1. Hormone Therapy In A Medi-SpaHormone Therapy In A Medi-Spa
Rex Moulton-Barrett, MD
Plastic & Reconstructive Surgery
Alameda & Brentwood Ca
Is there a safe and evidence based: angle to support
the value of therapy ?

2. 55 Components of Hormone TherapyComponents of Hormone Therapy
Optima (4)Optima (4)
• Skinny Shot 40 day Weight Loss Program *
• Bioidentical Hormones for Women: topical *
• Bioidentical Hormones for Men: topical *
• Hormone therapy for Gynecomastia: oral *
• Growth Hormone Stimulation: oral *
• Growth Hormone Supplementation: sub-lingual / subcutaneous

3. Skinny Shot 40 Pound Weight LossSkinny Shot 40 Pound Weight Loss
• Beta Chorionic Gonadotrophin: Glyco - 244 polypeptide

4. HCG:HCG: PlacentaPlacenta < 1 week gestation< 1 week gestation
mIU/mlmIU/ml
• Non-pregnant: < 5.0Non-pregnant: < 5.0
• 3 weeks LMP:3 weeks LMP: 5 - 505 - 50
• 4 weeks LMP:4 weeks LMP: 5 - 4265 - 426
• 5 weeks LMP:5 weeks LMP: 18 - 7,34018 - 7,340
• 6 weeks LMP:6 weeks LMP: 1,080 - 56,5001,080 - 56,500
• 7 - 8 weeks LMP:7 - 8 weeks LMP: 7, 650 - 229,0007, 650 - 229,000
• 17 - 24 weeks LMP: 4,060 - 165,40017 - 24 weeks LMP: 4,060 - 165,400
• 25 - 40 weeks LMP: 3,640 - 117,00025 - 40 weeks LMP: 3,640 - 117,000
Postmenopausal females: < 9.5 mIU/mlPostmenopausal females: < 9.5 mIU/ml

5. Skinny Shot 40 Pound Weight LossSkinny Shot 40 Pound Weight Loss
• Contraindications:
1. Diabetic: oral agents & or insulin-hypoglycaemia
2. Pregnancy: check urine pregnancy, teratogenic?
3. Labile hypertension: may lower BP3. Labile hypertension: may lower BP
4. Polycystic ovaries; may rupture, rare: IM > subcut4. Polycystic ovaries; may rupture, rare: IM > subcut
5. Alopecia: may lead to hair loss5. Alopecia: may lead to hair loss
6. Breast & Testicular cancer: hormone dependency?6. Breast & Testicular cancer: hormone dependency?
7. Precocious puberty7. Precocious puberty
8. Labile migraines especially hormone related: menstrual8. Labile migraines especially hormone related: menstrual

6. Skinny Shot 40 Pound Weight LossSkinny Shot 40 Pound Weight Loss
• Kit sent to office: 40 syringe/needles, alcohol,
sharps, documentation sheets, reconstitute from
powder with sterile H2O and add
cyanocobalamin( B12 ), custom nutrient
supplement, first injection in office.
• 10,000 IU FDA approved human b HCG: Novarel
or Pregnyl, ‘human urine extraction’ derived,
versus considering a new Ovidrel derived by DNA
technology- sub-cutaneous

7. Skinny Shot 40 Pound Weight LossSkinny Shot 40 Pound Weight Loss
• Pregnyl: chorionic gonadotropin for injection FDAchorionic gonadotropin for injection FDA
approvedapproved
to: a. induce ovulation &to: a. induce ovulation &
b. induce pregnancy in women with anovulation,b. induce pregnancy in women with anovulation,
following pretreatment with human gonadotropinsfollowing pretreatment with human gonadotropins
( FSH and LH )( FSH and LH )
• Will not help women with primary ovarian failureWill not help women with primary ovarian failure
• OFF LABEL USE FOR WEIGHT REDUCTIONOFF LABEL USE FOR WEIGHT REDUCTION
•• Patients to sign off label use consent formPatients to sign off label use consent form

8. Skinny Shot 40 Pound Weight LossSkinny Shot 40 Pound Weight Loss
• Pregnyl® may causePregnyl® may cause OvarianOvarian
Hyperstimulation Syndrome (OHSS):Hyperstimulation Syndrome (OHSS): rarerare
cause of death.cause of death.
• OHSS causes fluid build up within theOHSS causes fluid build up within the
abdomen and chestabdomen and chest
• S/S: severe pelvic pain (lower abdomen),S/S: severe pelvic pain (lower abdomen),
nausea, vomiting, sudden weight gain, ornausea, vomiting, sudden weight gain, or
reduced urine output.reduced urine output.

9. Skinny Shot 40 Pound Weight LossSkinny Shot 40 Pound Weight Loss
• Pregnyl® may also cause rupture of ovarian cystsPregnyl® may also cause rupture of ovarian cysts
resulting in internal bleeding (hemoperitoneum),resulting in internal bleeding (hemoperitoneum),
multiple births, and artery blockage by a bloodmultiple births, and artery blockage by a blood
clot (arterial thromboembolism).clot (arterial thromboembolism).
• Other side effects with Pregnyl® includeOther side effects with Pregnyl® include
headache, irritability, restlessness, depression,headache, irritability, restlessness, depression,
fatigue, edema, and pain at the site of injection.fatigue, edema, and pain at the site of injection.

10. Skinny Shot 40 Pound Weight LossSkinny Shot 40 Pound Weight Loss
• Novarel:hCG : 10,000U 1 day after menotrophinsNovarel:hCG : 10,000U 1 day after menotrophins
for anovulationfor anovulation
• Patients usually received previous treatment withPatients usually received previous treatment with
gonadotropins: BRAVELLE® (urofollitropin),gonadotropins: BRAVELLE® (urofollitropin),
MENOPUR® REPRONEX® (menotropins)MENOPUR® REPRONEX® (menotropins)
• In males: non - anatomic cryptorchism,In males: non - anatomic cryptorchism,
hypogonadotrophic hypogonadism:hypogonadotrophic hypogonadism:
4,000U/3xwk4,000U/3xwk

11. Skinny Shot 40 Pound Weight LossSkinny Shot 40 Pound Weight Loss
• 8x8x5 box arrived Fed Ex Ground 3 Business days $ 7.56
• Vial in powder vial store at room temperature
• Reconstitute: 4mls of water & 6mls of vit B12 = 1,000 U/ml
( 10ml total ), store in refrigerator up to 35 days
• inject subcutaneous: 125-250U/day ie. 0.125-.25mls
• Subcutaneous anterior thigh/abdo, test H20 inj in office
• If menstruating wait until complete before starting
• High calorie diet first 2 days then a 500K cal diet/day
• No topical hormones or GH supplements doing HCG

12. Skinny Shot 40 Days: 1 lb. Weight/daySkinny Shot 40 Days: 1 lb. Weight/day
• 500 K Cal diet after first 2 days until 3 days after HCG
• Diet : 3 meals, 1 snack, 10 glasses of water
• Strict adherence to diet is critical
• Breakfast: one fruit
• Lunch & Dinner: 100g cooked meat, no fat, one vegetable, one fruit,
one melba toast or breadstick
• Snack: can substitute fruit from lunch
• 30 minutes mild exercise: walking
• Gentle laxative for constipation
• Full 40 day program
• Then resume 2,200-3,000K cal diet

13. Skinny Shot 40 Pound Weight LossSkinny Shot 40 Pound Weight Loss
• Claimed weight loss 30 pounds 26- 40 days
• Suggested to incorporate self additional
nutritional consult
• WE DO NOT PROMISE WEIGHT LOSS
• We weigh them each visit: no shoes, belt coat,
jacket
• Flip video success stories, consent for U Tube
success-videos and before & afters

14. Skinny Shot 40 Pound Weight LossSkinny Shot 40 Pound Weight Loss
EVIDENCE BASED MEDICINE
• FDA: no evidence it causes weight loss
• 500K Cal diet may be harmful long term
• 125 Units HCG s/c versus placebo: ineffective
• Sicia, et al, 1976: Am J Clin Nut 29, 940-948.
• Greenway, et al, 1977: West J Med 127, 461-463.
• Bosch B, et al, 1990. Human chorionic gonadotrophin and weight
loss. A double-blind, placebo-controlled trial. S Afr Med J 77:185-
189.
• Lijesen, etal, 1995. Brit J Clin Pharm 40: 237-243

15. Am Soceity of Bariatric Medicine Statement 1997

16. Bioidentical Hormones for Women
Choices of Compounded Optima Gel:
• Topical Testosterone and DHEA,
• Thyroid hormone (Armour Thyroid),
• Growth Hormone secretagogue (MediTropin),
• Antioxidants
• Multi-vitamins
• Vitamin D:Replesta botanical aromatase inhibitors:
• Estradiol and Progesterone creams

17. Bioidentical Hormones for Women
Purpurted Responses to daily topical hormones:
• Energy increase
• Sexual drive increase
• Reduction in peri-menapausal flushing
• Improved skin quality

18. Bioidentical Hormones for Women
Labs ordered from Quest
( Call Optima for preselected panel to fax to us:
1 877-216-8004 option: 0 )
• Progesterone
• Estrogen
• Testosterone
• GH: IgF4
• Thyroxine
Repeat labs $130 6 and 12 months later

19. Bioidentical Hormones for Women
Method of application
• Topical
• Apply to clean moisturizer free surface
• Apply to Inside forearm or thigh
• Rub in until no longer visible 1/2 to 1 minute

20. Bioidentical Hormones for Men
Purported Effects
• Increased energy
• Increased sexual drive
• Increased muscle mass
• Increased hair thickness

21. Bioidentical Hormones for Men
Specific hormones measured in men:
• Testosterone
• DHEA
Testosterone

22. Bioidentical Hormones for Men
Specific hormones compounded
Optimus Gel:
• Botanical Aromatase inhibitors
• Reduce conversion testoterone to Estridiol
• may elevate testosterone
• without elevating estradiol

23. Bioidentical Hormones for Men
Risks of testosterone supplementation for normal ageing:
Risks include: sleep apnea
polycythemia
acne
prostate hyperplasia
gynacomastia *
limit sperm production *
( * Secondary to conversion to estrdiol )

24. Hormone Therapy for GynecomastiaHormone Therapy for Gynecomastia
Khan, HN, Rampaul, R, Blamey, RW, 2004. Breast 13(1), 61-5
Tamoxifen 20mg daily for 6-12 weeks 100% resolution lump type versus
62% fatty, non blinded, non placebo study
• In a double blind study vrs placebo: p < 0.005, long term results
• Can use up to 30mg/day
• Side effects: nausea, vomiting, flushes, liver, blood clots, boney pain
• Other druges effective:
Danazol 200mg/day for 3 months 8/42 failures: best for adults
Chomiphene 50mg/day for 3 months 5/12 failures

25. Growth Hormone Stimulation
• Meditrophan amino acid complex: oral sachet
• Purported to “Improve quality of life”
• For under 40 yr patients: causes elevation of GH
• No H and P and no baseline labs required
• However best to check IGF-1 prior tot starting
• Significant increase in IGF-1 level after 12 weeks
• =/- Follow-up labs every 3 months
• Unclear mechanism of action

26. Growth Hormone Stimulation
Purported Improvements ( < 40 yrs of age)
•< 6 weeks: skin improvement and energy increase
•< 3 months: increased exercise capacity
•< 6 months: decrease body fat,
increase muscle mass,
increase bone density,
reduced cholesterol profile,
lower diastolic BP

27. Growth Hormone Stimulation & or Injection
Contraindications:
• Active cancer < 5 yrs
• DM is not a contraindication
• Side effects:
edema
carpel tunnnel syndrome
acne
excessive muscle development
excessive sweating
difficulty with sleep ( check thyroid )

28. Is there really a visible evidence based support for the use
hormone therapy?