SPECIAL COMMUNICATION Ethical Issues Concerning Research in Complementary and Alternative Medicine

COMPLEMENTARY AND ALTERnative medicine (CAM) encompasses a wide range of popular treatment modalities that are outside conventional practice and generally lack sufficient scientific evidence of their safety and efficacy. These treatments include herbal agents, homeopathic preparations, chiropractic manipulations, massage, acupuncture, meditation, and prayer. Use of CAM in the United States is widespread and growing, as is the recognition that in many developing nations, the dominant form of medical care consists of similar indigenous traditional practices. Research on CAM has grown dramatically since 1992, when the Office of Alternative Medicine at the National Institutes of Health (NIH) was established by Congress with an initial budget of $2 million. The National Center for Complementary and Alternative Medicine, created in lieu of this office in 1998, has increased its budget from $50 million in 1999 to an estimated $114.1 million in 2003. Total funding by all the institutes and centers of the NIH for research on CAM and the training of investigators to study CAM will exceed $220 million in 2003, with additional funding being provided by other agencies and philanthropic foundations. Scant attention has been devoted to the ethics of research studies evaluating CAM treatments. In view of the rapid growth and investments in this field of inquiry, it is timely to address ethical issues relating to research on CAM more formally and substantively. After briefly explicating an ethical framework for clinical research, we apply this framework to 3 controversial ethical issues concerning research evaluating CAM treatments: the value of rigorous research on CAM, the val idi ty of randomized, placebocontrolled clinical trials of CAM treatments, and the justification for placebocontrolled trials of CAM treatments for medical conditions, despite proven effective conventional treatment. Finally, we explore the implications for practice and health care policy of CAM and conventional treatments that are found to be no better than placebo.