The Lancet publish the results of the PACE study, 18 February 2011


Despite previous evidence that both cognitive behavioural therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome (CFS), some patients’ organisations have reported that these treatments can be harmful and instead prefer pacing and specialist medical care (SMC). The PACE trial, published *Online First* and in an upcoming /Lancet/, shows that while CBT and GET have positive effects on CFS when combined with SMC as compared to SFC alone, adaptive pacing therapy (APT) with SMC is no more effective than SMC alone. The *Article*is by Profs Peter White (Barts and The London School of Medicine, UK), Trudie Chalder (King’s College London, UK), Michael Sharpe (University of Edinburgh, UK) and colleagues. The trial is funded by the UK Medical Research Council and various departments of UK governments.

CFS, sometimes called Myalgic Encephalomyelitis (ME), is a long-term, complex and debilitating condition that causes fatigue and other symptoms such as poor concentration and memory, disturbed sleep, and muscle and joint pain. The cause of the condition— affecting some 250,000 people in the UK alone—is unknown.

SMC consists of advice about CFS, including avoidance of activity extremes, and rest and self-help strategies. APT is based on the theory that CFS is an irreversible condition that leaves patients with a limited amount of energy, and that individuals adapt their lives to this available energy through use of a daily diary. CBT is based on the premise that cognitive responses (fear of engaging in activity) and behavioural responses (avoidance of activity) are linked and interact with physiological processes to perpetuate fatigue. GET helps a CFS patient gradually step up their level of physical activity to counter the deconditioning that has set in as their activity has fallen. Walking is a popular choice for this.

In PACE, 640 patients were assigned to one of SMC alone (160 patients), SMC/CBT (161), SMC/GET (160) and SMC/APT (159). After a follow-up of one year, mean fatigue and physical function scores had improved more after CBT and GET than after both APT and SMC alone. Serious adverse reactions to treatment were recorded in two APT patients (1%), three CBT patients (2%), two (1%) GET patients, and two (1%) in the SMC-only group.

The group plans to report in the near future on cost-effectiveness of these various treatments, and say that since even CBT and GET only offer a moderate improvement in symptoms, research into new effective treatments must go on.

The authors conclude: “We affirm that cognitive behaviour therapy and graded exercise therapy are moderately effective outpatient treatments for chronic fatigue syndrome when added to specialist medical care, as compared with adaptive pacing therapy or specialist medical care alone. Findings from PACE also allow the following interpretations: adaptive pacing therapy added to specialist medical care is no more effective than specialist medical care alone; our findings apply to patients with differently defined chronic fatigue syndrome and myalgic encephalomyelitis (ME) whose main symptom is fatigue; and all four treatments tested are safe.”

In a linked *Comment*, Dr Gijs Bleijenberg, and Dr Hans Knoop, Expert Centre for Chronic Fatigue, Radboud University NijmegenMedical Centre, Netherlands, say: “The central role of cognition in relation to fatigue might explain why graded exercise therapy is effectiveand adaptive pacing therapy is not.” They note that /in adaptive//pacing patients learn to focus on the fatigue in order to stop “in time”, which does not seem to help, while in graded exercise patients learn that they are able to do more than they thought possible.

They conclude: “Remarkably in this context, confidence in the treatment at the start is substantially lower with cognitive behaviour therapy than it is with adaptive pacing therapy. Despite lowered confidence in cognitive behaviour therapy, this therapy is more effective than is adaptive pacing therapy. Patient’s confidence in treatment can only change if a change in abilities is perceived, which generally seems to happen in cognitive behaviour therapy.”




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