Interpreting the Results and How to Safely Prescribe

Interpreting the results and
how to safely prescribe
hormones and their dosage
Naina Sachdev MD:
NAINAMD™BEVERLY HILLS
www.nainamd.com
st
Overview of 1 visit BioHRT
•  Introduction to Anti- Aging Medicine, Functional
Medicine, and Integrative Medicine
•  Discussion on Safety of Bioidentical HRT
•  Pertinent Patient History
•  Pertinent Physical Exam
•  Discussion on Laboratory Data needed and other
Significant Data
•  Informed Consent
Introduction to Anti -Aging Medicine, Functional
Medicine, and Integrative Medicine
}  Conventional medicine is no longer an optimal model for
practicing medicine
}  Two Platforms to Retrain
◦  Functional Medicine
◦  Anti-Aging Medicine
Discussion of Safety of BioHRT
•  Involves more than just dispensing Bioidentical
Hormones
•  Discussion on types of Estrogens
A.  E1-estrones, E2-estradiol, E3-estriol
B.  Good Estrogens vs. Bad Estrogens
C.  Metabolization of estrogens is important in defining
the risk
•  Goal is to correctly prescribe Bioidentical HRT and
optimize estrogen metabolism
•  Synthetic vs. “Natural” Progesterone's
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not all progestin's are the same
•  Importance of Testosterone Replacement Therapy
•  Importance of DHEA
•  Importance of other hormones
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Thyroid
Cortisol
Insulin
Melatonin
Growth Hormone
Discussion on Safety of
Bioidentical HRT
}  Minimize dosages of Bioidentical HRT prescribing by optimization
of estrogen metabolism and balancing any existing system
imbalances in terms of Functional Medicine Approach
◦  Thyroid dysfunction
◦  Adrenal dysfunction
◦  Neurotransmitter imbalances
◦  Gastrointestinal imbalances
◦  Mitochondrial dysfunction
◦  Inflammation reduction
◦  Immune system imbalances
◦  Environmental Toxin Exposure reduction
◦  Diet Regimens
◦  Exercise Regimens
Treatment Goal of
Bioidentical HRT
•  Very Important to get patient history as it
relates to estrogen metabolization
Pertinent Patient History
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Hx of prolonged antibiotic use
Family hx of cancer
Fibrocystic Breast Disease
Hx of uterine fibroids
Hx of endometriosis
Hx of menstrual periods
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Hx
Hx
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Hx
Dysmenorrheal
Length of menstrual cycle
Duration of menstrual cycle
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how OCP’s were tolerated
PMS and/or severity of symptoms and/or type of sx’s
nicotine abuse
alcohol use
drug reactions
abnormal pap
weight fluctuations and ranges
hirstuitism
stressful life events
diet (eating patterns, typical foods etc)
other medical problems in particular what age they were diagnosed
surgeries including pregnancies
medications used and list of current meds
Pertinent Patient History
}  Thyroid exam
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Thyroid enlargement
Thyroid nodules
}  Cardiac exam
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Cardiac murmurs
Arrhythmias
Heart rate
}  Abdominal exam
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Liver enlargement
Pelvic mass
Gallbladder pathology
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Skin texture
Loss of muscle mass
Lip volume loss
Skin jowls
Dark circles under eyes
}  Muscle strength
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Fibromyalgia trigger points
}  Waist to Hip Ratios
}  Gynecologic Exam
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Pap Smear
Pelvic Exam
Pertinent Physical Exam
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Hormone Saliva Test
Adrenal Saliva Test
Serum Blood Tests for
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Lipids, Chemprofile, CBC
Serum ferritin
Hs-CRP , Homocysteine , Fibrinogen
HBA1C
Serum insulin
25-OH Vitamin D levels
Free T4, Free T3, TSH
CTX bone marker
If saliva tests nor performed then estrones, estradiol, total estrogens, free and total testosterone, sex hormone binding
globulin, DHEA-sulfate levels
Dexa Scan
Mammogram
Urinanalysis
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pH of urine
Specific gravity
Glucose screening
Protein screening
Practical Laboratory
Testing
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Body temperature chart
Adrenal Fatigue Questionnaire
Food Dairy x 7days
Body Composition Analysis:Body fat and muscle
mass percentages
Other Pertinent Data to
Obtain
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Have patient read informed consent form.
Must initial each page
Witness signature
Patient name on each page
Give copy to patient
Option: patient may bring back on 2nd office
visit
Informed Consent
Absolute Must Have:
•  Hormone saliva or serum blood tests for
hormones and other serum blood tests
•  Urinanalysis
•  Pap normal results within one year on file in chart
•  Mammogram results within one year on file in
chart
•  Dexa scan results within 2 years on file
•  Body temperature chart – pt brings back
•  Food dairy- pt brings back
•  Informed consent filed in chart
nd
2 office visit
prescribing BioHRT
•  Clear definition of symptoms patient wants
treated
•  Very important as symptoms MD thinks should
be treated is not what patient may want treated
•  This will guide the success of Bioidentical HRT
Symptoms of Patient
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Hot Flashes
Abdominal weight gain (even despite exercise regimen)
Fatigue
Insomnia
Mood irritability/ Mood Swings
Generalized Anxiety
Depression
Abnormal weight gain
Palpitations
Vaginal Dryness
Lack of Libido
Skin changes
Headaches
Sense of Urgency of Urination
Frequent Yeast Infections
Rashes
Food Intolerances
GERD
Lack of interest/ lack of passion different from depression symptoms
Hunger cravings
Common Sx’s Patient
Seeks BioHRT
•  Recognize each individual has own biochemical
individuality
•  Differences in relative amounts of
progesterone, estrogen and testosterone
•  Many combinations of which hormones are
declining more rapidly relative to each other
•  Perimenopausal state hormones fluctuate
•  Bioidentical hormone replacement therapy
must be customized in terms of dosage
Functional Medicine
Approach
•  Becoming very prevalent as exogenous sources
of estrogen continue to increase
•  Related to higher incidence of anovulatory
cycles occurring earlier in age
•  Excessive stimulation by estrogen without
adequate levels of progesterone
Recognizing estrogen
dominance
•  Herbicides and pesticides estrogen-like effects
•  Plastic containers & water bottles exposed to
high temperatures or very cold temperatures
•  Hormone driven meat and dairy products
•  Toxins and pollutants in the environment
•  Alcohol
•  Pharmaceutical and recreational drugs
Exogenous sources of
Estrogens
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Hot flashes and/or night sweats
Temperature fluctuations
Vaginal dryness
Trouble falling asleep
Palpitations
Mental fogginess
Depression
Weight gain
Arthralgias/back pain
Headaches
Diminished sex drive
Hair loss and/or hair thinning
Symptoms of Estrogen
Deficiency
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Breast tenderness
Breast enlargement or swelling
Fluid retention/ abdominal bloating
Pelvic cramping
Nausea
Mood irritability
Symptoms of Estrogen
Excess
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Insomnia or getting up in the middle of the night
Anxiety
Water retention/ abdominal bloating
Irregular menstrual periods or shorter cycles
Frequent or heavy periods
Spotting before menstrual period
PMS
Painful breasts
Endometriosis
Uterine fibroids
Hunger or sugar cravings
Leads to estrogen dominance
Symptoms of Progesterone Deficiency
Symptoms of Testosterone Deficiency
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Lack of libido
Loss of muscle mass “sagginess”
Muscle weakness
Decreased endurance or stamina
Decreased pubic and/or body hair
Hair loss/ hair thinning
•  Many different options
•  Estrogen Replacement:
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Transdermal vs. Oral vs Sublingual
Start with topical Bi-est cream (80/20) 1.25mg/ml ½ ml qd and titrate upward to ½ ml
bid topically groin area am and pm.
If no improvement of symptoms increase to topical Bi-est 2.5mg/ml (80/20) ½ ml qd
and titrate to bid topically
If too much then decrease to Bi-est (80/20) .625mg /ml ½ ml qd and titrate to bid
dosing
If still not balanced then start to vary percentages of estriol to estradiol
If any therapy not working then consider switching to gels, then sublingual forms, then
oral forms
Sites of application: groin area, intravaginally.
•  If experiencing vaginal dryness must add
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Estriol cream 1mg/ml with acidophilus 1ml intravaginally everyday and then decrease to
1-2x/wk as symptoms resolve
Acidiophilus should not be added in patients lactose intolerant
Prescribing Bioidentical
HRT
•  Progesterone Replacement
•  Transdermal vs oral vs Sublingual
•  Start with ranges of 50-150mg/ml ½ ml topically qd
at night and titrate upward by 12.5mg/ml every 10
days
•  If no improvement then consider switch to gel forms,
then to oral micronized progesterone
•  Oral micronized progesterone from 75mg/ml,
100mg/ml, 150mg/ml, 200mg/ml
•  If no improvement in insomnia symptoms then
consider adding melatonin or initiating targeted
amino acid therapy for inhibitory support
•  Sites of application: groin area, intravaginally,
Prescribing Bioidentical
HRT
•  Testosterone Replacement
•  Transdermal vs Sublingual Do not use oral forms
•  Start with topical testosterone cream
•  2mg/mlwith DIM 30mg/ml or chrysin 30mg/ml 1/4ml
titrate upward from ½ ml to ¾ ml and then ½ ml bid
•  If no improvement of symptoms increase to
testosterone cream 4mg/ml with DIM 6omg/ml or
chrysin 60mg/ml ¼ ml and titrate upward to max of
1ml dosage per day.
•  Sites of application: upper inner arm area, clitoral
area, intravaginally
Prescribing Bioidentical
HRT
•  Follow up in 4-6 wks
•  Make dosage adjustments on the prescribed
hormones
•  Discussion now on how to optimize estrogen
metabolism
•  Customize entire nutriceutical protocol
•  Evaluate for adrenal fatigue
•  Evaluate for thyroid dysfunction
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3 office visit
•  Good estrogens vs. Bad estrogens
•  Consider testing for 2-methoxyestrones/16 –
alpha hydroxyestrone ratio
•  Enhance hydroxylation and methylation
reactions in the liver of estrogens
•  Golden flax meal, tumeric, green tea extracts
5-methyl
•  tetrahydrofolic acid, kudzu, selenium,
•  Indole 3-carbinol and DIM
•  Omega-3 fatty acids
•  Gamma tocopherols
Optimizing Estrogen
Metabolism
EPA/DHA X 1-2 tabs po bid
Estroblock 2-4 tabs/day
Golden flax meal 1 tbsp/day
Green tea 1-2 cups decaf/day
Dr. Nick Delgado’s blended drink (bokchoy)
Vit D-3 1000IU/day (25-0H vit D serum levels
keep between 40-60)
•  Vitamin E succinate 400mg or gamma
tocopherols
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Recommended Nutriceutical Protocol
•  Multivitamins
•  Good B-complex vitamin that includes 5methyltetrahydrofolic acid
•  Selenium up to 200mcg/day
•  Calcium hydroxyapatite 1000-1500mg/day or
calcium citrate 1000-1500mg/day if hx of
nephrolithiasis
•  Vitamin C 1000-4000mg/day
•  Customized anti-oxidant protocols
Recommended Nutriceutical Protocol
}  Adrenal Saliva Testing
}  If cortisol levels high use rhodiolia 100mg/day and/or
phosphatidylserine 100mg 3 tabs in the evening.
}  Cortico B5B6
}  Herbal adaptogens: Exhiliran 1 tab am and afernoon and/or Adreset
1 tab am and afternoon
}  If fatigue persists then add adrenal glandulars or Cortef to the
regimen
}  Adrenal glandulars are also very effective
}  Lastly, initiate DHEA replacement therapy DHEA 5-25mg/day for
women orally, transdermal or sublingual spray or 50mg-150mg for
men and monitor DHEA-sulfate levels saliva or serum.
Adrenal Fatigue
Assessment
Thyroid Function Assessment
}  Common Symptoms Clinically presented
◦  Despite optimum bioidentical HRT and adrenal fatigue treatment
fatigue still persistent
◦  Hard to get up in the morning
◦  Lack of mental clarity
◦  Cold intolerance
◦  Abnormal sleep pattern
◦  Weight gain continues despite optimum exercise, diet and
bioidentical HRT and adrenal fatigue treatment
•  Laboratory Data
•  Free T4, Free T3, Reverse T3
•  TSH
•  Thyroid peroxides antibody, thymoglobulin
antibody
•  Iodine deficiency testing
•  Basal body temperatures
Thyroid Function
Assessment
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Mediterranean Diet
Anti-inflammatory Diet
Avoidance of corn, green beans, peas,
Food Allergy Assessment
Minimize wheat and dairy
Essential fats, complex carbohydrates, soluble fibers, bioavailability of
proteins
Adequate water intake- alkaline water
Cruciferous vegetables
Hormone free meats and dairy products
Organic vegetables and herbs
Green Tea
Bok Choy
Diet
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Type of cardio exercise is very important
Jump roping at least 10minutes 3-5x/wk
Circuit training
Lunges, squats, kicks
Upper body most common workout not always the most effective
Abdominal crunches upper and lower abs
Back strengthening exercises
Must vary routine
Enhance exercise with music that stimulates the excitatory
neurotransmitters
}  Weight bearing exercises with leg weights and arm weights
Exercise
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54 y/o c/o abdominal wt gain, hair loss, fatigue, headaches, postmenopausal x1 yr, lack of mental clarity
PMH
•  Hypothyroidism do's age 51 yrs
•  Hx of endometriosis
•  IBS
Screening Tests
•  Pap normal within a year
•  Mammogram within a year
•  Average basal body temperature < 97.4
Laboratory Data
•  Borderline hyperlipidemia
•  Elevated hs-CRP 4.5
•  Homocysteine 10.3
•  TSH 1.37 FT4 0.97 FT3 2.8
•  25-OH vitamin D 34
•  Saliva hormone test E1 (estrone) 3.0 (9.6-20) E2 (estradiol) 3.5 (<6) E3 (estriol) 30 (1-41)
•  Progesterone 421.5 ( < 159), testosterone 116.6 (25-190), DHEA-S 4.7 (2.5-25.0)
•  Adrenal saliva test results showed nl range cortisol levels and low nl DHEA-S levels and the DHEA-S/
cortisol ratio low
Case Study #1
•  As stress response becomes maladaptive,
reduction in DHEA and increase in cortisol
synthesis can occur.
•  Pregnenlone metabolism shifts to increased
glucocorticoid synthesis rather than the
mineralcorticoid or androgen pathways.
•  Saliva DHEA-S Ranges in nmol/L
•  Postmenopausal <6.5
•  Premenopausal with OCP’s 2.0-8.0
•  Premenopausal without OCP’s use 2.5-25
DHEA-S/Cortisol Ratio
•  Treatment 3rd office visit (hormone saliva test
results were not back)
•  Omega 3- fatty acids, gamma tocopherols,
actifolate, probiotics, vit D-3, Iodorol, liquid
minerals, estroblock, lean ‘n fit , whey protein
•  Compounded thyroid titrated dose up to T-3 GR
10mcg + T-4 75mcg GR po qd
•  Diet: hormone free meat and dairy, minimize
wheat, green tea, golden flax meal, our clinic list
of recommended foods
•  Already on MVI, calcium/mg supplementation,
vitamin C
•  Exercise regimen given
Case Study #1
•  Treatment 4th office visit
•  Pt had already done very well in just a few weeks.
•  Increased mental clarity
•  General increased sense of well being
•  BP dramatically improved
•  Fatigue significantly improved
•  IBS significantly improved
•  Started on HRT
•  Progest cream 50m/ml ½ ml topically and titrate upward pm
•  Bi-est cream .625mg/ml 1/2ml topically and titrate upward am
•  Testosterone cream 2mg/ml with DIM 30mg/ml 1/4ml upper
inner arm area am
•  After 3 wks of rx initiate DHEA 5mg po qd
Case Study #1
•  5th office visit
•  Feeling great
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Energy level optimum
Hair loss resolved
Headaches resolved
Libido improved
Weight loss 8 lbs
BP dramatic improvement
Increased exercise endurance and exercise frequency
Skin changes improved occ breakouts resolved
Mood improved and now feels like she did “years ago”
Now consider repeat saliva testing in 6mos to 1 yr depending on
how she does
Also consider serum 2/16 estrogen ratio testing after 1 yr to
assess estrogen metabolism
Case Study #1
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57 y/o c/o muscle aches, joint aches, fatigue, abdominal bloating and gas, emotional
swings from overwhelmed feelings to lack of motivation, she feels like she is “aging to
fast”, lack of libido, demised sexuality, lack of passion
PMH
•  H x of hypothyroidism
•  Postmenopausal intermittently on HRT for < 6 mos took herself off as she felt she
was not balanced had lots of breast tenderness, pelvic cramping, abdominal
bloating increased
•  Hx of pacemaker insertion 9/00
•  Osteopenia
Laboratory Data & Other pertinent Data
Saliva hormone test and adrenal saliva test
Neurotransmitter testing do if relevant
Serum lipids, 25-OH vitamin D, hs-CRP, homocysteine,ANA , HBA1c, TSH, FT4, FT3,
Fasting insulin, TPO
Urinanalysis
Dexa Scan
Mammogram
H&P including pap
Body temp chart
Food dairy x 1 week
Case Study #2
Case Study #2
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Hormone saliva tests results reviewed
◦  estradiol 1.7 pg/ml low read as normal range by lab no estrone levels or estriol levels calculated by lab
◦  Progesterone 10.4pg/ml low read as low by lab
◦  Ratio of Pg/E2 6.1 low read as low by lab
◦  Testosterone 7.9pg/ml low but read as normal range by lab
◦  DHEA 52.4pg/ml normal read as low by lab
◦  Cortisol in nmol/L
◦  Cortisol morning 3.9 read as low by lab
◦  Cortisol noon 2.2 read as normal by lab
◦  Cortisol evening 0.3 read as low by lab
◦  Cortisol night <0.3 read as low by lab
◦  No DHEA /cortisol ratio calculated by lab
Borderline high LDL , normal Chemprofile, CBC
Hs-CRP 0.7 Homocysteine 11.5 (<8.0)
HbA1c 5.6 Fasting insulin 2.0
TSH 0.38 FT4 1.54 FT3 2.9 TPO and TBG antibodies normal
ANA negative
Neurotransmitter test results showed low urine epinephrine, low urine-serotonin, low urine-norepinephrine, low
urine-dopamine, low urine-GABA
U/A normal
Dexa Scan shows she is continuing to have bone loss compared with previous study
Mammogram normal
Pap normal
•  Protocol
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Progesterone cream 50mg/ml start with 1/2ml topically pm and titrate to ¾
ml in 2 weeks
Testosterone cream 2mg/ml w/ DIM 30mg/ml start with 1/4ml and titrate to
½ ml topically qd am
Adrenal Fatigue regimen with herbal adaptogens
Omega-3 fatty acids 1 gram/day
DHEA 5mg sublingually
Probiotics
Estroblock 2 tabs/day
5-methyl and 5-formyl tetrahydrofolic acid and other B-vitamins
Calcium hydroxyapatite 100mg
Vit D-3 1000iU/day
Liquid Minerals
Whey Protein lactose free preferably
Policosanol
Plant sterols
Continue synthroid 100mcg po qd
Added armour thyroid 15mg po qd and then increased to 30mg po qd in two
weeks
Case Study #2
•  6
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week follow up visit
Mental clarity improved
Fatigue significantly improved
Mood significantly improved, accomplishing more tasks
in a day without feeling overwhelmed
•  Skin texture improved
•  Able to start to exercise
•  Improved libido
Ø  Now initiated Bi-est cream (80/20) .625mg/ml ¼ ml
topically and titrate to ½ ml topically qam
Ø  After another 6wks she felt back to her “normal self” and
losing weight especially from the abdomen
Case Study #2
Adrenal Saliva Test
Adrenocortex Stress
Profile
Result
(nmol/L)
Range
(nmol/L)
Cortisol Profile AM
21.6
6.0-42.0
Cortisol Profile
Afternoon
13.6
0.0-15.0
Cortisol Profile PM
(2)
7.4
2.0-11.0
Cortisol Profile
Evening
3.8
1.0-8.0
DHEAS Profile AM
0.4 l
2.5-25.0
DHEAS/ Cortisol
Ratio
0.02 l
0.20-0.60
Case Study #2
•  6 months later repeat hormone saliva test
results showed:
Salivary Estrogens
Result
(pmol/L)
Range
(pmol/L)
Estrone (E1)
41.4 h
9.6-20.0
Estradiol (E2)
<2.0 l
Estriol (E3)
<6.9 l
11.0-41.0
E3/[E1+E2]
0.16 l
>1.00
Progesterone
585.3 l
Testosterone
26.1
25.0-190.0
DHEAS
0.8 l
2.5-25.0
Case study #2
}  Interpretation of test results
}  The estradiol is low because she is converting to estrones. This is cause
for concern. Emphasis must be on optimizing estrogen metabolism.
}  She admitted she was not taking the estroblock which is key
nutriceutical that has DIM and chrysin and indole-3-carbinol and much
more.
}  She admitted she was not being compliant with diet recommendations.
}  Kept her at the same dosage with her bi-est and testosterone creams.
She increased her progesterone cream 50mg/ml to 1 ml topically qd.
}  Within 3 wks pt called stating she was having hunger cravings, weight
gain, and feeling depressed. Instructed to decrease the progesterone
cream 1/2ml topically to the same previous level and her symptoms
resolved.
Case Study #2
•  If patient is on oral estradiol or premarin then
may need to consider switching to tri-est which
is 10% etrones, 10% estradiol and 80% estriol
orally, then transdermal or sublingual. After
several weeks/months switch to bi-est.
•  If on oral synthetic progestin and having
insomnia then switch to oral micronized
progesterone 100-200mg dosage po qd. Then
consider switching to transdermal or sublingual
forms.
Switching from Synthetic
to Bioidentical HRT
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Progesterone replacement
Adrenal fatigue treatment
Thyroid dysfunction treatment
Targeted amino acid therapy
Exercise
Diet
Over the counter medication use
Insomnia Rx
•  Boron
•  Necessary for formation of steroid hormones
•  Clinical trial 3mg/day x7wks postmenopausal
women significant increase in 17-beta estradiol and
testosterone levels
•  Two fold increase in testosterone concentrations
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•  Reference Nielson FH,et al. Effect of dietary bone on
mineral, estrogen, and testosterone metabolism in
postmenopausal women FASEB J 1987:87:394-397
Nutritional Approach
Hormonal Enhancement
•  Success in resolving patients symptoms is
balance adrenal, thyroid and estrogen,
progesterone and testosterone hormones.
•  Start with transdermals and if they don’t work
switch to sublingual and then to oral.
•  Generally start low and titrate upward.
•  Clinical response and test results don’t always
correlate.
•  Individualize treatment.
Conclusion of Bioidentical HRT
}  Compounded hormones are NOT the same
}  Delivery systems
}  Common base preparations in transdermals
}  Delivery forms
}  Oil preparations and common oils used
}  Other ingredients used
}  Raw materials
}  Standards and quality controls
}  Stability of hormones
}  Important to have good relationship with compounding
pharmacy
Final Observation in
Prescribing Bioidentical
HRT
•  Patient leaves your office happy, energized and
says “thank you, I’m feeling great”.
Success of Bioidentical
HRT
•  “Estrogens have widespread biological actions,
and there are naturally occurring
phytoestrogens that mimic some of the actions
of endogenous estrogens. In this review we will
focus on new biochemical and molecular
aspects of action of estrogens as well as the
clinical and physiological influences {of their
metabolism}”.
•  N Engl J Medicine 2002; 346-340
Beneficial Estrogen Metabolism
•  “Estrogens are also metabolized by
hydroxylation and subsequent methylation to
form catechol and methoxylated estrogens.
Hydroxylation of estrogens yields 2-hydroxyl
estrogens, 4-hydroxyl estrogens by catechol
•  O-methyl transferase yields methoxylated
estrogen metabolism”.
•  N Engl J Medicine 2002; 346:340
Beneficial Estrogen Metabolism
•  Dietary Modifications of Estrogen Metabolism and
Sensitivity
•  “Integration of new genetic information into
epidemiological studies can help clarify causal
relations between life-style and genetic factors and
risks of disease. Thus a balanced approach should
provide the most effective choice about the most
effective means to prevent disease.
•  Willett, Science 2002; 296:69
Beneficial Estrogen Metabolism