Trial Report Randomised controlled trial of patient education to encourage graded exercise in CFS, 2001, P Powell, R P Bentall, F J Nye, R H Edwards

[Liie]

Randomised controlled trial of patient education to encourage graded exercise in chronic fatigue syndrome​

P Powell, R P Bentall, F J Nye, R H Edwards

PMID: 11179154 PMCID: PMC26565 DOI: 10.1136/bmj.322.7283.387

2001

Abstract​

Objective​

To assess the efficacy of an educational intervention explaining symptoms to encourage graded exercise in patients with chronic fatigue syndrome.

Design​

Randomised controlled trial.

Setting​

Chronic fatigue clinic and infectious diseases outpatient clinic.

Subjects​

148 consecutively referred patients fulfilling Oxford criteria for chronic fatigue syndrome.

Interventions​

Patients randomised to the control group received standardised medical care. Patients randomised to intervention received two individual treatment sessions and two telephone follow up calls, supported by a comprehensive educational pack, describing the role of disrupted physiological regulation in fatigue symptoms and encouraging home based graded exercise. The minimum intervention group had no further treatment, but the telephone intervention group received an additional seven follow up calls and the maximum intervention group an additional seven face to face sessions over four months.

Main outcome measure​

A score of ⩾25 or an increase of ⩾10 on the SF-36 physical functioning subscale (range 10 to 30) 12 months after randomisation.

Results​

21 patients dropped out, mainly from the intervention groups. Intention to treat analysis showed 79 (69%) of patients in the intervention groups achieved a satisfactory outcome in physical functioning compared with two (6%) of controls, who received standardised medical care (P<0.0001). Similar improvements were observed in fatigue, sleep, disability, and mood. No significant differences were found between the three intervention groups.

Conclusions​

Treatment incorporating evidence based physiological explanations for symptoms was effective in encouraging self managed graded exercise. This resulted in substantial improvement compared with standardised medical care.

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[Liie]

This study is notable because the psycho-somatic proponents tried to make a fuss about it being excluded from the NICE 2021 review.

See this thread for example.

The reason for its exclusion seems to be given in the document Evidence reviews for the non-
pharmacological management of ME/CFS:

Serious indirectness relevant to the control group since it included an element of the intervention in that graded activity was encouraged.
...
Serious population indirectness – Oxford criteria used; PEM is not a compulsory feature [original analysis]; percentage of participants with PEM unclear [PEM reanalysis].