Author: Voeh S.

Source: British Journal of Clinical Pharmacology, Volume 56, Number 3, September 2003 , pp. 292-296(5)

Publisher: Wiley-Blackwell

Abstract:

This brief commentary considers a possible hitherto infrequently discussed factor that might contribute to the increase in the use of complementary medicines: the difficulties of using placebo within the context of evidence-based medicine, which represents the current standard for pharmacotherapy in most western culture countries. It discusses the possibility of placebo having a similar or better benefit–risk profile compared with an active compound in some diseases, and shows three examples in which this can be concluded from a clinical trial (insomnia, allergic rhinitis, irritable bowel disease). It is proposed that complementary medicine has under these circumstances taken the place of placebo therapy. By this, the commentary does not deny (and does not discuss) the possibility of an effect of complementary medicines other than the placebo effect. However, it recognizes that complementary medicine is open to the therapeutic application of the placebo effect by using a medicine with the claim that it has worked in similar situations and may work in the actual patient, without requiring hard data showing superiority to placebo. Physicians might be more open to the use of complementary medicines for indications in which the placebo effect is high, the conventional therapy carries a risk of side-effects and the omission of treatment with a pharmacologically active compound does not result in irreversible damage. The regulators on their part should probably not require proof of effectiveness compared with placebo in controlled clinical trials. However, whenever used in this sense, the complementary medicine product must unequivocally demonstrate its safety with respect to both the ingredients and the pharmaceutical quality. This is unfortunately not always the case.

Keywords: complementary medicine; evidence-based medicine; placebo; placebo effect; drug development; drug regulation

Document Type: Research article

DOI: http://dx.doi.org/10.1046/j.0306-5251.2003.01879.x

Publication date: 2003-09-01

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