Behavioural therapies can help with ME

Behavioural therapies can help to successfully treat chronic fatigue syndrome, new research has suggested. Published in the journal PLoS ONE, the study revealed these treatments, as well as exercise, are among the most cost-effective ways to combat the condition, which is commonly referred to as ME.

According to the analysis, a wide adoption of the approaches could save the UK economy millions of pounds, BBC News reports.

Professor Michael Sharpe from Oxford University noted: "This new evidence should encourage health service commissioners to provide these treatments to all those patients who need them."

It was demonstrated that no other treatments for the condition - symptoms of which include tiredness, poor memory and a lack of concentration - proved as successful and cost-effective as behavioural and exercise therapies.

Professor Paul McCrone, a Health Economist from King's College London, said the findings suggest the National Health Service might now begin to invest in these methods.

Professor Michael Hyland, a Fellow of the British Psychological Society, comments:

"The PACE trial is a well-conducted study which has provided evidence, contrary to the assertion of patient groups, that adaptive pacing does not lead to benefit whereas cognitive behaviour therapy (CBT) and graded exercise therapy do.

"Nevertheless, even with the best designed studies there are several possible interpretations of the data. Adaptive pacing involved “living within physical and mental limitations imposed by the illness” as well as avoiding overexercising. In the CBT and graded exercise therapy treatment arms, patients were advised to avoid over-exercising, but, additionally, these therapies suggested procedures that the patient could perform into to achieve a gradual improvement in health.

"So although all treatment arms of this study recommended avoidance of over-activity (i.e. an element of pacing), they also differed in the amount of effort invested by the patient during treatment.

"My own research shows that the greatest non-specific predictor of therapeutic outcome is effort invested by the patient in the therapy.  An important non-specific difference, therefore, between the treatment arms in this study is the extent to which the treatments provide hope and an effort-related plan of action for achieving recovery. We cannot tell whether it is the non-specific factors of hope and effort or the specific components of CBT and graded exercise therapy that are important for outcome.  Perhaps the safest conclusion from this study is that therapy works – but just why therapy works remains as controversial for chronic fatigue syndrome as it is always has been for other conditions - see Wampold's The Great Psychotherapy Debate."

I know this study and flagged up its methodological flaws when the first proposals were available.  Example:  If a therapy is aimed at increasing activity levels (graded exercise/GET), a researcher might use an objective measure such as a motion-sensing device at baseline and after treatment to check for compliance.  This study just tested at baseline, thus one cannot attribute any improvement following GET to an increase activity. A second issue.  Pacing is not the same as Adaptive Pacing therapy (APT).  The latter is a whole programme and its rationale is dubious.  No one expected APT to work and it didn't. I believe only AFME recommends APT.

If you sense hype, why not compute Cohen's d on the data from those who completed the treatments and you may find low to modest values at almost every time point. Then have a look at the means for the two main outcome measures: 58 and 59, at 52 weeks, both well below the normal range. Yes, there was a gradual improvement in terms of tiredness and being able to carry a bag of potatoes in the CBT and GET arms, but how many were able to return to a normal life? 

The key symptom of ME is not 'fatigue' but a weakening of muscle strength following minimal exertion.  I trust that everyone with chartered status can see the subtle difference. In light of the abnormal response to minimal exertion and growing evidence of ongoing infection and immune dysfunction, encouraging such patients to slowly increase activity levels is as sensible as telling people with lung cancer to slowly increase the amount they smoke. 

The literature on CFS is full of group-think and spin. Just keep it in mind.  

There was no improvement for a 'return to work' or a 'reduction of welfare benefit claims' after CBT or GET, so it is unclear how CBT and GET "could save the UK economy millions of pounds". This seems to be hyperbole. It should be noted that only three therapies were tested in the PACE Trial (CBT, GET, APT), of which APT (Adaptive Pacing Therapy) was an entirely untested novel therapy invented solely for the PACE Trial. So the fact that GET and CBT were slightly more successful than APT is not a surprise. APT is not the same as 'pacing'. CBT failed to demonstrate clinical usefulness for one of the two primary outcome measures (physical function.) This result was supported by the failure of CBT to improve physical disability in an objective secondary outcome measure. So the PACE Trial demonstrated that CBT is ineffective at reducing physical disability. CBT was found to be 'moderately effective' for improving the subjective symptom of fatigue. GET was found to have a 'moderate' effect size. In terms of the proportion of participants who achieved a clinically useful outcome, the results were as follows: CBT physical function 13% CBT fatigue 11% GET physical function 12% GET fatigue 15% The 'recovery rates', and the ‘deterioration rates’ (determined by an equivalent measure as the improvement rates) have not yet been published. The PACE Trial demonstrated that only about 13% of CFS/ME patients respond to treatment with CBT or GET. (NNT = 1 in 8) These results verify patient organisations’ surveys of their members, suggesting that patients’ experiences of pacing might also be verified, if tested. It is not surprising that CBT and GET remain controversial while they are promoted as therapies that reverse illness. This is not supported by the evidence of the PACE Trial. The PACE Trial paper reported: "...research into more effective treatments is needed."