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Bioidentical Hormone Restoration Best Medical Practice This presentation is available online. Hormones Neuro-endocrine-immune system Travel via blood to tissues Control cells’ metabolism, functions The most powerful molecules in biology Optimal levels Essential for Health Bioidentical: Same molecular structure as our natural hormones CRH, TRH, etc. control pituitary GH, FSH, LH, TSH, and ACTH control other glands T4, T3 Cortisol, DHEA, Aldosterone, Pregnenolone Insulin Adrenalin Estradiol, Progesterone Testosterone Testosterone Bioidentical Hormones are NOT Drugs No side effects, interactions, or reactions Non-toxic, inherently safe Proper fit in receptors, easily eliminated Blood levels can be monitored Restore health vs. modify disease The only potential problems: Excessive dose Lack of balance with other hormones Unphysiological delivery: route, timing, etc. Hormone Ignorance: The Tyranny of the Lab Report Reference Range=95% of the population Neither a normal nor an optimal range! Disease/No Disease instead of Continuum Male free testosterone: 35-155 5x! Female testosterone: 2-45 22x! Free T4: 0.6-1.8 3x! AM serum cortisol: 5-25 5x! Within RR: No diagnosis; pharmaceuticals Below RR (<97.5%): replace to within-RR Hypometabolism—Thyroid and Cortisol Insufficiencies Thyroid sets throttle (metabolic rate) Cortisol delivers the fuel (glucose) Optimal levels of both are required for health Even mild deficienciesreduced cellular metabolismfatigue, brain dysfunction, depression, pain, and disease Usual lab tests and ranges (TSH, AM cortisol) are insensitive Underdiagnosis, Undertreatment Mild-to-Moderate Cortisol Insufficiency Partial Secondary Insufficiency: brain (H-P) fails to maintain levels Fatigue, depression, pain, allergies, inflammation, hypoglycemia, low blood pressure, nausea, insomnia Clue: Prednisone improves mood, energy Diagnosis: saliva testing reveals free cortisol levels 4 times during the day Normal Saliva Cortisol Profile Common Dysfunctional Pattern Cortisol Insufficiency Addison’s Disease Cortisol Restoration Mild insufficiency—improves with stress, rest, and nutrients Moderate-to-severe insufficiency— requires cortisol restoration Low physiological doses are safe 40 years’ experience: see Dr. Jeffries’ Safe Uses of Cortisol Thyroid Insufficiency Mental fogginess Fatigue, depression, anxiety Cold extremities, low body temperature Aches and pains Thinning hair, dry skin Weight gain Constipation Puffy ankles and face Elevated cholesterol Continuum: Higher Thyroid Hormone Levels within the RRs: Reduced risk of severe atherosclerosis by 50% Clin Cardiol. 2003 Dec;26(12):569-73 Lower cardiac risk factors: cholesterol, triglycerides, C-reactive protein, homocysteine and lipoprotein(a) Lower blood pressure, dilates arteries Reduced tendency to form blood clots Relieve depression Reduced weight, increased weight loss The Increase in Fatigue, Fibromyalgia, and Depression Pre-1970s: Dessicated thyroid extract: T2, T3 and T4 dosed to eliminate symptoms Post-1970s: T4-only to “normalize” TSH TSH: Patient’s doses lowered by 30-50% TSH “normalizing” T4 doselow free T3, persistence of symptoms, weight gain Symptomatic persons with within-RR labs often improve with T3/T4 optimization Cortisol and Thyroid Optimization Any Questions? The Big Controversy What do we do about hormones lost to normal aging? DHEA—The Most Abundant Steroid Hormone In our Bodies 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—approved for SLE Improves immune system function Anti-atherosclerotic—may prevent heart disease Reduces platelet aggregation Ann N Y Acad Sci. 1995 Dec 29;774:281-90 Anti-cancer effects in animal studies Adrenopause DHEA-S Levels with Age Somatopause Growth Hormone (GH) Clinical Chemistry 48, No. 12, 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, cancers of the breast and prostate Fits Pharmaceutical Agenda: Don’t restore hormone levels: Take drugs for all problems caused by loss of hormones. Gonadal Steroids: Not Just “Sex Hormones” Estradiol, Progesterone, Testosterone Essential to all tissues in both sexes! Brain—Improve function, protect against Alzheimer’s Dz. Immune System Heart and blood vessel health Blood lipids, clotting Connective tissues—skin, muscle, bone Menopause: Estradiol Deficiency Hot flashes Fatigue, aches and pains Dry eyes and vagina, genital atrophy Loss of libido BP, LDL cholesterol, heart disease Atrophy of skin and bone (osteoporosis) Poor memory, depression, insomnia ’d risk of Alzheimer’s Disease Estrogen Replacement Prevents Alzheimer’s Disease Zandi PP, et al., Cache County Study. JAMA. 2002 Nov 6;288(17):2123-9. Women Killers Cardiovascular disease (CVD), breast cancer and osteoporosis are rare in premenopausal women They begin in perimenopause when progesterone and testosterone levels are lower. After menopause (loss of estradiol) osteoporosis accelerates and CVD rises faster than in men Higher risk of CVD 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. Menopause and Cardiovascular Disease 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. Male Andropause:“Just Gettin’ Old” Testosterone levels decline slowly Fatigue, passivity and moodiness Reduced mental function Loss of muscle and bone mass; fat Loss of libido and spontaneous morning erections BP, blood sugar, heart disease, Alzheimer’s Disease, autoimmune dz. Hormone Loss with Aging is BAD for Us Aging is an auto-destruct program. Starts around age 25! Glands and control systems deteriorate weight, BP, diabetes, heart attacks, autoimmune diseases, osteoporosis, etc. Occur years after hormone losses begin Occur more often in those with lower levels Hormone restoration helps prevent these diseases, and does not cause disease. Hormones and Aging Any Questions? Coming up: Male and Female Hormone Replacement Testosterone is Man’s Best 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 X Testosterone is Good for your Heart Low testosterone levels associated 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. Higher T levels don’t increase 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 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 which can lead to cancer Progesterone inactivates estrogen, stops proliferation and promotes differentiation Differentiated cells can’t become cancers High average progesterone/estrogen ratio prevents breast, uterine cancers 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 Estrogen Dominance: Progesterone Deficiency 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 Estradiol for Menopause Eliminates hot flashes Eliminates dryness of eyes and vagina Improves memory and mental function Maintains skin, bones Reduces risk of heart disease Reduces risk of Alzheimer’s disease Reduces blood sugar, blood pressure Improves energy, reduces aches Testosterone for Women Female testosterone levels decline 50% between age 20 and 45. Menopause. 2003 Sep-Oct;10(5):390-8 Improves energy, mood Improves libido, sexual sensation Increases muscle strength, stamina Increases bone density Probably decreases risk of heart attack J Reprod Med. 1999 Dec;44(12):1012-20 Womens Health. 1998 Sep;7(7):825-9 Osteoporosis A hormone deficiency disease (including Vit.D) Estradiol reduces 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 much 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 patentable “progestins” “HRT” = pills containing alien molecules Drug Co.s pushed doctors to use hormone substitutes and ignore bioidenticals! 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 long-term benefits. Birth Control Pills: 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 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 and does not cause blood clots! Circulation. 2007 Feb 20;115(7):840-5 The BIG Problem with HRT: Progestins Progesterone MPA (Provera) Megestrol Many Doctors Do not Know the Difference! Scientific studies show that: Progesterone Provera • • • • • • • • • • Maintains pregnancy Improves mood Improves sleep Diuretic Lowers blood sugar Maintains estradiol-induced arterial dilation Improves lipid profile Prevents heart attacks Reduces estrogenic breast stimulation Decreases risk of breast cancer 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 breast stimulation 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 male testosterone Oral, not transdermal, estradiol increases the risk of thrombi and strokes Some progestins cause endothelial inflammation, atherosclerosis, and clotting. Best Preventative Strategy—maintain youthful levels of natural sex-steroid hormones! But won’t that increase the risk of breast cancer? 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 More Progesterone 6,000 women 5 yr. F/U ORDET Study: Int. J. Cancer 112 (2004) (2), pp. 312–318. See also Cancer Causes Control. 2004 Feb;15(1):45-53. More Evidence Estradiol cream applied to the breast induces proliferation, adding progesterone reduces proliferation to baseline Fertil Steril 1995; 63:785-91 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 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 In vitro: Testosterone and DHT inhibit 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: Unopposed 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 natural hormones in the most physiological way and in natural balance should be considered beneficial until proven otherwise. Since perimenopausal and 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. What Your OB/GYN is Told ACOG NEWS RELEASE October 31, 2005 The American College of Obstetricians and Gynecologists A private organization funded by drug companies 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 Premarin, Provera, 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… “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 and disorder! Why Use Compounded Hormones? FAR less expensive than FDA-approved bioidentical products ($10-30 vs. $200/mo.) More convenient Individualized Physiological delivery—progesterone Reliable: Compounding pharmacies are PCCA members: standardized materials and procedures (http://www.pccarx.com) Where Do They Come From? Chemically synthesized from diosgenin (wild Mexican yams and soy) Compounding pharmacists prepare creams, tablets, etc. using USP-certified bulk hormones Doing HR Physician fee—according to time Forms available online Initial visit: order blood tests, saliva cortisol F/U visits: Review results—prescribe—retest F/U testing: blood, not saliva Office visit every 6 months, test only as needed. Telephone Consults—same hourly rate E-mail—No charge for brief responses Costs Physician time only as required--first year ~$200-$500; then <$200/yr. No Medicare or insurance billing; may submit claim for recognized diagnosis Hormones—$10 for 1 hormone, to $80/month for all, ±covered by insurance Diurnal salivary cortisol test—$120 Blood tests—insurance pays, lab kits $170$220, Saliva/blood kit—$299 Out-of-pocket expenses tax-deductible 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 (articles, abstracts) [email protected] Office: 570-836-0359