1. Bioidentical Hormones W hat Women Need to Know Presented by Daria C Yanez, MD Campus Chief at Riddle Hospital In collaboration with Beverly Vaughn, MD Medical Coordinator of Menopause and You Dr. Yanez & Dr. Vaughn WOMEN’S HEALTH SOURCE

2. 1. Identify Bioidentical Hormones 2. Discuss the risks and benefits of hormonal therapy in the post menopausal woman 3. Review current recommendations for hormone replacement Objectives

3. ACOG – American College of Obstetrics and Gynecology recommends the lowest dose for the least amount of time necessary to relieve menopausal symptoms They no longer recommend hormones for heart health or osteoporosis Current Recommendations for Hormone Replacement

4. Plant source of hormones Usually soy or wild yam root Considered natural Bioidentical Hormones

5. However plant compounds must undergo synthetic processing to obtain the hormones used Most commercial products prescribed today are synthesized from the same plant products

6. Bioidentical hormones have structures identical to human hormones and are compounded by pharmacists using bulk hormones There is no central oversight on the production, prescribing or dosing of compounded bioidentical hormones leading to variability in quality, purity and batch-to-batch consistency

7. Bioidentical hormones are routinely dispensed as capsules, transdermal creams, vaginal creams, sublingual drops, implanted pellets and buccal troches Common components of compounded bioidentical hormones include estrone, estradiol, estriol, testosterone and micronized progesterone Most are dosed twice daily

8. Commercially prepared hormones are dispensed as capsules, transdermal creams, transdermal sprays, transdermal patches, transdermal gels, vaginal creams, and vaginal rings Commercially prepared hormones are typically conjugated equine estrogens, dienestrol, estradiol acetate, esterified estrogens, estropipate, micronized estradiol, micronized progesterone, and may include testosterone They are usually dosed once daily

9. The main component of bioidentical hormones is estriol plus estradiol (biest) or estriol plus estradiol plus estrone (triest) Typical ratios are 80:20 in biest Estriol potency ranges from one-tenth to one-one hundredth of estradiol

10. By the bioidentical community estriol is considered the safer hormone based on some earlier rodent studies To date there have been no large, randomized, double-blind, placebo- controlled trials evaluating the safety or efficacy of biest or triest

11. Therefore, bioidentical hormones should be considered to have the same risks associated with conventional hormone therapy

12. Hormone Replacement Therapy – HRT Increases the risk of stroke Increases the risk of deep vein thrombosis Increases the risk of breast cancer with prolonged use May increase the risk of heart disease Decreases the risk of colon cancer Decreases the risk of osteoporosis Women’s Health Initiative – WHI – 2002

13. Many bioidentical hormones are compounded and dosed based on salivary hormone levels Hormone levels in the saliva can vary depending on time of day, diet, molecular weight of the hormone, lipid solubility and salivary flow rate

14. Premenopausal levels of hormones vary widely depending on where the woman is in her cycle There is no agreed upon serum level that should achieved when administering post-menopausal hormones So testing salivary hormones is pointless

15. Physicians typically tailor the dose of hormone therapy to a woman’s symptoms, starting at the lowest dose available and increasing the dose over time until she achieves relief of her symptoms Checking serum levels of her hormones are rarely needed

16. MythFact Bioidentical Hormones are naturalBioidentical refers to structure Natural refers to source Both bioidentical and commercially prepared hormones can be synthesized from plant sources

17. MythFact Bioidentical hormones are custom compoundedFDA approved drugs can provide bioidentical hormones

18. MythFact Bioidentical hormones are safeAll hormones can cause side effects and have risks. Bioidentical hormones should be evaluated and prescribed using the same criteria one would use for commercially prepared hormones

19. HormoneBrand NameSource EstradiolEstrace, genericSoy or yams EstradiolAlora, Fempatch, Climara, Menostar, Vivelle dot Synthetic soy or yams EstradiolDivigel, Elestrin, EstrogelSynthetic from a plant source EstradiolEvamistSoy or yams EstradiolEstringMexican yams EstradiolVagifemSoy or yams EstroneGenericSoy or yams Micronized progesteronePrometrium, CrinoneMexican yams Bioidentical Estrogens and Progesterones Commercially Produced

20. Needed to balance the effects of estrogen on the endometrium of the uterus and prevent uterine cancer The absorption of transdermal bioidentical cream is variable. It’s use is not advised to oppose the effects of estrogen. An oral preparation is recommended Progesterone

21. Bioidentical testosterone is not FDA approved for use by women Methyltestosterone, a synthetic preparation, is available in a generic form with an esterified estrogen Proposed positive effects include improved sexual function, mood, bone density and lean body mass Testosterone

22. Although there have been several large studies the data is inadequate to support the use of testosterone for menopausal symptoms, well-being, body composition, bone preservation or cognition

23. The risks of testosterone use includes acne, excess facial and body hair, deepening voice, weight gain, emotional liability and adverse lipid profile

24. DHEA – dehydroepiandrosterone DHEAS – dehydroepiandrosterone sulfate –Acts as a precursor for testosterone and estrogen synthesis is peripheral tissue –Touted to improve mood, sexual function, well-being, cognition, bone density, and anti-aging

25. Results from observational studies and randomized trials have been conflicting so there are no current recommendations on DHEA supplementation to date

26. The risks and benefits of compounded bioidentical hormones remain for the most part unexamined The current data is insufficient to support efficacy and safety claims Hormone therapy in any form has risks associated with it, whether bioidentical or conventional hormones Hormone therapy should be tailored for each woman after assessing her symptoms and her individual risks Conclusions

27. Time for Questions For a physician referral, call 1.888.876.8764 Learn more from the Menopause and You online library at mainlinehealth.org/whs WOMEN’S HEALTH SOURCE