Compounded bioidentical hormone therapy: identifying use trends and knowledge gaps among US women

Pinkerton, JoAnn V. MD1; Santoro, Nanette MD2

doi: 10.1097/GME.0000000000000420
Original Articles
Editorial

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

1University of Virginia Health System, Charlottesville, VA

2University of Colorado School of Medicine, Aurora, CO.

Address correspondence to: JoAnn V. Pinkerton, MD, University of Virginia, Box 801104, Charlottesville, VA 22908. E-mail: JVP9U@hscmail.mcc.virginia.edu

Received 3 October, 2014

Revised 25 November, 2014

Accepted 25 November, 2014

Funding/support: TherapeuticsMD supported the conduct and analysis of the surveys and funded medical writing support (provided by Christin Melton, ELS, CMPP, of Precise Publications LLC).

Financial disclosure/conflicts of interest: J.V.P. has received grants and research support (paid to the University of Virginia) from TherapeuticsMD Inc, Bionova Inc, and EndoCeutics Inc, and has served as a consultant (fees paid to the University of Virginia) for Pfizer Inc, Noven Pharmaceuticals Inc, TherapeuticsMD Inc, and Shionogi Inc. N.S. has received investigator-initiated grant support from Bayer Inc (paid to the University of Colorado School of Medicine) and has stock options in MenoGenix.

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© 2015 by The North American Menopause Society.