Issues in postmenopausal hormone therapy: A 3-part CME newsletter series

Counseling patients about bioidentical hormone preparations (Part 1 of 3)

Deciding how to manage menopausal symptoms is a balance between the desire to provide the most effective therapy and an individual’s risks. However, patients’ perceptions of the risks and benefits of hormone therapy can add additional complexity when selecting an agent. In this 3-part, case-based CME series, James H. Liu, MD, Nanette F. Santoro, MD, and Veronica A. Ravnikar, MD, FACOG, deftly navigate challenges in patient management, offering creative solutions to common problems.

In Case 1, Nanette F. Santoro, MD, discusses approaches to counseling patients about bioidentical hormone preparations. In Case 2, Veronica A. Ravnikar, MD, FACOG, addresses the risk for venous thromboembolism associated with hormone use in postmenopausal women. In Case 3, James H. Liu, MD, discusses alternatives to hormone therapy.

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Case: “Tired and run down”

Ms G, age 49, began experiencing menstrual irregularity 3 months ago. She has had amenorrhea and notes vaginal dryness, poor sleep, and occasional hot flushes.

Upon presentation, Ms G hands you a sheaf of pages from Internet sources describing the benefits of bioidentical hormone replacement therapy. She says she feels “tired and run down” and wants to “feel like herself again.” She believes a “bioidentical approach” is best for her. She has the results of her tests, which confirm multiple hormone deficiencies, and requests that you prescribe compounded estriol and estradiol cream, wild yam progesterone, and testosterone.

DISCUSSION: Are bioidentical hormone compounds safe?

The Dietary Supplement Health and Education Act (DSHEA) of 1994 made manufacturers—rather than the FDA—responsible for ensuring the safety of dietary supplements. Passage of the DSHEA was facilitated by widely held beliefs that individuals should be able to use folk and herbal remedies without FDA oversight and its standards of uniform manufacture, safety, and efficacy. Consequently, self-treatments, such as chamomile tea to help sleep or echinacea to prevent colds, are essentially unregulated. Products deemed unsafe by the FDA, however, may be pulled from the market and subjected to further testing.

Although the DSHEA helped resolve the problem of regulating herbal remedies, a loophole in the act allows compounded hormones applied to the skin to be treated as dietary supplements. Some have argued that a progesterone-containing cream made from the Mexican wild yam should be available under DSHEA because of the progesterone’s plant origin. In fact, the yam-derived progesterone is bioavailable only to plants, not to humans, so the potential for such agents to cause harm was considered minimal.

This loophole, however, has been exploited by entrepreneurs—most notably the former actress Suzanne Somers—and applied to a wide variety of topical substances, some of which include active hormones.^1,2 A highly profitable “bioidentical hormone movement” has proliferated through aggressive, Internet-based marketing with anti-establishment appeal, promising to restore youth to menopausal women by replacing “what’s missing.” Saliva tests, often purchased over the Internet from providers of bioidentical products, are used to confirm key deficiencies. A “customized” regimen is then prescribed.

The logic behind this movement dates back to missives such as Feminine Forever by Robert Wilson, MD (1966).³ Dr Wilson proposed that menopause was a hormone deficiency state similar to type 1 diabetes or hypothyroidism and that “replacement” was imperative to prevent female decrepitude. Mainstream medicine has moved away from this concept, as the hazards of high-dose hormones became obvious in the 1970s and the Women’s Health Initiative clinical trials showed a lack of overall benefit for estrogen alone and even overall harm for estrogen plus progestin.^4,5

Proponents of “bioidentical” hormone therapy cite the absence of data on harm as proof of its safety, but this reflects a lack of systematic study of these compounds. Indeed, medical evidence does not support hormone use as a menopausal replacement therapy in the absence of symptoms^4,5 and the lack of regulation of the bioidentical substances creates the potential for causing harm.

Although some of these products, such as dehydroepiandrosterone (DHEA), are available over the counter, others, such as those requested by Ms G, require a prescription. Some physicians fear that if they do not prescribe or suggest bioidenticals, their patients will go elsewhere. This is unwise medical practice. The Endocrine Society and the North American Menopause Society have both warned patients and practitioners of the shortcomings of bioidentical hormone treatment in terms of both data and quality.^6,7

A more prudent approach is to evaluate the patient’s symptoms and try to define the benefit that hormone therapy might provide. Many patients seeking “bioidentical” hormones can be redirected toward naturally occurring hormones that are physiologic, such as transdermal estradiol and micronized progesterone. These compounds both meet FDA safety and efficacy standards.

Physicians should educate patients about the dearth of evidence supporting use of salivary testing for assessing hormone deficiency. Physicians can then explain that hormone therapy will be titrated to the patient’s symptoms.

Case (continued)

The risks and benefits of hormone treatment were reviewed with Ms G, who was surprised to hear that there was no clear advantage to hormone creams and that their lack of FDA regulation indicated a possible lack of quality assurance of these compounds. She decided that her systemic symptoms of low estrogen (poor sleep and hot flushes) were not sufficiently bothersome to warrant systemic hormones and chose to use vaginal estradiol tablets twice weekly for relief of her dyspareunia. Six weeks later, she returns to the office, satisfied with her symptom control.

Sexuality, Reproduction & Menopause © 2009 Lebhar-Friedman, Inc.