Graded exercise therapy does not restore the ability to work in ME/CFS – Rethinking of a Cochrane review

Abstract

BACKGROUND: Cochrane recently amended its exercise review for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in response to an official complaint. OBJECTIVE: To determine if the amended review has addressed the concerns raised about the previous review and if exercise is an effective treatment that restores the ability to work in ME/CFS. METHOD: The authors reviewed the amended Cochrane exercise review and the eight trials in it by paying particular interest to the objective outcomes. We also summarised the recently published review of work rehabilitation and medical retirement for ME/CFS. RESULTS: The Cochrane review concluded that graded exercise therapy (GET) improves fatigue at the end of treatment compared to no-treatment. However, the review did not consider the unreliability of subjective outcomes in non-blinded trials, the objective outcomes which showed that GET is not effective, or the serious flaws of the studies included in the review. These flaws included badly matched control groups, relying on an unreliable fatigue instrument as primary outcome, outcome switching, p-hacking, ignoring evidence of harms, etc. The review did also not take into account that GET does not restore the ability to work. CONCLUSION: GET not only fails to objectively improve function significantly or to restore the ability to work, but it is also detrimental to the health of ≥50% of patients, according to a multitude of patient surveys. Consequently, it should not be recommended.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): An Overview

“…Data from eight randomized clinical trials concluded that physical therapy improves exhaustion, quality of sleep, and health status of the patients in the long term, thus showing beneficial potential [ 12 ]. This finding contradicts the widespread opinion that patients always feel uncomfortable after physical exertion, a phenomenon known as PEM [ 115 ]. One of the aims of CFS treatment is the prevention of depression and suicidal tendencies by managing the physical and emotional issues resulting from ME/CFS [ 3 ].…”

Experiences of Living with Severe Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

“…In work and educational institutions, the lack of understanding and provision for people with CFS/ME creates obstacles for people with the illness to remain in those environments. CBT and GET do not restore the ability of a person with CFS/ME to work [47]. People with CFS/ME who cannot remain in employment need to access the benefits system.…”

The draft updated NICE guidance for ME/CFS highlights the unreliability of subjective outcome measures in non-blinded trials

“…As found by the reanalysis of the amended Cochrane exercise review (Vink and Vink-Niese, 2020), analysis of objective outcomes from three CBT and GET trials for ME/CFS confirmed the unreliability of subjective outcomes in non-blinded studies, as shown by the following examples:…”