The recent release of data from the largest clinical trial of psychotherapy treatments for chronic fatigue syndrome (CFS), the ‘PACE-Trial’, has triggered a perfect storm of patient anger and professional defensiveness. The data were only released after a protracted freedom of information case brought by a patient with CFS. A tribunal ordered the lead author’s institution to release their data. Upon release, re-analysis showed that the levels of improvement and recovery observed in the released data were much lower than the levels reported in the published report (White et al., 2011a) and other related publications. The released data showed that the effectiveness of cognitive behavioural therapy (CBT) and graded exercise therapy (GET), in comparison to standard medical care (SMC) and adaptive pacing therapy (APT), fell by almost two-thirds.
Patient groups and independent experts have remarked that without data access, the medical establishment would have been left to accept the outcomes from the PACE-Trial, as robust evidence that CBT and GET are effective treatments for CFS. Instead, patients are calling for the wider scientific community to investigate their claim that the PACE-Trial authors overstated the benefits of CBT and GET. This editorial considers the ramifications of this unfolding story for patients with CFS, and its impact on the science of clinical trials of psycho-behavioural therapies.
Last November, the findings of a study (the Pace Trial) demonstrating much benefit from Cognitive Behaviour and Graded Exercise therapy, with a greater than 20 per cent recovery rate, elicited 1,200 critical comments from Telegraph readers, who drew attention to the uncertainty as to how “recovery” was defined.
This is no small matter, as those with CFS almost universally report that exertion exacerbates symptoms. Hence its official endorsement as an “effective” treatment could have seriously adverse consequences.
To their credit, six patients, with the help of sympathetic specialists, sought to clarify how researchers had conducted their trial. Undeterred by criticisms that they were “a very damaging group of individuals” whose inquiries “would harm the majority of patients”, after several refused attempts to invoke the Freedom of Information Act, they managed finally to obtain the raw data from which the researchers reached their conclusions. This revealed a series of difficulties lucidly summarised by mathematics professor Rebecca Goldin on the stats.org website.
Most significantly, as those Telegraph readers inferred, the criteria for “recovery” had been downgraded as the trial progressed, being redefined as the average physical function score of someone in their 80s. “The Pace Trial is worthless,” says Prof Jonathan Edwards of University College, London
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