General practitioners' perceptions of chronic fatigue syndrome and beliefs about its management, compared with irritable bowel syndrome: qualitative study
BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.38078.503819.EE (Published 03 June 2004) Cite this as: BMJ 2004;328:1354
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If there is one thing reading this debate has proved to me it is that
at present the only way out of this maze is for people with CFS/ME to take
responsibility for their own diagnosis and treatment.
Sadly it is the nature of the illness and economic reality to make
this an impossibility for many patients and so they are dependent upon
what the medical profession and the NHS has to offer them. In my
experience this falls far short of what may be desirable, with all
investigations ceasing as soon as a diagnosis of CFS was pronounced and
even routine prescriptions for symptomatic relief doled out on a strictly
rationed basis.
My own burgeoning health improvement after many years in a wilderness
of pain, fatigue and confusion is the result of a great deal of reading,
asking questions, a small number of relevent tests, a very few private
medical consultations and self medication.
The gentleman who suggests a new title for the illness NIME is bang
right in my view.
I am treating my immune system and at least one previously
undiagnosed chronic infection with a herbal medicine, my hypoadrenia and
hypothroidism with hormones and my pain and inflammation with herbs and
simple detoxification methods.
Unfortunately even these modest treatments would be out of the
question without relatives who are willing to foot the bill.
Victoria Loughlin
http://health.groups.yahoo.com/group/ME-CFS-FMS_infections/
Competing interests:
None declared
Competing interests: No competing interests
On one hand we have the ME patient community trying their best to
bring doctors’ attentions to the worldwide sound and scientific research
confirming the physiological aetiology of ME, and on the other hand a
group of psychiatrists ignoring most of this research in order to claim ME
as belonging to their own speciality. Their insistence upon the use of the
term CFS and the Oxford Criteria is further proof of the lengths these
psychiatrists will go to in an attempt to sell what is nothing more than
an untenable theory.
Whilst all this is going on ME patients are losing hope that this
dire situation in the UK will change, that the games and tactics will
finally come to an end, and that common sense will finally prevail. To add
to their frustrations tax payers money is being spent on PACE, which by
this stage in the debate must be recognised as a complete waste of such
valuable funds; whilst none of this tax payers money it would seem is
being used for scientific research into the causes, or the effectiveness
of more applicable treatment protocols being used outside the UK. Why?
Many of us have asked that the internationally recognised Canadian
Definition and Guidelines on treatment be put in place in the UK and there
are very good reasons for our doing so. The definition is more clear-cut
and so would put an end to those patients with less specific forms of
chronic fatigue being placed under the same diagnostic label as patients
with ME. This would immediately invalidate the PACE trails as they stand
now, so hence the reluctance on the part of Professor Simon Wessely, Dr
Peter White et al. to adopt them. They would also provide our GPs with the
information they need to treat us. So is refusing to adopt these
guidelines fair on GPs? I think not. Lastly it would ensure that the small
percentage of ME patients who have access to the new ME clinics and
centres of excellence will be offered treatments that will actually help,
rather than those which have already been proven potentially harmful.
Competing interests:
None declared
Competing interests: No competing interests
Sir
In response to Peter Morrells' question re. LGS:-
You could say all reality is nebulous, even dogs and telegraph poles,
depending on how you wish to represent them - do we not live an illusion?
Certainly disease tends to be nebulous, even the most widely researched
eg. HIV-AIDS remains nebulous since it is dependent on the isolation of,
and thence description of, a virus which (even after isolation) remains
nebulous at certain levels due to investigatory limitation.
The references I gave already in my previous response suggest that
scientists have already investigated the concept of LGS and have produced
a working description - as 'working' as so many medical concepts and
models.
From my TCM perspective and experience with ME/CFS sufferers I agree
with the viability of LGS because most, if not all, ME/CFS sufferers I
have treated this past 15 to 20 years show signs of 'small intestinal (SI)
dysfunction' - I won't go into detail of how that is diagnosed in TCM.
Food intolerances, and IBS, seem at times to create SI rather than LI
dysfunction (hence medics define IBS as 'irritable' suggesting
unidentifiable, guessing dysfunctional, without obvious physically
identifiable signs in the LI) in my ME/CFS patients who respond rapidly to
dietary change and acupuncture & moxibustion treatments involving SI
'manipulation'. People have described their IBS as feeling 'poisoned'
after certain foods, distended gut, much flatulence, tending to be
reversed by avoidiong certain foods (often cereals) with which they never
had a problem before developing IBS/CFS/ME. They may suffer several days
'fluiness', as though having a systemic infection which relieves within 4
to 7 days, from those foods and as the food would be expected to leave
their system and their immune systems restore order.
Their symptoms are often like those of 'infection', but in this case
(LGS like) are caused by specific dietary triggers (individualised to the
person); they are not unlike the kind of symptoms experienced by a person
who is found to have a physical lesion in the colon, but in many of these
IBS/CFS/ME sufferers the colon shows no abnormality by endoscopy plus many
IBS sufferers have normal regular stools, but have recurrent discomfort
bloating and wind which seems to affect the SI mainly and at times the LI.
Many of these IBS/ME/CFS sufferers appear to have contracted their
condition from a vaccination - typically Hep B or Anti-Tetanus which
research tends to support. Others have been prescribed anti-biotics during
a viral illness and found that their recoverey was suddenly halted on
taking anti-biotics leading to a downward spiral until CFS/ME is diagnosed
months later. Quite a number of my ME/CFS patients were able to check
dates of origin of their first taste of 'strong and unusual fatigue' early
in the illness and on checking vaccination dates found either Hep B
(medical workers) or anti-tetanus vaccinations were received within a week
or so of the onset of a downward spiral in health to what became ME/CFS.
To sum up, the idea of a damaged SI 'leaking' contents into the blood
stream is not new, it is supported by research, by scientific
plausibility, by signs and symptoms and patient histories, by lack of
other medical explanations for IBS as defined by Western Medicine; and for
me also by TCM diagnostic practices and concepts. Which part of the
spectrum from 'real' to 'nebulous' LGS lies must ultimately depend on a
sufferer's experience - it's 'real' enough to them.
Regards
John H.
Competing interests:
None declared
Competing interests: No competing interests
Sir
In response to David Jameson's
"Mr Heptonstall appears to have an irrational, negative attitude to
the idea that someone might recover from CFS due to the placebo effect. I
would suggest that it is because of attitudes like his that the state of
CFS research is in such a poor state"
I can assure David that I do not have a negative attitude to the idea
of placebo 'cures' for any condition, but I do have a negative attitude to
the idea that everyone who declares themselves 'cured' of CFS achieved
their cure by placebo.
I can also inform David that about 7 or 8 years ago I put a case to
several bodies that funded 'research into ME/CFS' as my Clinic has a good
response for ME/CFS sufferers - 'cures' and 'much improveds'. However, I
was surprised to find that curing and much improving ME/CFS was not of
high priority for research funds, one had to be researching biochemical
aspects of the conditions to gain funding - ie. be lab-based and not
'successful' Clinic-based much to my surprise and that of a number of
patients, and practitioners who had agreed to assist the project designed
to cost little for the patients and for which all staff had agreed to work
for little reward and to put a great deal of time in - we are that
committed. Some of the staff had 'recovered' from ME at my Clinic and
thereafter studied with me to become practitioners.
No doubt CFS research suffers from a variety of difficulties, I
suspect my attitude to placebo interventions is not one of them , not
least that the main 'cures' appear to emanate from the alternative &
complementary field which does not feature highly for research funds,
especially as most funding is pharmaceutical company derived nowadays;
with all the tax and subsidy pleasures those companies aspire to the
government obviously thinks that's a better way to spend our taxes than
fund research into treatments that cure disease.
Regards
John H.
Competing interests:
None declared
Competing interests: No competing interests
My apologies to John Heptonstall for not being clearer. What I really
wanted to know was whether LGS is a real entity or whether it is some
'idealised fiction.' I will try to make this a little clearer.
We human beings tend to arrange the contents of our experience along
a spectrum of real at one end—familiar and undisputed things like dogs and
telegraph poles—to nebulous at the other end, such as electrons, God, the
Milky Way. These often key concepts are at bottom essentially intangibles,
unknowables and nebulosities, the existence of which can only ever be
inferred at best, and which can never be confirmed directly through
personal experience; we take them very largely on trust, or reject them as
our personal experience dictates. And in between these extremes, reside
those things of an intermediate nature being either real but never
experienced or experienceable but not tangible...etc.
Many of these can be justly regarded as, "idealised entities,”
fictions compounded out of observed uniformities,” concepts and
categories” conditioned by human aims.” [Berlin, 301] Ultimately, all such
concepts comprise “a set of formulas, of imaginary entities and
mathematical relationships,” [Berlin, 302] that is, things made rather
than found.
Therefore, when someone says: "can Flegg show me visual
evidence...[for HIV] if Flegg can produce such evidence then I will be
convinced. To say that 'HIV' exists even though we cannot see it with all
the resources of modern technology is a bit like asking us to believe in
the Holy Ghost! Flegg would do well to distinguish between science and
theology," [Russell] then the answer is often no, one cannot always
observe the actual thing because it is an inferred entity, more strictly a
fiction that evidence points to as a probability, but which nobody has
actually seen.
Likewise when someone says, “your body is the temple of the Holy
Ghost,” [Corinthians Ch 5, v7] these are inferred entities, disputed
things, fictions, and concepts, apparently very different from dogs and
telegraph poles. Perhaps the 'distinction between science and theology'
that Russell requests, is far more subtle, blurred and, ahem, leaky than
we suppose.
Although there are fictional entities, we might consider why human
reasoning cannot proceed very far without them. I will use some quotes
from a book about medicine 500 years ago, but the points still remain
remarkably valid. The "rational doctor breaks down the composite and
confusing reality with which he is faced, and proceeds to inferences about
it." [Maclean, 204] Medicine is "an art relying on probabilities, facts
and inference...from effects to cause." [Maclean, 231] Medical knowledge,
just like any other, "has to be translated out of the order of sense into
the order of intellect...[including] intelligibilia which are not part of
the perceivable natural realm [such as privation, or infinity, or the
vacuum]," [Maclean, 235] but which nevertheless possess "coherence and
explanatory force." [Maclean, 35]
While some things clearly are "totally obvious of themselves,"
[Maclean, 235] others are "so hidden that man cannot understand them."
[Maclean, 235] Some things "in themselves are beyond mankind's grasp; the
mind of humans has to reduce everything to its own limitations." [Maclean,
235] In other words, we automatically construct external reality in our
own terms, just as mice, eagles and elephants must do the same, each
extracting the parts relevant to its own "station o' life," [Dickens, 375]
while ignoring or not even seeing the rest. Nature in the form of
"external reality is thus paradoxically both self-evident and
hidden...[and] the ability of man's mind to capture it either fully or
accurately through the senses or through the intellect can be doubted."
[Maclean, 236]
My guess therefore is that LGS is an intermediate concept, being more
inferred than observed, made rather than found. Perhaps I am wrong;
perhaps the gut wall has been shown to be leaky?
In any case, in nature cure and in herbal medicine the concept of
auto-toxication does not involve the ileum, as the LGS theory seems to
claim [correct me if I am wrong], it involves the colon and it is through
the colon that 'decomposing food wastes' are presumed to enter the blood
stream to cause bad breath, pimples, smelly armpits and a host of other
symptoms. When you consider the health effects of enemas, colonic
irrigation, and the views of many naturopaths and herbalists, then it is
the colon, which is implicated in auto-toxication, rather than the ileum.
My question therefore is this: is John Heptonstall, or anyone else,
saying that LGS definitely involves the ileum and is not the same as the
naturopathic concept of auto-toxication involving the colon? If so, where
is the evidence for it?
Hopefully, that is now a little clearer.
Sources
Isaiah Berlin, Georges Sorel, in Against the Current: Essays in the
History of Ideas, London: Pimlico, 1997, pp.298-302
Charles Dickens, The Pickwick Papers, 1836
Ian Maclean, Logic, Signs and Nature and in the Renaissance, the Case
of Learned Medicine, Cambridge: Cambridge University Press, 2002
Alexander H Russell, Response to Peter Flegg, 21 Apr 2004
http://bmj.com/cgi/eletters/328/7438/523-b#57276,
Competing interests:
None declared
Competing interests: No competing interests
Why did it take a housewife to discover the Lyme epidemic?
What lack of scientific method, behavioral problem or mental flaw made
doctors oblivious to what a Polly Murray, a housewife armed only with an
arsenal of common sense could see so clearly?; That the "genetically
induced Juvenile Rheumatoid Arthritis" that doctors were diagnosing in
Lyme Connecticut occurred at a rate of increasing prevalence distinctly
uncharacteristic of a "genetic" illness.
Polly Murrays book "The Widening Circle" describes her battle against
doctors who insisted that the Lyme epidemic was "All In Your Head" despite
unimpeachable evidence to the contrary.
Even after the contradiction of the "statistically almost impossible"
increasing prevalence was pointed out to doctors, they still failed to
respond in a scientific manner.
Physicians have the audacity to produce "scholarly" papers on the
mental behaviors of obstinate patients who refuse their recommendations
for mental health interventions while evidence continues to mount that the
entire crisis of patient confidence is being created by the inexplicable
behaviors of the physicians themselves. Where are the studies that explain
these repetitive failures of a "common sense" approach in doctors?
No patient expects all doctors to be all knowing, but at the same
time, denial of incontrovertible evidence and skepticism in the face of
obvious abnormalities by a significant number of doctors is undermining
the credibility of an institution whose function absolutely demands it.
The errors of omission that are so consistently being made were the point
of a lesson by the renowned physician, Sir William Osler who taught his
medical students the importance of keen observation. A memorable example
occurred one day when he showed his students a small bottle of a patient's
urine and told them that "this bottle contains a sample for analysis. It
is often possible by tasting it to determine the disease from which the
patient suffers." He demonstrated this by dipping his finger into the
bottle and tasting it, after which he instructed his students to do
exactly as he had just done. The students, with some trepidation and each
in turn, dipped their finger and sampled the bottle's contents, trying to
determine what important lesson they were about to learn. Osler surprised
his students by holding up the bottle and saying, "Now you will understand
what I mean when I speak about details. Had you been observant, you would
have seen that I put my index finger in the bottle but my middle finger
into my mouth!"
I believe that any physician who survived a course of study under Sir
William would have seized upon the clues that modern day doctors overlook
in favor of total reliance on their catalog of lab tests. It is the power
of observation that distinguishes a diagnostician from a pill purveyor.
It is training of the sort that Sir William Osler conducted which is
required to stem the crisis in confidence created by those doctors whose
practice includes medical malfeasance.
-Erik Johnson
Competing interests:
None declared
Competing interests: No competing interests
Sir,
Mr Heptonstall thinks I have "something against" people taking
responsiblity for restoring their health. That is certainly not the case,
and if he looks back at my message he will see this. I simply pointed out
that Erik Johnson's reason for why he recovered is probably incorrect.
Mr Heptonstall appears to have an irrational, negative attitude to
the idea that someone might recover from CFS due to the placebo effect. I
would suggest that it is because of attitudes like his that the state of
CFS research is in such a poor state.
If Mr Heptonstall is really as open-minded as he claimed in a
previous message, he is welcome to contact me by email and I will be happy
to have a discussion with him.
David Jameson
Competing interests:
None declared
Competing interests: No competing interests
Objectives - To compare general practitioners' perceptions of ME/CFS
and to consider the implications for patients.
Design - Qualitative analysis of transcripts of BMJ Rapid Responses.
Participants and setting - A randomly selected sample of Rapid
Responses in the BMJ
Results - Doctors who favour the Wessely schools' functional somatic
theory tended to stereotype patients with ME/CFS as having certain
undesirable traits. This stereotyping was due to a lack of empathy for
sufferers and contempt for the Hippocratic oath; ignorance of the
neurological classification (G93.3): a systematic denigration of a
neurological disease by those with a clear conflict of interest: the
(F48.0) mis-classification of ME/CFS by members of the Wessely school, and
a subsequent 'non-disease' poll in the BMJ. These factors have led to
difficulties for many general practitioners in managing patients with
ME/CFS.
Conclusions - Barriers to the sound research and clinical management
of patients with ME/CFS are partly due to doctors' faulty illness beliefs,
which result in negative stereotyping of patients with ME/CFS, and partly
the BMJ for not taking into account the best available evidence. The
consequence of these barriers have led to a contempt for sufferers which
can only be described as being tantamount to abuse.
Competing interests:
Struggling to survive on £43 per week since September after being refused Incapacity Benefit because of doctors' faulty illness beliefs - currently waiting an appeal.
Competing interests: No competing interests
Editor -
"Several randomised controlled trials, confirmed by four systematic
reviews, have shown that the benefits of both cognitive behaviour therapy
and graded exercise therapy considerably outweigh the risks in ambulant
adult patients" (White, Wessely & Sharpe, 7th June 2004)
Given the high drop out rates from these psychological/behavioural
trials of GET/CBT, the methodological inadequacies referred to in one of
these systematic reviews (1), the use of the confounding "Oxford
criteria", and the fact that these interventions are not "remotely
curative" (2) but only "modestly effective"(2), I am intrigued to know
what the authors are implying when appealing to "evidence based medicine"
(EBM).
It would appear that very few outside the particular field of
psychiatry promoting GET/CBT feel even remotely enthused over these rather
dismal results, and seem not to be persuaded that merely invoking
"evidence based medicine" (Randomised Controlled Trials) and "systematic
reviews" will magically transform this lack of enthusiasm.
If the results of these now rather aged "treatment approaches" are in
fact so modest and non-curative, then presumably, after all this cooking
time, there must be something quite wrong with the Basic Science
supporting these "treatment approaches" (see below).
Since reading Sehon and Stanley`s "Philosophical analysis of the
evidence-based medicine debate" (3) which reframes EBM`s alleged "paradigm
shift" within the more reasonable and less sensational Quinean "web of
belief" metaphor, I am rather more cautious when observing an appeal about
"treatment approaches" where the invocation of "EBM" (RCT`s, reviews etc)
appears to be rather hopefully backing up that appeal.
To illustrate something of the issues involved, a few passages from
that essay may be worth considering:
------------------------
Over the past decade, the term "evidence-based medicine" (or EBM) has
gained considerable currency. EBM has been described as a "paradigm shift"
[1] that will "change medical practice in the years ahead."[2] Some
suggest that the principles of EBM should be part of the standard training
of all physicians and that those physicians who violate its precepts
should ultimately face license suspension.[3] Critics of EBM claim that
"there is no evidence (and unlikely ever to be) that EBM provides better
medical care," and that EBM is simply "following its own political
agenda."[4] Other critics use even harsher rhetoric, claiming that EBM's
assumptions are "absurd" and "irrational".[5] Some commentators claim a
middle ground by saying that EBM and other approaches should be
"harmonized".[6]
The critics argue that EBM proponents overemphasize the value of
clinical trials. These critics suggest that there are other aspects to
medicine. Some note the fundamental role of basic science in understanding
the physiologic mechanisms of the body, the biology of disease, and the
cellular targets of drugs.[5,7] There are also critics who emphasize the
value of clinical experience and the judgment of individual physicians; [7
-10] these critics sometimes emphasize the art of medicine, [10] and
contrast this with the science of medicine, or they speak of techne vs.
theory or compassion vs. reason. And other critics might argue that there
are circumstances in which observational studies (or outcome studies)are a
better choice than clinical trials [11].
----------------------------
As has been noticed by others [7,13], the debate about the value of
EBM has been muddied by an unfortunate tendency to define the term
"evidence-based medicine" in an overly broad manner. For example, here is
one definition of EBM that has some claim to being authoritative: "The
conscientious, explicit and judicious use of current best evidence in
making decisions about the care of individual patients" [14]. In a similar
vein, Brian Haynes writes "Advocates of evidence-based medicine want
clinicians and consumers to pay attention to the best findings from health
care research that are both valid and ready for clinical application".[15]
Taken at face value, these definitions seem merely to say that EBM is the
wise use of the best evidence available. Given that characterization
alone, it would be astonishing that there is any dispute about EBM. It
would be equally astonishing that anyone could think EBM, defined in this
manner, revolutionary or even useful. After all, who could possibly be
opposed to using the best evidence wisely?
The very term "evidence-based medicine" seems similarly vacuous – as
if any alternative to EBM means doing medicine based on something other
than evidence. Even homeopaths base their treatments on evidence of a
sort, and we suspect that homeopaths would even claim that they are
conscientiously and explicitly using the best evidence available. Of
course they are wrong about the latter claim, but nothing in these
standard definitions of EBM tells us why homeopathy fails to be evidence-
based medicine. Furthermore, few would suggest that the very idea of using
evidence in medicine constitutes a revolutionary paradigm shift. Perhaps
advocates of the term "evidence-based medicine" have a philosophical
theory of evidence, a theory according to which everything that has passed
for evidence prior to the EBM movement was not evidence at all. However,
if they have such a theory, we have not seen it expressed.
-----------------------------
At the same time, Brian Haynes acknowledges that"most scientists and
EBM advocates are ignorant of the philosophy of science and give little or
no thought to constructing a philosophical basis for their
activities."[15]
-----------------------------
It seems to us that when proponents grandly describe EBM as a
paradigm shift, they not only make a philosophical mistake, but they
inadvertently have an unfortunate effect on the debate about the first
order questions, for talk of paradigm shifts unduly polarizes the debate
about the value of EBM.[23] Recall that Kuhn describes a paradigm as the
"entire constellation of beliefs, values, techniques, and so on shared by
the members of a given community".[19] When proponents of EBM suggest that
it is a new paradigm, this certainly fosters the impression that an entire
set of beliefs, values, and techniques is to be left behind, and that the
whole world of medical research and clinical practice is completely
different than it was in the days before EBM was recognized. This in turn
strongly suggests that physicians have a stark choice: accept the new
regime and completely reject the old, or defensively hold on to the old
and reject EBM entirely. If something as grand as a complete shift of
paradigm is in the offing, then the old physicians, with their old
understandings, training, and paradigm, are relics to be removed as soon
as possible. The prospect of this kind of consequence would certainly lead
to a defensive retrenchment and even anxiety. If you exaggerate the claims
for EBM, you intensify the natural defensiveness of those who feel
themselves not to be completely in line with the new regime. This is not a
productive atmosphere in which to hold a debate about the merits of EBM.
----------------------------
EBM and Basic Science
From our knowledge of human physiology, disease, and pharmacology we
might be able to infer whether a particular drug would be effective in
treating a given condition. With the basic science approach, we work up
from our knowledge of physiology and biochemistry to a prediction of what
will happen. Clinical trials essentially ignore, or suspend temporarily,
all of that and determine whether a treatment works by trying the
treatment in a large number of cases under controlled conditions.
Basic science and RCTs thus represent two different paths to
answering intervention questions. Seen explicitly in terms of the web
metaphor, RCTs seem to take the shortest path possible from the periphery
of the web towards the mid-web space where clinical decisions are made.
Within the course of a clinical trial, we will make observation statements
that seem very directly relevant to our original treatment question, for
we will be observing clinical endpoints for other patients with condition
Y when given treatment X. The basic science approach, on the other hand,
looks rather different. On the basis of biochemistry and physiology, we
might predict certain clinical endpoints for patients with condition Y
when given treatment X. These predictions will be based on a very
different set of observation statements than those involved in RCTs. The
observation statements that ultimately support the basic science approach
will be those that support our knowledge of biochemistry and physiology.
Although EBM and the basic sciences embody different approaches, this
does not mean that they are competitors. In fact, the two approaches need
each other; neither can stand alone. This is perhaps easiest to see with
basic science. If basic science could give us perfect confidence in the
safety and efficacy of an intervention, then clinical trials would indeed
be theoretically superfluous. However, we rarely, if ever, can be certain
of both the safety and efficacy of a treatment without clinical testing,
for our knowledge of the human body and how it interacts with the
environment is far from complete.
While it is perhaps less obvious, the method of clinical trials is
also not able to stand alone. RCTs can sometimes give us confident answers
to intervention questions even when our basic scientific knowledge is
insufficient for this purpose (e.g., on many questions concerning diet and
exercise); however, this does not mean that RCTs are completely
independent of basic science. If nothing else, a controlled trial needs a
hypothesis to test. Typically, treatments will be suggested as candidates
because of other more basic scientific research. A classic case of this is
the accidental discovery of penicillin by Alexander Fleming, though
Fleming himself initially paid little attention to the possible
therapeutic uses of the mold.[26] Contemporary basic scientific work on
thalidomide provides another example.[27]
But there is also a more fundamental way in which RCTs cannot stand
apart from basic science. Even when a clinical trial returns positive
results in the treatment arm that satisfy tests of statistical
significance, we will have more confidence in these results when they have
some antecedent biological plausibility.[28,29] Put more generally, we
would suggest that the degree of confidence appropriate for a clinically
tested claim is a function of both the strength of the clinical result and
the claim's antecedent biological plausibility. This relationship is
perhaps obscured by cases in which we understand very little about the
pharmacology of a drug (e.g., treatment of ulcerative colitis with
sulfasalazine). In such cases, it is perfectly appropriate that strong
clinical results yield a reasonably high degree of confidence. But we
shouldn't forget that we would be even more confident if the results were
exactly what biochemistry and physiology would lead us to expect.
More importantly yet, if the basic sciences gave us very strong
reason to believe that a drug would not be effective, then it is
appropriate to be very cautious when interpreting apparently positive
clinical results. For example, there have been some RCTs of homeopathic
remedies according to which subjects receiving the homeopathic remedy did
better than those receiving a placebo, and where the P-values are less
than .05 or even less than .001.[30] However, given that homeopathic
remedies are typically composed of nothing more than water, accepted basic
science should lead us to seriously doubt that these 'drugs' can be
effective. In any event, we cannot simply accept that pure water (in the
form of a homeopathic medicine) is medically effective unless we are also
willing to revise much of our basic scientific conception of chemistry and
the body. The interior of the web acts as a compass we use to interpret
the direction we should take from signals from a new RCT. Statistical
information from an RCT is virtually uninterpretable and meaningless if
stripped away from the backdrop of our basic understanding of physiology
and biochemistry. The dependence of RCTs upon the backdrop of basic
science is unsurprising from the Quinean perspective. The point is
essentially an application of the Quinean doctrine of holism, the claim
that our theories are put to the test as whole bodies rather than being
tested sentence by sentence. (Tonelli and Callahan [31] make a similar
point about the need for theory in interpreting empirical results.
However, they suggest that evidence concerning alternative medicine should
be weighed and interpreted in terms of its theory of disease, e.g.,
theories involving undetectable spirit essences or the like. This does not
follow at all. If we are judging the effectiveness of alternative
medicinal therapies, then we evaluate the evidence in light of the theory
about disease that we believe to be true. It would be a silly and
pointless exercise to evaluate evidence in light of a theory we believe to
be false.)
The dependence of RCTs on basic science appears not always to have
been fully appreciated by some EBM proponents. In some discussions of
hierarchies of medical evidence, basic physiology and biochemistry is put
at the very bottom or is ignored altogether.[14,32] Thus, these proponents
of EBM seem to say that we should only look at evidence from RCTs (when we
have it), and that medical practice is conducted in isolation of our
understanding of physiology and biochemistry. We claim that such views are
wrong.
On the other hand, this is not to say that if a clinical result flies
in the face of our physiological understanding that we should just reject
it out of hand, as suggested by Couto [5]. In general, given the
complexity of the human body and our nascent knowledge of it, if we use
basic science alone to judge the safety or efficacy of an intervention,
then our judgment will be fraught with a high degree of uncertainty. For
example, some laboratory evidence suggests that estrogen might have a
positive effect on brain cells, and thus suggesting that hormone therapy
might help to ward off dementia. However, a recent controlled trial
strongly suggests that whatever positive effect such hormones have, these
effects are outweighed by negative effects.[33] On the other hand, in an
extreme case like homeopathy, where the biological plausibility is so low,
our background biological knowledge does and should affect our
interpretation of the evidence from RCTs.
-------------------------------
If there are EBM proponents who think that medical practice can be
reduced to an algorithmic application of evidence from RCTs, they are
certainly mistaken.[37]
________________________
Sincerely
Douglas T Fraser
1.Interventions for the Treatment and Management of Chronic Fatigue
Syndrome A Systematic Review Penny Whiting, MSc; Anne-Marie Bagnall, PhD;
Amanda J. Sowden, PhD; John E. Cornell, PhD; Cynthia D. Mulrow, MD, MSc;
Gilbert Ramirez, DrPH Journal of the American Medical Association Vol.
286, #11, pp. 1360-1368
2. Chronic Fatigue Syndrome - Trials and Tribulations Simon Wessely,
MD, MSc, FRCP, FRCPsych, FMedSci Journal of the American Medical
Association
Vol. 286, #11 September 19, 2001
3.A philosophical analysis of the evidence-based medicine debate
Scott R Sehon and Donald E Stanley BMC Health Services Research 2003,
3:14 doi:10.1186/1472-6963-3-14
http://www.biomedcentral.com/1472-6963/3/14
Competing interests:
None declared
Competing interests: No competing interests
Possibility of more rapid recovery from CFS may change G.P.'s attitudes
Dear Sir/Madame
I would like to comment on the article “General practitioners’
perceptions of chronic fatigue syndrome and beliefs about its management,
compared with irritable bowel syndrome: qualitative study” that appeared
in BMJ 328: 1354–1356 (5 June 2004).
The article concerns barriers to the management of patients with
chronic fatigue syndrome, and, as it suggests, if effective medications
were available for the illness it would clearly help apart from the
patient’s own efforts at self-help. Stereotyping is an almost insuperable
obstacle otherwise.
I am a doctor who developed severe symptoms of ME/CFS early in 2000,
immediately after confirmed Influenza A. The illness lasted until April
of this year. I then had a rapid recovery following the use of small
doses of nimodipine (Nimotop, Bayer) prescribed by a North Berwick doctor
who himself had had ME for 15 years. He had undertaken self-
experimentation with the medication. My GP now prescribes it for my CFS
but I need it only rarely.
I attended a number of concerts at the recent at the recent Edinburgh
Festival. I haven’t been able to do anything like this for 4½ years and I
now have things that I only dreamed of coming true. I understand exactly
what it is to be stereotyped but I believe effective medication can
dramatically improve the health of a person with CFS for the better and
change general practitioners’ perceptions of the patient as improvements
occur. Everyone feels more positive. Something can be done now.
Yours sincerely,
Marilyn McNeill (Dr)marilynm@medix-uk.com
Competing interests:
None declared
Competing interests: No competing interests