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Bioidentical Hormone Restoration Best Medical Practice Relax: this presentation is available online.

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1 Bioidentical Hormone Restoration Best Medical Practice Relax: this presentation is available online

2 Topics Introduction Reference Range Endocrinology Hormone Loss with Age Hypometabolism: Thyroid and Cortisol Deficiency Steroids and DHEA in Rheumatic Diseases Vitamin D and Fish oil Sex hormone replacement for Women and Men

3 Hormones Parts of our integrated neuro-endocrine- immune system Travel via blood to all cells Control cells proliferation, differentiation, protein synthesis, metabolic rate, etc. The most powerful molecules in biology Optimal levels and effects are essential for health and quality of life

4 Master Gland Central Control TSH ACTH LH/FSH T3, T4 Cortisol, DHEA Aldosterone Estradiol, Progesterone Testosterone

5 Human Steroid Hormones Bioidentical Molecules Testosterone Estradiol Progesterone Cortisol DHEA Drug companies have patented ~5 to 200 variations of each molecule. Aldosterone

6 Bioidentical Hormones are not Drugs Correct molecular structuresame action at receptors, same metabolism and elimination Non-toxic: No side effects, only effects No interactions with drugs No allergic reactions Safe in youthful physiological levels/balance Negative effects: Due to excessive dose, wrong delivery method, or imbalance with other hormones

7 Pharmaceutical Model Funding all schools, journals, organizations, research Naturally-occurring molecules cannot be patented FDA-approve s any drug that works better than placebo in two short-term trials. Symptoms labeled as syndromes, treated with drugs (depression, fatigue, fibromyalgia, anxiety, etc.) Misinformation about hormones is rampant. Hormone and nutrient deficiencies underdiagnosed and undertreated.

8 Bioidentical Hormone Restoration is Good Medical Practice If a hormone is missing, replace it!; if present but deficient, optimize it! Type 1 Diabetes: bioidentical insulin Hypothyroidism: bioidentical T 4 Growth hormone def.: bioidentical GH Adrenal insufficiency: bioidentical cortisol The Controversies: How do we diagnose deficiency? How do we decide which dose is right? What do we do about deficiencies due to aging?

9 Why Docs Dont Get It: Reference Range Endocrinology Normal ranges on reports are misunderstood: 95% of all persons tested (only 2.5% low) 95% of tested persons of same age adjudicated diagnostic values (glucose, cholesterol) Docs assume that all ranges are diagnostic! Male free testosterone: x! Female free testosterone: ! Thyroid - Free T4: x! AM serum cortisol x! Normal result no hormonal dx/rx drugs May mean

10 Hormone Effect Hormone Level % population range Everything is Normal Too much Disease No Thyroid Disease Reference Range Endocrinology Thyroid Free T4 ng/dL But Hormone Effects vary continuously with concentration! Too little Disease One size fits all

11 Hormone Effect Hormone Level Intelligent Endocrinology Optimal?? FT4 ng/dL Tighter range based on healthy persons and on physiological research Individualized Diagnosis and Treatment

12 What should we do about hormones that are lost to normal aging?

13 DHEA DHEA-S J Clin Endocrinol Metab Aug;82(8): Adrenopause

14 Endocr Rev Dec;16(6): Thyropause TSH response to low T4 ( g/dL) Carle, Thyroid Feb;17(2): % decline

15 Growth Hormone (GH) Somatopause Clinical Chemistry 48, No. 12, 2002

16 Andropause Testosterone in Men

17 Steroid Loss in Women>>Men pg/ml DHEA-S 5,000,000pg/ml Cortisol 100,000 pg/ml Men Women Progesteron e average Testosterone Less estrogen than old men! 90% Loss50% loss

18 Common View 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 (?) Fits the Pharmaceutical Agenda: Take drugs for every symptom and disorder caused by hormone loss (!?!)

19 Against the Common View Aging is a natural self-destruct program that kicks in around age 25 in humans Obesity, high blood pressure, heart attacks, autoimmune diseases, and many cancers increase years after hormone deficiencies set in, and occur more often in those with lower hormone levels! Studies of balanced hormone restoration show the expected benefits and no proof of harm!!

20 New Paradigm: Restorative Endocrinology Endocrine glands and their feedback control systems deteriorate with age. Our bodies cease to regulate our hormones for optimal health. Partial hormone deficiencies are harmful. The restoration of youthful/optimal nutrient and hormone levels is: Essential to preventative medicine Essential to the treatment of disease Essential to our quality of Life!

21 Hypometabolism: Thyroid and Cortisol Insufficiency Thyroid sets throttle, cortisol delivers the fuel Our health and quality of life require optimal levels of both hormones! Deficiency reduced metabolic rate fatigue, brain dysfunction, depression, pain Conventional tests are insensitive to deficiencies Irrational fear of thyroid and cortisol supplementation Underdiagnosed, undertreatedDocs prescribe pharmaceuticals instead (SSRIs, amphetamines, anti-seizure drugs, anti-psychotics, sedatives, etc.)

22 Hypothyroidism Mental fog, poor concentration Depression Fatigue, need for excessive sleep Cold extremities Aches and pains Thinning scalp hair Weight gain Constipation Ankle swelling, puffy face

23 Thyroid Testing Doctors often order only a TSH test--Inadequate Thyroid stimulating hormone (TSH) is NOT a thyroid hormone, it is an indirect and fallible indicator of thyroid hormone levels. Must measure free T 4 and free T 3 levelsfor both diagnosis and monitoring therapy. Hypothyroidism: symptoms plus one or both hormone levels below middle of population ranges Severe hypothyroidism: signs and symptoms plus both hormones in lower third of ranges.

24 We Need Optimal T 4 /T 3 Levels Incidence of severe atherosclerosis cut in half with higher T 3 levels within the laboratory range Clin Cardiol Dec;26(12): Lowers cardiac risk factors: cholesterol, triglycerides, C-reactive protein, homocysteine and lipoprotein(a) Lowers blood pressure, dilates arteries Reduces tendency to form blood clots Helps prevent weight gain

25 Fatigue, Fibromyalgia and Depression Epidemic Chronic fatigue, fibromyalgia, and depression: low thyroid and/or low cortisol until proven otherwise Pre-1970s: Treat the patients signs and symptoms with T 4 and T 3 (desiccated thyroid-- Armour ) Post-1970s: Treat TSH test using T 4 only! Doctors often lowered doses by 30-50%! TSH-normalizing T 4 dose often lower free T 3 levels weight gain, persistence of symptoms Thyroid optimization helps most patients with symptoms and low-normal thyroid levels.

26 Restorative Thyroidology Do Not Rely on TSH test for diagnosis or treatment Fraser WD, Are biochemical tests of thyroid function of any value in monitoring patients receiving thyroxine replacement? Br Med J (Clin Res Ed) Sep 27;293(6550): Give T 4 plus T 3 (Armour, Cytomel +levothyroxine) Adjust dose according to symptoms and free T 4 and free T 3 levels Optimizing hormone levels within physiological ranges is safe: No bone loss if Vit. D and hormones are restored No cardiac dysfunction J Clin Endo Metab Jan;85(1): No muscle wasting Am J Phys Endo Metab Jun;288(6):E

27 Cortisol Made in the adrenal glands The bodys natural steroid--d levels needed in stress, inflammation Maintains blood sugar (delivers the fuel) Too much Diabetes, HTN, belly fat, osteoporosis Too little fatigue, depression, aches & pains, anxiety, hypoglycemia, insomnia, inflammation Modulates the immune systemprevents and treats allergies and autoimmune diseases We need higher levels with stress and disease

28 Cortisol (hydrocortisone) Dexamethasone (70x) Decadron® Methylprednisolone (5x) Medrol® Glucocorticoids (Steroids) Prednisone (4x)

29 Mild-to-Moderate Cortisol Insufficiency Common cause of chronic fatigue, pain Common cause of thyroid hormone intolerance Unrecognized: Docs taught to recognize only Addisons Disease (total adrenal gland failure) Serum cortisol and ACTH stimulation tests are insensitive Reimondo G, Pituitary. 2008;11(2): Streeten DH, J Clin Endocrinol Metab Jan;81(1): Best test is saliva cortisol levels throughout day. Gozansky WS, Clin Endocrinol (Oxf) Sep;63(3): Clues: Feels much better on prednisone, often needs steroids for allergies, illnesses, etc.

30 Normal Saliva Cortisol Profile

31 Cortisol Deficiency

32 Cortisol Restoration Mild deficiency will improve with stress, rest, adrenal supplements, licorice root Moderate-to-severe deficiencyneeds cortisol restoration Physiological doses of 15-30mg daily do not cause hypertension, osteoporosis, diabetes Taking cortisol or any glucocorticoid depresses DHEA, must replace. Doctors fear of low-dose cortisol therapy is unfounded Dr. William Jeffries Safe Uses of Cortisol

33 Adrenal Hormones and Rheumatic Diseases Rheumatic diseases assoc. with HPA activity, lower cortisol levels, and relative adrenal insufficiency Johnson EO, Ann N Y Acad Sci Nov;1088: Demir H, Scand J Rheumatol May-Jun;35(3): Chikanza IC, Arthritis Rheum Nov;35(11): Cutolo M, J Endo Invest. 2002;25(10 Suppl): Ann N Y Acad Sci Jun;1069: Gudbjornsson B, J Rheumatol Apr;23(4): Mastorakos G, Z Rheum.2000;59 Suppl 2:II/75-9. Kebapcilar L, J Endocrinol Invest Jul 20. Shah D, Kathmandu Univ Med J (KUMJ) Jul-Sep;7(27): Cortisol receptor isoforms and polymorphisms assoc. with autoimmune disease. Tait AS J Leukoc Biol Oct;84(4): Low DHEAS found years before onset of RA, and in all rheumatic diseases. Masi AT, Ann N Y Acad Sci Jun 22;876:53- 62; disc Stress is a trigger of autoimmune disease. Stojanovich L, Autoimmun Rev Jan;7(3): Low cortisol levels in fibromyalgia, chronic pain. Gur A, Ann Rheum Dis Nov;63(11): McBeth J, Arthritis Res Ther. 2005;7(5):R992-R1000.

34 The Female Dilemma Women make 1/2 as much cortisol as men. Vierhapper H, Metabolism Aug;47(8): Women release less cortisol under stress Takai N, Ann N Y Acad Sci Mar;1098: Estradiol lowers cortisol levels and opposes cortisol throughout the body. Kerdelhué B, Neuro Endocrinol Lett Oct;27(5): Ligeiro de Oliveira AP, Neuroimmunomodulation. 2004;11(1):20-7 Anti-depressants increase cortisol levels and effects. Sagud M, Neuropsychobiology. 2002;45(3): Female/Male ratios: Fibromyalgia 8:1, RA 3:1, SLE 9:1, PMR 2:1, Sjogrens 18:1, Chronic fatigue 4:1, Depression 2:1, Hashimotos /Graves thyroiditis 5:1, Anxiety 3:2, Mult. Sclerosis 3:1

35 DHEA Most abundant steroid hormone; yet ignored Cells make testosterone and estradiol with it Anabolicbuilds tissues, improves immunity Reduces intra-abdominal fat Villareal DT, JAMA Nov 10;292(18): Reduces inflammation Anti-atherosclerotic effect Anti-cancer effect in animal, in vitro studies Low levels of DHEAS found in autoimmune diseases Steroid therapy greatly reduces DHEA, must replace

36 DHEA DHEA-S J Clin Endocrinol Metab Aug;82(8): Adrenopause

37 DHEA Replacement Improves blood sugar control, lowers insulin levels, and counteracts negative effects of diabetes Brignardello E, Diabetes Care Nov;30(11): Dhatariya K, Diabetes Mar;54(3): Lasco A, Eur J Endocrinol Oct;145(4): mg/day improves mood, fatigue and joint pain in elderly men. Genazzani AR, Aging Male Jun;7(2): Improves fertility in older women Barad D, J Assist Reprod Genet Dec;24(12):629-34, Improves sexuality in postmenopausal women. Hackbert L, J Womens Health Gend Based Med Mar;11(2): Alleviates depression Bloch M, Biol Psychiatry Jun 15;45(12): Rabkin JG, Am J Psychiatry Jan;163(1): Schmidt PJ, Arch Gen Psychiatry Feb;62(2): Reduces painrestores natural endorphins Stomati M, Gynecol Endocrinol Feb;13(1):15-25.

38 DHEA Replacement Improves mood and energy in patients on steroid replacement Hunt PJ, Clin Endocrinol Metab Dec;85(12): Decreases platelet aggregation Jesse RL. Ann N Y Acad Sci 1995 Dec 29;774: Increases bioavailable IGF-1 Morales AJ, J Clin Endocrinol Metab Jun;78(6): Counteracts high cortisol level/effects Kroboth PD, J Clin Psychopharmacol Feb;23(1):96-9 Increases natural killer cell number and activity Casson, P Am J. Obstet Gynecol 169: Reduces inflammatory markers (IL-6, TNF- ) Daynes RA, J Immunol 1993 Jun 15;150(12): Beneficial in ulcerative colitis and Crohns disease Andus T, Aliment Pharmacol Ther :

39 DHEA for SLE SLE patient have very low DHEAS levels Given by prescription as Prasterone Increases IL-2 and reduces SLE disease activity Petri MA, Arthritis Rheum Sep;50(9): Allows reduction in steroid dose. Petri MA, Arthritis Rheum Jul;46(7): Suppresses IL-10, a cytokine that increases autoantibody production in Lupus Chang DM, Ann Rheum Dis Dec;63(12): Improves well-being, sexuality, and cognition in women with Lupus or adrenal insufficiency Arlt W, Endocr Res Nov;26(4): Nordmark G, Autoimmunity Nov;38(7):

40 TNF-α and Adrenal Hormones TNF-α is an inflammatory cytokine that is elevated in autoimmune diseases. Better cortisol and DHEAS levels suppress TNF-α levels. TNF-α suppresses cortisol and DHEAS production more inflammation, vicious cycle Anti-TNF-α drugs increase cortisol and DHEAS levels. Straub RH, Arthritis Rheum Apr;58(4): Arthritis Rheum Jun;48(6): , Ernestam S, J Rheumatol Jul;34(7):

41 Steroids in Rheumatic Disease Doctors view steroids as drugs, not hormones Long-term, low-dose treatment is actually hormone replacement (prednisone 7.5mg, Medrol 6mg) Low-dose prednisone (7.5mg/d) generally safe Da Silva JA, Ann Rheum Dis Mar;65(3): Short-term, high dose treatment is pharmacologicalfor disease suppression. Hydrocortisone preferred, but short-acting, long- acting tablets under development Prednisone/prednisolone are closest in structure to cortisol, but have more negative effects.

42 DHEA in Rheumatic Diseases Taking oral steroids drastically reduces DHEA levels DHEA prevents side effects of steroids and reduces pain and inflammation All patients on steroids should be given DHEA. Straub RH, Z Rheumatol. 2000;59 Suppl 2:II/ Best taken sublingually 2x/day, mg/day for women, 25 to 50mg/day for men. (Life Extension, dissolve-in-the-mouth 25mg tablets) Women may experience pimples, oily skin initially Start with low dose and work up gradually

43 Vitamin D A powerful hormone with anti-inflammatory effects Vit. D levels low in SLE patients, contributing to inflammation. Supplementation improves immune system abnormalities. Cutolo M, Lupus 2008;17(1):6-10. Kamen D, Aranow C. Curr Opin Rheumatol Sep;20(5): Higher Vit. D levels assoc. with lower TNF-α. Peterson CA, J Inflamm (Lond) Jul 24;5:10. Levels must be >30ng/ml for significant benefit Optimal levels 55-70ng/ml, usually requires 4000IU Vit. D3 daily.

44 Fish OilsOmega-3 Fatty Acids Decrease the production of inflammatory eicosanoids, cytokines, and reactive oxygen species. Calder PC. Am J Clin Nutr Jun;83(6 Suppl):1505S-1519S. Reduce TNF- α levels. Fetterman JW Jr, Am J Health Syst Pharm Jul 1;66(13): Improve SLE disease activity and have cardiovascular benefits. Duffy EM, J Rheumatol Aug;31(8): Wright SA, Ann Rheum Dis Jun;67(6): Proven to be beneficial in Rheumatoid Arthritis. Proudman SM, Rheum Dis Clin North Am May;34(2): Dose: 1500 to 3000mg EPA +DHA daily

45 Sex Hormones in Autoimmune Diseases Low testosterone and progesterone levels seen in men and women with RA. Testosterone and progesterone have immunosupressive effects. Wilder RL. J Rheumatol Suppl Mar;44:10-2. Schust DJ, Hum Reprod May;11(5): RA and MS improve during pregnancy worsen during breast feeding (low progesterone/estrogen). Higher testosterone levels helpful in autoimmune diseases that affect women>men Estrogen and testosterone beneficial in MS. Gold SM, Prog Brain Res. 2009;175:

46 Not Just Sex Hormones Estradiol, progesterone, testosterone and DHEA are required for the function, growth, and maintenance, of all tissues in both sexes! Maintain brain function and health neurosteroids affect mood, cognition, memory, pain, etc. Maintain the immune systemprogesterone and testosterone are mild immunosuppressants Maintain connective tissue: skin, hair, bone, muscle Improve insulin sensitivity: prevent diabetes, fatty liver Reduce blood pressureimprove endothelial function Prevent atherosclerosis (plaques in arteries)

47 Speroff L, Fritz M Clinical Gynecologic Endocrinology and Fertility, 7 th Ed. 30

48 Osteoporosis In menopause 5% bone loss each year for first 5 years=25%due to loss of estrogen! 20 yrs. post menopause50% 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, 7 th Ed.

49 Osteoporosis Prevention and Treatment A hormone deficiency diseasethe proper prevention and treatment is hormone restoration. Estradiol prevents resorption of old bone while testosterone, progesterone, DHEA and GH build new bone. Raisz LG, J Clin Endo Metab. 1996; 81: Barrett-Connor E, J Reprod Med Dec;44(12): Hormone restoration including Vit. D increases bone density better than bisphosphonates and preserves normal bone remodeling Women on prednisone 5 to 15mg/day gained bone mass with either estradiol/progesterone or DHEA replacement. Lukert BP, J Bone Miner Res Sep;7(9): Mease PJ, J Rheumatol Apr;32(4):

50 Estradiol Restoration Eliminates hot flashes, restores sleep Restores cognitive function and mood Maintains thickness, fullness of skin and hair Maintains genital/pelvic health-helps with vaginal lubrication, incontinence, bladder infections Protects against colon cancer and macular degeneration Protects against dementia Prevents atherosclerosis, hypertension Improves insulin sensitivityprevents diabetes Prevents osteoporosis and osteoarthritis Must be accompanied by progesterone

51 Female Hormone Replacement: Risks? WHI study showed that Premarin and Provera have serious risks. However, only oral estrogens (Premarin, BCPs) increase blood clotting (DVTs, stroke), transdermal estradiol does not. Canonico M, ESTHER study. Circulation Feb 20;115(7):840-5 Provera increases breast cancers and heart attacks, progesterone does not.

52 E3N-EPIC Study E2 plus progesterone: no increased risk of breast cancer! Int J Cancer Apr 10;114(3): Cohort study 55,000 women 8 years f/u c/w WHI-- 16,000, 6 yr. f/u TD-E2=transdermal estradiol Similar study: estradiol + progesterone 0.4; estradiol + synthetic progestin 0.94 Espié, Gynecol Endocrinol Jul;23(7): No HRT

53 Female Andropause Young womans free testosterone level is 2x her free estradiol DHEAS declines with agemain source of androgen effect in women Female testosterone levels decline 50% between age 20 and 45. Oral estrogens and birth control pills reduce free testosterone and DHEAS levels

54 Testosterone for Women Improves energy and mood Improves sexual desire and sensation Increases muscle and tissue strength With estradiol, increases bone density J Reprod Med Dec;44(12): Probably decreases risk of heart attack J Womens Health Sep;7(7):825-9 Opposes estradiol-induced breast stimulation and reduces risk of breast cancer Menopause Jul-Aug;10(4):292-8, Endocr Rev Jun;25(3): Menopause Sep-Oct;11(5):531-5, FASEB J Sep;14(12):

55 Andropause in Men

56 Testosterone Restoration for Men Improves mood and sociability Restores energy and ambition Improves cognition, protects against Alzheimers disease Increases libido and sexual performance Increases muscle and bone mass Reduces abdominal fat, improves insulin sensitivity, lowers blood pressure-- counteracts metabolic syndrome (Syndrome X)

57 Testosterone and the Heart Low testosterone levels correlate with coronary artery disease and stroke Arterioscler Thromb. 1994; 14: Eur Heart J 2000; 21; 890–4 Int J Cardiol Jan 31;63(2):161-4 Arterioscler Thromb Vasc Biol Jun;16(6): Testosterone dilates coronary arteries improves angina T increases heart muscle size, strength T decreases fibrinogen levelsprevents blood clots Endocr Res. 2005;31(4):335-44

58 Testosterone and the Prostate Lower testosterone levels increase the risk of prostate cancer. Endogenous sex hormones and prostate cancer: a collaborative analysis of 18 prospective studies. J Natl Cancer Inst Feb 6;100(3):170-83, also Morgenthaler A, Urology 2006;68: Testosterone supplementation does not increase the risk of prostate cancer. Morgentaler A, Testosterone replacement therapy and prostate risks: where's the beef? Can J Urol Feb;13 Suppl 1:40-3 Low testosterone associated with more aggressive prostate cancers Slater S, Drugs Aging 2000 Dec;17(6):431-9 Testosterone promotes prostate growth to a point, but does not promote prostate cancer. Prostate cancer growth can be temporarily slowed only by eliminating testosterone from the body.

59 Growth Hormone Declines 14% per decade after age 25 IGF-1 of many adults equal to hypopituitary patients (only vs. Deficiency heart disease, frailty, depression, body fat, bone loss GH restoration for GH-deficient adults: Improves cognition, mood, sleep, energy, stamina reduces abdominal fat lowers blood sugar, cholesterol, and blood pressure Increases muscle mass Improves bone density, skin thickness Downside: $200/mo. for low dose, daily injections

60 Approach to Rheumatic Diseases First, diagnose and treat adrenal, sex hormone, and thyroid deficiencies Cortisol and prednisone can be taken long- term in low doses and accompanied by DHEA. Optimize Vit D and Fish oil intake Pharmaceuticals as needed in consultation with rheumatologist

61 For More Information The Hormone SolutionStay Younger Longer Thierry Hertoghe, MD The Miracle of Natural Hormones David Brownstein, MD How to Achieve Healthy AgingLook, Live, and Feel Fantastic After 40 Neal Rouzier, MD Life Extension Foundation (www.lef.org) Information and hundreds of abstracts at Contact me:


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