People want to learn as much as possible from the PACE trial for chronic fatigue syndrome

One reason that the minutes are sought for the PACE (Pacing, Graded Activity, and Cognitive Behaviour Therapy—a Randomised Evaluation) trial, which looked at the effectiveness of treatments for chronic fatigue syndrome, is to find out why outcome measures were changed.1 None of the three primary outcomes were reported as in the protocol.2 The recovery criteria in the protocol were very different from what were reported on.2 3

Non-pharmacological therapies are less well regulated than pharmacological ones. For example, there is no equivalent to the yellow card system for adverse events seen with these therapies, so trial reporting becomes more important. Reporting of harms in trials of cognitive behavioural therapy and graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has generally been poor.4 Harms reporting in the PACE trial was improved but problems still remain.4 5

Outside of trials, people with ME/CFS have reported being made more ill by such interventions, but this has largely been ignored,4 which can make people frustrated.

This was an important trial: £5m (€6m; $8m) of taxpayers’ money was invested in it, and it was meant to be the definitive trial. It’s understandable that people want to get as much information from the trial as possible.