Re: Self help approach to graded exercise may help chronic fatigue syndrome
Susan Major’s (1) review of this recently published research in the Lancet (2) is woefully uncritical. Both of the main outcome metrics used in this trial are patient self-reported, questionnaire measures – fatigue and physical functioning. This pragmatic randomised controlled trial was not blinded. Together this causes difficulty interpreting the outcomes of such trials due to the potential for bias, highlighted and summarised by Jonathan Edwards (3). Had the researchers used objective measures, for example, actigraphy to determine if physical activity actually increased as proposed this would have provided a great deal more information. Moreover, it would have provided a clue as to actual adherence to the graded exercise hypothesis. This has been called for before this trial started, and is long overdue(5). When measures of activity have been used in CFS trials aimed at increasing patients activity no clear pattern could be ascertained even when patients self reported well-being improved(4).
Patients report very low levels of physical activity and high levels of fatigue compared to those reported by well controls of the same age and gender, at the beginning of the trial. It cannot be discounted due to the obvious possibility for bias that the modest, small changes for the better were more than likely accounted for by the placebo effect – patients wishing to please their therapists. It would be odd if they were not so. CFS patients require interventions with extremely large effect sizes to feel a great deal better – to recover to anything like ‘normal’ functioning for their age range.
To persuade this practicing psychologist that encouraging patients whose main symptoms include an inability to maintain and repeat even trivial amounts of physical and cognitive activity that doing more of what makes them very ill will help them, researchers at a minimum need to move to using objective measures if they are to demonstrate reliable improvement. Furthermore, researchers need to be a great deal more ambitions if they are to change patients’ lives for the better. The lack of attention to biomedical markers in immunology, neuroendocrinology, autonomic nervous system, cellular and mitochondrial dysfunction (6) is likely to bear fruit here and is wholly ignored in this type of research (2).
When I meet with patients with CFS in my clinics I do not find them desiring further psychologically based trials that repeat the same, small/modest effects that can be accounted for by the placebo effect. What I do find overwhelmingly is that patients, their families, carers, and their physicians want interventions aimed at recovery – which requires vast effect size changes across all measures of well-being, which can be objectively measured too. Including, for example, return to work (or equivalent), reduced need for sickness welfare and disability payments, reduced usage of medical resources and increased ability to complete standardised exercise tests (e.g. VO2Max) on two consecutive days unimpeded by debility. This is unlikely to come from psychologically based interventions.
1 Mayor S. Self-help approach to graded exercise may help chronic fatigue syndrome. BMJ 2017;357:j3057.
2 Clark LV, Pesola F, Thomas JM, et al. Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial. Lancet 2017. doi:10.1016/S0140-6736(16)32589-2.
3 Edwards, J. PACE team response shows a disregard for the principles of science. Journal of Health Psychology, March 28, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317700886
4 Friedberg, F. & Sohl, S (2009). Does graded activity increase activity? A case study of chronic fatigue syndrome. Journal of Behaviour Therapy and Experimental Psychiatry, 33, 203–215.
5 Haywood et al. (2011) Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review.
6 Komaroff, A.L., and Cho, T.A. (2011). Role of Infection and Neurologic Dysfunction in Chronic Fatigue Syndrome. Seminars in neurology. Vol 31(3).
Rapid Response:
Re: Self help approach to graded exercise may help chronic fatigue syndrome
Susan Major’s (1) review of this recently published research in the Lancet (2) is woefully uncritical. Both of the main outcome metrics used in this trial are patient self-reported, questionnaire measures – fatigue and physical functioning. This pragmatic randomised controlled trial was not blinded. Together this causes difficulty interpreting the outcomes of such trials due to the potential for bias, highlighted and summarised by Jonathan Edwards (3). Had the researchers used objective measures, for example, actigraphy to determine if physical activity actually increased as proposed this would have provided a great deal more information. Moreover, it would have provided a clue as to actual adherence to the graded exercise hypothesis. This has been called for before this trial started, and is long overdue(5). When measures of activity have been used in CFS trials aimed at increasing patients activity no clear pattern could be ascertained even when patients self reported well-being improved(4).
Patients report very low levels of physical activity and high levels of fatigue compared to those reported by well controls of the same age and gender, at the beginning of the trial. It cannot be discounted due to the obvious possibility for bias that the modest, small changes for the better were more than likely accounted for by the placebo effect – patients wishing to please their therapists. It would be odd if they were not so. CFS patients require interventions with extremely large effect sizes to feel a great deal better – to recover to anything like ‘normal’ functioning for their age range.
To persuade this practicing psychologist that encouraging patients whose main symptoms include an inability to maintain and repeat even trivial amounts of physical and cognitive activity that doing more of what makes them very ill will help them, researchers at a minimum need to move to using objective measures if they are to demonstrate reliable improvement. Furthermore, researchers need to be a great deal more ambitions if they are to change patients’ lives for the better. The lack of attention to biomedical markers in immunology, neuroendocrinology, autonomic nervous system, cellular and mitochondrial dysfunction (6) is likely to bear fruit here and is wholly ignored in this type of research (2).
When I meet with patients with CFS in my clinics I do not find them desiring further psychologically based trials that repeat the same, small/modest effects that can be accounted for by the placebo effect. What I do find overwhelmingly is that patients, their families, carers, and their physicians want interventions aimed at recovery – which requires vast effect size changes across all measures of well-being, which can be objectively measured too. Including, for example, return to work (or equivalent), reduced need for sickness welfare and disability payments, reduced usage of medical resources and increased ability to complete standardised exercise tests (e.g. VO2Max) on two consecutive days unimpeded by debility. This is unlikely to come from psychologically based interventions.
1 Mayor S. Self-help approach to graded exercise may help chronic fatigue syndrome. BMJ 2017;357:j3057.
2 Clark LV, Pesola F, Thomas JM, et al. Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial. Lancet 2017. doi:10.1016/S0140-6736(16)32589-2.
3 Edwards, J. PACE team response shows a disregard for the principles of science. Journal of Health Psychology, March 28, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317700886
4 Friedberg, F. & Sohl, S (2009). Does graded activity increase activity? A case study of chronic fatigue syndrome. Journal of Behaviour Therapy and Experimental Psychiatry, 33, 203–215.
5 Haywood et al. (2011) Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review.
6 Komaroff, A.L., and Cho, T.A. (2011). Role of Infection and Neurologic Dysfunction in Chronic Fatigue Syndrome. Seminars in neurology. Vol 31(3).
Competing interests: No competing interests