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Bioidentical Hormone Restoration Best Medical Practice This presentation is available online. Hormone Restoration Medically Necessary Safe Improves Health and Quality of Life Prevents and Treats Many Diseases Restores Sexuality Reduces need for: Blood sugar, blood pressure, cholesterol meds Anti-depressant, anti-anxiety, pain, sleep meds Osteoporosis meds Hormones Neuro-endocrine-immune system Travel via blood to tissues Control cellular metabolism, functions The most powerful molecules in biology Optimal levels are Essential for Health Bioidentical: Same molecular structure as our natural hormones Gonadal Steroids: Not Just “Sex Hormones” Estradiol, Progesterone, Testosterone Essential to all tissues in both sexes! Brain function Immune system Blood vessel health Blood lipids, clotting factors Connective tissue—skin, hair, muscle, bone CRH, TRH, etc. control pituitary GH, FSH, LH, TSH, and ACTH control other glands T4, T3 Cortisol, DHEA, Aldosterone, Pregnenolone Insulin Adrenalin Testosterone Estradiol, Progesterone Testosterone Bioidentical Hormones are NOT Drugs Inherently safe, Non-toxic Proper fit in receptors, easily eliminated No allergic reactions No “side effects” Monitor dose with usual blood tests Only potential problems: Excessive dose Lack of balance with other hormones Unphysiological delivery: route, timing, etc. The Tyranny of the Lab Report Reference Range=95% of the population NOT the optimal range for any person Male free testosterone: 35-155 5x! Female free testosterone: 0.0-2.2 ! Free T4: 0.6-1.8 3x! AM serum cortisol 5-25 5x! Within RR: pharmaceuticals for symptoms Below RR (<97.5%): replace to within-RR Disease/No Disease instead of Continuum Hypometabolism—Thyroid and Cortisol Insufficiencies Thyroid sets throttle Cortisol delivers the fuel Insufficiencyreduced metabolic ratefatigue, brain dysfunction, depression, pain Usual tests are insensitive Optimization improves health and quality of life Cortisol Adrenal glands Maintains blood sugar (delivers the fuel) Modulates immune system, brain function Need higher amounts with stress, disease Too muchDiabetes, HTN, osteoporosis Too littlehypoglycemia, fatigue, depression, aches, autoimmune diseases, allergies Insufficiency more prevalent than excess! Mild-to-Moderate Cortisol Insufficiency Central: brain (H-P) fails to maintain levels Common cause of chronic fatigue, pain Clue: Mood, energy improved on prednisone Saliva testing reveals free cortisol levels at 4 times during a normal day Normal Saliva Cortisol Profile Cortisol Insufficiency Common Dysfunctional Pattern Cortisol Restoration Mild— stress, rest, nutrients, other hormones Moderate-to-severe—cortisol restoration Low physiological doses are safe 40 years’ experience: see Dr. Jeffries’ Safe Uses of Cortisol Thyroid Hormones T4 T3 Maintain metabolism, mood, and energy T4 (Synthroid, Levoxyl) is bioidentical, but must be converted to T3 Thyroid gland makes T4 and T3; we should restore both hormones Can have thyroid hormone resistance Continuum: Higher Thyroid Hormone Levels within the RRs: 50% reduction in severe atherosclerosis Clin Cardiol. 2003 Dec;26(12):569-73 Lowers cardiac risk factors: cholesterol, triglycerides, C-reactive protein, homocysteine and lipoprotein(a) Lowers blood pressure, dilates arteries Reduces tendency to form blood clots Relieves depression Helps weight loss Continuum: Weight vs. Free T4 Within the RR J Clin Endocrinol Metab July 2005, 90(7):4019-4024 Thyroid Insufficiency Mental fog Fatigue, depression, anxiety Cold extremities Aches and pains Hair loss, esp. in women Weight gain Constipation Puffy ankles and face Elevated cholesterol Diagnosing Thyroid Insufficiency Signs and Symptoms plus free T4 or free T3 levels below mid-point of RR High TSH = thyroid gland failure Normal/Low TSH = H-P dysfunction Trial of thyroid hormone supplementation using T4 and T3 The Fatigue, Fibromyalgia, and Depression Epidemic Pre-1970s: T3 and T4 for symptoms Post-1970s: T4-only to “normalize” TSH Doses lowered by 30-50% TSH “normalizing” T4 doselow free T3, weight gain, persistence of symptoms People with fatigue, fibromyalgia, and depression often improve with T3/T4 optimization Cortisol and Thyroid Optimization Any Questions? The Controversy What do we do about hormones lost to normal aging? Adrenopause DHEA-S Levels with Age Somatopause Growth Hormone (GH) J Clin Endocrinol Metab 1999; 84(6):2013-2019 Thyropause Free T3 Endocr Rev. 1995 Dec;16(6):686-715 Male Andropause—Testosterone Baltimore Longitudinal Study of Aging (BLSA). Harman et al., 2001 pg/ml Andropause vs. Menopause Men Women 8000 Testosterone Progesterone 7000 average 6000 5000 4000 3000 2000 Estradiol 1000 0 Young ♂ Old ♂ Young ♀ Old ♀ T P E DHEA-S 5,000,000pg/ml Cortisol 100,000 pg/ml! Conventional View of Aging The loss of hormones is adaptive Higher levels cause heart attacks, breast and prostate cancers Pharmaceutical Corporation Agenda: Take drugs instead of replacing hormones. Against the Conventional View Aging is an auto-destruct program. Starts around age 25! Glands and control systems deteriorate in weight, BP, cholesterol, cancers, heart attacks, autoimmune diseases, etc. Occur years after hormone losses begin Occur more often in those with lower levels Hormone restoration improves parameters, does not cause increased disease. Women Killers Cardiovascular disease (CVD), breast cancer and osteoporosis are rare in premenopausal women They begin in perimenopause when progesterone and testosterone are low. After menopause, CVD rises faster than in men Higher risk than men after 65 Higher mortality after 70 Surgical menopause 2-7x risk of heart attacks Engl J Med 1987 Apr 30;316(18):1105-10 Am J Obstet Gynecol. 1981 Jan;139(1):47-51. DHEA—Most Abundant Steroid Precursor of testosterone and estradiol Lower levels assoc. with risk of death, disease Anabolic—builds tissues, improves immunity Reduces pain by increasing endorphins Anti-inflammatory Improves immune system function Anti-atherosclerotic Reduces platelet aggregation--blood clotting Anti-cancer effects Male Andropause:“Just Gettin’ Old” Testosterone levels decline slowly Fatigue Reduced mental function Passivity and moodiness Loss of muscle and bone mass Increased abdominal fat Loss of libido, no spontaneous morning erections Testosterone is Your Friend Improves mood and sociability Improves energy Improves cognition, protects against Alzheimer’s disease Neurology. 2004 Jan 27;62(2):188-93. Improves libido and erectile function Increases muscle and bone mass Reduces abdominal fat, improves insulin sensitivity, lowers blood pressure-counteracts metabolic syndrome Testosterone is Good for your Heart Low testosterone levels correlate with coronary artery disease and stroke Arterioscler Thromb. 1994; 14:701-706 Eur Heart J 2000; 21; 890–4 Int J Cardiol. 1998 Jan 31;63(2):161-4 Arterioscler Thromb Vasc Biol. 1996 Jun;16(6):749-54 T dilates coronary arteries T improves endothelial function T increases heart muscle size, strength T decreases fibrinogen levels—prevents blood clots Endocr Res. 2005;31(4):335-44 Testosterone Does Not Cause Prostate Cancer Testosterone promotes prostate growth to a point. Castration slows prostate cancer growth temporarily. Men with higher T levels don’t have higher risk of prostate cancer. Testosterone restoration does not increase the risk of prostate cancer. Low T levels associated with more aggressive prostate cancers. Where’s the Beef? “These results argue against an increased risk of prostate cancer with testosterone replacement therapy.” Testosterone replacement therapy and prostate risks: where's the beef? Morgentaler A. Can J Urol. 2006 Feb;13 Suppl 1:40-3 Hormones and Aging Testosterone For Men Any Questions? Coming up: Estradiol, Progesterone, and Testosterone for Women Female Endocrinology: Balance in a Complex System Reproduction makes special demands on the female body Breasts, uterus and ovaries undergo a monthly cycle of proliferation and breakdown No similar process in males Defects in this cycle can lead to cancers and other medical disorders. Estrogen—Progesterone Complementarity in Women Estrogen promotes tissue proliferation and growth Progesterone stops proliferation and promotes differentiation Differentiated cells can’t become cancers High average progesterone/estrogen ratio prevents cancers Anti-Estrogenic Actions of Progesterone Decreases synthesis of estradiol receptor molecules Increases conversion of estradiol to estrone (weak estrogen) in tissues Inhibits conversion of estrone to estradiol Increases sulfation of estrogens (inactivation) Williams Text. of Endocrinology, 10th Ed., p. 612 Normal Cycle and Balance Ovulation Menstrual Cycle Perimenopause Luteal Insufficiency=Estrogen Dominance Inadequate Luteal Phase shorter periods, early spotting Ovulation Menstrual Cycle Perimenopause Anovulation with Estrogen Dominance High estrogen, low progesterone ’d risk of cancer Menstrual Cycle Menopause Estrogen and Progesterone Deficiency Imbalance: Estrogen Dominance Allergies Autoimmune disease Anxiety, irritability Insomnia Decreased sex drive Depression Bloating and edema Fibrocystic breasts Uterine fibroids Breast cancer Ovarian cancer Uterine cancer Thyroid dysfunction Gallbladder disease Heavy/painful menses Migraines Seizures Endometriosis Perimenopause is Dangerous Females born with a fixed no. of oocytes (eggs) Aging fewer oocytes of lower quality are leftreduced progesterone productionestrogen dominance Anovulation no progesterone estrogen dominancebreast and uterine cancer Menopause: Estradiol Deficiency Irritability, depression, insomnia, ’d risk of Alzheimer’s dz. Fatigue, aches and pains Genital atrophy Loss of libido Atrophy and wrinkling of skin BP, LDL cholesterol, heart disease Osteoporosis Female Andropause Female testosterone levels decline 50% between age 20 and 45. Menopause. 2003 Sep-Oct;10(5):390-8 Birth control pills and menopausal HRT 25 to 40% in free testosterone and DHEAS levels Obstet Gynecol. 1997 Dec;90(6):995-8 DHEA declines with age—main source of androgens Testosterone for Women Improves energy, mood Reduces anxiety Improves sexual function Increases muscle strength, stamina Increases bone density J Reprod Med. 1999 Dec;44(12):1012-20 Probably decreases risk of heart attack J Womens Health. 1998 Sep;7(7):825-9 Speroff L, Fritz M Clinical Gynecologic Endocrinology and Fertility, 7th Ed. Osteoporosis In menopause 5% of bone mass is lost each year for first 5 years=25% 50% of women >65 yrs. old have spinal compression fractures 14% lifetime risk of hip fracture for 50 yr.old woman, 30% for 80 yr. old. Speroff L, Fritz M Clinical Gynecologic Endocrinology and Fertility, 7th Ed. Osteoporosis A hormone deficiency disease (incl. Vit. D) Estradiol controls resorption of old bone Testosterone, progesterone, DHEA, and GH build new bone J Clin Endo Metab. 1996; 81:37-43 J Reprod Med. 1999 Dec;44(12):1012-20 Combined hormone restoration increases bone density better than Fosamax and preserves normal bone remodeling Perimenopause and Menopause and Their Disorders Any Questions? Coming: The Problems with “HRT”: Breast Cancer, Strokes, and Heart Attacks So Why is Everyone Saying that Hormone Replacement is Dangerous? Q: What “hormones”? Given how? Bioidentical Human Steroid Hormones Complex Interactive System Estradiol Testosterone DHEA Progesterone Do Not Substitute Cortisol “HRT” has Always been Hormone Substitution! Pregnant mare’s urine: Premarin in 1942 Progesterone synthesized in 1942, altered to make “progestins” “HRT” = pills containing alien molecules Drug Co.s pushed doctors to use hormone substitutes and ignore bioidenticals! Confusion: Beware of the “HRT” Literature! “Estrogen” means anything with estrogenlike effects “Progesterone” often used for “progestins” like Provera, levonorgestrel, etc. “Testosterone” can mean alien molecules like methyltestosterone Biochemistry 101: Different molecules are not the same and do not have the same effects! Premarin : Close, but Not Human Human Estradiol-17β Horse Dihydroequilin-17β CEE contains at least 10 estrogens, only 3 are found in humans. CEE is similar to human estrogens and has similar benefits. The Problems with Oral Estrogens First-pass effect on the liverIGF-1 (growth hormone), SHBG, CRP clotting factorsblood clots and strokes Transdermal estradiol has none of these effects—does not cause blood clots! Circulation. 2007 Feb 20;115(7):840-5 Birth Control Pills: Very Unnatural Estradiol Ethinyl Estradiol Acetylene EE cannot be inactivated by normal oxidation! EE does not interact with estrogen receptor ! Oral EE is more thrombogenic than Premarin or estradiol The BIGGEST Problem: Progestins Progesterone MPA (Provera) Megestrol Many Doctors Do not Know the Difference! Scientific studies show that: Progesterone • • • • • • • • • • Maintains pregnancy Improves mood Improves sleep Diuretic Lowers blood sugar Maintains estradiol-induced arterial dilation Improves lipid profile Prevents heart attacks Reduces estrogenic stimulation of breasts Decreases risk of breast cancer Provera • • • • • • • • • • Causes birth defects Can cause depression Insomnia, irritability Fluid retention Raises blood sugar Reduces estradiol-induced arterial dilation Worsens lipid profile Causes heart attacks Increases estrogenic stimulation of breasts Increases risk of breast cancer Progestin Zoo Progesterone Provera Kuhl, Climacteric 2005;8(Suppl 1) 2002 WHI Study: “HRT” is Dangerous! >30 studies showed long term protection against heart disease with Premarin WHI: 60-70 y.o.’s started on “HRT” Premarin caused adverse effects in the first year (blood clots and strokes). Adding Provera (Prempro) caused many more adverse effects (breast cancers and heart attacks). Large increase in dementia—probably vascular in origin Progestins cause Atherosclerosis and Clotting “In both peripheral and cerebral vasculature (of live animals), synthetic progestins caused endothelial disruption, accumulation of monocytes in the vessel wall, platelet activation and clot formation, which are early events in atherosclerosis, inflammation and thrombosis. Natural progesterone or estrogens did not show such toxicity.” Thomas T, Rhodin J, Clark L, Garces A. Progestins initiate adverse events of menopausal estrogen therapy. Climacteric. 2003 Dec;6(4):293-301. Cardiovascular Disease My Conclusions: Youthful levels of steroid hormones protective. Estradiol and progesterone are more protective than testosterone Oral, not transdermal, estradiol increases the risk of thrombi and strokes Estradiol reduces atherosclerosis in the long run. Some progestins cause persistent endothelial inflammation, atherosclerosis, and clotting. Best Preventative Strategy—maintain youthful levels of sex-steroid hormones! Breast Cancer: Verdict: Progesterone is Innocent “The balance of the in vivo evidence is that progesterone does not have a cancer-promoting effect on breast tissue.” Progestins and progesterone in hormone replacement therapy and the risk of breast cancer. J Steroid Biochem Mol Biol. 2005 Jul;96(2):95-108. That’s the conservative interpretation of the evidence! In Fact: Progesterone Prevents Breast Cancer 55,000 women 8 years f/u c/w WHI-16,000, 6 yr. f/u No Hormones TD-E2=Transdermal Estradiol E3N-EPIC Cohort study Int J Cancer. 2005 Apr 10;114(3):448-54 More Progesterone=Less Breast Cancer 6,000 women 5 yr. F/U Less Breast Cancer More Progesterone ORDET Study: Int. J. Cancer 112 (2004) (2), pp. 312–318. See also Cancer Causes Control. 2004 Feb;15(1):45-53. Many Kinds of Evidence Progesterone prevents estradiol-induced breast tumors in rats as well as Tamoxifen Jpn J Cancer Res. 1985 Aug;76(8):699-704 Premenopausal women with low P levels had 5.4 times greater risk of early breast cancer Am J Epidem 1981; 114:209-17 Breast cancer victims have signs of progesterone resistance Br J Obstet Gynaecol. 1998 Mar;105(3):345-51. More Evidence Estradiol cream applied to the breast induces proliferation, adding progesterone reduces proliferation to baseline Fertil Steril 1995; 63:785-91 Estradiol upregulates cancer-promoting gene bcl-2, progesterone downregulates it. Ann Clin Lab Sci. 1998 Nov-Dec;28(6):360-9 In vitro: adding progesterone eliminates estradiol-induced proliferation and cancers in normal breast cells Eur J Cancer. 2000 Sep;36 Suppl 4:S90-1 J Steroid Biochem Mol Biol. 2000 Jun;73(3-4):171-81 Testosterone Prevents Breast Cancer in Estradiol-Replete Women Testosterone opposes estradiol-induced breast stimulation. Menopause. 2003 Jul-Aug;10(4):292-8 Endocr Rev. 2004 Jun;25(3):374-88. FASEB J. 2000 Sep;14(12):1725-30. Addition of testosterone to estrogen/progestin reduces breast cancer incidence to baseline. Menopause. 2004 Sep-Oct;11(5):531-5 Testosterone and DHT inhibit in vitro growth of breast cancer cell lines.Gynecol Endocrinol 2002; 16: 113-120 Testosterone is an effective treatment for breast cancer. Cancer Detect Prev. 1992;16(1):31-8(review) Breast Cancer My Conclusions: Estradiol promotes breast cancer. Some progestins promote breast cancer. Progesterone and testosterone help prevent breast cancer. Estradiol restoration is safe if accompanied by sufficient progesterone and testosterone to restore youthful balance. Hormone Restoration for Women Keeping a woman premenopausal by restoring hormones in the most physiological way and in natural balance should be considered beneficial until proven otherwise. Since menopausal hormone deficiencies are known to be harmful and to diminish quality of life, those who would deny women the restoration of their hormones have the burden of proof that there is harm that outweighs the benefits. Where Do They Come From? Chemically synthesized from diosgenin (wild Mexican yams and soy) Compounding pharmacists prepare creams, tablets, etc. using USP-certified hormones FAR less expensive and more convenient than similar FDA-approved comm. products Wyeth Corp. Propaganda: What Your OB/GYN is Told ACOG NEWS RELEASE October 31, 2005 The American College of Obstetricians and Gynecologists Washington, DC -- There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies,…all of them should be considered to have the same safety issues as those hormone products that are approved by the FDA (including Prempro, BCPs) and may also have additional risks unique to the compounding process… Furthermore, hormone therapy does not belong to a class of drugs with an indication for individualized dosing… ACOG to Women: Suffer from Deficiencies or Die from Our Substitutes! “HRT”, Breast Cancer, Strokes, and Heart Attacks Any Questions? What Else Can Hormone Restoration Help? Infertility, PMS, heavy bleeding Headaches and insomnia—almost always Heart failure, angina Mental disorders Autoimmune diseases (SLE, rheumatoid arthritis, ulcerative colitis, Crohn’s, etc.) Intra-abdominal fat (pot belly) Allergies, skin diseases Every disease/disorder?! Doing HR Cost—Hourly rate Forms available online Initial visit: order tests F/U visits: Review results—prescribe—retest Repeat until stabilized at proper dose Follow-up office visit every 6 months, test only as needed. Telephone Consults—same hourly rate E-mail—usually no charge For More Information The Miracle of Natural Hormones David Brownstein, MD How to Achieve Healthy Aging—Look, Live, and Feel Fantastic After 40 Neal Rouzier, MD The Hormone Solution—Stay Younger Longer Thierry Hertoghe, MD Life Extension Foundation: www.lef.org Hormonerestoration.com. [email protected] Office: 570-836-0359