ME/CFS NICE guideline based on a thorough review of the evidence
Criticisms by 50+ international researchers and clinicians of the ME/CFS NICE guideline were published in July 2023 and available on open access. In February 2024 a response from NICE was published, behind a paywall. After much lobbying this was made freely available on 7 March 2024
The criticisms
- the new definition of CFS/ME, which “downgraded” some trial evidence
- omitted data from standard trial end points used to assess efficacy
- wrongly discounted trial data when assessing treatment harm
- minimised the importance of fatigue as an outcome
- did not properly use GRADE (Grading of Recommendations, Assessment, Development and Evaluations trial evidence) when assessing trial evidence.
- misinterpreted GET as requiring inflexible graded increases of activity
- did not follow NICE recommendations of rehabilitation for related conditions e.g. pain
- recommended an energy management approach which was not evidence based.
Criticisms are based on misunderstanding
“We outline how these opinions are based on a misreading or misunderstanding of the guideline process or the guideline, which provides a balanced and reasoned approach to the diagnosis and management of this challenging condition.”
Energy management is not a cure
“There is a lack of evidence supporting energy management in people with ME/CFS, and no evidence that it is a ‘cure’. But there is also no signal of harm or deterioration with energy management programmes, unlike with GET.”
Conclusions
“The new guideline on ME/CFS was produced by an independent committee of clinicians who look after people with the condition, and people with lived experience of ME/CFS. Development followed a transparent process that conformed to recognised standards for guideline development, including extensive consultation with stakeholders prior to publication.
All evidence needs interpretation: evidence alone cannot determine the content of a recommendation. Criticisms of the guideline discussed in this paper are misplaced. The guideline has been welcomed and widely accepted by patient groups and clinicians leading services for people with ME/CFS in the UK.
We hope that the guideline will lead to better care and the development of more effective therapies for people with ME/CFS.”
NICE guideline on ME/CFS: robust advice based on a thorough review of the evidence, by Peter Walter Barry, Kate Kelley, Toni Tan, Ilora Finlay in Journal of Neurology, Neurosurgery and Psychiatry 8 February 2024. [doi: 10.1136/jnnp-2023-332731]
In the media:
MERUK: NICE responds to claims of “a controversial U-turn” on GET and CBT
Video interview with David Tuller: Adam Lowe Explains the NICE Response to Uninformed “Eight Anomalies” Critique of ME/CFS Guidelines
Abstract
In 2021, the National Institute for Health and Care Excellence produced an evidence-based guideline on the diagnosis and management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a disabling long-term condition of unknown cause. The guideline provides clear support for people living with ME/CFS, their families and carers, and for clinicians. A recent opinion piece published in the journal suggested that there were anomalies in the processing and interpretation of the evidence when developing the guideline and proposed eight areas where these anomalies were thought to have occurred. We outline how these opinions are based on a misreading or misunderstanding of the guideline process or the guideline, which provides a balanced and reasoned approach to the diagnosis and management of this challenging condition.
https://doi.org/10.1136/jnnp-2023-332731
