August 2009

Bioidentical Hormones: The Real Story

Author: Dr. Ann Gorman

“Bioidentical Hormone replacement therapy” or BHRT generally refers to a compounded mixture of plant-based hormones which are similar to, or identical to, those produced by the ovaries. They are used to alleviate the symptoms of menopause, including hot flashes, night sweats, insomnia, and decreased sex drive as well as general loss of sense of well-being. Hormones utilized may include any combination of estradiol, estrone, estriol, progesterone, testosterone, pregnenolone, and DHEA or dehydroepiandrosterone. They are typically mixed or compounded by an FDA approved lab in various gels, creams, suppositories or capsules. Marketers and prescribers of such products claim that they may be safer or more effective than FDA approved hormone therapies already available. Some practitioners are prescribing doses based on hormone levels run on blood or saliva samples. The idea is that the mixture can then be tailored to a woman’s individual needs. Such tests can be quite expensive and are often not covered by insurance companies.

So what’s the advantage? None, according to the FDA and the American College of Obstetricians and Gynecologists (ACOG). In fact, the FDA recently took action against some pharmacies which were making false claims regarding these products. Both FDA and ACOG recently published advisories recommending caution when using BHRT.

To summarize the advisories, there is no evidence that BHRT is safer or more effective than traditional HRT. They have not been sufficiently studied and are not approved by the FDA for use. Some of the components have not been studied for long-term side effects in women. Some studies indicate that testosterone-containing medications may increase the risk of breast cancer more than that seen in non-testosterone-containing HRT. In addition, salivary levels of hormones are according to ACOG “meaningless.” These levels vary so widely depending on diet, time of day, specific hormone being tested and other variables, that no useable information can be obtained.

The good news: There are some FDA approved products available which contain the same hormones as those made by the ovaries. These have been subject to intensive study and quality control as with any other FDA approved medication. They include estradiol and micronized progesterone, among others. ACOG recommends use of such products at the lowest dose needed to alleviate menopausal symptoms. No blood levels are needed, since the dose is adjusted based on symptoms rather than lab values. They are generally very safe, but, if used over five years of so, may slightly increase the risk of breast cancer. Interestingly, breast cancers detected on HRT are more often early stage, and therefore more likely to be cured. Estrogen-containing preparations of all types also increase the risk of blood clots and strokes, which becomes a more important issue in the older population.

Approved HRT is available in a variety of forms: pills, creams, gels, patches, sprays, suppositories and vaginal rings. In theory, at least, the non-oral forms, such as gels and patches, may be safer due to the fact they are not absorbed directly and do not go through the digestive tract and liver. The total amount needed will thus be lower. Whether that actually decreases the risk remains to be seen.

Whether a woman chooses to use HRT or not is a very personal decision best made in concert with her physician. Both risks and benefits vary considerably from person to person, and each woman’s overall health should be examined and understood before starting any new medication regimen.

For further reading, refer to the following Web sites: www.fda.gov/consumer/updates/bioidenticals010908.html or www.acog.org.

Dr. Ann Gorman is a practicing OB-GYN physician currently practicing in her own private medical office, Women’s Healthcare Associates, PA. Dr. Gorman has been practicing for many years in the low country and has experience, knowledge, and sincerity that many women seek.

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