Pinkerton JoAnn V, Santoro Nanette
1University of Virginia Health System, Charlottesville, VA 2University of Colorado School of Medicine, Aurora, CO.
Menopause. 2015 Sep;22(9):926-36. doi: 10.1097/GME.0000000000000420.
Two surveys (Harris and Rose surveys) were conducted to quantify the use of compounded hormone therapy (CHT; or bioidentical hormone therapy) among perimenopausal and postmenopausal women in the United States, to assess women's knowledge of CHT versus Food and Drug Administration (FDA)-approved hormone therapy, and to gather information on menopausal experience.
The Harris survey was administered to 801 women aged 45 to 60 years who had experienced at least one menopausal symptom. The Rose survey was administered to 2,044 women aged 40 years or older who were ever users of hormone therapy. Women were queried about menopausal symptoms, hormone therapy use, and knowledge of CHT. Findings from the Rose survey were extrapolated using US Census Bureau data and prescription claims for FDA-approved hormone therapy to estimate the prevalence of CHT use.
According to extrapolations using Rose data, up to 2.5 million US women aged 40 years or older may use CHT annually, accounting for 28% to 68% of hormone therapy prescriptions. Harris data showed that 86% of women surveyed were unaware that CHT products are not FDA-approved. The Rose survey asked a subset of 1,771 women whether their hormone therapy had been personalized based on hormone levels; 21% (378) answered "yes" whereas 27% (476) did not know. In both surveys, most hormone therapy users stated that their physician had recommended the treatment.
We estimate that 1 million to 2.5 million US women aged 40 years or older use CHT. The data suggest that many women are unaware that compounded hormones have not been evaluated or approved by the FDA. Providers have an educational opportunity to ensure that women considering hormone therapy understand the risks and benefits of inadequately regulated CHT.
开展两项调查（哈里斯调查和罗斯调查），以量化美国围绝经期和绝经后女性使用复方激素疗法（CHT；或生物同源激素疗法）的情况，评估女性对CHT与美国食品药品监督管理局（FDA）批准的激素疗法的了解程度，并收集有关绝经经历的信息。
哈里斯调查针对801名年龄在45至60岁且至少经历过一种绝经症状的女性进行。罗斯调查针对2044名40岁及以上曾使用过激素疗法的女性进行。询问女性有关绝经症状、激素疗法使用情况以及对CHT的了解。利用美国人口普查局数据和FDA批准的激素疗法的处方索赔数据对罗斯调查的结果进行推断，以估计CHT的使用 prevalence。
根据对罗斯调查数据的推断，每年可能有多达250万40岁及以上的美国女性使用CHT，占激素疗法处方的28%至68%。哈里斯调查数据显示，86%的受访女性不知道CHT产品未获FDA批准。罗斯调查询问了1771名女性中的一部分，她们的激素疗法是否根据激素水平进行了个性化定制；21%（378人）回答“是”，而27%（476人）表示不知道。在两项调查中，大多数激素疗法使用者表示是医生推荐了这种治疗。
我们估计有100万至250万40岁及以上的美国女性使用CHT。数据表明，许多女性不知道复方激素未经过FDA评估或批准。医疗服务提供者有教育机会来确保考虑使用激素疗法的女性了解监管不足的CHT的风险和益处。
