“Results are at serious variance to patient evidence on both cognitive therapy and exercise therapy”
This is the response from The ME Association to the results of the PACE trial, which were published in The Lancet on Friday 18 February 2011
An abstract of the paper can be found here: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext
The Lancet press release can be found here: http://www.meassociation.org.uk/?p=4621
The MEA will be producing a more academic response to The Lancet in due course.
All of the comments below can, if preferred, be placed as quotes from Dr Charles Shepherd, Hon Medical Adviser.
Headline comments from Dr Charles Shepherd, Hon Medical Adviser at the MEA:
“The largest ever clinical trial into the effects of CBT, GET and adaptive pacing therapy (APT) has produced results that are clearly at serious variance from those reported by the largest ever survey of patient opinion on these forms of treatment.
We find the trial results extremely worrying because pacing, in the form that the MEA recommends, may as a result no longer be offered as a treatment option in NHS clinics. And at the same time, NICE may well strengthen its inflexible and unhelpful recommendations regarding CBT and GET.
We also fear that the way in which the results are already being reported in media headlines – eg Got ME? Just get out and exercise, say scientists – will lead some doctors to advise inappropriate exercise regimes that will cause a serious relapse.
This is not a good day for people with ME/CFS.
They have a complex multisystem illness that requires a range of treatment options based on their individual symptoms as well as the stage and severity of their illness”
Additional comments from The ME Association
The ME Association does not accept the over-simplistic conclusions that CBT (cognitive behaviour therapy) and GET (graded exercise therapy) are safe and moderatively effective treatments for everyone with ME/CFS.
We continue to maintain that the results from large and repeated surveys of patient reporting (see additional information below) into the possible value of these two approaches to management provide a far more informed and unbiased view of both their safety and effectiveness in what is a complex multisystem disease with a wide range of clinical presentations.
Equally, we do not accept some of the seriously flawed reasoning behind the use of CBT and GET in ME/CFS.
The use of these two treatments in the PACE trial has been based on the belief that ME/CFS is caused by a combination of abnormal illness beliefs and behaviour, where fear and inactivity can result in physiological changes. We believe this is wrong. Firstly because there is now considerable and compelling evidence involving neurological, muscle, hormonal and immunological abnormalities to demonstrate that ME/CFS is a complex biomedical condition which is not the result of inactivity and deconditioning. Secondly because the vast majority of people with ME/CFS do not have abnormal illness beliefs and behaviour.
The form of adaptive pacing used in the PACE trial is not the same as the model we recommend and which is favoured by the overwhelming majority of people with ME/CFS. The form of pacing advocated by the MEA is not based on the theory that CFS is an irreversible condition and that people rigidly adapt their lives to this fact through the use of a daily diary.
The MEA accepts that CBT can sometimes be of some help to some people who are having difficulties coping with some aspects of ME/CFS. We also accept that activity management, which involves gradual and very flexible increases in both physical and mental activity, plays a key role in any management plan.
But we also feel that far too much time and money has been repeatedly spent on research into CBT and GET over the years and that the time has come to start using these financial resources to discover the underlying biomedical causes of this illness, along with really effective forms of treatment. This is why we welcome the MRC (Medical Research Council) initiative to provide £1.5 million of ring-fenced money for research into the biomedical aspects of ME/CFS.
* Our most recent survey of patient opinion on management options, which involved over 4,000 responses, was carried out at the same time as the PACE trial was in progress. The numbers involved exceed those in the PACE trial. Full report available here: http://www.meassociation.org.uk/?page_id=1345
* Results for CBT: 25% improved; 55% reported no change; 20% made worse (sample size=2137)
* Results for GET : 22% improved; 21 reported no change; 57% made worse (sample size = 997)
* Results for pacing: 71% improved; 24% no change; 5% made worse (sample size=906)
* A similar study to the PACE trial, which was carried out in Spain, and published in January 2011, found no benefits from CBT and GET when compared to standard medical care. Abstract can be found here: http://www.ncbi.nlm.nih.gov/pubmed/21234629
* Physical deconditioning does not seem to be a perpetuating factor in CFS – research abstract from paper by Bazelmans et al available here http://www.ncbi.nlm.nih.gov/pubmed/11200949
* MRC announcement of ring-fenced funding for biomedical research into ME/CFS can be found here: http://www.meassociation.org.uk/?p=4085.
* A further MRC announcement and press release is due next week.
The PACE trial
* The randomised controlled trial compared CBT, GET, adaptive pacing therapy and specialised medical care.
* The assessments took place in hospitals in Bristol, Edinburgh, Oxford and London.
* The trial was largely funded by the Medical Research Council and cost over £4million.
* The MEA has been opposed the PACE from the onset.
* NICE are currently considering whether they should review their guideline on ME/CFS to take account of the PACE trial results.
MEA contact information:
Tony Britton (press and public relations)
Tel: 01406 370293