Part 5: The Bioidentical Hormone Debate: Are Bioidentical Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy?

Written by BIH of Decatur on . Posted in Uncategorized

Discussion Physicians must translate both basic science results and clinical outcomes to decide on the safest, most efficacious treatment for patients. Evidence-based medicine involves the synthesis of all available data when comparing therapeutic options for patients. Evidence-based medicine does not mean that data should be ignored until a randomized control trial of a particular size and duration is completed. Rather, it demands an assessment of the patientcare_ref_serv_923_current available data to decide which therapies are likely to carry the greatest benefits and the lowest risks for patients.

Progesterone, compared with MPA, is associated with greater efficacy, patient satisfaction, and quality of life.  More importantly, molecular differences between synthetic progestins and progesterone result in differences in their pharmacological effects on breast tissue.   Some of the pro-carcinogenic effects of synthetic progestins contrast with the anticarcinogenic properties of progesterone, which result in disparate clinical effects on the risk of breast cancer.

Progesterone has an antiproliferative, antiestrogenic effect on both the endometrium and breast tissue, while synthetic progestins have antiproliferative, antiestrogenic effects on endometrial tissue, but often have a proliferative estrogenic effect on breast tissue.   Synthetic progestins show increased estrogen-induced breast tissue proliferation and a risk for breast cancer, whereas progesterone inhibits breast tissue proliferation and reduces the risk for breast cancer.

Until recently, estriol was available in the United States as a compounded prescription, but was banned in January;jsessionid=28AC80AEF73CC0019947E095714B5D5A8 by the FDA, which stated that it was a new, unapproved drug with unknown safety and effectiveness, although its symptomatic efficacy is generally not in question.192–196 The FDA has not received a single report of an adverse event in more than 30 years of estriol use. Estriol is also the subject of a US Pharmacopeia monograph. The FDA Modernization Act of 1997 clearly indicated that drugs with a US Pharmacopeia monograph could be compounded. It appears that the FDA took action, not because estriol is at least as safe and effective as current estrogens on the market, but in response to what was considered unsupported claims that estriol was safer than current forms of estrogen replacement and because there is no standardized dose. Estriol has unique physiologic properties associated with a reduction in the risk of breast cancer, and combining estriol with estradiol in hormone replacement preparations would be expected to decrease the risk for breast cancer.  In cardiovascular disease, synthetic progestins, as opposed to progesterone, negate the beneficial lipid and vascular effects of estrogen.

Transdermal bioidentical estrogen and progesterone are associated with beneficial cardiovascular and metabolic effects compared with the use of CEE and synthetic progestins.  BASED ON BOTH PHYSIOLOGICAL RESULTS AND CLINICAL OUTCOMES, CURRENT EVIDENCE DEMONSTRATES THAT BIOIDENTICAL HORMONES ARE ASSOCIATED WITH LOWER RISKS THAN THEIR NON-BIOIDENTICAL COUNTERPARTS. Until there is evidence to the contrary, current evidence dictates that bioidentical hormones are the preferred method of HRT.

Conclusion A thorough review of the medical literature supports the claim that bioidentical hormones have some distinctly different, often opposite, physiological effects to those of their synthetic counterparts. WITH RESPECT TO THE RISK FOR BREAST CANCER, HEART DISEASE, HEART ATTACK, AND STROKE, SUBSTANTIAL SCIENTIFIC AND MEDICAL EVIDENCE DEMONSTRATES THAT BIOIDENTICAL HORMONES ARE SAFER AND MORE EFFICACIOUS FORMS OF HRT THAN COMMONLY USED SYNTHETIC VERSIONS. More randomized control trials of substantial size and length will be needed to further delineate these differences.

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