Black cohosh, Actaea racemosa L (syn. Cimicifuga racemosa [L] Nutt), has enjoyed a rapid rise in popular use for the amelioration or alleviation of menopausal symptoms. At the same time, the last decade has witnessed a significant expansion of research on the chemistry, pharmacology, and clinical efficacy and safety of this botanical species. As a consequence of the growing body of data on black cohosh, together with the appearance of reports implicating this botanical in cases of liver damage, the Office of Dietary Supplements (National Institutes of Health) convened a workshop on the current state of knowledge for black cohosh (Gaithersburg, Maryland; June 2007); this review is based on that workshop. Based on the information presented and the ensuing discussions, several recommendations are proposed to facilitate better understanding and management of the safety of this botanical in the context of clinical trials
Joseph M. Betz, PhD, is the director of Analytical Methods and Reference Materials Program, Office of Dietary Supplements, National Institutes of Health.
Linda Anderson, PhD, is a principal pharmaceutical assessor in the Licensing Division of the Medicines and Healthcare Products Regulatory Agency, United Kingdom.
Mark I. Avigan, MD, is the director of the Division of Drug Risk Evaluation in the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration.
Joanne Barnes, PhD, is associate professor in herbal medicines in the School of Pharmacy, Faculty of Medical and Health Sciences at the University of Auckland, New Zealand.
Norman R. Farnsworth, PhD, is a distinguished university professor and research professor of pharmacognosy at the University of Illinois at Chicago College of Pharmacy.
Barbro Gerdén, MD, serves in the Medical Products Agency in Sweden.
Leigh Henderson, MS, is a senior scientific assessor in the Medicines and Healthcare Products Regulatory Agency, United Kingdom.
Edward J. Kennelly, PhD, is associate professor of biological sciences at Lehman College, City University of New York, and executive officer of the PhD program in Biochemistry at the Graduate Center, City University of New York.
Uwe Koetter, PhD, is the chief development officer and head of Research & Development at Max Zeller Söhne AG, Switzerland.
Stephanie Lessard, MS, is the head of the Health Risk Assessment Unit at the Bureau of Clinical Trials and Health Sciences within the Natural Health Products Directorate, Health Canada.
Tieraona Low Dog, MD, PhD, serves as director of education in the Program of Integrative Medicine at the University of Arizona in Tucson.
Michelle McLaughlin, BS, is the head of the Pre-Market Assessment Section of the Office of Complementary Medicines, Therapeutic Goods Administration, Australia.
Belal Naser, MD, is head of Drug Safety and Pharmacovigilance at Schaper & Brűmmer GmbH & Co, KG, in Germany.
Ruediger G. W. Osmers, MD, PhD, serves in the Department of Obstetrics and Gynecology at Hildesheim General Hospital in Germany.
Linda S. Pellicore, PhD, was a supervisory senior toxicologist in the Division of Dietary Supplements, US Food and Drug Administration, and is currently a senior toxicologist in the Division of Dermatology and Dental Products, Center for Drug Evaluation and Research, US Food and Drug Administration.
John R. Senior, PhD, is the associate director for science in the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration.
Richard B. van Breemen, PhD, is a professor of medicinal chemistry and pharmacognosy at the University of Illinois at Chicago College of Pharmacy.
Wolfgang Wuttke, MD, is a professor of endocrinology at the University of Gottingen in Germany.
John H. Cardellina II, PhD, is a health sciences administrator with the Office of Dietary Supplements, National Institutes of Health.The views expressed in this article are those of the authors and do not represent official opinions or positions of the US Federal Government or the Department of Health and Human Services, the UK Medicines and Healthcare Products Regulatory Agency, the European Herbal Medicinal Products Committee, Health Canada, or the Therapeutic Goods Administration of Australia.
Corresponding author: Joseph M. Betz, PhD, Office of Dietary Supplements, National Institutes of Health, 6100 Executive Blvd, Room 3B01, MSC 7517, Bethesda, MD 20892 (BetzJ@od.nih.gov).