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Exercise therapy beneficial for some ME/CFS patients new Cochrane report says

deleder2k

Senior Member
Messages
1,129
Exercise therapy beneficial for some ME/CFS patients says the independent Cochrane Collaboration in new meta-analysis on exercise therapy.

http://onlinelibrary.wiley.com/enhanced/doi/10.1002/14651858.CD003200.pub3

Abstract
Background
Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory. CFS presents as a common, debilitating and serious health problem. Treatment may include physical interventions, such as exercise therapy, which was last reviewed in 2004.

Objectives
The objective of this review was to determine the effects of exercise therapy (ET) for patients with CFS as compared with any other intervention or control.

• Exercise therapy versus 'passive control' (e.g. treatment as usual, waiting-list control, relaxation, flexibility).

• Exercise therapy versus other active treatment (e.g. cognitive-behavioural therapy (CBT), cognitive treatment, supportive therapy, pacing, pharmacological therapy such as antidepressants).

• Exercise therapy in combination with other specified treatment strategies versus other specified treatment strategies (e.g. exercise combined with pharmacological treatment vs pharmacological treatment alone).

Search methods
We searched The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), the Cochrane Central Register of Controlled Trials (CENTRAL) and SPORTDiscus up to May 2014 using a comprehensive list of free-text terms for CFS and exercise. We located unpublished or ongoing trials through the World Health Organization (WHO) International Clinical Trials Registry Platform (to May 2014). We screened reference lists of retrieved articles and contacted experts in the field for additional studies

Selection criteria
Randomised controlled trials involving adults with a primary diagnosis of CFS who were able to participate in exercise therapy. Studies had to compare exercise therapy with passive control, psychological therapies, adaptive pacing therapy or pharmacological therapy.

Data collection and analysis
Two review authors independently performed study selection, risk of bias assessments and data extraction. We combined continuous measures of outcomes using mean differences (MDs) and standardised mean differences (SMDs). We combined serious adverse reactions and drop-outs using risk ratios (RRs). We calculated an overall effect size with 95% confidence intervals (CIs) for each outcome.

Main results
We have included eight randomised controlled studies and have reported data from 1518 participants in this review. Three studies diagnosed individuals with CFS using the 1994 criteria of the Centers for Disease Control and Prevention (CDC); five used the Oxford criteria. Exercise therapy lasted from 12 to 26 weeks. Seven studies used variations of aerobic exercise therapy such as walking, swimming, cycling or dancing provided at mixed levels in terms of intensity of the aerobic exercise from very low to quite rigorous, whilst one study used anaerobic exercise. Control groups consisted of passive control (eight studies; e.g. treatment as usual, relaxation, flexibility) or CBT (two studies), cognitive therapy (one study), supportive listening (one study), pacing (one study), pharmacological treatment (one study) and combination treatment (one study). Risk of bias varied across studies, but within each study, little variation was found in the risk of bias across our primary and secondary outcome measures.

Investigators compared exercise therapy with 'passive' control in eight trials, which enrolled 971 participants. Seven studies consistently showed a reduction in fatigue following exercise therapy at end of treatment, even though the fatigue scales used different scoring systems: an 11-item scale with a scoring system of 0 to 11 points (MD -6.06, 95% CI -6.95 to -5.17; one study, 148 participants; low-quality evidence); the same 11-item scale with a scoring system of 0 to 33 points (MD -2.82, 95% CI -4.07 to -1.57; three studies, 540 participants; moderate-quality evidence); and a 14-item scale with a scoring system of 0 to 42 points (MD -6.80, 95% CI -10.31 to -3.28; three studies, 152 participants; moderate-quality evidence). Serious adverse reactions were rare in both groups (RR 0.99, 95% CI 0.14 to 6.97; one study, 319 participants; moderate-quality evidence), but sparse data made it impossible for review authors to draw conclusions. Study authors reported a positive effect of exercise therapy at end of treatment with respect to sleep (MD -1.49, 95% CI -2.95 to -0.02; two studies, 323 participants), physical functioning (MD 13.10, 95% CI 1.98 to 24.22; five studies, 725 participants) and self-perceived changes in overall health (RR 1.83, 95% CI 1.39 to 2.40; four studies, 489 participants). It was not possible for review authors to draw conclusions regarding the remaining outcomes.

Investigators compared exercise therapy with CBT in two trials (351 participants). One trial (298 participants) reported little or no difference in fatigue at end of treatment between the two groups using an 11-item scale with a scoring system of 0 to 33 points (MD 0.20, 95% CI -1.49 to 1.89). Both studies measured differences in fatigue at follow-up, but neither found differences between the two groups using an 11-item fatigue scale with a scoring system of 0 to 33 points (MD 0.30, 95% CI -1.45 to 2.05) and a nine-item Fatigue Severity Scale with a scoring system of 1 to 7 points (MD 0.40, 95% CI -0.34 to 1.14). Serious adverse reactions were rare in both groups (RR 0.67, 95% CI 0.11 to 3.96). We observed little or no difference in physical functioning, depression, anxiety and sleep, and we were not able to draw any conclusions with regard to pain, self-perceived changes in overall health, use of health service resources and drop-out rate.

With regard to other comparisons, one study (320 participants) suggested a general benefit of exercise over adaptive pacing, and another study (183 participants) a benefit of exercise over supportive listening. The available evidence was too sparse to draw conclusions about the effect of pharmaceutical interventions.

Authors' conclusions
Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes. A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible. The effectiveness of exercise therapy seems greater than that of pacing but similar to that of CBT. Randomised trials with low risk of bias are needed to investigate the type, duration and intensity of the most beneficial exercise intervention.

Any thoughts on this? Is there no evidence to support the claim that exercise therapy makes some patients worse?
 
Last edited:

Sasha

Fine, thank you
Messages
17,863
Location
UK

user9876

Senior Member
Messages
4,556
They've not done a very careful review since they mark risk of both incomplete outcome data and selective bias for pace as green which I assume is low. They clearly haven't compared the protocol with the data that they chose to published.

There results are wrong anyway since the summary stats don't make sense for the scales used.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Just one word: Oxford.

They've included studies with the discredited Oxford criteria.

Precise wording:
We have included eight randomised controlled studies and have reported data from 1518 participants in this review. Three studies diagnosed individuals with CFS using the 1994 criteria of the Centers for Disease Control and Prevention (CDC); five used the Oxford criteria.

Funny, isn't it, that almost everyone here would appear to have a different illness from those which are studied?

Not a laughing matter though. :(
 

Snow Leopard

Hibernating
Messages
5,902
Location
South Australia
How did they decide that the PACE study was not guilty of 'selective reporting' !?!

Also, none of the 'moderate' findings were follow up data, suggesting further bias.
 
Last edited:

Dolphin

Senior Member
Messages
17,567
This is open access: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003200.pub3/abstract

Intervention Review

Exercise therapy for chronic fatigue syndrome

Lillebeth Larun1,*,
Kjetil G. Brurberg1,
Jan Odgaard-Jensen2,
Jonathan R Price3

Editorial Group: Cochrane Depression, Anxiety and Neurosis Group

Published Online: 10 FEB 2015

Assessed as up-to-date: 9 MAY 2014

DOI: 10.1002/14651858.CD003200.pub3

Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Database Title

The Cochrane Library

Abstract

Background

Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory.

CFS presents as a common, debilitating and serious health problem.

Treatment may include physical interventions, such as exercise therapy, which was last reviewed in 2004.

Objectives

The objective of this review was to determine the effects of exercise therapy (ET) for patients with CFS as compared with any other intervention or control.

• Exercise therapy versus 'passive control' (e.g. treatment as usual, waiting-list control, relaxation, flexibility).

• Exercise therapy versus other active treatment (e.g. cognitive-behavioural therapy (CBT), cognitive treatment, supportive therapy, pacing, pharmacological therapy such as antidepressants).

• Exercise therapy in combination with other specified treatment strategies versus other specified treatment strategies (e.g. exercise combined with pharmacological treatment vs pharmacological treatment alone).

Search methods

We searched The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), the Cochrane Central Register of Controlled Trials (CENTRAL) and SPORTDiscus up to May 2014 using a comprehensive list of free-text terms for CFS and exercise.

We located unpublished or ongoing trials through the World Health Organization (WHO) International Clinical Trials Registry Platform (to May 2014).

We screened reference lists of retrieved articles and contacted experts in the field for additional studies

Selection criteria

Randomised controlled trials involving adults with a primary diagnosis of CFS who were able to participate in exercise therapy.

Studies had to compare exercise therapy with passive control, psychological therapies, adaptive pacing therapy or pharmacological therapy.

Data collection and analysis

Two review authors independently performed study selection, risk of bias assessments and data extraction.

We combined continuous measures of outcomes using mean differences (MDs) and standardised mean differences (SMDs). We combined serious adverse reactions and drop-outs using risk ratios (RRs).

We calculated an overall effect size with 95% confidence intervals (CIs) for each outcome.

Main results

We have included eight randomised controlled studies and have reported data from 1518 participants in this review.

Three studies diagnosed individuals with CFS using the 1994 criteria of the Centers for Disease Control and Prevention (CDC); five used the Oxford criteria.

Exercise therapy lasted from 12 to 26 weeks.

Seven studies used variations of aerobic exercise therapy such as walking, swimming, cycling or dancing provided at mixed levels in terms of intensity of the aerobic exercise from very low to quite rigorous, whilst one study used anaerobic exercise.

Control groups consisted of passive control (eight studies; e.g. treatment as usual, relaxation, flexibility) or CBT (two studies), cognitive therapy (one study), supportive listening (one study), pacing (one study), pharmacological treatment (one study) and combination treatment (one study).

Risk of bias varied across studies, but within each study, little variation was found in the risk of bias across our primary and secondary outcome measures.

Investigators compared exercise therapy with 'passive' control in eight trials, which enrolled 971 participants.

Seven studies consistently showed a reduction in fatigue following exercise therapy at end of treatment, even though the fatigue scales used different scoring systems: an 11-item scale with a scoring system of 0 to 11 points (MD -6.06, 95% CI -6.95 to -5.17; one study, 148 participants; low-quality evidence); the same 11-item scale with a scoring system of 0 to 33 points (MD -2.82, 95% CI -4.07 to -1.57; three studies, 540 participants; moderate-quality evidence); and a 14-item scale with a scoring system of 0 to 42 points (MD -6.80, 95% CI -10.31 to -3.28; three studies, 152 participants; moderate-quality evidence).

Serious adverse reactions were rare in both groups (RR 0.99, 95% CI 0.14 to 6.97; one study, 319 participants; moderate-quality evidence), but sparse data made it impossible for review authors to draw conclusions.

Study authors reported a positive effect of exercise therapy at end of treatment with respect to sleep (MD -1.49, 95% CI -2.95 to -0.02; two studies, 323 participants), physical functioning (MD 13.10, 95% CI 1.98 to 24.22; five studies, 725 participants) and self-perceived changes in overall health (RR 1.83, 95% CI 1.39 to 2.40; four studies, 489 participants).

It was not possible for review authors to draw conclusions regarding the remaining outcomes.

Investigators compared exercise therapy with CBT in two trials (351 participants).

One trial (298 participants) reported little or no difference in fatigue at end of treatment between the two groups using an 11-item scale with a scoring system of 0 to 33 points (MD 0.20, 95% CI -1.49 to 1.89).

Both studies measured differences in fatigue at follow-up, but neither found differences between the two groups using an 11-item fatigue scale with a scoring system of 0 to 33 points (MD 0.30, 95% CI -1.45 to 2.05) and a nine-item Fatigue Severity Scale with a scoring system of 1 to 7 points (MD 0.40, 95% CI -0.34 to 1.14).

Serious adverse reactions were rare in both groups (RR 0.67, 95% CI 0.11 to 3.96).

We observed little or no difference in physical functioning, depression, anxiety and sleep, and we were not able to draw any conclusions with regard to pain, self-perceived changes in overall health, use of health service resources and drop-out rate.

With regard to other comparisons, one study (320 participants) suggested a general benefit of exercise over adaptive pacing, and another study (183 participants) a benefit of exercise over supportive listening.

The available evidence was too sparse to draw conclusions about the effect of pharmaceutical interventions.

Authors' conclusions

Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes.

A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible.

The effectiveness of exercise therapy seems greater than that of pacing but similar to that of CBT.

Randomised trials with low risk of bias are needed to investigate the type, duration and intensity of the most beneficial exercise intervention.



Plain language summary

Exercise as treatment for patients with chronic fatigue syndrome

Who may be interested in this review?

• People with chronic fatigue syndrome and their family and friends.

• Professionals working in specialist chronic fatigue services.

• Professionals working in therapeutic exercise.

• General practitioners.

Why is this review important?

Chronic fatigue syndrome (CFS) is sometimes called myalgic encephalomyelitis (ME).

Research estimates that between 2 in 1000 and 2 in 100 adults in the USA are affected by CFS.

People with CFS often have long-lasting fatigue, joint pain, headaches, sleep problems, and poor concentration and short-term memory.

These symptoms cause significant disability and distress for people affected by CFS.

There is no clear medical cause for CFS, so people who are affected often deal with misunderstanding of their condition from family, friends and healthcare professionals.

National Institute for Health and Care Excellence (NICE) guidelines recommend exercise therapy for individuals with CFS, and a previous review of the evidence suggested that exercise therapy was a promising approach to the treatment.

It is thought that exercise therapy can help management of CFS symptoms by helping people gradually reintroduce physical activity into their daily lives.

This review is an update of a previous Cochrane review from 2004, which showed that exercise therapy was a promising treatment for adults with CFS.

Since the review, additional studies investigating the effectiveness and safety of exercise therapy for patients with CFS have been published.

What questions does this review aim to answer?

• Is exercise therapy more effective than ‘passive’ treatments (e.g. waiting list, treatment as usual, relaxation, flexibility)?

• Is exercise therapy more effective than other ‘active’ therapies (e.g. cognitive-behavioural therapy (CBT), pacing, medication)?

• Is exercise therapy more effective when combined with another treatment than when given alone?

• Is exercise therapy safer than other treatments?

Which studies were included in the review?

We searched databases to find all high-quality studies of exercise therapy for CFS published up to May 2014.

To be included in the review, studies had to be randomised controlled trials and include adults over 18 years of age, more than 90% of whom had a clear diagnosis of CFS.

We included eight studies with a total of 1518 participants in the review.

Seven studies used aerobic exercise therapy such as walking, swimming, cycling or dancing; the remaining study used non-aerobic exercise.

Most studies asked participants to exercise at home, between three and five times per week, with a target duration of 5 to 15 minutes per session using different means of incrementation.

What does evidence from the review tell us?

Moderate-quality evidence showed exercise therapy was more effective at reducing fatigue compared to ‘passive’ treatment or no treatment.

Exercise therapy had a positive effect on people’s daily physical functioning, sleep and self-ratings of overall health.

One study suggests that exercise therapy was more effective than pacing strategies for reducing fatigue. However exercise therapy was no more effective than CBT.

Exercise therapy did not worsen symptoms for people with CFS.

Serious side effects were rare in all groups, but limited information makes it difficult to draw firm conclusions about the safety of exercise therapy.

Evidence was not sufficient to show effects of exercise therapy on pain, use of other healthcare services, or to allow assessment of rates of drop-out from exercise therapy programmes.

What should happen next?

Researchers suggest that further studies should be carried out to discover what type of exercise is most beneficial for people affected by CFS, which intensity is best, the optimal length, as well as the most beneficial delivery method.


I gave each sentence its own paragraph to make it easier to read
 

Iquitos

Senior Member
Messages
513
Location
Colorado
The very phrase exercise "therapy" is nonsensical and misleading. It's part of the propaganda of blame the patient for "fear" of exercise. If these psychobabblers were studying exercise "therapy" for ALS, MS, Parkinson's, polio and cancer, they would get the disdain they deserve. Only with ME/CFS (SEID?) do they have the gall to promote this proven detrimental "therapy."
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Just noticed that there is actually no mention of ME in the review, so they are just supposedly looking at CFS - whatever that is.

Also noticed that the 'Editorial Group' is the 'Cochrane Depression, Anxiety and Neurosis Group'.

Would I be right to assume that this would be made up of psychologists and, by inference from what we know about psychology researchers, that they are less rigorous than scientific reviewers?
 

Tom Kindlon

Senior Member
Messages
1,734
Ellen Goudsmit has posted this on PubMed Commons http://www.ncbi.nlm.nih.gov/pubmed/25674924#cm25674924_9142:


I had contact with the main author to alert her to certain misconceptions published earlier. Sadly, I found I had wasted my time.

For example, we can not tell how many, if any, patients in the PACE trial met the London criteria. Having read that the researchers planned to select individuals with ME and had listed the criteria in the protocol, I checked that Prof. White would use the original version which had not been published. I had been the Chair of the Research Working Group at AFME when they were being tested and still had a copy. They came with a questionnaire as well as a physician to establish their reliability. Prof. White was unwilling to confirm that he would use the original so in light of the uncertainty, I requested that he did not cite me as a co-author. I did not work on the lay version published in the Westcare report which I felt was deeply flawed. I was right to be cautious. The trial manual indicates that the researchers adapted the lay version and I could tell from the results that the London criteria were not used as they exclude individuals with psychological disorders so the percentage for that variable should have been nil. It wasn’t.

A second point. The review does not pay the required attention to the lack of actigraphy, an objective measure to confirm fidelity to the protocol. This has been included in most studies conducted in the USA and the Netherlands. The results from actigraphy indicate that, except for 7 individuals, there were no significant increases in activity after GET and similar therapies. According to Friedberg who assessed the phenomenon, patients on exercise trials tend to reprioritise their activities, choosing those that result in less stress etc. In short, they learn to pace themselves (Goudsmit et al 2012). That is why they feel better and less fatigued, but it's not possible to attribute improvement to an increase in activity (or fitness).
Pacing was not defined and adaptive pacing therapy (APT) refers to a programme consisting of several components including stress management, advice on sleeping etc. There are no data for pacing alone in the PACE trial, so to conclude that GET is superior to pacing therapies is premature. There is only one pacing therapy. Pacing is not a therapy. It's a simple strategy. Research by Jason suggests that people who pace themselves feel better, irrespective of the protocol they are on.

Finally, we know that many patients have adverse reactions to activity. It's a criterion for diagnosis. To dismiss them ("no evidence that exercise therapy worsens outcomes") is hard to comprehend. Every survey in every country to date has revealed that GET does have marked adverse reactions and can result in relapse. See also Sisto et al and Black and McCully, cited in Goudsmit et al 2012.

To summarise: lack of a definition of pacing resulting in confusion, repetition of incorrect information, failure to consider the findings from objective measures suggesting patients did not adhere to the protocol and ignoring consistent reports from surveys that undermine one's conclusions. I expect more objectivity and attention to detail from the Cochrane Library.

Goudsmit, EM., Jason, LA, Nijs, J and Wallman, KE. Pacing as a strategy to improve energy management in myalgic encephalomyelitis/chronic fatigue syndrome: A consensus document. Disability and Rehabilitation, 2012, 34, 13, 1140-1147. Online 19th December. doi: 10.3109/09638288.2011.635746.
 

Tom Kindlon

Senior Member
Messages
1,734
The trial manual indicates that the researchers adapted the lay version and I could tell from the results that the London criteria were not used as they exclude individuals with psychological disorders so the percentage for that variable should have been nil. It wasn’t.
I'm not sure this is correct. Anyone have evidence she is right?

Every survey in every country to date has revealed that GET does have marked adverse reactions and can result in relapse.
I may be biased but I think a good reference for this is my paper:

Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
http://iacfsme.org/BULLETINFALL2011/Fall2011KindlonHarmsPaperABSTRACT/tabid/501/Default.aspx

I give the results from 10 surveys. I don't believe any other published gives that amount of survey data.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
I would like to coin a term, if it does not already exist.

BIBO

Babble In, Babble Out

I don't know who invented GIGO, but it needed an update.

The underlying flaws of the studies reviewed are ignored in the unjustified hope that they will go away. This might be OK for random bias, but the bias is systemic. Such bias is amplifed by meta-analyses.

This is an exemplar of what is wrong in "Evidence" Based Medicine. When the underlying studies are given a pass on scientific rigor, guess what happens to the meta-analysis?

I have found a different use of babble in, babble out, by Joanne Sales http://www.joannesales.com/articles/vacation_freedomfrom.html
 

Kati

Patient in training
Messages
5,497
Cochrane reviews are overrated.

Sadly, many of the Cochrane reviews end up in clinical guidelines for physicians. It is how CBT and GET ended up in clinical guidelines here in British Columbia.

Many busy physicians (.including those in general practice) couldn't be bothered researching deeper, so they rely on meta analysis to get to the conclusions and direct their practices.

Papers like these are the most dangerous. (and not the IOM report)