IMS Menopause Live

The safety and efficacy of compound bioidentical hormone therapy in peri- and postmenopausal women

12 April 2022


Due to the results of the 2002 WHI, many women decided to follow the advice of their doctors and switch from using synthetic hormones to using compounded bioidentical hormone therapy (cBHT). This led to an increase in the prescription of these compounds in the last decade to up to around 33 million annual prescriptions and with a progressive increasing trend. This prompted the FDA to ask NASEM (National Academy of Science, Engineering, and Medicine) to evaluate the available evidence on cBHT, concluding that there was a lack of high-quality research establishing the safety and efficacy of cBHT, and that studies with a higher level of evidence were needed, as well as a systematic review and a meta-analysis. Bearing this in mind, Liu and collaborators [1], carried out a systematic review and meta-analysis based on protocols registered in PROSPERO and carried out in accordance with the Cochrane Manual for Systematic Reviews of Interventions and the checklist of 27 items Preferred Reporting Items for Systematic Review and Meta-Analysis Statement (PRISMA) [2,3], in order to evaluate the existing evidence related to the safety and efficacy of cBHT that are prescribed to peri- and postmenopausal women. The authors searched across systems, choosing for analysis randomized controlled trials (RCTs) that compared outcomes in peri- and postmenopausal women using cBHT against placebo or FDA-approved hormonal products. They analyzed bias, according to the Cochrane risk of bias tool and took primary outcomes of safety (changes in lipid profile and glucose metabolism) and efficacy (changes in symptoms of vaginal atrophy). Secondary outcomes included changes in the endometrium, risk of adverse events, vasomotor symptoms, change in hormone levels, and change in bone mineral density.