The PACE trial in chronic fatigue syndrome

Abstract

Much has been made of the “recovery” achieved by some participants in Peter White and colleagues' PACE trial,1White PD Goldsmith KA Johnson AL et al.on behalf of the PACE trial management groupComparison 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: 611-690Summary Full Text Full Text PDF PubMed Scopus (33) Google Scholar one of the authors having stated to the media that “twice as many people on graded exercise therapy and cognitive behaviour therapy got back to normal”2Boseley S Study finds therapy and exercise best for ME.The Guardian. Feb 18, 2011; Google Scholar and the accompanying Comment stating that, by use of a “strict criterion” for recovery, “the recovery rate of cognitive behaviour therapy and graded exercise therapy was about 30%”.3Knoop H Bleijenberg G Chronic fatigue syndrome: where to PACE from here?.Lancet. 2011; 377: 786-788Summary Full Text Full Text PDF PubMed Scopus (10) Google Scholar Although the trial protocol4White PD Sharpe MC Chalder T et al.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; 7: 6Crossref PubMed Scopus (113) Google Scholar does give a strict definition for recovery, this information is omitted from the published paper, which instead refers to physical function and fatigue in the “normal range”. Whether the values given are indicative of normal function is open to question, however. For instance, although a score of 60 or more on the short-form 36 (SF-36) physical function subscale and of 18 or less on the Chalder fatigue questionnaire are characterised as being in the “normal range” by White and colleagues, and as “recovery” in the accompanying Comment, an SF-36 physical function score of 65 was low enough for a patient to be included in the trial to begin with. Additionally, the above definitions for recovery and normal range would not even have qualified as being a positive outcome (75 or more on SF-36, bimodal fatigue scale score 3 or less) as published in the original protocol. Data on increases in baseline scores, the other positive outcome measure, are not given. Also in question is how White and colleagues arrived at their reduced thresholds, since the trial protocol states that an SF-36 score of 70 is one SD below the mean of the UK adult population, but in the published paper this figure drops to 60 without explanation. I am a CFS patient. Patients' power and PACEOnce every few years, we publish a paper that elicits an outpouring of consternation and condemnation from individuals or groups outside our usual reach. The latest topic to have caused such a reaction is chronic fatigue syndrome (CFS), and—more specifically—Peter White and colleagues' randomised PACE trial published on March 5, this year. Full-Text PDF The PACE trial in chronic fatigue syndrome – Authors' replyThe PACE trial for patients with chronic fatigue syndrome (CFS) found that supplementation of specialist medical care with either cognitive behaviour therapy or graded exercise therapy was more effective in reducing fatigue and physical disability than was supplementation of specialist medical care with adaptive pacing therapy or specialist medical care alone. We chose patient-rated measures of fatigue and physical function as primary outcomes because this is how the disorder is defined. Full-Text PDF