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.

http://www.thecochranelibrary.com

T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

14DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

27CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

92DATA 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

127APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

128WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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


129HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

129CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

129DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

129SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

130DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .

130INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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


[Intervention Review]

Interventions for dysphagia and nutritional support in acuteand subacute stroke

Chamila Geeganage1, Jessica Beavan2, Sharon Ellender3, Philip MW Bath3

1Clinical Pharmacology and Pharmacy, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. 2Department of Stroke

Medicine, Royal Derby Hospital, Derby, UK. 3Division of Stroke Medicine, University of Nottingham, Nottingham, UK

Contact address: Philip MW Bath, Division of Stroke Medicine, University of Nottingham, Nottingham, NG5 1PB, UK.

[email protected].

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 fluid 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 review authors 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% confidence 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.

1Interventions for dysphagia and nutritional support in acute and subacute stroke (Review)


mailto:[email protected]

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 significant 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; I2 = 0%) and behavioural interventions (t = 5; n = 423;

OR 0.52; 95% CI 0.30 to 0.88; P = 0.01; I2 = 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; I2 = 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; I2 = 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 fluid 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; I2 = 0%), and, by definition, increased energy intake (t = 3; n = 174; MD

430.18 kcal/day; 95% CI 141.61 to 718.75; P = 0.003; I2 = 91%) and protein intake (t = 3; n = 174; MD 17.28 g/day; 95% CI 1.99

to 32.56; P = 0.03; I2 = 92%).

Authors’ conclusions

There remains insufficient data on the effect of swallowing therapy, feeding, and nutritional and fluid 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 benefit 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 significant 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 in many stroke patients

although at one month after stroke 15% of patients still have swal-

lowing problems (Smithard 1993). The early identification 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; FOOD 2003; 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 beneficial.

Description of the intervention

Interventions for treating dysphagia are often administered by

speech and language therapists (SLTs). These interventions involve

the modification of fluid 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 modified 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 (O’Mahony 1995), have

been highlighted by safety alerts from the UK National Patient

Safety Agency (NPSA 2005). Many patients find 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. PEG insertion

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, fluid, 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 review aimed to assess the effectiveness of interventions for the

treatment of dysphagia (swallowing therapy), and nutritional and

fluid 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

fluid 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

modification, 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 fluids.

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

Definitions

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, modified diet and fluid

assessments, swallowing test scores) by a range of clinicians, or

using videofluoroscopy, or using flexible endoscopic evaluation of

swallowing (FEES).

Malnutrition or under-nutrition

Subjective assessment based on body 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

difficult, 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 modification.

• Drug therapy.

• NMES.

• PES.

• Physical stimulation (thermal, tactile).

• TDCS.

• TMS.

Feeding and fluids

• 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 defined 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: videofluoroscopy, 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

fluids.

6. Aspiration: clinical, videofluoroscopy.

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 identification of studies

See the ’Specialized register’ section in the 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 identified 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. fluid supplementation; and



http://onlinelibrary.wiley.com/o/cochrane/clabout/articles/STROKE/frame.html



http://www.controlled-trials.com/

http://www.controlled-trials.com/

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 predefined 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 in the 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% confidence 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 medium intensity, and medium in-

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 artificially 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 from the 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 I2

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 each outcome we analysed different swallowing and nutritional

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 I2 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 classification;

Characteristics of ongoing studies.

We identified 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 classification).



Results of the search

The database searches identified 975 references. A further 21 ref-

erences were identified 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 flow 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 five 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 modifications such as upright positioning for feeding,

safe swallowing advice, and appropriate dietary modifications.

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 fluids

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 excluded several 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 fluids with thickened fluids alone in patients known

to aspirate thin fluids (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 final 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 assessed key 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

Thirteen studies involved randomisation by 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 random numbers 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 specific 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; Lim 2009; 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; FOOD 1 2005; FOOD 2 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 in eight studies (Norton 1996; Bath 1997; Garon 1997;

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; in another 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 from four 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, significant heterogeneity was noted (t

= 3; n = 256; MD -0.41; 95% CI -1.53 to 0.72; I2 = 91%; P <

0.0001) for swallow scores in acupuncture studies (Analysis 1.8).

Data on other outcomes were not available.

Behavioural interventions


Behavioural interventions significantly reduced dysphagia by end

of trial (t = 5; n = 423; OR 0.52; 95% CI 0.30 to 0.88; I2 = 22%;

P = 0.01) (Analysis 1.6).

Length of stay

A non-significant reduction in length of stay was noted (t = 4; n

= 370; MD -2.70; 95% CI -5.68 to 0.28; I2 = 19%; P = 0.08)

(Analysis 1.4).

Chest infection or pneumonia

A non-significant reduction in chest infection/pneumonia was

noted (t = 5; n = 423; OR 0.50; 95% CI 0.24 to 1.04; I2 = 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 significantly 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)


In one small trial, physical stimulation had no effect on case 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 fluids

Percutaneous endoscopic gastrostomy versus nasogastric

tube feeding

Data were available for five 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; I2 = 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)

PEG was associated with higher albumin (t = 3; n = 63; MD 4.92;

95% CI 0.19 to 9.65; P = 0.04; I2 = 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; I2 = 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 significantly 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 NGT versus 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).



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 from one small study (Garon 1997). 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;

I2 = 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; I2 = 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; I2 = 92%) (Analysis 5.7).


A non-significant reduction in case fatality was noted (t = 7; n

= 4343; OR 0.58; 95% CI 0.28 to 1.21; P = 0.14; I2 = 38%)

(Analysis 5.1).


A non-significant reduction in institutionalisation was noted (t =

1; n = 102; OR 0.48; 95% CI 0.22 to 1.07) (Analysis 5.3).



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 identified 33 studies that assessed feeding and swallowing 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, significant ef-

fects on functional outcome (primary outcome) or case fatality, al-

beit each based on limited data. Both acupuncture and behavioural

interventions significantly reduced dysphagia at the end of trial. In

the absence of significant effects on the primary outcome, signifi-

cant findings in secondary and explanatory outcomes may reflect

chance (e.g. owing to multiple comparisons) and further trials are

needed to test these observations.

Limited evidence from five studies suggested that there might be

a trend towards a lower death rate with PEG as compared with

NGT feeding, although the results were heterogeneous and largely



reflected 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-significant reduction in case fatality although,

again, considerable heterogeneity existed. Pressure sores were sig-

nificantly 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 inflammatory 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 first 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 videofluoroscopic 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 significant 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 beneficial. 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 difficult 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;

FOOD 2 2005; FOOD 3 2005) assessed quality of life, which has

relevance when balancing the risks and benefits of interventions in

severely disabled stroke survivors. In addition, several studies have

compared active treatments without a control group and were ex-

cluded from this 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 Jean Kerr and Ms Morwenna Collins (SLTs) for their

help with the early stages of the first version of the review, and

Cameron Sellars and David Smithard for their involvement in the

completion of the first 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 first 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 five 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):235–40.

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):

35–7.

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):

35–7.

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):624–30.

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;5:31–7.

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 Scientific 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):

191–2.

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;365:755–63.

The International Stroke Trials Collaboration. FOOD Trial

(Feed Or Ordinary Diet). Protocol.





1998;29:551.







191–2.






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;365:764–72.







1998;29:551.







191–2.




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;365:764–72.



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):315–19.

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 identified aspiration. Journal of

Neurological Rehabilitation 1997;11:139–48.

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;35:42–7.

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):567–73.

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):59–66.

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):969–73.

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):1737–46.

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):

155–61.

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):

1035–40.

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):174–8.

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):30–2.

Norton 1996 {published data only}

Norton B, Holmes GKT. Percutaneous endoscopic

gastrostomy feeding after acute dysphagic stroke. BMJ

1996;312:973–4.

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;312:13–6.

Norton B, Long RG, Holmes GKT. Tube feedings and file

drawers. Gastroenterology 1996;111:828–9.

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):58–60.

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):375–83.



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;13:12–6.

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):

49–55.

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):1856–61.

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):3722–3.

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):3834–5.

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 reflex after electrical

stimulation to lower leg acupoints in patients after stroke.

Journal of the American Geriatric Society 2009;57(10):

1959–60.

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;27:313–6.

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;352:115–6.


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):1819–20.


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):

8–12.

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

194:95–8.

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;16:1–5.

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.

Bülow 2008 {published data only}

Bülow 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):302–9.



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;70:195–7.

Chaudhuri 2006 {published data only}

Chaudhuri G, Brady S, Caldwell R. Electric stimulation for

dysphagia flowing 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 fiber added to

nasogastric tube-fed formulas in stroke or traumatic brain

injury patients. Journal of Korean Academy of Rehabilitation

Medicine 2000;24(5):870–6.

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):164–7.

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):

96–8.

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;155:81–4.

Cola 2010 {published data only}

Cola PC, Gatto AR, Silva RG, Spadotto AA, Schelp

AO, Henry MACA. The influence of sour taste and cold

temperature in pharyngeal transit duration in patients with

stroke. Arquivos de Gastroenterologia 2010;47(1):18–21.

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):

440–4.

DePippo 1994 {published data only}

DePippo KL, Holas MA, Reding MJ. Dysphagia therapy

following stroke: a controlled trial (abstract). Neurology

1993;43:A234–5.

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;44:1655–60.

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):344–9. [: 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):

414–8.

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;15:317–20.

Ebihara 1993 {published data only}

Ebihara T, Sekizawa K, Nakazaqa H, Sasaki H. Capsaicin

and swallowing reflex. 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):1401–6.

Ebihira 2004 {published data only}

Ebihara T, Takahasi H, Ebihira S, Okazaki T, Sasaki T,

Wabanto A, et al.Theophylline improved swallowing reflex

in elderly nursing home patients. Jourmal of the American

Geriatrics Society 2004;52(10):1787–8.

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;

53:824–8.

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):831–40.

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):466–74.

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):291–7.

Gandolfi 2007 {published data only}

Gandolfi 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):119–24. [: 7038]

Goulding 2000 {published data only}

Goulding R, Bakheit AMO. Evaluation of the benefits of

monitoring fluid thickness in the dietary management of

dysphagic stroke patients. Clinical Rehabilitation 2000;14:

119–24.

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):962–6.

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;106:13–7.

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):I–38.

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):722–6.

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;34:303–6.

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):

1067–72.

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):1049–52.

Iwasaki 1999 {published data only}

Iwasaki K, Wang Q, Nakagawa T, Suzuki T, Sasaki H. The

traditional Chinese medicine Banxia Houpo Tang improves

swallowing reflex. Phytomedicine 1999;6(2):103–6.

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):393–9.

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):243–53.

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):558–67.

Kim 2010 {published data only}

Kim H-G, Oh B-M, Yoon S-J, Han T-R. Influence 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 reflex. Lancet 1996;348:1320–1.

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;16:119–22.

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

reflux. Scandinavian Journal of Gastroenterology 2001;36(4):

343–6.

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):403–11.

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):79–83. [: 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;22:1–10.

Macqueen 2003 {published data only}

Macqueen CE, Taubert S, Cotter D, Stevens S, Frost GS.

Which commercial thickening agent do patients prefer?.

Dysphagia 2003;18:46–52. [: 7420]

McCormick 2008 {published data only}

McCormick SE, Stafford KM, Saqib G, Chronin DN,

Power D. The efficacy of pre-thickened fluids on total fluid

and nutrient consumption among extended care residents

requiring thickened fluids due to risk of aspiration. Age and

Ageing 2008;37:714–5.

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;

24:26–31.

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 3:61–2.

Michou 2011 {published data only}

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

Tyrrell P, et al.Neurostimulation techniques benefit 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 reflex. 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):194–8.

Nyswonger 1992 {published data only}

Nyswonger GD, Helmchen RH. Early enteral nutrition

and length of stay in stroke patients. Journal of Neuroscience

Nursing 1992;24:220–3.

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):318–23.

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;

35:1551–6.

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;

304:1406–9.

Park 1997 {published data only}

Park CL, O’Neill PA, Martin DF. A pilot exploratory study

of oral electrical stimulation on swallow function following

stroke: an innovative technique. Dysphagia 1997;12:161–6.


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:

2026–31.


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):177–82.

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):259–65.

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-specific enteral formula:

stage II of a randomized, controlled multicenter trial.

Journal of Parenteral and Enteral Nutrition 2009;33(1):

37–49.

Power 1997 {published data only}

Power M, Hamdy S, Nicholson D, Aziz O, Tallis RC,

Thompson DG. Effects of liquid consistency on pharyngeal

efficiency 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

fluids worth the trouble? A pilot RCT of dysphagia

management. Proceedings of the 3rd UK Stroke Forum

Conference. Harrogate, UK: The Stroke Association, 2008:

86–7.

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;88:150–8.

Robinson 1995 {published data only}

Robinson TG, Potter JF. Postprandial and orthostatic

cardiovascular changes after acute stroke. Stroke 1995;26

(10):1811–6. [: 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;34:1257–68.


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;11:225–33.


Rosenbek JC, Robbins JA, Willford WO, Kirk G, Schiltz A,

Sowell TW, et al.Comparing treatment intensities of tactile-

thermal application. Dysphagia 1998;13:1–9.

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;24:321–5.

Sanz-Paris 1999 {published data only}

Sanz-Paris A, Salazar-Garcia-Blanco I, Calvo L, Boudet-

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Schneider 2006 {published data only}

Schneider SM, Girard-Pipau F, Anty R, van der Linde EG,

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short-chain fatty acids and microbiota. Clinical Nutrition

2006;25:82–90.

Seki 2005 {published data only}

Seki T, Iwasaki K, Arai H, Sasaki H, Hayashi H, Yamada

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a video fluoroscopic study (letter). Journal of the American


Sekizawa 1998 {published data only}

Sekizawa K, Matsui T, Nakagawa T, Nakayama K, Sasaki H.

ACE inhibitors and pneumonia. Lancet 1998;352:1069.

Shaker 2002a {published data only}

Easterling C, Kern M, Nitschke T, Grande B, Kazandijan

M, Dikeman K, et al.Restoration of oral feeding in 17 tube

fed patients by the Shaker exercise. Dysphagia 2000;15(2):

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in patients with dysphagia following stroke. Unpublished

2007.

Stahlman 2001 {published data only}

Stahlman LB, Garcia JM, Chambers E, Smit AB, Hoag

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Suchner U, Senftleben U, Eckart T, Scholz MR, Beck K,

Murr R, et al.Enteral versus parenteral nutrition: effects on

gastrointestinal function and metabolism. Nutrition 1996;

12:13–22.

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Sukthankar SM, Reddy NP, Canilang EP, Stephenson

L, Thomas R. Design and development of portable

biofeedback systems for use in oral dysphagia rehabilitation.

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Suojaranta-Ylinen T, Kari A, Hernesniemi J, Vapalahti

M, Takala J. Hypermetabolism and increased peripheral

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van den Hazel SJ, Mulder CJJ, den Hartog G, Thies JE,

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Liu Y. Treatment of pseudobulbar paralysis by scalp

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Lu M, Fan DS, Shen Y. Effects of nasogastric feedings

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Nowicki NC, Averill A. Acupuncture for dysphagia

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Ouyang 2003 {published data only}

Ouyang HM, Wang XH, Song HQ. Applied research

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Pohl 2005 {published data only}

Pohl M, Mayr P, Mertl-Roetze M, Lauster F, Lerch M,

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Reidnauer 2006 {published data only}

Reidnauer S, Repsher S, Stryker D, Segal M. Vital

stimulation may be more effective than traditional treatment

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737.

Singh 2006 {published data only}

Singh S. A trial of pharyngeal electrical stimulation for the

treatment of dysphagia post stroke. Proceedings of the

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Steidl 2002 {published data only}

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rehabilitation. Rehabilittace a Fyzikalni Lekarstvi 2002;9(2):

67–70.

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Sun 2008 {published data only}

Sun J, Mi Z, Wang H, Xu D, Chen H. Study on therapeutic

effect of acupuncture on dysphagia after stroke. Journal

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PP003-139.

Tajiri 2008 {published data only}

Tajiri H, Mori T, Iwata T, Kamakura S. Short-term

clinical outcome following gastro-intestinal tube feeding

by immunonutrition-oriented or protein-oriented food in

acute stroke management: preliminary results. Stroke 2008;

39(2):600-1 (Abstract P125).

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Wang 2000 {published data only}

Wang X, Pan C. Prospective control study of early parenteral

nutrition in severe cerebral hemorrhage patients. Journal of

Xi’an Medical University 2000;21(1):49–51.

Xue 2004 {published data only}

Xue W. Early rehabilitation combined with acupuncture

treatment on patients with allo-swallowing because of

pseudo-medulla oblongata paralysis after apoplexy. Chinese

Journal of Composite Clinical Medicine 2004;6(12):25–6.

Yang 2008 {published data only}

Yang C, Lee J, Joo M, Shin Y. The effect of double

application of functional electrical stimulation in patients

with dysphagia after stroke. Journal of Rehabilitation

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142).

Zhang 2007 {published data only}

Zhang J, Zhao C, Jin M, Zhou Y, Wang C, Zhao X, et al.A

new effective method for larynx elevation could avoid a

special abnormal swallowing mode. Stroke 2007;38(2):571.

Zheng 2006 {published data only}

Zheng TH, Wang SS, Chen ZL, Yang JD, Zhao HF,

Cheng L. The effect of early enteral nutrition support on

immunological function in patients with acute stroke.

Chinese Journal of Cerebrovascular Diseases 2006;3(8):

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Zhong 2003 {published data only}

Zhong C-M, Rong G, He F-Z, Jin H-Y. Comparison of

head and body acupuncture in the treatment of deglutition

disorders in subacute period of stroke. Chinese Journal of

Clinical Rehabilitation 2003;7(19):2706–7.

Zhou 2002 {published data only}

Zhou Y. Clinical observation on treatment of pseudobulbar

paralysis-induced dysphagia with otopoint-pellet-pressing

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References to ongoing studies

Carnaby-Mann 2008 {published data only}

Carnaby-Mann G. Adjunctive Neuromuscular electrical

Stimulation for the Rehabilitation of Swallowing “ANSRS”,

2008. http://www.strokecenter.org/trials (accessed 30

August 2012).

Clavé 2011 {published data only}

Clavé P. Effect of transcutaneous electrical stimulation

on post-stroke dysphagic patients “EETI-01”, 2011.

www.strokecenter.org/trials (accessed 30 August 2012).

Hamdy 2003 {published data only}

Hamdy S. A randomised controlled trial of pharyngeal

electrical stimulation in the treatment of dysphagia after

brain injury. public.ukcrn.org.uk/search/ (accessed 30

August 2012).

He 2009 {published data only}

He C. Clinical evaluation of dysphagia therapeutic

apparatus on cerebrovascular disease. Chinese Clinical Trial

Registry (ChiCTR) www.chictr.org/ (accessed 30 August

2012).

Kalra 2011 {published data only}

Kalra L. Evaluation of respiratory muscle strengthening to

reduce chest infections in stroke patients with swallowing

problems.. public.ukcrn.org.uk/search/ (accessed 30 August

2012).

Lye 2003 {published data only}

Lye M. Comparison of intravenous and subcutaneous

bolus infusion in post-stroke hydration. www.controlled-

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Matsumoto 2010 {published data only}

Matsumoto S. Effect of electrical stimulation in post-stroke

patients with dysphagia. http://www.umin.ac.jp/ctr/ 2010.

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McCullough G. Identifying and treating arousal related

deficits in neglect and dysphagia. www.strokecenter.org/

trials (accessed 30 August 2012).

Robbins 2011 {published data only}

Robbins J. Exercise for swallowing problems after stroke.


SQACU01 2001 {published data only}

Heng D. SQACU01 - a randomised trial of acupuncture

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Clinical Trials and Epidemiology Research Unit Annual

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Steele 2011 {published data only}

Steele CM. Tongue Pressure Profile Training for dysphagia

post stroke “TPPT”. www.strokecenter.org/trials (accessed

30 August 2012).

STEPS 2012 {unpublished data only}

Love J, Bath PMW. A multi-centre, double blind,

randomised controlled clinical investigation to validate the

EPS1 device as a treatment for stroke-induced dysphagia: a

study of Swallowing Treatment using Electrical Pharyngeal

Stimulation (STEPS Study). Clinical Investigational Plan

2012.

TOAD 2009 {published data only}

Vriesema A. Randomised controlled open label trial to

evaluate tolerance and safety of a new pre-thickened energy

dense sip feed in subjects in need of oral nutritional support.

www.trialregister.nl (accessed 30 August 2012).


Verin E. Cortical neuromodulation in post stroke dysphagia.


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Xie Y. Randomized controlled study on the acupuncture for

dysphagia in convalescence phase of apoplexy . Chinese

Clinical Trial Registry (ChiCTR) www.chictr.org/ (accessed

30 August 2012).



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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 identified 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 identified

Dysphagia defined 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 Randomisation using a random number 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

modification, 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 videofluoroscopy) 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 fluids delivered via NGT over 2

weeks after randomisation

Secondary outcome measures at 2 weeks: mean volume of feed and fluids delivered,

proportion of participants not receiving any NGT feed, supplementary parenteral fluids,

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 NGT feeding, NGT had 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 stratified 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 videofluoroscopic 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 office, remote from the study en-

vironment; assignment to 1 of 3 treatment

options by giving a telephone

Call to the trial office 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 office,

remote from the study environment; assignment to 1 of

3 treatment options by giving a telephone

Call to the trial office was done by the study speech pathol-

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 randomisation systems were housed on

a secure server with access permitted, via a

password, only to those members of the co-

ordinating team who 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 (defined 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 fluids 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 fluids and free water (n = 10)

C: thickened fluids 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 fluids

Notes Exclusions: aspiration to thickened fluids

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 first 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 defined 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 defibrillator, 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 informed of which group they

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 difficulty 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 confirmed 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 to give informed consent 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 reflex)

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 reflex 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 first 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, unfit 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 specific 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 from ictus, 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 specific 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) form cardiovascular 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 first 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 videofluoroscopy), 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 videofluoroscopic 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 videofluoroscopy 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 identified 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 defined

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 defined 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 defined 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: modified Rankin Score

NGT: nasogastric tube

OR: odds ratio

PEG: percutaneous endoscopic gastrostomy

PHAD: Paramatta Hospital’s 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: videofluoroscopy

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 reflex

Excluded: no outcome data

Akkersdijk 1995 RCT assessing PEG insertion methods and antibiotic prophylaxis in dysphagic 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) definition of aspiration non-standard; (3) randomisation

unclear; (4) insufficient 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 fluids (n = 6)

Group 2: bolus subcutaneous fluids (n = 6)

Group 3: intravenous fluids (n = 5)

Outcomes: mean volume infused, hydration status, weight change, infection

Excluded: (1) outcome measures not relevant to this review

Bülow 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 fluids (n = 17)

Group 2: intravenous fluids (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 videofluoroscopy

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 fibre content on diarrhoea severity and frequency

Group 1: no fibre (n = 15)

Group 2: moderate fibre (3.5 g/L) (n = 15)

Group 3: high fibre (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 videofluoroscopy swallow test

Excluded: (1) non1RCT

Davalos 1994 Unpublished study comparing high versus low glucose in NGT feeding 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 deficit, 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 reflex 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 flow,

substance P; (3) definition 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 (definition 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) definition

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

fluid 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 videofluoroscopy

Outcome: dysphagia handicap index questionnaire, videofluoroscopy, and cortical mapping of pha-

ryngeal muscles

Excluded: (1) no control group

Gandolfi 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 fluids in 46 dysphagic stroke patients

Group 1: fluids thickened using a viscometer

Group 2: fluids thickened subjectively

Outcomes: aspiration, viscosity of thickened fluids

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) insufficient 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 efficiency score,

need for transfer back to acute care hospital, diagnosis for which transfer was required, final 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 reflex 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 videofluoroscopic 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 fluid consistency (thin, thick, ultra-thick) and delivery

method (teaspoon, cup) in 190 dysphagic patients

Outcomes: aspiration on videofluoroscopy

Excluded: (!) not RCT; (2) dysphagia of mixed aetiology (stroke 61%)

Lien 2001 Crossover trial comparing liquid meal versus saline on gastro-oesophageal reflux 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 fluids for 6 weeks versus fluids thickened at

the bedside using modified 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 RCT comparing traditional swallowing therapy versus Shaker Exercise in 6 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: videofluoroscopic 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 reflex


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 specific 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 fluid consistency (thin, thick) and volume (5 ml, 10 ml,

cup) in 21 dysphagic stroke patients

Outcomes: functional swallow, aspiration on videofluoroscopy


Pownall 2008 RCT assessing thickened fluids 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 fluids 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 fibre enriched formula for 2 weeks versus fibre-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) insufficient 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 first 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) insufficient data; (2) timing: > 3 months post stroke; (3) outcome methods unclear

Verin 2009 Non-RCT assessing repetitive transcranial magnetic stimulation in patients with post stroke dysphagia

Outcomes: dysphagia handicap index and videofluoroscopy

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 videofluoroscopic barium swallow

Excluded: (1) non-RCT; (2) no control group

Whelan 2001 RCT assessing fluid consistency in 24 dysphagic acute stroke patients

Group 1: pre-thickened fluids

Group 2: powder-thickened fluids

Outcomes: fluid 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 filled in a questionnaire relating to speech and swallowing problems in 162

admissions

Group 2: 2 wards who did not fill 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 fibre supplementation in dysphagic stroke patients

Group 1: Ultracal (contains 14.4 g/L of fibre)

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: Kubota’s Water Drinking Test Scale, standard swallowing function scale and TCM Scale

of Dysphagia After Stroke


Zhou 2006 High protein enteral nutrition formula versus standard enteral nutrition formula for 14 days in patients

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 intervention to improve 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 flow




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 PEG placement by single physician using endoscope holder versus PEG placement 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 fluid (10 mL tap water) versus thickened fluid (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 Modified 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

Clavé 2011

Trial name or title Effect of transcutaneous electrical stimulation on post-stroke dysphagic patients “EETI-01”

Methods RCT, safety and efficacy study

Participants Post-stroke dysphagic patients

Interventions Sensory stimulation versus motor stimulation

Outcomes Not provided

Starting date 2011

Contact information Pere Clavé, MD, [email protected] 937417700

Notes Funding: Hospital de Mataró 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 Shaheen Hamdy, 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 Benefit

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 in stroke. Evaluation of 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, King’s College Hospital NHS Trust, King’s 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 Videofluorography, Fujishima’s 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 deficits in neglect and dysphagia

Methods Randomised, double-blind (participant, investigator), cross-over assignment

Participants Stroke patients with neglect, dysphagia

Interventions Modafinil 200 mg once daily versus placebo for 3 days

Outcomes Predicting response to modafinil among participants with neglect, dysphagia

Starting date 2010

Contact information Gary McCullough, [email protected]

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 [email protected]

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 Profile Training for dysphagia post stroke “TPPT”

Methods Randomised, single blind (outcomes assessor)

Participants 60 patients with thin liquid flow-control difficulties secondary to stroke or acquired brain injury

Interventions Compare 2 different tongue-pressure resistance training protocols

Tongue-pressure profile training versus tongue-pressure strength-and-accuracy training

Outcomes Primary: change in penetration-aspiration scale

Secondary: change in bolus control for thin liquids on videofluoroscopy 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, modified

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), efficacy study

Participants 20 patients with post-stroke dysphagia

Interventions Sub-motor threshold stimulation of mylohyoid muscles versus control

Outcomes Videofluoroscopy 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 titleNo. 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


studies

No. of



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


studies

No. of



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


studies

No. of


1 Time to resolution of dysphagia

(days)


1.1 Free thin fluids 1 20 Mean Difference (IV, Random, 95% CI) -8.10 [-20.84, 4.64]

Comparison 5. Nutritional supplementation


studies

No. of



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: Tau2 = 0.0; Chi2 = 0.00, df = 1 (P = 0.97); I2 =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)Study or subgroup Treatment Control Odds Ratio Weight Odds Ratio

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 ]




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: Tau2 = 0.03; Chi2 = 1.14, df = 1 (P = 0.29); I2 =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 ControlMean

Difference WeightMean

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 ]



-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 ]




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 ]





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 ]




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)Study or subgroup Treatment Control Odds Ratio Weight Odds Ratio

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: Chi2 = 3.27, df = 5 (P = 0.66), I2 =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)



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



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 ]



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 ]



Test for subgroup differences: Chi2 = 2.55, df = 2 (P = 0.28), I2 =22%

-2 -1 0 1 2




Analysis 1.9. Comparison 1 Swallowing therapy, Outcome 9 Nutritional (albumin).



Outcome: 9 Nutritional (albumin)



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 ]



-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 ]




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 ]





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 ]





Beavan 2010 41/51 47/53 0.52 [ 0.18, 1.57 ]

Subtotal (95% CI) 51 53 0.52 [ 0.18, 1.57 ]





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 ]





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 ]





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)



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 ]




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 ]




-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 ]





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 ]





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 ]





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 ]





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 ]





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 ]





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)




0.01 0.1 1 10 100




Analysis 2.10. Comparison 2 Route of feeding, Outcome 10 Feed delivery (%).



Outcome: 10 Feed delivery (%)



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 ]




-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 betterMean


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 ]




-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 BetterMean


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 ]




-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 betterMean


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 ]




-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)



Difference


1 Free thin fluids

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 fluids and free water Favours thickened fluids



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 ]





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)



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 ]




-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 ]





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)



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: Tau2 = 58886.43; Chi2 = 23.12, df = 2 (P<0.00001); I2 =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)



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: Tau2 = 168.05; Chi2 = 25.61, df = 2 (P<0.00001); I2 =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)



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 ]




-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 fluid or fluid 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 fluid or fluid 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 fluid or fluid 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 modifications to

the analysis methodology, types of stroke patients and

outcome measures (Differences between protocol and

review).

14 March 2012 New citation required but conclusions have not changed Changes of authors. The conclusions have not changed.

H I S T O R Y

Protocol first published: Issue 1, 1997

Review first 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

JB was co-ordinator and author of one completed trial included in this review (Beavan 2010). PB was 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

• King’s 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

Modification of analysis methodology

The analysis methodology was changed from fixed-effect to random-effects models (OR, MD) since significant 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)).

Modification of type of stroke patients

To fit 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 modification 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 videofluoroscopy (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



cocrane ingles

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