By: Shelagh McNally for Fibroids1When the dangers of synthetic hormone replacement therapy (HRT) were brought to light, menopausal women began looking for alternatives and health experts began recommending bioidentical products. Now the American College of Obstetricians and Gynecologists (ACOG) is questioning their validity. In its October 2005 report, ACOG claimed there is little scientific evidence that these new “natural” therapy regimens are effective or even safe. “It is misleading and dishonest to make the claim that this approach is better and safer when there are no data to show this,” says Michele Curtis, MD, an associate professor of obstetrics and gynecology at Houston’s University of Texas Medical School who led the ACOG committee.
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Things to consider
Your medical history should be taken into consideration before any kind of hormone therapy is prescribed. If you have any of the following conditions or symptoms you should consult your doctor before taking any kind of hormones:
Recent heart attack
Poorly controlled angina
Family history of lung or leg blood clots, or a recent diagnosis of either condition
Family history of uterine or breast cancer, or a recent diagnosis of either condition
Undiagnosed vaginal bleeding
Uncontrolled high blood pressure
Liver disease or any abnormal liver function test results
Pregnancy
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Many women are drawn to bioidentical hormones because they are billed as a natural product. While bioidentical hormones are plant-derived they can hardly be considered an organic product sold in health food stores. They are a created in a laboratory and sold by pharmaceutical companies. The process involves extracting a molecule from either soy or Mexican yam and then using chemicals converting it into a hormone with the same structure as those produced by the body. In the end there is no trace of the original plant. Because bioidentical hormones mimic natural hormones, it’s thought they will offer the same results as human hormones, unlike synthetic hormones that produced substantially different effects. Bioidentical hormones are available in pills, creams, vaginal rings, skin patches or gel injection. There are two basic types. Pharmaceutical products are more regulated having been approved by the Food and Drug Administration (FDA). It’s the compounded products that have come under fire. Pharmacists make these custom-made hormones by following a doctor’s specific instructions and mixing up two or three different kinds of estrogen. While the hormones have been tested, the final compound product has not, which is why they are considered unsuitable by ACOG. Their report warned that “most compounded bioidentical hormone have not undergone enough rigorous clinical testing to be recommended as safe and effective alternative. Furthermore, hormone therapy does not belong to a class of drugs with an indication for individualized dosing.” Their findings supports the 2001 study done by the FDA that analyzed a variety of 29 product samples from 12 compounding pharmacies and found that 34 percent of them failed one or more standard quality tests.
Equally dubious to ACOG are the salivary hormone tests used to tailor bioidentical therapy. “This therapy isn't meaningful because salivary hormone levels vary within each woman depending on her diet, the time of day, the specific hormone being tested, and other variables,” stated ACOG. Obviously more clinical research needs to be done.
Authors Amy Allina and Adriane Fugh-Berman, MD (“The Truth About Hormone Replacement Therapy”) urge women to be aware that the natural label does not necessarily mean better or safer and the bioidentical hormones, like their synthetic counterparts, are powerful substances that do come with risks.
They also recommend that a change in diet, weight and lifestyle can help with menopausal symptoms.
