Pressure grows on Lancet to review “flawed” PACE trialBMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3621 (Published 22 August 2018) Cite this as: BMJ 2018;362:k3621
Over a hundred academics, patient groups, lawyers, and politicians have now signed an open letter to the Lancet calling on the journal to commission an independent reanalysis of the data from the PACE trial—a study into treatment for myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS), which it published the results of in 2011.1
The PACE trial showed that adding cognitive behavioural therapy and graded exercise therapy to usual specialist medical care moderately improved outcomes for people with ME/CFS but that adding adaptive pacing therapy was of no benefit.
The open letter—the signatories of which include academics from UCL, the London School of Hygiene and Tropical Medicine, Harvard, Berkeley, and Stanford—points out that the trial had “major flaws” and “unacceptable methodological lapses.” For example, 13% of the participants qualified at baseline as “recovered” or “within the normal range” for one of the study’s two primary measures (self reported physical function) but were still considered to meet the CFS criteria to enter the study.2
A five year battle by Australian patient, Alem Matthees, succeeded in getting Queen Mary University of London to release the original trial data under the UK Freedom of Information Act.34 A preliminary reanalysis of that data5 concluded that the previously reported recovery rates were inflated fourfold and that the recovery rates in the cognitive behavioural therapy and graded exercise therapy groups were not significantly higher than in the group that received specialist medical care alone.6
The £5m (€5.6m; $6.4m) publicly funded PACE trial has had widespread influence on research, treatments prescribed, and medical and public attitudes towards the illness. On its publication patients expressed anger because they thought that it suggested that ME/CFS was all in the mind and could be cured by cognitive behavioural therapy and exercise, when in fact some patients reported that such treatments caused them harm.
In 2016, Simon McGrath, who has a biochemistry degree from the University of Oxford and is unable to work because of ME/CFS, wrote a blog for The BMJ arguing that the PACE trial shows why patients need to scrutinise studies about their health.7
Academics are now voicing concerns about the trial, he wrote, but “for many years, researchers and the medical establishment would not engage with patients who made the same criticisms—simply because, it seems, they were patients.”
Ten members of UK parliament are among the politicians who signed the open letter, including Carol Monaghan (Glasgow North West), who predicted during a debate in February that “when the full details of the trial become known, it will be considered one of the biggest medical scandals of the 21st century.”8
The Lancet was approached for comment.