Tuesday, 10 January 2017

PACE trial recovery data and chronic fatigue syndrome

PACE mentioned in the title of this post refers to the PACE trial [1] which concluded that: "CBT [cognitive behaviour therapy] and GET [graded exercise therapy] can safely be added to SMC [specialist medical care] to moderately improve outcomes for chronic fatigue syndrome, but APT [adaptive pacing therapy] is not an effective addition."

The recent paper by Carolyn Wilshire and colleagues [2] who drew on "relevant normative data and other research" continues a peer-reviewed research theme focused on some of the details included in the original and subsequent PACE trial publications specifically that discussing the topic of recovery [3]. To quote from that 2013 paper [3] on the topic of the PACE trial: "The percentages (number/total) meeting trial criteria for recovery were 22% (32/143) after CBT, 22% (32/143) after GET, 8% (12/149) after APT and 7% (11/150) after SMC."

OK, anyone that knows anything about chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) will probably have seen or heard about the debates around the PACE trial; the trial now having it's own -gate suffix (see here). The ups-and-downs, twists-and-turns, surrounding this trial have rumbled on for years now; merging with more general criticism of the biopsychosocial (BPS) model (see here), moving into debates about data-sharing, including Information Commissioner legal stuff and allowing the word 'vexatious' to be banded around quite a few times. The term 'bad science' has also been used on occasion (see here) albeit not necessarily in the peer-reviewed domain context...

Quite a few of the authors on the Wilshire paper have been central to many of the discussions around the PACE trial, also including the respondent who is credited with getting the raw trial data released alongside the UK Information Commissioner. They set out to examine the recovery definition used in that 2013 PACE trial add-on paper and "whether these recovery claims are justified by the evidence". Their answer: "None of the changes made to PACE recovery criteria were adequately justified. Further, the final definition was so lax that on some criteria, it was possible to score below the level required for trial entry, yet still be counted as ‘recovered’." The sorts of recovery figures they arrived at were "only single-digit rates of “recovery” for all four groups in the study" according to another write-up of the study in comparisons to the 22% offered in the 2013 paper. Whilst this is important research, this is not the first time that the recovery criteria included in the PACE trial has been discussed. Indeed, this latest publication really just gets the whole thing into the peer-reviewed domain.

"The claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments." Strong words indeed from the authors and I expect there will eventually be a reply from the original PACE authors on this matter too. PACE-gate is set to rumble on into 2017...

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[1] White PD. 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 Mar 5;377(9768):823-36.

[2] Wilshire C. et al. Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial. Fatigue: Biomedicine, Health & Behavior. 2016. Dec 14.

[3] White PD. et al. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013 Oct;43(10):2227-35.

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ResearchBlogging.org Wilshire, C., Kindlon, T., Matthees, A., & McGrath, S. (2016). Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial Fatigue: Biomedicine, Health & Behavior, 1-14 DOI: 10.1080/21641846.2017.1259724