The Young ME Sufferers Trust
www.tymestrust.org
February 2004

======

Statement and detailed commentary on the new Canadian
diagnostic criteria and treatment recommendations

======

The full title of what has become known as the Canadian Definition
document is ‘Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Clinical
Working Case Definition, Diagnostic and Treatment Protocols’.

With regard to the Definition section; this represents, in our opinion,
the best of the contemporary definitions and we would like to see its
widespread adoption. It was developed for use in a clinical setting and
has obviously been compiled by physicians with real practical knowledge
of ME.

It addresses many of the misunderstandings that have come about through
the use of catch-all definitions which have so disastrously affected
research into treatments and also infiltrated their way into clinical
practice.

We believe that if the Canadian Definition is taken into widespread use
it will be much harder for people with chronic fatigue to be categorised
along with those who have true ME/CFS.

We also endorse the use of the correct name of the illness as listed by
the World Health Organisation under ICD10 G93.3.

The consensus panel’s collective experience in diagnosing and/or treating
the illness encompassed more than 20,000 patients.

There is a good description of ‘Post-Exertional Malaise and/or Fatigue’,
differentiating well between ‘ordinary’ fatigue and what is experienced
by a person with ME/CFS. ‘For example, a patient who has bought a few
groceries may be too exhausted to unpack them until the next day.’ How
many of us have indeed experienced that particular phenomenon!

In the Commentary below we list some of the other quotes that we would
like to draw to people’s attention. In the original text these quotes do
not all appear consecutively. Please bear in mind that the document
itself is extremely long and we have just selected some particularly
noteworthy statements for quoting here. There are many others deserving
of comment. Indeed, in many respects this document is the most thorough
and the most well-written of its kind that we have seen. Our Statement
could easily be twice the length, if we were to review all the sections
of the document in more detail.

We do have reservations with the full document, some of which we list in
the appropriate place in the Commentary. Others are listed at the bottom
of this Statement. However, in our opinion these do not outweigh the
advantages that we feel would accrue if the Definition itself were in
widespread use.

COMMENTARY

In its Introduction, the document anticipates the recently published
research papers into the role of viruses in ME/CFS.

A Neurological Disease

The panel states that the illness ‘manifests symptoms predominantly based
on neurological, immunological and endocrinological dysfunction’ and that
‘viral involvement is supported by an infectious initiating trigger in at
least half of the patients.’

It also points out that standard laboratory tests will not pick up an
‘incomplete or mutated pathogen replication’ which again mirrors the
latest research that speaks of ‘defective viral replication’ as a cause.

This in turn corroborates the aggregated knowledge and opinion of
specialist microbiologists over the years and supports the WHO’s
categorisation of the illness.

Unsuitability of CDC Criteria

‘As the CDC definition was primarily created to standardize research, it
may not be appropriate to use for clinical diagnoses, a purpose for which
it was never intended. There has been a growing demand within the medical
community for a clinical case definition for ME/CFS for the benefit of
the family physician and other treating clinicians.

‘The CDC definition, by singling out severe, prolonged fatigue as the
sole major (compulsory) criterion, de-emphasized the importance of other
cardinal symptoms, including post-exertional malaise, pain, sleep
disturbances, and cognitive dysfunction. This makes it more difficult for
the clinician to distinguish the pathological fatigue of ME/CFS from
ordinary fatigue or other fatiguing illnesses.’

‘The panel felt there was a need for the criteria to encompass more
symptoms in order to reflect ME/CFS as a distinct entity and distinguish
it from other clinical entities that have overlapping symptoms. As
fatigue is an integral part of many illnesses, the panel concurred that
more of the prominent symptoms should be compulsory.’

‘We hope that the clinical working case definition will encourage a
consideration of the ongoing interrelationships of each patient’s
symptoms and their coherence into a syndrome of related symptoms sharing
a complex pathogenesis rather than presenting a “laundry list” of
seemingly unrelated symptoms.’

‘We believe this will sharpen the distinction between ME/CFS and other
medical conditions that may be confused with it in the absence of a
definitive laboratory test for ME/CFS.’

Making a Positive Diagnosis for ME/CFS

‘If the patient has prolonged fatigue but does not meet the criteria for
ME/CFS, classify the diagnosis as idiopathic chronic fatigue.’

Ideopathic means ‘arising from an unknown cause’. This positive advice,
taken together with the more stringent ME/CFS criteria, should select out
those with chronic fatigue.

Separate Secondary Symptoms and Aggravators

‘It is important to try to separate the primary features of the syndrome
from those that are secondary to having a poorly understood chronic
illness in our society…’

Fatigue

‘Some patients may be able to do some work, but in order to do that they
have had to eliminate or severely reduce other aspects of their life
activities. Such interactive effects should be considered in the
assessment of whether activity reduction is substantial.’

Differences Between ME/CFS and Psychiatric Disorders

‘ME/CFS is not synonymous with depression or other psychiatric illnesses.
The belief by some that they are the same has caused much confusion in
the past, and inappropriate treatment.’

Assessing Prognosis

The panel does not shy away from discussing chronicity or death. The
problem with prognoses based on patients diagnosed under the CDC or
Oxford criteria, many of whom may have chronic fatigue of some other
type, is that it diminishes the potential severity and chronicity of
ME/CFS in the eyes of the medical profession, the press, the public and
the benefits agency and it leads to therapies being applied to those with
ME/CFS which could potentially damage them.

‘In a nine-year study of 177 patients, 12% of patients reported recovery.
The patients with the least severe symptomology at the beginning of the
study were the most likely to recover but there were no demographic
characteristics associated with recovery.’

‘Other studies suggest that less than 10% of patients return to premorbid
levels of functioning.’ Premorbid means before they were ill.

‘As the criteria become more stringent the prognosis appears to worsen.’

‘Infrequent deaths have been reported in the acute stage due to
orthostatic cardiac irregularity.’

‘The chronic, incurable and poorly understood nature of this illness
reduces the quality of medical and social support and may increase the
risk of suicide.’

The document indicates that the prognosis for children is better but
presumably the same argument applies; that the more stringent the
diagnostic criteria, the fewer patients have a ‘satisfactory outcome’ as
they represent true ME/CFS. We feel this could be explained more clearly
with regard to children, particularly as education authorities do not
take the illness as seriously as they might.

We also regret that there is no reference to ‘Post-ME/CFS’. Many adults
diagnosed for the first time in their middle years turn out to have
originally had ME/CFS in their teens and were thought to have recovered,
rather as polio survivors develop Post-Polio Syndrome. However, these
limitations do not detract a great deal from what is essentially a good
overview of prognosis.

Treatment Protocol

‘Patient support and well-being are the top priorities.’

‘Begin to reduce uncertainty by establishing a positive diagnosis,
reassuring continuity of care, and realistic hope based on as accurate an
assessment of the patient’s individual prognosis as possible.’

In other words, the physician is encouraged to be honest. ‘Realistic
hope’ is much more useful – and kinder – than unrealistic optimism as
advocated by some doctors and even some support groups and there is less
risk of let-down, disappointment, despair and a feeling of betrayal.

‘Patient participation and empowerment: The rules of healing differ from
those of curing and must come from within. A starting point for
empowerment is to validate the patients’ self-experience and knowledge,
as that is an integral part of their healing process.’

‘The limitations of the patients’ impairments/dysfunctions are a
biological reality of their illness.’

‘Empower the patient through respect. The autonomy of patients is vital
to their physical and psychological health.’

At this point the Treatment Protocol mentions ‘programs’, starting with
the statement: ‘Begin a program at a level that will ensure the patient’s
success’ and continuing ‘Pace the program to increase very gradually and
thus ensure the patient’s continued commitment and success.’

This reads to us more like control from someone else rather than patient
empowerment; the apparent demand for commitment to a program jars with
the language in which most of the document is couched. It is, indeed,
reminiscent of some of the language used in connection with Graded
Exercise Therapy.

We wonder whether there has been some disagreement amongst members of the
consensus panel, much as there was with the UK Chief Medical Officer’s
Working Group, and whether the compromise that was reached meant that
words like ‘program’ and later on ‘goals’ were incorporated into a
document that essentially aims to advocate healing, since ‘curing’ or
‘forcing to be healed’ is not possible.

However, given the use of this terminology we cannot fault the following:
‘The goal of a management/treatment program is to empower the patient by
encouraging them to trust their own experiences, to enhance the patients’
awareness of the activities and environments in which they can cope
without exacerbating symptoms and pace themselves accordingly.’

Patient Education

‘Should include the following: teaching patients to recognize early
warning signs and prevent crashes. Practical energy conservation
information and techniques: including self-help items that assist in the
patient’s daily living and functional needs…’

ME/CFS Exercise Programs

‘As much care must be taken in prescribing exercise as in prescribing
medications to ME/CFS patients. Exercise programs must be entered
cautiously and clinical studies have indicated that symptoms worsened in
approximated half of the ME/CFS patients. Exercise programs should adhere
to the previous stated goals and guidelines and be limited to non-fatigue
exercise.’

We have concerns over this statistic. The reference to 50% of patients
becoming worse through exercise refers to studies of patients not
diagnosed under the Canadian Definition and they may therefore encompass
patients who would not have been diagnosed with ME/CFS at all under these
criteria. The proportion of true ME/CFS patients under more stringent
criteria who are made worse through exercise may be much higher.

However, under the initial patient evaluation there is this: ‘Prior to
prescribing exercise, it is important to assess the patient’s history and
physical condition with special attention to cardiac function’.

Under the section on optimising medical management before introducing an
exercise program is the welcome warning: ‘Patients whose fatigue, pain
and concomitant conditions are under control may benefit from mild
non-fatiguing exercise. Beginning an exercise program early lessens the
likelihood of the patient succeeding. Exercise is not recommended for
some patients.’

Despite this statement, in our view there is insufficient strength in the
warning about the possible consequences of exercise on those who have
ME/CFS under the more stringent criteria. Anecdotal but frequent reports
of patients being restricted to wheelchairs when they were previously
ambulant and of this lasting many years should, we feel, have been
included and overall, we do not feel that a section on exercise programs
is necessarily desirable in a document of this nature, concerned as it is
with ME/CFS and not chronic fatigue.

Perhaps the consensus view was that if doctors were going to prescribe it
anyway, they had better have detailed advice on how best to do it – and
the advice is certainly extremely detailed.

Cognitive Behaviour Therapy (CBT) and Graded Exercise Therapy (GET)

Interestingly, the review of these is more promising.

‘To ignore the demonstrated biological pathology of this illness, to
disregard the patient’s autonomy and experience and tell them to ignore
their symptoms, all too often leads to blaming patients for their illness
and withholding medical support and treatment.’

We would advise in addition that it may also produce scenarios which
leave doctors and therapists open to law suits in the event of something
going seriously wrong.

‘It is unlikely that the CBT and GET studies that were included in the
recent review of treatments [JAMA 2001] dealt with comparable homogeneous
groups since different inclusion and exclusion criteria were used in
selecting the test patients and control groups.’

Examples are given, including the one we often refer to – the fact that
the Fulcher and White study (comparing graded aerobic exercise to
flexibility therapy) excluded ME/CFS patients with appreciable sleep
disorder, when this is a typical symptom of ME/CFS (94.8% of 951 patients
studied by De Becker et al).

‘In two of the studies reviewed, 22% and 26% of patients with chronic
fatigue reported recovery, respectively, whereas none and 6% of the
ME/CFS patients recovered from fatigue. Therefore, care must be taken not
to classify patients experiencing chronic fatigue as ME/CFS patients
unless they meet all the criteria for ME/CFS, as the outcomes for these
two patient groups are substantially different.’

‘Do study results represent a true reflection of the ME/CFS population
when there is a high drop-out rate?’

The panel points out that graded exercise had ‘the highest negative
rating of any of the pharmalogical, non-pharmalogical and alternate
approaches of management […] and may help explain the high drop out rates
noted in some of these programs.’

‘The question arises whether a formal CBT or GET program adds anything to
what is available in the ordinary medical setting. A well-informed
physician empowers the patient by respecting their experiences, counsels
the patients in coping strategies, and helps them achieve optimal
exercise and activity levels within their limits in a common sense,
non-ideological manner, which is not tied to deadlines or other hidden
agenda.’

Therapeutic Principles

‘Keep the therapeutic regimen as safe, simple, effective and inexpensive
as possible.’

‘Many patients with ME/CFS are hypersensitive to medications given in the
usual doses.’

‘There is no clear specific treatment. It is still a matter of trial and
error to find effective remedies. The primary therapeutic goal of
lifestyle adjustment – to determine that with which the patient can cope
without aggravating her/his symptoms – remains of paramount importance,
and should not be neglected in the search for remedies.’

‘There is no known cure for ME/CFS; however, the physician is usually
able to help reduce the severity of the patient’s symptomology.’

The panel concludes that ‘a comprehensive biological model of a primary
role of the central nervous system in ME/CFS is emerging. The normal
coordination between the brain and the bodily systems is disrupted.’

They point out that ‘it is apparent that a primary target organ […] is
the brain’.

They recommend that ‘further studies need to be carried out on the basic
biochemistry and biology of the illness’.

They call for further research to develop ‘a standardized diagnostic test
for ME/CFS’.

They end on the note that each patient is unique and that ‘knowing
results for different subsets of patients could make the search for
effective remedies more rational and efficient’. […] ‘It is hoped that
the fruition of further research will bring a greater understanding of
myalgic encephaloymyelitis/chronic fatigue syndrome and the successful
treatment of the patient.’

RESERVATIONS AND CONCLUSION

We note that some of the medications listed have been withdrawn in the UK
for use in anyone under 18. Apart from this, and apart from those
reservations described in the text above, we have three others.

1The panel points out that ‘all the symptoms which the De Becker et al
study recommended adding [to the Definition] to strengthen the ability to
select ME/CFS patients are in our definition, except paralysis, which the
panel did not consider prevalent enough for inclusion in a clinical
definition’.

In our work with children we do not have the impression that paralysis is
so rare in this age group; it seems to resolve over time with resting of
the affected limb(s) but is an important symptom to which physicians
should be alerted. Its exclusion might lead a physician to conclude that
he was not seeing a case of childhood ME/CFS after all.

2Sleep hygiene is an offensive term that has crept into medicine and
thence into this document. It carries the implication that patients need
to be cleaned of their dirty habit of not sleeping properly!

Many of the principles of ‘sleep hygiene’ are not in our view applicable
to people with ME/CFS – children included – who need to be empowered to
sleep as and when they need to, with or without soft soothing light
and/or music or other comforting sounds, as this relieves anxiety,
especially in the small hours when loneliness can aggravate fear.

Sleep is curative and should be facilitated in whatever way brings
comfort to the sufferer. Singing a lullaby to a baby would be excluded
from good practice under strict sleep hygiene ‘rules’.

Children especially need ‘permission’ to have pleasant occupations to do
whilst in bed, to distract from pain and other unpleasant symptoms.
Indeed, some children are only able to carry out brain-work (and thus
achieve an educational result) when allowed to rest physically in bed.
Perhaps these aspects of bed-rest would have been discussed if the sleep
section had been expanded.

3The Dowsett and Colby study is referenced, and described thus: ‘A
British study showed that ME/CFS was the single most common cause of
long-term absenteeism from school in Britain.’

This is not correct. Our study showed that ME/CFS was the single most
common cause of long-term sickness absence from school.

[Long Term Sickness Absence due to ME/CFS in UK schools; An
epidemiological study with medical and educational implications. Dowsett
EG, Colby J Journal of Chronic Fatigue Syndrome May 1997 Vol 3 (2) pp
29-42]

Our overall view is that the Canadian Definition is better than any
contemporary alternative available for selecting out patients with ME/CFS
although we would have liked to see the phenomenon of clusters
highlighted, since so many children are suspected of ‘copying’ their
siblings, relatives or friends who already have ME/CFS. Clusters are
common in families, schools and other communities but misunderstandings
amongst physicians unaware of this often lead to allegations against
parents of harming their children or encouraging them in a ‘sick role’.

What the document does lack (unless it is somewhere in the small print
and we have missed it) is the positive recommendation that if patients
wish, they should be ‘allowed’ – even encouraged – to go home and get on
with things in their own way, minus any pressure to be put on ‘programs’
controlled by someone else who does not have the illness and does not
have to live with it, however kind, understanding and experienced they
may be.

Once patients have the confidence to manage their own illness, consulting
the doctor when they need to, such as when new symptoms arise, and/or
about unrelated matters, many seem to prefer this as it empowers them to
have a life of their own and not just identify themselves with an illness
that needs perpetual medical management. We would like to see this
enshrined in the recommendations.

Our final comment is simply to congratulate the consensus panel on
putting together an excellent Definition of ME/CFS and to reiterate our
own wish to see it in widespread use.

[Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Clinical Working
Case Definition, Diagnostic and Treatment Protocols. Carruthers et al
Journal of Chronic Fatigue Syndrome Vol 11 Number 1 2003, pp7-115]

======

Copyright (c) 2004 The Young ME Sufferers Trust