Investigating Alternative Medicine Therapies in Randomized Controlled Trials

4many 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. Basis for Undertaking a Controlled Trial An important principle governing the justification for conducting an RCT 8 is that a condition of genuine clinical uncertainty, or “equipoise,” 9 exists among clinical experts regarding the relative benefits of the trial’s treatments. However, the application of this principle entails a community of colleagues sharing basic assumptions and a common knowledge base, with consensus views founded on empirical investigations. These conditions may not be satisfied with respect to considerations of alternative medicine, which typically involve heterogeneous groups comprising incommensurate cultural and evaluative frameworks and, more often than not, a paucity of systematically derived data. Even within the biomedical community, alternative medicine generates considerable controversy. 10 The application of traditional concepts of “clinical equipoise” to alternative medicine is therefore an unsettled question, much in need of elucidation and a statement of general principles. Lacking this, investigators of an alternative medicine treatment must negotiate the justification to conduct the trial, as well as criteria for informed consent, on a case-by-case basis. Relevant to this discussion is whether the alternative medicine treatment is being compared with a conventional treatment as an alternative, as a supplement, or, where no effective conventional treatment is available, with an inactive control condition, along with whatever preliminary evidence concerning safety and efficacy is available. Auricular acupuncture for the treatment of cocaine addiction demonstrates how a confluence of circumstances, within both Western medicine and alternative medicine, creates a context within which the evaluation of an alternative treatment can generate broad support. Among the circumstances