Hormones Matter TM

Bioidentical Hormone Therapy – Risks versus Benefits

January 30, 2012  |  Sergei Avdiushko, PhD

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Those of you who use or are considering hormonal replacement therapy know how confusing the subject might be. Which hormones to use, which are are safer, more efficient, and better for me in general? Let’s try to get a better understanding on a subject. Bioidentical hormones have become popular in recent years, partly because of celebrity endorsements and partly in reaction to reports of increased health risks with standard hormone therapy. There is a certain confusion surrounding the use of custom-compounded bioidentical hormone therapy for treatment of menopause-related symptoms such as hot flashes.

The term “bioidentical hormone therapy” is often used to describe a medication containing estradiol, progesterone, or other hormones that are chemically exact duplicates of hormones produced by women, primarily in the ovaries. This term “bioidentical” simply describes the hormones that are chemically identical to those your body produces. Many of these bioidentical hormones (e.g., estradiol, progesterone) are commercially available in several well-tested, government-approved, brand-name prescription drugs.

The use of bioidentical hormones and their effect on many aspects of women’s health was reviewed recently by several doctors from Mayo Clinic Mayo Clin Proc. 2011 Jul;86(7):673-80. They have shown how the change in hormonal milieu associated with perimenopause and menopause can lead to a wide variety of symptoms that may negatively affect a woman’s quality of life. The most common symptoms include hot flashes, night sweats, emotional lability, poor concentration, and sleep disturbance; these can range from mild to severe.

In 2002, results from the estrogen plus progestin (E+P) arm of the Women’s Health Initiative (WHI) revealed an increased risk of breast cancer, cardiovascular disease, stroke, and thromboembolic events in women taking conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA) compared with those in the placebo group. After these studies many women switched to a safer alternative, FDA-approved hormone therapy (HT) for treatment of menopausal symptoms. Within 3 months of the 2002 publication of the WHI findings, prescriptions for E+P decreased by 63%. As a result of the WHI, many women ask their physicians for non-FDA-approved compounded bioidentical HT (CBHT), which is also known as natural HT, believing that it is safer than FDA-approved therapy. It is estimated that CBHT is a multibillion-dollar industry, possibly affecting millions of women.

Authors show the extent of expansion of the CBHT industry worldwide: resources available to patients yielded more than 70 books listed on Amazon.com, numerous blogs and Web sites, online pharmacies, and an Internet company endorsing affiliated physicians as experts in the use of CBHT. The broad definition of BHTdoes not addresses the manufacturing, source, or delivery methods of the products and thus can include non-FDA-approved custom-compounded products as well as FDA-approved formulations. The term CBHT refers to hormone preparations that (1) have exactly the same chemical and molecular structure as the estrogens and progesterone produced within the human body, (2) are plant derived, and (3) are specifically compounded for an individual patient. Custom CBHT is not FDA-approved for treatment of menopausal symptoms. The most common compounded hormones include combinations of the endogenous estrogens (17ß-estradiol, estrone, estriol) and progesterone. Although testosterone, dehydroepiandrosterone, and pregnenolone are sometimes added to CBHT preparations, the main components are usually estrogen and progesterone.

Proponents of CBHT claim that compounded products containing plant-derived hormones that are bioidentical to those found in the human ovary offer better safety, efficacy, and tolerability than non-compounded, FDA-approved HT. Unfortunately, these claims have led to confusion among patients, who often look to their physicians for direction. Despite the contention by proponents that CBHT has been found to be safer, more efficacious, or less likely to cause breast or uterine cancer than FDA-approved HT, no reports published in peer-reviewed journals support this claim. Authors conclude that there is no evidence that custom CBHT formulations offer clinically relevant benefit over the FDA approved products available to treat the symptoms of menopause. Because of their wide array of formulations, dosages, and delivery systems, FDA-approved HT products can be used to individualize therapy and tailor it to meet the needs and expectations of patients desiring relief of menopausal symptoms.

Custom CBHT formulations provide practitioners the option to prescribe HT for women who cannot tolerate FDA-approved products or the nonhormonal ingredients contained in them. It is suggested by authors that women with menopausal symptoms should discuss their problems with a trusted physicians and get their advice on which hormones to use without being overly reliant on the recommendations of celebrities or feeling a pressure from the expanding CBHT industry. Get all the information you can get and then decide after consulting with your doctor which type of HT is better for you.