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Updated NICE guidance on chronic fatigue syndrome

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4774 (Published 16 December 2020) Cite this as: BMJ 2020;371:m4774

Rapid Response:

Re: Updated NICE guidance on chronic fatigue syndrome

Dear Editor,

I am sorry to say that I think the recent editorial [1] on the draft NICE guidelines for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is ill-informed, confused and unhelpful.

Having been involved in the guideline process as an expert witness I am confident that the downgrading of quality of evidence for therapist-delivered treatments for ME/CFS was not a result of the well-recognised failings of the GRADE system. If anything GRADE makes it difficult to adequately downgrade very poor randomised studies. The committee found a sensible way to do so [2].

Further arguments raised by Turner-Stokes and Wade about evidence quality are puzzling and contradictory. They imply that the evidence for efficacy of therapist-delivered modalities such as CBT and exercise is good. Yet they point out that the types of trial available for evaluation are not appropriate. Such trials cannot be blinded (they note), so with subjective endpoints are hopelessly at risk of expectation bias. As I pointed out in my written testimony to the guideline committee [3], you cannot say that if the best you can do must fall short of reliability you can then treat it as reliable. Turner-Stokes and Wade must surely be arguing that NICE made the right decision.

There is also an accusation (unsubstantiated) that NICE was swayed by qualitative evidence from patients, ignoring the fact that the bar for evidence is set lower for harm than efficacy. Further confusion then comes when the authors say they think we need new forms of assessment – which appear to rest on qualitative uncontrolled observations of patients. This reinforces the agreed point, made cogently by Geraghty [4], that we need new types of trial design for therapist-delivered modalities because the traditional format has failed, but surely not to fall back on uncontrolled clinical practice accounts.

The authors appear to assume that we can know that therapist-delivered treatments are effective on clinical practice grounds. Yet, as I explained in my testimony to NICE, the available trials show that any benefits, even if due to more than expectation bias, would be too marginal to separate from spontaneous improvement in clinical practice. Unfortunately, the presumption that the benefits of rehabilitative treatments can be reliably identified in routine practice is ingrained into the sector. Recent trials have shown this to be unjustified.

It was because of the impact of this muddled type of thinking from a small group of service providers that NICE decided to review the ME/CFS guidelines. The draft proposals look to be an enormous improvement to the very large patient community interested in the quality of the science. What is particularly important now is that muddled thinking is not used to justify ‘rehabilitation’ of people with persistent unexplained symptoms after Covid-19 infection. We have no reason to think that post-viral syndromes are likely to benefit from anything other than time and not trying to do too much. There is no valid analogy with stroke or trauma.

References
1. Turner-Stokes, L. and Wade, D. (2020). Updated NICE guidance on chronic fatigue syndrome. BMJ, 371, m4774.
https://www-bmj-com.libproxy.ucl.ac.uk/content/371/bmj.m4774

2. National Institute for Health and Care Excellence. (2020). Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Draft guidance consultation.
https://www.nice.org.uk/guidance/indevelopment/gid-ng10091/consultation/...

3. Edwards, J.C.W. (2020). In: National Institute for Health and Care Excellence. (2020). Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Draft guidance consultation. Supporting documentation.
https://www.nice.org.uk/guidance/gid-ng10091/documents/supporting-docume...

4. Geraghty, K.J. (2017) PACE-Gate: When clinical trial evidence meets open data access. J Health Psychol. 22(9):1106-1112.

Competing interests: No competing interests

17 December 2020
Jonathan CW Edwards
Professor Emeritus in Medicine
University College London
University College London