How Fine do you have to get ? My recent BMJ Responses
From BMJ : http://www.bmj.com/cgi/eletters/340/apr22_3/c1777
Stouten's comments are concerning because he is quoting fatigue as a cardinal symptom of CFS, which is fine if you separate CFS from ME and admit that you are really just looking at people who just have fatigue conditions rather than a neurological disease.
However people with ME do not even have to have a diagnosis of Fatigue, to have ME ; it is a glaring mistake to not use the Canadian criteria to define the group of people used in the research , which would much more clearly identify ME patients.
Looking at the percentages, quoted in Stouten, he points out that 86% of people still had significant fatigue at 70 weeks and 26% were made worse, which seems to suggest that these people probably had ME and the other 14% did not.
ME is an exhausting illness , however the fatigue the study should have been looking at is post exertional fatigue, which has nothing to do with "illness beliefs", or the fatigue the study was looking at, but with well documented (5000 + published papers)multi-system physical dysfunction.
It is a travesty to claim that this poorly identified group of participants represents ME only and more worryingly that Wearden et al are now scrabbling about with a fine tooth comb just to find any measurable change in fatigue at all.
Interestingly Wearden et al haven't even identified what percentage they have now arrived at.
The Chalder scale will, by definition, represent non-ME Fatigue, rather than the post exertional fatigue which is the hallmark of ME , because it is based upon illness beliefs and not physical illness. This is presumably why it only comes up with at best a "clinically modest " result.
When is it time to admit that this is not the way to go to help people with ME ?
More than enough time and money have spent on looking at wrong illness beliefs; a ridiculous issue to be focusing on, for such a severely physically and disabled group of people, who need biomedical input.
When will it be acknowledged that the biopsychosocial pathway has never been appropriate for ME, because it denies the physical truth ?
.........................
To which Goudsmit replied and here is my response to her :
Goudsmit's statement :".. the FINE Trial was designed just after the publication of the Canadian criteria and it's therefore rather unfair to criticise Wearden et al for not using what were at the time little known clinical criteria which had not yet been evaluated for use in research" cannot be allowed to go unchallenged.
The Oxford criteria upon which the FINE trial was based , were drawn up by psychiatrists in 1990 and broaden the 1988 Holmes et al CFS criteria to include all those with psychiatric “chronic fatigue" , while specifically excluding those with neurological disorders. ( Sharpe et al 1991)
Used only by a small group of English psychiatrists (the Wessely-school) and by the university of Nijmegen, Netherlands (Neilson 2002), the Oxford criteria , by definition, exclude all those with authentic Ramsay-defined ME from study .
By the time the MRC announced that the Oxford criteria were to be used as the criteria for the PACE/FINE trial, in May 2003, they had been well and truly superseded :
Research, for example, published in 2002 found that in terms of 'who has ICD ME/CFS' ? :
CDC1998 criteria 80% plus may have ME/ICD-CFS
CDC1994 criteria 40% may have ME/ICD-CFS
'Oxford' criteria 10% may have ME/ICD-CFS
(Neilson 2002)
Additionally , it is particularly significant how US researchers noted in 1999 that : “ "neither the 1988 nor the 1994 case definition identifies the sickest patients because information about symptom severity is not required to make a diagnosis of CFS” ( Hill et al 1999)
The FINE trail was supposed to be about those most severely affected.
In 2004 Lord Warner, confirmed that the UK accepted that ME/CFS is a neurological disease , listed as such by the World Health Organisation (WHO) under ICD-10 G93.3, yet the PACE/FINE trials still set out to study only psychosocial management regimes and treatments using as a set of criteria "ICD10: 48.0" : "Mental and Behavioural Disorders"; subtitled "Other Neurotic Disorders" (Neilson 2002)
Patients wrote to the MRC in 2004 pointing out how the Canadian Clinical Case Definition , "was produced by an Expert Medical Consensus Panel of eleven physicians who between them treated/diagnosed over 20,000 ME/CFS sufferers worldwide, enabling medical practitioners to more easily distinguish ME/CFS, with its pathological fatigue, from ordinary fatigue and other fatiguing illnesses." (Kennedy 2004)
Given that they specifically exclude people with ME from study, there was no compelling reason, whatsoever, to have based the FINE trial upon the Oxford criteria; apart from a serious case of discrimination.(cf Neilson 2002)
As Hooper (2010) points out the MRC's PACE/FINE trials:
".. seemingly inhabits a unique and unenviable position in the history of medicine. It is believed to be the first and only clinical trial that patients and the charities that support them have tried to stop before a single patient could be recruited and is the only clinical trial that the Departmen t for Work and Pensions (DWP) has ever funded."
Goudsmit states : “ the emphasis on fatigue in research into CFS and CFS/ME is unfortunate. “ The FINE trial results ,at least, have proved how true that is.
References ;
Hill et al 1999 Natural History of Severe Chronic Fatigue Syndrome. Arch Phys Med Rehab 1999:80:1090-1094).
Hooper (2010) Magical Medicine : How to Make a Disease Disappear http://www.investinme.org/Article400%20Magical%20Medicine.ht m
Kennedy A (2004) ME/CFS, complaint letter template http://www.prohealth.com/fibromyalgia/blog/boardDetail.cfm? id=370090
Neilson L(2002) New Canadian clinical definition - ME/CFS http://www.cfids-cab.org/cfs- inform/CFS.case.def/me.cfs.canadian.def03.txt
Sharpe et al (1991) A report – chronic fatigue syndrome: guidelines for research. JRSM 1991:84:118-121).
Stouten's comments are concerning because he is quoting fatigue as a cardinal symptom of CFS, which is fine if you separate CFS from ME and admit that you are really just looking at people who just have fatigue conditions rather than a neurological disease.
However people with ME do not even have to have a diagnosis of Fatigue, to have ME ; it is a glaring mistake to not use the Canadian criteria to define the group of people used in the research , which would much more clearly identify ME patients.
Looking at the percentages, quoted in Stouten, he points out that 86% of people still had significant fatigue at 70 weeks and 26% were made worse, which seems to suggest that these people probably had ME and the other 14% did not.
ME is an exhausting illness , however the fatigue the study should have been looking at is post exertional fatigue, which has nothing to do with "illness beliefs", or the fatigue the study was looking at, but with well documented (5000 + published papers)multi-system physical dysfunction.
It is a travesty to claim that this poorly identified group of participants represents ME only and more worryingly that Wearden et al are now scrabbling about with a fine tooth comb just to find any measurable change in fatigue at all.
Interestingly Wearden et al haven't even identified what percentage they have now arrived at.
The Chalder scale will, by definition, represent non-ME Fatigue, rather than the post exertional fatigue which is the hallmark of ME , because it is based upon illness beliefs and not physical illness. This is presumably why it only comes up with at best a "clinically modest " result.
When is it time to admit that this is not the way to go to help people with ME ?
More than enough time and money have spent on looking at wrong illness beliefs; a ridiculous issue to be focusing on, for such a severely physically and disabled group of people, who need biomedical input.
When will it be acknowledged that the biopsychosocial pathway has never been appropriate for ME, because it denies the physical truth ?
.........................
To which Goudsmit replied and here is my response to her :
Goudsmit's statement :".. the FINE Trial was designed just after the publication of the Canadian criteria and it's therefore rather unfair to criticise Wearden et al for not using what were at the time little known clinical criteria which had not yet been evaluated for use in research" cannot be allowed to go unchallenged.
The Oxford criteria upon which the FINE trial was based , were drawn up by psychiatrists in 1990 and broaden the 1988 Holmes et al CFS criteria to include all those with psychiatric “chronic fatigue" , while specifically excluding those with neurological disorders. ( Sharpe et al 1991)
Used only by a small group of English psychiatrists (the Wessely-school) and by the university of Nijmegen, Netherlands (Neilson 2002), the Oxford criteria , by definition, exclude all those with authentic Ramsay-defined ME from study .
By the time the MRC announced that the Oxford criteria were to be used as the criteria for the PACE/FINE trial, in May 2003, they had been well and truly superseded :
Research, for example, published in 2002 found that in terms of 'who has ICD ME/CFS' ? :
CDC1998 criteria 80% plus may have ME/ICD-CFS
CDC1994 criteria 40% may have ME/ICD-CFS
'Oxford' criteria 10% may have ME/ICD-CFS
(Neilson 2002)
Additionally , it is particularly significant how US researchers noted in 1999 that : “ "neither the 1988 nor the 1994 case definition identifies the sickest patients because information about symptom severity is not required to make a diagnosis of CFS” ( Hill et al 1999)
The FINE trail was supposed to be about those most severely affected.
In 2004 Lord Warner, confirmed that the UK accepted that ME/CFS is a neurological disease , listed as such by the World Health Organisation (WHO) under ICD-10 G93.3, yet the PACE/FINE trials still set out to study only psychosocial management regimes and treatments using as a set of criteria "ICD10: 48.0" : "Mental and Behavioural Disorders"; subtitled "Other Neurotic Disorders" (Neilson 2002)
Patients wrote to the MRC in 2004 pointing out how the Canadian Clinical Case Definition , "was produced by an Expert Medical Consensus Panel of eleven physicians who between them treated/diagnosed over 20,000 ME/CFS sufferers worldwide, enabling medical practitioners to more easily distinguish ME/CFS, with its pathological fatigue, from ordinary fatigue and other fatiguing illnesses." (Kennedy 2004)
Given that they specifically exclude people with ME from study, there was no compelling reason, whatsoever, to have based the FINE trial upon the Oxford criteria; apart from a serious case of discrimination.(cf Neilson 2002)
As Hooper (2010) points out the MRC's PACE/FINE trials:
".. seemingly inhabits a unique and unenviable position in the history of medicine. It is believed to be the first and only clinical trial that patients and the charities that support them have tried to stop before a single patient could be recruited and is the only clinical trial that the Departmen t for Work and Pensions (DWP) has ever funded."
Goudsmit states : “ the emphasis on fatigue in research into CFS and CFS/ME is unfortunate. “ The FINE trial results ,at least, have proved how true that is.
References ;
Hill et al 1999 Natural History of Severe Chronic Fatigue Syndrome. Arch Phys Med Rehab 1999:80:1090-1094).
Hooper (2010) Magical Medicine : How to Make a Disease Disappear http://www.investinme.org/Article400%20Magical%20Medicine.ht m
Kennedy A (2004) ME/CFS, complaint letter template http://www.prohealth.com/fibromyalgia/blog/boardDetail.cfm? id=370090
Neilson L(2002) New Canadian clinical definition - ME/CFS http://www.cfids-cab.org/cfs- inform/CFS.case.def/me.cfs.canadian.def03.txt
Sharpe et al (1991) A report – chronic fatigue syndrome: guidelines for research. JRSM 1991:84:118-121).
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