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If a treatment helps some patients, should it be described as being "effective" for that condition?
- Tom P Kindlon (13 December 2004)
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Concerns regarding this paper.
- Angela P. Kennedy (14 December 2004)
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Re criteria and 'effective' ain't wot it used to be
- Ellen Goudsmit (14 December 2004)
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Re: Re criteria and 'effective' ain't wot it used to be
- Angela P Kennedy (15 December 2004)
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A Bridge Too Far
- Erik R Johnson (15 December 2004)
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Re: Re: Re criteria and 'effective' ain't wot it used to be
- Ellen Goudsmit (15 December 2004)
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Ideological assumptions influence choice of criteria
- Angela P Kennedy (16 December 2004)
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Cognitive behaviour therapy for adolescents with chronic fatigue syndrome
- Douglas T Fraser (16 December 2004)
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Insufficient data, inappropriate conclusion
- Abhijit Chaudhuri (3 January 2005)
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Question for the Statistical Advisors of the BMJ
- Bart Stouten (8 January 2005)
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Accidental or Deliberate Denigration of ME?
- Angela Flack (10 January 2005)
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Re: Insufficient data, inappropriate conclusion
- Maja Stulemeijer, Lieke de Jong, Theo Fiselier, Sigrid Hoogveld and Gijs Bleijenberg (20 January 2005)
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Re: Re: Insufficient data, inappropriate conclusion
- Angela Kennedy (24 January 2005)
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The New Paradigm
- Erik R Johnson (25 January 2005)
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Have Psychologizers ever ONCE apologized?
- Erik R Johnson (28 January 2005)
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CBT, peer pressure and wishful thinking
- Ken S Linder (18 February 2005)
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Re: Question for the Statistical Advisors of the BMJ
- Maja Stulemeijer, Lieke de Jong, Theo Fiselier, Sigrid Hoogveld and Gijs Bleijenberg (7 March 2005)
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PACE
- Erik R Johnson (20 March 2005)
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Nutritional deficiencies, especially in female adolescents, with chronic fatigue syndrome
- Ellen C G Grant (20 June 2005)
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CBT has a Cohen's d value of 0.31 in this study
- Tom Kindlon (18 December 2007)
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Re: CBT has a Cohen's d value of 0.31 in this study
- Tom Kindlon (31 December 2007)
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CFS-Psycho
- Ian Hodgson (10 December 2008)
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Tom P Kindlon, Unavailable for work due to ill health Dublin, Rep. of Ireland
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Editor, Reading Stulemeijer et al's paper, I am struck by its use of language. To put it bluntly, it is as if the writers are salespeople, try to sell us Cognitive Behaviour Therapy (CBT) for patients with CFS, and choosing words that may help us come around to their point of view. For example, we are told that "Patients with chronic fatigue syndrome have debilitating unexplained severe fatigue that is not the result of an organic Disease": this is certainly a moot point as the World Health Organisation (WHO) classifies it as a neurological condition and numerous studies have found immunological and neurological abnormalities. We are then informed that "Several randomised controlled trials have shown that cognitive behaviour therapy is effective in adults." without defining what effective means. The evidence would suggest it doesn't seem to enable most people to go back to work full-time. L-Carnitine has shown to benefit some patients in some trials such as a cross-over trial with amantadine (2) - can it be defined as being "an effective treatment"? The magic word "recovery" is also invoked: "a complete resolution of additional symptoms is not a requirement of recovery, as has been suggested before." Who defines "recovery"? If a patient still have symptoms such as sensitive lymph nodes or sore throats, perhaps they are still ill. Just because they are able to go back to school full-time doesn't mean they are recovered? They could still be ill. And there is always the possibility that the condition could come back. Either the authors or someone in the BMJ also try to summarise the article for us "What this study adds: A cognitive behaviour therapy programme based on gradually increasing activity and challenging perpetuating beliefs can be used for adolescents with chronic fatigue Syndrome". However, for the active group, it wasn't as straight forward as this: Cognitive Behaviour Therapy took different forms based on whether one was said to be "pervasively passive" or "relatively active". This statement gives the impression that a homogeneous treatment was used. The approach used for "active" patients could possibly have been taught by giving patients information on the condition rather than the use of CBT. The emphasis on the words CBT gives the impression that the condition is solely maintained by maladaptive beliefs and behaviours when in fact there is evidence that there may be an underlying physiological process, but that some patients may not be dealing with the condition optimally. Table 5 suggests that the treatment for "active" patients (which involved, inter alia, learning to "respect the limitations" of the condition) seems to show a trend towards being more effective than the treatment for the "passive group". From a theoretical point of view, it would be interesting if a similar trial was being done in the future, if the whole group was randomised to receive one or other approach, rather than arbitrarily deciding that the less active patients required a different approach to the more active ones. Could it not be that at least some of the more inactive patients were actually more ill, and needed to were respecting their limitations, while others could do more? However, most patients I know feel that more than enough money has been given to researchers (usually psychiatrists and psychologists) who feel CBT is an "effective" approach for the condition: what such patients would like to see would be most or all money in the coming years be given to "biomedical" researchers such as those in Myalgic Encephalomyelitis Research Group for Education and Support (MERGE) (2) and the CFS Research Foundation (CFSRF) (3). It would also be nice if, in future, the readers of the BMJ could also be given the opportunity to read about such biomedical research. (1) "Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial". Maja Stulemeijer, Lieke W A M de Jong, Theo J W Fiselier, Sigrid W B Hoogveld, and Gijs Bleijenberg. BMJ 2004; (2) "Amantadine and L-carnitine treatment of Chronic Fatigue Syndrome." Plioplys AV, Plioplys S. Neuropsychobiology. 1997;35(1):16-23. (3) The MERGE website is http://www.meresearch.org.uk (4) The CFS Research Foundation's website is: http://www.cfsresearchfoundation.org.uk Details of their current research can be seen in their current newsletter: http://www.erythos.com/MERSC/Docs/CFSRF-10.rtf Competing interests: Patient with ME/CFS who initially was only mildly affected but has been severely and chronically affected for the last ten years because, it appeares, of a late diagnosis and advice to exercise |
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Angela P. Kennedy, Carer, Lecturer in Social Science Essex
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With regard to the above paper, my concern regards the ideological assumptions of the authors, research design, and patient sample, in which a number of problems present themselves. The criteria used in this paper is Fukuda, which presents a number of problems, such as a lack of necessary focus on neurological symptoms, for example. Since the ME/CFS Case Definition and Treatment Protocols (Carruthers et al) has been available since 2003, why were these not used instead? An answer may be found in the Reference list provided, in which papers produced by proponents of the psychiatric paradigm of ME/CFS are in abundance. A review of the biomedical literature documenting the organic physiological processes and abnormalities present in children (or anyone) with ME/CFS is conspicuous by its absence. The authors of this paper quite obviously, from their narrative, subscribe to the belief that ’CFS’ is a psychosomatic illness, and assume that ME/CFS child sufferers have perpetuating health beliefs contributing to their illness that need to be challenged . They therefore hold a specific ideological standpoint which is contested, but which also means they hold certain assumptions that bias their research approach. They believe that their patients have a psychosomatic illness that can be ‘cured’, or that ‘recovery’ from such illness can be effected, by challenging their patients’ ‘illness beliefs’. This approach cannot be proven as a definitive success, has been shown to be potentially harmful, and has been critiqued in the Canadian Guidelines, for example. As has been observed with the PACE Trial (Kennedy, 2004), proponents of the psychiatric paradigm of ‘CFS’ have consistently ignored the Canadian Guidelines. As these guidelines identify seriously affected sufferers of ME/CFS ICD-10 G93.3, a neurological illness, to use such guidelines would reveal fundamental flaws in the psychiatric paradigm, which comprises of varying constructions of discursive categories of ‘psychosomatic illness’ such as ‘malingerer’, ‘hypochondriac’, ‘deluded’ ‘personality disorder’ and unidirectional ‘mind over body’ control myths, (Kennedy 2004) descriptions which are applied as generalisations to people suffering with neurological, endocrinological, immunological, circulatory and other physiological abnormalities. (Also see Marshall et al, 2001). In any case, as the Canadian guidelines have been demonstrated to be more effective at differentiating seriously affected ME/CFS sufferers than Fukuda (see Jason et al, 2004), the enormous claim made in this Fukuda driven study, that ‘CBT can be used for adolescents with chronic fatigue syndrome’ per se are untenable, because: * They have not taken into account adequately severely affected children. Indeed, they instead assign discursive categories of ‘active’ and ‘passive’, indicating that functional impairment is somehow ‘optional’, a clear betrayal of their ideological assumptions about children with ME/CFS. * They have not taken into account children with neurological symptoms, or for that matter, signs. Indeed they have not taken into account any of the vast amount of literature documenting the many physiological problems in ME/CFS ICD-10 G93.3. *They show no understanding of the contested meaning of ME/ICD- defined CFS G93.3 against ‘CFS’ as first constructed in the Oxford Criteria, and CFS as constructed by Fukuda et al. * They had a high drop out rate. * They have ignored the documented harmful effects of CBT/GET (Graded Exercise is implied in this paper, though not explicitly discussed) and therefore have not designed for measuring this phenomenon. They seem to have ignored the fundamental problem of post-exertional malaise in ME/CFS. *They construct a meaning of ‘recovery’ as still having symptoms! This is as ludicrous as describing someone with a brain tumour as having ‘recovered’ from their illness, even if they exhibit permanent symptoms of brain damage, just because the tumour was removed (which in itself does not guarantee a permanent cure from cancer!). As most children in the UK DO NOT have careful investigation into viral infective agents, or any other precipitating condition or process, and therefore the originating precipitator is rarely established, the claim made about ’recovery’ in this paper becomes even more untenable, especially as the remission/relapse pattern documented in ME/CFS sufferers has not been accounted for by the authors. The time period for follow up therefore was inadequate also. * There is also the problem of the therapists/researchers ability to influence sufferer’s responses to their illness. An aggressive (or even manipulative) approach by authority figures to convince the child they are wrong may actually change a child’s belief about their illness. The child may even report an ‘improvement’ in order to live up to the expectations of others, such as therapists, even parents. But this does not mean a reported improvement is necessarily accurate. This theoretical problem has not been addressed by the authors. There is, unfortunately, a distinct lack of reflexivity (critical self reflection of one’s own methods and assumptions) in all the CBT advocacy papers on ME/CFS I have read. A lack of critical self reflection by certain members in the field of social science (of which psychology is a member, and to which psychiatry is irrevocably linked), in which frequent, untenable claims to ‘objectivity’ are made, has been strongly critiqued by feminist epistemologists (see for example, Harding, 1987, Brunskell, 1998). This paper provides yet another example of this epistemological problem, inherent in the literature of proponents of the psychiatric paradigm. In summary, one could indeed argue, as the authors in this paper do, that ‘CBT can be used for adolescents with chronic fatigue syndrome’. But then, so could counselling, or even primal scream therapy (or, and apologies for this, I believe necessary, recurring piece of flippancy, exorcism). The important question is whether CBT is of use, either as a coping strategy or, as the authors imply, a ’cure’, to child sufferers of the neurological disease ME/CFS G93.3, especially seriously affected sufferers, and this paper has certainly not established that. The possibility of further endangerment of health of child sufferers by CBT/GET looms as large as ever, and this paper does not provide adequate evidence to demonstrate otherwise. Angela Kennedy REFERENCES Brunskell, H. 'Feminist methodology' in Seale, C. (ed.) Researching Society and Culture (1998) Sage, London, 37-47. Carruthers, B. et al (2003) “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols” Journal of Chronic Fatigue Syndrome, Vol. 11(1), pp 7 - 115. Fukuda, K. Straus, S.E. Hickie, I. Sharpe, M.C. Dobbins, J.G. Komaroff, A. ‘The Chronic Fatigue Syndrome: A Comprehensive Approach to Its Definition and Study’ Annals of Internal Medicine, 15 December 1994, Vol. 121 Issue 12 pp 953-959. Harding, S. (ed.) Feminism and Methodology (1987) Open University Press, Milton Keynes. Jason, L.A. Torres-Harding, S.R. Jurgens, A. Helgerson, J. ‘Comparing the Fukuda et al Criteria and the Canadian Case Definition for Chronic Fatigue Syndrome’ Journal of Chronic Fatigue Syndrome, Vol. 12 Issue 1, pp. 37-52, 2004 ISSN: 1057-3321 Kennedy A. ‘When Doctors say ‘psychosomatic‘, what do they mean?’ April 2004. Published in Quest (Newsletter of the National ME/FM Action Network) number 66, Fall 2004. Also available on the One Click Group Website (ME/CFS Documents) http://www.theoneclickgroup.co.uk Kennedy A. ’A Summary of the Inherent Theoretical, Methodological and Ethical Flaws in the PACE Trial’ 21st October, 2004. Available on the One Click Group Website (Archive number 258) http://www.theoneclickgroup.co.uk Marshall, E.P, Williams, M. Hooper, M. ‘What is ME? What is CFS? Information for Clinicians and Lawyers’ December 2001. Available on the One Click Group Website http://www.theoneclickgroup.co.uk Montague, S. Hooper, M. ‘Concerns about the forthcoming UK Chief Medical Officer’s Report on Myalgic Encephalomyelitis (ME and Chronic Fatigue Syndrome (CFS), notably the intention to advise clinicians that only limited investigations are necessary.’ 1 May 2001. Available on the One Click Group Website (ME/CFS Documents) http://www.theoneclickgroup.co.uk Competing interests: None declared |
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Ellen Goudsmit, Psychologist Teddington TW11 9QX
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There are lots of valid criticisms one can make about the paper by Stulemeijer et al (online first bmj.com) but the failure to use the Canadian criteria for CFS/ME isn't one of them (Kennedy 14th December). The paper suggests that the data collection (i.e. trial proper) began in March 2002. The Canadian criteria were not published until 2003. One can't exactly blame the researchers for not using criteria which did not exist at the time. Also, as Kennedy knows, the Canadian criteria were designed for clinical use, not for research. The tweaking required to make them suitable for use in trials will take time but now they have been tested, they deserve serious consideration. The new Australian clinical guidelines are largely based on the Canadian criteria and a copy can be downloaded for free from www.me- cfs.org.au as well as other websites. Perhaps the best argument against the continued use of the CDC criteria is that many of those involved in their formulation no longer use them. If they don't, why should anyone else? The paper itself concludes that CBT is an "effective" treatment for adolescents with CFS, despite the fact that over 42% were still unable to go to school full-time and the mean physical functioning score remained below normal. Apart from that, about 30% of the participants did not rate themselves as improved. Fatigue, sleep and muscle pain improved, but there was little change in four other symptoms. And last but not least, we were not allowed to see the actometer scores. Could this be because the encouragement to increase activity did not actually lead to a significant increase in activity? In my day, "effective" meant more than 'useful to a degree'. E. Goudsmit C.Psychol. Editor ME and CFS References
Competing interests: None declared |
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Angela P Kennedy, Carer, Social Science Lecturer Essex
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Ellen Goudsmit is indeed right that the Canadian Guidelines were not in existence when the Stulemeijer et al project was started in 2002. However, even though this is the case, it remains significant and of concern that the authors of the Stulemeijer paper have still ignored the Canadian Guidelines in their evaluation, and failed to considered the limitations of their theories and findings in the light of the publication of these. Even if, in the unlikely case that that the authors, at any time in the study, did not know about the Canadian Guidelines and therefore should not be blamed for disregarding them, there is still the problem that, in light of the publication of the Canadian Guidelines (among other factors already discussed), the claims of the Stulemeijer paper present problems of both validity and reliability, meaning they are ultimately untenable. The Canadian Guidelines describe the clinical presentation of ME/CFS sufferers. They therefore provide clinical evidence in the same way as any other description of a condition. There is, therefore, no justification for any researcher to just ignore them, as has been the case, not just in the Stulemeijer study, but also in the research design of the much critiqued and fundamentally flawed PACE Trial, which has just started, over a year and a half after the Canadian Guidelines were published. (See the PACE Trial Summary, as referenced in my previous post in this forum). Exactly why the Canadian Guidelines would need so much ‘tweaking’ is never made clear either, I note, by those endeavouring to deny their suitability for use in clinical research in past months. The symptom criteria in their own right provide a means by which ME/CFS sufferers can be separated effectively from idiopathic chronic fatigue sufferers, and cardinal symptoms of the illness identified. This is of enormous benefit whether in a research or clinical setting. Bearing in mind that ‘criteria’ are, basically, another way of stating ‘signs and symptoms’ or ‘clinical presentation’ of a condition, which of course need to be used in clinical research, I do find the way that the Canadian Guidelines are being treated as if they are extraordinarily complex and not suitable for research rather worrying: I suspect this is a bit of a red herring. They certainly do cause huge inconvenience to those who subscribe to the psychiatric paradigm, however, as they highlight some of the discrepancies in this paradigm. As an interesting aside, the Fukuda Criteria have been used for years to diagnose in a clinical setting, even thought they were designed only for research! This was happening in 2003, and may still be going on. In summary, the Stulemejer et al paper is limited in its scope, and ignores fundamental issues in ME/CFS. Its claims are therefore untenable. I predict that proponents of the psychiatric paradigm will continue to ignore the Canadian Guidelines wherever possible (no matter how long ago they will have been published, or how many times they are found suitable for research), because they contradict their own (highly contested) ideological assumptions about sufferers of the devastating neurological disease ME/CFS. We wait and see. Competing interests: None declared |
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Erik R Johnson, n/a Incline Village 89450
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Professor Wessely recently dismissed the attempts of Gulf War Illness veterans to assail the "psychologizing" of their illness by the Nijmegen School of Psychiatry by presenting physiological evidence of neurotoxic dysfunction as being "A Bridge Too Far". An obvious reference to "Operation Market Garden" in which the Allies narrowly fell short of their objective when they failed to take the bridge at Nijmegen from the Nazis. And is a very interesting analogy for Professor Wessely to make... Veterans REJECT psychiatric theories of Gulf War Illness and are amassing the reserves of evidence necessary to cross that bridge and dislodge the "Nijmegen Stronghold of Psycho-terrorism". Did the doctors from the Numb-noggin Institute ask these adolescents whether they would rather have palliative therapy or research into the CAUSE of their illness as the Veterans have chosen? Claiming that CBT is an "effective treatment" is, I think, "A Bridge Too Far". -Erik Johnson Competing interests: None declared |
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Ellen Goudsmit, Psychologist Teddington TW11 9QX
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In reply to Ms. Kennedy's questions to why clinical guidelines cannot be used for research without some tweaking (response 15th December), I would refer her to a letter from the main author of the guidelines. I saw a reference to this on a website that she is involved in and I therefore assumed that she had read it. If this is not the case, I can send her a copy. He accepts the need for 'tweaking' but perhaps both of us have not been clear enough. I am therefore happy to repeat what I wrote earlier on this issue. In a clinical setting, one can diagnose an illness, say breast cancer, even if the patients also suffer from another disease, e.g. rheumatoid arthritis or depression. One can diagnose myalgic encephalomyelitis (ME), even if the patients also have arthritis and depression, both of which may exacerbate fatigue. In research, exclusion criteria are used to limit samples to people with the disease in question and to exclude those with other conditions likely to complicate the interpretation of the results. For example, the London criteria for ME, which I was involved with, exclude everyone with psychiatric disorders. One can study people with ME and depression, but they would form a seperate group (e.g. Costa et al 1995). The CDC criteria for research into chronic fatigue syndrome (CFS) exclude certain psychiatric disorders but not comorbid depression. However, studies have shown that it is a confounding factor in studies on brain function and cognitive impairment. The Canadian criteria do not specify what researchers should do with people who have concurrent disorders such as depression. It's just one of the questions which those involved need to address, and which the main author of the criteria is happy to deal with, if asked. I may be wrong but as I understand it, the Canadian criteria do not exclude patients with depression and phobic avoidance. As noted above, this is not a problem in a clinical setting. However, in research, this group would undoubtedly benefit from CBT, in the same way as people with CFS, selected using the CDC criteria. Or patients with ME and comorbid depression and anxiety. Using the Canadian criteria is therefore unlikely to produce different results. CBT is helpful, irrespective of severity of illness, or the presence of ongoing pathology. It focuses on the psychological complications associated with diseases like ME, as shown in an elegant study by Friedberg and Krupp (1994). I personally support the ME Association's decision not to support the PACE trial. To me, the use of specific criteria for ME simply doesn't justify the expense. We already have a considerable amount of information on the effectiveness of CBT and what we need now is more biomedical research. We need to focus our attention on developing a diagnostic test and evaluating the new antiviral drugs (Shepherd, BMJ this issue). With respect to the psychological aspects of ME and CFS, we need more studies assessing self-management interventions (SMIs). I do not feel that we need yet another study on CBT, and especially if there are no immunological and neurological measures. Costa DC, Tannock C and Brostoff J. Brainstem perfusion is impaired in patients with chronic fatigue syndrome. QJM 1995; 88: 767-773. Friedberg, F and Krupp, LB. a comparison of cognitive-behavioral treatment for chronic fatigue syndrome and primary depression. Clin Inf Dis 1994, 18, suppl. 1, S105-110. Competing interests: None declared |
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Angela P Kennedy, Carer, Social Science Lecturer Essex
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Ellen Goudsmit comments that “the Canadian criteria do not exclude patients with depression and phobic avoidance. As noted above, this is not a problem in a clinical setting. However, in research, this group would undoubtedly benefit from CBT, in the same way as people with CFS, selected using the CDC criteria.” How could Ms Goudsmit presume to know that this would be the case? This claim is just that, a claim, a hypothesis that could be tested, indeed SHOULD be tested, but it does not constitute a fact. This therefore in itself does not provide a satisfactory rationale for rejecting the Canadian Guidelines, even in their ‘un-tweaked’ form. But it also points to a fundamental issue, which has not been addressed by Ms Goudsmit but certainly needs to be, when considering the usefulness of CBT for sufferers of the neurological disease ME/CFS WHO ICD-10 G93.3: exactly HOW can CBT ‘undoubtedly’ ‘benefit’ such people, whether in a research or clinical setting? Some researchers are claiming that CBT is useful to enable sufferers to ‘cope’ with their illness (whether it is ME/CFS, Cancer, Multiple Sclerosis or other organic illness). But others are claiming that it actually improves symptoms in ME/CFS. These parties are claiming that CBT can improve symptoms (or even ‘cure’ or facilitate ‘recovery’) of a neurological condition with multi-system physiological abnormalities. If this was the case, why is CBT not being used to ‘cure’ or facilitate ’recovery’ from cancer, Multiple Sclerosis, and other organic illnesses? The issue here is that those who believe CBT can ‘cure’ ME/CFS do not, from their own words, appear to believe that the organic disease ME/CFS even exists, and that it is instead a ‘psychosomatic’ illness (with all the confusing assumptions that idea entails). ME/CFS therefore, in this scenario, is being treated fundamentally differently from say, breast cancer, where a co-morbid condition such as depression or anxiety would not necessarily prevent someone entering a research project about breast cancer (for example something that might stop the re-occurrence of the tumour). So, whether an ME/CFS sufferer has been diagnosed with ‘Anxiety’, ‘depression’, or ‘phobic avoidance’ becomes irrelevant, ironically, in two of the possible research scenarios. If researchers believe that ME/CFS is an organic disease, then whether sufferers have certain co-morbid ‘psychiatric’ problems should not theoretically affect, for example, whether an anti-viral drug improves neurological or endocrinal or vascular abnormalities. As such researchers would (presumably) not believe CBT will ’cure’ a neurological illness such as ME/CFS, then there would be, theoretically, for them no problem in using the Canadian Guidelines in a study on CBT as a ‘cure‘ for ME/CFS, especially as the CG provide extensively stricter and therefore more efficient criteria for identifying ME/CFS than Fukuda. If, however, researchers believe that ME/CFS is merely a ‘psychosomatic’ condition, then they will expect the sufferer to ‘improve’, whether or not they have other psychiatric conditions, because that sufferer’s dysfunctional belief system (the presumed ’cause’ of their symptoms) will have been ‘cured’ by CBT, and their ‘symptoms’ will be seen as resulting from a form of delusion, yet another psychiatric problem to add to their depression, anxiety and phobic avoidance. They therefore would be, theoretically, content to use Fukuda for example, but might be worried by the use of the CG because the patient sample, with all their specific physical abnormalities, might not ’recover’ and therefore would cause problems for (if not completely disprove) their hypothesis. But, placing a set of criteria such as the CG for selecting research populations that acknowledges an illness as organic and where physiological symptoms and signs present, against a hypothesis that ME/CFS is a psychiatric disorder, would be an extremely interesting and demanding project. It might present a challenge to the psychiatric paradigm that its proponents might desperately not want to take. I‘m willing to bet that ME/CFS sufferers, who have such high stakes in the research about them, would watch such a project with a lot of interest. The scenario where co-morbid ‘psychiatric’ problems may, theoretically, influence the outcome is where CBT is hypothesised as a useful intervention only to improve coping in serious illness, where personal mental and emotional ability to deal with illness might somehow be influenced by psychiatric disorders, according to such an hypothesis. With regard to the elusive London Criteria, unfortunately, they have never been published in a peer reviewed journal, the full authorship has yet to be confirmed, there is apparently more than one version, and clear reference is not made to them in any published papers, even those quoted by Goudsmit herself. If these criteria were peer-reviewed and published, and the authorship confirmed, they might indeed present an interesting opportunity for researchers. Unfortunately in their present state (unverified, more than one version) they cannot be used as they would present even more problems regarding clarity of concept in an area of research already fraught with such problems. As regards the issue of ‘tweaking’, I am perfectly aware of what was placed on my organisation’s website and its importance (The One Click Group). My comment was not dismissing any need for ‘tweaking’, but actually was concerned about the alleged amount of ‘tweaking’ needed to make the Canadian Guidelines suitable for research, and why this alleged need for so much ‘tweaking’ is being used by some researchers as an excuse to ignore the Canadian Guidelines, in favour of other criteria, such as Fukuda and Oxford which, although designed for research, are proving so highly flawed even for that task that they themselves are seriously confounding research projects, yet continue to be used regardless, for example, in the PACE Trial (see my previous references for details). Current psychiatric and psychological approaches to ME/CFS are fraught with epistemological and methodological problems. These disciplines have forgotten their roots in the social sciences. Their concepts are lacking in theoretical or linguistic clarity, indeed are often downright confused. Critical self- reflection and interrogation of one’s own assumptions are conspicuous by their absence, and they present unverifiable theories and ideological assumptions as if they were objective, irrefutable, proven fact. Evidence from the natural sciences, (which can be verified and where the limitations to findings are usually made properly explicit) that challenge the ideological assumptions of proponents of the psychiatric paradigm remain ignored by them. This intellectual arrogance is endangering and disenfranchising a whole section of society. At the very least, the Canadian Guidelines should form part of the discussion and literature reviews of all future papers purporting to be about ‘CFS’, ‘CFS/ME’ (sic), or ‘ME/CFS’, in order to clarify limitations to the study, and any underlying ideological assumptions that may be contested by the Canadian Guidelines. And yes the CG should be tweaked for research where necessary. Disregarding them in favour of other clearly flawed criteria is, however, inexcusable, yet this is exactly what has been happening. Unfortunately, whether Goudsmit (or anyone) believes studies about CBT in ME/CFS are redundant is irrelevant. These will continue to be done because certain researchers are concerned to keep their claims of the “CBT -as-‘cure’-for-the-‘pscyhosomatic’-illness-‘CFS’-and-by-the-way-ME -is- only-a-deluded-belief” variety in ascendancy. But certainly, in light of the serious theoretical and methodological problems that have been uncovered in the PACE Trial, it is scandalous that funding for it was granted by the MRC. It is therefore vitally important that careful, critical analysis is made of such studies such as PACE, the Stulemeijer paper etc. and here the Canadian Guidelines will prove an extremely useful tool, thankfully, even in their 'un-tweaked' state. Competing interests: None declared |
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Douglas T Fraser, Musician London W6
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Dear Ed The important breakthrough being announced by Maja Stulemeijer and her friends that "cognitive behaviour therapy is an effective treatment for chronic fatigue syndrome in adolescents" must be very exciting and encouraging news indeed for everyone affected by CFS, both young and not so young. Let`s hope that there may soon be many such wonderfully effective treatments for all manner of other terrible illnesses , if only this example of cutting edge science, with all it`s underlying epistemic purity, from Bleijenberg, Stulemeijer, de Jong, Fiselier, and Hoogveld, could serve as a splendid and inspiring model of how rigorously objective research should be carried out. I`m just a little puzzled by the end of their article. "As the prevalence of chronic fatigue syndrome seems to be lower than previously thought, we would not recommend widespread implementation of cognitive behaviour therapy but suggest that treatment should be centralised in specialised medical centres so that therapists can accumulate knowledge and maintain proficiency" This seems a pity because in the UK and US the prevalence* of CFS ranges between 200–400 per 100,000 - and there must be veritable armies of highly skilled CBT therapists in both countries champing at the bit to deliver "effective treatment" to these stupid people. But fortunately, here in the UK we will soon have a number of just such "specialised medical centres" for CFS. Well what a co-incidence! Douglas T Fraser *http://www.meresearch.org.uk/archive/prevalence.html Competing interests: None declared |
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Abhijit Chaudhuri, Senior Lecturer in Clinical Neurosciences University of Glasgow
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I have a few concerns regarding the design and interpretation of this published trial (1). First, the trial arms were not matched for the number of contacts with the health care professionals. Experience from larger and more carefully controlled randomised interventional trials of patients with chronic fatigue syndrome has clearly shown that short-term improvement in symptoms are directly related to the maintenance of regular contacts with the health care professionals rather than due to the therapeutic effect of the intervention itself and consequently, the improvement is not sustained once the contact is lost (2). The authors did not offer patients in their waiting list the opportunity to meet therapists regularly for five months but without having cognitive behaviour therapy (CBT). In addition, there are no follow-up data regarding patients in the intervention arm beyond five months to show that the specific treatment benefit was carried forward in the absence of regular contacts with the therapists. Taken together, one has to be extremely cautious in inferring direct benefit from CBT in the intervention arm (as opposed to short-term benefit from close contact with therapists) and such a claim would only reflect uncritical belief in the efficacy of CBT. Second, the authors indicated that a proportion of their patients were “passive”, i.e., adolescents who spend “most time lying down and go out infrequently… most do not attend school at all” (p2, intervention). The baseline characteristics show that all participants were attending school - either full time or part time (Table 1) and yet nearly a third of patients in the intervention arm were considered to be “passive” by the authors. I am not sure if these data are compatible with their own definition of passivity (1). May I ask what were the outcome results of subgroup analysis in the so-called “active” and “passive patients? Third, the results (Table 2) did not show how many adolescents in each arm returned to full-time schooling, clearly a more meaningful and simpler index of response to therapy. Fourth, it was suggested that the intervention (CBT) was effective by challenging patients’ belief that activity would aggravate symptoms (p2, “intervention” and p5,“what this study adds”). If it is true, then I am afraid the authors challenged a scientific fact because epidemiological data confirm that fatigue made worse by exercise is a characteristic feature of adolescents at risk of chronic fatigue syndrome (3). Encouraging activity in disabled patients is entirely different from challenging an accepted feature of the disease: e.g., when a patient with hemiparesis is encouraged to walk, the existence of weakness due to a stroke is not challenged. Finally, the trial recruited relatively small number of patients and given a high drop-out rate (nearly 20%) of the participants in the intervention arm, there is a possibility of Type 2 error. In conclusion, the study does not have the strength to conclude that “CBT is an effective treatment for chronic fatigue syndrome in adolescents”(1). Amendments regarding the conclusion and the rhetorical summary point of this paper are to be expected from the authors and/or the editors. Failure to do so would perpetuate the view that the BMJ has a selective bias towards research that supports a psychological view of chronic fatigue syndrome irrespective of the quality of the presented material. References: 1. Stulemeijer M, de Jong LWAM, Fiselier TJW, Hoogveld SWB, Bleijenbrg G. Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. BMJ 2005; 330: 14-18. 2. Blacker CV, Greenwood DT, Wesnes KA, et al. Effect of galantamine hydrobromide in chronic fatigue syndrome: a randomized controlled trial. JAMA 2004; 292: 1195-204. 3. Mears CJ, Taylor RR, Jordan KM, et al. Sociodemographic and symptom correlates of fatigue in an adolescent primary care sample. J Adolesc Health 2004; 35: 528e.21-6. Competing interests: None declared |
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Bart Stouten, n.a. Violierstraat 27, 5402 LA Uden, The Netherlands
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In the analysis section of their article on the effectiveness of cognitive behaviour therapy (CBT) for adolescents with chronic fatigue syndrome, Stulemeijer et al. state that they “carried forward last observations in cases of missing data” [1]. However, for the analysis of the primary outcome “school attendance” they did not. According to the third footnote of Table 2, two participants in the CBT arm who were not required to attend school at five months were left out of that analysis. If the authors had performed a “last observation carried forward” (LOCF) analysis, then the corresponding treatment effect would have been 16.6 instead of 18.2. More importantly, according to my calculations the 95% confidence interval for the LOCF analysis is at least [-0.2 , 33.4] (details available on request). Since this interval includes zero, it follows that there is no significant treatment effect for the primary outcome school attendance as calculated with the LOCF analysis. This clearly differs from the authors’ result. Their analysis produced a significant treatment effect. I understand that school attendance at five months cannot be computed for the two excluded participants, as this would require a division by zero. However, to be consistent with the rest of the article, the preferred way to deal with this situation is to treat these values as missing data instead of excluding the patients. Since I have not found any valid reason to exchange the LOCF analysis for an exclusion of subjects, I formally ask the Statistical Advisors of the BMJ for their opinion. Yours faithfully, Bart Stouten (email: bartstouten@wanadoo.nl) References: [1] Stulemeijer M, de Jong LWAM, Fiselier TJW, Hoogveld SWB, Bleijenberg G. Cognitive behaviour therapy for adolescents with chronic fatigue: randomised controlled trial. BMJ 2005; 330:14-18. Competing interests: None declared |
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Angela Flack, Early retired as a result of M.E. None
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Nature was kind and cruel to inflict three types of ME on my close family The kind part was having the advantage of learning on the job at close quarters, the unkind part was knowing that the outcome was uncertain, knowing in my heart that l was dealing with an unknown illness that could result in total disability for life.... Child No1 collapsed utterly and completely from day one very severe ME from age 4 very ill until aged 19 gradually recovered sufficiently to take a light job, now in full time work in the outdoors recovery is 75% but not able to have a life outside work at weekends when he collapses Child No2 was mildly effected from age 8 continued to attend school eventually collapsing at aged 13 until aged 22 now in full recovery My own ME was sudden viral and intense for a few months, a partial recovery was made at which time l returned to very part time work increasing to 30 hours a week over the next 18 months, sitting down in an office and needing a lot of help with household chores l collapsed within a year,l was not able to function at all,with severe cardiac (SVT) l was in bed for nearly 2 years, in a wheelchair for 2 years, progressed to electric scooter and independant travel. This journey took 10 years with many setbacks until stability was reached Today l live a much restricted life, l did not choose, but a life full of quality, hope, and love, despite being totally ignored by the NHS medical profession. My sanity has been preserved throught this journey by the educated support of the main charities for ME for which l will be forever grateful Competing interests: MEA Trustee |
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Maja Stulemeijer, Junior researcher Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, Lieke de Jong, Theo Fiselier, Sigrid Hoogveld and Gijs Bleijenberg
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We would like to respond to the issues raised by dr. Chaudhuri about our article on the effectiveness of cognitive behaviour therapy (CBT) for adolescents with chronic fatigue syndrome (CFS).(1) 1) Dr. Chaudhuri suggests that the improvement in symptoms could be directly related to the maintenance of contacts with health care professionals rather than due to the intervention itself. We agree that including an attention-placebo condition would have helped to elucidate the effectiveness of CBT-specific elements. However, we consider it unlikely that the effects of CBT are mainly attributable to non-specific treatment factors for two reasons. Firstly, several studies in adult CFS patients have shown that CBT was more effective than attention-control conditions shortly after treatment and at time of follow-up (for example therapist guided support groups (2) or relaxation therapy (3)). Secondly, in our study there were no differences between the 5-month assessment and the 8-month follow-up on any of the primary outcome variables, indicating that results were maintained for at least three months, even in the absence of contacts with the therapist. However, these results are uncontrolled since we found it to be unethical to deny the youngsters in the waiting list from therapy any longer. The ethical argument was reason for us to choose for a waiting list control instead of a placebo or real natural course. We are currently conducting a long-term follow-up in all patients to further evaluate the long-term effects of the treatment. 2) The distinction between passive and active patients has raised questions with regard to the diagnostic criteria used to define these patients. In contrast to what Table 1 perhaps suggests there were 13 youngsters (6 in the CBT condition and 7 in the waiting list condition) who did not attend school at all at the first assessment; these youngster were included in the group ‘partial school attendance’, which might be confusing. As is described in more detail in the Methods section, the distinction between relatively active and passive physical activity patients was made solely on basis of physical activity scores assessed with the actometer. A passive patient may or may not attend school on a regular basis, but in all cases is characterized by very low levels of physical activity. Visiting school is possible without being physically very active. The results of these subgroup analyses are presented in Table 5. 3) The results on full-time school attendance are presented in Table 3. We agree that full-time schooling is an important indication of recovery, but as is discussed briefly in the Discussion section, even if recovered, return to full-time schooling can be very difficult in some youngsters, for example in case of social isolation. In these cases it simply is not always possible or desirable to return to the same school, and all parties involved should cooperate to find other ways to guarantee education like going to a new school. 4) The goal of our treatment is to help adolescents with CFS to return to the level of functioning of a regular adolescent, and be able to perform age-appropriate activities. At the start of therapy all patients experience significant limitations in performing these activities, and therefore activity regulation is of key importance in the process of recovery. We do not challenge the patients’ experience of post-exertional malaise; our research group has studied this phenomenon extensively.(4) This does not mean however, that an increase of activity is beyond the scope of treatment, nor does it implicate that every activity leads to a debilitating increase in symptoms in each patient at every occasion. The distinction between physically active and more passive patients is helpful in this regard because, as we described, both types of patients require a different approach.(1)(2)(5) 5) A Type 2 error is an error made when an incorrect null hypothesis is not rejected when a treatment effect is in fact present, but not observed, perhaps because of too few events. In our study this would have meant falsely concluding that CBT was ineffective. Since our study showed significant treatments effects despite the relatively small sample the occurrence of a Type 2 error is not likely. We agree that CBT may not be a cure for all CFS patients. As in other chronic conditions not one therapy leads to recovery in all patients or establishes the same effect for all patients. We believe that our study clearly shows that many of the participants benefited from CBT and at the end of therapy as well as several months afterwards, many were able to function as normal adolescents. Lastly, we would like to stress that the assumption of several respondents that we consider CFS to be a psychological condition because we treat patients with a primarily psychological approach is incorrect. The views expressed enforce the old paradigm in which diseases or complaints were considered as either somatic or psychogenic in origin. The use of a psychological model does not preclude neurobiological processes, and a known somatic or psychic cause is not conditional for an effective treatment of a disorder.(6) Our research group has always applied a biopsychosocial approach to study CFS, and applies many different techniques to explore mechanisms involved in the facilitation, causation and perpetuation of complaints. Therefore, we also perform studies to detect the neurobiological mechanisms in CFS, for example by using (f)MRI and clinical neurophysiology as well as by studying the serotonergic system in CFS, see for example Schillings et al, De Lange et al.(7)(8) At present there are no evidence-based treatments available for adolescents with CFS, and our study is the first systematic and controlled evaluation of CBT for CFS in adolescents. We hope that scientist from different fields and with different methods continue to put effort in finding ways to help youngster with CFS overcome this debilitating condition and enable them to live their lives like healthy teens. Because in the end, isn't that what it's all about? Yours faithfully, Maja Stulemeijer, Lieke de Jong, Theo Fiselier, Sigrid Hoogveld & Gijs Bleijenberg References 1. Stulemeijer M, de Jong LWAM, Fiselier TJW, Hoogveld SWB, Bleijenbrg G. Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. BMJ 2005; 330: 14-18. 2. Prins JB, Bleijenberg G, Bazelmans E, Elving LD, de Boo Th, Severens JL, et al. Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. Lancet 2001;357: 841- 7. 3. Deale A, Chalder T, Marks I, Wessely S. Cognitive Behavior Therapy for Chronic Fatigue Syndrome: A Randomized Controlled Trial. Am J Psychiatry 1997;154: 408-414. 4. Bazelmans E, Bleijenberg G, van der Meer JWM and Folgering H. Is physical deconditioning a perpetuating factor in chronic fatigue syndrome? A controlled study on maximal exercise performance and relations with fatigue, impairment and physical activity. Psychological Med 2001; 31: 107 -114. 5. Bleijenberg G, Prins J, Bazelmans E. Cognitive-Behavioral Therapies. In: Jason LA, Fennel PA, Taylor RR, editors. Handbook of chronic fatigue syndrome, New Jersey: John Willey and Sons; 2003. p.493- 526 6. In: Prins JB. Cognitive behaviour therapy for chronic fatigue syndrome. PhD thesis University of Nijmegen; 2003. 7. Schillings ML, Kalkman JS, van der Werf SP, van Engelen BG, Bleijenberg G, Zwarts MJ. Diminished central activation during maximal voluntary contraction in chronic fatigue syndrome. Clin Neurophysiol 2004, 115, 11, 2518-2524. 8. Lange FP, Kalkman JS, Bleijenberg G, Hagoort P, vd Werf SP, van der Meer JWM, Toni I. Neural correlates of the chronic fatigue syndrome - an fMRI study. Brain 2004, 127(9): 1948 - 1957. Competing interests: None declared |
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Angela Kennedy, Social Sciences Lecturer, Carer Essex
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Stulemeijer et al may not be aware that the 'biopsychosocial approach' has been subjected to criticism for its inappropriate emphasis on the 'pscyho-social' at the expense of the biological. This criticism is particularly pertinent to ME/CFS, and any researchers working in this field MUST now address these methodological, theoretical and ethical problems, or their research will be found to be too flawed to be considered seriously. The 'biopsychosocial approach' is too closely aligned to the 'pscyhiatric paradigm', and the problems associated with that approach towards ME/CFS. (1)(2)(3) It really is not enough to claim that 'somatic' and 'pscyhogenic' cannot be separated because, as many branches of medicine illustrate, they quite clearly can. Psycho-social issues may need to be considered in all illnesses, but in for example, treatment of other diseases with organic causes, they do not take precedence over organic treatments. ME/CFS, a neurological disease, should be no different. Or are the authors claiming that the WHO neurological classification of ME/CFS is incorrect? If so, on what basis can they base such an astounding assertion? Or do they believe such classifications do not matter? If not, why? Would they then accept that Multiple Sclerosis or Motor Neurone Disease should not be classified as neurological because it 'doesn't matter'? Do they believe CBT would improve symptoms of MS to the point of 'recovery'? If not, why not? Or are the team studying a different disease to ME/CFS, as their choice of criteria might indicate? If the authors REALLY are concerned with helping child ME/CFS sufferers, then they really MUST consider the theoretical, methodological and ethical problems of their research. Ethically they have no other choice. Children's lives are at stake, and, though ignored by the authors in their latest post, the risks of CBT/GET to both adults and children's health, as evidenced in previous posts and the references below, remain. As regards the 'biopscyhosocial approach', The three references given in this text, accessible online, provide briefs review of the major problems in this approach, with further references which I hope the authors will take the time to consider. 1. Kennedy, A. (2004) A SHORT SUMMARY OF THE PSYCHIATRIC PARADIGM OF ME/CFS. Available on the One Click Group Website: http://www.theoneclickgroup.co.uk 2. Kennedy, A. (2004) WHEN DOCTORS SAY PSYCHOSOMATIC - WHAT DO THEY MEAN? Available on the One Click Group Website: http://www.theoneclickgroup.co.uk/documents/ME-CFS_docs/ 3. Kennedy, A. (2004) The distortion of holistic approaches to health care in ME. Available on the One Click Group Website: http://www.theoneclickgroup.co.uk/documents/ME-CFS_docs/ Competing interests: Carer of Child with ME/CFS. Social Science Researcher. Director of the One Click Group |
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Erik R Johnson, n/a Incline Village NV 89410
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Is it appropriate for psychiatrists to switch from "the old paradigm in which diseases or complaints were considered to be either somatic or psychogenic in origin" to "The New Pardigm" in which they consider that illnesses are "not primarily psychological" yet still employ a psychological model anyway? Sufferers of CFS/ME have struggled for years to overcome the intransigence of psychologizers who based their conceptual model of the illness on "maladaptive behaviors" and "disordered thinking" only to watch these very psychologizers switch smoothly from "Old Paradigm" into the New Paradigm without any retraction of their former beliefs and without any apology for the damage they have created - and without changing their methods. The frustration contained in the phrase "Doctors just don't get it" is due to the utter inability of doctors to develope an appropriate mental picture of the illness. Now it appears that CFS/ME sufferers must overcome the intransigence of psychologizers who clearly state that they believe this is "not primarily psychological" but fully intend to continue to use a psychological model for treatment until further notice. Sufferers of CFS/ME want approaches that arise from a "correct" model of illness rather than one that even the therapists admit is inappropriate, and isn't this what it's all about? -Erik Johnson Competing interests: None declared |
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Erik R Johnson, n/a Incline Village NV 89450
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Have psychologizers ever once apologized for the damage they have done? Did psychologizers ever say to an AIDS patient "I'm sorry I blamed your illness on you because of your lifestyle"? To a woman with PMS "I'm sorry I said you were a hysterical female"? Someone with ulcers from H - Pylori, "I'm sorry I kept telling you it was stress when it was really a bacterial infection"? Tuberculosis; "I'm sorry I told you that you brought this illness upon yourself by having a nervous disposition"? Thyroid; "I'm sorry that I said your weight problem was from a lack of discipline in your diet"? ADD/ADHD: "I'm sorry that I told you that this was from your bad choice of sugar laden foods"? Autism; "I'm sorry that I slapped your child and tried to shake him out of it"? SIDS/Cot Death; "I'm sorrry that I accused you of killing your own child"? Munchausen: "I'm sorry that I wrongly took your children away forever"? What do psychologizers plan to say to CFS/MS sufferers when psychologizers finally realize that they were wrong again and that CFS/ME is exactly what sufferers say it is? Is there any illness in history that didn't have psychologizers standing in the way of sick people seeking medical help by saying "They don't need that kind of help. They just need to change their attitude". When the etiology of any illness was finally found to be "Not Psychological", did psychologizers ever make the slightest attempt to undo the damage they created? Did psychologizers ever try to restore the credibility they stole from those they falsely told "It's All In Your Head"? Or did they scamper off to concentrate their "help" on the next "unexplained medical illness" they could find? How many more examples of this process do we need to go through before society prevents psychologizers from pronouncing their victims "Guilty! - until proven innocent of mental illness? -Erik Johnson Competing interests: None declared |
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Ken S Linder, disabled 5254
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If a patient went to the hospital complaining of chest pains, with numbness and tingling in the left arm, they would be checked for heart problems, not given a series of therapy "pep talks". Operant conditioning is not used to treat a blocked artery. If a group of psychologists recomended such an approach they would be laughed at. cardiac events have a verifable biocehmical imprint that they leave on the body. So does CFS/FM/MPS. So does all chronic pain. Yet here we are, after all this time spent on the hard science of these conditions, still in the realm of physicians and shrinks who don't believe in serious science (or their own governing bodies) but do believe in the idea that widespread endocrine disruption and immune problems in a patient (which happen to result in pain and exhaustion) can be "talked away" by instilling a positive attitide in the patient. This makes about as much sense as replacing a hospital trauma center with a new age seminar on the power of positive thinking. I would like very much to see a form of psychiatric therapy that could kill the mycoplasm and ricketsia infections in my body, increase my DHEA and testosterone levels (which are almost non-existent), fix my nonfunctional endocrine system, right my immune system, decrease my substance P level and make my liver chemisry, lipids, thyroid and cardiac function go back to normal. It is obvious that no form of motovational therapy can do this, any more than it can sucessfully treat a blocked artery or a broken leg. So why is this hokum being recomended? Despite many years of trying to prove the effectiveness of CBT in the treatment of chronic pain and various other chronic illnesses, there has never been a scientific peer reviewed paper that demonstrated any statisitaclly significant positive outcome from CBT in the actual reduction of pain or in the curing of an illness or even the reduction of physical symptoms. Yet, those dedicated to its use coninue to believe that if they do the same thing again and again (CBT in a CFS patient) they will get a different result. This is known as "Magical Thinking". There are a number of government and medical bodies who have stated their official position on CBT. Here is one such example . - "Because the available, published evidence either does not support or denies any demonstrable benefit, formal behavioural therapy cannot be recommended for acute back pain, other than as an experimental therapy." Yet, despite the fact that there is no no evidence that it works, CBT is still regularly recomended for people with chronic pain conditions. Why? Simply put, it is the same reason that NSAIDS are given to pain patients (destroying their livers). Because the doctor does not have to prescribe any opiates. Doctors are frightened to prescibe pain relief out of fear of legal ramifications. and they are frightened to do so. Yet it is well document that failure to prescribe opiod pain relief for chronic pain (including FMS/CFS) patients, often results in "central senstisation" which means that the body of the abandonded patient changes in reponse to their untreated pain. These changes are very painful and permanent. Competing interests: None declared |
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Maja Stulemeijer, Junior Researcher Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, Lieke de Jong, Theo Fiselier, Sigrid Hoogveld and Gijs Bleijenberg
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We would like to respond to the issue raised by dr. Stouten about the analysis of the primary outcome "school attendance". This analysis deviated from the 'last observation carried forward' approach applied for the other variables in the way that two participants in the Cognitive Behaviour Therapy condition were left out of that analysis because they did not require to attend school anymore at time of the post assessment. In his response, dr. Stouten questioned this approach, and suggested that the preferred way to deal with this situation is to treat these values as missing data instead of excluding the patients. Like dr Stouten, we too have thoroughly reflected on this matter, but come to a different conclusion. We believe that including these two patients, and assuming "no change' in the analyses would unjustly reflect reality which is that these youngsters did a fantastic job by passing their examinations. Furthermore, they both reported great decrease in fatigue severity as well as functional limitations. Before analysing the data we have consulted an experienced statistician in our hospital to discuss this approach and he, as well as the reviewers from BMJ later on, supported this analysis. Competing interests: None declared |
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Erik R Johnson, n/a Incline Village NV 89450
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The statistical relevance of the children in terms of developing an "Effective Therapy" is as meaningless as being taken to the hospital after an accident and having medical staff attempt to determine your statistical propensity for accidents instead of tending to your injuries. Ever seen someone respond to a television that flickers out by pounding on it? If it doesn't start working again, they pound harder. Of course they know that this is unlikely to actually fix the television but are quick to tell you that there is nothing to be lost by trying. If it works, there you have it: Evidence Based Therapy. This strategy of Pound and Check Effectiveness: PACE, is being touted as an "Effective" simply because researchers had a few instances where the subject flickered a bit and showed some signs of life. Even if there was any statistical improvement observed after applying PACE, this still wouldn't mean that it could be construed as scientific or methodical means to construct a therapy any more than having a repairman shake and pound on a broken television and consider it a job well done if it happened to start working again. ME/CFS sufferers must remove the "environment of validation" from researchers that allows them to persist in their work avoidance behaviors and phobias against researching physiological dysfunctions. I suggest that this lack of motivation on the part of researchers may be corrected by the judicious application of PACE. If it works, there you have it: Evidence Based Therapy. -Erik Johnson Competing interests: None declared |
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Ellen C G Grant, physician and medical gynaecologist Kingston-upon-Thames, KT2 7JU, UK
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90% of the adolescents in this study of the effect of cognitive behaviour therapy on patients with chronic fatigue syndrome were female but the reasons for this were not considered.1 The importance of adequate zinc levels and omega-3 essential fatty acid levels for growth and brain function were not mentioned in the study or in any of the responses. The implications of rises in copper levels at the menarche and the adverse effect of contraceptive hormones were also ignored. Exogenous hormone use further lowers zinc levels and raises copper levels, which increases adverse reactions to common foods and chemicals. Headache, impaired concentration, impaired memory, sensitive lymph nodes, sore throat, multi-joint pain, tiredness after exercise, unrefreshing sleep are symptoms suggestive of zinc, magnesium, B vitamin and EFA deficiencies. Low copper stores, diagnosable by a red blood cell superoxidase function test, are also a common.2,3 There was also no mention in this study of diet, smoking, alcohol, drug use or dyslexia, in adolescents with a mean age of 15 years. Dyslexic individuals are all likely to be zinc deficient and have higher copper levels as children. Adolescent dyslexic females have particular trouble coping with hormone-induced changes in mineral levels which increase their educational difficulties. They can easily suffer from low self esteem, which can in turn result in eating disorders such as anorexia and bulimia. 4,5 While I am sure good cognitive behaviour therapy can be beneficial to young people who are struggling to cope with abnormal brain chemistry, surely correcting any biochemical deficiencies and advising avoidance of common social poisons should be the first priority? 1 Stulemeijer M, de Jong L W A M, Fiselie T J W, et al. Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. BMJ 2005; 330: 14 2 Grant ECG. Nutritional deficiencies found in ME/CFS patients. http://bmj.com/cgi/eletters/330/7498/1012#106029, 6 May 2005 3 Grant ECG. Nutritional deficiencies and food and chemical allergies in ME/CFS patients. http://bmj.com/cgi/eletters/330/7498/1012#106241, 9 May 2005 4 Grant ECG. Psychologists ignore treatable biochemical abnormalities in dyslexia. http://bmj.com/cgi/eletters/313/7065/1096#102157, 31 Mar 2005 5 Grant ECG. Children with psychiatric disorders and learning disabilities have biochemical abnormalities. http://bmj.com/cgi/eletters/330/7494/742#102754, 5 Apr 2005 Competing interests: None declared |
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Tom Kindlon, Unavailable for work due to ill-health Dublin, Rep. of Ireland
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Given that the objective of this study was to "evaluate the efficacy of cognitive behaviour therapy for adolescents aged 10-17 years with chronic fatigue syndrome", some people might be interested in the size of an effect measure, the Cohen's d value, which has been calculated by Malouff et al[1]. For a meta-analysis of the efficacy of CBT for CFS patients, they calculated, d, using the following method: "Separate mean effect sizes were calculated for each category of outcome variable (e.g., fatigue self- rating) and for each type of outcome variable (mental, physical, and mixed mental and physical). Studies generally included multiple outcome measures. For all analyses except those that compared different categories or types of outcome variables, we used the mean effect size of all the relevant outcome variables of the study." The d value for this study (see Table 1) is 0.31. For anyone unfamiliar with Cohen's d values, they are not bounded by 1; also, the higher the score, the bigger the "effect size" i.e. the more "effective" a treatment was found to be. Cohen's d values are considered to be a small effect size at 0.2, a moderate effect size at 0.5, and a large effect size at 0.8[2]. Tom Kindlon [1] Malouff, J. M., et al., Efficacy of cognitive behavioral therapy for chronic fatigue syndrome: A meta-analysis. Clinical Psychology Review (2007), doi:10.1016/j.cpr.2007.10.004 [2] Cohen J: Statistical power analysis for the behavioural sciences. Edited by: 2. New Jersey: Lawrence Erlbaum; 1988. Competing interests: Assistant Chairperson, Irish ME/CFS Association - for Information, Support & Research (voluntary position) |
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Tom Kindlon, Unavailable for work due to ill-health Dublin, Rep. of Ireland
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Apologies: I forgot to include the 95% Confidence Intervals for this study that Malouff et al[1] calculated: -0.16 to 0.79 (as already stated, mean for Cohen's d of 0.31) (See Table 1). Tom Kindlon [1] Malouff, J. M., et al.: Efficacy of cognitive behavioral therapy for chronic fatigue syndrome: A meta-analysis. Clinical Psychology Review (2007), doi:10.1016/j.cpr.2007.10.004 Competing interests: Assistant Chairperson, Irish ME/CFS Association - for Information, Support & Research (voluntary position) |
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Ian Hodgson, Psychologist Palmerston North N.Z 4710
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We need to take the results of such clinical research into cfs lightly because it is easy to tear it to bits with rigorous research criteria. If conclusions are drawn from treatment programs which impute the cause of the illness then we do need to tear it to bits. The variables which render such research to be nearly useless are well known: 1. Poor diagnostic criteria (which introduce high levels of error from the start). 2. Highly varied symptomatology add to those errors. 3. Self reporting of symptoms and symptom changes via questionnaires. 4. Control over the variables of treatment protocols. 5. Un-blindedness of clinician/experimenter. etc. CBT is nothing more than teaching someone to learn how to adapt to adverse circumstances. My experience tells me that with cfs: 1. Some psychosocial and environmental events affect the intensity of symptoms. These seem to be somewhat idiosyncratic. 2. Some thoughts and attitudes are adaptive or maladaptive in the effects of any illness. 3. Some behaviours and habits can exacerbate or moderate some neurological symptoms. CBT is about understanding and controlling 1-3 in order to reduce symptoms to enable a person to live more effectively. In particular to increase the person's control over their symptoms and the course of the illness. If a CBT programme does that measurably then one can say it was effective, just as you would say a smoking cessation programme was effective if helped 20% of participants to quit smoking for more than 5 years, compared to no programme. Locus of control is inversely proportional to depression so a programme which averted depression could also be said to be effective. Assuming that co-morbid depression would be a worsening consequence of cfs. I often find myself walking people through the above to avoid an implication that psychological assistance implies psychological cause because people with cfs get touchy about this subject. I must also emphasise that the most effective aids to cfs: selective analgesics, deep relaxation, physical exercise and cognitive behaviour therapy have been no guide to its cause. I do agree with another reviewer that we don't really need any more research into CBT's effectivenes for cfs. We need some hard research into identifying its causes and some commitment to do that and cease the hurtful and trite psychologising which happens when clinical medicine does not know the cause of an illness or has no bio-markers. I have suffered from cfs/fibromyalgia for 13 years, my wife for 2 years and my daughter for 2 years. Why oh Why? Competing interests: None declared |
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