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Letters to the Editor
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Complementary medicine
Are results that unbelievable?
From Mr J. A. Tweed, MRPharmS
I read, with interest, the Article (PDF 60K) by Edzard Ernst on complementary
medicine (PJ, 13 November, p722). It raises questions which
require some thought.
It is unlikely that the study results referred to are untrue, if good
clinical practice has been followed. In today’s climate of regulation,
it should be difficult for poorly designed studies to achieve approval
and ethics committee endorsement. Certainly reviewers would look at the
power of the study, the choice of patients, their defined disease as
well as the appropriateness of the proposed treatment before the study
would be approved. Is there any evidence that, in the two studies referred
to in this article, their results are that unbelievable?
If we accept the proposition of reproducible “responders” to
a treatment, presumably these patients would not respond when given a
placebo? If so, has a study been designed to compare placebo and an “active
treatment” in this group of patients? Such a study would not be
difficult to design, but might add greatly to the knowledge of these
therapies and their efficacy or otherwise.
J. A. Tweed
Nottingham
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EDZARD ERNST replies:
I agree that proper design of a trial minimises
bias and thus also the chances of false positive or false negative
results. Yet, undeniably, seemingly rigorous trials of the same treatment
do
sometimes generate findings which contradict each other. This is one
reason why systematic reviews of clinical trials can be helpful to
produce an overall “bottom line”. In the case of flower remedies,
such an approach did not yield any conclusive evidence for their effectiveness.1 Thus,
I believe, the findings of the two mentioned randomised controlled
trials are probably correct.
As to “responders”, our study was placebo-controlled and identified
responders, ie, individuals who reproducibly respond to ginkgo and reproducibly
do not respond to placebo.2 References
1. Ernst E. “Flower remedies”: a systematic review of the clinical
evidence. Wiener Klinische Wochenschrift 2002;114:963–6.
2. Canter PH, Ernst E. Multiple n=1 trials in the identification of responders
and non-responders to the cognitive effects of Ginkgo biloba. International
Journal of Clinical Pharmacology and Therapeutics 2003;41:354–7. |
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