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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Dear Editor
Along with the majority of my fellow ME/CFS sufferers, I welcome the draft revised NICE guideline for ME/CFS (ref. 1) that sees significant changes in its recommendations on treatment.
The previous guideline recommended Graded Exercise Therapy, and a particular version of directive Cognitive Behavioural Therapy; both expected patients to keep increasing their activity regardless of symptom exacerbation. The review process for the new guideline has assessed the evidence for and against these treatments, and has confirmed what the patient population has been consistently trying to tell the medical community - that both GET and this version of CBT are ineffective and carry credible risk of harm. (ref. 2 & 3)
The concern that will remain is whether, or how soon, the change in the guideline will translate into the real life care that patients receive. The belief that exercise can only be beneficial is so widely accepted as a truism that it may be hard for well meaning medical practitioners to change their mindset when caring for ME/CFS patients.
There is currently no effective treatment for ME/CFS, so none can be recommended in the guideline; yet this need not leave practitioners helpless. Patients would prefer to be told honestly that this is the case than be offered an ineffective and potentially harmful treatment. The guideline provides information on the vital role medical staff play in monitoring, support and management of symptoms.
Elsewhere, NICE recently issued a warning against the use of GET (ref. 4) for patients suffering from Long Covid, and it’s fair to say that our lack of knowledge of what can be safely used, or not, to treat post-infection chronic conditions is due to the lack of investment into ME/CFS research over a very long time. While the estimated 250,000 (ref. 5) ME/CFS patients were heartened with the funding for the DecodeME study (ref. 6), a GWAS (Genome Wide Association Study) of a 20,000 strong patient cohort, the level of funding, £3.2m, is easily overshadowed by the recent announcement of £20m funding for Long Covid (ref. 7) - a deserved amount for Long Covid but one that, currently, the UK ME/CFS community can only dream of.
DecodeME is a promising change of direction in ME/CFS research in the UK, the hope will be that these revised guidelines clearly demonstrate the need for funding of further projects to help us finally understand the biology of ME/CFS.
References:
1. https://www.nice.org.uk/guidance/gid-ng10091/documents/draft-guideline
2. https://www.actionforme.org.uk/uploads/images/2020/02/Big-Survey-GET-and...
3. https://meassociation.org.uk/2019/0...urvey-on-cbt-and-get-in-me-cfs-03-...
4. https://www.bmj.com/content/370/bmj.m2912
5. https://meassociation.org.uk/wp-content/uploads/2020Health-Counting-the-...
6. https://www.nihr.ac.uk/news/largest-genetic-study-into-myalgic-encephalo...
7. https://www.ukri.org/news/long-covid-in-our-community-new-call-for-resea...
Competing interests: No competing interests
Dear Editor,
As someone who has been severely disabled by ME for nearly 30 years, I cautiously welcome the new NICE draft Guideline on Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome (ME/CFS) [1, 2]. Whilst it is deeply regrettable that there are currently no effective treatments for ME, it is far preferable that this reality is recognised – and addressed – rather than continuing to recommend ineffective, harmful therapies such as graded exercise (GET) and cognitive behavioural therapy (CBT).
Dr Alastair Miller, who has been prescribing GET and CBT to ME/CFS patients for nearly 30 years [3] claims: “There has never been any evidence of harm and [GET and CBT] remain the only evidence-based treatment approach in CFS” [1]. In his expert testimony to the NICE Guideline committee [4], Professor Jonathan Edwards clearly explains that there is no reliable evidence that GET or CBT are effective treatments for ME/CFS. Indeed, the methodological problems with the PACE trial and other similar studies which have been used to support the prescription of GET and CBT are well documented [for example: 5, 6, 7, 8].
One of the difficulties in assessing the harms of GET and CBT is that the Medicines & Healthcare products Regulatory Agency (MHRA) does not allow adverse health events resulting from non-pharmacological treatments such as GET/CBT to be recorded through its Yellow Card Scheme [9], and there is no other national system for collecting information from patients who believe they have been harmed by these therapies.
A 2019 survey of NHS ME/CFS clinics found that there was “an almost universal absence of criteria for detecting harm.” Of the 37 clinics which responded to information requests, none reported any cases of treatment-related harm, despite recording treatment dropout rates of up to 44% [10].
Notwithstanding the lack of protocols for reporting and recording adverse incidents, the evidence of harm from GET and CBT is strong. Surveys consistently show that patients experience a worsening of their condition following these therapies. For example, Dawes and colleagues found that 67.1% of the ME/CFS patients they surveyed who had been given GET reported that their physical health had deteriorated following treatment. When GET was combined with CBT the percentage who reported that they had deteriorated rose to 75.4 [11]. Similar evidence of harm has been published by Kindlon [12] and Vink & Vink-Niese [7, 8].
Furthermore, if one accepts that there is no reliable evidence that CBT or GET are effective treatments for ME/CFS, as NICE has provisionally concluded, then the evidence that they are harmful is self-evident. CBT and GET, as defined by the PACE trial manuals for therapists [13,14], are based on the unevidenced assumption that the illness is perpetuated by unhelpful beliefs and/or deconditioning. Therapists are instructed to inform patients that their illness can be reversed by their own efforts, by thinking and behaving differently. If this is not true, as must be assumed in the absence of any reliable evidence to the contrary, then these therapies are psychologically cruel. The failure of those who have developed and promoted these therapies to recognise such harm is particularly concerning given that most of them specialise in mental health.
Similarly, the risk that CBT and GET will lead to a deterioration in ME/CFS symptoms (and therefore cause harm) can be inferred without knowledge of surveys or evaluation of the studies which have reported evidence of abnormal physiological responses to exertion [for example: 15, 16]. If ME/CFS is characterised by post-exertional symptom exacerbation (PESE), as defined by the draft Guideline, then both PACE-type CBT and GET would appear to be contraindicated as they encourage patients to exert themselves by pushing through symptoms to increase activity and/or exercise. Anyone whose condition is not made worse by exertion, which the draft Guideline refers to as exceedingly one’s “energy envelope,” does not have ME/CFS by definition.
Professor Peter White, who is an author of the PACE trial to which he refers, states: “It is also 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 more than staying within one’s energy envelope” [1]. The NICE draft Guideline makes no reference to “post-exertional fatigue,” which is a common symptom experienced by many people who may benefit from graded exercise. PESE (which is also referred to as post-exertional malaise or PEM) is quite different and a clear contraindication to GET, as explained above.
Independent re-analysis of the PACE trial data (obtained by a court order [17]) raised “serious concerns about the robustness of the claims made about the efficacy of CBT and GET.” Wilshire and colleagues concluded, “The modest treatment effects obtained on self-report measures in the PACE trial do not exceed what could be reasonably accounted for by participant reporting biases … The time has come to look elsewhere for effective treatments” [5]. Quite so.
Now that NICE appears to be following the US Centres for Disease Control and Prevention, which rejected the CBT and GET as treatments for ME/CFS in 2017 [18], it would be helpful if those who have failed patients by promoting ineffective and harmful therapies were willing to acknowledge their mistakes and apologise.
References:
1. NICE backtracks on graded exercise therapy and CBT in draft revision to CFS guidance, Nov 2020: https://www.bmj.com/content/371/bmj.m4356
2. National Institute for Health and Care Excellence. Guideline, Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management, Draft for consultation, Nov 2020: https://www.nice.org.uk/guidance/GID-NG10091/documents/draft-guideline
3. Science Media Centre, expert reaction to NICE draft guideline on diagnosis and management of ME/CFS, Nov 2020: https://www.sciencemediacentre.org/expert-reaction-to-nice-draft-guideli...
4. NICE, Myalgic encephalomyelitis (or encephalopathy) / chronic fatigue syndrome: diagnosis and management Appendix 3: Expert testimonies, Nov 2020: https://www.nice.org.uk/guidance/GID-NG10091/documents/supporting-docume...
5. Wilshire C. et al. Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT. BMC Psychology, March 2018: https://doi.org/10.1186/s40359-018-0218-3
6. Journal of Health Psychology Special Issue: The PACE trial, Aug 2017: https://journals.sagepub.com/toc/hpq/22/9
7. Vink M and Vink-Niese A. Graded exercise therapy for ME/CFS is not effective and unsafe. Re-analysis of a Cochrane review. Health Psychology Open, Oct 2018: https://doi.org/10.1177/2055102918805187
8. M. and Vink-Niese A. CBT for ME/CFS is not effective. Re-analysis of a Cochrane review. Health Psychology Open, May 2019: https://doi.org/10.1177/2055102919840614
9. ME Research UK, CBT & GET – Parliamentary Question – Updated, July 2018: https://www.meresearch.org.uk/cbt-get-parliamentary-question/
10. McPhee G. et al. Monitoring treatment harm in myalgic encephalomyelitis/chronic fatigue syndrome: A freedom-of-information study of National Health Service specialist centres in England. Journal of Health Psychology, June 2019: https://doi.org/10.1177%2F1359105319854532
11. 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-content/uploads/NICE-Patient-Survey-Outc...
12. Kindlon T. Do graded activity therapies cause harm in chronic fatigue syndrome? Journal of Health Psychology, March 2017: https://doi.org/10.1177/1359105317697323
13. PACE trial, GET manual for therapists: https://www.qmul.ac.uk/wolfson/media/wolfson/current-projects/5.get-ther...
14. PACE trial, CBT manual for therapists: https://www.qmul.ac.uk/wolfson/media/wolfson/current-projects/3.cbt-ther...
15. Lien K. et al. Abnormal blood lactate accumulation during repeated exercise testing in myalgic encephalomyelitis/chronic fatigue syndrome. The Physiological Society, June 2019: https://doi.org/10.14814/phy2.14138
16. Davenport T. et al. Properties of measurements obtained during cardiopulmonary exercise testing in individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. IOS Press, July 2020: http://doi.org/10.3233/WOR-203170
17. Faulkner G. Major breakthrough on PACE trial, Centre For Welfare Reform, Aug 2016: https://www.centreforwelfarereform.org/news/major-breaktn-pace-trial/002...
18. ME Association, July 2017: https://meassociation.org.uk/2017/07/cdc-removes-cbt-and-get-as-recommen...
Competing interests: No competing interests
Dear Editor,
My father was a qualified Physician, practising in a village. His clinic was in a building just 30 feet across from the front yard of our house. When not in school, at play or studying I would spend time with him in the clinic, observing the people under his care, listening to their stories, observing my father work and helping him when I could.
Thus I heard people's stories, stories that perfectly fit the description of the Chronic Fatigue Syndrome, PANDAS, et cetra. I also noticed that other people thought that the stories of such people were lame excuses for avoiding work, and in the case of children, to avoid play and studies. Now, since NICE has officially accepted that people with Chronic Fatigue Syndrome should take the things at their own pace, in teir stride and within the limits of their comfort, hopefully they will face less contempt from others. Especially children, hopefully, will face less derision from peers, parents and teachers alike and may get more empathy and help to overcome their problem.
Arvind Joshi MBBS MD FCGP FAMS FICP.
Competing interests: No competing interests
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