Counseling Postmenopausal Women About Bioidentical Hormones

Ten Discussion Points for Practicing Physicians

Richa Sood, MD; Lynne Shuster, MD; Robin Smith, MD; Ann Vincent, MD; Aminah Jatoi, MD

Disclosures

J Am Board Fam Med. 2011;24(2):202-210. 

In This Article

Abstract and Introduction

Abstract

Bioidentical hormones are compounds that have exactly the same chemical and molecular structure as endogenous human hormones. In contrast, nonbioidentical, or synthetic, hormones are structurally dissimilar from endogenous hormones. Although available for years, bioidentical compounded hormone therapy (BCHT) has gained popularity in the United States only recently. This popularity has paralleled women's rising fears of conventional hormone therapy, especially since the publication of the Women's Health Initiative clinical trials. Although BCHT offers advantages, it is not the panacea of hormone therapy. The claims that BCHT lowers the risk of breast cancer, coronary artery disease, stroke, or thromboembolism are not supported by scientific research. The goal of this review is to present an overview of the available research evidence on BCHT, dispel myths about the use of compounded hormones, and provide helpful tips to answer commonly asked questions about BCHT.

Introduction

Menopausal women may experience hot flashes, vaginal dryness, mood changes, compromised cognition, sexual problems, and fatigue.[1] Health care providers often prescribe hormones for these symptoms. Hormone therapy (HT), containing estrogen with or without progestogen, is the most effective therapy for menopausal symptoms.[2] However, decisions about hormone therapy have become challenging because concerns about the safety of hormones have surfaced in recent years.[3–6] HT had been considered to be invariably favorable for the prevention of coronary heart disease and stroke, but now it is known to be harmful if initiated in older women many years after menopause.[3] Hulley et al,[4] showed that oral combined hormone therapy did not decrease coronary heart disease (CHD) events in women with pre-existing CHD. In another study, Viscoli et al,[5] showed that oral estradiol (E2) did not reduce mortality or stroke recurrence in women with pre-existing cerebrovascular disease. Finally, the Women's Health Initiative (WHI) study randomized 16,608 postmenopausal women to combined hormones versus placebo and showed that women who were given conjugated equine estrogens plus medroxyprogesterone acetate (MPA) had an increased risk of breast cancer, coronary heart disease (nonfatal myocardial infarction and CHD death), stroke, and venous thromboembolism, with hazard ratios (95% CIs) of 1.26 (1.00–1.59), 1.29 (1.02–1.63), 1.41 (1.07–1.85), and 2.13 (1.39–3.25), respectively.[6] In response, millions of women stopped hormone therapy.

Conventional hormone therapy (CHT) in the United States has traditionally utilized synthetic or nonbioidentical hormones. However, with rising concerns over the side effects of CHT, alternatives are becoming popular. Of these, bioidentical hormones, sometimes incorrectly referred to as "natural hormones," have gained favor among women.

Bioidentical hormones have been around for years, as suggested by historical accounts of older women consuming young women's urine to preserve youth. Bioidentical hormones were previously available as injectable preparations to avoid destruction by gut enzymes. Bioidentical preparations may now be delivered via oral, transdermal, or vaginal routes. Synthetic, or nonbioidentical hormones, were initially developed to enable oral hormone absorption and have been widely used for menopausal symptoms until recently.

Bioidentical hormone therapy (BHT) is a controversial topic because of the mistaken belief that BHT is synonymous with "bioidentical compounded hormone therapy" (BCHT). BHT is a broad term that encompasses BCHT, or custom-compounded hormones as well as the noncompounded, US Food and Drug Administration (FDA)-approved bioidentical prescription hormones. As will be discussed below, the individualization of hormone therapy with salivary hormone measurements, which has made BCHT popular, has not been well researched. Also, the claim that BCHT is safer than CHT with regards to breast cancer and cardiovascular outcomes is unsubstantiated. Therefore, to counsel patients, our aim here is to provide a balanced summary of available evidence combined with our experience derived from conversations with thousands of women exploring their hormonal options.

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