Hormone Therapy versus Compounded Bioidentical Hormones:
What’s Fact and What’s Fable
Questions about “bioidentical” hormones reflect the concerns patients have about hormone therapy as well as the success of self-help books in convincing them that there is a risk-free alternative. Typically, women who ask about “bioidentical” are interested in “individualized” treatment with “natural” hormones for their menopausal symptoms.
Compounded drugs are prepared, mixed, assembled, packaged, or labeled as a drug by a pharmacist. Unlike drugs that are approved by the U.S Food and Drug Administration (FDA) to be manufactured and sold in standardized dosage, compounded medications often are “custom made.”
A primary source of confusion for patients is the terminology used to describe compounded hormone creams. These products are described by their proponents as “natural, non-synthetic, and bioidentical.” This may be good marketing, but is it real science? Whether compounded or pharmaceutically manufactured, all estradiol, even if it comes from “natural” sources, is still synthetic. The hormones in compounded creams and most pharmaceutical hormone therapy products are synthesized from yams or soy, which contain neither estrogen nor progesterone. Diosgenin, a compound extracted from yams or soy, has a similar structure to that of human cholesterol, from which all human sex hormones are made. Diosgenin is then exposed to a series of enzymes in the laboratory and synthesized to bioidentical estradiol. This same process can produce bioidentical progesterone as well as cortisol. Labeling these hormones as “nonsynthetic” is purely public relations to allow for greater sales.
The term “bioidentical” refers to hormones that are the same as those naturally produced by the human body, such as estradiol, progesterone, and testosterone. All postmenopausal, non-oral estrogen products, when delivered by the transdermal or transvaginal route, are also bioidentical estradiol. Hence, patients do not need to resort to compounded preparations, which are not FDA approved, in order to use bioidentical hormones.
The use of compounded progesterone cream has repeatedly been shown not to offer adequate endometrial protection from uterine cancer because of absorption problems through the skin. A safer alternative would be to use the FDA approved oral micronized “natural” pharmaceutical progesterone on a daily basis to safely prevent endometrial buildup without bleeding.
FDA approval guarantees that products have been tested according to strict guidelines for dose consistency. Stability and consistency of dosage are extremely important with respect to the use of postmenopausal estrogen because even small decreases in levels of estrogen can cause symptoms, such as hot flashes and night sweats, migraine headaches, or irregular bleeding. With too high levels, breasted tenderness can occur. In contrast, compounded hormonal products do not have the same stringent oversight by the FDA so levels can vary. In one study in 2001, the FDA analyzed 29 product samples from 12 companies. Although none of the compounded products failed identity testing, 34% failed one or more standard quality tests performed. Nine of the 10 failing products contained less of the active ingredient than expected. In comparison, the analytical testing failure rate of FDA approved drug therapies was less than 2%. Additionally, the potency of compounded creams can vary widely, evenly within the same prescription. It is impossible to guarantee standardized dosing in a non-regulated environment. Using compounded products can be difficult not only to evaluate efficacy, but adjust regimens incrementally.
There is an abundance of pharmaceutical products that can be used as hormone therapy. There are various dosing ranges as well as delivery systems, so that individualization of therapy can be achieved for each patient. Your doctor will discuss the risks and benefits with regard to the latest findings in research and work with you to adjust dosages that work specifically for you using the lowest efficacious levels.
Blood and Saliva Tests
Compounded hormone regimens are said to be guided by blood and saliva testing that measures hormone levels and purportedly leads to individualization of therapy. The results are then used to alter the customized creams in order to “normalize” the patient’s hormone levels. Salivary test results can vary depending on diet, time of day, and the specific hormone being tested. Nothing in the medical literature indicates what optimal postmenopausal levels should be. All women are different, and they may have different estrogen needs postmenopausally. A woman’s need for estrogen is reflected best by symptoms and symptom relief using the lowest level of hormone therapy.