Reprint of The Herbal Alternatives for Menopause (HALT) Study: background and study design.
Reprint of The Herbal Alternatives for Menopause (HALT) Study: background and study design.
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更年期草药替代品 (HALT) 研究的重印:背景和研究设计。
DOI:
10.1016/j.maturitas.2008.11.014
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发表时间:
2008
期刊:
影响因子:
4.9
通讯作者:
LaCroix,AndreaZ
中科院分区:
文献类型:
--
作者:
Newton,KatherineM;Reed,SusanD;Grothaus,Lou;Ehrlich,Kelly;Guiltinan,Jane;Ludman,Evette;LaCroix,AndreaZ
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 160mg daily; (2) multibotanical (50mg 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±2.5mg 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 unanticipatedWomen'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.