NICE recommendations on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are not evidence-based, a group of researchers has said.
A paper outlining eight ‘shortcomings’ in the review process and interpretation of evidence has reignited a row over advice over use of exercise and cognitive behaviour therapy in treating patients.
The NICE guidelines updated in 2021 made changes to advice over graded exercise therapy (GET) and cognitive behaviour therapy (CBT).
Any programme based on fixed incremental increases in physical activity or exercise such as GET, should not be used, NICE said. No therapy based on exercise or physical activity should be given as a ‘cure’.
Personalised exercise programmes can be offered in people with ME/CFS who want the option but it should be overseen by a specialist physiotherapist and reviewed regularly.
CBT should only be offered to support people who live with ME/CFS to manage their symptoms, improve their functioning and reduce the distress associated with having a chronic illness and not as a ‘cure’, the guidelines said.
At the time there had been strong views over the recommendations with several members of the guideline committee reportedly walking out amidst the controversy. One issue appeared to be around different ways GET could be defined.
It led to a roundtable with members of several professional bodies to address concerns after which NICE said it was confident the guidelines could be effectively implemented.
Now over 50 researchers from the UK and other countries have written a systematic critique of the NICE process which they said has resulted in guidance that ‘deviates from the scientific evidence’ and could result in patients missing out on treatments that could help them.
NICE strongly rejected the claims and said it would provide a detailed response.
Co-led by researchers from the Institute of Psychiatry, Psychology & Neuroscience at King’s College London, the group said there were flaws in both processing and interpretation of evidence by the NICE guideline committee.
This included creating a new definition of ME/CFS which ‘downgraded the certainty of trial evidence’, they said.
And the committee had discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies as well as minimising the importance of fatigue as an outcome, they wrote in the Journal of Neurology, Neurosurgery and Psychiatry.
They also noted that in NICE guidelines on other relevant health conditions such as chronic unexplained pain, GET and CBT are still recommended, making it difficult for clinicians knowing what guidance to follow.
Co-author Professor Trudie Chalder, professor of cognitive behavioural psychotherapy at KCL, said: ‘In this analysis we have systematically assessed this NICE guideline for CFS and ME and found it to be inconsistent in its process of review and its consideration of evidence.
‘There is clearly a disconnect between the initial 2007 guideline that recommended two treatments, for which the research evidence has strengthened, not weakened, over the following decade.’
A NICE spokesperson said: ‘We reject entirely the conclusions drawn by the authors of this analysis, and in particular their conclusion that NICE has not followed international standards for guideline development which has led to guidance that could harm rather than help patients.
‘In developing our guideline, as well as bringing together the best available scientific evidence, we also listened to the real, lived experience and testimony of people with ME/CFS to produce a balanced guideline which has their wellbeing at its heart.
‘We will provide a detailed response to this analysis and in the meantime we are confident that system partners and the ME/CFS community will continue to work together to make sure the important recommendations in our guideline are implemented.’