18 February 2011
This morning, the Lancet published online the initial results of the PACE trial, a randomised controlled trial to compare four therapies for treating M.E./CFS. The results are surprising and disappointing.
The PACE trial was a £4.2 million study, funded by the Medical Research Council (MRC), Department of Health, Department for Work and Pensions (DWP) and the Scottish Chief Scientist Office.
The therapies tested were cognitive behaviour therapy (CBT), graded exercise therapy (GET), adaptive pacing therapy (APT) and specialised medical care (treatment of symptoms eg. pain relief, without additional therapy).
PACE stands for Pacing, graded Activity and Cognitive behaviour therapy – a randomised Evaluation.
Participants were referred from six specialist hospital CFS/M.E. clinics in Edinburgh, Oxford, Bristol and London.
Results
Action for M.E. is surprised and disappointed by the results of the PACE trial – and by some of the exaggerated claims being made about the effectiveness of two of the therapies: cognitive behaviour therapy and graded exercise, and by the unqualified assertion about the general safety of graded exercise.
Sir Peter Spencer, CEO of Action for M.E., says, "The findings of the PACE trial contradict the considerable evidence of our own surveys and those of other patient groups.
"Of the 2763 people with M.E. who took part in our 2008 survey, 82% found pacing helpful, compared with 50% for CBT and 45% for GET. Worryingly, 34% reported that GET made them worse.
"A smaller, more recent survey of 273 people with M.E. confirms that, inappropriately applied, graded exercise is still causing harm.
"Whilst these figures are not directly comparable with the PACE results, they cannot be ignored.
"Nor can the fact that, at best, PACE is telling us that the two main therapies currently recommended by the National Institute for Health and Clinical Excellence (NICE) are only moderately effective.
"It’s important to remember that safety outcomes under trial conditions are not representative of what is still happening in some parts of the NHS.
"And to focus on modest improvements in fatigue and physical functioning, which researchers can measure – rather than on how much better patients themselves say they feel overall – overstates the benefits and of these therapies."
The difference in emphasis to which Sir Peter refers relates to "clinically useful difference" (CUD) versus "clinical global impression" (CGI).
The Lancet article states first the CGI, saying that number of trial participants rating themselves as "much" or "very much" better after 52 weeks were 41% for cognitive behaviour therapy, 41% for graded exercise, 31% for adaptive pacing and 25% for specialised medical care.
The CUD ie. the numbers of participants who showed statistically significant but, from the patient perspective, modest improvements in fatigue and physical function at 52 weeks were graded exercise 61% (94/154), cognitive behaviour therapy 59% (87/148), specialised medical care 45% (68/152) and adaptive pacing 42% (64/153).
Tony Golding, Vice Chairman of Action for M.E., says, "The charity supported the PACE trial because we wanted pacing – the approach consistently rated as helpful, not harmful, by people with M.E. – to be assessed and legitimised by the NHS.
"We have already expressed our reservations about the current over-emphasis on CBT and GET in the NICE guideline.
"That the findings of the PACE trial are completely at odds with the patient voice is of grave concern. Treatment for people with M.E. cannot be limited to therapies which only some find effective. Patients need to have a choice of real treatments."
Fellow Vice Chair, Nadia Conway, adds, "The trustees and staff of Action for M.E. are unequivocal in their view that M.E. is neurological and may well have a viral cause.
"Currently, there are no effective treatments for M.E. This research shows that none of the therapies currently available results in a complete recovery. The need for more biomedical research is more paramount than ever before."
The PACE trial was limited to patients who were well enough to travel to hospital for therapy and those who had fatigue as a primary symptom.
Sir Peter continues, "We are still in the dark about therapies for severely affected patients and for those who experience, for example, pain rather than fatigue as their primary symptom.
"It is now more abundantly clear than ever that the UK needs to make a completely new start on scientific research in this neglected area. Resources must in future be concentrated on the biology of the condition in order to discover the underlying disease mechanisms.
"The MRC's recent announcement of £1.5m funding for research into the causes of CFS/M.E. may be a small step but it is a step in the right direction. It signals a marked change in the MRC's attitude towards this chronic condition and this is most welcome.
"We hope the researchers it attracts will make use of the UK's first biobank for M.E., which we are establishing together with the ME Observatory, ME Association and London School of Hygiene & Tropical Medicine."
Footnotes:
1. The MRC issued a press release about the trial.
2. The Lancet produced a podcast.and press release.
3. The CFIDS Association of America has produced an analysis of the research paper. (CFIDS = Chronic Fatigue and Immune Dysfunction Syndrome)
4. On 23 December, NICE deferred its decision on whether or not it will update its guideline on CFS/M.E., pending the results of the PACE trial. [NICE subsequently decided not to review its guideline until 2013]
