If you have been reading Suzanne Sommer's best seller, "The Sexy Years" and wondering what she has been touting as bioidentical and natural hormone therapy (NHT), you may wonder why you haven't found a Compounding pharmacist in your neighborhood selling these hormones. First you must understand that while hormones have been synthesized by drug companies since the 50's, it is only in the past 10 years that they have been readily available on the Internet from "gray market"  Compounding pharmacies. These hormones as tested by the FDA appear to be bioidentical with the same molecular structures as human estrogens and capable of producing the same effects as the natural hormones found in females.

Estrogens (Es) belong to the steroid class of hormones derived from Cholesterol and are naturally produced by the ovaries, adrenals and by peripheral fat in the breasts. Es include estradiol-E2, estrone-E1, estriol-E3 and progesterone. 17 beta Estradiol is produced by the ovary in the largest quantity and has the highest affinity for estrogen receptors in the breasts and female reproductive organs. Oral Es are first conjugated in the liver to inactive estrone and estriol, which have diminished potency, but then are excreted into the intestines where they are converted to active Es and reabsorbed into the circulation. This first pass effect stimulates the liver to improve your cholesterol and HDL lipid profile, but also produces binding proteins which carry the active hormones in the bloodstream to the receptors. The transdermal patch avoids this step and requires much smaller doses for the same estrogenic effect.

These bioidentical hormones are produced from a chemical structure found in Soybeans, Stigmasterol, or from a plant phytosterol in Mexican Wild Yams called Diosgenin. Since all human steroid hormones begin with a Cholesterol substructure and then are converted to active hormones by enzymes in the body, we can easily see how a similar chemical structure in plants can be converted by a half dozen chemical reactions to resemble the hormones in question. These are not natural, they are synthetic. Humans cannot metabolize or utilize these plant sterols without laboratory chemical synthesis of the hormones. The second problem for these bioidentical hormones is their method of delivery so that they may enter the blood stream without being destroyed. For instance, the half life of Estradiol in the blood stream can be measured in minutes and thus must be constantly and evenly absorbed. So while these bioidentical hormones are similar in structure, the Compounding pharmacies have not shown that they are similar in bioavailability. The only way this can be done is by rigorous testing of blood levels after the hormones are administered, not by a saliva test as these pharmacies propose. Testing is not an FDA requirement of Compounding Pharmacies since the FDA treats them as herbal supplements and not a unique patentable drug. So as with all herbal preparations you do not know what you are receiving and whether there is an appropriate dose-response to the preparation as noted in my article  "Hormonal Homeopathy".

Now some bioidentical hormones have passed FDA approval as micronized Progesterone, known as oral Prometrium, or the micronized Estradiol known as oral Estrace because the testing has been done. Micronization into small particles is probably the only delivery process that has been successfully copied by these Pharmacies. Delivery through the skin is a different and more complex story. So rubbing these hormones on your skin in the form of a cream or gel, will usually not deliver the hormones to your blood stream in appropriate amounts. Nor can they just zip these into a patch or a pellet.  But bioidentical Estradiol as an FDA approved transdermal patch is available as Vivelle, Combipatch, Alora and Climara. This would be my preference for Estrogen therapy.

Now in the true fashion of herbal supplements if they give low enough doses, they may only have a small effect on hot flashes, not breast development.  Here are the Estrogen preparations that are available from Compounding pharmacies. They are called Biestrogen and Triestrogen. In Biest the pill consists of 80% E3 and 20% E2. In Triest, the preparation contains 10% E2, 10% E1 and again 80% E3. E3 is the weakest Estrogen of the three and estimated to be 1/80 to 1/100 the estrogenic potency of E2 and E3 is the metabolic end product of E1 and E2. From an activity point of view the estrogen effect of the entire pill is negligible since its major contribution is E3. The small amount of E2 is probably responsible for any decrease in menopausal vasomotor symptoms.

The following is the conclusion of an article in the Journal Menopause, May 2004 entitled "Bioidentical Hormone Therapy".
"In the absence of a sound scientific basis, practitioners should not advocate the practice of Compounding (NHT) because it is not in the patient's best interest, it is potentially harmful and it lacks a scientific underpinning. Although E3 may have activity to decrease the symptoms of menopause, it seems to have no true advantage over conventional estrogen therapies. Furthermore, based on the small quantity present in these compounded preparations, the lure of a "safer estrogen" seems to be more of a marketing tool than a proven therapeutic advantage."  I concur whole heartedly that while the Women's Health Initiative study was a step toward understanding, Compounding is a step  backwards. On a personal note, I asked my Chief Pharmacist who oversees the purchase of millions of dollars of drugs, where these Compounding pharmacies procure these hormones and he thought from Mexico and China, where they are made in large quantities for International drug companies, who put them into their patented delivery systems. Enough said, as long as you do not ask Suzanne Sommers or Larry King for a referral.

Best of Luck in Your New Future,

Cerise Richards, M. D.