Compounded Bioidentical Hormone Therapy The National Academies Weigh In

After 21 months of data collection and analysis, the NASEM committee’s overarching conclusion was, “Given the paucity of data on the safety and effectiveness of cBHT…there is insufficient evidence to support the overall clinical utility of cBHT as treatment for menopause.”1(p9) Specific concerns included inadequate labeling requirements of cBHT preparations, paucity of reliable pharmacokinetic and bioavailability data, technical challenges with difficult-to-compound steroid hormones (particularly pellet therapies), and insufficient high-quality evidence to establish whether cBHT preparations are safe and effective. The committee further concluded that most marketing claims about safety and effectiveness are not supported by evidence from welldesigned, properly controlled studies. Incomplete adverse event reporting contributes to safety concerns. The committee acknowledged that in the absence of safety and effectiveness data for cBHT, patient preference should not be the sole driver for use.