Bioidentical Hormone Restoration Best Medical Practice

1
Bioidentical Hormone RestorationBest Medical
Practice

• This presentation is available online.

2
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

3
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
4
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.

5
Hormone IgnoranceThe Tyranny of the Lab Report

• Reference Range95 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 (lt97.5) replace to within-RR

6
HypometabolismThyroid and Cortisol
Insufficiencies

• Thyroid sets throttle (metabolic rate)
• Cortisol delivers the fuel (glucose)
• Optimal levels of both are required for health
• Even mild deficiencies?reduced cellular
  metabolism?fatigue, brain dysfunction,
  depression, pain, and disease
• Usual lab tests and ranges (TSH, AM cortisol) are
  insensitive
• Underdiagnosis, Undertreatment

7
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

8
Normal Saliva Cortisol Profile
9
Common Dysfunctional Pattern
10
Cortisol Insufficiency
11
Addisons Disease
12
Cortisol Restoration

• Mild insufficiencyimproves with
• ?stress, ?rest, and ?nutrients
• Moderate-to-severe insufficiencyrequires
  cortisol restoration
• Low physiological doses are safe
• 40 years experience see Dr. Jeffries Safe Uses
  of Cortisol

13
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

14
Continuum Higher Thyroid Hormone Levels within
the RRs

• Reduced risk of severe atherosclerosis by 50
  Clin Cardiol. 2003
  Dec26(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

15
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 Patients doses lowered by 30-50
• TSH normalizing T4 dose?low free T3,
  persistence of symptoms, weight gain
• Symptomatic persons with within-RR labs often
  improve with T3/T4 optimization

16
Cortisol and Thyroid Optimization

• Any Questions?

17
The Big Controversy

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

18
DHEAThe Most Abundant Steroid Hormone In our
Bodies

• Precursor of testosterone and estradiol
• Lower levels assoc. with ?risk of death, disease
• Anabolicbuilds tissues, improves immunity
• Reduces pain by increasing endorphins
• Anti-inflammatoryapproved for SLE
• Improves immune system function
• Anti-atheroscleroticmay prevent heart disease
• Reduces platelet aggregation Ann N Y Acad Sci.
  1995 Dec 29774281-90
• Anti-cancer effects in animal studies

19
DHEA-S Levels with Age
Adrenopause
20
Growth Hormone (GH)
Somatopause
Clinical Chemistry 48, No. 12, 2002
21
Thyropause
Free T3
Endocr Rev. 1995 Dec16(6)686-715
22
Male AndropauseTestosterone
Baltimore Longitudinal Study of Aging (BLSA).
Harman et al., 2001
23
Andropause vs. Menopause
Men Women
Testosterone
Progesterone average
pg/ml
Estradiol
?
?
?
?
DHEA-S 5,000,000pg/ml Cortisol 100,000 pg/ml!
24
Conventional View of Aging

• The loss of hormones is adaptive
• Higher levels cause heart attacks, cancers of the
  breast and prostate
• Fits Pharmaceutical Agenda Dont restore hormone
  levels Take drugs for all problems caused by
  loss of hormones.

25
Gonadal SteroidsNot Just Sex Hormones

• Estradiol, Progesterone, Testosterone
• Essential to all tissues in both sexes!
• BrainImprove function, protect against
  Alzheimers Dz.
• Immune System
• Heart and blood vessel health
• Blood lipids, clotting
• Connective tissuesskin, muscle, bone

26
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 Alzheimers Disease

27
Estrogen Replacement Prevents Alzheimers Disease
Zandi PP, et al., Cache County Study. JAMA. 2002
Nov 6288(17)2123-9.
28
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
  30316(18)1105-10 Am
  J Obstet Gynecol. 1981 Jan139(1)47-51.

29
Menopause and Cardiovascular Disease
30
Speroff L, Fritz M Clinical Gynecologic
Endocrinology and Fertility, 7th Ed.
31
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.

32
Male AndropauseJust 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, ?Alzheimers
  Disease, ?autoimmune dz.

33
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.

34
Hormones and Aging

• Any Questions?
• Coming up Male and Female Hormone Replacement

35
Testosterone is Mans Best 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 X

36
Testosterone is Good for your Heart

• Low testosterone levels associated 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

37
Testosterone Does Not Cause Prostate Cancer

• Testosterone promotes prostate growth to a point.
  
• Castration slows prostate cancer growth
  temporarily.
• Higher T levels dont increase risk of prostate
  cancer.
• Testosterone restoration does not increase the
  risk of prostate cancer.
• Low T levels associated with more aggressive
  prostate cancers.

38
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

39
Testosterone For Men

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

40
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.

41
EstrogenProgesterone Complementarity in Women

• Estrogen promotes tissue proliferation and growth
  which can lead to cancer
• Progesterone inactivates estrogen, stops
  proliferation and promotes differentiation
• Differentiated cells cant become cancers
• High average progesterone/estrogen ratio prevents
  breast, uterine cancers

42
Normal Cycle and Balance
Ovulation
Menstrual Cycle
43
Perimenopause Luteal InsufficiencyEstrogen
Dominance
Inadequate Luteal Phase shorter periods, early
spotting
Ovulation
Menstrual Cycle
44
Perimenopause Anovulation with Estrogen Dominance
High estrogen, low progesterone ?d risk of cancer
Menstrual Cycle
45
Menopause
Estrogen and Progesterone Deficiency
46
(No Transcript)
47
Estrogen Dominance Progesterone Deficiency

• 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

48
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 Alzheimers disease
• Reduces blood sugar, blood pressure
• Improves energy, reduces aches

49
Testosterone for Women

• Female testosterone levels decline 50 between
  age 20 and 45.
  
  Menopause. 2003 Sep-Oct10(5)390-8
• Improves energy, mood
• Improves libido, sexual sensation
• Increases muscle strength, stamina
• Increases bone density J Reprod Med. 1999
  Dec44(12)1012-20
• Probably decreases risk of heart attack
  
  Womens
  Health. 1998 Sep7(7)825-9

50
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
  8137-43
  J
  Reprod Med. 1999 Dec44(12)1012-20
• Combined hormone restoration increases bone
  density much better than Fosamax? and preserves
  normal bone remodeling

51
Perimenopause and Menopause and Their Disorders

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

52
So Why is Everyone Saying that Hormone
Replacement is Dangerous?
Q What hormones? Given how?
53
Bioidentical Human Steroid
Hormones
Complex Interactive System
Estradiol
Testosterone
DHEA
Do Not Substitute
Progesterone
Cortisol
54
HRT has Always been Hormone Substitution!

• Pregnant mares 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!

55
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 long-term benefits.
56
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
57
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 effects
  and does not cause blood clots!
  Circulation. 2007 Feb 20115(7)840-5

58
The BIG Problem with HRT Progestins
Progesterone MPA (Provera?)
Megestrol
?
Many Doctors Do not Know the Difference!
59
Progesterone ? Provera?
Scientific studies show that

• Maintains pregnancy Causes
  birth defects
• Improves mood Can
  cause depression
• Improves sleep Insomnia, irritability
• Diuretic Fluid retention
• Lowers blood sugar Raises blood sugar
• Maintains estradiol-induced Reduces
  estradiol-induced arterial dilation arterial
  dilation
• Improves lipid profile Worsens lipid profile
• Prevents heart attacks Causes heart attacks
• Reduces estrogenic breast Increases estrogenic
  breast stimulation stimulation
• Decreases risk of breast cancer Increases
  risk of breast cancer

60
Progestin Zoo
Progesterone
Provera?
Kuhl, Climacteric 20058(Suppl 1)
61
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

62
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

63
Cardiovascular DiseaseMy 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 Strategymaintain youthful
  levels of natural sex-steroid hormones!
• But wont that increase the risk of breast cancer?

64
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!

65
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
66
More ProgesteroneLess Breast Cancer
More Progesterone
6,000 women 5 yr. F/U
Less Breast Cancer
ORDET Study Int. J. Cancer 112 (2004) (2), pp.
312318. See also Cancer Causes Control. 2004
Feb15(1)45-53.
67
More Evidence

• Estradiol cream applied to the breast induces
  proliferation, adding progesterone reduces
  proliferation to baseline Fertil
  Steril 1995 63785-91
• 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

68
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
• 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.
  199216(1)31-8(review)

69
Breast CancerMy 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.

70
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.

71
What Your OB/GYN is Told

• ACOG NEWS RELEASE October 31, 2005The 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

72
HRT, Breast Cancer, Strokes, and Heart Attacks

• Any Questions?

73
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 and disorder!

74
Why Use Compounded Hormones?

• FAR less expensive than FDA-approved bioidentical
  products (10-30 vs. 200/mo.)
• More convenient
• Individualized
• Physiological deliveryprogesterone
• Reliable Compounding pharmacies are PCCA
  members standardized materials and procedures
  (http//www.pccarx.com)

75
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

76
Doing HR

• Physician feeaccording to time
• Forms available online
• Initial visit order blood tests, saliva cortisol
• F/U visits Review resultsprescriberetest
• F/U testing blood, not saliva
• Office visit every 6 months, test only as needed.
• Telephone Consultssame hourly rate
• E-mailNo charge for brief responses

77
Costs

• Physician time only as required--first year
  200-500 then lt200/yr.
• No Medicare or insurance billing may submit
  claim for recognized diagnosis
• Hormones10 for 1 hormone, to 80/month for all,
  covered by insurance
• Diurnal salivary cortisol test120
• Blood testsinsurance pays, lab kits 170-220,
  Saliva/blood kit299
• Out-of-pocket expenses tax-deductible

78
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 (articles, abstracts)
• Henry_at_hormonerestoration.com
• Office 570-836-0359