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

doi:10.1136/bmj.330.7501.1202

BMJ 2005;330:1202-1205 (21 May), doi:10.1136/bmj.330.7501.1202

Education and debate

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

Charlotte Paterson, special training fellow in health services research¹, Paul Dieppe, director¹

¹ MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol, Bristol BS8 2PR

Correspondence to: C Paterson c.paterson@bristol.ac.uk

The specific effects of non-pharmaceutical treatments are notalways divisible from placebo effects and may be missed in randomisedtrials

The first 150 words of the full text of this article appear below.

Introduction

The randomised double blind controlled trial has proved an invaluabletool for testing the efficacy of new drugs. However, it is nowused to evaluate complex non-pharmaceutical interventions, manyof 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, andacupuncture, which is often based on Chinese medicine. In orderto use a placebo or sham controlled design, an interventionhas to be divided into characteristic (specific) and incidental(placebo, non-specific) elements. However, recent research suggeststhat it is not meaningful to split complex interventions intocharacteristic and incidental elements. Elements that are categorisedas incidental in drug trials may be integral to non-pharmaceuticalinterventions. If this is true, the use of placebo or sham controlledtrial designs in evaluating complex non-pharmaceutical interventionsmay generate false negative results.

The characteristic effects of acupuncture . . . [Full text of this article]

Characteristic and incidental effects

Underlying assumptions of placebo controlled design

Diagnosis takes place before the intervention begins

Incidental factors are generic and independent of treatment effect

Characteristic and incidental effects are distinct and additive

Implications for trials of acupuncture

Other complex interventions

Conclusion

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Rapid Responses:

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Millions of people CAN be wrong - but they may benefit from it: Edwin P Kirk
bmj.com, 20 May 2005 [Full text]
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