ME Association challenges ‘Lancet’ claim about fear of exercise leading to its avoidance in ME/CFS | 14 January 2015

The ME Association has challenged a claim made in a leading psychiatric journal today that it is fear of exercise leading to its avoidance that makes the most compelling case for the use of Cognitive Behaviour Therapy and Graded Exercise in ME/CFS.

The claim – made in The Lancet Psychiatry as a follow-up to the PACE Trial published in 2011 – is based on a flawed model of illness causation, said the MEA. It did not take account of the medical complexities involved.

“In our experience, patients with ME/CFS are highly motivated to get better”, said MEA medical adviser Dr Charles Shepherd.

“They are very willing to take part in energy management programmes that establish a safe baseline of activity, take account of the stage and severity of their illness, involve increases in physical and mental activity that are gradual, flexible and do not result in the person going beyond their limitations and causing symptom exacerbation.

“We fear that the results of this study will be interpreted to reinforce the over-simplistic view that rest is bad and exercise is good for people with ME/CFS.

“And without discussing the medical complexities involved, they also infer that any reluctance to progressively increase activity levels is far more related to fear or avoidance behaviour than any underlying disease process.

“What we desperately need are high quality research studies that are aimed at producing a range of individual energy management programmes based on clinical presentation, stage, and severity of illness.”

Our statement and the study abstract appear in full below. We also publish links to a selection of press reports about this study.

Today’s study in The Lancet Psychiatry, entitled Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial was led by cognitive behavioural psychotherapist Professor Trudie Chalder and biostatistician Dr Kimberley Goldsmith from King’s College London. Collaborators included Professors Peter D White and Michael Sharpe.

It’s a spin-off from the £5m PACE Trial, published in 2011, which involved 641 participants in a multi-centre comparison of the benefits of different treatment regimes for the illness. Many patient support groups and individual sufferers have always disputed the findings of this trial.


MEA ASSOCIATION STATEMENT IN FULL

The ME Association believes that energy management, which involves both physical and mental activity, is the most important aspect of managing ME/CFS.

Consequently, we welcome research which aims to improve our knowledge of how this can best be achieved.

Energy management programmes should be individually tailored. And they must take account of the wide range of clinical presentations and disease pathways that come under the ME/CFS umbrella.

We are therefore very critical of over-simplistic exercise regimes which are based on deconditioning, fear of activity and the assumption that people just need to ‘try harder’ in order to get better.

This approach does not acknowledge the muscle, brain and immune system abnormalities in ME/CFS, which help to provide a physical explanation for the debilitating central (brain) and peripheral (muscle) fatigue that occurs in this illness.

Feedback from patients, who are not normally treated as part of research studies, consistently indicates that around 25% find exercise programmes to be of no value. Around 50% report that their condition worsens as a result.

So the real reason why cognitive behaviour therapy and graded exercise therapy are not producing significant benefits across the whole ME/CFS population is that they are based on a flawed model of illness causation. They are are not taking account of the medical complexities involved.

In our experience, patients with ME/CFS are highly motivated to get better.

They are very willing to take part in energy management programmes that establish a safe baseline of activity, take account of the stage and severity of their illness, involve increases in physical and mental activity that are gradual, flexible and do not result in the person going beyond their limitations and causing symptom exacerbation.

We fear that the results of this study will be interpreted to reinforce the over-simplistic view that rest is bad and exercise is good for people with ME/CFS.

And without discussing the medical complexities involved, they also infer that any reluctance to progressively increase activity levels is far more related to fear or avoidance behaviour than any underlying disease process.

What we desperately need are high quality research studies that are aimed at producing a range of individual energy management programmes based on clinical presentation, stage, and severity of illness.

Dr Charles Shepherd
Hon Medical Adviser, ME Association

Background information:

The MEA submission to NICE, regarding their recommendations relating to the use CBT and GET in their current (2007) guideline on ME/CFS:

CBT, GET and Pacing

Our principal reason for requesting a fundamental review of the NICE guideline on ME/CFS relates to the recommendation that CBT and GET should be automatically offered to everyone with mild or moderate ME/CFS.

This is coupled with the continuing failure of NICE to take note of highly consistent patient evidence, dating back to evidence that was published in the 2002 Chief Medical Officer’s report on ME/CFS, regarding the efficacy and safety of these two behavioural treatments.

The largest ever survey of patient evidence relating to all aspects of the management of ME/CFS was carried out by The ME Association and published in 2010 (ME Association). The report provided important evidence regarding concerns over the efficacy of CBT and the safety of GET.

For CBT (997 responses)Greatly improved: 2.8%Improved: 23.1%No change: 54.6%Slightly worse: 11.6%Much worse: 7.9%

For GET (906 responses)Greatly improved: 3.4%Improved: 18.7%No change: 21.4%Slightly worse: 23.4%Much worse: 33.1%

For Pacing (2137 responses)Greatly improved: 11.6%Improved: 59.6%No change: 24.1%Slightly worse: 3.5%Much worse: 1.2%

The MEA is currently in the final stages of preparing a further report covering the use of CBT, GET and Pacing – but this time in much greater depth. The report will be based on the answers to questions on the above three treatments that were provided through 3142 responses given by 1429 respondents during 2012.

Overall, the patient evidence contained in this new MEA report is very similar to the evidence contained in the 2010 report. The two MEA surveys show a total of 6599 responses about the effect of treatments on symptoms, and a total of 6838 responses about appropriateness of courses, effectiveness of self management and helpfulness of consultations and general satisfaction.

However, to date NICE has failed to consider any of this patient evidence and both MEA reports support the findings from patient surveys referred to in the Chief Medical Officer’s Working Group report into ME/CFS.

We are therefore looking at a consistent picture from patients with regard to all three approaches to management going back over at least a decade and the picture has not improved.

As a result of growing concern amongst people with ME/CFS about the efficacy and safety of CBT and GET, we will be making a number of radical recommendations regarding the future use of CBT and GET in ME/CFS in this report.

This is clearly important new evidence that cannot be ignored by NICE.

The PACE trial and the March 2011 surveillance review

Finally, in relation to CBT and GET and Pacing, we assume that the NICE guideline surveillance review that took place in March 2011, and which followed publication of the PACE trial results in February 2011, simply ‘rubber stamped’ the 2007 NICE guideline recommendations on the basis that the PACE trial had supported the recommendations relating to CBT and GET.

However, there has been widespread and valid criticism about the way in which the PACE trial was carried out, as well as the way in which the results were presented and reported.

In addition, it should be noted that the cost effectiveness paper by McCrone et al reported that take up of state sickness benefits had increased during the PACE trial for all four treatments (ie CBT, GET, Pacing and Standard Medical Care). The MEA report will also contain similar information on benefit status.


TODAY IN THE LANCET PSYCHIATRY

From The Lancet Psychiatry, 13 January 2014.

Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial

Prof Trudie Chalder PhD†, Kimberley A Goldsmith PhD†, Prof Peter D White MD, Prof Michael Sharpe MD, Prof Andrew R Pickles, PhD
† Contributed equally

Summary

BACKGROUND

Cognitive behaviour therapy (CBT) added to specialist medical care (SMC), or graded exercise therapy (GET) added to SMC, are more effective in reducing fatigue and improving physical function than both adaptive pacing therapy (APT) plus SMC and SMC alone for chronic fatigue syndrome. We investigate putative treatment mechanisms.

METHODS

We did a planned secondary mediation analysis of the PACE trial comparing SMC alone or SMC plus APT with SMC plus CBT and SMC plus GET for patients with chronic fatigue syndrome. 641 participants were recruited from six specialist chronic fatigue syndrome clinics in the UK National Health Service between March 18, 2005, and Nov 28, 2008. We assessed mediation using the product of coefficients method with the 12 week measure of the mediators and the 52 week measure of the outcomes. The primary outcomes were fatigue measured by the Chalder fatigue scale and physical function measured by the physical function subscale of the SF-36. We included confounder covariates and used treatment by mediator interaction terms to examine differences in mediator–outcome relations by treatment group.

FINDINGS

The largest mediated effect for both CBT and GET and both primary outcomes was through fear avoidance beliefs with an effect of larger magnitude for GET (standardised effects ×10, CBT vs APT, fatigue −1·22, 95% CI −0·52 to −1·97, physical function 1·54, 0·86 to 2·31; GET vs APT, fatigue −1·86, −0·80 to −2·89, physical function 2·35, 1·35 to 3·39). Increase in exercise tolerance (6 min walk distance) was a potent mediator of the effect of GET (vs APT, fatigue −1·37, 95% CI −0·76 to −2·21, physical function 1·90, 1·10 to 2·91), but not CBT.

INTERPRETATION

Our main finding was that fear avoidance beliefs were the strongest mediator for both CBT and GET. Changes in both beliefs and behaviour mediated the effects of both CBT and GET, but more so for GET. The results support a treatment model in which both beliefs and behaviour play a part in perpetuating fatigue and disability in chronic fatigue syndrome.

FUNDING

UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions, National Institute for Health Research (NIHR), NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust, and Institute of Psychiatry, Psychology, and Neuroscience, King’s College London.


HERE’S HOW THE PRESS HAS COVERED THE STORY

The Mail Online

The Guardian

The Independent

The Daily Telegraph

BBC News Online

British Medical Journal

MEA rapid response to the article in the BMJ

The Economist

Science Daily

NHS Choices News Review

Medical Xpress

Medical News Today

WebMD.Boots.com