On the surface, "natural hormones " make good sense. Unfortunately, because most are a blend of several different forms of estrogen made from scratch in small batches by compounding pharmacies the products can vary greatly from one pharmacy to the next, and sometimes even from batch to batch.
In fact, a spot check of compounded medicines conducted by the FDA in 2003 reported up to 34% didn't live up to their claims.
Moreover, because these compounds are plant derived, they don't have to answer to the FDA - which means they can also be sold without benefit of any testing. And experts say there have been almost no studies done - and that's potentially a huge problem.
"Right now there are no studies that I would put stock in, large enough, placebo controlled studies , showing bio identical compounds are either safe or effective," says Dr. Steve Goldstein, professor of OB/GYN at NYU Medical Center.
Any concerns that we might have about traditional HRT, he says, we are likely to have about compounded bio identical hormones - or worse, he says, likening them to a time bomb that could go off at any time.
Santoro agrees." There’s essentially no significant safety or efficacy data on these compounds- it's all a plural of anecdotes and it just doesn’t constitute true scientific testing," - a position that is echoed in statements from the American College of Obstetricians and Gynecologists (ACOG).
Moreover, Santoro says that because everyone metabolizes compounded medicine differently, even when made to spec, some women may still end up with almost nothing in their system, while others may experience a hormone overload.
"Without testing and manufacturing quality control, women may be playing with dynamite," says Santoro.
What Every Woman Can Do
If, in fact, you want to give bio identical hormones a try, there are some prescription forms manufactured by traditional pharmaceutical companies that have been tested in clinical trials.
The first is a natural form of estradiol ,the dominant form of estrogen made by the ovaries. It's sold in pill and cream form, by prescription, under the brand name "Estrace".
Also available as a prescription patch: Climara®, Alora®, Estraderm®, and FemPatch®. There is also a bio identical progesterone prescribed under the brand name Prometrium®."
To learn more about the KEEP heart-hormone study - or to find out if you are eligible- visit www.Keepstudy,org. .
