Q: I can’t find any good studies on bioidentical hormone replacement. As a post-menopausal woman who has tried the bioidentical creams, I am thinking about converting to the pellets. Please help a large group of the population understand this confusing dilemma. Thanks.
A: I wish I could, but this is a complex issue. Bioidentical hormone replacement therapy (BHRT) refers to plant-based or compounded estrogen products. These hormones are custom made, often in compounding pharmacies, with information garnered from a test performed on a woman’s saliva. This process isn’t a new one. BHRT was first used for symptoms of menopause in the 1930s when a researcher devised a method to extract an orally active estrogen from the urine of pregnant women.
In the 1980s the British Medical Journal recommended oral bioidentical progesterone as an option when side effects from synthetic progestogens mandated the treatment be discontinued. Today FDA-approved bioidentical hormones and compounded bioidentical hormones has resulted in a great deal of confusion regarding exactly what BHRT really is. What is known is that it is used to reduce the symptoms of menopause and is further promoted by some physicians for anti-aging, despite the fact there is little evidence to support such claims.
Generally speaking, compounded products of bioidentical hormones include estriol, estrone, estradiol, testosterone, progesterone, and sometimes DHEA (dehydroepiandrosterone) which are promoted as natural and safer, yet, there do not appear to be scientific studies to support such claims. These hormones are believed by some researchers to carry the same risks as conventional hormones that are made using the same products. Dosing of BHRT may be ten times higher than the oral dose of comparable HRT regimens and if women are unaware of this, it may be because package inserts do not commonly accompany (nor are they required) with compounded bioidentical preparations.
Bioidentical hormones are derived from soy and plant extracts and are modified to be structurally identical to endogenous hormones. The extracts are no different from what is presently used for most hormone preparations that are approved and commercially available for post-menopausal women (with the exception of conjugated hormones that are derived from urine). At this stage, the safety of bioidentical hormones has not been established. In fact, the FDA has published information for consumers, warning that many claims regarding efficacy and safety of compounded bioidentical hormone products are false and misleading.
Hormones are administered via vaginal creams, topical gels, vaginal rings, transdermal patches, and other methods. Creams and gels applied to the skin enter the blood directly, yet these products can vary from application to application depending on the condition of the skin and the temperature. The FDA has warned several pharmacies regarding making unsubstantiated claims about the safety and effectiveness of compounded hormone products that, by the way, have not been approved by the FDA.
An article first printed in the August 2006 issue of the Harvard Women’s Health Watch indicated many women and health experts continue to struggle with the turnaround in attitude toward hormone therapy in the wake of the Women’s Health Initiative trial of combined estrogen and progestin for preventing the ills women face as they age. The trial was stopped early because hormone users had a higher risk of breast cancer, heart disease, stroke, and blood clots. While the added risks were small, many women and their clinicians concluded they must discontinue hormone therapy. Hormone therapy is believed the most effective treatment for symptoms of menopause but women are not rushing back.
FDA-approved hormones for menopausal symptoms include countless products available on the market, of which a dozen or so are bioidentical. The question is, are bioidenticals safer? It appears no one knows. Studies have indicated they can help relieve symptoms of menopause but as yet, few large studies have investigated sufficiently the differences among the various hormones and methods of administration. And, more research is needed to further understand those differences so the risks and benefits can be compared.
Compounded hormones may help individualize treatment but the user should be aware that there is no evidence to support their safety, effectiveness or dosing consistency, nor is there evidence to prove they have fewer side effects or are more effective than FDA-approved hormone preparations. There is no evidence that hormonal levels in saliva correlate with response to treatment in post-menopausal women, nor is there sufficient evidence that estriol decreases the risk of breast cancer.
As Harvard stated, “just realize that, in a real sense, you’re going to be an experiment of one. Unless your clinician has considerable experience with bioidentical hormones and a particular compounding pharmacy, you’re better off with a prescription for commercially available hormones, many of which are bioidentical”.
