“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.”
“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.”
- Patients’ reanalysis sinks PACE’s “recovery” claims, at MEAction
- No ‘Recovery’ in PACE Trial, New Analysis Finds, from the Virology Blog
- A preliminary analysis of ‘recovery’ from chronic fatigue syndrome in the PACE trial using individual participant data, (PDF) by Alem Matthees, Tom Kindlon, Carly Maryhew, Prof Philip Stark, Prof Bruce Levin
- Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back, by Julie Rehmeyer at StatNews.com
- PACE: Grossly Exaggerated, by Jennie Spotila at ocupyme.net
- Data analysis Puts PACE Trial on Slippery Slope to Retraction, by Cort Johnson at Health Rising
- Trial By Error, Continued: The Real Data, by David Tuller at the Virology Blog
- Key points from the analysis of the PACE trial raw data for “recovery”, by Margaret Williams (PDF)
- PACE Trial Participants – were they exploited?, analysis and opinion by Peter Kemp MA
- Bad science has misled millions with chronic fatigue, court order reveals, by Bec Crew at Science Alert
- Exercise and therapy cure for ME is ‘seriously flawed’, by Tom Whipple, Science Editor of The Times
- Independent investigation reveals NICE approved treatment only a fraction as effective as experts claim it is, by Jerome Burne, at Health Insight UK
- The results they really didn’t want you to see: key ME/CFS trial data released, by Conrad Bower at The Canary.
- Studies on Cognitive Behavioral Therapy and Graded Exercise Therapy for ME/CFS are misleading, by Sten Helmfrid PhD
- ‘PACE-Gate’: When clinical trial evidence meets open data access, by Keith J Geraghty, University of Manchester (UK), in the Journal of Health Psychology
- Trial By Error Continued, by David Tuller PhD at the Virology Blog
- The PACE trial: Where “recovery” doesn’t mean getting your health back, by Simon McGrath at MEAction.
- Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial, by Wilshire, Kindlon, Mathees & McGrath in Fatigue: Biomedicine, Health & Behavior.
- A Study of Chronic Fatigue Syndrome Therapies Is Debunked (Again), by David Tuller at Undark.org