Letters published in The Lancet Psychiatry today.
FROM DR CHARLES SHEPHERD, MEDICAL ADVISER TO THE ME ASSOCIATION
PATIENT REACTION TO THE PACE TRIAL
The long-term follow-up of the PACE trial(1), which originally reported that cognitive behavioural therapy (CBT) and graded exercise therapy (GET) produced a significant and sustained improvement, even recovery, for some people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)(2) should, in theory, have been greeted positively by patients. However, Michael Sharpe and colleagues(1) found very little difference in outcomes at long-term follow-up between any of the four interventions (which also included adapted pacing therapy and specialist medical care) and the patient community has expressed both anger and despair.
Anger because the media, along with many health professionals, has concluded that people can recover from ME/CFS through a simplistic approach to management involving exercise and positive thinking.(3) Despair because the findings from the PACE trial have not been supported by patient evidence on CBT, GET, and pacing, which dates back to the 2002 Chief Medical Officer's Working Group report(4) on ME/CFS.
The largest and most recent survey(5) of patient evidence on the acceptability, efficacy, and safety of CBT, GET, and pacing was carried out by The ME Association and involved 1428 respondents. In this case, 73% of respondents reported that CBT had no effect on their symptoms and 74% that their symptoms were made worse by GET.
As a result, The ME Association has recommended that the National Institute for Health and Care Excellence should withdraw their recommendation that everyone with mild or moderate ME/CFS should be offered GET. And while accepting that some people may find CBT helpful when there are comorbid mental health problems, as can occur with any long-term condition, we believe that CBT should not be used as a primary intervention.
A report from the National Institutes of Health Pathways to Prevention Workshop(6) also concluded that CBT and GET should not be used as a primary treatment strategy in ME/CFS.
The patient community feels so strongly about this issue that a petition(7) asking for the retraction and correction of various parts of the PACE trial has gathered over 10 000 signatures.
The argument here is not with psychiatry. Mental illness is just as real and horrible as physical illness, and as with any long-term illness, some people with ME/CFS develop comorbid depression and other mental health problems. The argument is with a flawed model of causation that takes no account of the heterogeneity of both clinical presentations and disease pathways that come under the umbrella diagnosis of ME/CFS along with the conclusion that CBT and GET should to be used as one size fits all primary interventions for everyone with mild or moderate symptoms.
The only way to conclude if people on the PACE trial have recovered from ME/CFS is to re-interview them to confirm they are symptom free; have returned to normal health and functioning; have resumed any education or employment preceding the illness, and have ceased to claim any disability benefits.
Without robust objective evidence relating to improvement and recovery, the ME patient community will continue to regard the PACE trial as a tremendous waste of research funding money.
I am Medical Adviser of the ME Association. I declare no other competing interests.
References
1) Sharpe, M, Goldsmith, KA, Johnson, AL et al. Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial. Lancet Psychiatry. 2015; 2: 1067–1074
2) White, PD, Goldsmith, KA, Johnson, AL et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011; 377: 823–836
3) Knapton, S. Chronic fatigue syndrome sufferers can overcome symptoms of ME with positive thinking and exercise. Daily Telegraph (London), Oct 28, 2015. http://www.telegraph.co.uk/news/health/11959193/Chronic-Fatigue-Syndrome-sufferers-can-overcome-symptoms-of-ME-with-positive-thinking-and-exercise.html.
4) Department of Health. A report of the CFS/ME working Group: report to the chief Medical Officer of an Independent Working Group. Department of Health, London; 2002https://meassociation.org.uk/wp-content/uploads/CMO-Report-2002.pdf. ((accessed Nov 18, 2015).)
5) The ME Association. ME/CFS Illness Management Survey Results. “No decisions about me without me”. https://meassociation.org.uk/how-you-can-help/fundraising-support/. ((accessed Nov 18, 2015).)
6) Green, CR, Cowan, P, Elk, R, O'Neil, KM, and Rasmussen, AL. National Institutes of Health Pathways to Prevention Workshop: advancing the research on myalgic encephalomyelitis/chronic fatigue syndrome. Ann Intern Med. 2015; 162: 860–865
7) ME Action. Misleading pace claims should be retracted. http://my.meaction.net/petitions/pace-trial-needs-review-now. ((accessed Nov 18, 2015).)
FROM FRANK TWISK | AUTHORS'S REPLY
FROM JAMES CHARLES COYNE AND KEITH R LAWS | AUTHORS' REPLY
Seeing these, at last, in the Lancet has made my day. Thank you so much, Charles, for your excellent letter and indeed, for all the very patient and dilligent work that you have done over very many years on behalf of people with ME. I really hope it hasn’t been at too much cost to your own health.
I think it had surely come to a critical point at which had Richard Horton not published these robust letters debunking the already fatally debunked PACE, he really would have lost all credibility.
I suspect that the establishment “biopsychosocial” coterie and the Science Media Centre will still do its level best to salvage something on behalf of their pals, but my advice would be that the hole they are in is beyond massive and it was time to stop digging a long time ago.
Put the ridiculous “Oxford Criteria”, PACE etc. in some museum of medical follies and have done with it.
This is curious – this morning (19 January) Twitter hashtags which have been useful and prominent in recent months appear to be totally unavailable – these are #me/cfs, #PACEtrial and #pwme. I trust this is nothing to do with recent events such as the publication of the letters above?….. No, such a thought is surely “vexatious”….
Also hashtags #CFS and #SEID. None of them working.
Thank you so much Dr Shepherd for your herculean efforts to get the lancet to publish these letters and all ME Patients’ views of PACE into the open. Brilliant to see.
Findlow The websites you refer to have gone down, as you say. MEAction did post on their site that they were being bombarded with’Spambots’ and were trying to fix it. I think it has everything to do with what is happening at the moment re PACE.
Hope all turns out ok for us all.