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

January 14, 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

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

  1. This article has appeared in the ‘i’ today – the sister paper of The Independent with a large and damaging headline “Fear of exercise ‘could be holding ME sufferers back’ “. Please could the MEA contact the editor of the ‘i’ Oliver Duff and ask them to print, in full, an MEA response. The Independent and the ‘i’ are starting to look anything but ‘independent’ as they seem to be biased when it comes to reporting ME.
    This is such a shame when the MEA website on Monday reported an article by Medscape and also all the biomedical research that is being conducted. Headlines such as in today’s ‘i’ cause immense distress to those suffering this dreadful illness as it enforces the ‘publics’ perception that recovery is in the hands of the sufferer. Many ME sufferers have tried so hard to bring about an improvement in their condition and are left feeling they have failed.

  2. I wish MEA could persuade a national and popular newspaper to publish the US article and even better dispute this above article on national TV to put the public in the real picture please?

    This group of psychiatrists need to be brought to justice for their abominable behaviour and their actions be accounted for. We’ve heard it all so many times before and Dr Shepherd always has to defend us all.

    If MEA members can give their backing to Dr Shepherd then please speak out against this psychiatric nonsense.

    Thank you
    Annx

  3. I will challenge the theory with my benefits and Peter White can stake his reputation. I have never been scared off exercise and if you have a scientist willing to take the challenge then I am game.

    Had enough off sending money and being understanding, I have tried these treatments and I do believe they can help a little but not give us the real outcome we deserve.

    I have participated in both psychological and biological experiments. All I want is to ensure that my last thirty two years are not going to be repeated for others.

    Outcome is going to be more years wasted and lives destroyed. What a sad day for all those severely affected.

  4. As an ex triathlete and Advance Personal Trainer. I ended up with M.E after several bouts of viral meningitis of which I never recovered my full health from. I had mild M.E, I love sports and miss sports, so I jumped at the chance to start graded exercise. This was the most dangerous thing I should have done for M.E as I went from mild M.E to severe. I became bedbound for 2 years before I could start to potter about again indoor and I am even now unable to go outside very often or for long. To me exercise helps you but not for M.E, it’s as if it stirs up some virus inside you that leaves you exhausted, extremely weak that you struggle to lift a cup. So until BIOMEDICAL RESEARCH IS COMPLETED NO ONE CAN HELP US FROM AN ADVANCE PERSONAL TRAINER SUFFERING WITH M.E

  5. Am I being too cynical in noticing that one of the contributors to the funding is the Department of Work and Pensions, might they gain the most by having this sort of unhelpful ‘research’ to hand when it comes to those claiming benefits with M.E?

    I’m sure this isn’t a true picture of those with M.E. as the criteria will inevitably include those who have some fatiguing symptoms but don’t actually have M.E. so will benefit the most from some extra activity, probably including those who have depression related fatigue.

    As someone who is 90% bed bound I still find my physical limits are tiny and even a very small additional time spent on my feet leads to dramatically increased pain, I’m not restricting my feeble activity because I fear pain, I’m having to restrict it because the REAL pain that follows prevents me from doing more. It’s still a problem doing too much as opposed to doing too little.

    The psychiatrists seem to have a big chip on their shoulder when it comes to M.E. when they should more open minded and science based and look at up to date medical research (such as that from Stanford University, nicely reported on Cort Johnson http://www.cortjohnson.org/blog/2014/10/30/stanford-brain-study-sparks-media-reports-chronic-fatigue-study-real-disorder/) which should completely remove this illness out of their hands, maybe they don’t want to give it up and lose all those referrals?

    Much more time and money needs to be spent looking into the viral and bacterial origins that I believe are responsible for the inflammation in the brain and the subsequent varying degrees of severity of M.E.

  6. As a sufferer, and someone who has had to give up a good job as a result of being ill, I may be in the minority in welcoming this latest piece of research. I am fortunate in that I have not been bedbound (and cannot imagine what that must be like) but have struggled significantly with daily functioning – household chores, cooking, shopping, travelling, conversation, sustaining levels of activity. I appreciate that my views probably don’t accord with the majority of comments on this site, or the views of the ME Association, but I feel the report is positive and balanced – and not offensive in any way.

    I agree that more time and money needs to be spent on research to understand the complexities of the illness but this has to be an important step in the right direction.

    1. How does a report based on the PACE trial which has been roundly criticised on patient selection, recovery definitions and refusal to release recovery measure protocols be an important step in the right direction?

  7. I have had a look at this research in the Lancet and have a number of concerns about it. The participants were expected to do 13 hours therapy a week, I am wondering how most m.e. sufferers would manage this. I would not be able to manage this demanding therapy. The writing up of the research does not explain or discuss the details of how many people admitted that they were unable to manage the exertion of the therapies and how this was accounted for when measuring the effects of the treatments on all m.e. sufferers. If the severity of the therapy meant that only participants with mild m.e. symptoms could partipate in the therapies then the research is flawed. The researchers omittance of details of how debilitated and affected participants of the research is a concern. By not accounting for m.e. sufferers with moderate and severe m.e. symptoms, who would be too disabled to participate in the therapies suggests that the research is seriously flawed. Therefore, it is worryingly looking like a properganda exercise rather than some useful research to help support people with m.e. and fibromyalgia.
    I am concerned too that the participants were chosen from m.e. specialising clinics. Having visited an m.e. specialising clinic at Nuneaton Hospital, it did not take me long to work out that really the consultants have very little medical knowledge of m.e. The consultants cannot have any expertise because up to now there is still not enough known about the medical affects of m.e. The consultants in these clinics should be honest about how little they know about the illness. In fact, probably most m.e. sufferers know more about m.e. It can feel very patronising hearing the myths and incorrect assumptions made by some of the consultants that supposedly specialise in m.e. I found that trying to attend the clinics was too difficult because of my illness. Many m.e. sufferers are too debilitated to attend these clinics or only manage one or two visits because of debility. The research did not account for this variable at all. The fact that the more debilitated m.e. sufferers would have not been part of the cohort that the research chose the participants from suggests, again, that the study results are seriously flawed. Again, this suggests that the researchers were more concerned with proving their hypothesis than helping to uncover some useful therapies for m.e. sufferers.
    The fact that the research is paid for by the dwp and insurance companies suggests that there may be a hidden agenda from the groups who are providing the money for the research. Why doesn’t the dwp use tax payers money wisely and pay for research in m.e. that looks at the physical causes instead of trying to influence wrong perceptions of the money. The money would be much better spent stopping harmful chemicals that can cause m.e. from damaging any more people. (Mine was started with a carpet spray given to me by the vets that had organophosphate in).

  8. A good response from Dr Shepherd, but he really should learn when to use the word “imply” rather than “infer” (para 5 above)

  9. Looks to me as if this silly little paper is conveniently being flogged just in time for the take-over of the DWP disability assessment contract by US giant Maximus.
    Oh, that curiously revolving door of employees – Unum, Atos, DWP, Maximus……..well, well, well….

    “The decision of controversial outsourcing giant Maximus to hand consultancy work to Bill Gunnyeon comes just months after he quit his Department for Work and Pensions (DWP) post as chief medical adviser and director for health and well-being…….
    http://disabilitynewsservice.com/2015/01/concern-maximus-recruits-former-dwp-fit-work-boss/

    “Professor Michael O’Donnell, the former medical director of Atos, now plays a senior role in the American company Maximus, which has won a £500m Government contract to decide whether disabled people are able to return to work. His previous company walked away from the contract, which was supposed to end in 2015.

    Despite Government promises of a fresh start, Professor O’Donnell now works as the medical director of Health Management Limited (HML) which is a subsidiary of Maximus…………
    …………..Professor O’Donnell also previously worked for the controversial insurance company Unum, which campaigners say has had major influence over reform of the welfare state. Last year the Disability News Service obtained a document written by Professor O’Donnell for Unum which stated: “We know that our views and understanding are not yet in the mainstream of doctors’ thinking, but Government policy is moving in the same direction, to a large extent being driven by our thinking and that of our close associates.”
    http://www.independent.co.uk/news/uk/politics/senior-atos-executive-finds-new-role-at-the-american-company-taking-over-disability-benefit-9831973.html

  10. The NIH “Pathways to Prevention” draft report on M.E./cfs has recommended discontinuing the use of the Oxford criteria – which the PACE trial used for selecting participants – hence, logically, this is yet another reason why the PACE trial (and spin-off publications such as this one) should be withdrawn / discarded as bogus and flawed.

  11. Don’t forget that after considerable pushing by Prof Malcolm Hooper, trial author P.D. White was forced to eventually admit that the PACE trial was (by definition) a study of people with Oxford defined “Chronic Fatigue Syndrome” and not those specifically with M.E.

  12. Dr William Weir has moved to defend people with M.E. from the malevolent doctrine pedalled by this group of psychiatrists, by writing to the BMJ online
    http://www.bmj.com/content/350/bmj.h227/rr-13

    I quote:
    ” Most recently “exercise phobia” has been proposed as part of the problem, although a study of which I was a co-author in 2005 explicitly disproved this proposition (J Psychosom Res 58 (2005): 367-373). This paradigm has no plausible scientific basis and can only be described as a doctrine whose adherents continue to ignore the biomedical evidence which amply confirms the organic basis of the condition.”

  13. Interesting – I see The Daily Telegraph (see above link) has changed its opening sentence from:

    Fear of exercise exacerbates ME and sufferers need to get out of bed and exercise if they want to get better, a major study by King’s College has found. (Or words to that effect – all trace of it has now been expunged.)

    to

    ‘Fear of exercise exacerbates ME and sufferers need to try and get up out of bed if they want to get better, a major study by King’s College has found.’

  14. This was the original wording in The Telegraph.

    “People suffering from ME should get out of bed and exercise if they want to alleviate their condition, a major study by King’s College has found.”

    There seems almost no trace of it left as everyone cut and pasted the original and they all seem to have morphed into the amended version. Thought my mind was playing tricks on me for a moment or two. Just wanted to make sure there was still a true record of what The Daily Telegraph originally printed somewhere on the net.

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