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.