Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis

Abstract

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute for Health and Care Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive–behavioural therapy should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial.We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: (1) created a new definition of CFS/ME, which ‘downgraded’ the certainty of trial evidence; (2) omitted data from standard trial end points used to assess efficacy; (3) discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; (4) minimised the importance of fatigue as an outcome; (5) did not use accepted practices to synthesise trial evidence adequately using GRADE (Grading of Recommendations, Assessment, Development and Evaluations trial evidence); (6) interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated and symptom dependent; (7) deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain and (8) recommended an energy management approach in the absence of supportive research evidence.We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.

Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial

“…Finally, in October 2021, NICE revised its ME/CFS diagnostic criteria for technology appraisal [ 12 ]. We cannot retrospectively determine if the MAGENTA participants meet these new diagnostic criteria, which have been criticised [ 36 ]. We believe, however, that the MAGENTA findings remain relevant evidence to inform the treatment of children presenting with ME/CFS.…”

Practical Recommendations for Exercise Training in Patients with Long COVID with or without Post-exertional Malaise: A Best Practice Proposal

“…intensity at 50% of peak heart rate, at 70% from the anaerobic threshold, or just the advice to “start at a level that patients think they can do”) [ 62 ]. This paradigm change in the NICE guideline regarding GET evolved also into a controversial debate on the role of exercise training [ 63 – 65 ]. However, it is regarded as common sense that in patients with PEM, activity management strategies must be carefully customized to reflect the individual needs and limits of each individual [ 66 , 67 ].…”

Dangers of self-diagnosis in neuropsychiatry

“…For some, the primary attribute of the condition encapsulated in the neurological-sounding diagnostic labels myalgic encephalomyelitis/encephalopathy or 'ME', a diagnosis preferred by some self-help and advocacy groups, is its lack of any psychosocial underpinnings. This conflicts with the more neutral 'chronic fatigue syndrome', favored by most practitioners, and compatible with a boarder biopsychosocial model and effective treatment approaches (White et al, 2023).…”