Psuedo Science in the UK .A Stonebird response to
Just ahead of the PACE trail report, Peter White has published a report : Psychiatric misdiagnoses in patients with chronic fatigue syndrome, which found that out of 135 participants at a PACE trail center , diagnosed with "CFS" according to the Oxford Criteria , 56% had a" co-morbid psychiatric diagnosis."
Greg Crowhurst, Sept 17th 2010
Permission to repost
Of these :
- 31% had a major or minor depressive episode
- 11% had dysthymia
- 35% had an anxiety disorder
- 2% had a an obsessive compulsive disorder
- 6% had post-traumatic stress disorder
- 8% had Social Phobia
- 15% had a "specific phobia"
There were 14 assessing doctors :
- 10 were psychiatrists (one consultant and nine trainees).
- one was a consultant physician
- three were general practitioners with a special interest in CFS.
Is this a surprise ? No !!
White’s report simply confirms how much The Oxford Criteria have nothing to do with ME.
Way back in 1999 Fred Friedberg, Clinical Assistant Professor, Department of Psychiatry and Behavioural Science, State University of New York, pointed out the differences between CBT trials in England and the US:
"Several studies of graded activity-orientated cognitive behavioural treatment for CFS, all conducted in England, have reported dramatic improvements in functioning and substantial reductions in symptomatology. On the other hand, cognitive behavioural intervention studies conducted in Australia and the United States have not found significant improvements in functioning or symptoms. Descriptive studies of CFS patients in England, the US and Australia suggest that the CFS population studied in England shows substantial similarities to depression, somatization or phobia patients, while the US and Australian research samples have been clearly distinguished from primary depression patients and more clearly resemble fatiguing neurological illnesses. " (JCFS 1999:5: 3-4:149-159).
The Oxford criteria upon which the PACE and FINE trials were 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. The Oxford criteria state: "The following guidelines were agreed. There are no clinical signs characteristic of the condition. Psychiatric disorders (including depressive illness, anxiety disorders and hyperventilation syndrome) are not necessarily reasons for exclusion". (Williams 2004)
As Margaret Williams (2004) points out : "This opens the door to the world and his wife if they feel chronically tired for longer than six months without any medically determined cause ."
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
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)
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) Carruthers himself, lead author of the Canadian Criteria, wrote to the MRC confirming that there is no valid reason why the MRC should not use those Guidelines in its studies of ME/CFS (Williams 2004)
Carruthers had previously made it clear that : "the use of these Oxford criteria for selecting ME/CFS patients is a gross violation to the "International Classification of Diseases" (ICD) of the World Health Organization (WHO), and therefore at the same time a serious case of discrimination.""Journal of Chronic Fatigue Syndrome 11(1), 2003.
A DePaul University (US) study found that patients diagnosed according to the Canadian criteria had more variables that significantly differentiated them statistically from the psychiatric comparison group, and that the Canadian criteria selected cases with less psychiatric co-morbidity and more physical impairment (JCFS 2004:12(1):37-52) but in its Clinical Guideline CG53 on “CFS/ME”, NICE recommended that the Canadian Criteria should not be used in the UK. (Hooper 2010 Biomedical Evidence Summaries http://www.stonebird.co.uk/hooper.html)
Given that they specifically exclude people with ME from study, there was no compelling reason, whatsoever, to have based the PACE and 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 Department for Work and Pensions (DWP) has ever funded."
Is Peter White really not aware, by now, that :
ME/CFS and Chronic Fatigue are not the same.
ME is formally classified as a neurological disorder in the International Classification of Diseases (ICD10:G 93.3; WHO 1992), and the ICD separately classifies fatigue syndromes as a behavioural (psychiatric) disorder (ICD 10:F 48) Researchers have failed to distinguish between ME and CFS and/or between subgroups. (Anon 2001) As Carruthers & van de Sande (2005)point out: “Chronic fatigue must not be confused with ME/CFS because the ‘fatigue’ of ME/CFS represents pathophysiological exhaustion and is only one of many symptoms.
At a Press Briefing held on 3rd November 2006 by the US Centres for Disease Control to announce its ME/CFS awareness campaign, Anthony Komaroff, Professor of Medicine, Harvard Medical School, said:
" It’s a pleasure to be here today with several people who have dedicated successfully a big part of their lives to trying to understand and get recognition for this terrible illness.
"It’s not an illness that people can simply imagine that they have and it’s not a psychological illness. In my view, that debate, which was waged for 20 years, should now be over.
"Brain imaging studies…have shown inflammation, reduced blood flow and impaired cellular function in different locations of the brain…(and) they change a person’s life.
&quuot;Today we have powerful new research technologies and tools we didn’t have even 20 years ago, and they are being put to good use by laboratories all over the world".
ME/CFS is not a somatoform disorder.
According to Nancy Klimas : "there’s evidence that the patients with this illness experience a level of disability that’s equal to that of patients with late-stage AIDS, patients undergoing chemotherapy, patients with multiple sclerosis." (Hooper 2010 Biomedical Evidence Summaries) )
The documented biochemical, metabolic, vascular, neurological and muscle abnormalities in ME/CFS patients (Williams 2004) have led to the WHO classification of ME/CFS as a neurological illness. The UK Department of Health and the WHO Collaborating Centre at the Institute of Psychiatry have agreed that ME/CFS is undoubtedly neurological. There is no published evidence whatsoever, as opposed to opinion, that ME (as distinct from chronic fatigue) is a psychiatric disorder. (Williams 2004).
Unlike somatisation disorder, M.E. is not ‘medically unexplained.’ M.E. is a multi-system disease with many organ and bodily systems affected, producing a myriad of symptoms [and] many aspects of the pathophysiology of the disease have, indeed, been medically explained in volumes of research. (ME Society of America)
ME/CFS is not “cured” by Cognitive Behavioural Therapy (CBT) and Graded Exercise (GET).
It is very well known that CBT and GET are potentially harmful to anyone with neurological ME.
The Chief Medical Officer (2002) himself warned that exercise-based regimes advocated for less severely affected patients tend not to have been studied among those most severely affected. Shepherd (2001) warns that as much care should be taken in prescribing exercise as in prescribing pharmaceuticals for ME/CFS patients do not respond to exercise in a manner that is expected of healthy people (Streeten et al 2001)
As Neil Abbot points out : "There have been only five trials of CBT with a validity score greater than 10, one of which was negative for the intervention; and only three RCTs of GET with a validity score greater than 10. …..Until the limitations of the evidence base for CBT are recognised, there is a risk that psychological treatments in the NHS will be guided by research that is not relevant to actual clinical practice and is less
robust than is claimed".
ME/CFS is considered to be a rather harmless condition by most physicians, but patients with ME/CFS are often more functionally impaired than those suffering from type 2 diabetes, congestive heart failure, multiple sclerosis, and end-stage renal disease.
It is not "fatigue" or "tiredness" that is the one essential characteristic of ME/CFS but central nervous system (CNS) dysfunction (Bassett 2006). As leading M.E. expert Dr Byron Hyde MD (2003) explains: " The one essential characteristic of M.E. is acquired CNS dysfunction, [not] chronic fatigue. A patient with M.E. is a patient whose primary disease is CNS change, and this is measurable. We have excellent tools for measuring these physiological and neuropsychological CNS changes: SPECT, xenon SPECT, PET, and neuropsychological testing.7quot;' Drs Cheney and Peterson describe ME/CFS as " A global disablement, nearly comparable to paralysis." (Johnson 1996) Dowsett comments that "Fatigue" is the wrong word. Fatigue is a silly word." (Colby 1996) Dr David Bell M.D (1995) describes the word "fatigue" as: "A very inappropriate term for what patients experience. It’s not really fatigue at all, which is defined as a normal recovery state from exertion and that is precisely what does NOT happen in this illness. "
In 2003 The Canadian Expert Consensus Panel published its medical milestone, the first clinical case definition for the disease known as myalgic encephalomyelitis/chronic fatigue syndrome, making it compulsory that , unlike the Oxford Criteria, in order to be diagnosed with ME/CFS, a patient must become symptomatically ill after exercise and must also have neurological, neurocognitive, neuroendocrine, dysautonomic, and immune manifestations. In short, symptoms other than fatigue must be present for a patient to meet the criteria. (Carruthers et al 2003).
ME/CFS is not depression.
Research, for example, shows that CFS patients show more alpha electroencephalographic activity during non-REM sleep, but this is not seen in dysthymic or major depressive disorder (Whelton, Salit, & Moldofsky, 1992). Cognitive changes are also not due to psychiatric co-morbidity (Vercoulen et al 1998 Backwood et al 1998) SPECT cerebral blood flow studies of persons with CFS show decreased blood flow in several key areas such as frontal lobes and brain stem which are different from both healthy controls (Barnden et al, 2001Costa et al, 1995) and depressed subjects (Schwartz et al, 1994; Fischler et al, 1996). PET scan studies have reached similar conclusions (Tirelli et al, 1998. Bakheit, Behan, Dinan, Gray, and O'Keane 1992) found up-regulation of hypothalamic 5-hydroxytryptamine receptors in patients with postviral fatigue syndrome but not in those with primary depression.
The predominant psychiatric paradigm, still seems to be that patients have medically unexplained chronic fatigue, and that their problems derive from deconditioning consequent on physical inactivity at best, and simple avoidance behaviour (underpinned by abnormal illness beliefs) at worst. (Scottish Cross Party Submission 2005). Yet : " no proponent of a psychological aetiology has ever hinted at the exact psychological mechanism"(Walker 2003)
What happens in ME/CFS, however, has little to do with cardiovascular deconditioning (Spence & Stewart 2004) and is more related to chronic orthostatic intolerance/postural tachycardia syndrome (POTS), caused by vascular dysfunction. Goudsmit (2005) points out that studies have shown that most patients do not avoid minimal activity and that lack of fitness is not related to the fatigue in CFS (Bazelmans et al 2001 ) . Moreover, deconditioning cannot explain the documented delay between the end of exertion and the exacerbation of symptoms, the upregulated immune system etc. (De Merlier et al 2000)
In 1996, US neurologist Dr Benjamin Natelson et al evaluated patients with ME/CFS for a placebo effect in a randomised, double blind, controlled trial and found no evidence that ME/CFS is an illness due to patients being overly suggestible or that ME/CFS is a psychogenic illness, and that: “No clear effect of any treatment has ever been demonstrated in this devastating illness” (Psychopharmacology 1996:124:226-230).
In 1996, Natelson et al examined the rates of somatisation disorder (SD) in ME/CFS relative to other fatiguing illnesses and found that the diagnosis of SD is extremely problematic in terms of its validity because it involves a series of judgments that can be arbitrary and subjective: “(ME)CFS can be viewed as an organic disease involving many organ systems or as an undifferentiated somatoform disorder. A diagnosis of somatoform disorder may be so arbitrary as to be rendered meaningless in illnesses such as (ME)CFS” (Psychosom Med 1996:58(1):50-57).
Peter White's paper , based upon a cohort defined by the Oxford Criteria, which as White himself acknowledges is predominantly people with menatl health issues, negates any justification for CBT and GET for neurological ME. At best it belongs in the realm of what psychiatrist Alan Gurwitt in 2002, termed " Pseudo-science" in the UK":
"I have often been embarrassed by and angry at many of my colleagues who fall in line with self-declared ‘experts’ who see somatisation everywhere. Ever since the mid-1980s there have been ‘researchers’ with an uncanny knack at cornering research funds because of their already-formed biases that are in synch with the biases of the funding government organisations (and who) indicate that CBT and graded exercise will do the therapeutic job, thus implying a major psychological causative factor. I have noticed the following deficits in their work, their thinking, their word choices and their methods"
When is the UK finally going to to start acknowledging the difference between those who have the WHO -classified nuerological disease called Myalgic Encephalomyeltits and those who have a chronic fatigue /mental health disorder , who are being wrongly labelled as having ME - and stop pretending that one is the other ? Both groups are in need of help, but it is unfair to both to put them together and pretend they have the same illness; in the case of myalgic encephalomyelitis it is profoundly dangerous to keep on promoting the myth that ME is a mental health disorder.
As far as ME goes, the PACE trial is a ghastly waste of money As`Linda Crowhurst (2010) points out :
" 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.
"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. ""
( Crowhurst L 2010) It Should have Been Obvious
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