University of California, San Diego, School of Medicine, La Jolla, CA, USA.
Climacteric. 2021 Feb;24(1):11-18. doi: 10.1080/13697137.2020.1825668. Epub 2020 Oct 19.
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.
绝经激素治疗（MHT） 80 年发展历程中的一个决定性时刻是 2002 年公布的妇女健康倡议（WHI）临床试验联合激素治疗组的初步结果。监管机构批准的 MHT 迅速被摒弃，且反响强烈，同时复合药物“生物等效性”激素治疗行业迅速加速发展。在 WHI 之前，制剂商就已经招募了处方医生，并推广了复合生物等效性激素治疗（cBHT），然而 WHI 令人震惊的结果提供了一个催化剂，使得复合激素的产量迅速增加，这些复合激素的监管是可变的、基本上未经研究的，且标签不一致。在这篇综述中，cBHT 的兴起和监管双重标准的故事，只有被美国国家科学院、工程院和医学院 2020 年的发现和建议所掩盖。他们的调查是受美国食品和药物管理局委托进行的，任务是：提供 cBHT 临床应用的循证总结；评估安全性和疗效证据是否支持 cBHT 的使用；并确定可能需要 cBHT 替代批准药物产品的患者群体。他们的结论符合科学依据，建议与全球更年期协会一致。
