‘Failure of FINE trial comes as no surprise’ – MEA responds to study results in British Medical Journal

Published by BMJ.com, 11 May 2010

   

Editor

Having apparently spent £1,147,000 of Medical Research Council funding on a clinical trial to assess whether ‘pragmatic rehabilitation and supportive listening’ carried out by ‘specially trained general nurses’ would lead to significant improvements in the health of people with ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome), the results are disappointing but not surprising [1].


When we learnt of the FINE Trial, The ME Association felt that it was unlikely to contribute to our understanding of the illness, or to its management. For example, it included a number of flaws identified in previous trials, such as the lack of objective measures to confirm compliance with the exercise programme and the use of the bimodal scoring method for the Chalder Fatigue Scale, a measure with a low ceiling that does not permit those with maximal or near-maximal scores at baseline to record an exacerbation after treatment [2]. And from a theoretical perspective, we questioned the cognitive behavioural model underpinning the intervention. Studies had already shown that improvements were not dependent on changing somatic attributions and indeed, research first published in 2001 alerted us to the fact that positive outcomes cannot be attributed to increases in activity [3].

Since the start of the FINE Trial, studies of more individualised programmes have been shown to be as effective as those focused largely on increasing activity and improving sleep [4]. At present, the only form of activity management that meets with widespread approval and positive patient evidence of benefit is an approach known as pacing [5]. The strategy requires people to live within the limits imposed by the illness and avoid post-exertional fatigue. There are various versions and it is noteworthy that a randomized controlled trial of various interventions found that pacing was associated with a positive outcome across the groups [6]. However, we accept that there are scenarios where a trial of gentle, graded increases in activity would be more appropriate.

The really important message from this study is that while lifestyle advice can improve coping, it is not enough. In our view, lifestyle advice should be one element of a multi-component, multi-disciplinary approach. The time has come to abandon research which ignores the heterogeneity of the ME/CFS population, the complexity of this condition, the evidence of ongoing pathology in subsets, and the mistakes of the past.

Dr Charles Shepherd

Hon Medical Adviser, ME Association

Dr Ellen Goudsmit FBPsS

Hon Adviser, Psychology, ME Association

The ME Association, 7 Apollo Office Court, Radclive Road, Gawcott, Buckingham RM7 OAG

https://meassociation.org.uk

References:

[1] Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Riste L, Richardson G, Lovell K, Dunn G; Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group. Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial. BMJ 2010 Apr 23;340:c1777.

[2] Stouten B. Identification of ambiguities in the 1994 chronic fatigue syndrome research case definition and recommendations for resolution. BMC Health Serv Res 2005, 5:37. doi:10.1186/1472-6963-5-37

[3] Van Essen M, de Winter, LJM. Cognitieve gedragstherapie by het chronisch vermoeidheidssyndroom (cognitive behavior therapy for chronic fatigue syndrome). (Report No. 02/111, Appendix B). Amstelveen, Netherlands: College voor Zorgverzekeringen (CVZ). 2002.

[4] Goudsmit EM, Ho-Yen DO, Dancey, CP. Learning to cope with chronic illness. Efficacy of a multi-component treatment for people with chronic fatigue syndrome. Patient Educ Couns 2009;77:231-36.

[5] Report: ME Association questionnaire to assess current management options for ME/CFS. ME Association May 2010.

[6] Jason LA, Benton M, Torres-Harding S, Mudowny K. The impact of energy modulation on physical functioning and fatigue severity among patients with ME/CFS. Patient Educ Couns 2009;77:237-41.

Competing interests: Both authors act as unpaid advisers to The ME Association – a charity that funds biomedical research into ME/CFS.

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