Graded Exercise Therapy doesn’t restore the ability to work in ME/CFS. Rethinking of a Cochrane review, by Mark Vink, Friso Vink-Niese in Work vol. 66, no. 2, pp. 283-308, 20 July 2020 [doi:10.3233/WOR-203174]

 

Research 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’s also detrimental to the health of≥50% of patients, according to a multitude of patient surveys. Consequently, it should not be recommended.

 

Excerpts from paper:

5. Conclusion

The recently amended Cochrane exercise review for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) concluded that graded exercise therapy (GET) improves fatigue at the end of treatment compared to no-treatment. Larun et al. also concluded that there is no evidence that GET is safe. However, the review continues to ignore the unreliability of subjective outcomes in non-blinded studies and fails to address other key flaws of the studies in the review. These flaws included:

1) using criteria that also select people who do not have the disease;
2) not excluding patients with a psychiatric or self-limiting illness;
3) badly matched control groups;
4) relying on an unreliable fatigue instrument as primary outcome;
5) not using objective outcomes and/or ignoring them;
6) outcome switching;
7) p-hacking;
8) ignoring evidence of multi-system biological pathologies that can not be explained by their psychological treatment rationale;
9) ignoring evidence of harms.

Analysis of the objective outcomes shows that GET does not lead to clinically significant objective improvement. It also does not lead to improvement of CFS symptoms count or quality of life measurements, which remains lower for those with ME/CFS, than in many other debilitating illnesses.

Only 5% of patients recover. Many patients are unable to work and those who can work, often need a reduction in hours and/or reduction of physical intensity. Unfortunately, GET doesn’t restore the ability to work. Instead, more patients are unable to work and more are reliant on illness benefits after being treated with GET than before treatment with it.

Finally, to use the words of three leading exercise physiologists in the field of ME/CFS, “graded exercise [therapy]…not only fails to improve function, but is detrimental to the health of [ME/CFS] patients and should not be recommended” [106]

 

3.6 Important factors enabling a return to work

According to a report by NIVEL, the Netherlands Institute for Health Services Research [92], there are a number of important things which enabled ME/CFS patients to (return to) work. For 92%, the most important thing was support in finding the right balance between work and spare time. The second most important thing (84%), was support and cooperation from the employer to enable patients to continue to work. Other important things were the following:

• supplying information about ME/CFS to colleagues and superiors (62%);
• changing tasks (61%);
• reducing the number of hours they had to work (61%);
• more rest periods during working times (60%);
• the availability of a special rest place at work (45%);
• working from home (52%);
• individual support and coaching in general (51%);
• and by an occupational health physician in particular (44%);
• adjustments to working conditions (furniture, physical aids) (38%);
• and a regulation or provision for commuting to work (36%).

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