Ask the Docs
Bioidentical Hormone Therapy: 
What Every Woman Should Know
By Heather Loguidice, ARNP
Many questions surround the use of hormone therapy since the results from the Women’s Health Initiative Study were released in 2002 and 2004. The study results demonstrated an increased risk for stroke and deep vein thrombosis in women who took oral conjugated equine estrogens. In women who took combined therapy with estrogen and medroxyprogesterone acetate there was an increase risk for stroke, heart disease, pulmonary embolism, deep vein thrombosis, and breast cancer.
Further analysis of the data showed that women who started hormone therapy between the ages of 50 and 59 years or within 10 years of reaching menopause had a reduced risk for heart disease compared with women who began therapy later on. As a result, the current guidelines suggest that, in suitable women, hormone therapy should be administered at the lowest effective dose for the shortest possible time.
Over the past several years, the term bioidentical hormone therapy has created quite a buzz in the media. Interestingly, the term bioidentical hormone in not recognized by the Federal Drug Administration (FDA). Bioidentical hormones are generally considered to be derived from plants and made to be structurally indistinguishable from the hormones produced by the human body.
One of the major misconceptions surrounding bioidentical hormone therapy is that compounding pharmacies are the only providers, and that compounded therapies are the only way to tailor treatment toward an individual woman’s needs. In actuality, there are many conventional pharmaceutical hormone therapies that contain bioidentical hormones with multiple dosing and delivery options.
Conventional bioidentical hormone therapy has specific FDA approved indications for the treatment of symptoms associated with menopause, such as hot flashes, night sweats, and vaginal dryness. The FDA requires well regulated drug trials to ensure the safety and efficacy of any approved hormone therapy. Thus, all pharmaceutical company manufactured conventional bioidentical hormone therapy products have well-established safety and efficacy profiles.
By contrast, compounded bioidentical hormone therapies are not FDA approved and have no indication for treatment of any menopausal symptom. In addition, compounded hormone formulations do not undergo the same quality control measures that the FDA requires of commercial products. It is common for the potency of the medication and inactive ingredients to differ with each preparation. Poor sanitary practices can also lead to contamination of the product. Compounding pharmacies are not required to report adverse events associated with compounded drugs. To date, no controlled drug trials have been conducted on the most common forms of compounded bioidentical hormone therapy.
Nevertheless, numerous celebrity self-help books and websites promote compounded bioidentical hormone therapy products as safer and more effective alternatives to conventional products. No evidence exists to support any of these claims.
The FDA requires all conventional bioidentical hormone therapy products to include specific warnings for increased risks for heart attack, stroke, pulmonary embolism, deep vein thrombosis, and breast cancer. Since compounded bioidentical hormone therapies are not FDA approved, they are not required to provide any safety warnings. Many women are under the false belief that compounded hormone therapy does not carry the same risks as conventional products. Per the FDA, all hormone therapy should be assumed to carry the same risks.
Another concern associated with the use of compounded hormone therapy is the manner in which the hormones are measured, usually through saliva or serum. There is no evidence to support adjusting hormone therapy dosages based upon these tests. Hormone concentrations can vary depending on time of day, diet, stress, and type of hormone tested. Furthermore, estrogen levels in symptomatic and asymptomatic women can be identical. The American College of Obstetricians and Gynecologists and the FDA recommend that hormone therapy be guided by symptom response, and not serum hormone levels which are not clinically meaningful.
The cost associated with the use of compounded bioidentical hormone therapy is much more expensive than conventional hormonal therapy and typically not covered by insurance. This is due to the extra expense of laboratory service fees, the healthcare provider fee, and the monthly cost of the medication.
It is important for women to discuss the appropriate uses for hormone therapy replacement with their healthcare provider. With all of the media hype surrounding the use of compounded bioidentical hormone products, it is easy to get misleading information. If you would like more information, please call us at Family Medical and Wellness Center 561-721-1953.
Heather Loguidice, ARNP, joined doctors Glover and Vizcaino at the end of 200 and is certified in Family Practice. Her experience spans 14 years and she has worked in Fast-Track ER’s and a few large Family Practice offices. Her interests include Women’s Health and Pediatrics and she has a wide range of experience in all Family Practice related matters. Heather is a big Gator’s fan; she lives in Boynton Beach and enjoys spending her free time with her daughter.