The Truth About Bioidentical Hormones
Dr. Sandra Fleming is an obstetrician-gynecologist practicing in Wellesley, MA. Dr. Fleming specializes in women's health, particularly the female reproductive system, pregnancy, and childbirth. As an obstetrician-gynecologist, or OB-GYN, Dr. Fleming can treat a number of health issues related to the vagina, uterus, ovaries,... more
As women age, the natural levels of hormones in their bodies – primarily estrogen, progesterone, and testosterone – decline. In some women, this process can be more dramatic than others and can result in a variety of symptoms including hot flashes, night sweats, difficulty sleeping, fatigue, mood symptoms, poor concentration, and low sex drive.
To lessen the more severe symptoms, some women can consider hormone therapy. There have been conflicting reports in the press about what the best way is to get your hormones in check. Many women choose to try “bioidentical hormone therapy” (BHT). Some press has led women to believe this is a safer and more natural way to get your hormone replacement, but beware, the opposite may be true and it could potentially be more harmful.
What does it all mean?
BHT refers to compounds that have the same structure as hormones produced in the body. Providers who prescribe BHT compounds often conduct hormone testing with blood or saliva samples and then recommend “custom-compounded” hormone recipes of one or more hormones in varying amounts. A compounding pharmacist then prepares these. While this may sound ideal, there are some safety concerns most patients and many providers may not be aware of. In particular, the FDA has not vetted BHT compounds. They have not been studied the way currently available FDA-approved conventional hormones in the United States and Canada have been.
Concerns with BHT:
Inconsistent formulation – BHT compounds may contain some of the same active ingredients in FDA-approved products, but formulation methods vary between pharmacies and may result in varying amounts of medication. You may then get too little or too much hormone. Too little may result in ineffective treatment and too much may be unsafe.
Inconsistent absorption – BHT compounds come in different forms such as gel, cream, nasal spray, suppository, under the tongue tablet, under the skin pellet, and liquid. Absorption can be inconsistent, resulting in unpredictable hormone levels and uncertainty that you are getting safe levels of hormones in the body.
Compounding risks – Compounded hormone products may have additional risks related to the compounding process, inactive ingredients and may have batch-to-batch differences.
No safety packaging information – With conventional FDA-approved hormone therapy, regulations require pharmacies to include important safety information via package inserts. This is not required with BHT despite the potential for serious adverse effects. This can be misleading and cause misperception among women – either they believe that problems or dangers are exclusively related to conventional hormones because they include safety information. Or they think that BRT is safe with no side effects or risks because of a lack of safety information.
Costly – BHT can be expensive and is often not covered by health insurance plans.
Lack of evidence of benefit over FDA-approved HRT – The North American Menopause Society (NAMS), International Menopause Society, The American College of Obstetricians and Gynecologists, Society of Obstetricians and Gynecologists of Canada, The Endocrine Society, The FDA, American Association of Clinical Endocrinologists, American Medical Association, American Cancer Society, and the Mayo Clinic have released statements that there is a lack of evidence of any difference in either the benefits or risks of custom compounded bioidentical hormones compared to well-studied, conventional counterparts.
What is the right treatment for me?
Fortunately, there are many well-tested, FDA-approved bioidentical hormones that do not have to be custom-compounded (meaning custom mixed). They have the same chemical and molecular structure, as hormones produced in the body, are plant based, are commercially available from retail pharmacies, produced with monitored quality control and are likely covered by your health insurance plan. If you are having menopause symptoms that are affecting your quality of life, please see a doctor with experience in menopause to help you choose a treatment plan together that is FDA-approved, based on your unique needs, symptoms, medical and family history.
