Bioidentical Hormone Restoration

Best Medical Practice

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Hormone RestorationMedically 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, TestosteroneEssential to all tissues in both sexes! Brain functionImmune systemBlood vessel healthBlood lipids, clotting factorsConnective tissue—skin, hair, muscle, bone

Cortisol, DHEA,Aldosterone, Pregnenolone

Estradiol, ProgesteroneTestosterone

Testosterone

InsulinAdrenalin

T4, T3

GH, FSH, LH,TSH, and ACTH

control other glands

CRH, TRH, etc. control pituitary

Bioidentical Hormones are NOT Drugs

Inherently safe, Non-toxicProper fit in receptors, easily eliminatedNo allergic reactionsNo “side effects”Monitor dose with usual blood testsOnly potential problems:

Excessive doseLack of balance with other hormonesUnphysiological delivery: route, timing, etc.

The Tyranny of the Lab Report

Reference Range=95% of the populationNOT the optimal range for any personMale 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 symptomsBelow RR (<97.5%): replace to within-RRDisease/No Disease instead of Continuum

Hypometabolism—Thyroid and Cortisol Insufficiencies

Thyroid sets throttleCortisol delivers the fuelInsufficiencyreduced metabolic ratefatigue, brain dysfunction, depression, painUsual tests are insensitive Optimization improves health and quality of life

CortisolAdrenal 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 hormonesModerate-to-severe—cortisol restorationLow physiological doses are safe40 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 arteriesReduces tendency to form blood clotsRelieves depressionHelps weight loss

Continuum:Weight vs. Free T4 Within the RR

J Clin Endocrinol Metab July 2005, 90(7):4019-4024

Thyroid InsufficiencyMental fogFatigue, depression, anxietyCold extremitiesAches and painsHair loss, esp. in womenWeight gainConstipationPuffy ankles and faceElevated cholesterol

Diagnosing Thyroid Insufficiency

Signs and Symptoms plus free T4 or free T3 levels below mid-point of RRHigh TSH = thyroid gland failure Normal/Low TSH = H-P dysfunctionTrial 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 symptomsPeople 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?

DHEA-S Levels with AgeAdrenopause

Growth Hormone (GH) Somatopause

J Clin Endocrinol Metab 1999; 84(6):2013-2019

Free T3

Endocr Rev. 1995 Dec;16(6):686-715

Thyropause

Male Andropause—Testosterone

Baltimore Longitudinal Study of Aging (BLSA). Harman et al., 2001

Andropause vs. Menopause

pg/ml

DHEA-S 5,000,000pg/ml Cortisol 100,000 pg/ml!

0

1 0 0 0

2 0 0 0

3 0 0 0

4 0 0 0

5 0 0 0

6 0 0 0

7 0 0 0

8 0 0 0

Y o u n g O l d Y o u n g O l d

T

P

E

♀ ♀♂ ♂

Men WomenProgesterone

averageTestosterone

Estradiol

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 ViewAging 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 KillersCardiovascular 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 70Surgical menopause 2-7x risk of heart attacks Engl J

Med 1987 Apr 30;316(18):1105-10Am J Obstet Gynecol. 1981 Jan;139(1):47-51.

DHEA—Most Abundant SteroidPrecursor of testosterone and estradiolLower levels assoc. with risk of death, diseaseAnabolic—builds tissues, improves immunityReduces pain by increasing endorphinsAnti-inflammatoryImproves immune system functionAnti-atherosclerotic Reduces platelet aggregation--blood clottingAnti-cancer effects

Male Andropause:“Just Gettin’ Old”

Testosterone levels decline slowly FatigueReduced mental functionPassivity and moodinessLoss of muscle and bone massIncreased abdominal fatLoss of libido, no spontaneous morning erections

Testosterone is Your FriendImproves 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 HeartLow 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 arteriesT improves endothelial functionT increases heart muscle size, strengthT decreases fibrinogen levels—prevents blood clots Endocr Res. 2005;31(4):335-44

Testosterone Does Not Cause Prostate CancerTestosterone 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 AgingTestosterone 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 differentiationDifferentiated cells can’t become cancersHigh 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

Menstrual Cycle

Ovulation

Perimenopause Luteal Insufficiency=Estrogen Dominance

Menstrual Cycle

Inadequate Luteal Phaseshorter periods, early spotting

Ovulation

PerimenopauseAnovulation with Estrogen Dominance

Menstrual Cycle

High estrogen, low progesterone

’d risk of cancer

Menopause

Estrogen and Progesterone Deficiency

Imbalance: Estrogen DominanceAllergies

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 dominanceAnovulation no progesterone estrogen dominancebreast and uterine cancer

Menopause: Estradiol DeficiencyIrritability, depression, insomnia, ’d risk of Alzheimer’s dz.Fatigue, aches and painsGenital atrophyLoss of libidoAtrophy and wrinkling of skin BP, LDL cholesterol, heart diseaseOsteoporosis

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, moodReduces anxietyImproves sexual functionIncreases 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 fractures14% 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.

Osteoporosis

A hormone deficiency disease (incl. Vit. D)Estradiol controls resorption of old boneTestosterone, 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

Testosterone Estradiol

Progesterone Cortisol

DHEA

Do Not Substitute

ComplexInteractive

System

“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 estrogen-like 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

Estradiol-17β Dihydroequilin-17β

CEE contains at least 10 estrogens, only 3 are found in humans. CEE is similar to human estrogens and has similar benefits.

Human Horse

The Problems with Oral Estrogens

First-pass effect on the liverIGF-1 (growth hormone), SHBG, CRPclotting factorsblood clots and strokes Transdermal estradiol has none of these effects—does not cause blood clots!

Circulation. 2007 Feb 20;115(7):840-5

Estradiol Ethinyl Estradiol

EE cannot be inactivated by normal oxidation!EE does not interact with estrogen receptor !

Oral EE is more thrombogenic than Premarin or estradiol

Birth Control Pills: Very Unnatural

Acetylene

The BIGGEST Problem: Progestins

Progesterone MPA (Provera) Megestrol

Many Doctors Do not Know the Difference!

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 stimulation

of breasts• 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

stimulation of breasts• Increases risk of breast cancer

Scientific studies show that:

Progestin Zoo

Kuhl, Climacteric 2005;8(Suppl 1)

Progesterone

Provera

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 DiseaseMy 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

E3N-EPIC Cohort study Int J Cancer. 2005 Apr 10;114(3):448-54

55,000 women8 years f/uc/w WHI--16,000, 6 yr. f/u

TD-E2=Transdermal Estradiol

No Hormones

More Progesterone=Less Breast Cancer

ORDET Study: Int. J. Cancer 112 (2004) (2), pp. 312–318. See also Cancer Causes Control. 2004 Feb;15(1):45-53.

6,000 women5 yr. F/U

More Progesterone

Less Breast Cancer

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 CancerMy 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 WomenKeeping 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 HRCost—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, MDThe Hormone Solution—Stay Younger Longer Thierry Hertoghe, MD Life Extension Foundation: www.lef.orgHormonerestoration.com. Henry@hormonerestoration.comOffice: 570-836-0359