Compounded Bioidentical Hormone Therapy: Identifying Use Trends and Knowledge Gaps Among US Women

JoAnn V. Pinkerton, MD; Nanette Santoro, MD

Disclosures

Menopause. 2015;22(9):926-936. 

In This Article

Abstract and Introduction

Abstract

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.

Introduction

Hormone therapy (HT) effectively treats moderate to severe vasomotor symptoms (VMS) and symptomatic vaginal atrophy and prevents postmenopausal osteoporosis in women transitioning through menopause.[1] Although the use of commercially manufactured HT to treat menopausal symptoms has declined during the past 12 years in response to the now well-known safety findings of the Women's Health Initiative trials (primarily for women aged 60 y or older),[2,3,4,5,6,7,8] use of custom compounded hormone therapy (CHT) seems to have increased.[9,10,11,12] This seemingly paradoxical increase in CHT use suggests that postmenopausal women do not apply their concerns about the class effects of estrogens and progestogens identified in the Women's Health Initiative to CHT products.

Another driving force behind the use of CHT seems to be the absence of regulation governing product advertising, which allows purveyors of CHT to make unsubstantiated claims about its safety and efficacy.[12,13] In addition, high-profile celebrities such as Oprah Winfrey and Suzanne Somers have promoted CHT to postmenopausal women.[14,15] Physicians and pharmacists who stand to benefit economically from the sales of CHT may also have encouraged its use.[13,16,17]

Although the general consensus is that use of CHT has grown,[9,11,18] prescriptions for CHT are not systematically tracked in the United States, and no one knows exactly how many women are managing their menopausal symptoms with compounded hormones. In a survey of 184 women visiting a physician at the Mayo Clinic Women's Health Clinic (Rochester, MN) about 8 years ago, Iftikhar et al[19] found that 14% of respondents were current CHT users; this was twice the rate of prior CHT users. However, because of the survey's age and small nonrepresentative convenience sample, it cannot be assumed that these findings would apply to a broader population of postmenopausal women today.

Recently, two large Internet surveys of middle-aged or older US women were conducted—one conducted by Harris Interactive Inc (Harris) and one conducted by Rose Research LLC (Rose)—to measure the prevalence of HT and CHT use in the United States and to evaluate the extent to which perimenopausal and postmenopausal women recognize that CHT products are not approved by the US Food and Drug Administration (FDA). From the Rose survey, we extrapolated information on trends in HT use to US Census Bureau figures and used a report on HT prescriptions generated from Symphony Health's Pharmaceutical Audit Suite (PHAST) 2.0 database (Symphony Health, Horsham, PA) of US prescription information to estimate the amount of CHT used in the United States and the proportion of HT prescriptions that are compounded. We also examined survey data on menopausal experience, knowledge of and practices regarding HT, and treatment outcomes. We anticipated that the data would show a high rate of CHT use and limited knowledge regarding the regulatory status of CHT in a sample of reasonably representative perimenopausal and postmenopausal women.

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