Utilization of compounded bioidentical hormone therapy (cBHT) is a growing practice in perimenopausal and postmenopausal women, but clinicians should be cautious about prescribing this therapy, according to an editorial published in JAMA Internal Medicine.

The approval of menopausal hormone therapy by the US Food and Drug Administration (FDA) has substantially decreased in recent years, in part due to the 2002 Women’s Health Initiative (WHI) trial, which demonstrated that oral conjugated equine estrogens and medroxyprogesterone acetate result in harms that outweigh the chronic disease prevention benefits. In turn, many experts and industry stakeholders began supporting cBHT as a natural alternative with higher efficacy.

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Unfortunately, the rates of cBHT prescriptions have yet to be systematically tracked. Only estimates of prescription data exist. The investigators note that there are currently few data that demonstrate the efficacy, safety, or utility of cBHT in menopausal women. Randomized, placebo-controlled trials are typically standard for drugs to be approved for menopausal-associated symptoms, yet many of these studies are not performed for cBHT.

According to the researchers, the easiest issue to address with cBHT is the lack of patient package inserts. Products approved by the FDA, including low-dose vaginal estrogen therapies, provide inserts for patients communicating risks for serious adverse events. The investigators suggest similar labeling requirements be mandated for manufacturers of cBHTs.                                                

“Clinicians should be cautious about prescribing cBHT,” concluded the investigators. “State pharmacy boards could take the initiative to request that compounding pharmacists provide a patient package insert when these medications are dispensed. In the absence of such measures, clinicians should fully inform their patients.”

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Stuenkel CA, Manson JE. Compounded bioidentical hormone therapy: does the regulatory double standard harm women? [published online October 09, 2017] JAMA Intern Med doi:10.1001/jamainternmed.2017.5141