Dr. Ron’s Research Review – June 19, 2013

© 2013

This week’s research review contains review articles on BHRT.

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. (Sood, Shuster et al. 2011)

Some women are turning to alternative hormonal formulations known as compounded bioidentical hormone therapy because they perceive them to be a safer alternative. (Files, Ko et al. 2011)

The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? (Holtorf 2009)

Dr. Ron


Articles

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 therapy

(Files, Ko et al. 2011) Download

The change in hormonal milieu associated with perimenopause and menopause can lead to a variety of symptoms that can affect a woman's quality of life. Postmenopausal hormone therapy (HT) is an effective, well-tolerated treatment for these symptoms. However, combined HT consisting of conjugated equine estrogen and medroxyprogesterone acetate has been associated with an increased number of health risks when compared with conjugated equine estrogen alone or placebo. As a result, some women are turning to alternative hormonal formulations known as compounded bioidentical HT because they perceive them to be a safer alternative. This article defines compounded bioidentical HT and explores the similarities and differences between it and US Food and Drug Administration-approved HT. We will examine the major claims made by proponents of compounded bioidentical HT and recommend strategies for management of patients who request bioidentical HT from physicians.

The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy?

          (Holtorf 2009) Download

BACKGROUND: The use of bioidentical hormones, including progesterone, estradiol, and estriol, in hormone replacement therapy (HRT) has sparked intense debate. Of special concern is their relative safety compared with traditional synthetic and animal-derived versions, such as conjugated equine estrogens (CEE), medroxyprogesterone acetate (MPA), and other synthetic progestins. Proponents for bioidentical hormones claim that they are safer than comparable synthetic and nonhuman versions of HRT. Yet according to the US Food and Drug Administration and The Endocrine Society, there is little or no evidence to support claims that bioidentical hormones are safer or more effective. OBJECTIVE: This paper aimed to evaluate the evidence comparing bioidentical hormones, including progesterone, estradiol, and estriol, with the commonly used nonbioidentical versions of HRT for clinical efficacy, physiologic actions on breast tissue, and risks for breast cancer and cardiovascular disease. METHODS: Published papers were identified from PubMed/MEDLINE, Google Scholar, and Cochrane databases, which included keywords associated with bioidentical hormones, synthetic hormones, and HRT. Papers that compared the effects of bioidentical and synthetic hormones, including clinical outcomes and in vitro results, were selected. RESULTS: Patients report greater satisfaction with HRTs that contain progesterone compared with those that contain a synthetic progestin. Bioidentical hormones have some distinctly different, potentially opposite, physiological effects compared with their synthetic counterparts, which have different chemical structures. Both physiological and clinical data have indicated that progesterone is associated with a diminished risk for breast cancer, compared with the increased risk associated with synthetic progestins. Estriol has some unique physiological effects, which differentiate it from estradiol, estrone, and CEE. Estriol would be expected to carry less risk for breast cancer, although no randomized controlled trials have been documented. Synthetic progestins have a variety of negative cardiovascular effects, which may be avoided with progesterone. CONCLUSION: Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts. Until evidence is found to the contrary, bioidentical hormones remain the preferred method of HRT. Further randomized controlled trials are needed to delineate these differences more clearly.

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

Conaway, E. (2011). "Bioidentical hormones: an evidence-based review for primary care providers." J Am Osteopath Assoc 111(3): 153-64. [PMID: 21464264]

Files, J. A., M. G. Ko, et al. (2011). "Bioidentical hormone therapy." Mayo Clin Proc 86(7): 673-80, quiz 680. [PMID: 21531972]

Holtorf, K. (2009). "The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy?" Postgrad Med 121(1): 73-85. [PMID: 19179815]

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

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. [PMID: 21383221]