NaProTECHNOLOGY

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! n Alexander Fleming (1881­ 1955). Scottish bacteriologist who discovered penicillin (1928)
Chance favours the prepared mind! n 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 bacteria­free 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….. n 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 n The treatment approach matures and changes with time, allowing for new discoveries
NaProTECHNOLOGY n 3 Phases 1. 2. 3. Finding the problems average 3 months Fixing the problems average 3 months??? Counting “Good” cycles 1 to 12 (18) months
Diagnostic Categories 1. 2. 3. 4. Hormonal Deficiency –follicular/luteal Ovulation Defect – 6 categories Tubal abnormality – Selective HSG Surgical – Laparoscopy, Hysteroscopy
Diagnostic Categories 1. 2. 3. 4. 5. 6. 7. Hormonal Deficiency –follicular/luteal Ovulation Defect – 6 categories Tubal abnormality – Selective HSG Surgical – Laparoscopy, Hysteroscopy Infection Endorphin deficiency Immunological
Diagnostic Categories 1. 2. 3. 4. 5. 6. 7. 8. 9. Hormonal Deficiency –follicular/luteal Ovulation Defect – 6 categories Tubal abnormality – Selective HSG Surgical – Laparoscopy, Hysteroscopy Infection Endorphin deficiency Immunological Diet Herbal / New Medical treatments
Principles n n Listen History Look Chart
Principles n n n First do no harm Discuss experimental nature of treatment with patient/ couple Explain rationale for proposed new treatment
Concerns n May not be covered by medical malpractice insurance n Unexpected side effects may occur n Consent form
The case for Dietary strategies n Last year after AAFCP meeting ……… n I had all the endorphin deficiency symptoms and successfully treated them by changing my diet!
The case for Dietary strategies n Returned from conference n n Couple conceived by changing diet 5 yrs infertility, failed IVF, just started NaPro
The case for Dietary strategies n n Patient with TEBB n Improved after 18 months in programme n She changed her diet…. Her friend had tried NaPro unsuccessfully for 2 years n Changed her diet n Spontaneous Conception n Successful Live birth aged 43yrs
The case for Dietary strategies n Swiss NaPro Doctors n n “Sat in” for medical clinic 50% of couples appeared to have “Dietary issues”
First treatment group Those with imperfect response to treatment n n n n TEBB PMS Endorphin deficiency sx despite LDN What kind of Diet?? n n n n Gillian Mc Keith Marilyn Glenville Settled on “The Best Bet Diet”…Autoimmune
Immune modifying treatment n Already familiar with Low Dose Naltrexone…………………..
Naltrexone n Has been a part of NaProTECHNOLOGY infertility treatment since 1985
Naltrexone & NaProTECHNOLOGY Used to treat Endorphin Deficiency ­ Dr. Hilgers n PMS n Infertility n Miscarriage
A New Low Dose Naltrexone ­ LDN n Unlicensed use (“off label use”) Dr. Bahari n To treat Endorphin Deficiency n Improves immune function !?! n HIV n Auto­Immune disorders n Multiple Sclerosis n Rheumatoid Arthritis n Crohn’s Disease…etc
A New Low Dose Naltrexone ­ LDN n Compounding Pharmacist n Dose n 1.5mg, 3.0mg or 4.5 mg fast release tablet nightly before sleeping (9pm ­2am)
A New Low Dose Naltrexone ­ LDN n This will give a 3 fold increase in beta endorphin levels.
Beta Endorphin Levels pg/ml 45 endorphin levels
40 35 30 25 20 15 10 5 0 2 5 8 11 14 17 20 23 Time 24hrs ASSESSMENT OF BETA­ENDORPHIN AND MELATONIN CIRCADIAN RHYTHMS IN NORMOTENSIVE OBESE WOMEN OF REPRODUCTIVE AGE Z. OSTROWSKA, et al. ENDOCRINE REGULATIONS, Vol. 31, 193 Œ 200, 1997 A New Low Dose Naltrexone ­ LDN n Improving Endorphin Levels Has a “Stimulatory effect” on the immune system n Improves immune function
n A New Low Dose Naltrexone ­ LDN n Improving Endorphin Levels Halts the progression of HIV n Halts the immune system when it begins to attack “SELF” (Auto­immune illness) n Reduces Lifetime risk of developing cancer n www.lowdosenaltrexone.org
The Best Bet Diet n In LDN relapse patients or non responders… n Changing the diet had a very positive effect on improving response to treatment
The Best Bet Diet n n n Federally registered charity Group looking at Diet Research into the Cause and Treatment of Multiple Sclerosis Completely volunteer­driven Reliable science­based information on nutrition www.direct­ms.org
The Best Bet Diet n Free of the menacing effect of pharmaceutical companies to promote expensive medications….. n Unbiased information
Ashton Embry Research scientist for 30 years Son Diagnosed with MS in 1995 Plunged into the scientific literature for MS n n n n n Looking for answers Strong evidence for dietary strategies to treat and prevent MS
The Best Bet Diet n n n n n n n 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 n Vitamin D3 ­ 4000 IU This is best from pills not associated with any vitamin A. n 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. n n Calcium – 1000 to 1200 mg Magnesium – 500 to 600 mg
Basic Supplements ­ Vitamins n n n n n n 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 n n n n Zinc – 25 to 50 mg Copper – 1­2 mg Selenium – 200 mcg Manganese – 20 mg
Basic Supplements ­ Antioxidants (use one or two) n n n Ginkgo Biloba: 120 mg Grape Seed Extract: 2­4 capsules Coenzyme Q10: 60­90 mg
The Best Bet Diet n To improve immune function and general health n Stops MS and Rheumatoid Arthritis from progressing
The Best Bet Diet n n n To improve immune function and general health Stops MS and Rheumatoid Arthritis from progressing What about other immune related abnormalities?
The Best Bet Diet n n n n To improve immune function and general health Stops MS and Rheumatoid Arthritis from progressing What about other immune related abnormalities? What about fertility?
PMS n Fiona 34yo, G3, P3 1 st Aug 06 Severe PMS…nearly all the time… Worse pre­menstrual n Hx: Pernicious Anaemia ­ B12 deficiency
n n PMS n Started charting and LDN 2mg, 3mg 4.5mg maintenance n 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 n R/V 23 March 07 n n n n Terrible PMS 2 months Worse with HCG Not classic PMS…symptoms worse first 7 to 10 days of cycle ? What to do next?
PMS n R/V 23 March 07 n Stopped HCG n Continue LDN MS Diet n ? Need antidepressant?
n Catamenial Epilepsy 16yo female G0, P0 Seizures during Menses – 6 to 8 per year n EEG, MRI – Normal n 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 7. PMS Endometriosis TEBB Persistent fatigue Low Mood Anxiety Sleep disturbance 8. Personal/Family Hx Autoimmunity
1. 2. 3. 4. 5. 6. 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 n n n Vitamin D Calcium and Magnesium Omega 3 Review in 6 months…sooner if required
Recurrent Miscarriage Female 40yrs, Male 40yrs Feb 2007 n G14, P5, SA 9 n Full Investigations n n Chromosomal & Clotting Lap 2000 & Hysteroscopy Dx: Unexplained Recurrent Miscarriages
Recurrent Miscarriage History n 7 days of PMS severity 8 /10 n TEBB 3 to 5 days n Persistent fatigue energy 5/10 n ++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 Progesterone 30 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 Progesterone Patient prog 60 40 20 0 P+2 P+4 P+6 P+9 P+11 Clues for Endorphin deficiency 7. PMS Endometriosis TEBB Persistent fatigue Low Mood Anxiety Sleep disturbance 8. Personal/Family Hx Autoimmunity
1. 2. 3. 4. 5. 6. Recurrent Miscarriage Impression n Chronic Endometritis n Endorphin Deficiency n Immune factor
Recurrent Miscarriage Plan n Antibiotic treatment n n n 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 n LDN 2mg nocte 1 week, n LDN 3mg nocte 2nd week n 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 TEBB
No PMS !! Recurrent Miscarriage History n PMS almost completely gone n Energy 8 or 9/10 n Anxiety – much better n TEBB gone Couple keen to have Lap & Hysteroscopy ­ Pending Then ready to attempt conception!
Recurrent Miscarriage When P+ 17 do Pregnancy test n Continue n n n n n Diet LDN 4.5mg Vaginal Progesterone Aspirin 75mg Pregnancy scan at 7.5 weeks…& Pray!
Case 3 – Oestradiol deficiency n n n n n Female 33yrs, Male 35yrs Jan 2003 G3, P1, SA 2 First baby Feb 01 n 33wks premature, NVD, 5lb 5oz n 2 weeks in SCBU – Urticaria in pregnancy ­ Severe Cholestasis and itch ­ abn. LFT
Oestradiol deficiency n July 02 & Dec 02 Misc x2 @ 8 weeks n No Investigations n n 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 n n Findings Chart n n n n n Short post peak phase TEBB PMS Late ovulation Bloods n Low Prog & Oestradiol
Oestradiol deficiency n Impression n n n Treatment n n n Corpus luteum insufficiency Poor follicular function 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 n Review n n Low E2 Poor follicular function n increased clomiphene
Prog 120 (37.7) +ive test
E2 250 (68.1) Oestradiol deficiency n +ive test but worried n n n n Low E2 TEBB Late ovulation Uncontrolled PMS
Oestradiol deficiency Ultrasound n n TWINS!! EDD 19 July 2004
Oestradiol deficiency n Some abnormal immune factor? n n Prednisolone 5mg daily HCG 5000 iu twice weekly – 36 weeks
Oestradiol deficiency n But n n n n n n n 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
Prog 120 (37.7) +ive test E2 250 (68.1) Abnormal Chart and E2 Led to abnormal outcome What was the underlying cause?
Oestradiol deficiency n Returned in Feb 2006 female age 36yrs n n n n 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 n Impression n n Premature ovarian failure (?Auto­immune) Does it start with anti­ovarian or anti Oestrogen antibodies prior to causing an elevation in FSH levels?
Oestradiol deficiency n Question n Could her pregnancy problems of urticaria and cholestasis have an auto immune basis?
Oestradiol deficiency n Plan n n n n LDN 2mg nocte 1 st wk, 3mg 2 nd wk. LDN 4.5mg there­after 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 / peri­menopausal cycles
Oestradiol deficiency Scan n n Singleton EDD 5 th July 2007
Oestradiol deficiency n Plan n n Continue LDN 4.5mg throughout pregnancy No need for progesterone support
Oestradiol deficiency n Pregnancy n n No Urticaria Morning sickness / Nausea n Reduced LDN to 2 mg and then 3mg when tolerated
Oestradiol deficiency n Pregnancy n n n n n n 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 n Future n n n Watch diet…wheat & dairy free Aim for higher dose of LDN Monitor progesterone more closely
G.C. ­ 6 Miscarriages Presented Feb 2005 n Female 33yrs. Male 40yrs. n G6 SA6 from Oct 02 – Jan 05 n n n Miscarriage at 5 to 9 weeks each time Returned for another attempt Aug 2006
G.C. ­ 6 Miscarriages n Dx: Balanced Translocation Ch 7 and 18 n 30% miscarriage risk every time n 5% risk abnormal baby n n Additional Dx: n Uterine Fibroid – 2 x 3cm anterior fibroid
G.C. ­ 6 Miscarriages n Additional Problems with NPT Moderate PMT symptoms for 7 days n Abnormal bleeding n Low Progesterone on P+7 n n Query “Some immune factor?”
G.C. ­ 6 Miscarriages n Rx: Pre­conception n Letrozole 2.5mg for 5 days from day 3 n 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 n Rx: Pre­conception Letrozole 2.5mg for 5 days from day 3 n Luteal HCG 2,500 P+3,5,7,9 AND st nd n LDN 4.5mg nocte (2mg 1 wk, 3mg 2 wk)
n G.C. ­ 6 Miscarriages n Rx: Post­conception Gestone 200mg im twice weekly n HCG 5000 sc twice weekly n Prednisolone 5mg daily n n 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 n Rx: Post­conception n n Vaginal Progesterone Pessary Cyclogest 400mg twice daily LDN 4.5mg nightly
G.W. ­ 6 Miscarriages Hopes 1. 2. 3. Reduce need for progesterone support throughout pregnancy Better Progesterone levels 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 n AC 35yo, G0, P0 24 th May 06 Trying to conceive less than 1 year Oct 05 n Worried n n n Dysmenorrhoea Altered bowel during menses
Diet and Mucus n Hx: n n n PMS 5 days, severity 6/10 TEBB 3 days Aunt – Rheumatoid Arthritis
Clues for Endorphin deficiency 1. 2. 3. 4. 5. 6. 7. 8. PMS Endometriosis ­ Likely TEBB Persistent fatigue Low Mood Anxiety Sleep disturbance 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 n Noticed n n n n Improved mucus Improved irritable bowel sx Increased energy How did diet do this?
Diet and mucus # 2 n n n n 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 n MF 35yo, G0, P0 July 05 Trying to conceive – May 02 n DX PCOD n n n n 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 n What is the mechanism of action?
Diet thin endometrium n Could receptor deficiency be the root cause of poor mucus and thin endometrium?
Diet and fertility n n n If diet improves cervical mucus and endometrial thickness could there be an autoimmune basis to receptor deficiency? Possible anti­receptor antibodies? OR Some other pathological mechanism?
Herbalist and fertility n 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!