The ME Association stands by its continuing criticism of the use of graded exercise therapy (GET) and cognitive behaviour therapy (CBT) as primary interventions in ME/CFS.
We also stand by our criticisms on the design, the lack of objective measures of outcome, and the way in which the results of the PACE trial have been reported to mean that the people with ME/CFS will recover if only they start exercising and develop a positive mental attitude.
Our position is based on consistent and robust evidence on activity management collected from large numbers of people with ME/CFS – with our latest report indicating that over 70% found that GET made their symptoms worse.
As a result, we have called on NICE to withdraw their recommendation that GET should be a primary intervention for everyone with mild to moderate ME/CFS.
In addition, the conclusion that people with ME/CFS will respond to GET because they are simply inactive and deconditioned is no longer tenable.
Reputable research has demonstrated that there are significant abnormalities in the muscle, brain and immune system – all of which are almost certainly involved in the production of ME/CFS symptoms, including exercise induced fatigue.
The MEA report also finds that the majority of people with ME/CFS (= 73%) do not gain any benefit in symptom relief when CBT is used as a primary intervention.
So we have a second form of treatment based on a seriously flawed hypothesis – in this case the idea that ME/CFS is a psychological problem that is maintained by abnormal illness beliefs and behaviours.
At a time when international medical opinion is at long last accepting that ME/CFS is a serious neurological and immunological condition, it is deeply depressing to find that NICE is continuing to recommend two forms of treatment that are often ineffective, and in the case of GET potentially harmful.
Dr Charles Shepherd
Hon Medical Adviser, ME Association
28 October 2015
FURTHER INFORMATION
MEA report on patient evidence relating to acceptability, safety and efficacy of CBT, GET and Pacing:
www.meassociation.org.uk/how-you-can-help/fundraising-support/
Minutes of meeting with Professor Mark Baker to discuss revision of the NICE guideline on ME/CFS:
Detailed critique of the PACE trial from David Tuller, University of California:
RECOMMENDATIONS FROM THE ME ASSOCIATION REPORT RELATING TO CBT, GET AND PACING
RECOMMENDATIONS
Our part 1 recommendations are based on the full results from our survey in respect of the three main therapeutic approaches to illness management, and are as follows:
Cognitive Behavioural Therapy (CBT)
We conclude that CBT in its current delivered form should not be recommended as a primary intervention for people with ME/CFS.
CBT courses, based on the model that abnormal beliefs and behaviours are responsible for maintaining the illness, have no role to play in the management of ME/CFS and increase the risk of symptoms becoming worse.
The belief of some CBT practitioners that ME/CFS is a psychological illness was the main factor which led to less symptoms improving, less courses being appropriate to needs, more symptoms becoming worse and more courses being seen as inappropriate.
Our results indicate that graded exercise therapy should form no part of any activity management advice employed in the delivery of CBT, as this also led to a negative impact on outcomes.
There is a clear need for better training among practitioners. The data indicates that deemed lack of knowledge and experience had a direct effect on outcomes and remained a key factor even where courses were held in specialist clinics or otherwise given by therapists with an ME/CFS specialism.
However, our results did indicate that when used appropriately the practical coping component of CBT can have a positive effect in helping some patients come to terms with their diagnosis and adapt their lives to best accommodate it.
CBT was also seen to have a positive effect in helping some patients deal with comorbid issues – anxiety, depression, stress – which may occur at any time for someone with a long-term disabling illness.
An appropriate model of CBT – one that helps patients learn practical coping skills and/or manage co-morbid issues such as those listed above – could be employed, where appropriate, for ME/CFS as it is for other chronic physical illnesses such as multiple sclerosis, Parkinson’s disease, cancer, heart disease, and arthritis etc.; and we recommend all patients should have access to such courses as well as access to follow-up courses and/or consultations as and when required.
Graded Exercise Therapy (GET)
We conclude that GET should be withdrawn with immediate effect as a primary intervention for everyone with ME/CFS.
One of the main factors that led to patients reporting that GET was inappropriate was the very nature of GET itself, especially when it was used on the basis that there is no underlying physical cause for their symptoms, and that patients are basically ill because of inactivity and deconditioning.
A significant number of patients had been given advice on exercise and activity management that was judged harmful with symptoms having become worse or much worse and leading to relapse.
And it is worth noting that, despite current NICE recommendations, a significant number of severe-to-very severe patients were recommended GET by practitioners and/or had taken part in GET courses.
The other major factor contributing to poor outcomes was the incorrect belief held by some practitioners that ME/CFS is a psychological condition leading to erroneous advice that exercise could overcome the illness if only patients would ‘push through’ worsening symptoms.
We recognise that it is impossible for all treatments for a disease to be free from side-effects but, if GET was a licensed medication, we believe the number of people reporting significant adverse effects would lead to a review of its use by regulatory authorities.
As a physical exercise-based therapy, GET may be of benefit to a sub-group who come under the ME/CFS umbrella and are able to tolerate regular and progressive increases in some form of aerobic activity, irrespective of their symptoms. However, identifying a patient who could come within that sub-group is problematic and is not possible at present.
Some patients indicated that they had been on a course which had a gentle approach of graded activity rather than a more robust and structured approach of graded physical exercise. There were some reports that patients were told they should not exercise when they felt too unwell to do so. These led, for some, to an improvement in symptoms or to symptoms remaining unaffected.
However, we conclude that GET, as it is currently being delivered, cannot be regarded as a safe and effective form of treatment for the majority of people with ME/CFS. The fact that many people, including those who consider themselves severely affected, are being referred to specialist services for an intervention that makes them either worse or much worse is clearly unacceptable and in many cases dangerous.
GET should therefore be withdrawn by NICE and from NHS specialist services as a ‘one size fits all’ recommended treatment with immediate effect for everyone who has a diagnosis of ME/CFS. This advice should remain until there are reliable methods for determining which people who come under the ME/CFS umbrella are likely to find that GET is a safe and effective form of management.
Pacing
Pacing was consistently shown to be the most effective, safe, acceptable and preferred form of activity management for people with ME/CFS and should therefore be a key component of any illness management programme.
The benefit of Pacing may relate to helping people cope and adapt to their illness rather than contributing to a significant improvement in functional status. Learning coping strategies can help make courses more appropriate to needs even if they do not lead to immediate or even longer term improvement in symptoms.
For some, improvement may be a slow process so, whilst they may be somewhat better by the end of the course, the improvement is not enough to take them into a better category of severity for some time, perhaps not until they have self-managed their illness for a few years.
Pacing can be just as applicable to someone who is severely affected, as to someone who is mildly or moderately affected, although additional measures need to be taken to ensure that a person who is severely affected has equal access to services.
However, proposed increases in activity, both mental and physical, must be gradual, flexible and individually tailored to a patient’s ability and circumstance, and not progressively increased regardless of how the patient is responding.
There must be better training for practitioners who are to deliver such management courses and all patients should have access to suitable courses, follow-up courses and/or consultations as and when required.
THE SUMMARY IN ‘LANCET PSYCHIATRY'
Published online 27 October 2015 (Full text available free of charge)
Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial
Prof Michael Sharpe, MD†, Kimberley A Goldsmith, PhD†, Prof Anthony L Johnson, PhD, Prof Trudie Chalder, PhD, Jane Walker, PhD, Prof Peter D White, MD
†Joint first authors
Summary
BACKGROUND
The PACE trial found that, when added to specialist medical care (SMC), cognitive behavioural therapy (CBT), or graded exercise therapy (GET) were superior to adaptive pacing therapy (APT) or SMC alone in improving fatigue and physical functioning in people with chronic fatigue syndrome 1 year after randomisation. In this pre-specified follow-up study, we aimed to assess additional treatments received after the trial and investigate long-term outcomes (at least 2 years after randomisation) within and between original treatment groups in those originally included in the PACE trial.
METHODS
The PACE trial was a parallel-group randomised controlled trial of patients meeting Oxford criteria for chronic fatigue syndrome who were recruited from six secondary care clinics in the UK between March 18, 2005, and Nov 28, 2008. Participants were randomly allocated to receive SMC alone or plus APT, CBT, or GET. Primary outcomes (were fatigue measured with Chalder fatigue questionnaire score and physical functioning with short form-36 subscale score, assessed 1 year after randomisation. In this long-term follow-up, we sent postal questionnaires to assess treatment received after the trial and outcomes a minimum of 2 years after randomisation. We assessed long-term differences in outcomes within and between originally randomised groups. The PACE trial is registered at http://isrctn.org, number ISRCTN54285094.
FINDINGS
Between May 8, 2008, and April 26, 2011, 481 (75%) participants from the PACE trial returned questionnaires. Median time from randomisation to return of long-term follow-up assessment was 31 months (IQR 30–32; range 24–53). 210 (44%) participants received additional treatment (mostly CBT or GET) after the trial; with participants originally assigned to SMC alone (73 [63%] of 115) or APT (60 [50%] of 119) more likely to seek treatment than those originally assigned to GET (41 [32%] of 127) or CBT (36 [31%] of 118; p<0·0001). Improvements in fatigue and physical functioning reported by participants originally assigned to CBT and GET were maintained (within-group comparison of fatigue and physical functioning, respectively, at long-term follow-up as compared with 1 year: CBT −2·2 [95% CI −3·7 to −0·6], 3·3 [0·02 to 6·7]; GET −1·3 [–2·7 to 0·1], 0·5 [–2·7 to 3·6]). Participants allocated to APT and to SMC alone in the trial improved over the follow-up period compared with 1 year (fatigue and physical functioning, respectively: APT −3·0 [–4·4 to −1·6], 8·5 [4·5 to 12·5]; SMC −3·9 [–5·3 to −2·6], 7·1 [4·0 to 10·3]). There was little evidence of differences in outcomes between the randomised treatment groups at long-term follow-up.INTERPRETATIONThe beneficial effects of CBT and GET seen at 1 year were maintained at long-term follow-up a median of 2·5 years after randomisation. Outcomes with SMC alone or APT improved from the 1 year outcome and were similar to CBT and GET at long-term follow-up, but these data should be interpreted in the context of additional therapies having being given according to physician choice and patient preference after the 1 year trial final assessment. Future research should identify predictors of response to CBT and GET and also develop better treatments for those who respond to neither.FUNDINGUK 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, King's College London.
COMMENTARY IN ‘LANCET PSYCHIATRY'
Published online 27 October 2015. Full text available free of charge.
Chronic fatigue syndrome: what is it and how to treat?
Steven Moylane, Harris A Eyre, Michael Berk
Summary
Ever since neurologist George Miller Beard coined the term neurasthenia in the 19th century,1 dozens of names have been used to describe illnesses resembling chronic fatigue syndrome. The diverse nomenclature reflects heterogeneity in the disorder's conceptualisation, spawning terms as divergent as chronic Epstein–Barr virus, epidemic neuromyasthenia, systemic exertion intolerance disease, post-viral fatigue syndrome, myalgic encephalomyelitis, and chronic fatigue immune dysfunction syndrome. The diversity in nomenclature parallels the diversity in therapies assessed for this frequently refractory cluster of symptoms, which include pharmacological (eg, fluoxetine, rintatolimod, galantamine), psychological (eg, cognitive therapy, adaptive pacing therapy), and lifestyle interventions (eg, exercise).
THE OXFORD UNIVERSITY PRESS RELEASE
28 October 2015
Treatments offer hope for Chronic Fatigue Syndrome (CFS/ME)
Researchers have found that two treatments for Chronic Fatigue Syndrome have long term benefits for people affected by the condition.
The team from Oxford University, King’s College London and Queen Mary University of London were following up patients who took part in a study published in 2011, funded by the Medical Research Council. In that study they looked at four potential treatments for Chronic Fatigue Syndrome (CFS) and found that cognitive behavioural therapy (CBT) and graded exercise therapy (GET) achieved better outcomes than standard medical care (SMC) and adaptive pacing therapy (APT) at one year.
In this study they contacted the people who took part in the original study to find out how they were fairing two and a half years after starting the treatments.
Three quarters of the original trial participants took part in the follow up. It showed that the improvements in fatigue and physical functioning seen at one year in the trial with CBT and GET were maintained in the long-term.
Professor Michael Sharpe from the University of Oxford said: ‘The finding that participants who had cognitive behavioural therapy and graded exercise therapy had maintained their improvement over 2 years after entering the trial, tells us that these treatment can improve the long-term health of people with CFS.'
The team also found that participants who originally had CBT or GET were less likely to have sought additional therapy after the trial than those who originally had standard medical care alone or APT.
Dr Kimberley Goldsmith from the Institute of Psychiatry, Psychology & Neuroscience at King’s College London said: ‘We found that participants who had originally been given SMC or APT appeared to be doing as well as those who had CBT or GET in the longer term. However as many had received CBT or GET after the trial, it does not tell us that these treatments have as good a long term outcome as CBT and GET.'
There were no significant differences between the four original treatment groups in the number reporting a long-term deterioration in their general health (around 1 in 10 of each group). This showed that there was no evidence that those who received CBT and GET were more likely to worsen in the long term.
Professor Peter White from Queen Mary University of London said: ‘Finding no significant differences in the proportions getting worse over time is a reassurance for those who worry that some of these treatments might make things worse. But it is also a reminder that these treatments do not help everybody, and more research is needed into finding other treatments that help.'
The paper is published in journal The Lancet Psychiatry on 28 October 2015: doi: 10.1016/S2215-0366(15)00475-7
Thank you MEA & Dr Shepherd for speaking out so forcefully.
However, it might be better if you reviewed the title of the press release, which is perhaps a bit misleading.
Ta, I will.
There is a good and sound scientific reason why exercise might help some individuals with ME. There are established links between CFS/ME and human exposure to aluminium (Exley et al., 2009 Medical Hypotheses 72, 135-139; I can provide this pdf if required) (see also; http://pubs.rsc.org/en/content/articlelanding/2013/em/c3em00374d#!divAbstract). We have recently demonstrated that possibly the most effective way by which the body excretes aluminium is through sweating (J Trace Elem Med Biol 2014 28, 87-88; pdf available upon request). If aluminium has a role to play in some individuals with ME then more effective removal of aluminium from the body through greater sweating, perhaps due to a higher level of exercise, will be helpful. Where so little is known about the aetiology of this devastating disease one should not be quite so quick to discount potential causes and remedies.
Thank you Dr Shepherd for your response to this disgraceful report on the PACE trial and the equally disgraceful media response.
I ask, why an old black vinyl record covered in muck, warped from age and heat, needle stuck, then skips the dirt to repeat repeat repeat, is actually news anymore.
Perhaps the US Doctors back up of David Tuller’s fascinating, in depth analysis of the PACE Trial will actually force a positive change of direction for ME sufferers and the truth be taken on board by the health authorities here.
I still live in Hope
x
alas reports like this are jumped on as it is a possible excuse and a way for the dwp to force ill people off esa, there are people who may benefit from this i have found pacing very effective alas i am complicated now having also got post-polio, it is akin to all things that cost the goverment money and there is no answer, seek the most public acceptable answer and fund it, then introduce an answer that the public will like and place it in a supportive publication, then change the rules in the dwp replying and answering using the results from a short trial as the answer, has this been found in america, it will be as it their way of not funding it, alas many will be forced to work and sign off! and that is the target not the cure no compassion, i myself have tried all and it does make me worse.. enuff said
Radio 2 BBC live broadcast with Vanessa Felt and Psychiatrists on ME and Therapies now!!!
I’d like to thank all those who told Vanessa exactly how CBT and GET had adversely affected them or friends. It certainly helped to counteract the claims given by Sharpe and Dr Michael Smith.
The very excellent Prof. Jonathon Edwards describes the PACE trial as “valueless”:
http://www.meaction.net/2015/11/01/prof-jonathan-edwards-pace-trial-is-valueless/
And a lengthy,but must-read from Prof. James Coyne – devastatingly informative, and somewhat easier to read than David Tuller’s:
http://blogs.plos.org/mindthebrain/2015/10/29/uninterpretable-fatal-flaws-in-pace-chronic-fatigue-syndrome-follow-up-study/#.VjJenRjUV3Y.twitter