Dr. Ron’s Research Review – May 2, 2012

This week’s research review focuses recent articles on BHRT.

An innovator, Jonathan Wright, MD, evaluated women’s options for estrogen replacement. After menses ceases and menopause begins, estrogen levels begin to decline. In a quest for safer estrogen options, Wright reviewed the breast cancer research done by Henry Lemon, MD, in the 1960s. The use of BiEst and TriEst is common in complementary medicine, and in some circles it has become the de facto definition of bioidentical hormone replacement (BHRT). (Marsden 2010)

Bioidentical hormones that are approved by the FDA may be preferred over standard hormone replacement because of their physiologic benefits and safety profile. (Conaway 2011)

Although BCHT offers advantages, it is not the panacea of hormone therapy. The claims that BCHT lowers the risk of breast cancer, coronary artery disease, stroke, or thromboembolism are not supported by scientific research. The goal of this review is to present an overview of the available research evidence on BCHT, dispel myths about the use of compounded hormones, and provide helpful tips to answer commonly asked questions about BCHT. (Sood, Shuster et al. 2011)

The objectives of the present commentary are: 1) to show that the so-called “bioidentical” hormones in custom-compounded HT preparations may not be identical to those made in the body; and 2) to point out how the lack of regulation of these hormone products can cause adverse effects in postmenopausal women using them. Because the custom-compounding of HT products is not regulated, a particular concern is that some women may be overdosed, or treated with ineffective products, or subject to unidentified risk. (Bhavnani and Stanczyk 2011)

Dr. Ron


Articles

Misconception and Concerns about Bioidentical Hormones Used for Custom-Compounded Hormone Therapy

         (Bhavnani and Stanczyk 2011) Download

Bioidentical hormones: an evidence-based review for primary care providers

         (Conaway 2011) Download

CONTEXT: Since 2002, when the US Food and Drug Administration (FDA) placed a black box warning on women's hormone replacement products, women and their providers have been struggling with whether to proceed with hormone replacement therapy. Out of the controversy has grown a popular movement promoting the use of bioidentical hormones. Many providers are still unsure if they want to recommend these products and, if so, how to use them appropriately. OBJECTIVE: To inform primary care providers (eg, physicians, physician assistants, nurse practitioners) about current data on the safety and efficacy of bioidentical hormone replacement therapy and to provide a context for patient perceptions. METHODS: Literature published between 1999 and 2009 was reviewed through MD Consult's Medline and Ovid search engines. A Google search of popular media was also performed using the same terms. RESULTS: Randomized clinical trial data are sufficient to support the prescription of only estropipate, estradiol, and progesterone for the relief of menopausal symptoms. Estropipate is approved by the FDA for the management of menopausal symptoms. 17beta-Estradiol is FDA approved for menopausal symptoms, may have cardioprotective effects, and may have fewer adverse effects on blood pressure than conjugated equine estrogens. Estriol is not FDA approved but is widely used in Europe and is effective for relieving menopausal symptoms. Progesterone is approved by the FDA for the management of menopausal symptoms and for the prevention of endometrial hyperplasia; it should be used orally to oppose estrogen. Testosterone is FDA approved in combination with estrogen for the management of vasomotor symptoms. Dehydroepiandrosterone is not FDA approved, but small-scale studies indicate it may improve bone mineral density. Data are conflicting about efficacy in improving sexual dysfunction. There is an abundance of misleading information available in the media and on the Internet for our patients. Compounded bioidenticals and salivary hormone testing are unnecessary, are not standardized, and should be avoided. CONCLUSION: Bioidentical hormones that are approved by the FDA may be preferred over standard hormone replacement because of their physiologic benefits and safety profile.


Bioidentical Hormone Replacement: Guiding Principles for Practice

         (Marsden 2010) Download

Counseling postmenopausal women about bioidentical hormones: ten discussion points for practicing physicians

            (Sood, Shuster et al. 2011) Download

Bioidentical hormones are compounds that have exactly the same chemical and molecular structure as endogenous human hormones. In contrast, nonbioidentical, or synthetic, hormones are structurally dissimilar from endogenous hormones. Although available for years, bioidentical compounded hormone therapy (BCHT) has gained popularity in the United States only recently. This popularity has paralleled women's rising fears of conventional hormone therapy, especially since the publication of the Women's Health Initiative clinical trials. Although BCHT offers advantages, it is not the panacea of hormone therapy. The claims that BCHT lowers the risk of breast cancer, coronary artery disease, stroke, or thromboembolism are not supported by scientific research. The goal of this review is to present an overview of the available research evidence on BCHT, dispel myths about the use of compounded hormones, and provide helpful tips to answer commonly asked questions about BCHT.


References

Bhavnani, B. R. and F. Z. Stanczyk (2011). "Misconception and Concerns about Bioidentical Hormones Used for Custom-Compounded Hormone Therapy." J Clin Endocrinol Metab.

Conaway, E. (2011). "Bioidentical hormones: an evidence-based review for primary care providers." J Am Osteopath Assoc 111(3): 153-64.

Marsden, T. (2010). "Bioidentical Hormone Replacement: Guiding Principles for Practice." Natural Medicine Journal 23(3).

Ruiz, A. D., K. R. Daniels, et al. (2011). "Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study." BMC Womens Health 11: 27.

Sood, R., L. Shuster, et al. (2011). "Counseling postmenopausal women about bioidentical hormones: ten discussion points for practicing physicians." J Am Board Fam Med 24(2): 202-10.