Many postmenopausal women are turning to "natural" or "bioidentical" hormone therapy after concerns about the conventional hormone preparations came to a head 2-3 years ago. Many are aware of the controversy surrounding Bioidentical Hormone Therapy which stems from the lack of evidence that these products are either safe or effective.
The terms "natural" or "bioidentical" hormone therapy are used to describe hormone treatment with individually compounded recipes of certain steroids in various dosage forms including testosterone, progesterone, estrone, estradiol, and estriol among others. These can be compounded as pills, gels, sublingual tablets, or suppositories. Based on the results of a person's salivary hormone levels, the final composition of the compounded dosage form is individualized to that specific person.
Supporters claim that bioidentical hormone therapy is better tolerated than manufactured products and possibly safer but that has not been shown to be true in the medical literature. A review of the medical literature was performed and published in the May-June 2004 Issue of Menopause 11(3):356-67 and little evidence was found to support individualized hormone dosing based upon saliva hormone concentrations. The conclusion of the authors was that evidence suggests that although individualized hormonal products may decrease some symptoms of menopause, it seems they have no proven advantage over conventional hormone therapies and their use is not supported by evidence regarding pharmacokinetics, safety, and efficacy.
What is a compounding pharmacy? The quality of compounded products may be substandard in some cases and that, among other things, is what worries the FDA and physicians. Compounding is the art of making custom made prescription medications specifically for an individual patient. There is an accreditation board and you should look for a compound pharmacy that carries the PCAB (Pharmacy Compounding Accreditation Board) approval. The U.S. Food and Drug Administration (FDA) has begun enforcement action against seven compounding pharmacies, stating that the claims made by these pharmacies about safety and efficacy of compounded "bioidentical hormones" are false and misleading, with no credible scientific evidence to support them.
What you need to know. While it appears that bioidentical hormone replacement therapy may decrease hot flashes there is no evidence that "bioidentical" hormones have any advantage over conventional hormone therapies. There are two factors to consider:
1. Their safety has not been established.
2. This approach is expensive and many providers perform frequent and unnecessary biochemical monitoring which you are paying "out of pocket" for in most cases.
How do I feel about it? Many of my patients take bioidentical hormone therapy and I watch them closely and remind them of the hesitations I have listed in the discussion above. This is an individual decision and as long as the risks and benefits are discussed I will always support my patients who seek complementary and alternative therapies, and I see this as no different.