MEAction UK have been in communication with the BMJ and are delighted to announce that the Journal of Neurology, Neurosurgery & Psychiatry (JNNP) are publishing an edited version of our rapid response to  ‘Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis’. We have taken out some of the more direct language but left the sense and the sentiment intact. We agreed to a few selected edits as we think it’s important to have our response to the article on the record and permanently attached to the article.

You can read the original response here, which the JNNP deemed suitable for publication before withdrawing, and that we still stand by.  The updated version of our rapid response can be read below.

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Dear Editor,

In the article ‘Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis’ published in the Journal of Neurology, Neurosurgery & Psychiatry on 10th July 2023, the authors claim NICE invented a new definition of ME. These claims are unfounded as NICE used the Institute of Medicine (IOM) criteria which is now 8 years old and was created using a more robust process than many other definitions as it drew on samples from different countries and compared the most widely used definitions of ME.

One area where NICE felt there was a gap in the IOM criteria was the lack of an empirical process alongside other methods. Leonard Jason’s four-item empiric criteria were the only criteria that used adequate empiric methods, and this aligned very closely with the IOM criteria. As a result, NICE operationalised the IOM criteria for use in the NHS, with the four-item criteria helping to substantiate their approach.

NICE does not measure a trial’s success based on the researchers’ own terms but by analysing the raw data and applying the committee’s agreed protocol. This allows NICE to measure whether a treatment had an effect or not. This is striking when looking at the assertion that research showed that the favoured treatments of CBT and GET were safe, when, in reality, safety data either was not collected or was incomplete or uninterpretable. These treatments have led to many complaints from people with ME that they were harmful and led to deterioration. This was illustrated in the MEAction UK 2019 report, ME services in the UK Not Fit For Purpose. 

The authors of this critique also claim that NICE didn’t aggregate data properly, but there are hundreds of pages of meta-analysis proving they were meticulous and gave detailed consideration to every trial they looked at. The real complaint here seems to be that NICE didn’t aggregate data in the way the authors of this paper wish they had. For example, the Cochrane review of exercise in ME, which many of these authors favour, pools results from multiple different interventions with very different protocols, and this has been argued to provide an evidence base for GET by extension. But that would be like pooling the evidence for CBT, DBT, ABA, psychoanalysis and counselling, and then claiming this proves ABA alone is effective. NICE sensibly grouped “like with like”, so that trials with similar protocols were grouped together, improving the accuracy and specificity of their analysis.

The criticism that NICE gave too much weight to survey evidence, and the lived experience of people with ME, was factored into the committee’s decisions alongside other evidence. ‘NICE considers all types of evidence in its evaluations. This includes evidence from published and unpublished data, data from non-UK sources, databases of ongoing clinical trials, end-to-end studies, conference proceedings, and data from registries, real-world evidence and other observational sources.’

The complaint that energy management isn’t evidenced is bizarre. Energy management isn’t offered as a therapy and it isn’t curative. It is essentially the same as the activity management of the last guideline – which many of the same authors were happy to accept when they contributed to that guideline. Energy management is essentially a continuation of those same principles of care but it is not offered or presented as a treatment. The Forward ME group of charities has also endorsed this approach.

With regard to GET and whether fixed increments in activity were required, NICE had to look at the evidence from the trials. Numerous trials refer to increments that are fixed and shouldn’t be changed except with the approval of the clinician. The PACE manual for therapists explains that GET is based on the deconditioning model and discourages reductions in exercise when in a crash, ‘A central concept of GET is to MAINTAIN exercise as much as possible during a CFS/ME setback. This is to reduce the many negative consequences of rest, and to allow the body to habituate to the increase in activity. If activity and exercise is reduced at this time, the boom/bust cycle continues, and the body is not able to desensitise to the increase in activity: which is, of course, an essential component of a graded increase in exercise and activity.’ If the treatment was delivered in a different way in practice it would indicate that the GET as researched wasn’t effective in clinical settings.

Similarly, it cannot be merely assumed that because one approach is helpful elsewhere, that it is helpful here. There is no treatment that is suitable for all diseases. Chronic primary pain isn’t ME and asthma isn’t diabetes and it should be self-evident that different illnesses need different treatments. 

We are also concerned that news coverage about this paper (and previous news coverage quoting the same authors) continues to paint people with ME as unreliable witnesses to their own illness and lives. This is a long-standing form of bias against disabled people.

In conclusion, this article reads as an attack on the 2021 NICE guideline for ME/CFS by a group of researchers who have focussed on treating ME with Graded Exercise Therapy and CBT.  By contrast, the patient community welcomes the NICE guideline and the robust review of the evidence that NICE carried out. The guideline is a real improvement on the previous version and the removal of Graded Exercise Therapy as a recommended treatment was greeted with relief. It is now time for researchers and medical staff to work with people living with ME to implement the NICE guideline throughout the NHS. Further delay and obstruction will cause more harm and increase the suffering of a very vulnerable group of people.

Denise Spreag
Janet Sylvester
Malcolm Bailey

Conflict of Interest: All authors are trustees of #MEAction UK