Bioidentical hormones

Abstract

After the results of the Women’s Health Initiative trials were published, patient and clinician interest in potential alternatives to conventional hormone therapy (HT) has grown. A commonly used alternative therapy involves custom-compounded steroid hormone preparations, formulated by compounding pharmacies. Many postmenopausal women consider the hormones as natural or bioidentical, in contrast to hormones used in conventional HT, which they consider synthetic. In actuality, the chemical structures of many of the hormones used in bioidentical HT (BHT) are the same as those used in conventional HT. To customize formulations, compounding pharmacies frequently use saliva testing to measure hormones. However, there is a misconception that salivary hormone levels are equivalent to non-protein-bound (free) hormones in blood. Because hormonal custom-compounded formulations are not approved by the Food and Drug Administration (FDA), there are concerns regarding their purity, potency, and quality. Evolving regulatory guidelines by the FDA on oversight of these products should lessen the concerns regarding their safety and efficacy. This review addresses important misconceptions and uncertainties pertaining to BHT, the relationship between salivary and serum/plasma steroid hormone concentrations, the effect of topical progesterone creams on the endometrium, the variability in custom-compounded steroid preparations, and FDA oversight of custom-compounded products.

摘要

在妇女健康倡议试验的结果公布后, 患者和临床医生对传统激素治疗（hormone therapy, HT）的潜在替代治疗的兴趣日益增长。常用的替代治疗涉及通过药厂配制的定制混合类固醇激素制剂。许多绝经后女性认为这些激素是天然或生物性质相同的, 与传统的HT中应用的合成性激素性质不同。实际上, 生物学相同的HT（bioidentical hormone therapy, BHT）中应用的许多激素的化学结构与传统HT中应用的激素相同。为了定制混合制剂的配方, 制药公司常应用唾液检查来测量激素。然而, 有一种误解认为唾液激素水平等同于血液中非结合蛋白（自由）激素。并且定制激素的混合配方还未得到食品和药物管理局的批准, 人们担心它们的纯度、药效和质量。FDA在监督这些产品的监管指南不断的改进, 应该会减轻人们对其安全性和有效性的担忧。本文汇总了与BHT有关的重要误解和不确定性, 以及唾液和血清/血浆类固醇激素浓度之间的关系。外用孕激素乳膏对子宫内膜的影响, 定制混合类固醇激素制剂的变异性, 以及FDA对定制混合产品的监管。

Keywords:

• Bioidentical
• estrogens
• compounding
• progesterone
• salivary testing
• postmenopause

Potential conflict of interest

No potential conflict of interest was reported by the authors.

Source of funding

Nil.