Monday, 6 May 2019

CBT for ME/CFS is not effective


Cognitive behavioural therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective. Re-analysis of a Cochrane review

Mark Vink, Alexandra Vink-Niese

First Published May 2, 2019

Abstract

Analysis of the 2008 Cochrane review of cognitive behavioural therapy for chronic fatigue syndrome shows that seven patients with mild chronic fatigue syndrome need to be treated for one to report a small, short-lived subjective improvement of fatigue. This is not matched by an objective improvement of physical fitness or employment and illness benefit status. Most studies in the Cochrane review failed to report on safety or adverse reactions. Patient evidence suggests adverse outcomes in 20 per cent of cases. If a trial of a drug or surgical procedure uncovered a similar high rate, it would be unlikely to be accepted as safe. It is time to downgrade cognitive behavioural therapy to an adjunct support-level therapy, rather than a treatment for chronic fatigue syndrome.

Introduction

For years, the recommended treatments for chronic fatigue syndrome (CFS) have been cognitive behavioural therapy (CBT) and graded exercise therapy (GET). These recommendations have been based on Cochrane reviews (Larun et al., 2017; Price et al., 2008) and a large randomised controlled trial by White et al. (2011), informally referred to as the PACE trial (‘Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation’). This trial concluded that CBT and GET were moderately effective treatments, leading to recovery in 22 per cent of patients. Due to its size (n = 640) and promotion, it has been very influential in the promotion of CBT and GET as effective treatments for CFS (Wilshire et al., 2018b). Recently, a number of re-analyses of the PACE trial, including a special issue of the Journal of Health Psychology (Marks, 2017), have raised significant concerns with the published outcomes of the trial. If the PACE trial had not made a significant number of outcome changes, which led to an overlap in entry and recovery criteria, then there would not have been a difference in recovery rate between CBT and GET and the two control groups (no treatment (specialist medical care) and adaptive pacing therapy) (Geraghty, 2017a; Vink, 2016; Wilshire et al., 2018b). Essentially, the recovery rate would have been the same as the natural occurring one (Cairns and Hotopf, 2005). The absence of objective improvement in the PACE trial (fitness and 6-minute walk test (6MWT)) and the increase in illness and unemployment benefits, matched the findings from the evaluation of the use of CBT and GET in the Belgium CFS knowledge centres (Stordeur et al., 2008). As noted by O’Leary (2018), ‘although PACE [has] dictated management of ME/CFS across the globe for many years, the study fails to meet basic standards of scientific methodology’. ‘Indeed, it is difficult to imagine how such a large-scale investigation could have developed, proceeded and passed through the review process unless its scientific failings were actually characteristic of its field’. Analysis of the Dutch FITNET trial of Internet CBT for adolescents (Ghatineh and Vink, 2017), of the Dutch FatiGo trial of multidisciplinary rehabilitation treatment (Vink and Vink-Niese, 2018a) and of five Dutch hallmark CBT studies (Twisk and Corsius, 2017) supported this observation. A recent re-analysis of the Cochrane exercise review for CFS (Vink and Vink-Niese, 2018b) revealed a number of methodological concerns with many of the studies reviewed as part of the Cochrane review of GET for CFS and a lack of objective evidence for improvement in physical function. It also showed that the problems noted by O’Leary are not confined to Dutch studies. O’Leary also concluded that ‘the PACE controversy suggests a need to evaluate the scientific credibility of psychosomatic medicine generally’. As such, we carried out an analysis of the Cochrane review of CBT treatment for CFS by Price et al. (2008), to ascertain if this review contained any of the problems identified in Vink and Vink-Niese (2018b), by O’Leary (2018) or Geraghty (2017a) and also to assess whether or not the conclusions of this Cochrane review – that CBT is somewhat effective with moderate size effects – is justified by the data contained within the primary studies included in the review. In our analysis, we concentrated on the objective outcome measures to establish if improvements in self-report (fatigue) translate to observable improvement in objective tests (physical ability, fitness, etc.) as there is an inverse relationship between fatigue and physical activity (Rongen-van Dartel et al., 2014).

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