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College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5355 (Published 30 August 2013) Cite this as: BMJ 2013;347:f5355

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Re: College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules

One of the reasons the minutes are sought for this trial is to find out why outcome measures were changed. None of the three primary outcomes have been reported as in the protocol (1). The recovery criteria in the protocol are a lot different from what have been reported on (1,2).

Non-pharmacological therapies are not as well regulated as pharmacological interventions. For example, there is no equivalent to the yellow card system for adverse events observed with such interventions. This makes the reporting in trials of such therapies more important. Reporting of harms in trials of cognitive behavioural therapy (CBT) and graded exercise therapy (GET) for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has generally been poor (3). Harms reporting in the PACE Trial was much improved but some issues still remain (3,4).

Outside of trials, significant numbers of individuals with ME/CFS have reported being made more ill by such interventions but this largely been ignored, most likely due to the fact that the therapies are non-pharmacological (3). Not surprisingly, this can make such people, and people who know them, frustrated.

This was a very significant trial: £5m of taxpayers' money was invested in it. One might say it was supposed to be the definitive trial. I think it's understandable that some people have been focused on getting as much information from the trial as possible.

References:

1. White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group. Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol. 2007 Mar 8;7:6.

2. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M; PACE Trial Management Group. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013 Jan 31:1-9.

3. Kindlon T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Bulletin of the IACFS/ME. 2011;19(2):59-111.

4. Kindlon T. The PACE trial in chronic fatigue syndrome. Lancet. 2011 May 28;377(9780):1833

Competing interests: I work in a voluntary capacity for the Irish ME/CFS Association

31 August 2013
Tom Kindlon
Assistant Chairperson
Irish ME/CFS Association
PO Box 3075, Dublin 2, Ireland