Optima hormone therapy slideshare

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Hormone Therapy In A Medi-Hormone Therapy In A Medi-SpaSpa

Rex Moulton-Barrett, MD Plastic & Reconstructive Surgery Alameda & Brentwood Ca

Is there a safe and evidence based: angle to support the value of therapy ?

55 Components of Hormone Components of Hormone Therapy 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

Skinny Shot 40 Pound Weight Skinny Shot 40 Pound Weight

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• Beta Chorionic Gonadotrophin: Glyco - 244 polypeptide

HCG: HCG: PlacentaPlacenta < 1 week < 1 week gestationgestation

mIU/mlmIU/ml• Non-pregnant: < 5.0Non-pregnant: < 5.0 • 3 weeks LMP: 3 weeks LMP: 5 - 50 5 - 50 • 4 weeks LMP: 4 weeks LMP: 5 - 426 5 - 426 • 5 weeks LMP: 5 weeks LMP: 18 - 7,340 18 - 7,340 • 6 weeks LMP: 6 weeks LMP: 1,080 - 56,500 1,080 - 56,500 • 7 - 8 weeks LMP: 7 - 8 weeks LMP: 7, 650 - 229,000 7, 650 - 229,000 • 17 - 24 weeks LMP: 4,060 - 165,400 17 - 24 weeks LMP: 4,060 - 165,400 • 25 - 40 weeks LMP: 3,640 - 117,000 25 - 40 weeks LMP: 3,640 - 117,000

Postmenopausal females: < 9.5 mIU/mlPostmenopausal females: < 9.5 mIU/ml

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: 8. Labile migraines especially hormone related: menstrualmenstrual

9. Previous DVT and or PE9. Previous DVT and or PE’’ss

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• 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      

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LossLoss • Pregnyl: chorionic gonadotropin for injection FDA chorionic gonadotropin for injection FDA

approved approved

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 following pretreatment with human gonadotropins 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

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• Pregnyl® may cause Pregnyl® may cause Ovarian Ovarian Hyperstimulation Syndrome (OHSS):Hyperstimulation Syndrome (OHSS): rare cause of death. rare cause of death.

• OHSS causes fluid build up within the OHSS causes fluid build up within the abdomen and chest abdomen and chest

• S/S: severe pelvic pain (lower S/S: severe pelvic pain (lower abdomen), nausea, vomiting, sudden abdomen), nausea, vomiting, sudden weight gain, or reduced urine output.weight gain, or reduced urine output.

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LossLoss • Pregnyl® may also cause rupture of Pregnyl® may also cause rupture of

ovarian cysts resulting in internal bleeding ovarian cysts resulting in internal bleeding (hemoperitoneum), multiple births, and (hemoperitoneum), multiple births, and artery blockage by a blood clot (arterial artery blockage by a blood clot (arterial thromboembolism).thromboembolism).

• Other side effects with Pregnyl® include Other side effects with Pregnyl® include headache, irritability, restlessness, headache, irritability, restlessness, depression, fatigue, edema, and pain at the depression, fatigue, edema, and pain at the site of injection. site of injection.

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• Novarel:hCG : 10,000U 1 day after Novarel:hCG : 10,000U 1 day after menotrophins for anovulationmenotrophins for anovulation

• Patients usually received previous Patients usually received previous treatment with gonadotropins: treatment with gonadotropins: BRAVELLE® (urofollitropin), MENOPUR® BRAVELLE® (urofollitropin), MENOPUR® REPRONEX® (menotropins)REPRONEX® (menotropins)

• In males: non - anatomic cryptorchism, In males: non - anatomic cryptorchism, hypogonadotrophic hypogonadotrophic

hypogonadism: hypogonadism: 4,000U/3xwk4,000U/3xwk

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LossLoss • 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

Skinny Shot 40 Days: 1 lb. Skinny Shot 40 Days: 1 lb. Weight/dayWeight/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

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LossLoss • 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

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LossLoss 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

Am Soceity of Bariatric Medicine Statement 1997

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

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

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

Bioidentical Hormones for Women

Purpurted Responses to daily topical hormones:

• Energy increase• Sexual drive increase• Reduction in peri-menapausal flushing• Improved skin quality

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

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

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

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

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

Bioidentical Hormones for Men

Purported Effects

• Increased energy

• Increased sexual drive

• Increased muscle mass

• Increased hair thickness

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

Bioidentical Hormones for Men

Specific hormones measured in men:

• Testosterone

• DHEA

Testosterone

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

Bioidentical Hormones for Men

Specific hormones compounded Optimus Gel:

• Botanical Aromatase inhibitors• Reduce conversion testoterone to Estridiol• may elevate testosterone • without elevating estradiol

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

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 )

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

Hormone Therapy for Hormone Therapy for

GynecomastiaGynecomastia 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

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

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

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

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

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

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 )

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