Bioidentical Hormone Restoration Best Medical Practice

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Bioidentical Hormone RestorationBest Medical
Practice

• This presentation is available online.

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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

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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

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Gonadal SteroidsNot 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 tissueskin, hair, muscle, bone

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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
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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.

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The Tyranny of the Lab Report

• Reference Range95 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 (lt97.5) replace to within-RR
• Disease/No Disease instead of Continuum

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HypometabolismThyroid and Cortisol
Insufficiencies

• Thyroid sets throttle
• Cortisol delivers the fuel
• Insufficiency?reduced metabolic rate?fatigue,
  brain dysfunction, depression, pain
• Usual tests are insensitive
• Optimization improves health and quality of life

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Cortisol

• Adrenal glands
• Maintains blood sugar (delivers the fuel)
• Modulates immune system, brain function
• Need higher amounts with stress, disease
• Too much?Diabetes, HTN, osteoporosis
• Too little?hypoglycemia, fatigue, depression,
  aches, autoimmune diseases, allergies
• Insufficiency more prevalent than excess!

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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

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Normal Saliva Cortisol Profile
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Cortisol Insufficiency
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Common Dysfunctional Pattern
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Cortisol Restoration

• Mild? stress, ?rest, nutrients, other hormones
• Moderate-to-severecortisol restoration
• Low physiological doses are safe
• 40 years experience see Dr. Jeffries Safe Uses
  of Cortisol

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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

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Continuum Higher Thyroid Hormone Levels within
the RRs

• 50 reduction in severe atherosclerosis
  
  Clin Cardiol. 2003
  Dec26(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

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ContinuumWeight vs. Free T4 Within the RR
J Clin Endocrinol Metab July 2005,
90(7)4019-4024
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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

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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

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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 dose?low free T3, weight
  gain, persistence of symptoms
• People with fatigue, fibromyalgia, and depression
  often improve with T3/T4 optimization

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Cortisol and Thyroid Optimization

• Any Questions?

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The Controversy

• What do we do about hormones lost to normal aging?

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DHEA-S Levels with Age
Adrenopause
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Growth Hormone (GH)
Somatopause
J Clin Endocrinol Metab 1999 84(6)2013-2019
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Thyropause
Free T3
Endocr Rev. 1995 Dec16(6)686-715
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Male AndropauseTestosterone
Baltimore Longitudinal Study of Aging (BLSA).
Harman et al., 2001
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Andropause vs. Menopause
Men Women
Testosterone
Progesterone average
pg/ml
Estradiol
?
?
?
?
DHEA-S 5,000,000pg/ml Cortisol 100,000 pg/ml!
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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.

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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.

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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 30316(18)1105-10
• Am J Obstet Gynecol. 1981 Jan139(1)47-51.
  

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DHEAMost Abundant Steroid

• Precursor of testosterone and estradiol
• Lower levels assoc. with ? risk of death, disease
• Anabolicbuilds tissues, improves immunity
• Reduces pain by increasing endorphins
• Anti-inflammatory
• Improves immune system function
• Anti-atherosclerotic
• Reduces platelet aggregation--blood clotting
• Anti-cancer effects

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Male AndropauseJust 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

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Testosterone is Your Friend

• Improves mood and sociability
• Improves energy
• Improves cognition, protects against Alzheimers
  disease Neurology. 2004 Jan 2762(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

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Testosterone is Good for your Heart

• Low testosterone levels correlate with coronary
  artery disease and stroke
• Arterioscler Thromb. 1994
  14701-706
• Eur Heart J 2000 21 8904
• Int J Cardiol. 1998 Jan
  3163(2)161-4
• Arterioscler Thromb Vasc
  Biol. 1996 Jun16(6)749-54
• T dilates coronary arteries
• T improves endothelial function
• T increases heart muscle size, strength
• T decreases fibrinogen levelsprevents blood
  clots Endocr Res. 200531(4)335-44

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Testosterone Does Not Cause Prostate Cancer

• Testosterone promotes prostate growth to a point.
  
• Castration slows prostate cancer growth
  temporarily.
• Men with higher T levels dont 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.

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Wheres 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 Feb13 Suppl 140-3

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Hormones and AgingTestosterone For Men

• Any Questions?
• Coming up Estradiol, Progesterone, and
  Testosterone for Women

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Female EndocrinologyBalance 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.

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EstrogenProgesterone Complementarity in Women

• Estrogen promotes tissue proliferation and growth
  
• Progesterone stops proliferation and promotes
  differentiation
• Differentiated cells cant become cancers
• High average progesterone/estrogen ratio prevents
  cancers

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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
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Normal Cycle and Balance
Ovulation
Menstrual Cycle
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Perimenopause Luteal InsufficiencyEstrogen
Dominance
Inadequate Luteal Phase shorter periods, early
spotting
Ovulation
Menstrual Cycle
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Perimenopause Anovulation with Estrogen Dominance
High estrogen, low progesterone ?d risk of cancer
Menstrual Cycle
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Menopause
Estrogen and Progesterone Deficiency
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Imbalance Estrogen Dominance

• Breast cancer
• Ovarian cancer
• Uterine cancer
• Thyroid dysfunction
• Gallbladder disease
• Heavy/painful menses
• Migraines
• Seizures
• Endometriosis

• Allergies
• Autoimmune disease
• Anxiety, irritability
• Insomnia
• Decreased sex drive
• Depression
• Bloating and edema
• Fibrocystic breasts
• Uterine fibroids

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Perimenopause is Dangerous

• Females born with a fixed no. of oocytes (eggs)
• Aging ? fewer oocytes of lower quality are
  left?reduced progesterone production?estrogen
  dominance
• Anovulation ?no progesterone? estrogen
  dominance?breast and uterine cancer

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Menopause Estradiol Deficiency

• Irritability, depression, insomnia,
• ?d risk of Alzheimers dz.
• Fatigue, aches and pains
• Genital atrophy
• Loss of libido
• Atrophy and wrinkling of skin
• ?BP, ? LDL cholesterol, ?heart disease
• Osteoporosis

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Female Andropause

• Female testosterone levels decline 50 between
  age 20 and 45.
• Menopause. 2003 Sep-Oct10(5)390-8
• Birth control pills and menopausal HRT? 25 to 40
  ? in free testosterone and DHEAS levels
  Obstet
  Gynecol. 1997 Dec90(6)995-8
• DHEA declines with agemain source of androgens

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Testosterone for Women

• Improves energy, mood
• Reduces anxiety
• Improves sexual function
• Increases muscle strength, stamina
• Increases bone density
• J Reprod Med. 1999 Dec44(12)1012-20
• Probably decreases risk of heart attack
• J Womens Health. 1998 Sep7(7)825-9

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

• In menopause 5 of bone mass is lost each year
  for first 5 years25
• 50 of women gt65 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.
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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 8137-43
• J Reprod Med. 1999 Dec44(12)1012-20
• Combined hormone restoration increases bone
  density better than Fosamax? and preserves normal
  bone remodeling

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Perimenopause and Menopause and Their Disorders

• Any Questions?
• Coming
• The Problems with HRT
• Breast Cancer, Strokes, and Heart Attacks

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So Why is Everyone Saying that Hormone
Replacement is Dangerous?
Q What hormones? Given how?
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Bioidentical Human Steroid
Hormones
Complex Interactive System
Estradiol
Testosterone
DHEA
Do Not Substitute
Progesterone
Cortisol
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HRT has Always been Hormone Substitution!

• Pregnant mares 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!

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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!

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Premarin? Close, but Not Human
Human Horse
Estradiol-17ß
Dihydroequilin-17ß
CEE contains at least 10 estrogens, only 3 are
found in humans. CEE is similar to human
estrogens and has similar benefits.
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The Problems with Oral Estrogens

• First-pass effect on the liver??IGF-1 (growth
  hormone), ?SHBG, ?CRP
• ?clotting factors?blood clots and strokes
• Transdermal estradiol has none of these
  effectsdoes not cause blood clots!
• Circulation. 2007 Feb 20115(7)840-5

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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
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The BIGGEST Problem Progestins
Progesterone MPA (Provera?)
Megestrol
?
Many Doctors Do not Know the Difference!
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Progesterone ? Provera?
Scientific studies show that

• 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

• 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

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Progestin Zoo
Progesterone
Provera?
Kuhl, Climacteric 20058(Suppl 1)
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2002 WHI Study HRT is Dangerous!

• gt30 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 dementiaprobably vascular in
  origin

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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
  Dec6(4)293-301.

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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 Strategymaintain youthful
  levels of sex-steroid hormones!

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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
  Jul96(2)95-108.

Thats the conservative interpretation of the
evidence!
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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-E2Transdermal Estradiol
E3N-EPIC Cohort study Int J Cancer. 2005 Apr
10114(3)448-54
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More ProgesteroneLess Breast Cancer
6,000 women 5 yr. F/U
Less Breast Cancer
More Progesterone
ORDET Study Int. J. Cancer 112 (2004) (2), pp.
312318. See also Cancer Causes Control. 2004
Feb15(1)45-53.
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Many Kinds of Evidence

• Progesterone prevents estradiol-induced breast
  tumors in rats as well as Tamoxifen?
• Jpn J Cancer Res. 1985 Aug76(8)699-704
  
• Premenopausal women with low P levels had 5.4
  times greater risk of early breast cancer
• Am J Epidem 1981 114209-17
  
• Breast cancer victims have signs of progesterone
  resistance
• Br J Obstet Gynaecol. 1998
  Mar105(3)345-51.

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More Evidence

• Estradiol cream applied to the breast induces
  proliferation, adding progesterone reduces
  proliferation to baseline
  
  Fertil Steril 1995 63785-91
• Estradiol upregulates cancer-promoting gene
  bcl-2, progesterone downregulates it.
• Ann Clin Lab Sci. 1998
  Nov-Dec28(6)360-9
• In vitro adding progesterone eliminates
  estradiol-induced proliferation and cancers in
  normal breast cells
• Eur J Cancer. 2000 Sep36 Suppl 4S90-1
• J Steroid Biochem Mol Biol. 2000
  Jun73(3-4)171-81

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Testosterone Prevents Breast Cancer in
Estradiol-Replete Women

• Testosterone opposes estradiol-induced breast
  stimulation. Menopause. 2003
  Jul-Aug10(4)292-8
• Endocr Rev. 2004 Jun25(3)374-88.
• FASEB J. 2000 Sep14(12)1725-30.
• Addition of testosterone to estrogen/progestin
  reduces breast cancer incidence to baseline.
• Menopause. 2004 Sep-Oct11(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.
  199216(1)31-8(review)

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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.

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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.

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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

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Wyeth Corp. PropagandaWhat 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!
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HRT, Breast Cancer, Strokes, and Heart Attacks

• Any Questions?

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What Else Can Hormone Restoration Help?

• Infertility, PMS, heavy bleeding
• Headaches and insomniaalmost always
• Heart failure, angina
• Mental disorders
• Autoimmune diseases (SLE, rheumatoid arthritis,
  ulcerative colitis, Crohns, etc.)
• Intra-abdominal fat (pot belly)
• Allergies, skin diseases
• Every disease/disorder?!

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Doing HR

• CostHourly rate
• Forms available online
• Initial visit order tests
• F/U visits Review resultsprescriberetest
• Repeat until stabilized at proper dose
• Follow-up office visit every 6 months, test only
  as needed.
• Telephone Consultssame hourly rate
• E-mailusually no charge

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For More Information

• The Miracle of Natural Hormones
  David Brownstein, MD
• How to Achieve Healthy AgingLook, Live, and Feel
  Fantastic After 40 Neal Rouzier, MD
• The Hormone SolutionStay Younger Longer Thierry
  Hertoghe, MD
• Life Extension Foundation www.lef.org
• Hormonerestoration.com.
• Henry_at_hormonerestoration.com
• Office 570-836-0359