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Bio-Identical Hormone Replacement Therapy
Bio-Identical Hormone Replacement Therapy
Credit

Debbie L. Brinkman, CMA
Credit

Debbie L. Brinkman, CMA

Dr. Julie Marchiol, DC, FIMA
Growing old is not for sissies
Be prepared !!
Bio-Identical Hormone Replacement Therapy

Goal is to replace and restore natural
hormones that decrease as we age to
optimum levels
Improve one's well being and quality of life
Promote a longer and healthier life span: the
essence of preventive and restorative medicine
Bio-Identical Hormone Replacement Therapy

Prescribe only natural hormones that are
made by our human body for our body
Molecular structure is biologically identical
to the hormones found in the human body
Vital steroid hormones are derived from soy
and yam oils
Bio-Identical Hormone Replacement Therapy

1999-2000
Bio-Identical Hormone Replacement Therapy

2003-2010 offered BHRT, weight loss, and
sexual dysfunction to my patients
Outsourced through an independent Ob-Gyn
Wonderful synergy with cosmetic surgery
practice with various anti-aging modalities
Longevity and preventive medicine is a natural
extension of cosmetic surgery
Optimized surgical healing and recovery
Bio-Identical Hormone Replacement Therapy

Sense of Well Being
Improved Libido

Improved Health
Prevention of Medical
Diseases
Bio-Identical Hormone Replacement With
Testosterone Pellet Therapy

August 17-19, 2012
September 7-9, 2012
October 19-21, 2012
Anti-Aging Clinic
BHRT
Nutrition
Weight Management
Stress Reduction
Exercise
Cardiac Health
Anti-inflammatory
Management

Osteoporosis
Antioxidants
Detoxification
Nutraceuticals
Supplements
Patient Lifestyle
Changes
Bio-Identical Hormone Replacement Therapy

Natural hormones
Hormones that are produced by our body for
our body
Molecular structure is biologically identical
and exact to the hormones in our body
Natural Versus Synthetic
CH3
C

O

CH3
O

O

Progesterone

CH3
Provera
Progesterone

C

O
O C

O
CH3
Bio-Identical Hormone Replacement Therapy
Goal is to replace and restore hormones that
decrease as we age to optimum levels
Optimum levels are those of young adults in
their mid-twenties and early thirties
Improves one‟s quality of life and sense of
well being
Longer and healthier life
Bio-Identical Hormone Replacement Therapy
Basic Science
What are hormones?
Hormones are chemical messengers
produced and secreted by endocrine
cells into the bloodstream
Hormones regulate, integrate and
control cellular functions downstream
Endocrine Glands
Pineal
Hypothalmus
Pituitary
Thyroid

Adrenals
Ovaries
Testes
What are target cells?
Target cells refer to cells that contain
specific receptors (binding sites) for a
particular hormone
Once a hormone binds to receptors on
a target cell, a series of cellular events
unfold that is dependent upon gene
expression
Growth Hormone
Growth Hormone Binding To
Growth Hormone Receptors On
Target Cells

Growth Hormone

Growth Hormone Bound
To Cell Receptor
Are hormones harmful or beneficial?
Are they safe?
Medical studies demonstrate the severe harm
associated with use of synthetic hormones
Synthetic hormones are dangerous and
should not be used
The real harm occurs when we lose our own
natural hormones
There is no harm when using bio-identical
hormones
If BHRT is so good for you, then why has
my doctor not offered it to me?
Western medicine is an “allopathic based”
medical system
Allopathic medicine uses medications, drugs,
or surgery to treat and/or suppress symptoms
of diseases

Stroke

MI

Uterine CA
If BHRT is so good for you, then why has
my doctor not offered it to me?
Post graduate medical education is heavily
influenced by Wall Street
money talks
Semantics: real confusion exist between
„synthetic‟ and „bio-identical‟ hormones in the
medical journals, medical literature and media
False premise prevails to give hormone therapy
to control symptoms for the shortest period of
time
What happens when our natural
hormones are not replaced?
Macular degeneration is an eye disease
of aging that is a major cause of blindness
Women who are treated with bio-identical
estrogen experience 80% less chance of
developing macular degeneration
What happens when our natural
hormones are not replaced?
Women who have taken natural
estrogen for 15 years or more
have a very low incidence
of Alzheimer‟s disease
Several studies demonstrate that
bio-identical estrogen protects
against dementia
What happens when our natural
hormones are not replaced?
Estrogen protects against bone
loss and osteoporosis
In women over 65 years of age or
older who suffer hip fractures,
50% die within 2 years
What happens when our natural
hormones are not replaced?
Most physicians fail to advise their female
patients of their loss of protection against
breast cancer from loss of progesterone
Progesterone decreases breast density
and down regulates breast receptor sites,
thereby lowering the risk of breast cancer
Bio-Identical Hormone Replacement Therapy

Vital Hormones Lost With Aging
Testosterone
Estrogen
Progesterone
Pregnenolone
DHEA
Cortisol

Human Growth
Hormone
Thyroid
Oxytocin
Melatonin
PATIENTS CAN SENSE,
“THINGS ARE JUST
NOT RIGHT”
MOST FREQUENT COMPLAINTS
Tiredness
Less Energy
Poor Sleep

↓ Sex Drive
Hot Flashes
Night Sweats
Vaginal Dryness
Dry Skin
Anxiety
Mood Swings
Headaches
Weight Gain
Depression
Memory Loss
Palpitations

Osteoporosis
Hair Loss
Food Cravings
Irritability
Painful Joints
Loss of Pubic Hair
Painful Intercourse
Irregular Menstruation
Overly Emotional
Lack of Self Esteem
Restless Leg Syndrome
Chronic Fatigue Syndrome
Poor Sexual Performance
Erectile Dysfunction
Urinary Frequency
Testosterone
Benefits of testosterone
therapy in women

Women
≠
Estrogen
Women ≠ Estrogen
15-20 times more testosterone
Testosterone has been ignored except for
it's role in sexual function and libido
Androgen receptors found in brain,
bones, heart, blood vessels, nerves,
muscles, skin breast, uterus, ovaries, etc
Testosterone is the major substrate for
estradiol
Benefits of testosterone
therapy in women
Improvement in:
Sense of well being
Memory
Improved sleep
Self-assertiveness
Energy levels
Benefits of testosterone
therapy in women
Improvement in:
Muscle mass
Decreased fat
Bone density
Sexual desire and
satisfaction
Clitoral sensitivity
Benefits of testosterone
therapy in women
Improvement in:
Depression and anxiety
Migraine or menstrual
headaches
Decreased aches, pains,
and stiffness
Skin quality (increase
collagen and elastin)
Benefits of testosterone
therapy in women
Prevents against:
Visceral fat
Muscle loss
Ligament injury
Bone loss
Benefits of testosterone
therapy in women
Prevents against:
Loss of cognition
Loss of libido
Loss of emotional
stability
Benefits of testosterone
therapy in women
Indications
Any women at any age with symptoms
of testosterone deficiency
Any women with low testosterone levels
Any women that wants to improve their
health, wellness, strength, confidence,
and aesthetics
Contraindication of Testosterone Therapy
Pregnancy
Planned pregnancy
Side effects of testosterone
therapy in women
Side effects of testosterone
therapy in women
Too high levels of testosterone may cause
Increase in facial hair
Mild acne breakout
Increased Libido
Treat by lowering the testosterone dose
Treat with Spironolactone 100 mg/day
WAYS TO ADMINISTER
TESTOSTERONE IN WOMEN
PILLS ~ CREAMS ~
INJECTIONS ~ PATCHES

Variability of hormone
concentrations from one hour
to next (half life too short)
Concentration elevates quickly
and in short time falls
roller
coaster effect
Prone to non-compliance
Testosterone Treatment with Subcutaneous
Pellet Implants
Testosterone Treatment with Subcutaneous
Pellet Implants
History of hormone pellet implants

Subcutaneous hormone implants have
been used in Europe, US and Australia
since 1938
Superior to other methods of hormone
delivery (oral, IM, topical)
Deliver consistent, effective levels of
physiologic hormones
Mishnell 41, Greenblatt 49, Thom 81, Stanczyk 88
Testosterone Treatment with Subcutaneous
Pellet Implants
Testosterone Treatment with Subcutaneous
Pellet Implants
Testosterone Treatment with Subcutaneous
Pellet Implants
Testosterone Treatment with Subcutaneous
Pellet Implants
Testosterone in Men
Testosterone in Men
Bottom line:
Raising a man’s testosterone levels
through natural hormone replacement
helps to revitalize every aspect of his
life!
EVERY MALE PATIENT IS DEFICIENT OR
WILL BECOME DEFICIENT IN
TESTOSTERONE
Why do men lose testosterone ?
Andropause
After age 30, the amount of testosterone
declines and continues throughout life
The decline is poorly understood and
controversial
90-95% of testosterone is produced by the
Leydig cells in the testes
What happens when men
lose testosterone ?
What happens when men
lose testosterone ?
Men in forties and older experience a
decrease in hormone levels
Morning erections cease
Muscle definition fades
Men get flabby around the middle
What happens when men
lose testosterone ?
Men in forties and older experience a
decrease in hormone levels
Men start to worry about sexual their
performance
Maintain an erection during sex ?
Dependent upon an ED drug ?
What happens when men
lose testosterone ?
Erectile Dysfunction

Growing older should not be the
end of a man’s sex life
What happens when men
lose testosterone ?
Men in forties and older experience a
decrease in hormone levels
Symptoms of andropause slowly
worsens over time
Male ego and psyche at risk
Medical health risks greatly increases
Bio-Identical Hormone Replacement
Therapy
Sense of Well Being
Improved Libido

Improved Health
Prevention of Medical
Diseases
What happens when men lose testosterone ?

Increased risk of:
CAD and CVD
Osteoporosis
Visceral fat
Loss of the sense of well being
Testosterone
Routes of Delivery
Injectable
 Painful
 Roller-coaster effect

Patches: not user friendly
Troche: poor levels
Testosterone
Routes of Delivery

Transdermal cream
 ETOH gels 10% maximum = 100 mg/gm
Lipoderm cream: maximum = 200 mg/gm
Androgel 1%: 10 mg/gm
 More expensive

Compliance concerns
Accidental transference concerns
Testosterone
Routes of Delivery

Pellets:





Preferred method of choice
No Compliance issues
No transference concerns
Even, steady state release
Testosterone’s side effectsin men
Acne; oily skin
Aggression ? No !
Decrease sperm count (concern
in younger men and family planning)
Decrease in testicular size
Transference to others
Increase red blood cell count
Testosterone’s side effectsin men
Testosterone does not cause
prostate cancer
In men with prostate cancer,
testosterone may cause the
cancer to grow more rapidly
Mild prostate enlargement
Rectal exams and PSA levels
are a medical necessity
Indications for Testosterone
Indications for Testosterone
Any man or woman that wishes to improve
quality of life, decrease morbidity or
mortality, or increase longevity as
documented in the medical literature
Menopause
Menopause is much
more than not having
a period for 12 months
MOST FREQUENT COMPLAINTS
Tiredness
Less Energy
Poor Sleep

↓ Sex Drive
Hot Flashes
Night Sweats
Vaginal Dryness
Dry Skin
Anxiety
Mood Swings
Headaches
Weight Gain
Depression
Memory Loss

Palpitations
Osteoporosis
Hair Loss
Food Cravings
Irritability
Painful Joints
Loss of Pubic Hair
Painful Intercourse
Irregular Menstruation
Overly Emotional
Lack of Self Esteem
Restless Leg Syndrome
Chronic Fatigue Syndrome
Bloating
Bio-Identical Hormone Replacement Therapy
Menopause
Menopause
Women‟s Health Initiative
Message:
Don’t fear bio-identical
estrogen or progesterone
Fear the loss of these natural
hormones
Do not replace with synthetic,
chemically altered hormones
Estrogen
Estrogen
Bottom Line

Optimum levels of natural estrogen
are necessary for every aging woman
It builds bone, protects the heart, and
prevents Alzheimer’s in its tracks
Which Estrogen is Most Important ?
Estradiol
Is the most important and vital estrogen
for health and wellness management
Is the estrogen that we will monitor and
replace when needed
What happens when
women lose estrogen ?
Increased risk of:
Coronary Artery Disease
Stroke
Diabetes Mellitus
Alzheimer’s disease
Osteoporotic fractures
What happens when
women lose estrogen ?
Increased risk of:
Urogenital atrophy
Macular Degeneration
Colon cancer
Tooth loss
What happens when
women lose estrogen ?
Estrogen‟s benefit:
Improves memory
Prevents Alzheimer’s disease
Decreases symptoms of menopause
Decreases insulin resistance
Prevents osteoporosis
Protects against heart disease
What happens when
women lose estrogen ?
Breast cancer in women
2012, the estimated number of deaths
claimed from breast cancer was 39,510

©2012, American Cancer Society, Inc., Surveillance Research
What happens when
women lose estrogen ?
Heart disease in women
The risk of heart disease in women
increases with age
Is the leading cause of death in
women over 40 years old, especially
after menopause
Every year, more than 400,000 U.S.
women die of heart disease
What happens in women
with too much estrogen ?
Estrogen‟s side-effects in high doses:
Increased body fat
Increased fluid retention
Headaches
Irritability
What happens in women
with too much estrogen?
The 5 B‟s
Breast tenderness
Bleeding
Bloating (fluid retention)
Bitchiness (crying, mood swings)
Break out
Due to estrogen dominance;
either too much or too sensitive
What happens in women
with too much estrogen ?
Estrogen dominance
Due to excess blood levels
Due to increased receptor site sensitivity
Treatment:
 Lower dose of estradiol
 Balance (oppose) with progesterone
Estrogen Replacement
Annual Requirements
Annual PAP, pelvic exam, and
mammogram
Monitor HRT levels
Estrogen Replacement
Estradiol
Is the most important estrogen for
health benefits
Delivery







Capsule
Sublinqual
Cream
Patch
Vaginal
Pellet
What about estrogen for men?
What about estrogen for men?
Estrogen is falsely accused of being harmful
in men
Medical literature does not demonstrate that
endogenous estrogen in men is harmful
Over emphasized and over-hyped
No study supports lowering estrogen in men
No study supports that high levels are
harmful
What about estrogen for men?
Protects against
Bone loss and osteoporosis
Alzheimer's disease and dementia
CVD, DM, IR
Optimal levels are associated with less CAD,
morbidity, and mortality
Low levels are harmful in both men and
women
Progesterone
Healthy Benefits of Progesterone
Bottom Line
Progesterone used in conjunction with
adequate levels of estrogen provides
women significant relief to many diseases
and symptoms associated with aging and
menopause
Progesterone protects against breast and
uterine cancer
Healthy Benefits of Progesterone
Progesterone
Estrogen’s natural sidekick
Important to treat and maintain natural
balance between estrogen and
progesterone
Reduces symptoms of PMS
Reduces estrogen dominance and
related untoward symptoms
Healthy Benefits of Progesterone
Progesterone
After menopause, women cease to
make progesterone
Without progesterone’s protective
properties, estrogen dominance occurs
and over-stimulation of receptor sites
in the breast and uterus leading to an
increase risk of cancer
J. Natl Cancer Inst.
92(4):328-332
Adding the synthetic, chemically altered,
ProveraÂź (progestin) to estrogen
replacement therapy, markedly increases
the risks of breast cancer 29% over
baseline
Healthy Benefits of Progesterone
Progesterone protects against
Breast cancer
Uterine cancer
Coronary artery disease
Osteoporosis
Healthy Benefits of Progesterone
Progesterone protects and provides
Lower cholesterol
Satisfactory quality of life
Enhancement of estrogen’s benefits
Vaginal atrophy
Relief of PMS
Healthy Benefits of Progesterone
Progesterone protects against
Menstrual cramps, mood swings, heavy
bleeding, depression, bloating, and
menstrual migraines
Post menopausal symptoms
Overall feelings of dysphoria and loss of
well-being
Progesterone
Formulations
Oral
 Sublingual triturate
 Rapid dissolve tablet (RDT)
 Cream
Dose QD, BID, QID
Pellets
What are the side effects of progesterone?

Natural progesterone has no harmful
side effects
In oral form taken at night, may cause
sleepiness
DHEA

Dehydroepiandrosterone
DHEA
One of the most abundant hormones
in the body
Precursor „mother‟ hormone because
DHEA converts into:
 Estrogen
 Testosterone
 Progesterone
DHEA Decline and Aging
4000

DHEA-S
(ng/ml)

3500
3000
2500
Men
Women

2000
1500
1000
500
0
10 20 30 40 50 60 70 80

Age (years)
DHEA
Powerful antioxidant
One of the best biochemical markers
for chronological age
 age gauge
Produced by the adrenals, gonads
and brain
DHEA
Acts as a neurosteroid
Induces an improved sense of mental,
psychological and emotional health
Restores energy, joy and motivation
Benefits of DHEA
Prevents and treats:

Cardiovascular disease
Diabetes
Hypertension
Loss of sex drive
Depression
Benefits of DHEA
Prevents and treats:

Fibromyalgia
Rheumatoid arthritis
Lupus
Crohn‟s disease
Herpes
Benefits of DHEA
Prevents and treats:

Cancer
Osteoporosis
Alzheimer‟s
Asthma and allergies
Stress
Pregnenolone

The Brain Hormone
Healthy Benefits of Pregnenolone
Pregnenolone
Produced in the brain and adrenal
glands
Keeps our brain functioning at peak
capacity
Healthy Benefits of Pregnenolone
Pregnenolone
Precursor to the other hormones
Functions as a memory enhancer
Promotes cellular repair in the
brain and nervous tissue
Healthy Benefits of Pregnenolone
Pregnenolone protects
Cerebral function
Against cerebral atrophy
Against neuronal injury
Against Alzheimer‟s disease
Healthy Benefits of Pregnenolone
Pregnenolone improves
Arthritis
Depression
Fatigue
Moodiness
Risk of Pregnenolone
Extremely safe
Rare acne
Rare drowsiness
Responds to lower dose
Cortisol

The Hormone of Stress
Cortisol
Produced by the adrenal glands
the same
glands that produce DHEA
Body's way of dealing with physical or
psychological demands of life

40% of hypothyroid patients are found to
have adrenal insufficiency or fatigue
Cortisol
Vital for life in order to cope with stressful
situations and conditions
Body's way of dealing with physical or
psychological demands of life

Designed more for acute stress situations
rather than chronic ones

Hydrocortisone
Diurnal Cortisol Release

Morning peak at 9am

Midnight trough
06:00

12:00

18:00

24:00

06:00
Cortisol
Low production of cortisol results

In an increased susceptibility to illness
Longer recovery times
System is geared more for acute conditions;
chronic may result in adrenal deficiency

Hydrocortisone
Symptoms of Adrenal Fatigue
Cortisol deficiency causes
Fatigue, especially in the afternoon
Stress
Sugar/Salt cravings
Low blood sugar

Hydrocortisone
Symptoms of Adrenal Fatigue
Cortisol deficiency causes
Allergies, asthma, sinusitis
Chemical sensitivity (perfume, detergents, odors)
Eczema
Aches, pains (especially neck and back)

Hydrocortisone
Symptoms of Adrenal Fatigue
Cortisol deficiency causes
Muscle stiffness, joint pain, arthritis
Hives, itching, skin sensitivity, reaction
to bug bites, acne
Weak immune system, repeated infections,
pneumonia

Hydrocortisone
Symptoms of Adrenal Fatigue
Cortisol deficiency causes
Autoimmune diseases (thyroiditis, Crohns
disease, inflammatory bowel disease)
Low blood pressure, low fluid volume
(dehydrates easily)

Hydrocortisone
Cortisol
Chronic Stress Can Cause
Heart disease
High blood pressure
High blood sugars
Sleep problems
Decrease bone
formation
Muscle wasting
Digestive problems

Depression
Obesity
Decrease breakdown
of fat
Memory impairment
Immune suppression
Skin problems
Melatonin

Much More Than A sleep Aid
Healthy Benefits of Melatonin
Chemical structure identified in 1958
Sleep aid
Potent antioxidant
Mood enhancer
Immune system booster
Cancer inhibitor
Treatment for blood pressure
Treatment for migraine headaches
Melatonin Synthesis
Made from the essential amino acid
tryptophan and serotonin
Made predominantly at night in the
pineal gland
Freely diffuses into the bloodstream
and crosses the brain barrier

Melatonin
Melatonin

Melatonin levels decreases with age
Brownstein, David. The Miracle of Natural Hormones, 3 ed., Medical Alternative Press. 2003.
rd
Growth Hormone

Growth Hormone Bound
to Receptor
Growth Hormone

HGH half life is 20 minutes
IGF-1 levels remain fairly constant
throughout the day
IGF-1 levels are are used to monitor hGH
therapy
Growth Hormone
The safest hormone

One of the most beneficial hormone
The most abused hormone,especially
in the sporting world

1986

2003

2005
Growth Hormone
The most maligned hormone

The most over-hyped hormone
The most expensive hormone

1986

2003

2005
Thyroid Hormone
Thyroid Hormone
 Affects every cell in body
 Cannot achieve optimum health
without a properly functioning thyroid
gland
 Hypothyroidism may be the most
commonly missed diagnosis today
 40% of the population may have
undiagnosed hypothyroidism
Brownstein, David. The Miracle of Natural Hormones, 3rd ed., Medical Alternative Press. 2003.
Thyroid Hormone
Regulates
 Temperature
 Metabolism
 Cerebral function
 Energy
Thyroid Hormone
 Increases fat breakdown resulting
in weight loss
 Lowers cholesterol
 Protects against cardiovascular disease
 Protects against cognitive impairment
 Prevents memory loss
 Prevents fatigue
Thyroid Production
Thyroid

T4

T3

Effects On Body
Thyroid Replacement and Preventative
Medicine

“Low normal thyroid levels result in increased
cholesterol, increased heart disease, fatigue,
low energy, depression, and memory loss.
Thyroid replacement eliminates these risks. No
study has shown any harm or adverse effect of
treatment.”
Consultant 2000 Dec: 2397-2399.

.
Treatment of Hypothyroidism
Armour Thyroid, Westhyroid, and Natural
Thyroid (desiccated thyroid)


Composed of T1, T2, T3, and T4



Porcine derivative



Doses are in tablets

1/4 1/2 1 2
3 grain (60 mg)
15 30 60 120 180 mg
Oxytocin

More Than A Hormone of Labor &
Delivery
Oxytocin

Important features
“Love hormone”
Improves organism in women and men
Increases clitoral/ penile „erection‟
Help mothers be moms
Reduces anger
Reduces stress
Oxytocin

Important features
Increase social bonding
Increases trust
Increases generosity
Increases healing
Diet Aid, reduces appetite
Reduces pain
Oxytocin

Deficiency is associated with
Autism
Schizophrenia
Low Estrogen
Low Thyroid
Depression
AIDS
CMV Infection
Oxytocin

Deficiency is associated with
Autism
Schizophrenia
Low Estrogen
Low Thyroid
Depression
AIDS
CMV Infection

Multiple Sclerosis
Fibromyalgia
Chronic Stress
Opioid Dependency
Parkinsons Disease
Loneliness
Anxiety Disorders
Oxytocin

Risk factors associated with deficiency
Loneliness
Lack of familial and social contacts
Fear
Anger
Drug abuse
Detachment
Bad social experiences
Prolonged or even short negative stress
Drinking excessive amounts of fluid/water
Vitali-T’s VIP Price Sheet
http://vitalitmed.com/what-is-hormone-therapy/

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Bio-Identical Hormone Replacement Therapy

  • 2.
  • 5. Credit Debbie L. Brinkman, CMA Dr. Julie Marchiol, DC, FIMA
  • 6. Growing old is not for sissies Be prepared !!
  • 7. Bio-Identical Hormone Replacement Therapy Goal is to replace and restore natural hormones that decrease as we age to optimum levels Improve one's well being and quality of life Promote a longer and healthier life span: the essence of preventive and restorative medicine
  • 8. Bio-Identical Hormone Replacement Therapy Prescribe only natural hormones that are made by our human body for our body Molecular structure is biologically identical to the hormones found in the human body Vital steroid hormones are derived from soy and yam oils
  • 10. Bio-Identical Hormone Replacement Therapy 2003-2010 offered BHRT, weight loss, and sexual dysfunction to my patients Outsourced through an independent Ob-Gyn Wonderful synergy with cosmetic surgery practice with various anti-aging modalities Longevity and preventive medicine is a natural extension of cosmetic surgery Optimized surgical healing and recovery
  • 11. Bio-Identical Hormone Replacement Therapy Sense of Well Being Improved Libido Improved Health Prevention of Medical Diseases
  • 12. Bio-Identical Hormone Replacement With Testosterone Pellet Therapy August 17-19, 2012 September 7-9, 2012 October 19-21, 2012
  • 13. Anti-Aging Clinic BHRT Nutrition Weight Management Stress Reduction Exercise Cardiac Health Anti-inflammatory Management Osteoporosis Antioxidants Detoxification Nutraceuticals Supplements Patient Lifestyle Changes
  • 14. Bio-Identical Hormone Replacement Therapy Natural hormones Hormones that are produced by our body for our body Molecular structure is biologically identical and exact to the hormones in our body
  • 16. Bio-Identical Hormone Replacement Therapy Goal is to replace and restore hormones that decrease as we age to optimum levels Optimum levels are those of young adults in their mid-twenties and early thirties Improves one‟s quality of life and sense of well being Longer and healthier life
  • 19. What are hormones? Hormones are chemical messengers produced and secreted by endocrine cells into the bloodstream Hormones regulate, integrate and control cellular functions downstream
  • 21. What are target cells? Target cells refer to cells that contain specific receptors (binding sites) for a particular hormone Once a hormone binds to receptors on a target cell, a series of cellular events unfold that is dependent upon gene expression
  • 23. Growth Hormone Binding To Growth Hormone Receptors On Target Cells Growth Hormone Growth Hormone Bound To Cell Receptor
  • 24. Are hormones harmful or beneficial? Are they safe? Medical studies demonstrate the severe harm associated with use of synthetic hormones Synthetic hormones are dangerous and should not be used The real harm occurs when we lose our own natural hormones There is no harm when using bio-identical hormones
  • 25. If BHRT is so good for you, then why has my doctor not offered it to me? Western medicine is an “allopathic based” medical system Allopathic medicine uses medications, drugs, or surgery to treat and/or suppress symptoms of diseases Stroke MI Uterine CA
  • 26. If BHRT is so good for you, then why has my doctor not offered it to me? Post graduate medical education is heavily influenced by Wall Street
money talks Semantics: real confusion exist between „synthetic‟ and „bio-identical‟ hormones in the medical journals, medical literature and media False premise prevails to give hormone therapy to control symptoms for the shortest period of time
  • 27. What happens when our natural hormones are not replaced? Macular degeneration is an eye disease of aging that is a major cause of blindness Women who are treated with bio-identical estrogen experience 80% less chance of developing macular degeneration
  • 28. What happens when our natural hormones are not replaced? Women who have taken natural estrogen for 15 years or more have a very low incidence of Alzheimer‟s disease Several studies demonstrate that bio-identical estrogen protects against dementia
  • 29. What happens when our natural hormones are not replaced? Estrogen protects against bone loss and osteoporosis In women over 65 years of age or older who suffer hip fractures, 50% die within 2 years
  • 30. What happens when our natural hormones are not replaced? Most physicians fail to advise their female patients of their loss of protection against breast cancer from loss of progesterone Progesterone decreases breast density and down regulates breast receptor sites, thereby lowering the risk of breast cancer
  • 31. Bio-Identical Hormone Replacement Therapy Vital Hormones Lost With Aging Testosterone Estrogen Progesterone Pregnenolone DHEA Cortisol Human Growth Hormone Thyroid Oxytocin Melatonin
  • 32. PATIENTS CAN SENSE, “THINGS ARE JUST NOT RIGHT” MOST FREQUENT COMPLAINTS Tiredness Less Energy Poor Sleep ↓ Sex Drive Hot Flashes Night Sweats Vaginal Dryness Dry Skin Anxiety Mood Swings Headaches Weight Gain Depression Memory Loss Palpitations Osteoporosis Hair Loss Food Cravings Irritability Painful Joints Loss of Pubic Hair Painful Intercourse Irregular Menstruation Overly Emotional Lack of Self Esteem Restless Leg Syndrome Chronic Fatigue Syndrome Poor Sexual Performance Erectile Dysfunction Urinary Frequency
  • 34. Benefits of testosterone therapy in women Women ≠ Estrogen
  • 35. Women ≠ Estrogen 15-20 times more testosterone Testosterone has been ignored except for it's role in sexual function and libido Androgen receptors found in brain, bones, heart, blood vessels, nerves, muscles, skin breast, uterus, ovaries, etc Testosterone is the major substrate for estradiol
  • 36. Benefits of testosterone therapy in women Improvement in: Sense of well being Memory Improved sleep Self-assertiveness Energy levels
  • 37. Benefits of testosterone therapy in women Improvement in: Muscle mass Decreased fat Bone density Sexual desire and satisfaction Clitoral sensitivity
  • 38. Benefits of testosterone therapy in women Improvement in: Depression and anxiety Migraine or menstrual headaches Decreased aches, pains, and stiffness Skin quality (increase collagen and elastin)
  • 39. Benefits of testosterone therapy in women Prevents against: Visceral fat Muscle loss Ligament injury Bone loss
  • 40. Benefits of testosterone therapy in women Prevents against: Loss of cognition Loss of libido Loss of emotional stability
  • 41. Benefits of testosterone therapy in women Indications Any women at any age with symptoms of testosterone deficiency Any women with low testosterone levels Any women that wants to improve their health, wellness, strength, confidence, and aesthetics
  • 42. Contraindication of Testosterone Therapy Pregnancy Planned pregnancy
  • 43. Side effects of testosterone therapy in women
  • 44. Side effects of testosterone therapy in women Too high levels of testosterone may cause Increase in facial hair Mild acne breakout Increased Libido Treat by lowering the testosterone dose Treat with Spironolactone 100 mg/day
  • 45. WAYS TO ADMINISTER TESTOSTERONE IN WOMEN PILLS ~ CREAMS ~ INJECTIONS ~ PATCHES Variability of hormone concentrations from one hour to next (half life too short) Concentration elevates quickly and in short time falls
roller coaster effect Prone to non-compliance
  • 46. Testosterone Treatment with Subcutaneous Pellet Implants
  • 47. Testosterone Treatment with Subcutaneous Pellet Implants History of hormone pellet implants Subcutaneous hormone implants have been used in Europe, US and Australia since 1938 Superior to other methods of hormone delivery (oral, IM, topical) Deliver consistent, effective levels of physiologic hormones Mishnell 41, Greenblatt 49, Thom 81, Stanczyk 88
  • 48. Testosterone Treatment with Subcutaneous Pellet Implants
  • 49. Testosterone Treatment with Subcutaneous Pellet Implants
  • 50. Testosterone Treatment with Subcutaneous Pellet Implants
  • 51. Testosterone Treatment with Subcutaneous Pellet Implants
  • 53. Testosterone in Men Bottom line: Raising a man’s testosterone levels through natural hormone replacement helps to revitalize every aspect of his life!
  • 54. EVERY MALE PATIENT IS DEFICIENT OR WILL BECOME DEFICIENT IN TESTOSTERONE
  • 55. Why do men lose testosterone ? Andropause After age 30, the amount of testosterone declines and continues throughout life The decline is poorly understood and controversial 90-95% of testosterone is produced by the Leydig cells in the testes
  • 56. What happens when men lose testosterone ?
  • 57. What happens when men lose testosterone ? Men in forties and older experience a decrease in hormone levels Morning erections cease Muscle definition fades Men get flabby around the middle
  • 58. What happens when men lose testosterone ? Men in forties and older experience a decrease in hormone levels Men start to worry about sexual their performance Maintain an erection during sex ? Dependent upon an ED drug ?
  • 59. What happens when men lose testosterone ? Erectile Dysfunction Growing older should not be the end of a man’s sex life
  • 60. What happens when men lose testosterone ? Men in forties and older experience a decrease in hormone levels Symptoms of andropause slowly worsens over time Male ego and psyche at risk Medical health risks greatly increases
  • 61. Bio-Identical Hormone Replacement Therapy Sense of Well Being Improved Libido Improved Health Prevention of Medical Diseases
  • 62. What happens when men lose testosterone ? Increased risk of: CAD and CVD Osteoporosis Visceral fat Loss of the sense of well being
  • 63. Testosterone Routes of Delivery Injectable  Painful  Roller-coaster effect Patches: not user friendly Troche: poor levels
  • 64. Testosterone Routes of Delivery Transdermal cream  ETOH gels 10% maximum = 100 mg/gm Lipoderm cream: maximum = 200 mg/gm Androgel 1%: 10 mg/gm  More expensive Compliance concerns Accidental transference concerns
  • 65. Testosterone Routes of Delivery Pellets:     Preferred method of choice No Compliance issues No transference concerns Even, steady state release
  • 66. Testosterone’s side effectsin men Acne; oily skin Aggression ? No ! Decrease sperm count (concern in younger men and family planning) Decrease in testicular size Transference to others Increase red blood cell count
  • 67. Testosterone’s side effectsin men Testosterone does not cause prostate cancer In men with prostate cancer, testosterone may cause the cancer to grow more rapidly Mild prostate enlargement Rectal exams and PSA levels are a medical necessity
  • 69. Indications for Testosterone Any man or woman that wishes to improve quality of life, decrease morbidity or mortality, or increase longevity as documented in the medical literature
  • 71. Menopause is much more than not having a period for 12 months MOST FREQUENT COMPLAINTS Tiredness Less Energy Poor Sleep ↓ Sex Drive Hot Flashes Night Sweats Vaginal Dryness Dry Skin Anxiety Mood Swings Headaches Weight Gain Depression Memory Loss Palpitations Osteoporosis Hair Loss Food Cravings Irritability Painful Joints Loss of Pubic Hair Painful Intercourse Irregular Menstruation Overly Emotional Lack of Self Esteem Restless Leg Syndrome Chronic Fatigue Syndrome Bloating
  • 75. Women‟s Health Initiative Message: Don’t fear bio-identical estrogen or progesterone Fear the loss of these natural hormones Do not replace with synthetic, chemically altered hormones
  • 77. Estrogen Bottom Line Optimum levels of natural estrogen are necessary for every aging woman It builds bone, protects the heart, and prevents Alzheimer’s in its tracks
  • 78. Which Estrogen is Most Important ? Estradiol Is the most important and vital estrogen for health and wellness management Is the estrogen that we will monitor and replace when needed
  • 79. What happens when women lose estrogen ? Increased risk of: Coronary Artery Disease Stroke Diabetes Mellitus Alzheimer’s disease Osteoporotic fractures
  • 80. What happens when women lose estrogen ? Increased risk of: Urogenital atrophy Macular Degeneration Colon cancer Tooth loss
  • 81. What happens when women lose estrogen ? Estrogen‟s benefit: Improves memory Prevents Alzheimer’s disease Decreases symptoms of menopause Decreases insulin resistance Prevents osteoporosis Protects against heart disease
  • 82. What happens when women lose estrogen ? Breast cancer in women 2012, the estimated number of deaths claimed from breast cancer was 39,510 ©2012, American Cancer Society, Inc., Surveillance Research
  • 83. What happens when women lose estrogen ? Heart disease in women The risk of heart disease in women increases with age Is the leading cause of death in women over 40 years old, especially after menopause Every year, more than 400,000 U.S. women die of heart disease
  • 84. What happens in women with too much estrogen ? Estrogen‟s side-effects in high doses: Increased body fat Increased fluid retention Headaches Irritability
  • 85. What happens in women with too much estrogen? The 5 B‟s Breast tenderness Bleeding Bloating (fluid retention) Bitchiness (crying, mood swings) Break out Due to estrogen dominance; either too much or too sensitive
  • 86. What happens in women with too much estrogen ? Estrogen dominance Due to excess blood levels Due to increased receptor site sensitivity Treatment:  Lower dose of estradiol  Balance (oppose) with progesterone
  • 87. Estrogen Replacement Annual Requirements Annual PAP, pelvic exam, and mammogram Monitor HRT levels
  • 88. Estrogen Replacement Estradiol Is the most important estrogen for health benefits Delivery       Capsule Sublinqual Cream Patch Vaginal Pellet
  • 90. What about estrogen for men? Estrogen is falsely accused of being harmful in men Medical literature does not demonstrate that endogenous estrogen in men is harmful Over emphasized and over-hyped No study supports lowering estrogen in men No study supports that high levels are harmful
  • 91. What about estrogen for men? Protects against Bone loss and osteoporosis Alzheimer's disease and dementia CVD, DM, IR Optimal levels are associated with less CAD, morbidity, and mortality Low levels are harmful in both men and women
  • 93. Healthy Benefits of Progesterone Bottom Line Progesterone used in conjunction with adequate levels of estrogen provides women significant relief to many diseases and symptoms associated with aging and menopause Progesterone protects against breast and uterine cancer
  • 94. Healthy Benefits of Progesterone Progesterone Estrogen’s natural sidekick Important to treat and maintain natural balance between estrogen and progesterone Reduces symptoms of PMS Reduces estrogen dominance and related untoward symptoms
  • 95. Healthy Benefits of Progesterone Progesterone After menopause, women cease to make progesterone Without progesterone’s protective properties, estrogen dominance occurs and over-stimulation of receptor sites in the breast and uterus leading to an increase risk of cancer
  • 96. J. Natl Cancer Inst. 92(4):328-332 Adding the synthetic, chemically altered, ProveraÂź (progestin) to estrogen replacement therapy, markedly increases the risks of breast cancer 29% over baseline
  • 97. Healthy Benefits of Progesterone Progesterone protects against Breast cancer Uterine cancer Coronary artery disease Osteoporosis
  • 98. Healthy Benefits of Progesterone Progesterone protects and provides Lower cholesterol Satisfactory quality of life Enhancement of estrogen’s benefits Vaginal atrophy Relief of PMS
  • 99. Healthy Benefits of Progesterone Progesterone protects against Menstrual cramps, mood swings, heavy bleeding, depression, bloating, and menstrual migraines Post menopausal symptoms Overall feelings of dysphoria and loss of well-being
  • 100. Progesterone Formulations Oral  Sublingual triturate  Rapid dissolve tablet (RDT)  Cream Dose QD, BID, QID Pellets
  • 101. What are the side effects of progesterone? Natural progesterone has no harmful side effects In oral form taken at night, may cause sleepiness
  • 103. DHEA One of the most abundant hormones in the body Precursor „mother‟ hormone because DHEA converts into:  Estrogen  Testosterone  Progesterone
  • 104. DHEA Decline and Aging 4000 DHEA-S (ng/ml) 3500 3000 2500 Men Women 2000 1500 1000 500 0 10 20 30 40 50 60 70 80 Age (years)
  • 105. DHEA Powerful antioxidant One of the best biochemical markers for chronological age
 age gauge Produced by the adrenals, gonads and brain
  • 106. DHEA Acts as a neurosteroid Induces an improved sense of mental, psychological and emotional health Restores energy, joy and motivation
  • 107. Benefits of DHEA Prevents and treats: Cardiovascular disease Diabetes Hypertension Loss of sex drive Depression
  • 108. Benefits of DHEA Prevents and treats: Fibromyalgia Rheumatoid arthritis Lupus Crohn‟s disease Herpes
  • 109. Benefits of DHEA Prevents and treats: Cancer Osteoporosis Alzheimer‟s Asthma and allergies Stress
  • 111. Healthy Benefits of Pregnenolone Pregnenolone Produced in the brain and adrenal glands Keeps our brain functioning at peak capacity
  • 112. Healthy Benefits of Pregnenolone Pregnenolone Precursor to the other hormones Functions as a memory enhancer Promotes cellular repair in the brain and nervous tissue
  • 113. Healthy Benefits of Pregnenolone Pregnenolone protects Cerebral function Against cerebral atrophy Against neuronal injury Against Alzheimer‟s disease
  • 114. Healthy Benefits of Pregnenolone Pregnenolone improves Arthritis Depression Fatigue Moodiness
  • 115. Risk of Pregnenolone Extremely safe Rare acne Rare drowsiness Responds to lower dose
  • 117. Cortisol Produced by the adrenal glands
the same glands that produce DHEA Body's way of dealing with physical or psychological demands of life 40% of hypothyroid patients are found to have adrenal insufficiency or fatigue
  • 118. Cortisol Vital for life in order to cope with stressful situations and conditions Body's way of dealing with physical or psychological demands of life Designed more for acute stress situations rather than chronic ones Hydrocortisone
  • 119. Diurnal Cortisol Release Morning peak at 9am Midnight trough 06:00 12:00 18:00 24:00 06:00
  • 120. Cortisol Low production of cortisol results In an increased susceptibility to illness Longer recovery times System is geared more for acute conditions; chronic may result in adrenal deficiency Hydrocortisone
  • 121. Symptoms of Adrenal Fatigue Cortisol deficiency causes Fatigue, especially in the afternoon Stress Sugar/Salt cravings Low blood sugar Hydrocortisone
  • 122. Symptoms of Adrenal Fatigue Cortisol deficiency causes Allergies, asthma, sinusitis Chemical sensitivity (perfume, detergents, odors) Eczema Aches, pains (especially neck and back) Hydrocortisone
  • 123. Symptoms of Adrenal Fatigue Cortisol deficiency causes Muscle stiffness, joint pain, arthritis Hives, itching, skin sensitivity, reaction to bug bites, acne Weak immune system, repeated infections, pneumonia Hydrocortisone
  • 124. Symptoms of Adrenal Fatigue Cortisol deficiency causes Autoimmune diseases (thyroiditis, Crohns disease, inflammatory bowel disease) Low blood pressure, low fluid volume (dehydrates easily) Hydrocortisone
  • 125. Cortisol Chronic Stress Can Cause Heart disease High blood pressure High blood sugars Sleep problems Decrease bone formation Muscle wasting Digestive problems Depression Obesity Decrease breakdown of fat Memory impairment Immune suppression Skin problems
  • 126. Melatonin Much More Than A sleep Aid
  • 127. Healthy Benefits of Melatonin Chemical structure identified in 1958 Sleep aid Potent antioxidant Mood enhancer Immune system booster Cancer inhibitor Treatment for blood pressure Treatment for migraine headaches
  • 128. Melatonin Synthesis Made from the essential amino acid tryptophan and serotonin Made predominantly at night in the pineal gland Freely diffuses into the bloodstream and crosses the brain barrier Melatonin
  • 129. Melatonin Melatonin levels decreases with age Brownstein, David. The Miracle of Natural Hormones, 3 ed., Medical Alternative Press. 2003. rd
  • 130. Growth Hormone Growth Hormone Bound to Receptor
  • 131. Growth Hormone HGH half life is 20 minutes IGF-1 levels remain fairly constant throughout the day IGF-1 levels are are used to monitor hGH therapy
  • 132. Growth Hormone The safest hormone One of the most beneficial hormone The most abused hormone,especially in the sporting world 1986 2003 2005
  • 133. Growth Hormone The most maligned hormone The most over-hyped hormone The most expensive hormone 1986 2003 2005
  • 135. Thyroid Hormone  Affects every cell in body  Cannot achieve optimum health without a properly functioning thyroid gland  Hypothyroidism may be the most commonly missed diagnosis today  40% of the population may have undiagnosed hypothyroidism Brownstein, David. The Miracle of Natural Hormones, 3rd ed., Medical Alternative Press. 2003.
  • 136. Thyroid Hormone Regulates  Temperature  Metabolism  Cerebral function  Energy
  • 137. Thyroid Hormone  Increases fat breakdown resulting in weight loss  Lowers cholesterol  Protects against cardiovascular disease  Protects against cognitive impairment  Prevents memory loss  Prevents fatigue
  • 139. Thyroid Replacement and Preventative Medicine “Low normal thyroid levels result in increased cholesterol, increased heart disease, fatigue, low energy, depression, and memory loss. Thyroid replacement eliminates these risks. No study has shown any harm or adverse effect of treatment.” Consultant 2000 Dec: 2397-2399. .
  • 140. Treatment of Hypothyroidism Armour Thyroid, Westhyroid, and Natural Thyroid (desiccated thyroid)  Composed of T1, T2, T3, and T4  Porcine derivative  Doses are in tablets 1/4 1/2 1 2 3 grain (60 mg) 15 30 60 120 180 mg
  • 141. Oxytocin More Than A Hormone of Labor & Delivery
  • 142. Oxytocin Important features “Love hormone” Improves organism in women and men Increases clitoral/ penile „erection‟ Help mothers be moms Reduces anger Reduces stress
  • 143. Oxytocin Important features Increase social bonding Increases trust Increases generosity Increases healing Diet Aid, reduces appetite Reduces pain
  • 144. Oxytocin Deficiency is associated with Autism Schizophrenia Low Estrogen Low Thyroid Depression AIDS CMV Infection
  • 145. Oxytocin Deficiency is associated with Autism Schizophrenia Low Estrogen Low Thyroid Depression AIDS CMV Infection Multiple Sclerosis Fibromyalgia Chronic Stress Opioid Dependency Parkinsons Disease Loneliness Anxiety Disorders
  • 146. Oxytocin Risk factors associated with deficiency Loneliness Lack of familial and social contacts Fear Anger Drug abuse Detachment Bad social experiences Prolonged or even short negative stress Drinking excessive amounts of fluid/water

Hinweis der Redaktion

  1. 1997: A Federal clinical trial, known as the Women’s Health Initiative (WHI), begins to evaluate theeffectiveness of Premarin¼ and Prempro¼ (FDA-approved drugs manufactured by Wyeth). These were – and still are – the most commonly prescribed treatment for menopausal symptoms such as hot flashes and vaginal dryness, having been on the market since the early 1940s.JUL 2002: Federal officials abruptly halt a phase of the WHI study after finding increased rates of breastcancer, heart attack, and stroke in the women taking Prempro.FEB 2004: Federal officials halt another phase of the WHI study after finding increased rates of stroke anddementia in the women taking Premarin.2002-present: Wyeth’s sales of Premarin plummet (from more than $2 billion in 2001 to $880 million in 2004) as women and their practitioners evaluate alternative treatments for menopausal symptoms, with many switching to custom compounded BHRT prescriptions.OCT 2005: Wyeth files a “citizen petition” requesting that the FDA essentially ban all bioidentical hormones that compete with their products.AUG 2006: A Texas District Court rules that pharmaceutical compounding upon the order of a licensedprescriber is not considered a “new drug” and therefore not subject to FDA scrutiny. The FDA appeals the case, and Wyeth continues to advocate banning all BHRT compounding on behalf of the FDA.JAN 2008: The FDA issues a warning letter to seven compounding pharmacies (2 more letters were issuedthereafter), threatening to ban BHRT, specifically any compound containing estriol, which is an ingredient in about 80% of BHRT. The letter also bans any false claims of safety or efficacy, including banning the use of the term “bioidentical,” even though it is commonly used in marketing some FDA-approved drugs. The letter indicates that the FDA may broaden the threat to all compounding pharmacies that provide BHRT.MAR 2008: The FDA issues a warning letter to suppliers of compounding pharmacies regarding theirdistribution of bulk estriol.APR 2008: The FDA issues an “Import Alert” cutting off the supply of estriol and other ingredients of custom compounded BHRT.APR 2008: A huge public response to the FDA’s actions regarding BHRT prompts Senator Tom Coburn,MD, to request “documentation of specific adverse events and demonstrated safety issues related to the use of estriol” and other details on the research or studies that support the FDA’s decision. To date, the FDA has not responded to this request.MAY 2008: More than a dozen professional medical associations, all substantially funded or supportedby Wyeth, submit a joint letter to members of congress in support of the FDA’s actions, withoutdisclosing their ties to Wyeth.MAY 2008: US House Representatives Mike Ross (D-Ark.) and Jo Ann Emerson (R-Mo.) introduceresolution H.Con.Res.342 to counter the efforts of the FDA and Wyeth against compounded BHRT. The resolution states that the “FDA has acknowledged that it is unaware of any adverse events” associated with the use of estriol, and raises serious concern over the FDA’s move to ban the use of it. The resolution asks for a reversal of the FDA’s action, deeming it “not in the public interest.”JUN 2008: The International Academy of Compounding Pharmacists (IACP) visit Capitol Hill, and SenatorJohn Cornyn (R-Tex.) introduces a concurrent resolution, S.Con.Res.88, also asking for areversal of the FDA’s action because it does not serve the public interest.
  2. 1997: A Federal clinical trial, known as the Women’s Health Initiative (WHI), begins to evaluate theeffectiveness of Premarin¼ and Prempro¼ (FDA-approved drugs manufactured by Wyeth). These were – and still are – the most commonly prescribed treatment for menopausal symptoms such as hot flashes and vaginal dryness, having been on the market since the early 1940s.JUL 2002: Federal officials abruptly halt a phase of the WHI study after finding increased rates of breastcancer, heart attack, and stroke in the women taking Prempro.FEB 2004: Federal officials halt another phase of the WHI study after finding increased rates of stroke anddementia in the women taking Premarin.2002-present: Wyeth’s sales of Premarin plummet (from more than $2 billion in 2001 to $880 million in 2004) as women and their practitioners evaluate alternative treatments for menopausal symptoms, with many switching to custom compounded BHRT prescriptions.OCT 2005: Wyeth files a “citizen petition” requesting that the FDA essentially ban all bioidentical hormones that compete with their products.AUG 2006: A Texas District Court rules that pharmaceutical compounding upon the order of a licensedprescriber is not considered a “new drug” and therefore not subject to FDA scrutiny. The FDA appeals the case, and Wyeth continues to advocate banning all BHRT compounding on behalf of the FDA.JAN 2008: The FDA issues a warning letter to seven compounding pharmacies (2 more letters were issuedthereafter), threatening to ban BHRT, specifically any compound containing estriol, which is an ingredient in about 80% of BHRT. The letter also bans any false claims of safety or efficacy, including banning the use of the term “bioidentical,” even though it is commonly used in marketing some FDA-approved drugs. The letter indicates that the FDA may broaden the threat to all compounding pharmacies that provide BHRT.MAR 2008: The FDA issues a warning letter to suppliers of compounding pharmacies regarding theirdistribution of bulk estriol.APR 2008: The FDA issues an “Import Alert” cutting off the supply of estriol and other ingredients of custom compounded BHRT.APR 2008: A huge public response to the FDA’s actions regarding BHRT prompts Senator Tom Coburn,MD, to request “documentation of specific adverse events and demonstrated safety issues related to the use of estriol” and other details on the research or studies that support the FDA’s decision. To date, the FDA has not responded to this request.MAY 2008: More than a dozen professional medical associations, all substantially funded or supportedby Wyeth, submit a joint letter to members of congress in support of the FDA’s actions, withoutdisclosing their ties to Wyeth.MAY 2008: US House Representatives Mike Ross (D-Ark.) and Jo Ann Emerson (R-Mo.) introduceresolution H.Con.Res.342 to counter the efforts of the FDA and Wyeth against compounded BHRT. The resolution states that the “FDA has acknowledged that it is unaware of any adverse events” associated with the use of estriol, and raises serious concern over the FDA’s move to ban the use of it. The resolution asks for a reversal of the FDA’s action, deeming it “not in the public interest.”JUN 2008: The International Academy of Compounding Pharmacists (IACP) visit Capitol Hill, and SenatorJohn Cornyn (R-Tex.) introduces a concurrent resolution, S.Con.Res.88, also asking for areversal of the FDA’s action because it does not serve the public interest.
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  22. Fatigue or feeling tired is the number one complaint you will hear from patients. Patient’s will be napping in the middle of the day before receiving the pellets.Less energy: patients are always taking breaks, but after pellets, they will say, “boy I can achieve so much in a day now”Poor Sleep: I’m finally sleeping all through the nightLibido: Drastically increased in both men and women and women especially think about sex everyday whereas, before pellet therapy interest was zeroHot flashes: Usually eliminated in three days timePainful intercourse from vaginal dryness: you will have patients who will say, “This saved my marriage”, Before pellets, intercourse was so painful and now I enjoy being with my husband again, we were close to a divorce, the change usually happens within five days timeDry skin: Oils return to the skinAnxiety: Level of stress is reducedMigraine/Menstrual headaches: Usually cause by Menstrual cycle and alleviated with pellet therapyWeight gain: Pellets hormone therapy give the patient the energy and in most cases patient feels like exercising and will lose weight on a diet whereas, before pellets patients were yo-yo dieters and would gain weight after being on a diet for 2 weeks.Depression: Almost 99.9% of patient on SSRI’s will come off their medication as a result of BHRT. Men and women who take SSRI’s have sexual dysfunction or find it very difficult to have an orgasm.Memory Loss: Drastically improved with pellet therpyFibromyalgia: Symptoms are somewhat mitigated. Palpitations: Patien usually sees relief within 1 to 2 daysOsteoporosis, Fosomix, Bonevia chemically harsh and causes esophageal erosion. You need both testosterone and estradiol to increase bone densityHair Loss: Patients will notice hair thickness returningFood Cravings: Major cause weight gain seems to diminishIrritability: the percentages of divorce after age 50 is staggering! Husbands say, “I’m out of here! I can’t take her mood swings anymore.Painful Joints: Aches seem to diminishMuscle Loss: Testosterone helps rebuild muscleIrregular Menstruation: Patient’s Menstrual Cycle has more of a rhythm Overly Emotional: Patient tend to be happier therefore do not seem to become over emotional in stressful situationsLack of Self Esteem: Patients feel better and look better which leads to feeling good about themselves.Restless Leg Syndrome: Becomes a problem of the past because patients fall asleep quickly and sleep for a full eight hoursChronic Fatigue Syndrome: Symptoms are alleviated.
  23. BCRP’s Breast cancer resistance proteins
  24. BCRP’s Breast cancer resistance proteins
  25. BCRP’s Breast cancer resistance proteins
  26. BCRP’s Breast cancer resistance proteins
  27. BCRP’s Breast cancer resistance proteins
  28. BCRP’s Breast cancer resistance proteins
  29. BCRP’s Breast cancer resistance proteins
  30. BCRP’s Breast cancer resistance proteins
  31. BCRP’s Breast cancer resistance proteins
  32. BCRP’s Breast cancer resistance proteins
  33. BCRP’s Breast cancer resistance proteins
  34. BCRP’s Breast cancer resistance proteins
  35. Variability of hormone concentrations from one hour to next (half life too short)Concentration elevates quickly and in short time is so low and essentially ineffective Almost impossible to elevate the concentrations  high enough to be of practical  benefit to relieve symptomsNon-Compliance because patient often forgets to take as directed Pellet hormone therapy is a remarkably simple, hassle free method of natural hormone replacement that can return you to the balance and well being of healthy hormone levels. With balanced hormones, you can once again look your best and feel healthy, sexual and alive!
  36. Burris et al. found Hypogonadal Men have statistically significant reductions in Incidence of Nocturnal ErectionsDegree of Rigidity During ErectionFrequency of Sexual ThoughtsFeelings of DesireSexual FantasiesAre pellets a good way to deliver testosterone?There is no better, safer or more convenient way to deliver testosterone in men and women than with pellets.  In men, the pellets deliver healthy levels of testosterone while maintaining normal levels of estrogen.  Men should be tested as soon as symptoms develop which is usually between 45 and 55 years of age.  Some men need to be tested and treated even earlier. It is never too late to improve your health with hormone therapy.Testosterone is needed for optimal health in women.  Testosterone delivered by pellets does not increase the risk of breast cancer or liver failure like oral, synthetic methyl- testosterone.
  37. Who Gets ED?Sexual dysfunction and ED become more common as men age. According to the Massachusetts Male Aging Study, about 40% of men experience some degree of ED at age 40 compared with 70% of men at age 70. And the percentage of complete ED increases from 5% to 15% as age increases from 40 to 70 years. But this does not mean growing older is the end of your sex life. ED can be treated at any age.
  38. Vitality Medical Clinix
  39. Fatigue or feeling tired is the number one complaint you will hear from patients. Patient’s will be napping in the middle of the day before receiving the pellets.Less energy: patients are always taking breaks, but after pellets, they will say, “boy I can achieve so much in a day now”Poor Sleep: I’m finally sleeping all through the nightLibido: Drastically increased in both men and women and women especially think about sex everyday whereas, before pellet therapy interest was zeroHot flashes: Usually eliminated in three days timePainful intercourse from vaginal dryness: you will have patients who will say, “This saved my marriage”, Before pellets, intercourse was so painful and now I enjoy being with my husband again, we were close to a divorce, the change usually happens within five days timeDry skin: Oils return to the skinAnxiety: Level of stress is reducedMigraine/Menstrual headaches: Usually cause by Menstrual cycle and alleviated with pellet therapyWeight gain: Pellets hormone therapy give the patient the energy and in most cases patient feels like exercising and will lose weight on a diet whereas, before pellets patients were yo-yo dieters and would gain weight after being on a diet for 2 weeks.Depression: Almost 99.9% of patient on SSRI’s will come off their medication as a result of BHRT. Men and women who take SSRI’s have sexual dysfunction or find it very difficult to have an orgasm.Memory Loss: Drastically improved with pellet therpyFibromyalgia: Symptoms are somewhat mitigated. Palpitations: Patien usually sees relief within 1 to 2 daysOsteoporosis, Fosomix, Bonevia chemically harsh and causes esophageal erosion. You need both testosterone and estradiol to increase bone densityHair Loss: Patients will notice hair thickness returningFood Cravings: Major cause weight gain seems to diminishIrritability: the percentages of divorce after age 50 is staggering! Husbands say, “I’m out of here! I can’t take her mood swings anymore.Painful Joints: Aches seem to diminishMuscle Loss: Testosterone helps rebuild muscleIrregular Menstruation: Patient’s Menstrual Cycle has more of a rhythm Overly Emotional: Patient tend to be happier therefore do not seem to become over emotional in stressful situationsLack of Self Esteem: Patients feel better and look better which leads to feeling good about themselves.Restless Leg Syndrome: Becomes a problem of the past because patients fall asleep quickly and sleep for a full eight hoursChronic Fatigue Syndrome: Symptoms are alleviated.
  40. BCRP’s Breast cancer resistance proteins
  41. BCRP’s Breast cancer resistance proteins
  42. BCRP’s Breast cancer resistance proteins
  43. BCRP’s Breast cancer resistance proteins
  44. BCRP’s Breast cancer resistance proteins
  45. BCRP’s Breast cancer resistance proteins
  46. BCRP’s Breast cancer resistance proteins
  47. BCRP’s Breast cancer resistance proteins
  48. BCRP’s Breast cancer resistance proteins
  49. BCRP’s Breast cancer resistance proteins
  50. BCRP’s Breast cancer resistance proteins
  51. BCRP’s Breast cancer resistance proteins
  52. BCRP’s Breast cancer resistance proteins
  53. BCRP’s Breast cancer resistance proteins
  54. BCRP’s Breast cancer resistance proteins
  55. BCRP’s Breast cancer resistance proteins
  56. BCRP’s Breast cancer resistance proteins
  57. BCRP’s Breast cancer resistance proteins
  58. BCRP’s Breast cancer resistance proteins
  59. BCRP’s Breast cancer resistance proteins
  60. BCRP’s Breast cancer resistance proteins
  61. BCRP’s Breast cancer resistance proteins
  62. BCRP’s Breast cancer resistance proteins
  63. BCRP’s Breast cancer resistance proteins
  64. BCRP’s Breast cancer resistance proteins
  65. BCRP’s Breast cancer resistance proteins
  66. BCRP’s Breast cancer resistance proteins
  67. BCRP’s Breast cancer resistance proteins
  68. BCRP’s Breast cancer resistance proteins
  69. BCRP’s Breast cancer resistance proteins
  70. BCRP’s Breast cancer resistance proteins
  71. BCRP’s Breast cancer resistance proteins
  72. BCRP’s Breast cancer resistance proteins
  73. Vitality Medical Clinix
  74. Vitality Medical Clinix
  75. Vitality Medical Clinix
  76. Vitality Medical Clinix
  77. Vitality Medical Clinix
  78. 1997: A Federal clinical trial, known as the Women’s Health Initiative (WHI), begins to evaluate theeffectiveness of Premarin¼ and Prempro¼ (FDA-approved drugs manufactured by Wyeth). These were – and still are – the most commonly prescribed treatment for menopausal symptoms such as hot flashes and vaginal dryness, having been on the market since the early 1940s.JUL 2002: Federal officials abruptly halt a phase of the WHI study after finding increased rates of breastcancer, heart attack, and stroke in the women taking Prempro.FEB 2004: Federal officials halt another phase of the WHI study after finding increased rates of stroke anddementia in the women taking Premarin.2002-present: Wyeth’s sales of Premarin plummet (from more than $2 billion in 2001 to $880 million in 2004) as women and their practitioners evaluate alternative treatments for menopausal symptoms, with many switching to custom compounded BHRT prescriptions.OCT 2005: Wyeth files a “citizen petition” requesting that the FDA essentially ban all bioidentical hormones that compete with their products.AUG 2006: A Texas District Court rules that pharmaceutical compounding upon the order of a licensedprescriber is not considered a “new drug” and therefore not subject to FDA scrutiny. The FDA appeals the case, and Wyeth continues to advocate banning all BHRT compounding on behalf of the FDA.JAN 2008: The FDA issues a warning letter to seven compounding pharmacies (2 more letters were issuedthereafter), threatening to ban BHRT, specifically any compound containing estriol, which is an ingredient in about 80% of BHRT. The letter also bans any false claims of safety or efficacy, including banning the use of the term “bioidentical,” even though it is commonly used in marketing some FDA-approved drugs. The letter indicates that the FDA may broaden the threat to all compounding pharmacies that provide BHRT.MAR 2008: The FDA issues a warning letter to suppliers of compounding pharmacies regarding theirdistribution of bulk estriol.APR 2008: The FDA issues an “Import Alert” cutting off the supply of estriol and other ingredients of custom compounded BHRT.APR 2008: A huge public response to the FDA’s actions regarding BHRT prompts Senator Tom Coburn,MD, to request “documentation of specific adverse events and demonstrated safety issues related to the use of estriol” and other details on the research or studies that support the FDA’s decision. To date, the FDA has not responded to this request.MAY 2008: More than a dozen professional medical associations, all substantially funded or supportedby Wyeth, submit a joint letter to members of congress in support of the FDA’s actions, withoutdisclosing their ties to Wyeth.MAY 2008: US House Representatives Mike Ross (D-Ark.) and Jo Ann Emerson (R-Mo.) introduceresolution H.Con.Res.342 to counter the efforts of the FDA and Wyeth against compounded BHRT. The resolution states that the “FDA has acknowledged that it is unaware of any adverse events” associated with the use of estriol, and raises serious concern over the FDA’s move to ban the use of it. The resolution asks for a reversal of the FDA’s action, deeming it “not in the public interest.”JUN 2008: The International Academy of Compounding Pharmacists (IACP) visit Capitol Hill, and SenatorJohn Cornyn (R-Tex.) introduces a concurrent resolution, S.Con.Res.88, also asking for areversal of the FDA’s action because it does not serve the public interest.