Zheng 2006
Methods RCT
Participants Acute stroke patients with dysphagia within 72 hours of admission
Interventions NGT feeding versus nasal feeding of liquid diet
Zhong 2003
Methods RCT
Participants Dysphagic stroke patients 15 to 40 days post stroke
Interventions Head acupuncture versus body acupuncture versus control
Zhou 2002
Methods RCT
Participants Patients with severe stroke
Interventions High protein enteral nutrition formula versus standard enteral nutrition formula
Outcomes Survival and risk of hypoalbuminaemia
FES: functional electrical stimulation
Characteristics of ongoing studies [ordered by study ID]
Carnaby-Mann 2008
Trial name or title Adjunctive Neuromuscular electrical Stimulation for the Rehabilitation of Swallowing ANSRS
Methods RCT, double blind (participant, investigator, outcomes assessor)
Participants 53 stroke patients with dysphagia
Interventions Arm 1: usual care, Arm 2: sham neuromuscular electrical stimulation, Arm 3: neuromuscular electrical
stimulation
Outcomes Clinical response at 3 weeks and 3 months post treatment
Starting date 2008
Contact information Giselle Carnaby-Mann, University of Florida
Notes Funding: University of Florida, National Center for Medical Rehabilitation Research
Clav 2011
Trial name or title Effect of transcutaneous electrical stimulation on post-stroke dysphagic patients EETI-01
Methods RCT, safety and efcacy study
Participants Post-stroke dysphagic patients
Interventions Sensory stimulation versus motor stimulation
Outcomes Not provided
Starting date 2011
Contact information Pere Clav, MD, pclave@csdm.cat 937417700
Notes Funding: Hospital de Matar Lead, CIBEREHD
Hamdy 2003
Trial name or title A randomised controlled trial of pharyngeal electrical stimulation in the treatment of dysphagia after brain
injury
Methods RCT Phase II
Participants Hospitalised stroke patients within 6 weeks of their stroke
Hamdy 2003 (Continued)
Interventions Pharyngeal electrical stimulation versus control
Outcomes Swallow function
Starting date 2003
Contact information Prof ShaheenHamdy, Hope Hospital, Clinical Sciences Building, Department of GI Sciences, Hope Hospital,
Stott Lane, Salford, Greater Manchester, M6 8HD, UK
Notes Funding: NIHR Research for Patient Benet
He 2009
Trial name or title Clinical evaluation of dysphagia therapeutic apparatus on cerebrovascular disease
Methods RCT
Participants Stroke patients 2 to 60 days from onset
Interventions Dysphagia therapeutic apparatus on acupoints versus regular dysphagia rehabilitation versus both
Outcomes Dysphagia therapeutic apparatus versus control
Starting date 2009
Contact information Chengqi He, No. 37, Guoxue Alley, Wuhou District, Chengdu, Sichuan, China
Notes Funding: State Plan for High-Tech Research and Development
Kalra 2011
Trial name or title Respiratory muscle training instroke. Evaluationof respiratory muscle strengthening to reduce chest infections
in stroke patients with swallowing problems
Methods RCT Phase II
Participants 60 ischaemic stroke patients with dysphagia aged between 50 to 80 years
Interventions Expiratory muscle, inspiratory muscle or sham training
Outcomes Aspiration, cough, chest infections, respiratory muscle strength
Starting date 2011
Contact information Prof Lalit Kalra, Kings College Hospital NHS Trust, Kings College Hospital NHS Trust, Bessemer Road,
London, SE5 9PJ, UK
Kalra 2011 (Continued)
Notes Funding: NIHR - Central commissioning facility
Lye 2003
Trial name or title Comparison of intravenous and subcutaneous bolus infusion in post-stroke hydration
Methods -
Participants Patients: 150
Multicentre
Interventions Intravenous versus subcutaneous hydration
Outcomes -
Starting date 2000
Contact information Prof M Lye, Department of Geriatrics, 3rd Floor Duncan Building, Daulby Street, Liverpool, L69 3GB UK
Notes Funding: NHS Executive North West (16,500)
Matsumoto 2010
Trial name or title Effect of electrical stimulation in post-stroke patients with dysphagia
Methods RCT, open but assessors are blinded
Participants Post-stroke patients with dysphagia
Interventions Electrical stimulation versus control
Outcomes Videouorography, Fujishimas grade, motion analysis
Starting date 2010
Contact information Shuji Matsumoto, Department of Rehabilitation and Physical Medicine, Kagoshima Universit, y3930-7
Takachiho, Makizono-cho, Kirishima City, Japan
Notes Funding: self funding
McCullough 2010
Trial name or title Identifying and treating arousal related decits in neglect and dysphagia
Methods Randomised, double-blind (participant, investigator), cross-over assignment
Participants Stroke patients with neglect, dysphagia
Interventions Modanil 200 mg once daily versus placebo for 3 days
Outcomes Predicting response to modanil among participants with neglect, dysphagia
Starting date 2010
Contact information Gary McCullough, gmccullough@uca.edu
Notes Funding: University of Arkansas, Eunice Kennedy Shriver National Institute of Child Health and Human
Development
Robbins 2011
Trial name or title Exercise for swallowing problems after stroke
Methods Randomised, open label
Participants 200 post-stroke patients
Interventions Group 1: lingual press (high-intensity, oral, non-swallowing)
Group 2: effortful swallowing (high-intensity swallowing)
Group 3: natural swallowing (high-frequency, low-intensity swallowing)
Group 4: non-oral sham (control) exercise
Outcomes Composite score of Penetration/Aspiration Scale and Residue Scale with no worsening of either at baseline,
week 4, and week 8
Starting date 2011
Contact information Jacqueline Hind, MS jahind@wisc.edu
Notes Funding: Department of Veterans Affairs Lead, University of Wisconsin, Madison
SQACU01 2001
Trial name or title SQACU01 - a randomised trial of acupuncture as adjuvant therapy for dysphagia due to recent stroke
Methods
Participants Acute stroke < 1 week
Size: ?
SQACU01 2001 (Continued)
Interventions Acupuncture versus sham acupuncture for 16 sessions
Outcomes Tube feeding, pneumonia, mortality, each at 6 months
Starting date 2001
Contact information Dr D Heng, Clinical Trials & Epidemiology Research Unit, Ministry of Health, Block A, Unit 02-02, 226
Outram Road, Singapore 169039
Notes Funding: ?
Further information awaited
Steele 2011
Trial name or title Tongue Pressure Prole Training for dysphagia post stroke TPPT
Methods Randomised, single blind (outcomes assessor)
Participants 60 patients with thin liquid ow-control difculties secondary to stroke or acquired brain injury
Interventions Compare 2 different tongue-pressure resistance training protocols
Tongue-pressure prole training versus tongue-pressure strength-and-accuracy training
Outcomes Primary: change in penetration-aspiration scale
Secondary: change in bolus control for thin liquids on videouoroscopy versus baseline
Starting date 2011
Contact information Catriona M Steele, Toronto Rehabilitation Institute, Canada
Notes Funding: Toronto Rehabilitation Institute
STEPS 2012
Trial name or title Swallowing Treatment using Electrical Pharyngeal Stimulation (STEPS) study
Methods Randomised, single blind, outcome blind
Participants 140 patients with post-stroke dysphagia < 6 weeks
Interventions Pharyngeal electrical stimulation: active versus sham
Outcomes Primary: change in penetration-aspiration scale at 2 weeks from baseline; secondary: Toronto Bedside Swal-
lowing Screening Test, Dysphagia Severity Rating Scale, National Institute of Health Stroke Scale, modied
Rankin Scale
STEPS 2012 (Continued)
Starting date March 2012
Contact information Philip M Bath, University of Nottingham, 0115 823 1765
Notes Funding: Phagenesis Ltd
TOAD 2009
Trial name or title Randomised controlled open label trial to evaluate tolerance and safety of a new pre-thickened energy dense
sip feed in patients in need of oral nutritional support
Methods RCT, open label
Participants Dysphagic patients requiring oral nutritional support
Interventions Pre-thickened sip feed versus a standard sip feed thickened with a commercially available thickening powder
Outcomes Stool frequency, incidence and intensity of gastrointestinal symptoms, safety parameters in blood
Starting date 2009
Contact information Dr A Vriesema, Numico Research BV, PO Box 7005, 20 Bosrand Road, Wageningen, 6700 CA, The Nether-
lands
Notes Funding: Danone Research BV
Verin 2007
Trial name or title Cortical neuromodulation in post stroke dysphagia
Methods RCT, double blind (participant, investigator), efcacy study
Participants 20 patients with post-stroke dysphagia
Interventions Sub-motor threshold stimulation of mylohyoid muscles versus control
Outcomes Videouoroscopy before and after (once a day for 5 consecutive days)
Starting date 2007
Contact information Eric Verin, Rouen University, France
Notes Funding: University Hospital, Rouen
Xie 2007
Trial name or title Randomised controlled study on the acupuncture for dysphagia in convalescence phase of apoplexy
Methods RCT
Participants Patients with dysphagia in the convalescence phase of stroke (2 and 6 months)
Interventions Combination of body acupuncture, scalp acupuncture and electroacupuncture versus routine rehabilitation
training
Outcomes Safety and tolerability of the acupuncture
Starting date 2007
Contact information Yue Xie, 9-312, No. 32 Fuxing Road, Haidian District, Beijing, China
Notes Funding: Beijing Public Health Bureau
D A T A A N D A N A L Y S E S
Comparison 1. Swallowing therapy
Outcome or subgroup title
No. of
studies
No. of
participants
Statistical method Effect size
1 Case fatality at end of trial 6 Odds Ratio (M-H, Random, 95% CI) Subtotals only
1.1 Behavioural interventions 2 306 Odds Ratio (M-H, Random, 95% CI) 0.83 [0.46, 1.51]
1.2 Drug therapy 1 17 Odds Ratio (M-H, Random, 95% CI) 1.14 [0.06, 21.87]
1.3 Pharyngeal electrical
stimulation
1 28 Odds Ratio (M-H, Random, 95% CI) 4.31 [0.19, 98.51]
1.4 Physical stimulation
(thermal, tactile)
1.5 Transcranial magnetic
stimulation
2 Death or dependency at end of
trial
2 Odds Ratio (M-H, Random, 95% CI) Subtotals only
3 Institutionalisation 2 Odds Ratio (M-H, Random, 95% CI) Subtotals only
4 Length of stay (days) 4 Mean Difference (IV, Random, 95% CI) Subtotals only
4.1 Behavioural interventions 4 370 Mean Difference (IV, Random, 95% CI) -2.70 [-5.68, 0.28]
5 Chest infection or pneumonia 7 Odds Ratio (M-H, Random, 95% CI) Subtotals only
stimulation
6 Dysphagia at end of trial 13 Odds Ratio (M-H, Random, 95% CI) Subtotals only
6.1 Acupuncture 4 256 Odds Ratio (M-H, Random, 95% CI) 0.24 [0.13, 0.46]
6.4 Neuromuscular electrical
stimulation
(thermal, tactile)
6.6 Transcranial direct current
stimulation
7 Pharyngeal transit time (seconds) 3 Mean Difference (IV, Random, 95% CI) Subtotals only
7.1 Drug therapy 1 17 Mean Difference (IV, Random, 95% CI) -0.21 [-0.91, 0.49]
stimulation
1 28 Mean Difference (IV, Random, 95% CI) -0.15 [-0.51, 0.20]
(thermal, tactile)
1 16 Mean Difference (IV, Random, 95% CI) -0.19 [-0.34, -0.04]
8 Swallow score 5 Mean Difference (IV, Random, 95% CI) Subtotals only
8.1 Acupuncture 3 175 Mean Difference (IV, Random, 95% CI) -0.41 [-1.53, 0.72]
8.2 Neuromuscular electrical
stimulation versus behavioural
interventions
0 0 Mean Difference (IV, Random, 95% CI) 0.0 [0.0, 0.0]
(thermal, tactile)
1 16 Mean Difference (IV, Random, 95% CI) 1.40 [-2.58, 5.38]
8.4 Transcranial direct current
stimulation
9 Nutritional (albumin) 2 Mean Difference (IV, Random, 95% CI) Subtotals only
9.1 Behavioural interventions 2 64 Mean Difference (IV, Random, 95% CI) 0.20 [-4.77, 5.17]
Comparison 2. Route of feeding
No. of
studies
No. of
participants
1.1 PEG versus NGT 5 455 Odds Ratio (M-H, Random, 95% CI) 0.81 [0.42, 1.56]
1.2 NGT with loop versus
NGT
trial
NGT
NGT
4 Length of stay in hospital (days) 3 Mean Difference (IV, Random, 95% CI) Subtotals only
4.1 PEG versus NGT 2 384 Mean Difference (IV, Random, 95% CI) 14.32 [-12.04, 40.
68]
NGT
5 Pressure sores 2 Odds Ratio (M-H, Random, 95% CI) Subtotals only
NGT
6 Chest infection or pneumonia 3 Odds Ratio (M-H, Random, 95% CI) Subtotals only
NGT
7 Dysphagia at end of trial 2 Odds Ratio (M-H, Random, 95% CI) Subtotals only
8 Treatment failure 4 Odds Ratio (M-H, Random, 95% CI) Subtotals only
NGT
9 Gastrointestinal bleeding 2 Odds Ratio (M-H, Random, 95% CI) Subtotals only
NGT
10 Feed delivery (%) 2 Mean Difference (IV, Random, 95% CI) Subtotals only
10.1 PEG versus NGT 1 30 Mean Difference (IV, Random, 95% CI) 22.0 [16.15, 27.85]
NGT
1 104 Mean Difference (IV, Random, 95% CI) 18.0 [6.66, 29.34]
11 Weight at end of trial (last value
carried forward) (kg)
2 Mean Difference (IV, Random, 95% CI) Subtotals only
11.1 PEG versus NGT 2 34 Mean Difference (IV, Random, 95% CI) 4.08 [-4.32, 12.48]
12 Mid-arm circumference (last
value carried forward) (cm)
12.1 PEG versus NGT 3 58 Mean Difference (IV, Random, 95% CI) 2.29 [-0.30, 4.89]
13 Albumin (last value carried
forward) (g/L)
13.1 PEG versus NGT 3 63 Mean Difference (IV, Random, 95% CI) 4.92 [0.19, 9.65]
Comparison 3. Timing of feeding
No. of
studies
No. of
participants
1.1 Early versus late feeding 1 859 Odds Ratio (M-H, Random, 95% CI) 0.79 [0.61, 1.04]
2 Death or disabled at end of trial 1 Odds Ratio (M-H, Random, 95% CI) Subtotals only
Comparison 4. Fluid supplementation
No. of
studies
No. of
participants
1 Time to resolution of dysphagia
(days)
1.1 Free thin uids 1 20 Mean Difference (IV, Random, 95% CI) -8.10 [-20.84, 4.64]
Comparison 5. Nutritional supplementation
No. of
studies
No. of
participants
1.1 Sip feeding 7 4343 Odds Ratio (M-H, Random, 95% CI) 0.58 [0.28, 1.21]
trial
3.1 Sip feed 1 102 Odds Ratio (M-H, Random, 95% CI) 0.48 [0.22, 1.07]
4 Length of stay in hospital (days) 2 Mean Difference (IV, Random, 95% CI) Subtotals only
4.1 Sip feeding 2 4114 Mean Difference (IV, Random, 95% CI) 1.40 [-0.81, 3.60]
5 Pressure sores 2 Odds Ratio (M-H, Random, 95% CI) Subtotals only
6 Energy intake (kcal/day) 3 Mean Difference (IV, Random, 95% CI) Subtotals only
6.1 Sip feeding 3 174 Mean Difference (IV, Random, 95% CI) 430.18 [141.61,
718.75]
7 Protein intake (g/day) 3 Mean Difference (IV, Random, 95% CI) Subtotals only
7.1 Sip feeding 3 174 Mean Difference (IV, Random, 95% CI) 17.28 [1.99, 32.56]
8 Albumin (last value carried
forward)
8.1 Sip feeding 2 144 Mean Difference (IV, Random, 95% CI) 0.29 [-0.65, 1.24]
Analysis 1.1. Comparison 1 Swallowing therapy, Outcome 1 Case fatality at end of trial.
Review: Interventions for dysphagia and nutritional support in acute and subacute stroke
Comparison: 1 Swallowing therapy
Outcome: 1 Case fatality at end of trial
Study or subgroup Treatment Control Odds Ratio Weight Odds Ratio
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 Behavioural interventions
Carnaby 2006a 10/51 23/102 51.9 % 0.84 [ 0.36, 1.93 ]
Carnaby 2006b 17/102 10/51 48.1 % 0.82 [ 0.35, 1.95 ]
Subtotal (95% CI) 153 153 100.0 % 0.83 [ 0.46, 1.51 ]
Total events: 27 (Treatment), 33 (Control)
Heterogeneity: Tau
2
= 0.0; Chi
2
= 0.00, df = 1 (P = 0.97); I
2
=0.0%
Test for overall effect: Z = 0.61 (P = 0.54)
2 Drug therapy
Perez 1997 1/8 1/9 100.0 % 1.14 [ 0.06, 21.87 ]
Subtotal (95% CI) 8 9 100.0 % 1.14 [ 0.06, 21.87 ]
Heterogeneity: not applicable
3 Pharyngeal electrical stimulation
Jayasekeran 2010 2/16 0/12 100.0 % 4.31 [ 0.19, 98.51 ]
Subtotal (95% CI) 16 12 100.0 % 4.31 [ 0.19, 98.51 ]
0.002 0.1 1 10 500
Therapy better Therapy worse
(Continued . . . )
(. . . Continued)
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
4 Physical stimulation (thermal, tactile)
Bath 1997 7/11 5/8 100.0 % 1.05 [ 0.16, 6.92 ]
Subtotal (95% CI) 11 8 100.0 % 1.05 [ 0.16, 6.92 ]
5 Transcranial magnetic stimulation
Khedr 2009 0/14 1/12 100.0 % 0.26 [ 0.01, 7.12 ]
Subtotal (95% CI) 14 12 100.0 % 0.26 [ 0.01, 7.12 ]
0.002 0.1 1 10 500
Analysis 1.2. Comparison 1 Swallowing therapy, Outcome 2 Death or dependency at end of trial.
Outcome: 2 Death or dependency at end of trial
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
Carnaby 2006a 35/51 72/102 49.5 % 0.91 [ 0.44, 1.89 ]
Carnaby 2006b 72/102 34/51 50.5 % 1.20 [ 0.58, 2.47 ]
Subtotal (95% CI) 153 153 100.0 % 1.05 [ 0.63, 1.75 ]
Heterogeneity: Tau
2
= 0.0; Chi
2
= 0.28, df = 1 (P = 0.60); I
2
=0.0%
Test for subgroup differences: Not applicable
0.2 0.5 1 2 5
Analysis 1.3. Comparison 1 Swallowing therapy, Outcome 3 Institutionalisation.
Outcome: 3 Institutionalisation
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
Carnaby 2006a 8/51 26/102 50.0 % 0.54 [ 0.23, 1.31 ]
Carnaby 2006b 19/102 9/51 50.0 % 1.07 [ 0.45, 2.56 ]
Subtotal (95% CI) 153 153 100.0 % 0.76 [ 0.39, 1.48 ]
Heterogeneity: Tau
2
= 0.03; Chi
2
= 1.14, df = 1 (P = 0.29); I
2
=12%
0.2 0.5 1 2 5
Analysis 1.4. Comparison 1 Swallowing therapy, Outcome 4 Length of stay (days).
Outcome: 4 Length of stay (days)
Study or subgroup Treatment Control
Mean
Difference Weight
Mean
Difference
N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI
Carnaby 2006a 51 19.2 (13.3) 102 21.4 (12.4) 34.3 % -2.20 [ -6.57, 2.17 ]
Carnaby 2006b 102 19.1 (10.5) 51 19.2 (13.3) 36.6 % -0.10 [ -4.28, 4.08 ]
Yuan 2003a 11 31 (9.4) 24 37 (14.7) 12.3 % -6.00 [ -14.09, 2.09 ]
Yuan 2003b 18 24 (8.5) 11 31 (9.4) 16.8 % -7.00 [ -13.80, -0.20 ]
Subtotal (95% CI) 182 188 100.0 % -2.70 [ -5.68, 0.28 ]
Heterogeneity: Tau
2
= 1.77; Chi
2
= 3.68, df = 3 (P = 0.30); I
2
=19%
-20 -10 0 10 20
Analysis 1.5. Comparison 1 Swallowing therapy, Outcome 5 Chest infection or pneumonia.
Outcome: 5 Chest infection or pneumonia
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
Carnaby 2006a 13/51 48/102 38.6 % 0.38 [ 0.18, 0.81 ]
Carnaby 2006b 28/102 13/51 37.5 % 1.11 [ 0.51, 2.38 ]
Song 2004 0/29 3/24 5.4 % 0.10 [ 0.01, 2.12 ]
Yuan 2003a 0/18 1/11 4.6 % 0.19 [ 0.01, 5.07 ]
Yuan 2003b 2/11 10/24 13.9 % 0.31 [ 0.05, 1.76 ]
Subtotal (95% CI) 211 212 100.0 % 0.50 [ 0.24, 1.04 ]
Heterogeneity: Tau
2
= 0.22; Chi
2
= 6.10, df = 4 (P = 0.19); I
2
=34%
2 Drug therapy
Gosney 2006 1/25 6/33 100.0 % 0.19 [ 0.02, 1.67 ]
Subtotal (95% CI) 25 33 100.0 % 0.19 [ 0.02, 1.67 ]
Jayasekeran 2010 2/16 3/12 100.0 % 0.43 [ 0.06, 3.09 ]
Subtotal (95% CI) 16 12 100.0 % 0.43 [ 0.06, 3.09 ]
0.001 0.01 0.1 1 10 100 1000
Analysis 1.6. Comparison 1 Swallowing therapy, Outcome 6 Dysphagia at end of trial.
Outcome: 6 Dysphagia at end of trial
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 Acupuncture
Bai 2007a 13/18 32/35 17.2 % 0.24 [ 0.05, 1.17 ]
Bai 2007b 22/40 13/17 25.8 % 0.38 [ 0.10, 1.36 ]
Huang 2010 1/32 10/30 9.4 % 0.06 [ 0.01, 0.54 ]
Liu 2000 16/54 19/30 47.6 % 0.24 [ 0.09, 0.63 ]
Subtotal (95% CI) 144 112 100.0 % 0.24 [ 0.13, 0.46 ]
Heterogeneity: Tau
2
= 0.0; Chi
2
= 1.97, df = 3 (P = 0.58); I
2
=0.0%
Carnaby 2006a 18/51 45/102 35.3 % 0.69 [ 0.34, 1.38 ]
Carnaby 2006b 31/102 19/51 34.5 % 0.74 [ 0.36, 1.49 ]
Song 2004 6/29 10/24 15.8 % 0.37 [ 0.11, 1.23 ]
Yuan 2003a 8/11 22/24 6.7 % 0.24 [ 0.03, 1.73 ]
Yuan 2003b 6/18 9/11 7.8 % 0.11 [ 0.02, 0.68 ]
Subtotal (95% CI) 211 212 100.0 % 0.52 [ 0.30, 0.88 ]
Heterogeneity: Tau
2
= 0.08; Chi
2
= 5.14, df = 4 (P = 0.27); I
2
=22%
3 Drug therapy
Perez 1997 3/8 5/9 100.0 % 0.48 [ 0.07, 3.35 ]
Subtotal (95% CI) 8 9 100.0 % 0.48 [ 0.07, 3.35 ]
4 Neuromuscular electrical stimulation
Lim 2009 6/13 6/9 100.0 % 0.43 [ 0.07, 2.50 ]
Subtotal (95% CI) 13 9 100.0 % 0.43 [ 0.07, 2.50 ]
0.005 0.1 1 10 200
(Continued . . . )
(. . . Continued)
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
Bath 1997 3/4 3/3 100.0 % 0.33 [ 0.01, 11.34 ]
Subtotal (95% CI) 4 3 100.0 % 0.33 [ 0.01, 11.34 ]
6 Transcranial direct current stimulation
Kumar 2011 6/7 7/7 100.0 % 0.29 [ 0.01, 8.39 ]
Subtotal (95% CI) 7 7 100.0 % 0.29 [ 0.01, 8.39 ]
Test for subgroup differences: Chi
2
= 3.27, df = 5 (P = 0.66), I
2
=0.0%
0.005 0.1 1 10 200
Analysis 1.7. Comparison 1 Swallowing therapy, Outcome 7 Pharyngeal transit time (seconds).
Outcome: 7 Pharyngeal transit time (seconds)
Mean
Difference Weight
Mean
Difference
1 Drug therapy
Perez 1997 8 2.19 (0.64) 9 2.4 (0.83) 100.0 % -0.21 [ -0.91, 0.49 ]
Subtotal (95% CI) 8 9 100.0 % -0.21 [ -0.91, 0.49 ]
Jayasekeran 2010 16 1.089 (0.68) 12 1.24 (0.204) 100.0 % -0.15 [ -0.51, 0.20 ]
Subtotal (95% CI) 16 12 100.0 % -0.15 [ -0.51, 0.20 ]
Power 2006 8 0.74 (0.14) 8 0.93 (0.17) 100.0 % -0.19 [ -0.34, -0.04 ]
Subtotal (95% CI) 8 8 100.0 % -0.19 [ -0.34, -0.04 ]
-1 -0.5 0 0.5 1
Analysis 1.8. Comparison 1 Swallowing therapy, Outcome 8 Swallow score.
Outcome: 8 Swallow score
Mean
Difference Weight
Mean
Difference
1 Acupuncture
Bai 2007a 18 5.48 (1.2) 35 6.03 (1.39) 32.1 % -0.55 [ -1.27, 0.17 ]
Bai 2007b 40 4.21 (1.44) 17 5.48 (1.2) 32.1 % -1.27 [ -1.99, -0.55 ]
Wei 2005 32 5.51 (0.81) 33 5.01 (0.62) 35.8 % 0.50 [ 0.15, 0.85 ]
Subtotal (95% CI) 90 85 100.0 % -0.41 [ -1.53, 0.72 ]
Heterogeneity: Tau
2
= 0.88; Chi
2
= 21.72, df = 2 (P = 0.00002); I
2
=91%
2 Neuromuscular electrical stimulation versus behavioural interventions
Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]
Test for overall effect: not applicable
Power 2006 8 23.1 (4.07) 8 21.7 (4.05) 100.0 % 1.40 [ -2.58, 5.38 ]
Subtotal (95% CI) 8 8 100.0 % 1.40 [ -2.58, 5.38 ]
4 Transcranial direct current stimulation
Kumar 2011 7 4.71 (1.7) 7 3.71 (1.11) 100.0 % 1.00 [ -0.50, 2.50 ]
Subtotal (95% CI) 7 7 100.0 % 1.00 [ -0.50, 2.50 ]
2
= 2.55, df = 2 (P = 0.28), I
2
=22%
-2 -1 0 1 2
Analysis 1.9. Comparison 1 Swallowing therapy, Outcome 9 Nutritional (albumin).
Outcome: 9 Nutritional (albumin)
Mean
Difference Weight
Mean
Difference
Yuan 2003a 11 36.8 (10.32) 24 36.6 (9.8) 47.0 % 0.20 [ -7.05, 7.45 ]
Yuan 2003b 18 37 (6.7) 11 36.8 (10.3) 53.0 % 0.20 [ -6.63, 7.03 ]
Subtotal (95% CI) 29 35 100.0 % 0.20 [ -4.77, 5.17 ]
Heterogeneity: Tau
2
= 0.0; Chi
2
= 0.00, df = 1 (P = 1.00); I
2
=0.0%
-10 -5 0 5 10
Analysis 2.1. Comparison 2 Route of feeding, Outcome 1 Case fatality at end of trial.
Comparison: 2 Route of feeding
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 PEG versus NGT
Bath 1997 6/10 6/9 10.1 % 0.75 [ 0.11, 4.90 ]
FOOD 3 2005 79/162 76/159 48.4 % 1.04 [ 0.67, 1.61 ]
Hamidon 2006 2/10 2/13 7.9 % 1.38 [ 0.16, 11.94 ]
Norton 1996 2/16 8/14 10.6 % 0.11 [ 0.02, 0.66 ]
PEGASUS 2004 10/32 9/30 22.9 % 1.06 [ 0.36, 3.13 ]
Subtotal (95% CI) 230 225 100.0 % 0.81 [ 0.42, 1.56 ]
Heterogeneity: Tau
2
= 0.18; Chi
2
= 5.91, df = 4 (P = 0.21); I
2
=32%
2 NGT with loop versus NGT
Beavan 2010 16/51 23/53 100.0 % 0.60 [ 0.27, 1.33 ]
Subtotal (95% CI) 51 53 100.0 % 0.60 [ 0.27, 1.33 ]
2
= 0.34, df = 1 (P = 0.56), I
2
=0.0%
0.01 0.1 1 10 100
Favours PEG/NGT with loop Favours NGT
Analysis 2.2. Comparison 2 Route of feeding, Outcome 2 Death or dependency at end of trial.
Study or subgroup Treatment Control Odds Ratio Odds Ratio
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 PEG versus NGT
Bath 1997 10/10 9/9 0.0 [ 0.0, 0.0 ]
FOOD 3 2005 144/162 129/159 1.86 [ 0.99, 3.50 ]
PEGASUS 2004 24/31 27/29 0.25 [ 0.05, 1.34 ]
Subtotal (95% CI) 203 197 0.80 [ 0.12, 5.55 ]
Heterogeneity: Tau
2
= 1.58; Chi
2
= 4.84, df = 1 (P = 0.03); I
2
=79%
Beavan 2010 41/51 47/53 0.52 [ 0.18, 1.57 ]
Subtotal (95% CI) 51 53 0.52 [ 0.18, 1.57 ]
2
= 0.14, df = 1 (P = 0.71), I
2
=0.0%
0.005 0.1 1 10 200
Analysis 2.3. Comparison 2 Route of feeding, Outcome 3 Institutionalisation.
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 PEG versus NGT
FOOD 3 2005 48/162 43/159 58.9 % 1.14 [ 0.70, 1.85 ]
PEGASUS 2004 10/22 16/21 41.1 % 0.26 [ 0.07, 0.96 ]
Subtotal (95% CI) 184 180 100.0 % 0.62 [ 0.15, 2.57 ]
Heterogeneity: Tau
2
= 0.83; Chi
2
= 4.28, df = 1 (P = 0.04); I
2
=77%
Beavan 2010 24/51 18/53 100.0 % 1.73 [ 0.78, 3.81 ]
Subtotal (95% CI) 51 53 100.0 % 1.73 [ 0.78, 3.81 ]
2
= 1.53, df = 1 (P = 0.22), I
2
=35%
0.01 0.1 1 10 100
Analysis 2.4. Comparison 2 Route of feeding, Outcome 4 Length of stay in hospital (days).
Outcome: 4 Length of stay in hospital (days)
Mean
Difference Weight
Mean
Difference
1 PEG versus NGT
FOOD 3 2005 162 55 (68) 159 53 (52) 54.4 % 2.00 [ -11.23, 15.23 ]
PEGASUS 2004 32 92 (48) 31 63 (34) 45.6 % 29.00 [ 8.51, 49.49 ]
Subtotal (95% CI) 194 190 100.0 % 14.32 [ -12.04, 40.68 ]
Heterogeneity: Tau
2
= 287.08; Chi
2
= 4.71, df = 1 (P = 0.03); I
2
=79%
Beavan 2010 51 64 (38) 53 57 (42.5) 100.0 % 7.00 [ -8.48, 22.48 ]
Subtotal (95% CI) 51 53 100.0 % 7.00 [ -8.48, 22.48 ]
2
= 0.22, df = 1 (P = 0.64), I
2
=0.0%
-100 -50 0 50 100
Analysis 2.5. Comparison 2 Route of feeding, Outcome 5 Pressure sores.
Outcome: 5 Pressure sores
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 PEG versus NGT
FOOD 3 2005 12/162 4/159 100.0 % 3.10 [ 0.98, 9.83 ]
Subtotal (95% CI) 162 159 100.0 % 3.10 [ 0.98, 9.83 ]
Beavan 2010 5/51 5/53 100.0 % 1.04 [ 0.28, 3.84 ]
Subtotal (95% CI) 51 53 100.0 % 1.04 [ 0.28, 3.84 ]
2
= 1.50, df = 1 (P = 0.22), I
2
=33%
0.01 0.1 1 10 100
Analysis 2.6. Comparison 2 Route of feeding, Outcome 6 Chest infection or pneumonia.
Outcome: 6 Chest infection or pneumonia
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 PEG versus NGT
Norton 1996 3/16 6/14 33.5 % 0.31 [ 0.06, 1.59 ]
PEGASUS 2004 11/32 11/31 66.5 % 0.95 [ 0.34, 2.68 ]
Subtotal (95% CI) 48 45 100.0 % 0.65 [ 0.23, 1.86 ]
Heterogeneity: Tau
2
= 0.15; Chi
2
= 1.30, df = 1 (P = 0.25); I
2
=23%
Beavan 2010 20/51 23/53 100.0 % 0.84 [ 0.39, 1.84 ]
Subtotal (95% CI) 51 53 100.0 % 0.84 [ 0.39, 1.84 ]
2
= 0.15, df = 1 (P = 0.70), I
2
=0.0%
0.01 0.1 1 10 100
Analysis 2.7. Comparison 2 Route of feeding, Outcome 7 Dysphagia at end of trial.
Outcome: 7 Dysphagia at end of trial
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 PEG versus NGT
Norton 1996 10/13 11/11 37.6 % 0.13 [ 0.01, 2.84 ]
PEGASUS 2004 11/21 7/21 62.4 % 2.20 [ 0.63, 7.66 ]
Subtotal (95% CI) 34 32 100.0 % 0.76 [ 0.05, 11.77 ]
Heterogeneity: Tau
2
= 2.73; Chi
2
= 2.90, df = 1 (P = 0.09); I
2
=66%
0.001 0.01 0.1 1 10 100 1000
Favours PEG Favours NGT
Analysis 2.8. Comparison 2 Route of feeding, Outcome 8 Treatment failure.
Outcome: 8 Treatment failure
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 PEG versus NGT
Bath 1997 0/10 3/9 32.3 % 0.09 [ 0.00, 2.00 ]
Hamidon 2006 0/10 5/13 34.1 % 0.07 [ 0.00, 1.53 ]
Norton 1996 0/16 3/14 33.6 % 0.10 [ 0.00, 2.12 ]
Subtotal (95% CI) 36 36 100.0 % 0.09 [ 0.01, 0.51 ]
Heterogeneity: Tau
2
= 0.0; Chi
2
= 0.02, df = 2 (P = 0.99); I
2
=0.0%
Beavan 2010 13/51 9/53 100.0 % 1.67 [ 0.64, 4.34 ]
Subtotal (95% CI) 51 53 100.0 % 1.67 [ 0.64, 4.34 ]
2
= 8.32, df = 1 (P = 0.00), I
2
=88%
0.001 0.01 0.1 1 10 100 1000
Analysis 2.9. Comparison 2 Route of feeding, Outcome 9 Gastrointestinal bleeding.
Outcome: 9 Gastrointestinal bleeding
Study or subgroup Experimental Control Odds Ratio Weight Odds Ratio
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 PEG versus NGT
FOOD 3 2005 5/162 18/159 100.0 % 0.25 [ 0.09, 0.69 ]
Subtotal (95% CI) 162 159 100.0 % 0.25 [ 0.09, 0.69 ]
Total events: 5 (Experimental), 18 (Control)
Beavan 2010 6/51 4/53 100.0 % 1.63 [ 0.43, 6.17 ]
Subtotal (95% CI) 51 53 100.0 % 1.63 [ 0.43, 6.17 ]
Total events: 6 (Experimental), 4 (Control)
2
= 4.85, df = 1 (P = 0.03), I
2
=79%
0.01 0.1 1 10 100
Analysis 2.10. Comparison 2 Route of feeding, Outcome 10 Feed delivery (%).
Outcome: 10 Feed delivery (%)
Mean
Difference Weight
Mean
Difference
1 PEG versus NGT
Norton 1996 16 100 (8.16) 14 78 (8.16) 100.0 % 22.00 [ 16.15, 27.85 ]
Subtotal (95% CI) 16 14 100.0 % 22.00 [ 16.15, 27.85 ]
Test for overall effect: Z = 7.37 (P < 0.00001)
Beavan 2010 51 75 (29) 53 57 (30) 100.0 % 18.00 [ 6.66, 29.34 ]
Subtotal (95% CI) 51 53 100.0 % 18.00 [ 6.66, 29.34 ]
2
= 0.38, df = 1 (P = 0.54), I
2
=0.0%
-50 -25 0 25 50
Analysis 2.11. Comparison 2 Route of feeding, Outcome 11 Weight at end of trial (last value carried
forward) (kg).
Outcome: 11 Weight at end of trial (last value carried forward) (kg)
Study or subgroup PEG better NGT better
Mean
Difference Weight
Mean
Difference
1 PEG versus NGT
Bath 1997 6 59.8 (24.2) 7 51 (11.6) 15.7 % 8.80 [ -12.38, 29.98 ]
Norton 1996 13 61 (11) 8 57.8 (10) 84.3 % 3.20 [ -5.95, 12.35 ]
Subtotal (95% CI) 19 15 100.0 % 4.08 [ -4.32, 12.48 ]
Heterogeneity: Tau
2
= 0.0; Chi
2
= 0.23, df = 1 (P = 0.63); I
2
=0.0%
-50 -25 0 25 50
Analysis 2.12. Comparison 2 Route of feeding, Outcome 12 Mid-arm circumference (last value carried
forward) (cm).
Outcome: 12 Mid-arm circumference (last value carried forward) (cm)
Study or subgroup PEG better NGT Better
Mean
Difference Weight
Mean
Difference
1 PEG versus NGT
Bath 1997 7 27 (6.2) 7 25.6 (3.2) 25.2 % 1.40 [ -3.77, 6.57 ]
Hamidon 2006 10 31.4 (7.42) 13 27.8 (16.9) 6.4 % 3.60 [ -6.67, 13.87 ]
Norton 1996 13 26.3 (5.3) 8 23.8 (1.8) 68.4 % 2.50 [ -0.64, 5.64 ]
Subtotal (95% CI) 30 28 100.0 % 2.29 [ -0.30, 4.89 ]
Heterogeneity: Tau
2
= 0.0; Chi
2
= 0.19, df = 2 (P = 0.91); I
2
=0.0%
-20 -10 0 10 20
Analysis 2.13. Comparison 2 Route of feeding, Outcome 13 Albumin (last value carried forward) (g/L).
Outcome: 13 Albumin (last value carried forward) (g/L)
Study or subgroup PEG better NGT better
Mean
Difference Weight
Mean
Difference
1 PEG versus NGT
Bath 1997 7 27.9 (6.1) 8 27 (6.3) 28.4 % 0.90 [ -5.38, 7.18 ]
Hamidon 2006 10 39.5 (6.45) 13 36 (12.97) 21.3 % 3.50 [ -4.60, 11.60 ]
Norton 1996 15 30.1 (3.6) 10 22.3 (2.2) 50.3 % 7.80 [ 5.52, 10.08 ]
Subtotal (95% CI) 32 31 100.0 % 4.92 [ 0.19, 9.65 ]
Heterogeneity: Tau
2
= 10.23; Chi
2
= 4.77, df = 2 (P = 0.09); I
2
=58%
-20 -10 0 10 20
Analysis 3.1. Comparison 3 Timing of feeding, Outcome 1 Case fatality at end of trial.
Comparison: 3 Timing of feeding
Study or subgroup Early feeding Late feeding Odds Ratio Weight Odds Ratio
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 Early versus late feeding
FOOD 2 2005 182/429 207/430 100.0 % 0.79 [ 0.61, 1.04 ]
Subtotal (95% CI) 429 430 100.0 % 0.79 [ 0.61, 1.04 ]
Total events: 182 (Early feeding), 207 (Late feeding)
0.5 0.7 1 1.5 2
Favours early feeding Favours late feeding
Analysis 3.2. Comparison 3 Timing of feeding, Outcome 2 Death or disabled at end of trial.
Outcome: 2 Death or disabled at end of trial
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
FOOD 2 2005 339/429 344/430 100.0 % 0.94 [ 0.68, 1.31 ]
Subtotal (95% CI) 429 430 100.0 % 0.94 [ 0.68, 1.31 ]
0.5 0.7 1 1.5 2
Analysis 3.3. Comparison 3 Timing of feeding, Outcome 3 Institutionalisation.
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
FOOD 2 2005 94/429 86/430 100.0 % 1.12 [ 0.81, 1.56 ]
Subtotal (95% CI) 429 430 100.0 % 1.12 [ 0.81, 1.56 ]
0.5 0.7 1 1.5 2
Analysis 4.1. Comparison 4 Fluid supplementation, Outcome 1 Time to resolution of dysphagia (days).
Comparison: 4 Fluid supplementation
Outcome: 1 Time to resolution of dysphagia (days)
Mean
Difference Weight
Mean
Difference
1 Free thin uids
Garon 1997 10 19.1 (9.71) 10 27.2 (18.12) 100.0 % -8.10 [ -20.84, 4.64 ]
Subtotal (95% CI) 10 10 100.0 % -8.10 [ -20.84, 4.64 ]
-20 -10 0 10 20
Favours thickened uids and free water Favours thickened uids
Analysis 5.1. Comparison 5 Nutritional supplementation, Outcome 1 Case fatality at end of trial.
Comparison: 5 Nutritional supplementation
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 Sip feeding
FOOD 1 2005 241/2016 253/2007 44.8 % 0.94 [ 0.78, 1.14 ]
Gariballa 1998 2/21 7/21 13.2 % 0.21 [ 0.04, 1.17 ]
Ha 2010 9/58 8/66 24.3 % 1.33 [ 0.48, 3.71 ]
Nutristroke 2009a 1/9 1/2 4.1 % 0.13 [ 0.00, 4.00 ]
Nutristroke 2009b 0/20 1/6 4.4 % 0.09 [ 0.00, 2.51 ]
Nutristroke 2009c 0/12 1/3 4.1 % 0.07 [ 0.00, 2.16 ]
Rabadi 2008 0/51 2/51 5.1 % 0.19 [ 0.01, 4.11 ]
Subtotal (95% CI) 2187 2156 100.0 % 0.58 [ 0.28, 1.21 ]
Heterogeneity: Tau
2
= 0.31; Chi
2
= 9.74, df = 6 (P = 0.14); I
2
=38%
0.002 0.1 1 10 500
Favours treatment Favours control
Analysis 5.2. Comparison 5 Nutritional supplementation, Outcome 2 Death or dependency at end of trial.
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 Sip feeding
FOOD 1 2005 953/2016 918/2007 100.0 % 1.06 [ 0.94, 1.20 ]
Subtotal (95% CI) 2016 2007 100.0 % 1.06 [ 0.94, 1.20 ]
0.5 0.7 1 1.5 2
Analysis 5.3. Comparison 5 Nutritional supplementation, Outcome 3 Institutionalisation.
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 Sip feed
Rabadi 2008 17/51 26/51 100.0 % 0.48 [ 0.22, 1.07 ]
Subtotal (95% CI) 51 51 100.0 % 0.48 [ 0.22, 1.07 ]
0.2 0.5 1 2 5
Analysis 5.4. Comparison 5 Nutritional supplementation, Outcome 4 Length of stay in hospital (days).
Outcome: 4 Length of stay in hospital (days)
Mean
Difference Weight
Mean
Difference
1 Sip feeding
FOOD 1 2005 2011 34 (48) 2001 32 (45) 58.6 % 2.00 [ -0.88, 4.88 ]
Rabadi 2008 51 25.98 (10.12) 51 25.44 (7.32) 41.4 % 0.54 [ -2.89, 3.97 ]
Subtotal (95% CI) 2062 2052 100.0 % 1.40 [ -0.81, 3.60 ]
Heterogeneity: Tau
2
= 0.0; Chi
2
= 0.41, df = 1 (P = 0.52); I
2
=0.0%
-4 -2 0 2 4
Analysis 5.5. Comparison 5 Nutritional supplementation, Outcome 5 Pressure sores.
Outcome: 5 Pressure sores
n/N n/N
M-
H,Random,95%
CI
M-
H,Random,95%
CI
1 Sip feeding
FOOD 1 2005 15/2016 26/2007 72.1 % 0.57 [ 0.30, 1.08 ]
Rabadi 2008 7/51 12/51 27.9 % 0.52 [ 0.19, 1.44 ]
Subtotal (95% CI) 2067 2058 100.0 % 0.56 [ 0.32, 0.96 ]
Heterogeneity: Tau
2
= 0.0; Chi
2
= 0.03, df = 1 (P = 0.87); I
2
=0.0%
0.1 0.2 0.5 1 2 5 10
Analysis 5.6. Comparison 5 Nutritional supplementation, Outcome 6 Energy intake (kcal/day).
Outcome: 6 Energy intake (kcal/day)
Mean
Difference Weight
Mean
Difference
1 Sip feeding
Aquilani 2008 24 1548 (212) 24 1109 (206) 34.7 % 439.00 [ 320.74, 557.26 ]
Gariballa 1998 21 1807 (318) 21 1084 (343) 31.3 % 723.00 [ 522.95, 923.05 ]
Ha 2010 46 1197.42 (328.87) 38 1045.17 (303.06) 34.1 % 152.25 [ 16.91, 287.59 ]
Subtotal (95% CI) 91 83 100.0 % 430.18 [ 141.61, 718.75 ]
Heterogeneity: Tau
2
= 58886.43; Chi
2
= 23.12, df = 2 (P<0.00001); I
2
=91%
-1000 -500 0 500 1000
Analysis 5.7. Comparison 5 Nutritional supplementation, Outcome 7 Protein intake (g/day).
Outcome: 7 Protein intake (g/day)
Mean
Difference Weight
Mean
Difference
1 Sip feeding
Aquilani 2008 24 67 (17) 24 39 (9) 33.2 % 28.00 [ 20.30, 35.70 ]
Gariballa 1998 21 65.1 (13.8) 21 44.1 (12.8) 32.9 % 21.00 [ 12.95, 29.05 ]
Ha 2010 46 52.1 (14.5) 38 48.9 (15.7) 34.0 % 3.20 [ -3.32, 9.72 ]
Subtotal (95% CI) 91 83 100.0 % 17.28 [ 1.99, 32.56 ]
Heterogeneity: Tau
2
= 168.05; Chi
2
= 25.61, df = 2 (P<0.00001); I
2
=92%
-20 -10 0 10 20
Analysis 5.8. Comparison 5 Nutritional supplementation, Outcome 8 Albumin (last value carried forward).
Outcome: 8 Albumin (last value carried forward)
Mean
Difference Weight
Mean
Difference
1 Sip feeding
Gariballa 1998 21 36.4 (2.8) 21 34.9 (4.7) 13.8 % 1.50 [ -0.84, 3.84 ]
Rabadi 2008 51 3.61 (0.32) 51 3.51 (0.38) 86.2 % 0.10 [ -0.04, 0.24 ]
Subtotal (95% CI) 72 72 100.0 % 0.29 [ -0.65, 1.24 ]
Heterogeneity: Tau
2
= 0.26; Chi
2
= 1.37, df = 1 (P = 0.24); I
2
=27%
-4 -2 0 2 4
A P P E N D I C E S
Appendix 1. MEDLINE search strategy
1. stroke.mp.
2. infarction.mp.
3. exp cerebral infarction/
4. exp cerebrovascular disease/
5. cerebrovascular disease.mp.
6. hemorrhage.mp.
7. exp cerebral hemorrhage/
8. cerebral haemorrhage.mp.
9. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8
10. (dysphagia or deglutition or swallowing or deglutition disorders or swallowing disorders or malnutrition or undernutrition).mp.
11. (intervention or supplementation or feeding or nutrition or nutritional supplementation or therapy or swallowing therapy or tube
feeding or uid or uid supplementation or sip feeding or feeding route or timing or diet or hydration).mp.
12. 10 or 11
13. 9 and 12
14. (randomized controlled trial.pt. or controlled clinical trial.pt.or randomized.ab. or placebo.ab. or clinical trials as topic.sh. or
randomly.ab. or trial.ti.) and humans.sh.
15. 13 and 14
Appendix 2. EMBASE search strategy
1. stroke.mp.
2. infarction.mp.
3. exp brain Infarction/
4. cerebrovascular disease.mp.
5. exp cerebrovascular disease/
6. hemorrhage.mp.
7. exp cerebral hemorrhage/
8. cerebral haemorrhage.mp.
9. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8
10. (dysphagia or deglutition or swallowing or deglutition disorders or swallowing disorders or malnutrition or undernutrition).mp.
11. (intervention or supplementation or feeding or nutrition or nutritional supplementation or therapy or swallowing therapy or tube
feeding or uid or uid supplementation or sip feeding or feeding route or timing or diet or hydration).mp.
12. 10 or 11
13. 09 and 12
14. ((RANDOMIZED-CONTROLLED-TRIAL/ or RANDOMIZATION/ or CONTROLLED-STUDY/ or MULTICENTER-
STUDY/ or PHASE-3-CLINICAL-TRIAL/ or PHASE-4-CLINICAL-TRIAL/ or DOUBLE-BLIND-PROCEDURE/ or
SINGLE-BLIND-PROCEDURE/) or ((RANDOM* or CROSS?OVER* or FACTORIAL* or PLACEBO* or VOLUNTEER*) or
((SINGL* or DOUBL* or TREBL* or TRIPL*) adj3 (BLIND* or MASK*))).ti,ab) and human*.ec,hw,fs.
15. 13 and 14
Appendix 3. CINAHL search strategy
S1. stroke
S2. infarction
S3. brain Infarction
S4. cerebrovascular disease
S5. hemorrhage
S6. cerebral hemorrhage
S7. cerebral haemorrhage
S8. S1 or S2 or S3 or S4 or S5 or S6 or S7
S9. dysphagia or deglutition or swallowing or deglutition disorders or swallowing disorders or malnutrition or undernutrition
S10. intervention or supplementation or feeding or nutrition or nutritional supplementation or therapy or swallowing therapy or tube
feeding or uid or uid supplementation or sip feeding or feeding route or timing or diet or hydration
S11. S9 or S10
S12. S8 and S11
S13. randomised controlled trials or controlled clinical trial or randomized or clinical trials
S14. S12 and S13
W H A T S N E W
Last assessed as up-to-date: 14 March 2012.
Date Event Description
14 March 2012 New search has been performed We have added the results of 27 new studies involving
6567 patients to the review. A total of 33 studies involv-
ing 6779 patients are now included. We also added 15
(Continued)
new ongoing studies. There have been modications to
the analysis methodology, types of stroke patients and
outcome measures (Differences between protocol and
review).
14 March 2012 Newcitation required but conclusions have not changed Changes of authors. The conclusions have not changed.
H I S T O R Y
Protocol rst published: Issue 1, 1997
Review rst published: Issue 4, 1999
Date Event Description
13 April 2008 Amended Converted to new review format.
C O N T R I B U T I O N S O F A U T H O R S
Chamila Geeganage: undertook searches in 2011 to 2012, data extraction, analysis and interpretation of data, and updated the review
in 2012.
Jessica Beavan: undertook searches in 2007, data extraction, analysis and interpretation of data, and wrote an interim update of the
review in 2007 (unpublished).
Sharon Ellender: undertook paper reviews, data extraction, analysis of data, and contributed to writing the 2007 interim update.
Philip Bath: conceived and designed the review, undertook searches, analysis of data, interpretation of data, wrote the original review,
and updated it in 2007 (interim update) and 2012.
D E C L A R A T I O N S O F I N T E R E S T
JBwas co-ordinator and author of one completed trial included inthis review(Beavan 2010). PBwas chief investigator of one completed,
included trial (Bath 1997), principal investigator of two completed trials (FOOD 1 2005; FOOD 3 2005), and is chief investigator
of one ongoing trial (STEPS 2012), which is funded by Phagenesis Ltd. He consults for this company and receives honoraria as well
as expenses for this. No pharmaceutical, device or feeding companies, or other commercial entities were involved in data analysis, data
interpretation, or in writing this review.
S O U R C E S O F S U P P O R T
Internal sources
Kings College Hospital Audit Committee, UK.
Division of Stroke, University of Nottingham, UK.
External sources
South Thames NHS Executive, UK.
Trent NHS Executive, UK.
Wolfson Foundation, UK.
The Stroke Association, UK.
Royal College of Physicians, UK.
Dunhill Medical Trust, UK.
Stroke Research Network, UK.
National Institutes of Health Research - Cochrane Incentive Scheme, UK.
D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W
Modication of analysis methodology
The analysis methodology was changed from xed-effect to random-effects models (OR, MD) since signicant trial and statistical
heterogeneity were present. Three studies had more than one intervention group (Yuan 2003; Carnaby 2006; Jing 2007) equating with
different treatment intensities. In these cases the low-intensity (middle) groups were divided and data from the study entered as two
data sets (e.g. data set 1: medium (M), low (L), or none, and data set 2: high (H), medium (M)).
Modication of type of stroke patients
To t the timing of interventions after stroke better, we included subacute trials so that trials enrolling patients within six months were
included. (Previously, subacute trials were variably included or excluded depending on what proportions of participants were enrolled
acutely.)
Addition or modication of outcome measures
We divided swallowing therapy into subcategories: acupuncture, drug therapy, NMES, PES, physical stimulation (thermal, tactile),
TDCS, and TMS.
We added additional outcome measures, especially focusing on intermediate outcomes: pneumonia rates, gastrointestinal bleeding,
and pressure sores. We divided swallowing therapy outcomes into relevant types of intervention (e.g. acupuncture, behavioural, drug
therapy, and electrical stimulation). Outcomes related to improvement of dysphagia remained as listed with dysphagia at end of trial.
However, we also included changes in some measurements on videouoroscopy (pharyngeal transit time) and changes of swallow
scores. We added food intake (as calories or volume) as an outcome measure. Discharge destination was included within the outcome
institutionalisation; the number of patients discharged to long-term care.
I N D E X T E R M S
Medical Subject Headings (MeSH)
Acupuncture Therapy [methods]; Acute Disease; Deglutition; Deglutition Disorders [etiology; mortality;

rehabilitation]; Nutritional
Support [
methods]; Physical Stimulation [
methods]; Randomized Controlled Trials as Topic; Stroke [
complications; rehabilitation]
MeSH check words
Humans

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Interventions for dysphagia and nutritional support in acute

and subacute stroke (Review)

Carnaby G, Hankey GJ, Pizzi J. Behavioural intervention

The FOOD trial collaboration. Routine oral nutritional

The FOOD Trial Collaboration. Effect of timing and

The FOOD Trial Collaboration. Effect of timing and

Gariballa SE, Parker SG, Castledon CM. A randomised

Norton B, Homer-Ward M, Donnelly MT, Long RG,

Perez I, Smithard DG, Davies H, Kalra L. Pharmacological

Challiner YC, Jarrett D, Hayward MJ, Al-Jubouri MA,

DePippo KL, Holas MA, Reding MJ, Mandel FS, Lesser

Michou E, Mistry S, Jefferson S, Singh S, Rothwell

Nakagawa T, Wada H, Sekizawa K, Arai H, Sasaki H.

Rosenbek JC, Roecker EB, Wood JL, Robbins J. Thermal

Shaker R, Easterling C, Kern M, Nitschke T, Massey B,

Verin E, Leroi AM. Poststroke dysphagia rehabilitation

Indicates the major publication for the study

methods]; Physical Stimulation [

methods]; Randomized Controlled Trials as Topic; Stroke [

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