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Bioidentical Hormone Restoration Best Medical Practice [email protected] Hormones Neuro-endocrine-immune system Travel via blood to cells’ receptors Control cells’ proliferation, protein manufacture, metabolic rate, etc. Most powerful molecules in our bodies Optimal levels essential for health and quality of life Hormones and Aging Why Doctors Don’t Get It Bioidentical Hormone Restoration is Common Sense If a hormone is missing, replace it! If present but insufficient, optimize it! Type 1 Diabetes: bioidentical insulin Hypothyroidism: bioidentical T4 Growth hormone def.: bioidentical GH Adrenal insufficiency: bioidentical cortisol But what about hormones lost to aging? Pregnenolone—Mother Steroid J Clin Endocrinol Metab. 1997 Aug;82(8):2396-402. DHEA DHEA-S J Clin Endocrinol Metab. 1997 Aug;82(8):2396-402. Somatopause Growth Hormone (GH) Normal Adults Pituitary Disease Sufficiency fatigue Log scale J Clin Endocrinol Metab. 1999 Jun;84(6):2013-9. Testosterone Progesterone Estradiol pg/ml 8000 7000 6000 5000 4000 3000 2000 1000 0 Andropause Menopause T P E Young ♂ Old ♂ Young ♀ Old ♀ DHEA–10,000 pg/ml, DHEA-S 5,000,000 pg/ml ! Hormonal Changes With Aging Hormones that build tissues and improve immunity decline with age by 50-80% (DHEA, Testosterone, GH) Progesterone starts to decline at age 30. Estradiol disappears at 50—menopause Thyroid hormone production and sensitivity decline Insulin output declinesDiabetes By age 50—20 years of hormonal deficiency Conventional View of Hormones and Aging The loss of hormones is adaptive–helps us to live longer Persistence of youthful levels of hormones would cause more heart attacks and cancers as we age Losing our hormones is good for us(?!) Fits the Pharmaceutical Agenda: Take drugs for every symptom and disorder caused by hormone loss! Against the Conventional View Aging is a self-destruct program that kicks in at age 25 in humans Aging is natural degeneration! Weight gain, high blood pressure, high cholesterol, cancers, heart attacks, autoimmune diseases, etc. occur years after hormone deficiencies begin and occur more often in people with lower hormone levels! Studies of balanced hormone restoration show the expected benefits and no proof of harm!! Example: Growth Hormone Declines 14% per decade after age 25 IGF-1 of many adults equal to hypopituitary patients (only 80-110 vs. 350 @25yrs.old) Deficiency heart disease, frailty, depression, body fat, bone loss GH restoration reduces abdominal fat, lowers blood sugar and blood pressure Improves cognition, mood, sleep, energy Increases muscle, decreases fat & cholesterol Improves bone density, skin thickness Downside: high cost, nightly injections The Endocrinology of Aging Endocrine glands and their feedback control systems deteriorate with age Our bodies cease to regulate our hormones for optimal health Hormone losses speed our general deterioration: a vicious cycle. The symptoms of hormone loss are warning signs of physical deterioration Win-Win: Hormone restoration makes you feel better and improves your health! Since the Loss of Hormones is Harmful,THEN… Restoring youthful hormone levels is: essential preventative medicine essential to the treatment of disease essential to Quality of Life! We have the need and the right to restore hormones lost to aging! Hormones and Aging Any Questions? Human Steroid Hormones Estradiol Testosterone DHEA Progesterone Cortisol Where Do They Come From? All steroid hormones (including substitutes) are chemically synthesized from diosgenin (wild Mexican yams, soy, and other plants). Not Just “Sex Hormones” Estrogen, progesterone, testosterone and DHEA essential to cellular growth and function in all tissues in both sexes! Maintain brain function—modulators of mood, cognition, pain, etc. Maintain the immune system—progesterone and testosterone are immunosuppressants Maintain connective tissue: skin, hair, bone, muscle, and blood vessels Female Endocrinology Nature makes special demands on the female body for reproduction Breast, uterine and ovarian tissues undergo a monthly cycle of proliferation, differentiation, and breakdown Defects in this cycle can lead to cancers in female organs and to many medical disorders. Estrogen—Progesterone Complementarity Estrogen promotes breast/uterine tissue proliferation and growth Progesterone stops proliferation and promotes maturation and differentiation Differentiated cells can’t become cancer cells High average progesterone/estrogen ratio suppresses proliferation and prevents cancers of female organs Progesterone Deficiency Estrogen Dominance Allergies Autoimmune diseases 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 periods Migraines Seizures Progesterone and Iodine/Kelp reduce estrogen dominance Historical Perspective Throughout most of human history, women were usually: Pregnant—high progesterone Breastfeeding—low estrogen (both protect against breast cancer) Women cycled for 4 years avg.; today many cycle for 35 years Cycling=risk of estrogen dominance and other hormonal disorders Perimenopause Females born with a fixed no. of oocytes which are continually lost to age and ovulation With aging, fewer oocytes of lower quality are leftreduced progesterone production beginning around age 30estrogen dominance No ovulation=no progesterone Estrogen swings from very high to very low—often for several years. Normal Progesterone Dominance Ovulation Menstrual Cycle Perimenopause Luteal Insufficiency=Estrogen Dominance Inadequate Luteal Phase shorter periods, early spotting Ovulation Menstrual Cycle Perimenopause Anovulation=Estrogen Dominance Menstrual Cycle Menopause Estrogen and Progesterone Deficiency Also Uterine and Ovarian Cancer Menopause Estrogen Deficiency Progesterone Deficiency Testosterone Deficiency After menopause, women depend upon their adrenal glands for androgens and estrogens, so: Menopause +Adrenal Insufficiency = BIG TROUBLE Effects of Combined SexHormone Deficiency Irritability, insomnia, brain dysfunction Alzheimer’s dementia Fatigue, aches and pains. Osteoporosisfractures, loss of teeth Genital atrophy, vaginal dryness Atrophy of skin and connective tissue Heart disease—higher risk than men after 65, higher mortality after 70! Estradiol Restoration Eliminates hot flashes Restores mood and mental function Probably protects against Alzheimer’s disease Maintains genital/vaginal skin and lubrication Increases thickness, fullness of skin and hair Prevents heart disease Prevents colon cancer and macular degeneration Improves insulin sensitivity—helps diabetes Prevents osteoporosis and osteoarthritis Speroff L, Fritz M Clinical Gynecologic Endocrinology and Fertility, 7th Ed. Osteoporosis In menopause 5% bone loss each year for first 5 years=25%—all due to loss of estrogen! 20 yrs. post menopause—50% reduction in trabecular bone, 30% in cortical bone 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—the proper treatment is hormone restoration! Estrogen prevents resorption of old bone while 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 BHR increases bone density far better than Fosamax and preserves normal bone remodeling (no “rotting jaw”, eye inflammation, Ca++). Estrogen, Progesterone, and Osteoporosis Any Questions? Total and Free Testosterone in Men Baltimore Longitudinal Study of Aging (BLSA). Harman et al., 2001 Andropause in Men Testosterone levels decline slowly in men— ”Just getting old.” Fatigue, reduced mental function Passivity and moodiness—loss of drive and ambition Loss of muscle mass, increased abdominal fat Lastly: loss of libido, no morning erections Increased risk of heart and prostate disease Increased risk of Alzheimer’s dementia Increased risk of autoimmune diseases Testosterone Restoration Improves mood and sociability Restores energy and ambition Improves cognition Increases libido and sexual performance Increases muscle and bone mass Reduces abdominal fat, improves insulin sensitivity, lowers blood pressure--counteracts metabolic syndrome Testosterone and the 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—improves angina T increases heart muscle size, strength T decreases fibrinogen levels—prevents blood clots Endocr Res. 2005;31(4):335-44. Testosterone and the Prostate Higher testosterone levels do not increase the risk of prostate cancer. Studies of testosterone supplementation have shown no increase in prostate cancer—even though so many men have it! Low testosterone correlated with more aggressive prostate cancers Testosterone promotes prostate growth to a point, but not prostate cancer 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? Can J Urol. 2006 Feb;13 Suppl 1:40-3. Estrogen Dominance Theory of Prostate Disease In many men, free testosterone declines > estradiol Estrogen dominance is a probable cause of prostrate enlargement and a possible cause of prostate cancer Elevated estrogen/Test. ratios in BPH Scandinavian Journal of Urology and Nephrology, 1995; 29: 65-68. High levels of estradiol and estrone found in BPH tissues Estradiol upregulates oncogenes Female Andropause Young woman’s free testosterone level in serum is 2x her free estradiol Female testosterone levels decline 50% between age 20 and 45 Birth control pillstestosterone and DHEA levels DHEA declines with age—main source of androgens in women Testosterone for Women Improves energy, mood Improves sexual desire and response Increases muscle strength and reduces muscle and joint aches With estradiol, 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. Given with estradiol and progesterone, reduces risk of breast cancer Menopause. 2003 Jul-Aug;10(4):292-8, Endocr Rev. 2004 Jun;25(3):374-88. Menopause. 2004 Sep-Oct;11(5):531-5, FASEB J. 2000 Sep;14(12):1725-30. Testosterone Any Questions? “My doctor says that hormone replacement is dangerous and there’s no evidence that bioidentical hormones are safer!” Two Approaches to Medicine Natural-Scientific—Identify the deficiency/excess at the molecular level and correct it with bioidentical molecules Pharmaceutical—Create non-natural, patentable substances that will produce some improvement Natural Science should be primary; Pharmaceutical Science secondary. Problems with Pharmaceuticals Alien molecules: not recognized, not easily eliminated Negative functions: disrupt normal physiology by blocking receptors, inhibiting enzymes, etc. Toxic: 1. 2. 3. Side effects even at low doses Allergic reactions Long-term damage Pharmaceutical Billions Mission: Sell pharmaceuticals Information control—journals, CME, med. schools, professional org.s, etc. Strategy: Suppress competition (natural vitanutrients and hormones—human physiology!!) Conventional Docs: Unaware Result: Unfounded fear of hormone optimization; unfounded confidence in toxic drugs History of “Hormone Replacement Therapy” Horse-derived Premarin approved in 1942 Progesterone synthesized in 1942. Poorly absorbed orally Chemically altered to make “progestins”— among the first drugs to be patented. “HRT” came to mean the use of alien molecules that had hormone-like effects Drug co.s became dependent on HRT profits Drug co.s push doctors to use hormone substitutes and to ignore or fear natural hormones!! Dirty Secret: Conventional “HRT” is really HST! Progesterone substitutes: medroxyprogesterone acetate (MPAProvera) and 30+ other “progestins” Estradiol substitutes: conjugated equine estrogens (CEE-Premarin) and ethinyl estradiol (birth control pills) Testosterone substitute: oral methyltestosterone Patented drugs—not hormones! Most docs don’t know the difference! Premarin Conjugated Equine Estrogens (CEE) Human Estradiol-17β Horse Dihydroequilin-17β CEE contains at least 10 estrogens, only 3 are human. CEE contains 3x more Dihydroequilin than Estradiol. DHE has 10% higher binding affinity for est. receptors. DHE binds far less to SHBG and has a slower metabolic clearance The most abundant estrogen in CEE is Equilin sulfate. Kuhl H, Climacteric 2005;8(Suppl 1):3–63 EE in Birth Control Pills Estradiol Ethinyl estradiol Acetylene EE cannot be inactivated by normal oxidation! EE does not interact with estrogen receptor ! EE is 12,000-60,000 times more potent by weight! EE is much more thrombogenic than estradiol Progesterone vs. Progestins Progesterone MPA (Provera) Megestrol Every progestin has a different spectrum of androgenic, estrogenic, glucocorticoid, and progestational effects! Progestin Zoo Progesterone Kuhl, Climacteric 2005;8(Suppl 1) NAMS-”Call ‘em all Progestogens” Headlines: “Testosterone therapies increase risk of breast cancer.” Testosterone Substitution Testosterone Methyltestosterone Methyltestosterone (in Estratest) aromatizes to an alien estrogen and increases risk of breast cancer, also causes liver damage and breast enlargement in bodybuilders Sex Bias If a Man’s testes are removed or nonfunctional, bioidentical testosterone replacement is started immediately If a woman’s ovaries are removed or nonfunctional, she is offered horse hormones or hormone-like drugs; or is told to “Live with it ”. It IS a Man’s World! Birth Control Hormone Substitution is Dangerous 2x risk of stroke, heart attack 2-30x risk of blood clots 1-3x risk of breast cancer Increased blood sugar, blood pressure 1.5x risk systemic lupus erythematosis UpToDate 2006 Liver tumors Instead:: Diagnose and fix the hormonal disorder Use a copper IUD for contraception!! 2002 WHI Study—Menopausal Prempro HST is Dangerous! Oral CEE (Premarin) alone had adverse effects in the first year (strokes, blood clots) Adding MPA (Provera, PremPro) caused more adverse effects (breast cancers, heart attacks) CEE/MPA caused a large increase in dementia And we know why these forms of hormone substitution are dangerous! Dangers of Oral Estrogen Replacement First-pass effect on the liverIGF-1, SHBG, CRP, clotting factors blood clots, strokes, heart attacks in the first year Smokers have greater risk of clots EE increases clotting much more than estradiol, Premarin® Transdermal estradiol has none of these effects! Dangers of Estrogen-only HRT Estrogen alone, estrogen-progestin HST and BCPs all reduce DHEAS and testosterone levels 25-60% Estrogen without progesterone and testosteroneestrogen dominance and risk of breast cancer and other medical disorders Scientific studies show that: Progestins are Dangerous Provera • • • • • • • • • • Causes birth defects Can cause depression Insomnia, irritability Fluid retention Raises blood sugar Counteracts estrogeninduced arterial dilation Worsens lipid profile Causes heart attacks Increases estrogenic stimulation of breasts Causes breast cancer Progesterone • • • • • • • • • • Maintains pregnancy Improves mood Improves sleep Diuretic Lowers blood sugar Maintains estrogen-induced arterial dilation Improves lipid profile No evidence of CVD Reduces estrogenic stimulation of breasts Prevents breast cancer 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.” Climacteric. 2003 Dec;6(4):293-301 Progesterone and Breast Cancer—the Evidence Premenopausal women with low P levels had 5.4 times greater risk of early breast cancer, 10x greater risk for all cancers 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. P downregulates BRCA1 and induces apoptosis in breast cancer cell lines. Anticancer Res. 2005 Jan-Feb;25(1A):243-8. Progesterone and Breast Cancer—the Evidence cont. Estrogen cream applied to the breast induces proliferation, adding progesterone cream reduces proliferation to baseline Fertil Steril 1995; 63:785-91 Estrogen is carcinogenic in breast cell cultures unless progesterone is present J Steroid Biochem Mol Biol. 2003 Oct;87(1):1-25. Estrogen upregulates cancer-promoting gene bcl-2, progesterone downregulates it. Ann Clin Lab Sci. 1998 Nov-Dec;28(6):360-9. No Evidence that BHRT is safer? E3N-EPIC Study Cohort study 54,000 women 5.8 years f/u c/w WHI-16,000, 6 yr. f/u Int J Cancer. 2005 Apr 10;114(3):448-54. Bioidentical estradiol plus progesterone decreased the risk of breast cancer! Int. J. Cancer 112 (2004) (2), pp. 312–318. ORDET Study 6,000 women 5 yr. F/U Higher progesterone=lower risk of breast cancer Progesterone and Breast Cancer—Conclusion “The balance of the in vivo evidence is that progesterone does not have a cancerpromoting effect on breast tissue.” J Steroid Biochem Mol Biol. 2005 Jul;96(2):95-108 In fact, the balance of the evidence indicates that progesterone protects against breast cancer! So…women can be given estradiol as long as it’s balanced by progesterone and testosterone! Pharmaceutical Corps’ Dilemma They need to control the HRT market Their progesterone and estradiol substitutes are dangerous They can’t patent natural hormones Pharm. Corps. have to get FDA-approval for every natural hormone preparation $$$ Compounding pharmacies can dispense natural hormones cheaply Pharm. Corps’ Choices Stop compounding pharmacies so they can control of the BHR marketWyeth’s appeal to the FDA, media propaganda blitz Suppress BHR in favor of their substitutes Keep looking for substitutes that will provide benefits without risks Result: Your doctors will never learn the truth about hormones unless he/she goes looking for it Common Sense Substitutes are alien molecules! Problems caused by hormone substitutes cannot be attributed to human hormones until proven otherwise. Bioidentical hormone restoration should be considered safe until proven otherwise! Hormone Substitution Any Questions? Metabolic Regulators: Thyroid and Cortisol Thyroid sets throttle, cortisol delivers fuel Deficiencyreduced metabolic ratefatigue, brain dysfunction, depression, pain Subtle deficiencysymptoms and disease Usual blood tests are insensitive Irrational fear of supplementation Underdiagnosed, undertreated—Docs prescribe pharmaceuticals (SSRIs) instead Hormone Ignorance: the Tyranny of the Lab Report Reference Range=95% of “normal people” optimum Male free testosterone: 35-155 5x Female free testosterone: 0.0-2.2 Free T3: 1.8-3.2 2x TSH: 0.3-5 17x If “within normal limits” no diagnosis; pharmaceuticals for symptoms If below normal, just replace to “WNL” Hypothyroidism—Symptoms Mental fog, depression, anxiety Fatigue Cold extremities Aches and pains Hair falling out Weight gain Constipation Self-Test: Basal body temperature <97.8°F axillary in bed in AM Thyroid Hormone—T3 Maintains metabolism, mood, and energy Controlled partly by thyroid stimulating hormone (TSH) from the pituitary gland TSH test is indirect: does not measure T3 levels or effects in various tissues Docs prescribe T4 only (Synthroid and Levoxyl)—prohormone that must be converted to T3 Docs rarely measure free T3 levels! We Need Optimal T3 Levels Incidence of severe atherosclerosis doubled with lower T3 or higher TSH levels within the normal range 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 Prevents weight gain Fatigue, Fibromyalgia and Depression Epidemic Pre-TSH: Treat the patient’s symptoms Post-TSH: Treat the test (?) 1970s—Doctors lowered doses by 30% TSH-normalizing T4 doselow T3 levels! Williams’ Textbook of Endocrinology. Saunders, Philadelphia, pp 357-488) T3 alone often effective in fibromyalgia T3 alone relieves depression even if tests “normal”! J Affect Disord. 2006 Feb Rational Approach to Thyroid Restoration If S/S of hypothyroidism: Treat! Give T4 plus T3 (Armour, Cytomel) Endocrinology 1996;137:2490-2502 Increase dose until symptoms gone or S/S of excess appear Safe--even moderate TSH suppression does not cause: bone loss Horm Res. 2005;64(6):293-8. Epub 2005 Nov 1. cardiac abnormalities J Clin Endo Metab. 2000 Jan;85(1):159-64. muscle wasting Am J Phys Endol Metab. 2005 Jun;288(6):E1067-73. Pharmaceuticals, Labs, and Thyroid Any Questions? Cortisol Made in the adrenal glands Maintains blood sugar (delivers the fuel) Modulates immune system Need high amounts when stressed Too muchDiabetes, HTN, osteoporosis Too littlehypoglycemia, fatigue, autoimmune diseases, aches and pains www.adrenalfatigue.org Cortisol Deficiency Fatigue, depression Aches and pains Can’t stay asleep Can’t deal with exercise, stress, or illness 2nd wind late at night Hypoglycemia, feels better after eating Nausea, abdominal discomfort, diarrhea Allergies, autoimmune diseases Hard to gain, hard to lose weight Low blood pressure, salt and sugar cravings Mild-to-Moderate Cortisol Deficiency Blood tests are insensitive, need diurnal salivary cortisol profile Underdiagnosed: Docs taught only about severe “adrenal insufficiency” due to physical destruction of the adrenal glands (Addison’s Disease) or pituitary Common cause of chronic fatigue, pain Clue: Felt great when taking prednisone Normal Saliva Cortisol Profile Cortisol Deficiency Cortisol Deficiency—Normal Waking Cortisol Depression—Elevated PM Cortisol Cortisol Restoration Mild deficiency can resolve with stress, rest, nutrient restoration Moderate-to-severe—need cortisol, not cortisol substitutes like prednisone Physiological doses (5 to 20mg=<1-4mg prednisone)—NOT excessive doses that cause hypertension, diabetes, osteoporosis, etc. Fears of low-dose cortisol unfounded Dr. William Jeffries’ Safe Uses of Cortisol DHEA—The Other Adrenal Hormone Most abundant steroid hormone yet ignored Cells make testosterone and estradiol with it Levels decline with age, stress and disease Anabolic—builds tissues, improves immunity Reduces abdominal fat Reduces pain—restores natural endorphins Reduces inflammation (IL-6, TNF-, IL-2) Anti-cancer effect in animal, in vitro studies Lower levels assoc. with disease, mortality Fatigue, Depression, and Pain Should be considered as due to a nutrient, thyroid, cortisol, or DHEA deficiency until proven otherwise by testing and by trials of nutrient and hormone restoration. Cortisol and DHEA Any Questions? What Else Can Hormone Replacement Help? Infertility, PMS, heavy bleeding Insomnia—almost always helps Heart failure Mental disorders Autoimmune diseases (systemic lupus erythematosis, rheumatoid arthritis, ulcerative colitis, Crohn’s disease, etc.) Allergies, skin diseases Hormone Restoration Unresolved issues—more investigation needed Need more long-term randomized studies to study long-term results Questions about delivery and monitoring Medical profession should be studying bioidentical hormones instead of hormone substitutes! Local Compounding Pharmacies Winola Pharmacy—Rt. 307 at Lake Winola, 378-2885 Harrold’s Pharmacy—Wilkes-Barre, 8225794 Fino’s Pharmacy—Dallas, 675-1141 Hazle Drugs Apothecary—Hazelton phone 1-800-439-2026 Doing BHRT History, consent, fees online Initial visit: order tests F/U visit: Results—prescribe—retest Repeat until stabilized at proper dose Follow-up office visit once every 6 months, test only as needed. Telephone and e-mail contact—charges for clinical decisions, refills, etc. Costs Physician time only as required--first year ~$200-$400; then <$200/yr. No insurance billing; may submit claim for recognized diagnosis Hormones—$10 to $70/month, some covered by insurance (GH adds $130/mo.) Diurnal salivary cortisol test—$120 Blood tests—insurance may pay, 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) BHRT info. and hundreds of abstracts at www.hormonerestoration.com. Contact me: [email protected]