The Doctor’s Note: Bioidentical Hormone Replacement Therapy

On average, menopause occurs in women at 51 years of age. Common symptoms include hot flashes, mood changes, sleep disruption and altered tissue linings of the vagina and urinary tract. Loss of ovary function and estrogen production are responsible for these changes.

American women have seen an increase in expected lifespan, from less than 50 years of age in 1900, to 80 years in 2000. Women now live for decades after the onset of menopause. 30 years ago, physicians were trained to recommend hormone replacement therapy for most menopausal women. It seemed reasonable that estrogen replacement could help symptoms of menopause, possibly even prevent dementia, cardiovascular disease, osteoporosis, stroke and other age-related ailments. As more experience and data has been gained, we discovered hormones do not prevent dementia or cardiovascular disease as previously hoped. Additionally, risks related to uterine cancer, breast cancer and blood clots have been defined. 

Currently it is recommended that women approaching menopause discuss the risks and benefits of hormone replacement therapy with their physician. Individualized treatment considering medical and family history help guide therapy. Many well-studied Food and Drug Administration (FDA) approved options and routes of administration are available to help alleviate symptoms of menopause while minimizing risks.

An unproven industry has developed around compounded Bioidentical Hormone Replacement Therapy (BHRT). There is no evidence-based research to support claims of a safer or “natural” product. The FDA has not approved these regimens and they may not be covered by insurance.

BHRT is concocted by compounding pharmacies. The compounding process can lead to widely fluctuating concentrations of drugs, with no oversight or quality control to protect the consumer. Ingredients may include estrogen, progesterone, DHEA and the male hormone testosterone. The ingredients are no more “natural” than FDA approved drugs, as the same manufacturing processes is employed for both.

Ordering of this treatment is often accompanied by expensive and repeated laboratory testing rather than guidance by impact on menopausal symptoms. This is unproven and only increases the burden on the consumer.

Experts including the North American Menopause Society, the American College of Obstetricians and Gynecologists, and the Endocrine Society have all issued statements advising against the use of compounded BHRT. Safety and efficacy have not been proven.

My advice is talk to your physician about FDA-approved treatments if or when the time comes to treat menopausal symptoms. BHRT is not proven to be effective or safer. This unproven therapy may even end up costing you more as it may not be covered by insurance.

Kent Haverkamp, M.D., is board certified in both internal medicine and pediatrics. Prior to joining BCBSKS in 2013 as a medical director, Haverkamp worked for Cotton-O’Neil Clinic from 1993 to 2013 as a primary care provider for adult and pediatric patients.

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