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BMJ Rapid Responses to article
Tuesday 25 May 2010
The British Medical Journal recently published a paper entitled "Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial". (Both the abstract and full text are available.)
The article prompted many responses from a variety of people. Here is a small selection:
It should have been obvious !
To anyone who has genuine myalgic encephalomyelitis (ME) it would have been obvious that the sort of interventions, used in the FINE trial, would not make the participants well or improve their functional ability or energy.
ME is a WHO classified neurological disease with multi- system dysfunction and the people who have it, like me, are extremely physically ill. It would be like saying " you have cancer or AIDS, let's treat you by changing your thoughts and getting you to exercise". That's just not going to be effective.
Interestingly, the criteria used to identify the participants was the Oxford criteria, a very limited criteria that can and does include people with mental health issues and not the far more detailed Canadian Criteria, which patients want to see as the benchmark in the UK.
Does this study then indicate that they were not even able to help people with mental health issues, who supposedly should benefit from this type of intervention ? Not very impressive.
It also appears to show that GP intervention is currently not helping people with ME and again this is a cause for concern, that highlights the need for new physical research.
If a third of patients continued their normal GP input, with no improvement, it doesn't say a lot about the effectiveness of GP input. Perhaps this is an indicator of how physically seriously ill people with ME actually are and how what is currently on offer in the medical system is failing them
This is not surprising given the shocking lack of biomedical emphasis upon the physical needs of people with ME in the UK.
The results of this study are a wake-up call to the whole of the medical establishment to take ME seriously. It shows that everything they are currently doing is failing and is not even of statistical significance.
The medical establishment surely has to do better .
Perhaps now the MRC will stop wasting millions of pounds like this on psychological studies when biomedical research, teats and treatments are so greatly needed for desperately ill ME patients across the country.
It must now be obvious that it is time for a change of emphasis and a recognition of the physical nature of ME. The unnecessary suffering of ME patients has been increased by the establishment's focus on biopsychosocial interventions.
Surely enough is enough ?
We need help now . Hopefully these results will open people's eyes and bring about a change in policy and practice in the NHS.
I really hope it will not be used as an excuse to say more research is needed and larger studies ad therefore more money wasted. This would be a travesty, and going completely in the wrong direction.
We, the people who have neurological ME want a true biomedical approach, which is long overdue.
Nothing else will do.
Research regarding ME/CFS, which is exclusively categorized by the World Health Organization under G93.3 organic brain diseases, is often hampered by widely varying research definitions selecting cohorts that may not even have this specific disease.
The Oxford definition (Sharpe et al 1991) used by these authors lacks the pathogenic, hallmark criteria of postexertional malaise upon very little exertion lasting 24-hours or more - often medically referred to as exercise intolerance.
Thus no one knows the actual percentage of patients with ME/CFS in this study.
As well, many of the fatigue scales such as the Chalder scale are well known to have a glass ceiling. Although perhaps appropriate to measure ordinary tiredness relieved by rest, they are not designed to accurately measure the extreme pathogenic fatigue experienced by ME/CFS patients.
Thirdly, without objective physiological measurement of results, it is difficult to say with certainty what the actual impact of any treatment is.
Unfortunately, such handicaps severely limit extrapolation of results to CFS patients defined by the Fukada criteria (Fukada et 1994) and ME/CFS patients defined by the Canadian Consensus criteria (Carruthers et al, 2003).
World Health Organization (ICD-10 G93.3) 2006 Alphabetical index pg 528
Patarca et al Dysregulated Expression of Tumor Necrosis Factor in Chronic Fatigue Syndrome: Interrelations with Cellular Sources and Patterns of Soluble Immune Mediator Expression. Clinical Infectious Diseases, Vol. 18, Supplement 1. Chronic Fatigue Syndrome: Current Concepts (Jan., 1994), pp. S147-S153
Stouten B: Identification of ambiguities in the 1994 chronic fatigue syndrome research case definition and recommendations for resolution. BMC Health Serv Res. 2005 May 13;5:37
Friedberg F, Jason LA Selecting a Fatigue Rating Scale http://www.cfids.org/archives/2002rr/2002-rr4-article02.asp 03.09.2009
A valedictory dispatch from the Psychosocial School?
Does Pragmatic Rehabilitation (PR) reduce the "fatigue" experienced by people diagnosed with CFS/ME according to the Oxford criteria (1)? Wearden et al report in the Abstract of their paper that after 20 weeks of PR participants had "significantly improved fatigue" and, in their linked editorial, Moss-Morris and Hamilton state that participants receiving PR were "significantly less fatigued". However, in the body of the text, Wearden et al describe the improvement as being "small" and "clinically modest". Thus, in the same journal, we find that the effect of PR on fatigue is simultaneously "significant" and "small".
The effect cannot be both large and small, so which interpretation best matches the data?
A participant's fatigue was measured using the 11 item Chalder Fatigue Scale (ChFS) "scored dichotomously on a four point scale (0, 0, 1, or 1)". The ChFS has been criticised because it "has a low ceiling, so patients with maximal scores at baseline will not be able to record an exacerbation after treatment." (2) The maximum one can score on the ChFS is 11, after which it cannot detect further deterioration. It can be seen from the published data that participants receiving PR had a mean baseline ChFS score of 10.49 from which it can be calculated that between 47 and 88 of the 95 participants started therapy with a ChFS score of 11. Therefore,at least half of the participants could not report that PR had worsened their fatigue, even if such were the case. PR involves graded exercise so one would expect this therapy more than "supportive listening" or normal GP treatment (unspecified) to exacerbate fatigue but, had this occurred, the ChFS could not have detected it. Thus, the inability of the ChFS to measure deterioration in this patient cohort biases the trial in favour of finding "improvements" in fatigue and, in particular, favours PR because exercise-induced relapses cannot be recorded.
A genuine improvement in fatigue would, axiomatically, lead to increased physical capacity, but no statistically significant change in physical function was found in the PR group and, in fact, participants randomised to the control group (GP treatment as usual) experienced greater improvement in physical function.
Thus the conclusion that PR led to a real improvement in participants' fatigue must be interpreted with caution.
The authors suggest that "treatment effects may have been enhanced had we been able to provide post-treatment booster sessions." However, it is instructive to note that the mean ChFS score fell from 10.49 at baseline to 8.39 after 20 weeks of therapy where, according to the text, "total scores of four or more on the fatigue scale designate clinically significant levels of fatigue." Therefore, even if extra sessions had trebled the efficacy of Pragmatic Rehabilitation, participants would still have "clinically significant levels of fatigue".
Notwithstanding, Wearden et al comment: "it is likely that our trial gives an accurate indication of the effectiveness of nurse delivered pragmatic rehabilitation and supportive listening for CFS/ME in primary care." Indeed it does: the data provide strong evidence that the anxiety and deconditioning model of CFS/ME on which the trial is predicated is either wrong or, at best, incomplete. These results are immensely important because they demonstrate that if a cure for CFS/ME is to be found, one must look beyond the psycho-behavioural paradigm.
(1) Sharpe MC, Archard LC, Banatvala JE, et al. (February 1991). "A report--chronic fatigue syndrome: guidelines for research". J R Soc Med 84 (2): 118–21
Failure of FINE trial comes as no surprise
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 .
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 . 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 .
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 . 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 . 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 . 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
Dr Ellen Goudsmit FBPsS
The ME Association, 7 Apollo Office Court, Radclive Road, Gawcott, Buckingham RM7 OAG
 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.
 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
 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.
 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.
 Report: ME Association questionnaire to assess current management options for ME/CFS. ME Association May 2010.
 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.
All the responses can be found here.
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