Custom-compounded Bioidentical Hormone Therapy
Custom-compounded Bioidentical Hormone Therapy
Unsubstantiated claims, lack of scientific safety and efficacy data, and lack of quality control surround custom-compounded bioidentical hormone products. FDA-approved hormone therapy provides tested and regulated therapy without the risks of unregulated and untested custom preparations.
Bioidentical hormones, a marketing term not recognized by the US Food and Drug Administration (FDA), refers to exogenous hormones biochemically similar to those produced within the body and includes 17A-estradiol (predominant estrogen before menopause), estrone (predominant estrogen after menopause), estriol (from placenta), progesterone (ovaries, placenta, and adrenal glands), testosterone (ovaries and adrenal glands), and their conjugates. These are derived from soy and yam precursors and must be chemically processed to make them able to be absorbed by the human body.
Hormones that meet the definition of bioidentical are available as FDA-approved prescription therapies and include estradiol (oral, patch, gel, lotion, mist, and vaginal ring, cream, or tablet) and micronized progesterone (oral or vaginal). The FDA has not approved estriol. Custom-compounded bioidentical hormone products are prepared, assembled, and packaged according to a provider's prescription into gels, creams, lotions, sublingual tablets, subdermal implants, suppositories, or troches. Transdermal therapies avoid the first-pass effect through the liver, and there is evidence that they have a lower clotting risk. Progesterone may have fewer negative effects than synthetic progestins on lipids, sleep and mood, and breast (density, tenderness, and cancer risk) when combined with estrogen. No FDA-approved testosterone therapy (bioidentical or otherwise) is available for women.
Abstract and Introduction
Abstract
Unsubstantiated claims, lack of scientific safety and efficacy data, and lack of quality control surround custom-compounded bioidentical hormone products. FDA-approved hormone therapy provides tested and regulated therapy without the risks of unregulated and untested custom preparations.
Introduction
Bioidentical hormones, a marketing term not recognized by the US Food and Drug Administration (FDA), refers to exogenous hormones biochemically similar to those produced within the body and includes 17A-estradiol (predominant estrogen before menopause), estrone (predominant estrogen after menopause), estriol (from placenta), progesterone (ovaries, placenta, and adrenal glands), testosterone (ovaries and adrenal glands), and their conjugates. These are derived from soy and yam precursors and must be chemically processed to make them able to be absorbed by the human body.
Hormones that meet the definition of bioidentical are available as FDA-approved prescription therapies and include estradiol (oral, patch, gel, lotion, mist, and vaginal ring, cream, or tablet) and micronized progesterone (oral or vaginal). The FDA has not approved estriol. Custom-compounded bioidentical hormone products are prepared, assembled, and packaged according to a provider's prescription into gels, creams, lotions, sublingual tablets, subdermal implants, suppositories, or troches. Transdermal therapies avoid the first-pass effect through the liver, and there is evidence that they have a lower clotting risk. Progesterone may have fewer negative effects than synthetic progestins on lipids, sleep and mood, and breast (density, tenderness, and cancer risk) when combined with estrogen. No FDA-approved testosterone therapy (bioidentical or otherwise) is available for women.