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by Mette M. Andersen, MD (Denmark).
Thank you for the opportunity to comment on the Draft Clinical Practice Guidelines on the evaluation of prolonged fatigue and the diagnosis and management of chronic fatigue syndrome.
I have worked as a physician for 16 years in hospital practice and in Public Medicine. My work has included co-authorship as well as censorship of clinical guidelines for physicians and patients. I have had an affiliation with the Danish ME/CFS society as a consultant for several years.
The technical impression is good and the figures and drawings are excellently performed. The draft is easily read and understood, the language is fine.
There are however in my opinion some serious problems with the contents of the draft, six of which are listed and discussed below.
1. Confusing CFS with "fatigue states".
2. Underestimation of the various organic symptoms needing medical attention.
3. Overestimation of Cognitive Behavioral Therapy.
4. Recommendations about exercise that are dangerous for CFS patients
5. Mixing of evidenced based medicine with popular beliefs and hearsay.
6. Failure in guidance for the most sick CFS patients.
The title of the draft report is "Chronic fatigue syndrome". This is rather misleading, since the report mostly deals with "the spectrum of fatigue states".
CFS is defined by the WHO ICD-10 as an encephalopathy, ie a disease of the nervous tissue. Chronic fatigue on the other hand is in ICD-10 classified among the psychiatric diseases (F48).
If the Working Group intentionally overlooks or disagrees with the WHO, this should be clearly expressed in the guidelines.
The draft report correctly mentions the CDC definition for CFS (Fukuda K et al.1994) as being the best and most relevant case definition at present. However there is no consistency in where and when this definition is being used in the draft and in the references cited.
By constantly mixing the different disease categories, the reader is left somewhat confused and annoyed. In substance the results of the incorrect and disturbing mixing of the different diseases are:
This is very difficult to understand for someone who has worked closely with CFS patients for many years. Maybe the Working Group found "the easy way out" and disregarded all organic symptoms as non-existing. However, the current state of knowledge about CFS does not leave room for this. It must be considered outdated in relation to CFS to equal the phrase "medically unexplained" with a psychiatric condition. Preferably and more correctly the term should be "medically not yet explained".
In most CFS patients fatigue is not the worst problem. Loss of cognitive skills weigh stronger as well as pain, arthritis, sleep problems or allergies.
Most clinical characteristics of CFS differ from those of depression. The fluctuations occur over hours, days or a few weeks,(in opposition to the circadian rhythm and seasonal variation seen in major depression).The pattern differs from one patient to another and within patients too. By disregarding this profound characteristic of the disease, references to recovery studies may be misleading. Some "recoveries" may be expressions of statistically normal variations in terms of remission phases.
The guidelines should point this fluctuation out as a very important clue to the pathophysiology of CFS.
On p.2, box 2 a graph is presented showing the supposed percentage of patients with continuing symptoms of CFS versus time. A "model" of CFS it's called. There are no references given to support this "model" which is understandable, since it is unsubstantiated. It contrasts all evidence known to researchers and patient support groups regarding CFS.
Faults like this may discredit the entire report.
The following examples are literature that should have been included in the draft:
1. Bates DW et al. Archives Int Med 1995;155(1):97-103.
2. Bennett AL et al. J Clin Immunol 1997;17(2):160-6. 3. Bennett AL et al. J
Psych Res 1997;31(1):91-6. 4. Chaudhuri A et al. J Chron Fatigue Syndr
1997;3(1):3-16. 5. Dinan TG et al. Psychoneuroendocrin 1997;22(4):261-7. 6.
Franklin AJ. BMJ 1997;315:947.
7. Hilgers A & Frank J. J Chron Fatigue Syndr 1996;2(4):35-47.
8. Jason LA et al. Am Psychologist 1997;52(9):973-83.
9. Lapp CW. Am J Med 1997;103(1):83-4.
10. Lerner AM et al. Infect Dis Clin Practice 1997;6:239-43.
11. Lerner AM et al. ibid p.327-33.
12. Lerner AM et al. ibid 6(2):110-17.
13. Lutgendorf S et al. J Chron Fatigue Syndr 1995;1(2):23-41.
14.Shepherd C & Macintyre A. BMJ 1997;315:947.
15.Strayer DR et al. J Chron Fatigue Syndr 1995;1(1):35-53.
16.Suhadolnik RJ et al. Clin Infect Dis 1994; 18(1):96-104.
17 .Suhadolnik RJ et al. J Interferon Cytokin Res 1997;17(7):377-85.
General practitioners (GPs), specialists and caretakers for CFS patients are faced with multiple questions deriving from medical problems other than fatigue symptoms, the most frequent being:
When and how should this condition be evaluated and treated? Should increased salt intake and/or Florinef be prescribed?
Both muscular pain, headache and generalized pain is common in CFS patients. Whether on not to prescribe medication and what kind of pain killers should be used is very important problems that cannot be ignored.
If the patient have these problems to the degree that he cannot attend at social occasions, then what? What medications can be prescribed?
Are there any help to offer patients for improving severe cognitive impairment? What can the doctor do if the patient insists on driving his car despite the family being frightened about him doing so?
What help is there to offer here?
Is it any use to prescribe medications here or does the patient "just have to learn to live with it"?
Should the usual clinical judgement be used here for when to prescribe NSAIDs and/or prednisone, and should one take into consideration the fact that CFS patients can have low cortisone response (Demitrack et al.1991) ?
New allergies often develop during the course of CFS, where and by whom should this be managed?
Mostly patients describe this as recurrent flu-like symptoms, and if these symptoms were diminished much more physical and mental exercise could be obtained. Is there any help to hope for?
Should the extra systoles/heart palpitations be treated. Is there any case for giving antibiotics (Lerner et al. 1997)? The Guidelines do not in my opinion provide sufficient guidance for the GPs to answer these questions. Neither do the Guidelines suggest to what specialist(s) the patient should be referred (neurologist, rheumatologist, infectious diseases specialist, toxicologist, gastroenterologist, psychiatrist, virologist, endocrinologist).
The disease model adopted by the Working Group, where CFS is mixed with "fatigue states" and the organic symptoms disregarded, is the basis necessary for the recommendations by the draft on cognitive behavioral therapy (CBT) for all fatigue sufferers.
However, the emphasis on CBT is not justified by the research cited.
The basic assumption by the draft, that it is incorrect illness beliefs that causes the inactivity in people with CFS is wrong. Just the opposite is true (Friedberg & Krupp 1994).
Loss of motivation is certainly not a feature of CFS.
Although CBT can prove to be effective in reducing fatigue, it has never been proven to be effective in treating headaches, pain, cognitive difficulties, food sensitivities, cardiac abnormalities or NMH.
All in all the recommendations of behavioral schedules would be appropriate for depressed people, but seem to be misplaced and wrong in the context of CFS.
Although it may be good advice for healthy persons recovering or for tired, fatigued persons without CFS, it is not known how graded aerobic exercise will affect people in the initial phases of CFS. Equally important, neither is it known how exercise affects the more severely sick patients. In fact no research has ever been done into the appropriate advice regarding rest/activity in the first weeks and months of CFS.
By nature CFS is a fluctuating disease and mostly so in the early phase. It repeatedly waxes and wanes over days or a few weeks (as opposed to the circadian rhythm and seasonal fluctuation of major depression). The great majority of patients with CFS are as active as possible and are functioning at the upper limit of their ability. The greatest danger does not come from inactivity, but from overexertion.
Nobody has ever before recommended exercise to people having infections, active autoimmune diseases or unresolved brain disorders. If the Working Group feels the time has come for this, they must argue much better for its safety. Alternatively, the Working Group must prove the increasing amount of research suggesting organic/biochemical disease processes involved in CFS wrong.
I know this is out of order, but one gets the impression that the person who wrote the chapter about exercise has had no direct clinical contact with CFS patients.
The following quotes from the draft are examples of unverified, exaggerated or wrong statements:
p.2 "No pharmacological agent has been reliably shown to be effective treatment for CFS". In the case of Ampligen this statement could be proven wrong shortly. Many pharmacological agents have shown their effectiveness for sleep, pain and allergic problems in CFS patients. The statement should be updated with current knowledge.
p.3 "People with CFS may have increased susceptibility to drug side effects". This is a very popular quote being repeated over and over also in the public media, but where is the scientific basis to support it?
p.4 FAQ box "people with CFS who have been ill for less than two years have a high likelihood of recovery within the following two to three years". This is only wishful thinking with no evidence to back it up.
p.12 "In fact, as the diagnosis of CFS currently identifies a heterogeneous group of people, it is unlikely that any one diagnostic test will emerge". As the paper cited (Hickie et al.1995) to back this statement up, is a statistical multiple variables analysis of symptoms it cannot provide evidence for whether or not there exists pathophysiological heterogeneity in CFS.
p.17 "at least 30% - 50% of people with CFS typically demonstrate improvement in the non-specific (or placebo) treatment arm of controlled trials". If one calculates the mean placebo response from the studies cited in Table 4, it is less than 20%. I don't know how else to reach a mean figure for placebo response, so the draft must be exaggerating the figure.
p.17 "any claim that a particular treatment can cure most people with CFS is likely to be spurious, or the treatment will be acting via a non-specific mechanism". In light of the current lack of knowledge about the exact pathophysiological mechanisms underlying CFS, the above statement is absurd. Only the future will show if one treatment can cover most cases or not. (Ironically the draft itself points at one single therapy suited for all: CBT).
p.21 "In CFS, sleeping longer does not improve physical or mental functioning". This is not only unproven by research, it is also counterproved by CFS patients by their own experiences.
p.22 "a psychologically determined response to infection or other stimuli occurring in `vulnerable´ individuals." There is no evidence to support this in the papers cited. This looks more like a moral judgement.
p.22 "retrovirus do not cause CFS". A statement like this can by nature only refer to known retroviruses.
The most sick CFS patients are those that are housebound, needing a wheelchair or even to be in bed part of the day due to exhaustion.
These guidelines offer the GP no assistance in how to manage these patients, or how to support their families. The number of patients in this category is underestimated and there is no guidance in how to address their specific medical problems. These people are at risk of being diagnosed with somatization, and the guidelines have no suggestions on how to avoid this. Moreover, there are specific needs to be met in the paramedical fields. Who should the GP cooperate with and what are the financial prospects?
Due to the major problems described above, there should be re-writing of many chapters of the draft. Author(s) suited for this task should be certified in Internal Medicine and have had long time experience in treating CFS patients.
With new information accumulating fast and doctors and patients with access to the Internet, it is very important for these guidelines not to be outdated before publication.
Mette M. Andersen, MD
February 1998
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Moira A Smith - Canberra, Australia
last revised 22 February, 1998