title: The Herbal Alternatives for Menopause (HALT) Study: background and study design.
abstract: We designed a randomized double-blind randomized trial to examine the short and long-term effects of alternative approaches commonly used to manage menopause symptoms. Women were randomly assigned to: (1) black cohosh 160 mg daily; (2) multibotanical (50 mg black cohosh, alfalfa, chaste tree, dong quai, false unicorn, licorice, oats, pomegranate, Siberian ginseng, boron) four capsules daily; (3) multibotanical plus telephone counseling to increase dietary soy; (4) conjugated equine estrogen 0.625 mg +/- 2.5 mg medroxyprogesterone acetate; or (5) placebo. Working with a skilled CAM provider helped us choose interventions that reflected naturopathic practices worthy of study. Mass mailing, with careful tracking and rapid responses to recruitment rates, was an effective and cost-effective recruitment strategy. Creativity was necessary to construct methods for blinding capsules and the dietary soy intervention. Independent testing of herbal products was vital to confirming their constituents. The Data and Safety and Monitoring Committee, and project officers at the funding agency, were critical partners in designing responses to unanticipated Women's Health Initiative findings published during the HALT trial. Careful monitoring of adverse events may provide much needed information about side effects of herbal products and supplements. Despite inherent challenges, the study of alternative therapies for menopause symptoms is a rewarding and important area deserving of further inquiry.
authors.affiliation: Center for Health Studies, Group Health Cooperative, Seattle, WA 98101, USA. newton.k@ghc.org
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Newton
authors.forename: Susan D
authors.initials: SD
authors.lastname: Reed
authors.forename: Lou
authors.initials: L
authors.lastname: Grothaus
authors.forename: Kelly
authors.initials: K
authors.lastname: Ehrlich
authors.forename: Jane
authors.initials: J
authors.lastname: Guiltinan
authors.forename: Evette
authors.initials: E
authors.lastname: Ludman
authors.forename: Andrea Z
authors.initials: AZ
authors.lastname: Lacroix
mesh_terms: D031885:Cimicifuga; D000529:Complementary Therapies / Q000379:methods* / Q000592:standards; D004311:Double-Blind Method; D004966:Estrogens, Conjugated (USP) / Q000627:therapeutic use; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000627:therapeutic use; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods* / Q000592:standards; D028321:Plant Preparations / Q000627:therapeutic use*; D030262:Soybean Proteins / Q000627:therapeutic use
chemical_list: D004966:Estrogens, Conjugated (USP); D028321:Plant Preparations; D030262:Soybean Proteins; D017258:Medroxyprogesterone Acetate