Although this report was submitted by Craig Ellis in MAY 2002 for the Royal
Australian College of Physicians and the Consumer Health Forum, to have a representative
to produce a draft Clinical Practice Guidelines for Chronic Fatigue Syndrome.
.
He made recommendation but as far as I know they were never officially adopted.
The CFS community
invested time and effort to make submissions and contribute to the process.
Some people were angered while others, disillusioned.
The evidence-based clinical practice involves not only the best
available research
evidence, but also exercise of the practitioner's clinical judgment, taking
account of individual
patient preferences.
Will the guidelines cause genuine harm to people with CFS or will they benefit people with CFS and be of assistance to their
doctors?
The physicians' maxim is, 'First do no harm', and so it should be with the
guidelines.
The whole purpose of the guidelines is to assist people with CFS by instructing
their doctors in appropriate methods of diagnosing and managing the illness, and
by educating doctors about different aspects of the illness.
In the view of CFS health consumers who made submissions to the Working Group,
the greatest potential for harm arising from the use of the guidelines lies in
the application of the management strategies of graded exercise therapy (GET),
cognitive behaviour therapy (CBT) and sleep management. There should be a collaborative approach between the patient and doctor.
"Cognitive behavioural therapy should be used on an individual basis if
possible. A consistent pattern of living - including work, rest, sleep and
physical activity - should be applied, and a slow increase of daily activities
introduced. It should be explained that even a slow increase in physical
exercise can cause an exacerbation of symptoms, but often these subside with
time and there is improvement." 3
"Recently, cognitive behaviour therapy has been shown in randomised, controlled
trials to be an
acceptable, effective treatment for CFS; of importance is the fact that
improvements are sustained
and continue over 6-12 months of follow-up." 4
People with CFS can face years - even decades - of illness, and many endure an
incredible amount of suffering.
When there is no cure, the ideal situation for anyone with a chronic disease is
to experience just the disease itself without all the accumulated stresses and
problems that compound the difficulty of managing the condition. Factors such as
social isolation and loss of confidence are not trivial in the context of
long-term disability; similarly, the adverse pathophysiological consequences of
extended periods of inactivity cannot be dismissed lightly. This is why the
guidelines state that
"... people with CFS should be encouraged to adopt the widest possible view of
the medical, physical, and psychological management strategies to assist in
coping with the illness."1
The non-pharmacological management strategies advocated in the guidelines
address issues that are common to chronic illness. That is, issues that are
overlaid on the disease process itself. For example, exercise - graded or
non-graded - has been shown to be helpful for at least some people in several
chronic diseases that are associated with severe fatigue and other symptoms well
known to people with CFS. These diseases include post-polio syndrome, rheumatoid
arthritis, multiple sclerosis and FIBROMYALGIA.
This was obviously not a graded exercise program. The approach taken by this
doctor falls well outside the approach advocated in the guidelines (which were
not available in their present form when these unfortunate circumstances
occurred). Mistreatment could still occur, even now that the revised guidelines
have been published!
The real issue is whether the problem lies with the guidelines themselves, or
with individual practitioners who do not follow the recommendations in the
guidelines. For example, with just about any prescription drug it is possible to
harm people by giving them a dose that is higher than that recommended. The
approach taken in our society is not to ban medical drugs because of their
potential for harm if misused, but to deal specifically with those doctors who
do not comply with recommended dosage levels.
If graded exercise programs are misused or misinterpreted by some doctors, the
problem clearly lies with those doctors and not with the guidelines. The
guidelines do recommend a cautious approach and do discuss limitations in the
available evidence. The focus should be on those doctors who abuse the therapy,
as it would be if any other form of medical malpractice had been inflicted on a
patient.
In reality, it is a futile exercise to try and eliminate graded exercise from
the CFS agenda. A much more constructive approach is to educate doctors and
patients about its appropriate use in a primary care setting.
The issue of sleep management is not particularly well covered in the
guidelines. However, the guidelines now properly acknowledge that evidence for
the effectiveness of sleep management strategies in CFS is lacking, and just
provide suggestions based on what has been found to be helpful in other
illnesses. The guidelines are now trying to be helpful rather than dogmatic. I
believe that if the content and intent of the guidelines are followed, the
implementation of the sleep management strategies will not cause genuine harm to
people with CFS. The acknowledged lack of evidence means that doctors and
patients who try different sleep management strategies
cannot justifiably have pre-determined expectations of what the outcome should
be. If, by cutting out daytime naps, a patient's condition deteriorates to the
extent that there is more than a short term, minor exacerbation of symptoms,
there is no basis in the guidelines for the doctor to insist that this strategy
should be maintained in the hope of improvement in the future.
T
a) Do the guidelines address issues of importance to people with CFS?
Do they treat CFS as a serious illness?
Do they treat people with CFS with respect and empathy?
Do they treat CFS as a medical illness, a psychological illness, or something in
between?
Do they adequately describe CFS as experienced by the patient?
Are the management strategies advocated presented in such a way that they are of
practical use?
Are the management strategies advocated presented with appropriate cautions
about the uncertainties in the evidence and the potential harmful effects of the
treatments?
Are day-to-day problems, as experienced by people with CFS, adequately
acknowledged?
Is the feedback provided by consumers to the Working Group reflected in the
guidelines?
Overall, are people with CFS given a 'fair go'?
b) Do the guidelines address issues of importance to doctors?
Are major issues such as diagnosis and management adequately addressed?
'Do the guidelines address issues of importance to
doctors?
"[The link between infections and CFS remains uncertain."
"These studies indirectly suggest the presence of a chronic viral infection, but
are far from constituting proof of such infection."
"So far, no microbes have been isolated and correlated to symptoms."
"Although not specific for CFS, depressed NK cell function has been consistently
seen. The clinical
implications of this finding remain uncertain."
"Other markers of immune activation also have been found…It is not clear that
these abnormalities have any relationship to the symptoms reported by patients
with CFS."…………
"Thus, there is considerable evidence of abnormalities in the CNS, particularly
the limbic system, in patients with CFS. The aetiology of the abnormalities, and
their relationship to the symptoms of CFS, remains obscure."
These statements were made in a November 1999 review co-authored by Professor
Anthony Komaroff Like those in the guidelines, the comments in this review
reflect the uncertain significance associated with many pathophysiological
findings in CFS. This does not mean that there is not a pathophysiological
basis to CFS, but simply that the research is 'work in progress' and it is too
early to draw firm conclusions about the exact nature of the pathophysiological
processes responsible for making people sick.
If the results of overseas epidemiological studies are applicable in Australia,
then it can be expected that between 40,000 and 140,000 Australians will meet
research criteria for CFS at any one time. An even greater number of people will
have idiopathic chronic fatigue, and these people will also come under the
influence of the guidelines.
A cynical distrust now permeates some people's views of the guidelines and the
Working Group. This outcome was unnecessary and should have been avoided.
Because there are aspects of the guidelines that could be improved
significantly, it is difficult to give them unqualified support. The following
points represent my major concerns with the published version of the document:
Discussion of the spectrum of severity of CFS, and the symptoms that may be
associated with the illness, is poor. This will not necessarily affect the
process of diagnosing CFS, but doctors may be confronted with symptoms they do
not associate with CFS, which could cause unnecessary confusion. It would have
been more helpful if the guidelines contained a table detailing the outcomes of
CBT/GET trials. This would have allowed both doctor and person with CFS to make
better-informed decisions about the effectiveness, relevance and appropriate use
of these therapies. The detection and treatment of neurally mediated
hypertension could have legitimately been discussed in Chapter 3, and would have
potentially given GPs another avenue by which to help some of their CFS
patients. Treatment options other than fludrocortisone do exist.
Far more CFS health consumer "evidence," as provided in written submissions
could have been included. This inadequacy calls into question the interpretation
and use of the National Health and Medical Research Council's "levels of
evidence" as required in evidence-based guidelines. CFS health consumer
experience can often be seen to be ahead of research projects and agenda. Such
experience needs to be treated more seriously. Other suitable formats within the
guidelines could have been used to enable their expression. It could also be
used to pre-empt
suitable research projects.
The guidelines receive at least a satisfactory grade for the issues listed as
Level 1 and Level 2 priorities, as discussed previously. For Level 3 priority
issues I believe some problems still exist, but in the overall context of the
guidelines these problems are generally minor (but annoying nonetheless). For
Level 4 priority issues, the guidelines receive an unsatisfactory grade owing to
problems with the guideline-development process. However, as I discussed above,
the
impact of the process on the content of the guidelines - and thus on the
overwhelming majority of people with CFS - is very limited.
Craig Ellis B.A., B.S.W. (Hons), Cert. E.F.M., Cert. Adv. Eng.
June 2002
Consumer Health Forum representative, December 1996 - June 2002
Member, CFS Guidelines Working Group, December 1996 - May 2002
Member, ME/CFS Society of Victoria Inc.
