Recovery in the PACE trial

In 2012, the UK’s Medical Research Council allocated £1.65 million for biomedical projects into ME/CFS – to widespread congratulations from patients and charities. But several years before, it had funded two large, expensive clinical trials (FINE and PACE) of cognitive behavioural approaches for ME/CFS, and the consequences are still reverberating. The FINE trial found that ‘pragmatic rehabilitation’ of severely affected patients had some benefits in the short-term, but these were not maintained after one year, and the cost-benefits of treatment were minimal (BMC Family Practice, 2013).

When the PACE trial was finally published in the Lancet in 2011, it reported improvements in fatigue and physical functioning in some ME/CFS patients after cognitive behavioural therapy (CBT) or graded exercise therapy (GET), compared with medical care alone. Overall, around 10 to 15% of patients benefitted over and above the beneficial effects of standard medical care – an unsurprising finding since we already know from surveys that some patients can be helped by non-specific therapies. For instance, the ME Association’s survey of 2010 found GET to “improve/ greatly improve” symptoms in 22.1% of respondents (906 responses), while the equivalent figures were 25.9% for CBT (997 responses) and 53.7% (1675 responses) for meditation or relaxation techniques.

Now a second report, this time in Psychological Medicine, has been published on the numbers of people who ‘recovered’ from illness after treatment in the PACE trial. ‘Trial recovery’ was defined as occurring when a patient was in the normal ranges for fatigue and physical function, no longer met the Oxford case definition of CFS, and had ratings of ‘very much’ or ‘much’ better on the Clinical Global Impression scale.

As the table shows, around 15% of participants derived extra benefit from CBT and GET over and above standard medical care, reiterating the previous findings. However, 85% of patients did not derive this additional benefit from the therapies, and 90% or more of patients had not recovered from ME/CFS after 12 months of basic care.

The authors themselves recognise this problem when they say, “The relatively small proportion of recovered patients…should also spur us on both to enhance currently available therapies and to develop new and better treatments.” Patients with chronic illnesses such as ME/CFS have a variety of useful nonspecific psychological approaches available to them. However, these cannot substitute for the whole clinical and therapeutic armoury required to treat and (ultimately) cure the underlying disease, and this is where biomedical research comes into its own.

Reference: Recovery from chronic fatigue syndrome after treatments given in the PACE trial. White et al Psychological Medicin, 2013 Oct; 43(10): 2227-35.


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