Bio-identical Hormones For Women – Are They A Safe Alternative?

Posted in Women's Health.

In response to studies linking the use of hormone replacement therapy (HRT) and breast cancer, many post-menopausal women look for alternatives. One of the more popular alternatives to conventional HRT is the use of “bio-identical hormone” therapy (BHRT).

  Prompted by celebrity endorsement, promises of safety and anti-aging benefits, some woman seek compounding pharmacies that will, upon prescription, make personalized formulas of hormones to replace the those naturally waning after menopause.

Recently, the FDA cracked down on claims made by some compounding pharmacies regarding BHRT, calling use of the term, “bio-identical” unscientific. The FDA is not discouraging the use of compounding pharmacies. Specifically, the FDA cracked down on claims for one of three estrogens used in BHRT, estriol. Estriol is a weaker estrogen and promoters of BHRT claim that it does not increase the risk of breast cancer.  The problem is that claims regarding the safety of estriol have never been proven in clinical trails.

Frequently Asked Questions

To help clarify the situation for women, several frequently asked questions are addressed.

What are bio-identical hormones?

The term “bio-identical” was coined by MDs who practice natural medicine and by naturalpaths and by compounding pharmacists about 15 years ago.  Bio-identical hormones have the exact chemical structure as those produced by the human body. Three estrogens are typically incorporated into BHRT formulas – estrone (E1), estradiol (E2), and estriol (E3). Estrone is about 1/3 as potent as estradiol; estriol is about 1/5 as potent. Typically, bio-identical estrogen formulations are at least 80% estriol. Preparations also may include progesterone and testosterone.

Are bio-identical hormones “natural hormones”?

No, they are not “natural” because they are made in laboratories.

Are bio-identical hormones safer than conventional HRT?

There is no evidence that bio-identical hormones are safer. Doctors with years of experience using BHRT believe they are safer, but there are no well-designed clinical trials to verify their position. Women who decide to use bio-identical hormone therapy should do so with their eyes open.  This author strongly advises that you use your regular physician, not someone you find on the Internet. Regular checkups, mammograms, self-examination are as important as ever. Do not be lulled into complacency. If you are using progesterone and / or testosterone, in addition to estrogen, keep tabs on your blood pressure and cholesterol levels.

Observational studies that look at the number of years a woman menstruate, and relate that variable to the incidence of breast cancer shed light on the question of safety. Women who begin menstruation earlier in life and / or go through menopause later than the norm have a higher risk for breast cancer. In other words, women who go through a longer time exposed to their own, bio-identical estrogen are at greater risk for breast cancer than those who spend fewer years of their life exposed to their own estrogen. Based upon this information, in this author’s opinion, it is prudent to assume that both HRT and BHRT carry breast cancer risk.

Is bio-identical progesterone safe?

Bio-identical progesterone is claimed to be safer than its synthetic counterparts, which are collectively called progestins. The most commonly used progestin is medroxyprogesterone.

In the Women’s Health Initiative Trial, the study arm that took Prempo® (a combination of medroxyprogesterone and conjugated equine estrogen) had a higher risk of breast cancer compared to placebo. Scientists surmise that, while estrogen stimulates the growth of breast cancer, progestin increases the blood supply to tumors, facilitating growth. Bio-identical progesterone has the same effect on breast tissue, so there is no reason to assume it is safer than progestins with regard to breast cancer. After menopause woman make estrogen in fat tissue. If you have a significant amount of estrogen, even though you are post-menopausal, and you use OTC progesterone, you may be increasing your risk of breast cancer.

Topical progesterone products are available over the counter. This author advises that they not be presumed to be safe. Some women experience elevated blood pressure from these products.

Do drug companies make bio-identical hormones?

Yes, drug companies have been making bio-identical hormones for years, in pill, patch and vaginal products. Estradiol is used in many pharmaceutical preparations.

Difficult Decisions

Today, most doctors use HRT for menopause symptoms only and for the shortest length of time possible. Proponents of BHRT, however, present it as a way to prevent or reverse aging. Estrogen does protect bone and soft tissue. Post-menopausal women, when pondering the use of estrogen, face a “breast vs. bone” decision.  Hopefully you now have some additional knowledge so that you, along with your physician, can better address the decisions at hand. 

These statements have not been evaluated by the Food and Drug Company. They are not intended to diagnose, cure, prevent or treat any disease.

Debbie Edson is a registered pharmacist, with a background in hospital and community practice. She is proprietor of Healthy Morning, LLC. Her passion is educating people about evidence based natural healing. She is a recent contributor to the best selling book, Prescription For Nutritional Healing, 4th Ed. Debbie lives in Massachusetts with her husband, David. She has one child, Laura Novak, who is a photographer in Wilmington, Delaware.  Her e-mail is This email address is being protected from spambots. You need JavaScript enabled to view it.




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