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Bioidentical hormone therapy: a panacea that lacks supportive evidence

Boothby, Lisa Aa,b; Doering, Paul Lc,d

Current Opinion in Obstetrics and Gynecology: August 2008 - Volume 20 - Issue 4 - p 400–407
doi: 10.1097/GCO.0b013e3283081ae9
Reproductive endocrinology: Edited by David L. Olive

Purpose of review In the practice of ‘bioidentical hormone therapy’, it is our belief that pharmacists are compounding bioidentical hormone therapy with the best intentions. These pharmacists are, however, ill informed regarding the lack of scientific underpinning associated with the efficacy and safety of the practice of bioidentical hormone therapy. It is the purpose of this review to systematically examine the scientific rigor of the arguments posed by the proponents of bioidentical hormone therapy, and to differentiate the practice of bioidentical hormone therapy from the legitimate practice of pharmacy compounding.

Recent findings Most medical organizations have in essence refuted the bioidentical hormone therapy claims as unsubstantiated. The profession of pharmacy needs to address this issue in an authoritarian, scientific way, outside of the compounding issue.

Summary Bioidentical or natural hormones are expected to have similar efficacy and safety profiles as the commercially available hormonal therapies that have been studied in clinical trials, regardless of whether the active principle hormones are compounded by individual pharmacies or manufactured by large companies. Estriol is a weak estrogen that is not Food and Drug Administration approved for use as a prescription drug in the United States; thus, clinical trials are necessary to demonstrate the efficacy and safety profile for estriol. Further, supplementary clinical trials are necessary to determine whether there are efficacy or safety differences between natural progesterone and synthetic progestin, as studies to date are inconclusive.

aAuburn University, Harrison School of Pharmacy, Auburn, Alabama, USA

bDrug Information Services, Columbus Regional Healthcare System, Columbus, Georgia, USA

cDepartment of Pharmacy Practice, University of Florida, College of Pharmacy, USA

dSHANDS Drug Information and Pharmacy Resource Center, Gainesville, Florida, USA

Correspondence to Dr Lisa A. Boothby, PharmD, BCPS, Columbus Regional Healthcare System, 710 Center Street, Columbus, GA 31902, USA Tel: +1 706 660 6295; fax: +1 706 571 1625; e-mail:

© 2008 Lippincott Williams & Wilkins, Inc.