Characteristic and incidental (placebo) effects in complex interventions such as acupuncture

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Abstract
Introduction The randomised double blind controlled trial has proved an invaluable tool for testing the efficacy of new drugs. However, it is now used to evaluate complex non-pharmaceutical interventions, many of which are based on different therapeutic theories. For example, randomised controlled trials are used to test physiotherapy, a complex intervention with a basis in biomedical theory, and acupuncture, which is often based on Chinese medicine. In order to use a placebo or sham controlled design, an intervention has to be divided into characteristic (specific) and incidental (placebo, non-specific) elements. However, recent research suggests that it is not meaningful to split complex interventions into characteristic and incidental elements. Elements that are categorised as incidental in drug trials may be integral to non-pharmaceutical interventions. If this is true, the use of placebo or sham controlled trial designs in evaluating complex non-pharmaceutical interventions may generate false negative results. The characteristic effects of acupuncture extend beyond needling Credit: WELLCOME PHOTOGRAPHIC LIBRARY