Further commentary on the PACE trial: Biased methods and unreliable outcomes

Abstract

Geraghty in the year 2016, outlines a range of controversies surrounding publication of results from the PACE trial and discusses a freedom of information case brought by a patient refused access to data from the trial. The PACE authors offer a response, writing 'Dr Geraghty's views are based on misunderstandings and misrepresentations of the PACE trial'. This article draws on expert commentaries to further detail the critical methodological failures and biases identified in the PACE trial, which undermine the reliability and credibility of the major findings to emerge from this trial.

The ‘cognitive behavioural model’ of chronic fatigue syndrome: Critique of a flawed model

“…This trial has attracted criticism after it was discovered that the authors deviated from their published trial protocol and lowered key measurement criteria midtrial (Geraghty, 2017b). Re-analysis using the published trial protocol reveals a recovery rate for CBT closer to 7 per cent (not the 22% reported; Geraghty, 2017a;Wilshire et al, 2016). The PACE trial also demonstrated that little improvement in objective tests of physical function and the size of between-group differences (CBT-GET vs pacing therapy or standard medical care) was not sustained at 2-year follow-up (Chalder et al, 2015;Geraghty, 2017a;Sharpe et al, 2015).…”

“…Findings from these trials resulted in criticism that the efficacy of these treatments is poor (Geraghty and Blease, 2016;Wilshire et al, 2018). The PACE trial reported a recovery rate of 22 per cent using CBT, whereas re-analysis of data from PACE puts recovery below 10 per cent (Chalder et al, 2017;Geraghty, 2017a;Wilshire et al, 2016) -only little higher than the recovery rate observed in the de facto control group of usual medical care (Sharpe et al, 2015). Clinicians and medical philosophers argue that the CBM of ME/CFS downplays the severity of the illness, stigmatising sufferers with claims that recovery from the illness is dependent on a patient's efforts and engagement in psychotherapy (Blease et al, 2017;Komaroff, 2015).…”

Treating medically unexplained symptoms via improving access to psychological therapy (IAPT): major limitations identified

“…Treatment of ME/CFS remains problematic given a lack of consensus on aetiology and pathogenesis. Over the past few decades, cognitive behavioural therapy and graded exercise therapy (GET) have been tested on ME/CFS patients with modest benefits reported [39].However, this evidence has been robustly criticised [40] with post-hoc analysis of trial evidence showing the added benefits from CBT to be negligible [22,41,42].…”

The Importance of Accurate Diagnosis of ME/CFS in Children and Adolescents: A Commentary

“…The PACE trial reported CBT and GET to be moderately effective compared with pacing treatment or standard medical care. However, recent commentaries have questioned whether PACE recruited true-positive ME/CFS cases (17, 18)—-the Oxford Criteria was employed to select participants. Recent reanalyses of data from the PACE trial suggests treatment benefits were grossly over-stated (19).…”

“…What we can take from this observation is that CBT or exercise therapy perform little better than no care over the longer term. There are other reasons some trials show modest benefits over the short-term, such as selection of milder cases and strong treatment promotion effects (18, 46). Taking this into consideration, in addition to noting high rates of natural recovery in children and adolescents, the case for early intervention with psycho-behavioral therapy is rather weak.…”