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Proponents of these therapies argue that these very sick patients harbored “unhelpful beliefs” that they had an organic illness that limited their capacity to exert themselves. According to this theory, patients are deconditioned from too much rest and can recover if they overcome their fear of activity and get back into shape.
But as the new re-analysis by an academic researcher and three patients showed, the promise of recovery using the two treatments appeared to be an illusion. When the study’s findings were first published, patients and some scientists noted a stunning problem: The investigators had weakened their outcome measures from their trial protocol so much that participants could actually deteriorate on physical function and still qualify as “recovered.” Thirteen percent entered the trial already having met the definition of “recovered” on that measure. The investigators have argued that this didn’t matter since participants also had to meet additional recovery criteria.
These critiques received little attention until 2015, when Virology Blog, a science site, published a 15,000-word investigation of PACE written by one of us. This led dozens of scientists and clinicians to demand that The Lancet seek an independent review.
In December, the journal Fatigue: Biomedicine, Health and Behavior published the re-analysis of some of the data. The PACE investigators claimed in the journal Psychological Medicine that 22 percent of those undergoing either psychotherapy or graded exercise “recovered” from their illness. But that was not based on the study’s original definition for recovery but on the looser one adopted by the researchers after the trial began.
Using the original definition, the re-analysis found that 7 percent or less had “recovered” with no statistically significant differences between those who did and did not receive the treatments. In their response, the investigators argue that there is no “generally agreed-on measure of recovery.”
Last week, Virology Blog posted an open letter to Psychological Medicine, which one of us helped draft and which was signed by more than 100 clinicians, scientists, experts and patient groups, requesting the retraction of the PACE recovery study results to “protect patients from ineffective and possibly harmful treatments.” The journal has said it has no plans to retract the study but is open to publishing a re-analysis of data in any papers it has published.
In The Lancet, the trial also claimed that around 60 percent of patients in the exercise and psychotherapy arms “improved.” But according to the investigators’ own recent re-analysis of their data, using their stricter protocol measure of improvement rather than the looser one they used for The Lancet, only about 20 percent receiving each therapy in addition to medical care “improved” — and half of those would have improved with specialized medical care alone.
Even that limited finding is questionable. The improvement rates and other reported findings were based largely on patients’ subjective self-ratings, which are vulnerable to bias. In contrast, none of the trial’s objective measures supported the claims of treatment success.
In short, this episode has damaged public trust in science.
Doctors and medical organizations must stop recommending these two therapies for ME/CFS as treatment options. Next, the disputed findings must be retracted. Finally, health agencies must ramp up funding for medical research to develop accurate diagnostic tests and pharmacological treatments.
A million Americans are waiting.Continue reading the main story