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Use of compounded hormone therapy in the United States

report of The North American Menopause Society Survey.

A national survey was conducted to determine the extent of use of compounded hormone therapy (C-HT) and to characterize the differences between C-HT users and users of hormone therapy approved by the US Food and Drug Administration (FDA-HT users).

This Internet survey enrolled 3,725 women aged 40 to 84 years who were postmenopausal or experiencing the menopause transition. The sample was weighted slightly by age, region, education, and race to reflect population attributes based on US Census data.

Overall, 9% of women were current users of HT, and 28% of all respondents were ever-users of HT. C-HT users represented 31% of ever-users of HT, 35% of current users of HT, and 41% of ever-users aged 40 to 49 years. Approximately 13% of ever-users indicated current or past use of testosterone. The most cited reason for using HT was vasomotor symptoms (~70%). Nonapproved indications for using HT were selected more often by C-HT users. There were four reports of endometrial cancer among the 326 C-HT users compared with none reported among the 738 FDA-HT users. Significance was not determined because of small numbers.

This survey indicates substantial use of C-HT across the country and the possibility of higher rates of endometrial side effects with such products. There is a need for standardized data collection on the extent of use of compounded hormones and their potential risks.

The authors also conclude that the widespread use of C-HT suggests a double standard among prescribers who acquiesce to patient demand for C-HT but otherwise prescribe FDA-approved medical therapies for treatment of hypertension, osteoporosis, and other midlife health concerns. The magnitude of C-HT use also reveals a double standard in regulation of the medication supply chain. Pharmaceutical companies are held to FDA-stipulated and enforced standards of manufacturing,  requiring demonstrated efficacy, safety, and purity.

Reference

Gass ML, Stuenkel CA, Utian WH, LaCroix A, Liu JH, Shifren JL; This survey was developed by The North American Menopause Society (NAMS) Advisory Panel consisting of representatives of the NAMS Board of Trustees and other experts in womenʼs health. Use of compounded hormone therapy in the United States: report of The North American Menopause Society Survey. Menopause. 2015 Sep 25. [Epub ahead of print] DOI: 10.1097/GME.0000000000000553

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