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.