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NICE backtracks on graded exercise therapy and CBT in draft revision to CFS guidance

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4356 (Published 10 November 2020) Cite this as: BMJ 2020;371:m4356

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Re: NICE backtracks on graded exercise therapy and CBT in draft revision to CFS guidance: time for Cochrane to withdraw the reviews

Dear Editor

Thank you for reporting the welcome news NICE no longer recommends graded exercise therapy (GET) and CBT in its draft revision to its guidance for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Dr Alastair Miller, reviewer of serious adverse events on the largest ever trial of GET and CBT for ME/CFS [1], comments: “There has never been any evidence of harm and [GET and CBT] remain the only evidence-based treatment approach in CFS”. Professor Peter White, lead investigator on this trial [1], is also quoted as saying it is “…remarkable that the committee use the symptom of post-exertional fatigue as a reason for not providing GET, when the largest ever trial of GET showed that it significantly reduced this symptom…”

Until now, the theories of deconditioning, which underpins GET, and unhelpful illness beliefs, which underpins CBT have not been questioned. Maybe this is why harm has not been considered a possibility. Healthcare providers such as the NHS do not have the resources to carry out systematic surveillance studies, particularly on behavioural and psychological treatments, and there is no "yellow card" system for patients to raise the alarm if a treatment doesn’t work or causes harm.

Regarding the evidence of benefit, trials of therapist-delivered treatments such as GET and CBT cannot be blinded. The bias caused by lack of blinding combined with a reliance on subjective outcomes has not been adequately acknowledged in trials or systematic reviews. This blind spot is not limited to trials on treatments for ME/CFS. In his expert testimony to the NICE Committee [2], Professor Jonathan Edwards gave an example of being advised to remove any reference to bias caused by lack of blinding in one of his own studies. “…It was recommended that I not mention problems with unblinded trials, not because my critique was wrong but because it would cast doubt on almost all treatment studies in clinical psychology. One referee asked specifically for removal of such comments.”

The NICE committee have recognised the weaknesses in the trials and systematic reviews conducted on treatments for ME/CFS which have claimed benefit. They also considered only evidence from trials where the patient populations had the key symptom of ME/CFS, post-exertional malaise. They have also acknowledged the considerable evidence of harm [3, 4, 5].

I made a formal complaint [6] to Cochrane about their review Exercise therapy for chronic fatigue syndrome [7] in 2018, and requested they withdraw it. I call once again for Cochrane to withdraw this review which, despite watering down its overly positive conclusions in 2019, still concludes that “Exercise therapy probably has a positive effect on fatigue in adults with CFS…. evidence regarding adverse effects is uncertain.”. I also call for the withdrawal of the review Cognitive behaviour therapy for chronic fatigue syndrome in adults [8]. This review is twelve years out of date yet is used in four clinical guidelines. It concludes that “CBT is effective in reducing the symptoms of fatigue at post-treatment compared with usual care and may be more effective in reducing fatigue symptoms compared with other psychological therapies”.

According to the Cochrane withdrawal policy [9], a review should be withdrawn if “…following the conclusions of the published review could result in harm to patients…”. The findings of the NICE guideline committee have led to a reversal of the recommendations for GET and CBT to treat ME/CFS because of lack of evidence of benefit and credible evidence of harm. This means following the conclusions of the Cochrane reviews which both state that GET and CBT may be helpful could result in harm to patients.

1. Expert reaction to NICE draft guideline on diagnosis and management of ME/CFS: declarations of interest: https://www.sciencemediacentre.org/...deline-on-diagnosis-and-management...
2. Myalgic encephalomyelitis (or encephalopathy) /chronic fatigue syndrome: diagnosis and management Appendix 3: Expert testimonies: https://www.nice.org.uk/guidance/GID-NG10091/documents/supporting-docume...
3. Geraghty K, Hann M, Kurtev S. Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and pacing treatments: Analysis of a primary survey compared with secondary surveys. Journal of Health Psychology. 2019;24(10):1318-1333. doi:10.1177/1359105317726152
4. McPhee G, Baldwin A, Kindlon T, Hughes BM. Monitoring treatment harm in myalgic encephalomyelitis/chronic fatigue syndrome: A freedom-of-information study of National Health Service specialist centres in England. J Health Psychol2019;1359105319854532. doi:10.1177/1359105319854532 pmid:31234662
5. ME Association. Consolidated report: Evaluation of a survey exploring the experiences of adults and children with ME/CFS who have participated in CBT and GET interventional programmes, April 2019: https://meassociation.org.uk/wp-con...nd-GET-Final-Consolidated-Report-0...
6. My complaint to the Cochrane Governing Board about the Cochrane review of Exercise for chronic fatigue syndrome (November 2018) https://healthycontrolblog.wordpres...iew-of-exercise-for-chronic-fatigu...
7. Larun L, Brurberg KG, Odgaard-Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome. Cochrane Database of Systematic Reviews 2019, Issue 10. Art. No.: CD003200. DOI: 10.1002/14651858.CD003200.pub8.
8. Price JR, Mitchell E, Tidy E, Hunot V. Cognitive behaviour therapy for chronic fatigue syndrome in adults. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD001027. DOI: 10.1002/14651858.CD001027.pub2.
9. Withdrawing published Cochrane Reviews July 2019: https://documentation.cochrane.org/display/EPPR/Withdrawing+published+Co...

Competing interests: No competing interests

18 November 2020
Caroline Struthers
Senior Research Fellow
University of Oxford
Oxford, UK