Additional Resources for Hormone Replacement Therapy
This page contains treatments details specific to hormone replacement therapy at Peach. This page is not meant to diagnose or recommend. If you have any questions, please contact us at one our facilities.
Review of NAMS opinion on BHRT
- The FDA has approved many prescription products that contain bio-identical hormones.
- The major difference between the FDA approved prescriptions bio-identical hormone products and custom compounded products is that the former are regulated by the FDA and tested by purity, potency, efficacy and safety.
- Products from compounding pharmacies are not regulated in this fashion. As a result, dosing and purity can vary, and safety and efficacy are unknown.
- There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies.
- Salivary hormone level testing used by proponent to tailor HT is not felt to be meaningful because salivary hormone levels vary in each individual woman throughout the day and are not believed to reflect tissue levels of hormone.
- A woman with an intact uterus needs adequate endometrial protection with FDA approved oral or vaginal progesterone. Wren et al conducted a double blind, randomized controlled trial of transdermal progesterone cream, finding no clinical beneficial effect. Of greater concern, no measured effect of the progesterone was found on the endometrium, and thus estrogen induced endometrial proliferation would not be suppressed.
Menopause Medicine: The Bottom Line on Bio-identical Hormone Therapy
- FDA approved prescription BHT is regulated by the FDA and testing for purity, potency, efficacy, and safety. Products from compounding pharmacies are not regulated in a similar fashion; thus, dosing and purity can vary, and safety and efficacy are unknown.
- The FDA analyzed 29 product samples. 34% of them failing, 90% contained less of the active ingredient than expected.
- There is no scientific evidence to support claims that individualized estrogen or progesterone regimens prepared by compounding pharmacies are safe and more effective.
- There are no peer reviewed, randomized, controlled trials (RCTs) regarding products made by compounding pharmacies.
- There are no large studies showing that BHT reduces osteoporosis risk or prevents breast cancer (as claimed by some of the pharmacies). In addition, custom topical progesterone cream has not been shown to prevent estrogen‐induced endometrial hyperplasia, as claimed.
- Scientifically unsubstantiated claims of fewer risks with BHT than with conventional HT are offered.
- BHT compounds can be considered unproven, experimental, innovative, and not the standard of care.
Clinician’s Forum. Menopause Management. 2007 July/August;16(4):38-44. Pg. 4 – The
North American Menopause Society. Menopause medicine: The bottom line on bioidentical hormone therapy. Geriatrics. 2008 Sept;63(9):28.
Pinkerton JV. "Bioidentical” hormones: What you (and your patient) need to know. OBG Management. 2009 January;21(1):42-52.