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Arthur Margolin, PhD; S. Kelly Avants, PhD; Herbert D. Kleber, MD

JAMA. 1998;280:1626-1628.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

INTRODUCTION

BECAUSE ALTERNATIVE medicine therapies are used by a significant number of Americans^1-2 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 . . . [Full Text of this Article]

Basis for Undertaking a Controlled Trial

Is the Treatment to Be Evaluated Codified and Accepted?

Identification of Objective Outcomes

Devising Adequate Controls

Difficulties of Blinding Procedures

Guarding Against and Checking on Bias

Conclusions

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).

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