Transcript Hormone Balance 2004

Hormone Balance
& Health
Rebecca L. Glaser M.D., F.A.C.S.
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www.hormonebalance.org
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Conventional Medicine
• The fifth leading cause of death in the United States
is prescription medications given in the correct dose
• 2.2 million people per year have an ‘in hospital’
adverse reaction to drugs
• 7.5 million unnecessary medical and surgical
procedures are performed per year
• Total number of deaths caused by conventional
medicine is 800,000 per year
• Overmedicating seniors
– The average senior receives 20 new prescriptions per year
– Common side effects include confusion, dizziness, apathy,
problems with balance, memory and sedation
Balance
• Hormones, in balance, are critical to health
and disease prevention
• Hormones, in balance, protect against breast
cancer
• Hormones out of balance, may contribute to
an increased risk of breast cancer
• Synthetic chemical hormones (Prempro, Provera,
Estratest, Methyl testosterone) increase the risk of
breast cancer
• Diet and lifestyle are critical to
hormone balance and overall health
• Stress affects hormone balance
Conventional HRT
Women's Health Initiative Trial
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Prempro, Premphase, Provera
41% increase in strokes
29% increase in heart attacks
26% increase in breast cancer
Twice the rate of blood clots
Possible contributor to Alzheimer's
vs.
• Estrogen alone arm (Premarin)
– No increase in breast cancer
Synthetic (Chemical) Progestins
• Increase the risk of breast cancer
• Increase the risk of heart disease
– Coronary vasoconstrictor
– Negate the beneficial effects of estrogen
• Fluid retention and edema
• Increase incidence of blood clots
– Venous thrombosis
– Pulmonary embolism
– Stroke
• Cause weight gain
Synthetic Progestins (cont.)
• Negative effect on mood, mental status and
well being
• Increase the risk of dementia
• Headaches
• Birth defects
• Hair loss
• Acne, skin discoloration
• Patentable…profitable
Progesterone
• Does not increase the risk of breast cancer
• Does not have toxic effects on the vascular
system
– Does not negate the beneficial effects of estrogen
– Vasodilator
• Does not adversely affect lipids
• Neuro-protective
• Necessary to maintain pregnancy
Synthetic chemical v.s. hormone
Provera
is not
Progesterone
So, how can they say…
• “But there's no evidence that
bioidenticals are any safer and they
may even have other risks”
Dr. Robert Vigersky AMA
“…the risks and benefits of all
estrogens and all progesterones
are equivalent.”
Rossouw 07 WHI branch of the NIH
Million Women Study 1,084,110
• No difference between ‘estrogen formulations’
– Topical vs. oral, Estradiol vs. Premarin vs. Ethinyl-estradiol
– BUT Vaginal estrogen therapy (estriol) did NOT increase the
risk of breast cancer RR 0.67
• No difference between synthetic chemical ‘progestins’
– BUT Progesterone, the hormone, was not used in the study
2003 Lancet
Fournier 07 (BCRT)
• ‘E3N’ French Prospective Cohort Study 1990
– 98,995 women 40-65 risk factors for cancer
• Results on >80,000 post menopausal women
– Estrogen alone increased the risk of breast cancer
– No difference between oral estrogen (RR 1.32)
and percutaneous/TD estrogen (RR 1.28)
• Oral 13/3598 Non-oral 56/14,826
– Progesterone (RR 1.0) did not increase the risk of
breast cancer vs. synthetic progestins (RR 1.69)
– Oral or vaginal estriol (RR 0.7) or Promestriene
did not increase the risk of breast cancer (RR 0.9)
Bioidentical (Human) Hormones
• Are chemically converted from yams or soy and are
identical in composition to human hormones
• Are not patentable
• Have been used in Europe (and the US) for over 60
years
• Have been extensively researched
• Estradiol, progesterone, and testosterone are FDA
approved
– FDA approval is required for implanted medical devises and
medications which are to be marketed to the public
• In balance, they do NOT have the same risks as
CHRT
Patented/Conventional
Bio-identical Hormones
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Prometrium
Crinone, Utrogestin
Estrace, Climera
Estraderm, Vivelle
Estrogel, Sandrena
Androgel, Testim
Androderm
ESTring, Menoring,
Femring
• Vagifem
• Ovestin (OTC, Europe)
• Ovesterin (not Synapause)
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Cortef
Saizon, Genotropin
Cytomel (T3)
Synthroid (T4)
Pellets (Australia, South
Africa, UK and US)
– Fused testosterone
– Riselle (E2 25 mg, Organon)
– Testopel
Bio-identical Hormones
• Compounded
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Estrone
Estradiol
Estriol
Progesterone
Testosterone
DHEA
Cortisol
HGH (reconstituted)
T3
T4
• Methods of delivery
– Oral
– Topical
• Creams
• Gels
– Sublingual drops, troches
– Vaginal/mucous
membrane
• Cream
• Suppository
– Pellets
– SQ injection
Estrogens
• Estrone (E1)……SHBG
• Estradiol (E2)…..SHBG
• Estriol (E3)
metabolites
metabolites
– Bi-Estrogen
– Used in Europe both orally and vaginally (OTC)
• Data on vaginal and oral use
– Absorption, efficacy, side effects
• Vaginal estriol does not stimulate the uterine lining or breast
tissue
• Vaginal estriol does NOT increase the risk of breast cancer
• Does not cause weight gain or fluid retention
• Vaginal estriol increases bone density
• Lack of data on topical use (skin)
Balance
Balance vs. Estrogen Dominance
• Estrogen dominance is
a condition in which
there is too much
estrogen, especially
the stronger estrogens,
insulin and chemical
estrogens in proportion
to the balancing phytonutrients, progesterone
and testosterone.
Estrogen
• Estrogen dominance (diet & lifestyle)
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Weight gain, fluid retention
Anxiety, irritability, depression, fatigue
Insulin resistance
Breast pain, FCD, endometriosis, fibroids
Increased risk of breast and uterine cancer
• Estrogen deficiency
– Breast loose fullness
– Low body fat, cannot maintain weight
– (Hot flashes, insomnia, bone loss, depression etc.
see testosterone deficiency)
Prevention of Estrogen Dominance
• Balanced hormone therapy
– Testosterone
– Progesterone (NOT progestins)
• Stress Reduction
• Get rid of chemicals, pesticides etc.
• Improved diet, reduce carbohydrates, whole
foods
– Lower insulin levels
• Exercise
• Fiber / supplements / flaxseed
Hormone Deficiency
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Hot flashes, night sweats
Vaginal dryness, urgency, incontinence
Breast loose fullness (estrogen)
Insomnia
Heart palpitations
Bone loss, aches, pains
Thinning skin, hair loss
Heart disease
Brain deterioration, memory loss
Progesterone Excess
• Sleepiness
– Metabolites from oral progesterone
– Hepatic overload
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Breast tenderness
Mild depression
Bloating
Water retention
Testosterone Deficiency
• Levels decline with age in both men
and women
– A 40 yo woman has half the testosterone as a 20 yo
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Decreased libido, erectile dysfunction
Decreased energy, fatigue, lack of endurance
Depression
Lack of motivation, self confidence, insecure
Anxiety, emotional lability, overwhelmed
Sleep disturbances, insomnia, sleep apnea
Decreased concentration, memory loss
Testosterone deficiency
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Bone loss, muscle mass loss
Increased fat
Aches, pains, decreased coordination
Hot flashes, vaginal dryness, incontinence
Dry, thinning skin, wrinkles, hair loss
Alzeheimer’s and Parkinson’s
Increased heart disease
Diabetes, metabolic syndrome
Anemia, poor immune function
Methyl-testosterone
is not
Testosterone
Archives of Internal Medicine
• Oral, synthetic, chemical methyl testosterone
increased the risk of breast cancer
– Estratest
• Non-oral, testosterone (hormone) prevents the
stimulation of breast tissue and lowers the risk of
breast cancer
Cortisol
• Produced in the adrenal gland from progesterone and
androstenedione
• It is the body’s major defense against stress,
including infections & injuries
• Natural anti-inflammatory hormone
• Critical for function of the
immune system
• Involved in blood sugar
regulation
Cortisol Deficiency
• Fatigue, immune dysfunction
– Infections, pneumonia
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Sugar cravings, salt cravings
Low blood pressure, weak rapid heartbeat
Allergies, asthma, hives, itching, eczema
Sinusitis, chemical sensitivities, dermatitis
Aches, pains, muscle stiffness
Arthritis
Saliva testing to diagnose
Cortisol Excess High potency steroids, chronic stress
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Fatigue
Sleep disturbances
Bone loss
Weight gain waist
Loss of muscle mass, thinning skin
Memory lapse, anxiety
Cortisol (5 mg three times daily or 10 mg twice daily)
• A physiologic dose (up to 20-30 mg per day) of
cortisol does NOT cause:
– Bone loss
– Weight gain
– Elevated glucose, sugar cravings (a normal level of cortisol
regulates blood sugar)
– Anxiety, sleep disturbances
– Thinning skin, easy bruising
– Suppression of the immune system
– Suppression of endogenous adrenal production (it takes 40
mg of cortef for at least 3 months to suppress your natural
cortisol production)
Wichers 99, Jodar 03, McConnell 02, McK.Jefferies 96
Side effects
• Vioxx: CVA, CHF, DVT, MI, PE, HTN crisis,
acute renal failure, GI bleed, liver failure, death
• Mobic: face edema, anaphylactic rxn, CHF,
HTN, MI, dyspnea, liver failure, ulcers, death
• Celebrex: Heart failure, kidney failure, fainting,
HTN, ringing in ears, deafness, ulcers,
bleeding, blurred vision, death
Thyroid Deficiency
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Basal Body T < 97
TSH > 3.0, low T4 or T3
Decreased metabolism
Weight gain
Fatigue, lack of endurance
Muscle weakness, joint stiffness, aches
Headaches, decreased concentration, brain fog,
memory problems
• Dry skin, dry brittle hair, hair loss (balding all over)
• Loss of lateral 1/3 of eyebrow, diminished reflexes
• Elevated cholesterol, increased ASHD
Wren 1971
• 347 patients, ages 43-86, high risk/sx. Heart dz.
• 9% low thyroid by testing
• Treated all patients with Thyroid hormone
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Mortality decreased by 50%
70% reduction in episodes of chest pain
50% reduction in heart attacks
22% reduction in cholesterol
80% of patients felt better, more alert & motivated
Thyroid Excess
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Weight loss/gain
Fatigue, weakness, decreased muscle mass
Shakiness, restlessness, rapid heartbeat
Shortness of breath
Heat intolerance, increased thirst, sweating
Anxiety, panic attacks
Hair loss, brittle nails
Elevated Insulin = weight gain
• Increases inflammation: increases the risk of
heart disease, arthritis, and cancer
• Increases hunger and obesity
• Increases LDL & Triglycerides/decreases
HDL
• Decreases lifespan
Hormone Imbalance
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Symptoms overlap
Men and women at any age
GET TESTED
Low normal may not be optimal for health
Many labs do not have ‘age specific ranges’
Guideline and ranges change
– New ranges for TSH (thyroid)
Testing
• Blood: Estradiol, FSH, Testosterone (total and free),
(Estriol and Progesterone ng/ml, not tested)
Thyroid Panel (free T4, TSH, free T3, TPO)
Men also need a PSA, Hb & Hct, Hepatic panel
• Saliva: Profile I (estradiol (E2), progesterone, testosterone,
DHEAS, and cortisol)
Profile II (as above, am and pm cortisol)
• 24 hour Urine
Bioidentical Hormone Replacement
Rx. or compounded
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Capsules (oral)
Creams/gels (skin)
Vaginal Suppositories and Creams
Sublingual lozenges/drops
Patches
• Pellets (testosterone, estradiol)
Oral Capsules
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Most convenient
Absorb best with a fatty meal
First pass through the liver (metabolites)
Testosterone converts to estradiol and is rapidly
degraded
• Conventional (oral) HRT has been shown to cause
liver damage and increase the risk of thrombosis
(blood clots)
• Variability in absorption
• FDA approved estradiol and progesterone
Creams & Gels
• Variability in absorption: individual, site, surface area,
thickness of skin and base
• Depot effect (especially progesterone)
• Maintains a consistent level of hormones in the
bloodstream avoiding the peaks and valleys
• Avoids first pass through the liver
• Does not increase the risk of blood clots
• Can transfer hormones through skin contact
• Lack of data on Bi-est
• FDA approved
– Estradiol for women
– Testosterone for men
Mucous Membrane/ Vaginal
Application
• Consistent absorption
– Relieves menopausal symptoms
• Relieves vaginal dryness, urinary urgency,
frequency, incontinence and repeated UTI’s
• Safe
– Vaginal estrogens (estriol) do not increase the risk
of breast cancer
– No increase in blood clots or metabolites
• Do not develop tolerance
• No accumulation of hormones or metabolites
Vaginal application of hormones
cont.
• Deliver multiple
hormone in a single
cream
– Convenient
– Cost effective
• Small volume of cream
• Applied 3 to 6 times
weekly
• Can transfer to spouse
Sublingual Drops & Troches
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Avoids first pass through the liver
Rapid onset of action
Careful not to swallow saliva
Multiple doses to maintain blood levels
Drops make it easy to increase or decrease
dosage which is useful in perimenopause
• Variability of absorption
Patches
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Patented products (delivery system)
Estradiol: Estraderm, Estradot, Vivelle Dot, Climara
Testosterone: Androderm (males $$$$)
Consistent delivery over time (…not)
Estrogen applied once or twice weekly
Testosterone applied daily
Only delivers estradiol (women)
– Strong estrogen
• Problems with adhesive, uncomfortable
Hormone Implants: Pellets
• Pellets made up of
either testosterone or
estradiol compressed
into very small, solid
cylinders
• There is an ‘FDA
approved’ 75 mg
testosterone pellet
• In the U.S. other
formulations and
dosages need to be
‘compounded’ by
trained pharmacists
Pellets/Implants
• Used in the United States since 1940
• Tremendous amount of data supporting use
– England, Australia and the US
• Only licensed form of testosterone for women in England
• Testosterone for men and women
• Rarely use an estradiol pellet in women
– Young women with a surgical hysterectomy
– Need to gain weight
– Problems with bleeding
Hormone Implants cont.
• More effective than oral or topical hormones
for relief of menopausal symptoms
• Most effective form of testosterone
replacement in men & women
• Not only maintains bone density but
increases bone density.
• Most consistent and convenient method of hrt
• Safe form of HRT
– Does not increase the risk of blood clots or strokes
– Does not effect the liver
– Testosterone implants are breast protective
Testosterone pellet implants
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Increases bone density and muscle mass
Decreases fatty tissue
Relieves depression, improves anxiety
Improves memory and concentration
Relieves joint and muscle pain
Improves sleep
Relieves hot flashes and
night sweats
• Improves sex drive and libido
Simple procedure
• The insertion of pellets is a
simple, 5 minute office
procedure done under local
anesthesia
• They are placed in the fatty
tissue just under the skin of
the hip or lower abdomen
• They completely dissolve
over time
– 3-5 months in women
– 4-6 months in men
Most successful HRT
(supported by data)
• Testosterone pellet implant: Men and Women
– Vaginal cream (2-6 days per week) may be added
in women
• Estriol
– Relieves vaginal and urinary symptoms
– Does NOT stimulate breast tissue
– Does NOT cause weight gain or fluid retention
• Estradiol (may leave out)
• Progesterone
– Does not accumulate, no metabolites, high dose to uterine
lining,
• (Testosterone if NOT used as a pellet implant)
– Not as effective as pellet implant (bone density,
depression, anxiety, aches, pains, libido, energy etc.)
Hormones in balance do not cause
breast cancer
• Hormones are critical for health
• High levels of unopposed strong estrogens
increase the risk of breast cancer
– Bio-identical estradiol and Premarin
– Vaginal estriol relieves menopausal symptoms and
does not increase the risk of breast cancer
• Synthetic chemical progestins (Provera) and
synthetic chemical testosterone (Methyl-test,
Estratest) increase the risk of breast cancer
• Progesterone, the hormone, does not increase
the risk of breast cancer
Hormones in balance do not cause
breast cancer
• Testosterone is breast protective
– Balances estrogen
– Prevents the proliferation of breast tissue by estrogen with
progestins
– Prevents the growth of breast cancer cells
– Lowers the risk of breast cancer
– Has been used to treat breast cancer
• Stress creates hormone imbalance and
increases the risk of breast cancer
– DHEA and cortisol are critical for immune function
• Cancer cells over-express insulin receptors and
feed on glucose
TI BCa P 0108
Testosterone Implant Breast Cancer Prevention Trial 0108
• Dimitrakakis, Glaser, Khera
• IRB approved 10 year, prospective trial
looking at the incidence of breast cancer in
women treated with testosterone implants
– A study from Australia found that women who
received testosterone pellet implants in addition to
estrogen/progestin therapy had a lowered risk of
breast cancer
Bio-identical hormone balance
• Hormones in balance maintain health and PREVENT
disease
• Hormones, in balance, do NOT increase the risk of
breast cancer
• Bio-identical hormones (not given orally) do not
increase the risk of blood clots
• Hormone replacement therapy should be
individualized
• Sensationalism sells news
• Pharmaceutical companies are powerful forces in
medicine, politics and the economy (in the US)
• Doctors often adamantly state what they ‘think’…
without research or knowledge
Conclusion
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BALANCE
Individual
Baseline Levels
Bioidentical Hormones
Diet and Lifestyle
Exercise
Disease Prevention
Active Participant
Commentary
56
Evista
Barrett-Connor 06
NEJM
• Effects of Raloxifene on CV Events and
Breast Cancer in Postmenopausal Women
• Raloxifene (Evista) SERM prevents bone
loss without stimulating breast or uterus
• 10,101 patients placebo or Raloxifene 5.6 yrs
Evista
• No effect on coronary events
• Raloxifene reduced the risk of invasive (ER pos)
breast cancer
– 40 vs. 70, 30 cases over 5 years in 5000 females, 1.2 breast
cancers per 1000 women per year
– No difference in death rate
• Raloxifene increased risk of:
– fatal strokes (59 vs. 39, .7 per 1000 women per year)
– venous thromboembolism (103 vs. 71, 1.2 per 1000
women years)
• Reduced the risk of clinical vertebral fx. (64 vs. 97)
Raloxifene (Evista)
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Prevented less than 1 (0.6) breast cancers per 100 patient treated for 5
years (.65 vert fx)
Cost 100 x 365 x 5 x $2 $365,000
– over $600,000 to prevent one breast cancer
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Side effects besides DVT, PE, Stroke
– More common
• Bloody or cloudy urine; chest pain; difficult, burning, or painful
urination; fever; frequent urge to urinate; infection, including body aches
or pain, congestion in throat, cough, dryness or soreness of throat, and loss
of voice; runny nose ; leg cramping; skin rash ; swelling of hands, ankles,
or feet; vaginal itching
– Less common
• Abdominal pain (severe); aching body pains; congestion in
lungs; decreased vision or other changes in vision; diarrhea ; difficulty in
breathing; hoarseness; loss of appetite; nausea; trouble in
swallowing; weakness
– More common
• Hot flashes, including sudden sweating and feelings of warmth (especially
common during the first 6 months of treatment); increased white vaginal
discharge; joint or muscle pain; mental depression; problems of stomach
or intestines, including passing of gas, upset stomach, or vomiting; swollen
joints; trouble in sleeping; weight gain (unexplained)
Rebecca L. Glaser M.D., FACS
Millennium Wellness Center
For Men & Women
937.436.9821
*****
www.hormonebalance.org