Hormone Balance & Health

1. Hormone Balance & Health Rebecca L. Glaser M.D., F.A.C.S.

2. www.hormonebalance.org Data Username: data Password: data

3. Conventional Medicine • The fifth leading cause of death in the United States is prescription medications given in the correct dose • 2.2 million people per year have an ‘in hospital’ adverse reaction to drugs • 7.5 million unnecessary medical and surgical procedures are performed per year • Total number of deaths caused by conventional medicine is 800,000 per year • Overmedicating seniors • The average senior receives 20 new prescriptions per year • Common side effects include confusion, dizziness, apathy, problems with balance, memory and sedation

4. Balance • Hormones, in balance, are critical to health and disease prevention • Hormones, in balance, protect against breast cancer • Hormones out of balance, may contribute to an increased risk of breast cancer • Synthetic chemical hormones (Prempro, Provera, Estratest, Methyl testosterone)increase the risk of breast cancer • Diet and lifestyle are critical to hormone balance and overall health • Stress affects hormone balance

5. Conventional HRTWomen's Health Initiative Trial • Prempro, Premphase, Provera • 41% increase in strokes • 29% increase in heart attacks • 26% increase in breast cancer • Twice the rate of blood clots • Possible contributor to Alzheimer's vs. • Estrogen alone arm (Premarin) • No increase in breast cancer

6. Synthetic (Chemical) Progestins • Increase the risk of breast cancer • Increase the risk of heart disease • Coronary vasoconstrictor • Negate the beneficial effects of estrogen • Fluid retention and edema • Increase incidence of blood clots • Venous thrombosis • Pulmonary embolism • Stroke • Cause weight gain

7. Synthetic Progestins (cont.) • Negative effect on mood, mental status and well being • Increase the risk of dementia • Headaches • Birth defects • Hair loss • Acne, skin discoloration • Patentable…profitable

8. Progesterone • Does not increase the risk of breast cancer • Does not have toxic effects on the vascular system • Does not negate the beneficial effects of estrogen • Vasodilator • Does not adversely affect lipids • Neuro-protective • Necessary to maintain pregnancy

9. Synthetic chemical v.s. hormone Provera is not Progesterone

10. So, how can they say… • “But there's no evidence that bioidenticals are any safer and they may even have other risks” Dr. Robert Vigersky AMA “…the risks and benefits of all estrogens and all progesterones are equivalent.” Rossouw 07 WHI branch of the NIH

11. Million Women Study 1,084,110 • No difference between ‘estrogen formulations’ • Topical vs. oral, Estradiol vs. Premarin vs. Ethinyl-estradiol • BUT Vaginal estrogen therapy (estriol) did NOT increase the risk of breast cancer RR 0.67 • No difference between synthetic chemical ‘progestins’ • BUT Progesterone, the hormone, was not used in the study 2003 Lancet

12. Fournier 07 (BCRT) • ‘E3N’ French Prospective Cohort Study 1990 • 98,995 women 40-65 risk factors for cancer • Results on >80,000 post menopausal women • Estrogen alone increased the risk of breast cancer • No difference between oral estrogen (RR 1.32) and percutaneous/TD estrogen (RR 1.28) • Oral 13/3598 Non-oral 56/14,826 • Progesterone (RR 1.0) did notincrease the risk of breast cancer vs. synthetic progestins (RR 1.69) • Oral or vaginal estriol (RR 0.7) or Promestriene did notincrease the risk of breast cancer (RR 0.9)

13. Bioidentical (Human) Hormones • Are chemically converted from yams or soy and are identical in composition to human hormones • Are not patentable • Have been used in Europe (and the US) for over 60 years • Have been extensively researched • Estradiol, progesterone, and testosterone are FDA approved • FDA approval is required for implanted medical devises and medications which are to be marketed to the public • In balance, they do NOT have the same risks as CHRT

14. Prometrium Crinone, Utrogestin Estrace, Climera Estraderm, Vivelle Estrogel, Sandrena Androgel, Testim Androderm ESTring, Menoring, Femring Vagifem Ovestin (OTC, Europe) Ovesterin (not Synapause) Cortef Saizon, Genotropin Cytomel (T3) Synthroid (T4) Pellets (Australia, South Africa, UK and US) Fused testosterone Riselle (E2 25 mg, Organon) Testopel Patented/Conventional Bio-identical Hormones

15. Compounded Estrone Estradiol Estriol Progesterone Testosterone DHEA Cortisol HGH (reconstituted) T3 T4 Methods of delivery Oral Topical Creams Gels Sublingual drops, troches Vaginal/mucous membrane Cream Suppository Pellets SQ injection Bio-identical Hormones

16. Estrogens • Estrone (E1)……SHBG metabolites • Estradiol (E2)…..SHBG metabolites • Estriol (E3) • Bi-Estrogen • Used in Europe both orally and vaginally (OTC) • Data on vaginal and oral use • Absorption, efficacy, side effects • Vaginal estriol does not stimulate the uterine lining or breast tissue • Vaginal estriol does NOT increase the risk of breast cancer • Does not cause weight gain or fluid retention • Vaginal estriol increases bone density • Lack of data on topical use (skin)

17. Balance

18. Balance vs. Estrogen Dominance • Estrogen dominance is a condition in which there is too much estrogen, especially the stronger estrogens, insulin and chemical estrogens in proportion to the balancing phyto-nutrients, progesterone and testosterone.

19. Estrogen • Estrogen dominance (diet & lifestyle) • Weight gain, fluid retention • Anxiety, irritability, depression, fatigue • Insulin resistance • Breast pain, FCD, endometriosis, fibroids • Increased risk of breast and uterine cancer • Estrogen deficiency • Breast loose fullness • Low body fat, cannot maintain weight • (Hot flashes, insomnia, bone loss, depression etc. see testosterone deficiency)

20. Prevention of Estrogen Dominance • Balanced hormone therapy • Testosterone • Progesterone (NOT progestins) • Stress Reduction • Get rid of chemicals, pesticides etc. • Improved diet, reduce carbohydrates, whole foods • Lower insulin levels • Exercise • Fiber / supplements / flaxseed

21. Hormone Deficiency • Hot flashes, night sweats • Vaginal dryness, urgency, incontinence • Breast loose fullness (estrogen) • Insomnia • Heart palpitations • Bone loss, aches, pains • Thinning skin, hair loss • Heart disease • Brain deterioration, memory loss

22. Progesterone Excess • Sleepiness • Metabolites from oral progesterone • Hepatic overload • Breast tenderness • Mild depression • Bloating • Water retention

23. Testosterone Deficiency • Levels decline with age in both men and women • A 40 yo woman has half the testosterone as a 20 yo • Decreased libido, erectile dysfunction • Decreased energy, fatigue, lack of endurance • Depression • Lack of motivation, self confidence, insecure • Anxiety, emotional lability, overwhelmed • Sleep disturbances, insomnia, sleep apnea • Decreased concentration, memory loss

24. Testosterone deficiency • Bone loss, muscle mass loss • Increased fat • Aches, pains, decreased coordination • Hot flashes, vaginal dryness, incontinence • Dry, thinning skin, wrinkles, hair loss • Alzeheimer’s and Parkinson’s • Increased heart disease • Diabetes, metabolic syndrome • Anemia, poor immune function

25. Methyl-testosterone is not Testosterone

26. Archives of Internal Medicine • Oral, synthetic, chemical methyl testosterone increased the risk of breast cancer • Estratest • Non-oral, testosterone (hormone) prevents the stimulation of breast tissue and lowers the risk of breast cancer

27. Cortisol • Produced in the adrenal gland from progesterone and androstenedione • It is the body’s major defense against stress, including infections & injuries • Natural anti-inflammatory hormone • Critical for function of the immune system • Involved in blood sugar regulation

28. Cortisol Deficiency • Fatigue, immune dysfunction • Infections, pneumonia • Sugar cravings, salt cravings • Low blood pressure, weak rapid heartbeat • Allergies, asthma, hives, itching, eczema • Sinusitis, chemical sensitivities, dermatitis • Aches, pains, muscle stiffness • Arthritis • Saliva testing to diagnose

29. Cortisol Excess High potency steroids, chronic stress • Fatigue • Sleep disturbances • Bone loss • Weight gain waist • Loss of muscle mass, thinning skin • Memory lapse, anxiety

30. Cortisol (5 mg three times daily or 10 mg twice daily) • A physiologic dose (up to 20-30 mg per day) of cortisol does NOT cause: • Bone loss • Weight gain • Elevated glucose, sugar cravings (a normal level of cortisol regulates blood sugar) • Anxiety, sleep disturbances • Thinning skin, easy bruising • Suppression of the immune system • Suppression of endogenous adrenal production (it takes 40 mg of cortef for at least 3 months to suppress your natural cortisol production) Wichers 99, Jodar 03, McConnell 02, McK.Jefferies 96

31. Side effects • Vioxx: CVA, CHF, DVT, MI, PE, HTN crisis, acute renal failure, GI bleed, liver failure, death • Mobic: face edema, anaphylactic rxn, CHF, HTN, MI, dyspnea, liver failure, ulcers, death • Celebrex: Heart failure, kidney failure, fainting, HTN, ringing in ears, deafness, ulcers, bleeding, blurred vision, death

32. Thyroid Deficiency • Basal Body T < 97 • TSH > 3.0, low T4 or T3 • Decreased metabolism • Weight gain • Fatigue, lack of endurance • Muscle weakness, joint stiffness, aches • Headaches, decreased concentration, brain fog, memory problems • Dry skin, dry brittle hair, hair loss (balding all over) • Loss of lateral 1/3 of eyebrow, diminished reflexes • Elevated cholesterol, increased ASHD

33. Wren 1971 • 347 patients, ages 43-86, high risk/sx. Heart dz. • 9% low thyroid by testing • Treated all patients with Thyroid hormone • Mortality decreased by 50% • 70% reduction in episodes of chest pain • 50% reduction in heart attacks • 22% reduction in cholesterol • 80% of patients felt better, more alert & motivated

34. Thyroid Excess • Weight loss/gain • Fatigue, weakness, decreased muscle mass • Shakiness, restlessness, rapid heartbeat • Shortness of breath • Heat intolerance, increased thirst, sweating • Anxiety, panic attacks • Hair loss, brittle nails

35. Elevated Insulin = weight gain • Increases inflammation: increases the risk of heart disease, arthritis, and cancer • Increases hunger and obesity • Increases LDL & Triglycerides/decreases HDL • Decreases lifespan

36. Hormone Imbalance • Symptoms overlap • Men and women at any age • GET TESTED • Low normal may not be optimal for health • Many labs do not have ‘age specific ranges’ • Guideline and ranges change • New ranges for TSH (thyroid)

37. Testing • Blood: Estradiol, FSH, Testosterone (total and free), (Estriol and Progesterone ng/ml, not tested) Thyroid Panel (free T4, TSH, free T3, TPO) Men also need a PSA, Hb & Hct, Hepatic panel • Saliva: Profile I (estradiol (E2), progesterone, testosterone, DHEAS, and cortisol) Profile II (as above, am and pm cortisol) • 24 hour Urine

38. Bioidentical Hormone ReplacementRx. or compounded • Capsules (oral) • Creams/gels (skin) • Vaginal Suppositories and Creams • Sublingual lozenges/drops • Patches • Pellets (testosterone, estradiol)

39. Oral Capsules • Most convenient • Absorb best with a fatty meal • First pass through the liver (metabolites) • Testosterone converts to estradiol and is rapidly degraded • Conventional (oral) HRT has been shown to cause liver damage and increase the risk of thrombosis (blood clots) • Variability in absorption • FDA approved estradiol and progesterone

40. Creams & Gels • Variability in absorption: individual, site, surface area, thickness of skin and base • Depot effect (especially progesterone) • Maintains a consistent level of hormones in the bloodstream avoiding the peaks and valleys • Avoids first pass through the liver • Does not increase the risk of blood clots • Can transfer hormones through skin contact • Lack of data on Bi-est • FDA approved • Estradiol for women • Testosterone for men

41. Mucous Membrane/ Vaginal Application • Consistent absorption • Relieves menopausal symptoms • Relieves vaginal dryness, urinary urgency, frequency, incontinence and repeated UTI’s • Safe • Vaginal estrogens (estriol) do not increase the risk of breast cancer • No increase in blood clots or metabolites • Do not develop tolerance • No accumulation of hormones or metabolites

42. Vaginal application of hormonescont. • Deliver multiple hormone in a single cream • Convenient • Cost effective • Small volume of cream • Applied 3 to 6 times weekly • Can transfer to spouse

43. Sublingual Drops & Troches • Avoids first pass through the liver • Rapid onset of action • Careful not to swallow saliva • Multiple doses to maintain blood levels • Drops make it easy to increase or decrease dosage which is useful in perimenopause • Variability of absorption

44. Patches • Patented products (delivery system) • Estradiol: Estraderm, Estradot, Vivelle Dot, Climara • Testosterone: Androderm (males $$$$) • Consistent delivery over time (…not) • Estrogen applied once or twice weekly • Testosterone applied daily • Only delivers estradiol (women) • Strong estrogen • Problems with adhesive, uncomfortable

45. Hormone Implants: Pellets • Pellets made up of either testosterone or estradiol compressed into very small, solid cylinders • There is an ‘FDA approved’ 75 mg testosterone pellet • In the U.S. other formulations and dosages need to be ‘compounded’ by trained pharmacists

46. Pellets/Implants • Used in the United States since 1940 • Tremendous amount of data supporting use • England, Australia and the US • Only licensed form of testosterone for women in England • Testosterone for men and women • Rarely use an estradiol pellet in women • Young women with a surgical hysterectomy • Need to gain weight • Problems with bleeding

47. Hormone Implants cont. • More effective than oral or topical hormones for relief of menopausal symptoms • Most effective form of testosterone replacement in men & women • Not only maintains bone density but increases bone density. • Mostconsistent and convenient method of hrt • Safe form of HRT • Does not increase the risk of blood clots or strokes • Does not effect the liver • Testosterone implants are breast protective

48. Testosterone pellet implants • Increases bone density and muscle mass • Decreases fatty tissue • Relieves depression, improves anxiety • Improves memory and concentration • Relieves joint and muscle pain • Improves sleep • Relieves hot flashes and night sweats • Improves sex drive and libido

49. Simple procedure • The insertion of pellets is a simple, 5 minute office procedure done under local anesthesia • They are placed in the fatty tissue just under the skin of the hip or lower abdomen • They completely dissolve over time • 3-5 months in women • 4-6 months in men

50. Most successful HRT (supported by data) • Testosterone pellet implant: Men and Women • Vaginal cream (2-6 days per week) may be added in women • Estriol • Relieves vaginal and urinary symptoms • Does NOT stimulate breast tissue • Does NOT cause weight gain or fluid retention • Estradiol (may leave out) • Progesterone • Does not accumulate, no metabolites, high dose to uterine lining, • (Testosterone if NOT used as a pellet implant) • Not as effective as pellet implant (bone density, depression, anxiety, aches, pains, libido, energy etc.)