Compounded bioidentical menopausal hormone therapy – a physician perspective

Abstract

One of the defining moments of the 80-year evolution of menopausal hormone therapy (MHT) was the 2002 reveal of the initial results of the combined hormone therapy arm of the Women’s Health Initiative (WHI) clinical trial. The exodus from regulatory approved MHT was prompt and profound and accompanied by a rapid acceleration of the compounding pharmacy ‘bioidentical’ hormone therapy industry. Compounders had recruited prescribers and promoted compounded bioidentical hormone therapy (cBHT) well before the WHI, yet the startling results provided a catalyst that enabled a leap in production of compounded hormones that were variably regulated, basically unstudied, and inconsistently labeled. In this review, the story of the rise of cBHT and the regulatory double standard is eclipsed only by the 2020 findings and recommendations of the US National Academies of Science, Engineering, and Medicine. Their investigation, commissioned by the US Food and Drug Administration, was tasked to: provide an evidence-based summary of the clinical utility of cBHT; evaluate whether the evidence of safety and efficacy supports the use of cBHT; and identify patient populations that might need cBHT in lieu of an approved drug product. Their conclusions are consistent with sound science and their recommendations are in harmony with global menopause societies.

摘要

在绝经激素治疗（MHT）80年发展中2002年女性健康启动（WHI）临床试验中连续联合激素治疗组的初步结果的发布是决定性的时刻之一。监管部门批准MHT的终止是迅速而影响深远的, 随即混合的生物同质性激素治疗迅速发展。早在WHI之前, 制药公司就已经招募处方医师并推广了混合的生物同质性激素治疗（cBHT）, 但WHI令人吃惊的结果成为了催化剂, 使得混合激素的生产有了飞跃, 但它们受不同程度的监管, 基本上未经研究, 且标记不一致。本文叙述了cBHT的兴起和2020年美国国家科学、工程与医学院的调查和建议。由美国食品和药物管理局委托的调查任务是：提供cBHT临床实用性的循证证据；评估安全性和有效性的证据是否支持cBHT的应用；并确定可能需要cBHT代替批准的药品的患者人群。而他们的结论与科学的结果相一致, 其建议与全球的绝经学会的建议相吻合。

激素治疗（MHT）80年发展中2002年女性健康启动（WHI）临床试验中连续联合激素治疗组的初步结果的发布是决定性的时刻之一。监管部门批准MHT的终止是迅速而影响深远的, 随即混合的生物同质性激素治疗迅速发展。早在WHI之前, 制药公司就已经招募处方医师并推广了混合的生物同质性激素治疗（cBHT）, 但WHI令人吃惊的结果成为了催化剂, 使得混合激素的生产有了飞跃, 但它们受不同程度的监管, 基本上未经研究, 且标记不一致。本文叙述了cBHT的兴起和2020年美国国家科学、工程与医学院的调查和建议。由美国食品和药物管理局委托的调查任务是：提供cBHT临床实用性的循证证据；评估安全性和有效性的证据是否支持cBHT的应用；并确定可能需要cBHT代替批准的药品的患者人群。而他们的结论与科学的结果相一致, 其建议与全球的绝经学会的建议相吻合。

Keywords:

• Compounded
• bioidentical
• menopause
• hormone therapy
• risks and benefits

Potential conflict of interest

C. A. Stuenkel, MD, is a founding member of the North American Menopause Society and has served as President (2009–2010), Scientific Chair for the NAMS Annual Meeting (2012), and Contributor to the North American Menopause Society Hormone Therapy Position Statements (2007–2017), chaired the Writing Group for the Endocrine Society Clinical Practice Guidelines on Treatment of Symptoms of Menopause (2015), was an invited speaker for The National Academies of Science, Engineering, and Medicine Task Force on Clinical Utility of Compounded Bioidentical Hormone Therapy, Context for the Current Study, 6 May 2019, Washington, DC, and on the Data and Safety Monitoring Board, ICON Clinical Research, LLC, on behalf of Mithra Pharmaceuticals, Liege, Belgium since December 2019.

Source of funding

Nil.