Cited by 38Fibromyalgia and Chronic Fatigue Syndrome ResearchLong-Term Effects of COVID-19Traumatic Brain Injury Research

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

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Vink, Mark, Vink-Niese, Alexandra·2022·Healthcare

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.

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Authors
Vink, M., & Vink-Niese, A.
Affiliations
  • Independent Researcher, 1096 HZ Amsterdam, The Netherlands
  • Independent Researcher, 30159 Hannover, Germany
Corresponding author
Vink, Mark
Venue
Healthcare
Publisher
MDPI AG
Published
2022-05-12
Volume
10
Issue
5
Pages
898
ISSN
2227-9032 (ISSN-L)
OpenAlex
W4280620338
Cited by
38
References
77
Citations by year
2026: 8 · 2025: 10 · 2024: 7 · 2023: 10 · 2022: 3
FWCI
1.29
Type
journal article
Language
en
Open access
Locations
  • Healthcare (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
  • Health Sciences › Medicine › Neurology › Long-Term Effects of COVID-19
  • Health Sciences › Medicine › Epidemiology › Traumatic Brain Injury Research
Keywords
chronic fatigue syndrome, NICE guidelines, cognitive behavioral therapy, graded exercise therapy, trial design flaws, selective reporting, self-limiting disease, recovery criteria, treatment efficacy and safety, evidence-based medicine

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