PACE trial’s findings fundamentally challenged by a new study

In a nutshell: Analysing PACE the way the authors originally promised to do showed that CBT and GET didn’t do much to improve self-reported physical function and fatigue and did not lead to recovery. Even the very limited self-reported gains in this unblinded trial are likely to be illusory because they are not backed up by meaningful gains in objective measures, such as fitness. The self-report gains also appear not to last. We now need biomedical research to pave the way for effective treatments.

Researchers and patients have been pointing out problems with the PACE trial for years. A new paper goes further by reanalysing the raw data to give the results the way the trial authors originally said they would give them, before they opted for softer measures of success. The new paper, published in the journal BMC Psychology, also sets out all the flaws of the PACE trial in one place.

Rethinking the treatment of chronic fatigue syndrome—A reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT

Carolyn E. Wilshire, Tom Kindlon, Robert Courtney, Alem Matthees, David Tuller, Keith Geraghty and Bruce Levin

carolyn-wilshire photo
Dr Carolyn Wilshire

It comes from a team that was led by research psychologist Dr Carolyn Wilshire and included a professor of biostatistics and several researcher-patients, each of whom has a string of publications to their name. Alem Matthees, whose long Freedom of Information battle with the PACE authors secured the release of the underlying data, is among the co-authors.

The new work, using the original analysis method published in the study protocol, revealed results that are much less impressive than the ones published by the PACE authors.

How PACE’s results really looked

Read morePACE trial’s findings fundamentally challenged by a new study

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