Bioidentical Hormone Therapy

By: 
By Ekta Kapoor, MD
shopping for hormone supplements

The term “bioidentical hormones” essentially means hormones that are identical to and have the exact same chemical and molecular structure as hormones that are produced in the human body. This includes commercially available hormones that are approved by the United States Food and Drug Administration (FDA) as well as custom compounded preparations made in pharmacies that are not regulated by the FDA. As it turns out, the term “bioidentical” is a marketing term, rather than a medical term, used to convey meanings such as “natural,” “organic” and “plant-derived.” However, it has not been proven that custom compounded bioidentical hormone therapy is more effective or safer than the FDA-approved hormone preparations.

There is a huge demand for custom compounded bioidentical hormones due to widespread marketing and a perception of better safety of these formulations. These products are often promoted as a remedy and preventive strategy for a number of conditions including sexual problems, aging, dementia, and cancer, etc. Some of these products are also marketed as being safer in comparison to the long-term risks that may be associated with hormone replacement therapy, including breast cancer. However, there is no evidence to support these claims. In fact, these preparations are not regulated by the FDA, and there can be significant batch to batch variation in the amount of the active drug, which leads to the risk of receiving a lower dose, or worse still, higher than prescribed due to variance. There are also concerns regarding the purity of these formulations. As such, these preparations are potentially unsafe, and physicians should discourage the use of compounded bioidentical hormone therapy. It is therefore very important to counsel and educate patients in this regard.

FDA-approved bioidentical estrogen is available in a number of formulations, including pills and preparations to be used on the skin (patches, gels, etc.) Similarly, bioidentical progesterone is available in pill form. Custom-compound hormone preparations are available as capsules, troches, gels, creams, lotions, suppositories, or pellets. The use of pellets should be avoided since they often lead to concentrated doses of the hormone for the patient. Once the pellets have been placed, they cannot be removed, and the patient is left with high levels of hormones until the pellet wears off.

"These preparations are not regulated by the FDA, and there can be significant batch to batch variation in the amount of the active drug, which leads to the risk of receiving a lower dose, or worse still, higher than prescribed due to variance... As such, these preparations are potentially unsafe."

There are some situations where custom compounded hormone therapy is necessary, such as a patient allergy or sensitivity to the preservatives in FDA-approved estrogen products. In this situation, the estrogen can be compounded in a preservative-free base in a pharmacy. For example, a woman with a peanut allergy may be allergic to the FDA-approved micronized progesterone pill because it contains peanut oil, so a product without peanut oil may need to be compounded. Sometimes patients request a particular strength or route of the hormone formulation that is not FDA-approved. In this situation, a custom compounded preparation can also be considered; however, a pharmacy that specializes in custom compounded bioidentical hormone therapy should be used.

Providers who prescribe custom compounded bioidentical hormone therapy should include hormone level testing in the saliva or blood as part of routine care of these patients. Patients are often recommended to maintain a certain hormonal profile and make changes to their dosing based on these hormone levels; however, there is no evidence to support this. If a patient does not have the expected response to hormone therapy use and there are concerns regarding absorption of the medication, testing the levels of estrogen hormone in the blood is recommended. However for the most part, in routine care of patients on hormone therapy, there is no role for hormone level testing. The hormone dosing is adjusted based on the control of symptoms and not based on levels of the hormones. Moreover, salivary hormone testing is not reliable at all in this setting and is not recommended.

In general, we prefer to treat patients with the FDA-approved formulations. However, if the patient chooses to stay on custom compounded bioidentical hormone therapy, they should have regular follow-up with their provider, and they should be closely monitored for the adverse effects associated with conventional FDA-approved hormone therapy, including venous thromboembolism and breast cancer. Women on custom compounded testosterone therapy need to be closely monitored for symptoms and signs of overdosing, including acne, voice changes and increased hair growth.