NIH Consensus Development Conference on Acupuncture November 3-5, 1997 William H. Natcher Conference Center National Institutes of Health Bethesda, Maryland Sponsored by: Office of Alternative Medicine • Office of Medical Applications of Research Cosponsored by: National Cancer Institute • National Heart, Lung, and Blood Institute • National Institute of Allergy and Infectious Diseases • National Institute of Arthritis and Musculoskeletal and Skin Diseases • National Institute of Dental Research • National Institute on Drug Abuse • Office of Research on Women’s Health Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Panel Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Speakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Planning Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Abstracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 I. Introduction: History and Status of Acupuncture Treatment What Is Acupuncture? Lorenz K.Y. Ng, M.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Acupuncture: History, Context, and Long-Term Perspectives Ted J. Kaptchuk, O.M.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Acupuncture Licensure, Training, and Certification in the United States Kevin V. Ergil, M.A., M.S., L.Ac. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Current Utilization of Acupuncture by United States Patients Patricia D. Culliton, M.A., Dipl.Ac, L.Ac.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 II. Issues Affecting Incorporation of Acupuncture Into Today’s Health Care System Methodological and Ethical Issues in Acupuncture Research Richard Hammerschlag, Ph.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Safety and Regulation of Acupuncture Needles and Other Devices C. David Lytle, Ph.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 III. Efficacy of Acupuncture in Treating Various Conditions Acupuncture Activates Endogenous Systems of Analgesia Ji-Sheng Han, M.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Overview of Clinical Trials on Acupuncture for Pain Brian M. Berman, M.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 iii Efficacy of Acupuncture in Treating Low Back Pain: A Systematic Review of the Literature Daniel C. Cherkin, Ph.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Overview of the Efficacy of Acupuncture in the Treatment of Headache and Face and Neck Pain Stephen Birch, L.Ac., Ph.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Efficacy of Acupuncture in the Treatment of Osteoarthritis and Musculoskeletal Pain Gary Kaplan, D.O. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Dental and Postoperative Pain Lixing Lao, Ph.D., L.Ac. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Neuropathic Pain Judith C. Shlay, M.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 The Role of Physiologic Imaging in the Investigation of the Effects of Pain and Acupuncture on Regional Cerebral Function Abass Alavi, M.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Summary of Acupuncture and Pain Bruce Pomeranz, M.D., Ph.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Nausea and Vomiting Andrew Parfitt, Ph.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 Neurological Rehabilitation: Acupuncture and Laser Acupuncture To Treat Paralysis in Stroke and Other Paralytic Conditions and Pain in Carpal Tunnel Syndrome Margaret A. Naeser, Ph.D., Lic.Ac., Dipl.Ac. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Acupuncture and Addictions Janet Konefal, Ph.D., Ed.D., M.P.H., C.A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Gastrointestinal Indications David L. Diehl, M.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Induction of Ovulation With Acupuncture Jin Yu, M.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 iv IV. New Horizons for Acupuncture Protective Effect of Acupuncture on Immunosuppression Xiaoding Cao, M.D., Ph.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Late-Breaking Data and Other News from the Clinical Research Symposium (CRS) on Acupuncture at NIH Hannah V. Bradford, M.Ac. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 American Acupuncture: Primary Care, Public Health, and Policy Alan I. Trachtenberg, M.D., M.P.H. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 v Introduction Acupuncture is a family of procedures involving penetration of specific superficial anatomic locations on the skin called acupuncture points by thin, solid, generally metallic needles. Closely related to and often practiced with acupuncture is moxibustion, the local and focused application of heat to acupuncture points using a compressed, powdered combustible substance (moxa), which is burned at or near the points to be stimulated. Acupuncture and moxibustion are the two best-known aspects of traditional Chinese medicine (TCM) in the United States and are used by many Americans. There are a variety of approaches to functional diagnosis and treatment in American acupuncture that incorporate medical traditions from China, Japan, Korea, France, and other countries. Because an acupuncture treatment is a procedure like a psychotherapy session or surgery (rather than a drug), it has been difficult to study using the gold standard of randomized double-blind trials. Nevertheless, acupuncture is used by millions of American patients and performed by thousands of physicians, dentists, master’s degree-level acupuncturists, and other practitioners for relief or prevention of pain and for a variety of health problems. The Food and Drug Administration, after years of deliberation, 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 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 and/or moxibustion. Such applications may include prevention and treatment of nausea and vomiting; treatment of pain and addictions to alcohol, tobacco, and other drugs; prevention of pulmonary problems such as asthma and bronchitis; and rehabilitation from neurological damage such as that caused by stroke. To address the most important issues regarding the American use of acupuncture, NIH has organized this 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. The conference will bring 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 l1/2 days of presentations and audience discussion, an independent, non-Federal consensus panel chaired by Dr. David J. Ramsay, president of the University of Maryland 1 Medical Center, will weigh the scientific evidence and write a draft statement that will be presented to the audience on the third day. The consensus statement will address 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 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 can be appropriately incorporated into today's health care system? • What are the directions for future research? On the final day of the meeting, the conference chairperson, Dr. David J. Ramsay, will read the draft statement to the conference audience and invite comments and questions. A press conference will follow to allow the panel and chairperson to respond to questions from media representatives. General Information Conference sessions will be held in the Natcher Conference Center, National Institutes of Health, Bethesda, Maryland. Sessions will run from 8:30 a.m. to 5:00 p.m. on Monday, from 8:00 a.m. to 12:45 p.m. on Tuesday, and from 9:00 a.m. to 11:00 a.m. on Wednesday. The telephone number for the message center is (301) 496-9966. The fax number is (301) 480-5982. Cafeteria The cafeteria in the Natcher Conference Center is located one floor above the auditorium on the main floor of the building. It is open from 7:00 a.m. to 2:00 p.m., serving breakfast and lunch. 2 Continuing Education Credit American Medical Association The NIH/FAES is accredited by the Accreditation Council for Continuing Medical Education to sponsor continuing medical education for physicians. The NIH/FAES designates this continuing medical education activity for a maximum of 14 credit hours in Category I of the Physician’s Recognition Award of the American Medical Association. Each physician should claim only those hours of credit that he/she actually spent in the educational activity. American Academy of Family Physicians An application has been filed with the American Academy of Family Physicians for continuing education credits for this conference. Sponsors The primary sponsors of this conference are the NIH Office of Alternative Medicine and the NIH Office of Medical Applications of Research. The conference is cosponsored by 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 National Institutes of Health. 3 4