Publication of the PACE trial

In the early 2000s, the UK’s Medical Research Council (MRC) funded two large clinical trials of ‘cognitive behavioural’ approaches for ME/CFS, at a cost exceeding £3 million. The first of these (the FINE trial) reported in the British Medical Journalthat ‘pragmatic rehabilitation’ for severely affected patients had some short-term benefits, but only a small, non-significant effect after one year. Indeed, at the end of 12 months, only 17 out of 81 patients allocated to pragmatic rehabilitation were classified as having improved physical functioning, compared with 10 out of 86 patients receiving GP treatment as usual. A surprise result? Not really, given that pragmatic rehabilitation with its cognitive behavioural components does not, and was never intended to, address the pathophysiological basis of disease in these severely ill people.

The second MRC-funded study (the PACE trial), now published in the Lancet, reports modest improvements in some ME/CFS patients after cognitive behavioural (CBT) or graded exercise therapy (GET), compared with medical care alone. Despite some media spin surrounding the results (“Brain and body training treats ME, UK study says,” trumpeted the BBC), the effects of these cognitive behavioural approaches are modest as the table shows, benefiting around 10 to 15% of patients over and above the benefit of standard medical care. Indeed, the PACE trial investigators themselves were far more cautious than the media in their conclusions, stating that the addition of these therapies can “moderately improve outcomes” in some patients, while an accompanying Lancet editorial asked a most pertinent question: “…have patients recovered after treatment? The answer depends on one’s definition of recovery…”

The results of these two expensive trials simply confirm what we already know from the most recent Cochrane Collaboration systematic review, and from the most comprehensive meta-analysis to date: that psychosocial interventions can help some moderately affected ME/ CFS patients manage or cope with their symptoms, but otherwise have only an adjunctive role in the treatment of the illness. In fact, the situation is exactly the same as in other chronic illnesses, such as multiple sclerosis, where non-specific psychological approaches can help some patients to manage symptoms, but are no substitute for the whole clinical and therapeutic armoury required to treat and (ultimately) cure the underlying disease.

Reference:  Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. White PD et al. Lancet 2011 Mar 5; 377(9768): 823-36.

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