| Jan van Roijen 2005-01-15, 2:08 am |
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10 January 2005
Editorship : j.van.roijen@chello.nl
Outgoing mail scanned by Norton AV
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The well-known ME expert Dr. Abhijit Chaudhuri - Senior
Lecturer in Clinical Neurosciences of the university of Glasgow
(UK) - wipes the floor with a new study from the biassed CFS
Group of the university Nijmegen (Jos van der Meer, Gijs
Bleijenberg, et al. - loyal followers of the psychiatric Wessely
school)
~jvr
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Rapid Responses to:
PAPERS:
Maja Stulemeijer, Lieke W A M de Jong, Theo J W Fiselier,
Sigrid W B Hoogveld, and Gijs Bleijenberg
Cognitive behaviour therapy for adolescents with chronic fatigue
syndrome: randomised controlled trial
BMJ 2005; 330: 14
Full text at:
http://bmj.bmjjournals.com/cgi/content/full/330/7481/14
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http://bmj.bmjjournals.com/cgi/elet...0/7481/14#91025
Insufficient data, inappropriate conclusion
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3 January 2005
Abhijit Chaudhuri,
Senior Lecturer in Clinical Neurosciences
University of Glasgow
I have a few concerns regarding the design and interpretation of
this published trial (1).
First, the trial arms were not matched for the number of contacts
with the health care professionals. Experience from larger and
more carefully controlled randomised interventional trials of
patients with chronic fatigue syndrome has clearly shown that
short-term improvement in symptoms are directly related to the
maintenance of regular contacts with the health care
professionals rather than due to the therapeutic effect of the
intervention itself and consequently, the improvement is not
sustained once the contact is lost (2).
The authors did not offer patients in their waiting list the
opportunity to meet therapists regularly for five months but
without having cognitive behaviour therapy (CBT).
In addition, there are no follow-up data regarding patients in the
intervention arm beyond five months to show that the specific
treatment benefit was carried forward in the absence of regular
contacts with the therapists.
Taken together, one has to be extremely cautious in inferring
direct benefit from CBT in the intervention arm (as opposed to
short-term benefit from close contact with therapists) and such a
claim would only reflect uncritical belief in the efficacy of CBT.
Second, the authors indicated that a proportion of their patients
were “passive”, i.e., adolescents who spend “most time lying
down and go out infrequently… most do not attend school at all”
(p2, intervention).
The baseline characteristics show that all participants were
attending school - either full time or part time (Table 1) and yet
nearly a third of patients in the intervention arm were considered
to be “passive” by the authors.
I am not sure if these data are compatible with their own
definition of passivity (1). May I ask what were the outcome
results of subgroup analysis in the so-called “active” and
“passive patients?
Third, the results (Table 2) did not show how many adolescents
in each arm returned to full-time schooling, clearly a more
meaningful and simpler index of response to therapy.
Fourth, it was suggested that the intervention (CBT) was
effective by challenging patients’ belief that activity would
aggravate symptoms (p2, “intervention” and p5,“what this study
adds”).
If it is true, then I am afraid the authors challenged a scientific
fact because epidemiological data confirm that fatigue made
worse by exercise is a characteristic feature of adolescents at
risk of chronic fatigue syndrome (3).
Encouraging activity in disabled patients is entirely different from
challenging an accepted feature of the disease: e.g., when a
patient with hemiparesis is encouraged to walk, the existence of
weakness due to a stroke is not challenged.
Finally, the trial recruited relatively small number of patients and
given a high drop-out rate (nearly 20%) of the participants in the
intervention arm, there is a possibility of Type 2 error.
In conclusion, the study does not have the strength to conclude
that “CBT is an effective treatment for chronic fatigue syndrome
in adolescents”(1).
Amendments regarding the conclusion and the rhetorical
summary point of this paper are to be expected from the authors
and/or the editors. Failure to do so would perpetuate the view
that the BMJ has a selective bias towards research that
supports a psychological view of chronic fatigue syndrome
irrespective of the quality of the presented material.
References:
1. Stulemeijer M, de Jong LWAM, Fiselier TJW, Hoogveld SWB,
Bleijenbrg G. Cognitive behaviour therapy for adolescents with
chronic fatigue syndrome: randomised controlled trial. BMJ
2005; 330: 14-18.
2. Blacker CV, Greenwood DT, Wesnes KA, et al. Effect of
galantamine hydrobromide in chronic fatigue syndrome: a
randomized controlled trial. JAMA 2004; 292: 1195-204.
3. Mears CJ, Taylor RR, Jordan KM, et al. Sociodemographic
and symptom correlates of fatigue in an adolescent primary care
sample. J Adolesc Health 2004; 35: 528e.21-6.
Competing interests: None declared
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