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PACE trial

Action for M.E. notes that the PACE trial, with 641 eligible participants, shows that specialist Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET) are ‘moderately effective’ treatments for people with M.E./CFS. All participants in the PACE Trial were assessed at hospital and the trial did not include house/bed bound patients.

When combined with Specialist Medical Care (SMC), the following had improved by at least two points for fatigue and at least eight points for physical function at 52 weeks:

  • 64 (42%) of 153 participants in the Adaptive Pacing Therapy (APT) group
  • 87 (59%) of 148 participants for CBT
  • 94 (61%) of 154 participants for GET
  • 68 (45%) of 152 participants for SMC alone.

This is not the same as being recovered; it identifies an improvement for those patients that undertook CBT and GET over and above any benefit of standard medical care alone (14-16% improvement), which included advice on self-management.

Several large surveys of M.E. patients by M.E. organisations showed that many patients reported that GET and, to a lesser extent CBT, caused them harm. This is why the PACE trial was carefully designed to measure the safety of these therapies in particular. The trial showed that, however safety was assessed, all therapies, as applied in this trial, were safe, including CBT and GET.

Clearly there’s a discrepancy here which could be caused by the “graded exercise therapies" referred to in previous surveys not being so clearly defined or professionally provided and therefore they may not have been either "graded" or “therapy." For example, feedback from our members includes being told to undertake activities that are inappropriate given their condition such as joining a gym or pushing themselves beyond their physical capabilities too hard or too soon. GET and CBT should only be applied by appropriately trained professionals who have experience in dealing with the illness.

Action for M.E. was surprised that the PACE trial did not indicate that APT was an effective strategy for managing the condition alongside SMC. Surveys by Action for M.E. and other M.E. charities have consistently shown that the majority of people with M.E. find that pacing helps them to manage their illness. However, this large trial clearly showed that adding APT (as delivered in this trial) to SMC helped 42% of patients, a little less than those helped by SMC alone, showing that it was not an effective treatment.

Action for M.E. supports the World Health Organisation definition that M.E. is a neurological illness and notes that the PACE trial report states: “Our finding that studied treatments were only moderately effective also suggests research into more effective treatments is needed. The effectiveness of behavioural treatments does not imply that the condition is psychological in nature.” (White et al, 2011)

Action for M.E. will continue to support high quality biomedical research to try to alleviate the plight of people with M.E. We do this by a variety of means, including sponsoring pilot schemes that are high quality and peer reviewed.

 

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