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https://www.sciencedirect.com/science/article/abs/pii/S0022399921001781
Journal of Psychosomatic Research
Available online 28 May 2021, 110533
In Press, Journal Pre-proof
Adverse outcomes in trials of graded exercise therapy for adult patients with chronic fatigue syndrome
P.D.White a
J.Etherington b
a
Wolfson Institute of Preventive Medicine, St Bartholomew's and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
b
Pure Sports Medicine, 12 Finsbury Square, London, UK
Received 16 March 2021, Revised 20 May 2021, Accepted 20 May 2021, Available online 28 May 2021.
https://doi.org/10.1016/j.jpsychores.2021.110533Get rights and content
Highlights
•
Participants were no worse after graded exercise therapy than control interventions.
•
No more participants withdrew from graded exercise therapy than control interventions.
•
More participants dropped out from trial follow up after graded exercise therapy.
•
Graded exercise therapy probably is safe when properly prescribed and supervised.
Abstract
Objectives
Graded exercise therapy (GET) is an effective treatment for chronic fatigue syndrome (CFS), but concerns have been raised about its safety. Two randomised controlled trials have not supported these concerns. We further assessed safety outcomes in all ten published trials of GET for CFS.
Methods
We undertook meta-analyses of three outcomes: Self-ratings of Clinical Global Impression (CGI) change scores of 6 or 7 (“much worse” or “very much worse”), numbers of participants withdrawing from treatments, and numbers of participants dropping out of trial follow up. We provide risk ratios (95% confidence intervals (CI)), comparing GET with control interventions.
Results
The 10 trials involved 1279 participants. CGI scores of 6 or 7 were reported by 14/333 (4%) participants after GET and 26/334 (8%) participants after control interventions (RR (CI): 0.62 (0.32, 1.17)). Withdrawals from treatment occurred in 64/535 (12%) participants after GET and 53/534 (10%) participants after control interventions (RR (CI):1.21 (0.86, 1.69)). Drop-outs from trial follow up occurred in 74/679 (11%) participants after GET and 41/600 (7%) participants after control interventions (RR (CI): 1.51 (1.03, 2.22)). The certainty of this evidence was rated low by GRADE, due to imprecision.
Conclusions
There was no evidence of excess harm with graded exercise therapy by either self-rated deterioration or by withdrawing from GET, in comparison to control interventions. More GET participants dropped out of trial follow up in comparison to control interventions. Future research should ascertain the most effective and safest form of graded exercise therapy.
Keywords
Chronic fatigue syndrome
Graded exercise therapy
Safety
Adverse outcomes
© 2021 Elsevier Inc. All rights reserved.
See this post for the full paper:
https://www.s4me.info/threads/adver...ome-2021-white-etherington.20767/#post-347678
Journal of Psychosomatic Research
Available online 28 May 2021, 110533
In Press, Journal Pre-proof
Adverse outcomes in trials of graded exercise therapy for adult patients with chronic fatigue syndrome
P.D.White a
J.Etherington b
a
Wolfson Institute of Preventive Medicine, St Bartholomew's and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
b
Pure Sports Medicine, 12 Finsbury Square, London, UK
Received 16 March 2021, Revised 20 May 2021, Accepted 20 May 2021, Available online 28 May 2021.
https://doi.org/10.1016/j.jpsychores.2021.110533Get rights and content
Highlights
•
Participants were no worse after graded exercise therapy than control interventions.
•
No more participants withdrew from graded exercise therapy than control interventions.
•
More participants dropped out from trial follow up after graded exercise therapy.
•
Graded exercise therapy probably is safe when properly prescribed and supervised.
Abstract
Objectives
Graded exercise therapy (GET) is an effective treatment for chronic fatigue syndrome (CFS), but concerns have been raised about its safety. Two randomised controlled trials have not supported these concerns. We further assessed safety outcomes in all ten published trials of GET for CFS.
Methods
We undertook meta-analyses of three outcomes: Self-ratings of Clinical Global Impression (CGI) change scores of 6 or 7 (“much worse” or “very much worse”), numbers of participants withdrawing from treatments, and numbers of participants dropping out of trial follow up. We provide risk ratios (95% confidence intervals (CI)), comparing GET with control interventions.
Results
The 10 trials involved 1279 participants. CGI scores of 6 or 7 were reported by 14/333 (4%) participants after GET and 26/334 (8%) participants after control interventions (RR (CI): 0.62 (0.32, 1.17)). Withdrawals from treatment occurred in 64/535 (12%) participants after GET and 53/534 (10%) participants after control interventions (RR (CI):1.21 (0.86, 1.69)). Drop-outs from trial follow up occurred in 74/679 (11%) participants after GET and 41/600 (7%) participants after control interventions (RR (CI): 1.51 (1.03, 2.22)). The certainty of this evidence was rated low by GRADE, due to imprecision.
Conclusions
There was no evidence of excess harm with graded exercise therapy by either self-rated deterioration or by withdrawing from GET, in comparison to control interventions. More GET participants dropped out of trial follow up in comparison to control interventions. Future research should ascertain the most effective and safest form of graded exercise therapy.
Keywords
Chronic fatigue syndrome
Graded exercise therapy
Safety
Adverse outcomes
© 2021 Elsevier Inc. All rights reserved.
See this post for the full paper:
https://www.s4me.info/threads/adver...ome-2021-white-etherington.20767/#post-347678
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