Many women who opt for custom-compounded bioidentical hormone replacement therapy do so because they believe it’s a natural and safer option than hormone replacement therapy (also called menopausal hormonal therapy).
Indeed, a 2015 survey by the North American Menopause Society (NAMS) found that about 30 percent of women who ever used hormone replacement therapy tried formulations custom-mixed for them at a place like a compounding pharmacy.
But compounded bioidentical hormone replacement therapy is anything but natural. Although these products may originally be plant-based, at least 15 chemical reactions in a laboratory are required to manufacture them. Plus, there’s no way to know whether they’re safe. But keep the following in mind if you’re considering compounded bioidentical hormone replacement therapy:
• The US. Food and Drug Administration doesn’t regulate or test compounded bioidentical hormones but has ruled that some compounding pharmacies producing the hormones have made false claims about the hormones’ safety and effectiveness.
• Bioidentical hormone therapy carries the same risks as FDA-approved hormone replacement therapy—and may have added hazards of its own. For example, soy compounds, found in many natural hormone supplements, may stimulate the growth of breast tumors. Because the compounding industry isn’t well regulated, it’s difficult to know the specific ingredients and their consistency and purity in any particular compounded hormone therapy from batch to batch.
• Little reliable evidence from high-quality clinical trials exists about compounded bioidentical hormone therapy’s safety and effectiveness and how it compares with FDA-approved hormone replacement therapy.
• Bioidentical hormone therapy may contain hormones that aren’t FDA approved and monitored.
• Bioidentical hormone therapy may contain ingredients such as dyes and preservatives that may cause side effects in some women.
• Product labeling or package inserts that should include known side effects and contraindications may be incomplete or misleading.
• Prescribing bioidentical hormone therapy practitioners use an inaccurate and unreliable method of saliva testing to determine each patient’s hormone formulation.
Most major women’s health organizations, including NAMS and the American College of Obstetricians and Gynecologists, advise against using compounded bioidentical hormone replacement therapy.