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Policy Perspectives
November 11, 1998

Investigating Alternative Medicine Therapies in Randomized Controlled Trials

Author Affiliations

From the Substance Abuse Center, Yale University School of Medicine, New Haven, Conn (Drs Margolin and Avants); and Center on Addiction and Substance Abuse at Columbia University, New York, NY (Dr Kleber).

JAMA. 1998;280(18):1626-1628. doi:10.1001/jama.280.18.1626

BECAUSE ALTERNATIVE medicine therapies are used by a significant number of Americans1,2 and people worldwide,3 there is an urgent need for their efficacy to be evaluated formally. The most stringent evaluation would take place within the "gold standard" for clinical research: the randomized controlled clinical trial (RCT). However, alternative medicine comprises a large and heterogeneous group of treatments,4 many of which are procedures that are not readily testable under blinded conditions and for which the choice of appropriate control conditions is by no means straightforward. Furthermore, alternative medicine therapies may also possess a theoretical basis, may stem from a cultural tradition that is seemingly antithetical to a quantitative, biomedical framework,4-7 or may possess little foundational research on which to base a controlled evaluation. In this article, we discuss a number of key methodological issues that arise in the controlled evaluation of one widely used alternative medicine procedure—acupuncture for the treatment of cocaine addiction, and we offer some suggestions for how these issues may be addressed.