New Developments Low Dose Naltrexone, Role of Diet, Food Intolerences, Vitamin Deficiencies



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NaProTECHNOLOGY AAFCP meeting Wichita, Kansas, 20 th July 07 New Developments Low Dose Naltrexone, Role of Diet, Food Intolerences, Vitamin Deficiencies Dr. Phil Boyle

Chance favours the prepared mind! Alexander Fleming (1881 1955). Scottish bacteriologist who discovered penicillin (1928)

Chance favours the prepared mind! Winner of the Nobel Prize in Physiology or Medicine 1945, in 1928, while working on influenza virus, Fleming observed that mould had developed accidentally on a staphylococcus culture plate and that the mould had created a bacteria free circle around itself. He was inspired to further experiment and he found that a mould culture prevented growth of staphylococci, even when diluted 800 times. He named the active substance penicillin.

Remember.. The greatest scientific discoveries of our time were not discovered through well designed clinical trials...but by chance and a prepared mind!

Crucially.. The FertilityCare chart can let us know if the treatment plan is effective.or not!

NaProTECHNOLOGY The treatment approach matures and changes with time, allowing for new discoveries

NaProTECHNOLOGY 3 Phases 1. Finding the problems average 3 months 2. Fixing the problems average 3 months??? 3. Counting Good cycles 1 to 12 (18) months

Diagnostic Categories 1. Hormonal Deficiency follicular/luteal 2. Ovulation Defect 6 categories 3. Tubal abnormality Selective HSG 4. Surgical Laparoscopy, Hysteroscopy

Diagnostic Categories 1. Hormonal Deficiency follicular/luteal 2. Ovulation Defect 6 categories 3. Tubal abnormality Selective HSG 4. Surgical Laparoscopy, Hysteroscopy 5. Infection 6. Endorphin deficiency 7. Immunological

Diagnostic Categories 1. Hormonal Deficiency follicular/luteal 2. Ovulation Defect 6 categories 3. Tubal abnormality Selective HSG 4. Surgical Laparoscopy, Hysteroscopy 5. Infection 6. Endorphin deficiency 7. Immunological 8. Diet 9. Herbal / New Medical treatments

Principles Listen History Look Chart

Principles First do no harm Discuss experimental nature of treatment with patient/ couple Explain rationale for proposed new treatment

Concerns May not be covered by medical malpractice insurance Unexpected side effects may occur Consent form

The case for Dietary strategies Last year after AAFCP meeting I had all the endorphin deficiency symptoms and successfully treated them by changing my diet!

The case for Dietary strategies Returned from conference Couple conceived by changing diet 5 yrs infertility, failed IVF, just started NaPro

The case for Dietary strategies Patient with TEBB Improved after 18 months in programme She changed her diet. Her friend had tried NaPro unsuccessfully for 2 years Changed her diet Spontaneous Conception Successful Live birth aged 43yrs

The case for Dietary strategies Swiss NaPro Doctors Sat in for medical clinic 50% of couples appeared to have Dietary issues

First treatment group Those with imperfect response to treatment TEBB PMS Endorphin deficiency sx despite LDN What kind of Diet?? Gillian Mc Keith Marilyn Glenville Settled on The Best Bet Diet Autoimmune

Immune modifying treatment Already familiar with Low Dose Naltrexone..

Naltrexone Has been a part of NaProTECHNOLOGY infertility treatment since 1985

Naltrexone & NaProTECHNOLOGY Used to treat Endorphin Deficiency PMS Infertility Miscarriage Dr. Hilgers

A New Low Dose Naltrexone LDN Unlicensed use ( off label use ) Dr. Bahari To treat Endorphin Deficiency Improves immune function!?! HIV Auto Immune disorders Multiple Sclerosis Rheumatoid Arthritis Crohn s Disease etc

A New Low Dose Naltrexone LDN Compounding Pharmacist Dose 1.5mg, 3.0mg or 4.5 mg fast release tablet nightly before sleeping (9pm 2am)

A New Low Dose Naltrexone LDN This will give a 3 fold increase in beta endorphin levels.

Beta Endorphin Levels pg/ml 45 40 endorphin levels 35 30 25 20 15 10 5 0 2 5 8 11 14 17 20 23 Time 24hrs ASSESSMENT OF BETA ENDORPHIN AND MELATONIN CIRCADIAN RHYTHMS IN NORMOTENSIVE OBESE WOMEN OF REPRODUCTIVE AGE Z. OSTROWSKA, et al. ENDOCRINE REGULATIONS, Vol. 31, 193 Π200, 1997

A New Low Dose Naltrexone LDN Improving Endorphin Levels Has a Stimulatory effect on the immune system Improves immune function

A New Low Dose Naltrexone LDN Improving Endorphin Levels Halts the progression of HIV Halts the immune system when it begins to attack SELF (Auto immune illness) Reduces Lifetime risk of developing cancer www.lowdosenaltrexone.org

The Best Bet Diet In LDN relapse patients or non responders Changing the diet had a very positive effect on improving response to treatment

The Best Bet Diet Federally registered charity Group looking at Diet Research into the Cause and Treatment of Multiple Sclerosis Completely volunteer driven Reliable science based information on nutrition www.direct ms.org

The Best Bet Diet Free of the menacing effect of pharmaceutical companies to promote expensive medications.. Unbiased information

Ashton Embry Research scientist for 30 years Son Diagnosed with MS in 1995 Plunged into the scientific literature for MS Looking for answers Strong evidence for dietary strategies to treat and prevent MS

The Best Bet Diet No Wheat (gluten) No Dairy No Legumes (Beans and Peas) No refined Sugars Less red meat More fish, chicken More fresh fruit, veg

Basic Supplements Essentials Vitamin D3 4000 IU This is best from pills not associated with any vitamin A. Omega 3 Essential Fatty Acids 3 grams of EPA +DHA. This is best gotten from fish oil such as salmon oil (.3 grams EPA + DHA per 1 gram capsule). One tablespoon of cod liver oil is also an option but ensure that vitamin A content does not exceed 5000 IU. The addition of 1 tablespoon of flax oil can be of value because it contains alpha linolenic acid, a precursor to EPA and DHA. Calcium 1000 to 1200 mg Magnesium 500 to 600 mg

Basic Supplements Vitamins Vitamin A 5000 IU Vitamin B complex 50 mg Folic acid 1 mg Vitamin B12 100 mcg Vitamin C 1 g Vitamin E (natural) 400 IU

Basic Supplements Minerals Zinc 25 to 50 mg Copper 1 2 mg Selenium 200 mcg Manganese 20 mg

Basic Supplements Antioxidants (use one or two) Ginkgo Biloba: 120 mg Grape Seed Extract: 2 4 capsules Coenzyme Q10: 60 90 mg

The Best Bet Diet To improve immune function and general health Stops MS and Rheumatoid Arthritis from progressing

The Best Bet Diet To improve immune function and general health Stops MS and Rheumatoid Arthritis from progressing What about other immune related abnormalities?

The Best Bet Diet To improve immune function and general health Stops MS and Rheumatoid Arthritis from progressing What about other immune related abnormalities? What about fertility?

PMS Fiona 34yo, G3, P3 1 st Aug 06 Severe PMS nearly all the time Worse pre menstrual Hx: Pernicious Anaemia B12 deficiency

PMS Started charting and LDN 2mg, 3mg 4.5mg maintenance R/V 2 months

10 th Nov 06 Feels great on LDN Dramatic improvement 1 month later some deterioration.added HCG P+3,5,7,9

PMS R/V 23 March 07 Terrible PMS 2 months Worse with HCG Not classic PMS symptoms worse first 7 to 10 days of cycle? What to do next?

PMS R/V 23 March 07 Stopped HCG Continue LDN MS Diet? Need antidepressant?

Catamenial Epilepsy 16yo female G0, P0 Seizures during Menses 6 to 8 per year EEG, MRI Normal Pelvic ultrasound Normal Advised OCP to control seizures

Catamenial Epilepsy Additional history Grandmother NIDDM Endometriosis Diarrhoea with menses Nil else No PMS

Clues for Endorphin deficiency 1. PMS 2. Endometriosis 3. TEBB 4. Persistent fatigue 5. Low Mood 6. Anxiety 7. Sleep disturbance 8. Personal/Family Hx Autoimmunity

Catamenial Epilepsy Possible to commence experimental treatment with LDN 3 mg nocte AND Eliminate wheat and dairy in diet

Catamenial Epilepsy OCP cannot prevent further spread of endometriosis LDN & Diet.might do this through improving immune function

Catamenial Epilepsy 1 month later March 07 started LDN (after having another seizure in February 07) Review July 07 no seizure for 4 months (since starting LDN)

Catamenial Epilepsy Also advised Vitamin D Calcium and Magnesium Omega 3 Review in 6 months sooner if required

Recurrent Miscarriage Female 40yrs, Male 40yrs Feb 2007 G14, P5, SA 9 Full Investigations Chromosomal & Clotting Lap 2000 & Hysteroscopy Dx: Unexplained Recurrent Miscarriages

Recurrent Miscarriage History 7 days of PMS severity 8 /10 TEBB 3 to 5 days Persistent fatigue energy 5/10 ++anxiety And Pelvic pain unknown cause

Hormone profile Prog & Oestradiol Peak +2,4,6,9,11

Hormone profile Prog & Oestradiol Peak +2,4,6,9,11 70 60 50 40 30 Progesterone 20 10 0 P+2 P+4 P+6 P+9 P+11

Hormone profile Prog & Oestradiol Peak +2,4,6,9,11 140 120 100 80 60 Progesterone Patient prog 40 20 0 P+2 P+4 P+6 P+9 P+11

Clues for Endorphin deficiency 1. PMS 2. Endometriosis 3. TEBB 4. Persistent fatigue 5. Low Mood 6. Anxiety 7. Sleep disturbance 8. Personal/Family Hx Autoimmunity

Recurrent Miscarriage Impression Chronic Endometritis Endorphin Deficiency Immune factor

Recurrent Miscarriage Plan Antibiotic treatment Flagyl 400mg tid Doxycycline 100mg od Zinnat (Cephalosporin) 250mg bd For husband and wife for 2 weeks

Abcs P+7 May 07 Started Diet Antibiotics. Little Impact!

Recurrent Miscarriage Plan LDN 2mg nocte 1 week, LDN 3mg nocte 2nd week LDN 4.5mg nocte continuous AND No Wheat, No Dairy to compliment LDN

Started LDN April 07 +++ PMS LDN.. Still TEBB and +++ PMS

Started LDN April 07 May 07 Started Diet No PMS!! No TEBB

Recurrent Miscarriage History PMS almost completely gone Energy 8 or 9/10 Anxiety much better TEBB gone Couple keen to have Lap & Hysteroscopy Pending Then ready to attempt conception!

Recurrent Miscarriage When P+ 17 do Pregnancy test Continue Diet LDN 4.5mg Vaginal Progesterone Aspirin 75mg Pregnancy scan at 7.5 weeks & Pray!

Case 3 Oestradiol deficiency Female 33yrs, Male 35yrs Jan 2003 G3, P1, SA 2 First baby Feb 01 33wks premature, NVD, 5lb 5oz 2 weeks in SCBU Urticaria in pregnancy Severe Cholestasis and itch abn. LFT

Oestradiol deficiency July 02 & Dec 02 Misc x2 @ 8 weeks No Investigations As per medical advice Started NaPro Jan 03

Prog 6.8 (2.1) E2 149 (40.5) Prog 87 (27.3) E2 167 (45.5)

Oestradiol deficiency Findings Chart Short post peak phase TEBB PMS Late ovulation Bloods Low Prog & Oestradiol

Oestradiol deficiency Impression Corpus luteum insufficiency Poor follicular function Treatment Clomiphene x 3 days, day 3 HCG 2,000 P+3,5,7,9 Review

Prog 6.8 (2.1) E2 149 (40.5) Prog 87 (27.3) E2 167 (45.5) Prog 62 (19.5) E2 246 (67)

Oestradiol deficiency Review Low E2 Poor follicular function increased clomiphene

+ive test Prog 120 (37.7) E2 250 (68.1)

Oestradiol deficiency +ive test but worried Low E2 TEBB Late ovulation Uncontrolled PMS

Oestradiol deficiency Ultrasound TWINS!! EDD 19 July 2004

Oestradiol deficiency Some abnormal immune factor? Prednisolone 5mg daily HCG 5000 iu twice weekly 36 weeks

Oestradiol deficiency But Developed Urticaria same as previously Cholestasis at 29 weeks Bile acids doubled every week severe itch Spontaneous delivery at 34.5 weeks Boy 4lb 11 oz Girl 4lb 14 oz Spent 1 week in SCBU

+ive test Prog 120 (37.7) E2 250 (68.1) Abnormal Chart and E2 Led to abnormal outcome What was the underlying cause?

Oestradiol deficiency Returned in Feb 2006 female age 36yrs Amenorrhoea 6 months (since stopped Breast feeding in Aug 05) FSH elevated 18.1 IU LH 8.8 E2 143 (38.9pg)

Ultrasound showed: retroverted uterus thin endometrium small ovaries

Oestradiol deficiency Impression Premature ovarian failure (?Auto immune) Does it start with anti ovarian or anti Oestrogen antibodies prior to causing an elevation in FSH levels?

Oestradiol deficiency Question Could her pregnancy problems of urticaria and cholestasis have an auto immune basis?

Oestradiol deficiency Plan LDN 2mg nocte 1 st wk, 3mg 2 nd wk. LDN 4.5mg there after After 1 month clomiphene 50mg x 6 days and titrate dose according to P+7

Prog 70 E2 108 Prog 86 E2 287

+ive test P+7 Prog 396 (124.5) E2 548 (149) Previously had twins with P+7 Prog 120 (37.7) E2 250 (68.1)

+ive test P+7 Prog 396 (124.5) E2 548 (149) Previously had twins with P+7 Prog 120 (37.7) E2 250 (68.1) Usually takes 5 to 6 months for LDN to influence high FSH / peri menopausal cycles

Oestradiol deficiency Scan Singleton EDD 5 th July 2007

Oestradiol deficiency Plan Continue LDN 4.5mg throughout pregnancy No need for progesterone support

Oestradiol deficiency Pregnancy No Urticaria Morning sickness / Nausea Reduced LDN to 2 mg and then 3mg when tolerated

Oestradiol deficiency Pregnancy No itch until 35 weeks (compared with 29wk) Elevated bile salts, and low Prog Induced at 38weeks Girl 7lbs 0 oz No SCBU Mum healthy

Oestradiol deficiency Future Watch diet wheat & dairy free Aim for higher dose of LDN Monitor progesterone more closely

G.C. 6 Miscarriages Presented Feb 2005 Female 33yrs. Male 40yrs. G6 SA6 from Oct 02 Jan 05 Miscarriage at 5 to 9 weeks each time Returned for another attempt Aug 2006

G.C. 6 Miscarriages Dx: Balanced Translocation Ch 7 and 18 30% miscarriage risk every time 5% risk abnormal baby Additional Dx: Uterine Fibroid 2 x 3cm anterior fibroid

G.C. 6 Miscarriages Additional Problems with NPT Moderate PMT symptoms for 7 days Abnormal bleeding Low Progesterone on P+7 Query Some immune factor?

G.C. 6 Miscarriages Rx: Pre conception Letrozole 2.5mg for 5 days from day 3 Luteal HCG 2,500 P+3,5,7,9

P+ 7 P =78.1 E2=950 Conceived on an Optimum cycle

G.C. 6 Miscarriages Rx: Pre conception Letrozole 2.5mg for 5 days from day 3 Luteal HCG 2,500 P+3,5,7,9 AND LDN 4.5mg nocte (2mg 1 st wk, 3mg 2 nd wk)

G.C. 6 Miscarriages Rx: Post conception Gestone 200mg im twice weekly HCG 5000 sc twice weekly Prednisolone 5mg daily Continued treatment until 35 weeks

G.W. 6 Miscarriages Problems 1. Needed to continue treatment throughout pregnancy 2. Low Progesterone persisted 3. Baby smaller than avg. 5lb 5oz

G.C. 6 Miscarriages Rx: Post conception Vaginal Progesterone Pessary Cyclogest 400mg twice daily LDN 4.5mg nightly

G.W. 6 Miscarriages Hopes 1. Reduce need for progesterone support throughout pregnancy 2. Better Progesterone levels 3. Bigger baby

Cyclogest nightly

Cyclogest Alt. nights

Cyclogest nightly

Cyclogest Twice daily

G.W. 6 Miscarriages EDD 13 th Sept 2007 Pray!!

Diet and Mucus AC 35yo, G0, P0 24 th May 06 Trying to conceive less than 1 year Oct 05 Worried Dysmenorrhoea Altered bowel during menses

Diet and Mucus Hx: PMS 5 days, severity 6/10 TEBB 3 days Aunt Rheumatoid Arthritis

Clues for Endorphin deficiency 1. PMS 2. Endometriosis Likely 3. TEBB 4. Persistent fatigue 5. Low Mood 6. Anxiety 7. Sleep disturbance 8. Personal/Family Hx Autoimmunity

P 37 E 368 P 57 E 500 LDN P 66 E 391

LDN P 127 E 769?LUF HCG 10,000 P 103 E 996 P 82 E 1101

P 96 E 1070 P 69 E 370 P 126 E 790 No Wheat No Dairy P 85 E 470

Diet and mucus Noticed Improved mucus Improved irritable bowel sx Increased energy How did diet do this?

Diet and mucus # 2 RB 32yo, G1 P1 (12 yrs previous) NaPro Oct 2005 6 years trying Moderately severe Endometriosis 2003 No previous ovulation Induction

Discontinued clomid.. ++ Side effects

What happened here? No stressful event identified. How can we explain this?

WEIGHT WATCHERS DIET!!

Diet thin endometrium MF 35yo, G0, P0 July 05 Trying to conceive May 02 DX PCOD 6 cycles of clomid 8 cycles of FSH 1 failed IVF march 05 Thin Endometrium

Previous endometrium 4 to 5mm

With Diet endometrium 7 to 7.5mm

Diet thin endometrium What is the mechanism of action?

Diet thin endometrium Could receptor deficiency be the root cause of poor mucus and thin endometrium?

Diet and fertility If diet improves cervical mucus and endometrial thickness could there be an autoimmune basis to receptor deficiency? Possible anti receptor antibodies? OR Some other pathological mechanism?

Herbalist and fertility Persistent TEBB improved in 2 patients who attended the local herbalist

Remember.. The FertilityCare chart and careful monitoring of the patient s responses to new treatment approaches will let us know if our intervention is effective...or not!