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Fatigue evidence gathers PACE
The PACE study, the largest randomised trial of its kind, has found CBT and graded exercise therapy to be more effective treatments for ME/CFS than the popular pacing approach (The Lancet: tinyurl.com/5som2pq).
Professor Peter White at Queen Mary, University of London, and his colleagues recruited 641 patients diagnosed with ME/CFS - a condition characterised by excessive fatigue in the absence of an identifiable organic cause. All received specialist medical care and advice (at least three sessions with a medical expert, and drug prescriptions for symptoms) over the ensuing 12 months. Additionally, over the first 24 weeks, 161 of them also concurrently undertook up to 14 sessions CBT therapy, 160 undertook the same amounts of graded exercise therapy, and 160 undertook equivalent sessions of adaptive pacing therapy.
Briefly, the CBT focused on patients' thoughts and behaviours that could be perpetuating their fatigue, especially their fear of engaging in activity; the graded exercise therapy focused on building up patients' capacity for exertion; whilst the ethos of the pacing was to adapt to chronic fatigue by avoiding over-exertion.
A year after the study start, 30 per cent of CBT patients and 28 per cent of exercise patients had returned to 'normal' function based on their self-report scores on measures of fatigue and physical function. This was a superior outcome, described as 'moderately effective' by the authors, compared with patients who received only specialist medical care, 15 per cent of whom had returned to normal function. In contrast to the CBT and exercise groups, just 16 per cent of patients who undertook pacing therapy plus medical care reached normal function at follow-up, no better than the medical care only group.
The general pattern of results was the same using the Oxford criteria for CFS diagnosis by which all the patients were recruited (chronic fatigue must be the main symptom in the absence of key concomitant psychiatric or other medical conditions, including any depressive or anxiety disorder), and when the analysis was restricted to those patients who met the version 2 London criteria for ME, or the international criteria for chronic fatigue.
The findings of the PACE trial are controversial because CBT and graded exercise therapy are both founded on the idea that chronic fatigue is reversible and can be ameliorated through changes in thoughts and behaviour. Moreover, adaptive pacing is popular with patients and patient advocacy groups. Indeed, patients in the current trial who were allocated to pacing were more confident in their therapy at the outset than were patients in the CBT group. Another concern among patient groups is that patients undergoing CBT or exercise therapy could be at increased risk of suffering adverse effects - however no evidence was found for this.
Sir Peter Spencer, CEO of Action for ME (an organisation that approved the pacing therapy manuals used in the current trial) told the press he was disappointed by the results. 'The findings of the PACE trial contradict the considerable evidence of our own surveys and those of other patient groups,' he said, pointing to one survey conducted in 2008 of 2763 people with ME, in which 82 per cent said pacing was helpful compared with 50 per cent for CBT and 45 per cent for graded exercise.
Other critics have questioned the diagnostic criteria used and the fact that more severe patients, who were unable to reach the hospital, were excluded. BPS Fellow and co-developer of pacing Dr Ellen Goudsmit told us that the findings of the new trial were difficult to interpret. 'A third of the participants did not meet the current international criteria for CFS, nearly a half had a psychiatric disorder and the researchers did not use actigraphy to check that the aim of graded exercise - i.e. to increase activity - was achieved,' she said. 'Also, the authors did not assess vitamin D levels (a common source of fatigue) or immune status (those with abnormalities respond less well to CBT and graded exercise). Two outcome measures indicated that many were still impaired at 52 weeks, and despite the claims, the trial didn't evaluate the version of pacing recommended by most support groups.'
Goudsmit, a visiting fellow at the University of East London, added: 'Pacing is simple, acceptable, safe and helps to stabilise the illness. It's judged in every audit and survey to be extremely helpful.'
In contrast, another BPS member, Chartered Health Psychologist Dr Peter Spencer at Leeds Trinity University College, welcomed the new findings, which he said reinforced results from his own research in the nineties. 'CBT and graded exercise have been shown to be more effective than any other approach in the management of ME/CFS,' he said. 'However, some people and groups find CBT/graded exercise not suited to them. Given this, perhaps the most important finding is that there is no need for a nihilistic approach to this illness... Many patients, using a range of strategies, have managed their illness and, like me, have made a full recovery.'
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