The Updated NICE Guidance Exposed the Serious Flaws in CBT and Graded Exercise Therapy Trials for ME/CFS

Abstract

The British National Institute for Health and Care Excellence (NICE) recently published its updated guidelines for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). NICE concluded, after an extensive review of the literature, that graded exercise therapy (GET) is harmful and should not be used, and that cognitive behavioural therapy (CBT) is only an adjunctive and not a curative treatment. Leading proponents of the cognitive behavioural model (CBmodel) find it difficult to accept this paradigm shift. In, for example, an article in The Lancet, they try to argue that the new NICE guideline is based on ideology instead of science. In this article we reviewed the evidence they used to support their claims. Our analysis shows that the trials they used in support suffered from serious flaws which included badly designed control groups, relying on subjective primary outcomes in non-blinded studies, including patients in their trials who didn’t have the disease under investigation or had a self-limiting disease, selective reporting, outcome switching and making extensive endpoint changes, which created an overlap in entry and recovery criteria, using a post-hoc definition of recovery which included the severely ill, not publishing results that contradict their own conclusion, ignoring their own (objective) null effect, etc. The flaws in these trials all created a bias in favour of the interventions. Despite all these flaws, treatments that are said to lead to recovery in reality do not lead to objective improvement. Therefore, these studies do not support the claim that CBT and GET are effective treatments. Moreover, the arguments that are used to claim that NICE was wrong, in reality, highlight the absence of evidence for the safety and efficacy of CBT and GET and strengthen the decision by NICE to drop CBT and GET as curative treatments for ME/CFS.

Lived experience of patients with Long COVID: a qualitative study in the UK

“…41 For example, it is widely acknowledged that key triggers (physical, cognitive and emotional) can prompt postexertional symptom exacerbation and/or relapse, 8 which could explain why previous attempts to repurpose existing clinical interventions for Long COVID services have not been accepted and in some cases have been damaging (ie, the prescription of physical activity and graded exercise therapy). [42][43][44] Early indications of the effectiveness of a personalised approach have been positive; 45 however, these lack the involvement of the patient experiences in the design and testing process and so also risk rejection if not suitable in the applied setting. Gorna et al 12 propose that an approach involving an individualised physical assessment by physicians with medical expertise to identify organ and multisystem dysfunction is also needed.…”

“…However, to be effective, it is important the lived experience is captured and incorporated into the entirety of the process to ensure the codesign and delivery of services address patient needs, are safe and are accepted by Long COVID patients 41. For example, it is widely acknowledged that key triggers (physical, cognitive and emotional) can prompt postexertional symptom exacerbation and/or relapse,8 which could explain why previous attempts to repurpose existing clinical interventions for Long COVID services have not been accepted and in some cases have been damaging (ie, the prescription of physical activity and graded exercise therapy) 42–44. Early indications of the effectiveness of a personalised approach have been positive;45 however, these lack the involvement of the patient experiences in the design and testing process and so also risk rejection if not suitable in the applied setting.…”

Orthostatic Intolerance in Long-Haul COVID after SARS-CoV-2: A Case-Control Comparison with Post-EBV and Insidious-Onset Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients

“…Moreover, we have shown that the abnormal cerebral blood flow reduction was similar in patients with no deconditioning, with mild or severe deconditioning [ 43 , 44 ]. Due to the similarity of long-haul COVID and ME/CFS, exercise therapy should be cautiously given to long-haul COVID patients, as it may also be detrimental [ 45 , 46 , 47 ].…”

What Primary Care Practitioners Need to Know about the New NICE Guideline for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in Adults

“…The 2021 NICE guideline is an important document that will influence the future diagnosis and management of ME/CFS in the UK and beyond [ 15 ]. Both the patient community and health professionals have awaited its publication expectantly because of the recommendations in the earlier 2007 guideline to use GET and CBT as treatments for ME/CFS—interventions which many people with ME/CFS have found ineffective and harmful [ 16 , 17 , 18 ].…”