What is Bioidentical Hormone Therapy?

Many women wonder whether or not to pursue hormone therapy as they experience menopause symptoms that are affecting the quality of their lives. Some are not comfortable with the idea of conventional hormone replacement therapy and would prefer natural hormonal or non-hormonal alternatives.

For safe and effective treatment of menopause symptoms, one option to consider is bioidentical hormones. Medical professionals who are proponents of bioidentical hormones cite 196 medical studies showing the effectiveness of bioidentical hormones.

What is the difference between conventional HRT and bioidentical HRT?

The most popular form of conventional HRT is a product consisting of synthetic estrogen plus progestin (a synthetic form of progesterone). This is sometimes referred to as combined hormone therapy. Another form of conventional HRT is synthetic-estrogen only.

It is a little more difficult to describe bioidentical HRT products. The Endocrine Society has defines bioidentical hormones as "compounds that have exactly the same chemical and molecular structure as hormones that are produced in the human body."

BHRT is sometimes referred to as compounded hormone therapy. Compounded refers to the fact that the bioidentical hormones dosages are customized for each individual woman based on tests that show the current levels of the hormones in her body.

Advocates of bioidentical HRT describe the estrogen and progesterone that they use as natural (as opposed to synthetic). They say that because they are biologically identical to the hormones made by a woman’s body, they function in the same way as the hormones made by your own bodyThe International Hormone Society says there sufficient evidence confirming the greater safety of bioidentical sex hormones compared to the nonbioidentical ones, in particular when the transdermal, nasal or intramuscular routes are used instead of the oral route.

Common criticisms of BHRT

1. Compounded bioidentical hormones are not FDA approved. Although compounded bioidentical hormones have not been approved by the FDA as a treatment for menopause symptoms, Kathleen Uhl, MD, the FDA’s assistant commissioner for women’s health says the fact that the FDA does not give its approval to compounded products does not mean that compounding is bad; in fact she says compounding can be useful, but because compounding is done on a patient-by-patient basis, "There’s nothing that’s submitted to FDA to evaluate, so they’re not FDA approved." As well, compounding pharmacies are regulated at the state level, not by the federal government, so FDA approval is not required for compounding pharmacies to dispense compounded bioidentical hormones.

2. No randomized clinical trials have been done to determine the safety of compounded bioidentical hormones. It is true that there have been no clinical trials to determine the safety of compounded bioidentical hormones. However, as mentioned earlier in this post, 196 observational studies support the safety and benefits of bioidentical hormones.

My take on BHRT

BHRT has yet to conclusively demonstrate safety and efficacy by means of well-designed, head-to-head clinical trials in which they are compared against conventional HRT. Such trials may be a long time in coming, as many clinical trials are funded by pharmaceutical companies which may see the providers of BHRT as competitors. Pharma companies have billions of dollars invested their conventional HRT products.

However, I can see advantages in avoiding synthetic HRT products if possible and using a natural alternative is available that appears to be safe and at least as effective.


This article is reproduced with the permission of Menopause Matters.


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