Pressure grows on Lancet to review ‘flawed’ PACE trial


  • Dawn O'Shea
  • Univadis Medical News
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Over a hundred academics, patient groups, lawyers, and politicians have signed an open letter calling on the Lancet to commission an independent reanalysis of the Pacing, Activity, and Cognitive behaviour therapy: a randomised Evaluation (PACE) trial, the British Medical Journal reports.

In 2011, the Lancet published results from the trial which suggested that adding cognitive behavioural therapy (CBT) and graded exercise therapy to usual specialist medical care moderately improved outcomes for people with myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS) but adding adaptive pacing therapy was of no benefit.

However, the signatories of the open letter say the trial had “major flaws” and “unacceptable methodological lapses”. It points out that at baseline 13 per cent of participants qualified as “recovered” or “within the normal range” according to self-reported physical function but were still considered to meet the study entry criteria.

A five-year battle previously succeeded in forcing one of the academic centres involved in the trial to release the original data. A preliminary reanalysis of the data, which was previously reported, concluded that the reported recovery rates were inflated four-fold and the recovery rates in the CBT and graded exercise groups were not significantly higher than in the group receiving specialist medical care alone.