This is in response to the comment piece in New Scientist by Esther Crawley.

Myalgic Encephalomyelitis (ME) has been studied for decades from Ramsay through Behan to Hornig and Newton. As a result, many would say we know rather a lot about the illness. We know that patients show neurological, immunological and endocrinological changes. We know that ME is not depression; that patients do not respond more to placebo; that patients do not fear exercise; that ME is not caused by physiological deconditioning. We also know that patients do not harass researchers and that the primary symptom is post-exertional malaise.

It is not true that patients believe clinicians secretly think the illness is psychological. There is no secret: the major proponents of the Cognitive Behavioural Therapy-Graded Exercise Therapy (CBT-GET) model say ME is a self-perpetuating cycle of exercise avoidance. They have all stated quite clearly that ME has no ongoing underlying biological cause: it is neurasthenia, ‘simply a belief’, a functional somatic syndrome (Simon Wessely); it is perpetuated by beliefs (Peter White); ME is a pseudo-disease, a somatoform disorder, perpetuated by misinterpretation of bodily sensations, abnormalities of mood and unhelpful coping behaviour (Michael Sharpe). If others, such as Dr Crawley, disagree and do not mean to imply that ME itself has a psychological element, then perhaps they could say so unambiguously.

While it is of course true that anything which brings about changes is ‘biological’, implicit in CBT is the notion that responsibility for recovery lies with the patient. If only patients think differently, then they will no longer be ill. No one disputes psychotherapy can help with a broad spectrum of illnesses, but there is no evidence it can reverse organic damage (injury, infection, inflammation). There is no evidence CBT can address the changes in ME patients found by Lipkin, Montoya and Naviaux.

It is true that ME is likely to prove to be more than one illness, or an illness with more than one sub-type. It is also true though that many people diagnosed with ME, do not in fact have it. This difficulty in diagnosis due to the absence of a biomarker is one which causes problems for clinical trials. Many patients think the criteria used by Dr Crawley are too broad and are likely to include patients who have a generic ‘chronic fatigue’. It is a view shared by the US Institute Of Medicine and the US Agency for Healthcare Research and Quality, which has recently stopped recommending CBT for ME because any claims for its efficacy come from trials which used the discredited Oxford criteria.

The other challenge for trials of interventions for ME is to distinguish between placebo, improved coping with the effects of the illness and a genuine treatment of the underlying illness. Since the severely ill do not respond at all to CBT and the small, subjective, self-reported benefit in the moderately ill is only temporary, many patients think that claims for effectiveness of CBT are unsafe. They are not convinced FITNET-NHS contains sufficient safeguards against this confound.

Whichever measurements of recovery and improvement are used, whether the ones initially chosen by the investigators or the ones to which they switched part-way through the trial when some data had already been collected, we do know from PACE that the vast majority of patients do not benefit at all from CBT-GET. Since NHS clinics are based on this approach, many patients do not bother attending them. Any trial, then, gathering subjects from these clinics would not only exclude the most severely ill, who are unable to travel, but also the large numbers of patients who gain no advantage from the interventions and so do not waste time and effort in going to the clinics. On the other hand, since these clinics use broad criteria to select for ME, patients fear that people with illnesses other than ME would be included.

Patients agree that it is important we all work together. We would ask, though, that any research uses strict criteria to exclude chronic fatigue; takes into account the physiological changes found in people with ME; is based on plausible theory; is not based implicitly or explicitly on the notion the illness is one of false beliefs; includes meaningful patient involvement, from the broader patient community not just the established charities; benefits all patients, including the most severely affected; has, where applicable, proper controls against confounds; and unconditionally shares all anonymized data with anyone who wants to see it.

Thanks to (& #FF) Samei Huda for advice, though his help should not be seen as any kind of endorsement or agreement.