In the wake of the Women's Health Initiative 2002, many women and health experts continue to struggle with hormone replacement therapy. The trial was stopped early in 2002, because hormone users had a higher risk of breast cancer, heart disease, stroke and blood clots. Though the added risks were small, many women and their physicians concluded to stop their hormone therapy. These women soon discovered that hot flashes, sleeplessness, and other menopausal symptoms returned with a vengeance.
Still, hormone replacement therapy (HRT) is considered the most effective treatment for these menopausal symptoms. However, women are now turning to alternatives they think are safe – but may not be.
In Search of "Natural"
Many women assume that "natural" hormones would be better or safer, bu the term "natural" is open to interpretation. Technically, any product whose principal ingredient has an animal, plant, or mineral source is considered "natural". It doesn't matter if that substance is ground, put into capsules, and sold over the counter or extracted in a laboratory, manufactured by a pharmaceutical company and made available only via prescription. For example, many women take soy supplements to ease their symptoms; but soy is also used, along with yams to make the estrogen in the FDA-approved hormone drug by the name of Estrace. But unlike Estrace, soy supplements aren't regulated and aren't tested in humans, so we don't know if they are safe or effective.
Bio-identical hormones are hormones that are identical in molecular structure to the hormones women produce in their bodies. These hormones are not found in this form in nature, but are made, or synthesized, from a plant chemical extract from yams and soy beans. Bio-identical hormones are the identical duplication of the native hormones (Estriol, 17 Beta Estradiol, Estrone, Progesterone, Testosterone and DHEA) found in the body. Because they are the same, these hormones have the same physiological effect on the female body.
Bio-identical hormone therapy i9s often called "natural hormone therapy" because the hormones act in the body just like the hormones we produce. But here, again, the use of the word "natural" can bring confusion, because a pregnant mare's urine is natural, but Premarin, the drug made from it is not bio-identical to human estrogen. The same is true for the drug Cenestin, which is made from plants, but is not bio-identical.
The human body cannot distinguish bio-identical hormones from the hormones your body produces. Supporters of bio-identical hormone therapy assert that the advantage comes from being able to monitor estrogen levels more precisely and thus, make treatments more individualized. Skeptics counter that it hardly matters because no one knows exactly what hormone levels to aim for and that symptoms and not hormone levels should be treated and monitored.
What About Compounded Bio-Identical Hormones?
Much of the confusion about bio-identical hormones comes from the mistaken notion that they must be custom mixed at a compounding pharmacy. But custom compounding is necessary only when a clinician wants to prescribe hormones in combinations, doses or preparations, such as lozenges or suppositories, not routinely available, or to prescribe hormones not approved for women, such as testosterone and DHEA. Compounding pharmacies use some of the same ingredients that are made into FDA-approved products, but their products are not FDA-approved or regulated.
Are Bio-Identical Hormones Safer?
The answer is that no one knows. There are no studies that prove that compounded bio-identical hormone therapy have fewer side effects or are more effective than FDA-approved preparations. Also, compounded bio-identical hormones are mixed to order, so there are no tests of their safety, effectiveness nor dosing consistency.
The Bottom Line
All hormone replacement therapy, regardless of whether FDA approved or bio-identical from a compounding pharmacy, carry the risk of breast cancer, heart attack, stroke and blood clots. Studies have recommended that patients use the lowest dose of hormone therapy for the shortes amount of time to control menopausal symptoms. As a patient, it is important for you to be proactive and work closely with your clinician to decide what is right for you.