PACE trial recovery rates were grossly exaggerated

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From ME Action:

“Patients and statisticians have used the recently released data from the PACE trial to show that cognitive behavioural therapy and graded exercise therapy did not help patients in the study to recover.

Alem Matthees, an Australian patient who obtained the data after a two-year battle over his Freedom of Information request, applied the study authors’ own pre-planned analyses that they had abandoned after the trial had finished.

Working with independent statisticians and other patients with mathematical expertise, he showed that only 7% of the cognitive behavioural therapy group, 4% of the graded exercise group, and 3% of a no-therapy comparison group recovered. Differences between the groups were within chance variation, indicating no effect of the therapies.”

Matthees and co write:

“The PACE trial tested interventions for chronic fatigue syndrome, but the published ‘recovery’ rates were based on thresholds that deviated substantially from the published trial protocol. Individual participant data on a selection of measures has recently been released under the Freedom of Information Act, enabling the re-analysis of recovery rates in accordance with the thresholds specified in the published trial protocol. The recovery rate using these thresholds is 3.1% for specialist medical care alone; for the adjunctive therapies it is 6.8% for cognitive behavioural therapy, 4.4% for graded exercise therapy, and 1.9% for adaptive pacing therapy. This re-analysis demonstrates that the previously reported recovery rates were inflated by an average of four-fold. Furthermore, in contrast with the published paper by the trial investigators, the recovery rates in the cognitive behavioural therapy and graded exercise therapy groups are not significantly higher than with specialist medical care alone. The implications of these findings are discussed.”

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