Swallowing therapy for dysphagia in acute and subacute stroke

Philip M Bath; Han Sean Lee; Lisa F Everton

doi:10.1002/14651858.CD000323.pub3

Cochrane Database of Systematic Reviews

Tratamiento para la deglución para la disfagia en el accidente cerebrovascular agudo y subagudo

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DOI:

https://doi.org/10.1002/14651858.CD000323.pub3 Copy DOI

Database:

Cochrane Database of Systematic Reviews

Version published:

30 October 2018see what's new

Type:

Intervention

Stage:

Review

Cochrane Editorial Group:

Cochrane Stroke Group

Copyright:

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

Philip M Bath

Correspondence to: Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital, Nottingham, UK

[email protected]
Han Sean Lee

Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital, Nottingham, UK
Lisa F Everton

Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital, Nottingham, UK

Contributions of authors

Philip Bath: conceived and designed the review, undertook searches, analysed and interpreted data, wrote the original review, and updated the review in 2007 (interim update), 2012, and 2018.

Han Sean Lee: undertook searches, extracted data, analysed and interpreted data, and updated the review in 2018.

Lisa Everton: undertook searches and data extraction, analysed and interpreted data, and updated the review in 2018.

Sources of support

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.
National Institutes of Health Research Stroke Research Network, UK.

Support for recruitment of patients into UK‐based trials
National Institutes of Health Research ‐ Cochrane Incentive Scheme, UK.

Declarations of interest

PB was chief investigator of two included trials (Bath 1997, academic; STEPS 2016, commercial ‐ funded by Phagenesis Ltd); he consults for this company and receives honoraria and expenses for this work; he did not contribute to decisions on PES studies including deciding which trials should be included and extracting outcome data. No pharmaceutical or device companies, or other commercial entities, were involved in data analysis, data interpretation, writing of this review, or comments on it.

SL: none known.

LE: none known.

Acknowledgements

We thank the following people who were review authors in previous versions of this review.

Version 1 (1999): Jean Kerr, Morwenna Collins, Cameron Sellars, and David Smithard; they variously contributed to searches, data extraction, analysis and interpretation of data, and updating of the review.
Version 2 (2012): Jessica Beavan, Sharon Ellendar, and Chamilla Geeganage; they variously undertook searches, data extraction, and analysis and interpretation of data, and updated the review.

We thank the Cochrane Stroke Group for assistance in identifying trials and conducting searches, 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 (Belgium). 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 mistakes are our own. We would be very grateful to be informed of any completed or ongoing trials that are not listed in the review, and to know of outcome data from existing trials that have not been included.

Version history

Published

Title

Stage

Authors

Version

2018 Oct 30

Swallowing therapy for dysphagia in acute and subacute stroke

Review

Philip M Bath, Han Sean Lee, Lisa F Everton

https://doi.org/10.1002/14651858.CD000323.pub3

2012 Oct 17

Interventions for dysphagia and nutritional support in acute and subacute stroke

Review

Chamila Geeganage, Jessica Beavan, Sharon Ellender, Philip MW Bath

https://doi.org/10.1002/14651858.CD000323.pub2

1999 Oct 25

Interventions for dysphagia in acute stroke

Review

Philip MW Bath, Fiona J Bath‐Hextall, David Smithard

https://doi.org/10.1002/14651858.CD000323

Differences between protocol and review

Separation of dysphagia treatment from nutritional support

For this version of the review, we removed all trials related to nutritional support and feeding to allow focus on swallowing therapy for post‐stroke dysphagia.

Modification of analysis method

We changed the analysis method from fixed‐effect to random‐effects models (odds ratio (OR), mean difference (MD)) because we noted the presence of significant trial and statistical heterogeneity. Two studies included more than one interventional group (Yuan 2003; Carnaby 2006), producing different treatment intensities. In these cases, we divided the low‐intensity (middle) groups and entered data from the study as two data sets (e.g. data set 1: medium (M), low (L), or none; and data set 2: high (H) or medium (M)). Similarly, in the case of repetitive transcranial magnetic stimulation, when a trial compared high‐ versus low‐frequency stimulation or unilateral versus bilateral stimulation (Kim 2012i; Kim 2012ii; Du 2016i; Du 2016ii; Park 2016a (i); Park 2016a (ii)), we divided control group participants equally between treatment groups to prevent counting control participants more than once, thereby artificially narrowing the confidence intervals (CIs).

We combined different interventions, collectively referred to as 'swallowing therapy', for the purposes of analysing their effects on main outcomes to evaluate whether any intervention is better than no intervention, and to try to establish where the most positive effects are seen, and where more research is needed.

Modification of type of stroke patients

We excluded trials in which a majority of participants did not present with stroke, along with trials for which enrolment occurred after six months.

Addition or modification of outcome measures

Modification of search strategies: we have revised and updated the search strategies used for this review to account for newly identified relevant terms keywords and indexing terms. We have included both versions of each search strategy in the review appendices.

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: chest infection or pneumonia rates and penetration aspiration scores. We retained outcomes related to improvement of dysphagia as listed with proportion of participants with dysphagia at end of trial. However, we also included changes in some measurements on videofluoroscopy (pharyngeal transit time) and changes in swallowing ability as determined by change in swallow scores. We included discharge destination within the outcome 'institutionalisation': the number of participants discharged to long‐term care.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

PICOs

Population

Intervention

Comparison

Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Figure 1

Study Flow Diagram, *86 studies awaiting classification.

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Figure 2

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Swallowing therapy, Outcome 1 Functional outcome ‐ death or dependency, death or disability at end of trial.

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Analysis 1.2

Comparison 1 Swallowing therapy, Outcome 2 Case fatality at end of trial.

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Analysis 1.3

Comparison 1 Swallowing therapy, Outcome 3 Length of inpatient stay (days).

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Analysis 1.4

Comparison 1 Swallowing therapy, Outcome 4 Proportion of participants with dysphagia at end of trial.

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Analysis 1.5

Comparison 1 Swallowing therapy, Outcome 5 Swallowing ability.

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Analysis 1.6

Comparison 1 Swallowing therapy, Outcome 6 Penetration aspiration score.

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Analysis 1.7

Comparison 1 Swallowing therapy, Outcome 7 Chest infection or pneumonia.

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Analysis 1.8

Comparison 1 Swallowing therapy, Outcome 8 Pharyngeal transit time (seconds).

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Analysis 1.9

Comparison 1 Swallowing therapy, Outcome 9 Institutionalisation.

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Analysis 1.10

Comparison 1 Swallowing therapy, Outcome 10 Nutritional (albumin).

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Summary of findings for the main comparison. Swallowing therapy compared to placebo for dysphagia in acute and subacute stroke

Swallowing therapy compared to placebo for dysphagia in acute and subacute stroke
Patient or population: dysphagia in acute and subacute stroke Setting: in hospital Intervention: swallowing therapy Comparison: placebo
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Risk with placebo	Risk with swallowing therapy
Death or dependency at end of trial	Study population		OR 1.05 (0.63 to 1.75)	306 (2 RCTs)	⊕⊕⊕⊝ Moderate	a
	693 per 1000	703 per 1000 (587 to 798)
Case fatality at end of trial	Study population		OR 1.00 (0.66 to 1.52)	766 (14 RCTs)	⊕⊕⊕⊝ Moderate	b
	197 per 1000	197 per 1000 (140 to 272)
Length of inpatient stay (days)	Mean length of inpatient stay (days) ranged from 19 to 119	MD 2.9 lower (5.65 lower to 0.15 lower)	‐	577 (8 RCTs)	⊕⊕⊕⊝ Moderate	c
Proportion of participants with dysphagia at end of trial	Study population		OR 0.42 (0.32 to 0.55)	1487 (23 RCTs)	⊕⊕⊝⊝ Low	d
	570 per 1000	357 per 1000 (298 to 421)
Swallowing ability	Mean swallowing ability was 0	SMD 0.66 lower (1.01 lower to 0.32 lower)	‐	1173 (26 RCTs)	⊕⊝⊝⊝ Very low	e
Penetration aspiration score	Mean penetration aspiration score was 0	SMD 0.37 lower (0.74 lower to 0 )	‐	303 (11 RCTs)	⊕⊕⊝⊝ Low	f
Adverse event: chest infection or pneumonia	Study population		OR 0.34 (0.17 to 0.71)	676 (10 RCTs)	⊕⊝⊝⊝ Very low	g
	343 per 1000	151 per 100 (82 to 271)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aDowngraded by one level due to lack of precision (one study split into two trials). ^bDowngraded by one level for indirectness of the evidence (i.e. multiple different interventions). ^cDowngraded by one level due to indirectness of the evidence (i.e. multiple different interventions). Note also that two studies had unclear blinding. ^dDowngraded by two levels due to indirectness of the evidence and blinding ‐ a large number of studies did not clarify blinding status. ^eDowngraded by three levels due to indirectness of the evidence (i.e. multiple different interventions), considerable heterogeneity, and fair number of studies did not clarify blinding status. ^fDowngraded by two levels due to indirectness of the evidence (i.e. multiple different interventions) and moderate heterogeneity. ^gDowngraded by three levels due to indirectness of the evidence (i.e. multiple different interventions), substantial heterogeneity, and fair number of studies did not clarify blinding status.

Summary of findings for the main comparison. Swallowing therapy compared to placebo for dysphagia in acute and subacute stroke

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Comparison 1. Swallowing therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Functional outcome ‐ death or dependency, death or disability at end of trial Show forest plot	2	306	Odds Ratio (M‐H, Random, 95% CI)	1.05 [0.63, 1.75]

1.1 Behavioural interventions	2	306	Odds Ratio (M‐H, Random, 95% CI)	1.05 [0.63, 1.75]
2 Case fatality at end of trial Show forest plot	14	766	Odds Ratio (M‐H, Random, 95% CI)	1.00 [0.66, 1.52]

2.1 Behavioural interventions	2	306	Odds Ratio (M‐H, Random, 95% CI)	0.83 [0.46, 1.51]
2.2 Drug therapy	3	148	Odds Ratio (M‐H, Random, 95% CI)	1.40 [0.31, 6.28]
2.3 Pharyngeal electrical stimulation	4	215	Odds Ratio (M‐H, Random, 95% CI)	0.92 [0.38, 2.26]
2.4 Physical stimulation (thermal, tactile)	1	19	Odds Ratio (M‐H, Random, 95% CI)	1.05 [0.16, 6.92]
2.5 Transcranial magnetic stimulation	4	78	Odds Ratio (M‐H, Random, 95% CI)	0.28 [0.03, 2.93]
3 Length of inpatient stay (days) Show forest plot	8	577	Mean Difference (IV, Random, 95% CI)	‐2.90 [‐5.65, ‐0.15]

3.1 Behavioural interventions	4	370	Mean Difference (IV, Random, 95% CI)	‐2.70 [‐5.68, 0.28]
3.2 Pharyngeal electrical stimulation	4	207	Mean Difference (IV, Random, 95% CI)	‐6.05 [‐16.40, 4.31]
4 Proportion of participants with dysphagia at end of trial Show forest plot	23	1487	Odds Ratio (M‐H, Random, 95% CI)	0.42 [0.32, 0.55]

4.1 Acupuncture	8	676	Odds Ratio (M‐H, Random, 95% CI)	0.31 [0.20, 0.49]
4.2 Behavioural interventions	6	511	Odds Ratio (M‐H, Random, 95% CI)	0.45 [0.28, 0.74]
4.3 Drug therapy	1	17	Odds Ratio (M‐H, Random, 95% CI)	0.48 [0.07, 3.35]
4.4 Neuromuscular electrical stimulation	2	76	Odds Ratio (M‐H, Random, 95% CI)	0.51 [0.18, 1.49]
4.5 Pharyngeal electrical stimulation	3	66	Odds Ratio (M‐H, Random, 95% CI)	0.55 [0.15, 2.11]
4.6 Physical stimulation (thermal, tactile)	2	127	Odds Ratio (M‐H, Random, 95% CI)	0.65 [0.07, 5.85]
4.7 Transcranial direct current stimulation	1	14	Odds Ratio (M‐H, Random, 95% CI)	0.29 [0.01, 8.39]
5 Swallowing ability Show forest plot	26	1173	Std. Mean Difference (IV, Random, 95% CI)	‐0.66 [‐1.01, ‐0.32]

5.1 Acupuncture	6	496	Std. Mean Difference (IV, Random, 95% CI)	‐0.55 [‐1.20, 0.11]
5.2 Behavioural intervention	3	121	Std. Mean Difference (IV, Random, 95% CI)	‐0.56 [‐1.07, ‐0.05]
5.3 Drug therapy	1	71	Std. Mean Difference (IV, Random, 95% CI)	‐0.46 [‐0.93, 0.01]
5.4 Neuromuscular electrical stimulation	2	100	Std. Mean Difference (IV, Random, 95% CI)	‐1.34 [‐3.39, 0.71]
5.5 Pharyngeal electrical stimulation	3	194	Std. Mean Difference (IV, Random, 95% CI)	0.06 [‐0.22, 0.34]
5.6 Physical stimulation (thermal, tactile)	1	16	Std. Mean Difference (IV, Random, 95% CI)	‐0.30 [‐1.29, 0.68]
5.7 Transcranial direct current stimulation	2	34	Std. Mean Difference (IV, Random, 95% CI)	‐0.33 [‐2.22, 1.56]
5.8 Transcranial magnetic stimulation	8	141	Std. Mean Difference (IV, Random, 95% CI)	‐1.29 [‐2.37, ‐0.21]
6 Penetration aspiration score Show forest plot	11	303	Std. Mean Difference (IV, Random, 95% CI)	‐0.37 [‐0.74, ‐0.00]

6.1 Behavioural intervention	1	27	Std. Mean Difference (IV, Random, 95% CI)	‐0.88 [‐1.68, ‐0.08]
6.2 Neuromuscular electrical stimulation	1	18	Std. Mean Difference (IV, Random, 95% CI)	0.57 [‐0.38, 1.52]
6.3 Pharyngeal electrical stimulation	4	177	Std. Mean Difference (IV, Random, 95% CI)	‐0.17 [‐0.53, 0.19]
6.4 Transcranial magnetic stimulation	5	81	Std. Mean Difference (IV, Random, 95% CI)	‐0.53 [‐1.22, 0.16]
7 Chest infection or pneumonia Show forest plot	9	618	Odds Ratio (M‐H, Random, 95% CI)	0.36 [0.16, 0.78]

7.1 Behavioural interventions	6	473	Odds Ratio (M‐H, Random, 95% CI)	0.56 [0.31, 1.00]
7.2 Drug therapy	1	60	Odds Ratio (M‐H, Random, 95% CI)	0.06 [0.01, 0.21]
7.3 Neuromuscular electrical stimulation	1	57	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
7.4 Pharyngeal electrical stimulation	1	28	Odds Ratio (M‐H, Random, 95% CI)	0.43 [0.06, 3.09]
8 Pharyngeal transit time (seconds) Show forest plot	6	187	Mean Difference (IV, Random, 95% CI)	‐0.23 [‐0.32, ‐0.15]

8.1 Drug therapy	1	17	Mean Difference (IV, Random, 95% CI)	‐0.21 [‐0.91, 0.49]
8.2 Neuromuscular electrical stimulation	3	126	Mean Difference (IV, Random, 95% CI)	‐0.23 [‐0.39, ‐0.08]
8.3 Pharyngeal electrical stimulation	1	28	Mean Difference (IV, Random, 95% CI)	‐0.15 [‐0.67, 0.37]
8.4 Physical stimulation (thermal, tactile)	1	16	Mean Difference (IV, Random, 95% CI)	‐0.19 [‐0.34, ‐0.04]
9 Institutionalisation Show forest plot	3	447	Odds Ratio (M‐H, Random, 95% CI)	0.75 [0.47, 1.19]

9.1 Behavioural interventions	2	306	Odds Ratio (M‐H, Random, 95% CI)	0.76 [0.39, 1.48]
9.2 Pharyngeal electrical stimulation	1	141	Odds Ratio (M‐H, Random, 95% CI)	0.73 [0.36, 1.48]
10 Nutritional (albumin) Show forest plot	3	169	Mean Difference (IV, Random, 95% CI)	0.37 [‐1.50, 2.24]

10.1 Behavioural interventions	2	64	Mean Difference (IV, Random, 95% CI)	0.20 [‐4.77, 5.17]
10.2 Pharyngeal electrical stimulation	1	105	Mean Difference (IV, Random, 95% CI)	0.40 [‐1.62, 2.42]

Comparison 1. Swallowing therapy

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Declarations of interest

Acknowledgements

Version history

Differences between protocol and review

Separation of dysphagia treatment from nutritional support

Modification of analysis method

Modification of type of stroke patients

Addition or modification of outcome measures

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

PICOs

PICOs

Population

Intervention

Comparison

Outcome

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