Acupuncture has been used by millions of American patients and performed by thousands of physicians, dentists, acupuncturists, and other practitioners for relief or prevention of pain and for a variety of health conditions. After reviewing the existing body of knowledge, the U.S. Food and Drug Administration recently removed acupuncture needles from the category of "experimental medical devices" and now regulates them just as it does other devices, such as surgical scalpels and hypodermic syringes, under good manufacturing practices and single-use standards of sterility.

Over the years, the National Institutes of Health (NIH) has funded a variety of research projects on acupuncture, including studies on the mechanisms by which acupuncture may have its effects, as well as clinical trials and other studies. There is also a considerable body of international literature on the risks and benefits of acupuncture, and the World Health Organization lists a variety of medical conditions that may benefit from the use of acupuncture or moxibustion. Such applications include pre-vention and treatment of nausea and vomiting; treatment of pain and addictions to alcohol, tobacco, and other drugs; treatment of pulmonary problems such as asthma and bronchitis; and rehabilitation from neurological damage such as that caused by stroke.

To address important issues regarding acupuncture, the NIH Office of Alternative Medicine and the NIH Office of Medical Applications of Research organized a 2¹/₂-day conference to evaluate the scientific and medical data on the uses, risks, and benefits of acupuncture procedures for a variety of conditions. Cosponsors of the conference were the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Dental Research, the National Institute on Drug Abuse, and the Office of Research on Women's Health of the NIH. The conference brought together national and international experts in the fields of acupuncture, pain, psychology, psychiatry, physical medicine and rehabilitation, drug abuse, family practice, internal medicine, health policy, epidemiology, statistics, physiology, and biophysics, as well as representatives from the public.

After 1¹/₂ days of available presentations and audience discussion, an independent, non-Federal consensus panel weighed the scientific evidence and wrote a draft statement that was presented to the audience on the third day. The consensus statement addressed the following key questions:

• What is the efficacy of acupuncture, compared with placebo or sham acupuncture, in the conditions for which sufficient data are available to evaluate?

• What is the place of acupuncture in the treatment of various conditions for which sufficient data are available, in comparison with or in combination with other interventions (including no intervention)?

• What is known about the biological effects of acupuncture that helps us understand how it works?

• What issues need to be addressed so that acupuncture may be appropriately incorporated into today's health care system?

• What are the directions for future research?

The primary sponsors of this meeting were the National Human Genome Research Institute and the NIH Office of Medical Applications of Research. The conference was cosponsored by the National Institute of Diabetes and Digestive and Kidney Diseases; the National Heart, Lung, and Blood Institute; the National Institute of Child Health and Human Development; the NIH Office of Rare Diseases; the National Institute of Mental Health; the National Institute of Nursing Research; the NIH Office of Research on Women's Health; the Agency for Health Care Policy and Research; and the Centers for Disease Control and Prevention.