ME/Chronic Fatigue Syndrome/Fibromyalgia Association of Qld

RE: CHRONIC FATIGUE SYNDROME CLINICAL PRACTICE GUIDELINES

We wish to inform you that we have no confidence in the revised version of the above guidelines, and are extremely concerned about the potential for harm to chronic fatigue syndrome (CFS) patients. We request that the RACP withdraw its approval/auspicing from the process and take what steps it can to halt the process.

Our reasons are as follows:

1. Recommending treatments without appropriate evidence

The working group's task was to produce and to disseminate evidence based guidelines on the diagnosis and treatment of chronic fatigue syndrome (CFS) for the assistance of general practitioners. The group's recommendations for treatment and the lack of evidence are:

1. Sleep hygiene/restriction (P10-11, 43-44 revised version). The document freely admits on P11 that there is no clinical evidence for the suggestion (other than the writers' experience). Our experience and that of many doctors who treat large numbers of CFS patients indicates that many patients cannot "force" themselves into these practices, without making themselves quite ill. Trying to impose no more than eight to nine hours sleep is not reasonable.
2. Cognitive Behaviour Therapy (CBT) and Graded Exercise (GE) (P9-10, 40-43). We are a little handicapped in addressing this area due to the general lack of citations in the revised version. However, one (1) of the two (1, 2) controlled studies we are aware of that support the use of CBT, and all 3 studies said to support the use of GE (3-5) do not have an appropriately defined CFS patient group. These studies use what is commonly referred to as the "Oxford definition" which at its minimum requires only 3 months of fatigue out of 6 months (6). No other symptoms are necessary.

The working group has appropriately selected what is commonly called the "CDC revised definition" (7) as the diagnostic criteria for CFS (P15, 17). These criteria are currently generally accepted as the best we have at the present time. Under these criteria, the patient must have 6 months of fatigue that results in substantial reduction in previous levels of activity plus 4 out of 8 neurocognitive/viral symptoms: impaired memory or concentration, sore throat, tender cervical or axillary lymph nodes, muscle pain, multi-joint pain, headaches of a new type pattern or severity, unrefreshing sleep and post-exertional malaise.

As can be immediately appreciated, the CDC revised definition describes a much severer, viral-like illness compared with the Oxford definition. People under the Oxford definition may simply be "tired" for various social, behavioural or psychological reasons. This group may have absolutely no relationship to the CFS patients defined by the CDC revised criteria.

This problem and others with the studies are deftly skipped over in the third paragraph of P42, before the start of the fourth paragraph concludes, "on balance, the current evidence suggests that rehabilitative, behavioural and cognitive approaches should be an integral component of management of people with CFS." There is no "on balance" — there simply is inadequate evidence that such approaches are safe, let alone helpful, in patients with CDC defined CFS. Only a single study (2) with a reasonably well defined patient group, supports the use of CBT, and, as is pointed out at P42, two studies could not find a benefit (8) (9).

There is a further problem with these studies in that, by their nature, they can not be double blinded. Physicians, who clearly believe in the efficacy of their treatments, know whether they are giving the active arm of treatment or the controlled arm to patients. Patients know whether they are receiving CBT or GE or some other form of treatment. While this should not rule out the use of these techniques, large studies with properly defined CFS patients should be done before recommendations are made for these approaches.

2. Evidence that suggests recommended treatments may be dangerous to patients

1. There are now four studies (10-13) which confirm that a subgroup of CFS patients have a problem with othostatic hypotension (OH). This fact is not mentioned anywhere in the body of the revised guidelines. As can readily be appreciated, if this problem is left untreated, exercise or increased activity can exacerbate the symptoms. One physician has commented that she has seen patients pulses go from 120 to 40 on the treadmill, and the line between help and harm in these approaches is fine (14).
2. Three studies report the upregulation/dysfunction of an antiviral pathway (15-17) suggesting an ongoing battle with infection. One study has reported a high prevalence of mycoplasma infection (18)
3. One study (19) suggests that an early cardiomyopathy is involved.

3. Reports to patient associations of harm caused by the recommended treatments

1. In 1999, the "Panorama" program in Britain ran an "exposé" on the use of the above treatments on children. 700 parents of children with CFS were interviewed. 60% of patients had these treatments suggested to/forced upon them. Only 5% of the total were willing to take part, emphasising how unacceptable these methods are to patients. Of the 5%, none felt better and most felt worse. The program ran a number of the horror stories of those who were made sicker.
2. A survey of members by the British ME Association (ME or myalgic encephalomyelitis is a widely used name for CFS, particularly in Britain) found 38% of responders claimed to have been injured by graded exercise programs. This topped the "harm" list ahead of all other therapies including various "alternative" treatments.
3. The medical adviser to the British ME Association reports that complaints about exercise programs are now the number one complaint to the Association.
4. In relation to the parents in the Panorama story, 7% were threatened with having their child taken into Children's Protective Services Custody if they did not force their child to comply with the behavioural/exercise regimes. Some children were taken into custody. We have had a number of situations in Queensland, SA and NSW where the same thing has happened. CFS children, mainly in a hospital setting, have been made quite ill by these practices, and when parents intervene to halt the harm, they are threatened with loss of the child if they do not allow the practices to continue. In Queensland, two children were taken into custody — one is now suing the hospital involved.

4. Additional concerns

1. The revised version does not adequately take into account patients at the severe end of the spectrum - particularly those who are almost bedbound or in need of wheelchairs. They are very vulnerable to being injured and distressed by behavioural/exercise programs, and doctors must be made aware of their existence.
2. The pathology testing is far too restrictive. A number of studies suggest treatment avenues (such as with OH) or there are controlled studies supoorting certain treatments, albeit they have not reached one of the high levels of evidence. GPs and patients should be allowed to consider all reasonable possible avenues of treatment.

5. Incomplete state of the revised version

The document supplied to us has most of the scientific references missing, and diagrams/tables/boxes missing or out of order. We have not been able to obtain a updated reference list. While we appreciate

1. the working group involved were under pressure to produce something after a four year delay since the final result was supposed to be published in June 1997, and
2. the document was not meant to be a complete, final version,

meaningful comment is greatly hampered by the lack of references. We would be very disappointed if members of the working group were prepared to sign off on a document without seeing an updated reference list.

We further note that the revised version fails to refer to some critical recent studies published since the December 1997 first draft eg:

1. 2 OH studies (12,13) which have important consequences for behavioural/exercise regimes,
2. A study (20) which contradicts the assertion at P22 that a patient's belief that the illness is purely physical in origin is associated with poorer outcome,
3. A report (21) of high levels of coeliac disease in CFS patients.

These matters concern us as to whether a thorough literature review has been performed in relation to post 1997 studies.

Yours faithfully


Peter Evans
Chairperson
ME/Chronic Fatigue Syndrome/Fibromyalgia Association of Qld

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(14) Klimas N. New England Journal of Medicine HealthNews July 15, 1997, P4.
(15) Suhadolnik RJ. Upregulation of the 2-5A Synthetase/RnaseL Antiviral Pathway Associated with Chronic Fatigue Syndrome. Clinical Infectious Diseases 1994;18(Suppl1):S96-104.
(16) Suhadolnik RJ, et al. Biochemical Evidence for a novel low molecular weight 2-5A dependent RnaseL in chronic fatigue syndrome. Journal of Interferon and Cytokine Research 1997;17:377-385.
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(18) Vojdani A, et al. Detection of Mycoplasma genus and mycoplasma fermentans by PCR in patients with Chronic Fatigue Syndrome. FEMS Immunology and Medical Microbiology 22 (1998) 355-365.
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