Research
Ethical Issues in CAM and CAM Research
Summary: This research area analyzes ethical questions related to research and clinical practice in complementary and alternative medicine (CAM). It seeks to examine how existing ethical concepts apply to CAM and understand factors that influence the social value of CAM research.
| Section: | Human Subjects Research | ||||||||||||||
| Principal Investigators | Jon C. Tilburt, M.D. Franklin G. Miller, Ph.D. |
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Background: The growing attention paid to CAM research at NIH, has led to a range of ethical questions related to the conduct of CAM research and the translation of that research into clinical practice. For instance,
- "Is it ethical to conduct sham controlled acupuncture trials?"
- "How do we understand risk/benefit ratio for trials of herbal medicines with historical use but no early phase trial evidence?"
- "Do the results of CAM research make any difference to the public or health practitioners?"
As part of its 2005–2009 strategic planning process, the National Center for Complementary and Alternative Medicine, in partnership with the Department of Bioethics, established an initiative in ethical issues related to CAM practice and CAM research. The objectives of this initiative were: 1) to identify and train an ethicist for a career focusing on ethical issues related to CAM and 2) to initiate a core group of intramural CAM, ethics research projects.
Departmental Research Initiative: The Department has begun a diverse core group of projects to build the quality and depth of scholarship in the ethics of CAM. To date these projects have focused on conceptual analyses of topics in CAM.
Research Ethics
In 2004, Miller et al. published an article in JAMA discussing the major ethical issues in CAM research. They argue that in general research on CAM should adhere to the same ethical requirements for all clinical research, and specifically that randomized, placebo-controlled clinical trials should be used for assessing the efficacy of CAM treatments whenever possible. In a 2004 article discussing sham procedures including acupuncture, Miller and Kaptchuk argued that the deception necessary to conduct sham controlled trials (e.g., acupuncture trials) is justified so long as the role of the investigator as scientist is well understood by investigator and participants. A forthcoming book chapter by Tilburt gives an overview of ethical and methodological difficulties in conducting CAM trials using a framework outlined by a recent Institute of Medicine report. An article in press from the Journal of Medical Ethics by Miller and Kaptchuk claims that current consent practices for acupuncture trials are deceptive and argues for more accurate disclosure regarding the use of sham acupuncture is warranted.
Clinical Ethics
A 2005 article by Kaptchuk and Miller explores the relationship between conventional and alternative medicine from an ethical perspective. They argue that neither opposition nor integration is desirable, and instead outline a third position — pluralism — to define the most ethical relationship between CAM and conventional medicine.
Impact of Research: Because this is a relatively new initiative in the Department, the full impact of this research may be difficult to measure. The number of citations for the Miller et al. article from JAMA 2004 is currently 25.
Future Research Initiatives: There are two areas of investigation that our CAM initiative will be exploring in the coming years.
1) Social Value of CAM Research
Provider Perceptions of CAM Research: A National Survey
This is a national survey to assess the social value of CAM research for alternative and conventional providers. We will sample 2,400 providers (600 rheumatologist, 600 general internists, 600 acupuncturists, and 600 naturopathic doctors) regarding their awareness of and attitudes toward CAM research. The study will address the following questions.
- What factors in reports of CAM research results influence provider judgments about that research?
- Are providers familiar with recently published CAM trials? If so, have they changed their practice in light of the research?
- Do CAM and conventional providers differ in their ratings of the value of randomized controlled trials?
This study is support by the Department and by NCCAM. An interdisciplinary team of intramural and extramural investigators has been assembled to implement the survey. The projected time of implementation is January 2007. This will lead to several publications exploring health provider factors that may influence the social value of CAM research.
The Impact of Negative Trials
Most of the NIH-sponsored CAM trials have shown no definitive evidence of efficacy. Nevertheless, with emerging attention to issues of publication bias, there is increasing awareness the important role negative research trials should play in shaping consumer and provider decisionmaking. Yet little is known about the extent to which negative trials have a social impact. This project will explore the potential impact of negative CAM trials on sales of botanical product by examining historical sales trends in common botanical products and relate those temporal trends with the publication of negative trial results regarding those products.
2) Clinical Ethics and CAM
The 2005 IOM report, Complementary and Alternative Medicine in the United States, introduces the concept of medical pluralism as a core value commitment for understanding the ethics of CAM. Tilburt and Miller have examined this concept in relation to the principles of biomedical ethics in a manuscript currently under review. Future conceptual ethics papers will focus on the concept of "integrative medicine."
Publications:
Miller FG, Emanuel EJ, Rosenstein DL, Straus SE. Ethical issues concerning research in complementary and alternative medicine. JAMA 2004;291(5):599-604.
Kaptchuk TJ, Miller FG. Viewpoint: what is the best and most ethical model for the relationship between mainstream and alternative medicine: opposition, integration, or pluralism? Acad Med 2005;80(3):286-90.
Tilburt J. Whose Evidence? Which Methods? Ethical Challenges in CAM Research. Complementary and Alternative Medicine: Ethics, the Patient, and the Physician. Lois Snyder, ed. Totowa, NJ: Humana Press, 2006 (in press).
Miller FG, Kaptchuk TJ. Acupuncture trials and informed consent. Journal of Medical Ethics (in press).
