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Biomedical Treatments for

Neurodevelopmental,

Autoimmune and other Chronic

Disorders

David Berger, MD

Medical Director

Wholistic Pediatrics

Tampa, FL

(813) 960-3415

www.wholisticpeds.com

Autistic Spectrum Disorders





ADHD Asperger’s PDD Autism

Syndrome



In many of our patients, there are multiple

biological abnormalities

Discover Magazine, 3/14/07

Intestinal

 Abnormal flora (dysbiosis)

 Abnormal permeability (leaky gut)

 Illeal lymphoid hyperplasia

 Persistent Measles virus

Immune System

 Th1 Th2 type of WBC

 Low TH1 can cause susceptibility to

infections, with potential increased

exposure to antibiotics.

– Related Yeast Overgrowth in Intestinal Tract

as well as Clostridia and Parasites



 High TH2 can lead to inappropriate

antibody formation

– Auto-antibodies

– Food antibodies

Biochemical Abnormalities

 Low sulfur amino acids

 Low zinc levels

 Low selenium levels

 High copper to zinc ratios

 Low omega – 3 fatty acids

 High ammonia levels

 Abnormal methylation metabolism

 High microbial metabolites

 Elemental Toxins: Mercury, Lead, etc

Robert Cade, MD, Professor,

University of Florida Medical

School

“A gluten and casein free

diet resulted in significant

improvement in 81% of

children with autism within

three months.”

Rationale for Casein/Gluten

Free Diet

 Gluten and casein have immune, as well as

neurotransmitter impacts.

 Many ASD children have food hypersensitivities

 Improper digestion leads to buildup of opiate-like

peptides. These can be identified in the urine of

many children with ASD.

 Dr Cade at UF recently injected rats with

casomorphin, causing the rats to develop autistic-

like behaviors

DPP-IV



Dipeptidyl Peptidase IV, carboxypeptidase A, and aminopeptidase are some

of the main enzymes that brake down the opiate peptides.

Some of the enzymes are zinc dependent, and it’s activity can be inhibited

by mercury, among other things.

A first generation enzyme containing DPP-IV is available from Kirkman

Labs. Although for most children it can not serve as a sole replacement for

the C/G free diet, giving it with these foods allow some children to take c/g

foods with out negative reactions, and it can be administered in cases of

accidental exposure

Dr. Lewis’

book is the

essential

starting point

for a gluten

and casein

free diet.

Milk: It does your body good?

Frank Oski -

Past chairman of

Johns Hopkins

Department of

Pediatrics and Past-

President of the

American Academy of

Pediatrics

Evaluating Children

 Urine and Stool Studies

 Thyroid profile

 Toxic Metals

 Inborn Errors of Amino Acids

 Fragile X, Chromosomal Analysis

 Metallothionein analysis

 RBC Fatty Acids

 Brain auto-antibodies

 Immunoglobulins, WBC activity

 Detoxification Metabolism

 Hormone Profiles

Autism Speaks Launches Pediatrician

Outreach Initiative to Increase Awareness

about the Diagnosis and Treatment of

Gastrointestinal Problems



Consensus Statement Developed by Expert Panel Includes

Recommendations for Care Specific to Children with

Autism



February 28, 2007

Abnormal Stool & Urine

Findings

 Best, and in some cases imperative to treat these

prior to starting more advanced therapies such as

chelation

 Stool : Yeast (Candida), Parasites (Giardia,

Dientameoba, and others), Malabsorption, Blood,

etc.

 Urine : Yeast and Bacterial metabolites, abnormal

Kreb’s cycle metabolites, oxalates, opiate

peptides, etc

Treat Stool & Urine Findings

 Yeast Killers: Nystatin, Diflucan, Sporonox,

Uva Ursi, MCT, goldenseal, Garlic, Candex

(digestive enzyme) and others.

 Clostridia Killers: high dose lactobacillus,

Metronidazole (benzoate by compounding),

Vancomycin

 Parasites: the ones we see most often are

also sensitive to Metronidazole Benzoate,

other specific natural and pharmacological

agents used depending on the particular

organism

OAT test

OAT After Culturelle and Nystatin

Nicholas (8 y/o)After Culturelle and

Nystatin

(3 months later)

 Attention span has definitely improved since the last visit.

 getting very good reports fro the teachers

 more "with it", not spacey

 now will respond much faster when spoken to.

 Reading skills vastly improved, with good comprehension skills.

Reading instruction manuals and understanding it. Wants to

keep reading on and on.

 performing skills at school that he never did before. Amazing

memory for spelling.

 Learned how to tell time.

 Can perform addition.

 less problems with interactions with his peers, but he prefers

solitary play when in his house. When visiting others he will

interact more. He does much better in small and quiet groups

 getting better balance of his body.

Sulfation

 Sulfur is an element critical to the structure and

functioning of body mechanisms.

 Dr. Rosemary Waring reports that most autistic children

show a deficiency of sulfates in their plasma. Of the

autistic children she tested, 92% had sulfate levels that

were only 12% of normal

 Low sulfates can lead to a leaky gut, as well as a

weakness in the phenolsulfotransferase (PST) system.

 the PST pathway is important in removing toxins

 A weakness in the PST system is often characterized by

night sweats, red face and ears, allergies, and keratosis

pilaris (red bumps on back of arms)

 Tx: Epsom Salt by bath or transdermal application, or

oral sulfates such as glucosamine sulfate and MSM

After Epsom Salt Baths

Eric’s (6 y/o) Response to Epson

Salt Baths

•Making new statements. Becoming more creative with

language. Responding to answers appropriately

•still needs help focusing for long periods of time, but

paying more attention

•echolalia is gone

•showed much more interest in presents that he received

for the holidays.

•getting more involved with his brother, they are fighting a

bit now.

Ammonia

•Ammonia is a known toxin to the brain.

•High enough levels can cause can cause neurological

symptoms, even coma. This is usually associated with liver

disease

•About 5-10% of ASD patients we check have mild to moderate

elevations in Ammonia levels (in the presence of normal liver

tests)

•Proposed mechanism: Proteins >> Amino Acids >>Ammonia

>>liver fuses 2 ammonia molecules to form urea >> excreted

in urine. Gut pathogens >> leaky gut. Urease enzyme made by

certain gut pathogens >> Urease enters the bloodstream >>

splits urea back to ammonia at a pace faster then urea can be

formed.

Connor’s original Ammonia level

Connor’s ammonia after 2 capsules of

alpha ketoglutaric acid









•Increased speech, repeating everything

•socializing better, especially with sister

•Separation still a problem when school starts

•When peer tantrums, Conor gets upset. He did approach a

crying child instead of running away, and when sister was crying

he sought help instead of withdrawing

Connor After 4 capsules of Alpha Ketoglutaric

Acid









•No more episodes of the rapid eye blinking or enlarged pupils

•interacting better with sister

•less melt-downs when others tantrum

•speech improving on a weekly basis

sound sensitivities seem to no longer be a problem

Essential Fatty Acids



The Omega Factor

Omega 3’s in Autism

Replacing and Omega-3 deficiency

(source independent)

Vs.

Addressing Omega deficiency and

Supplementing with natural Vitamin A

(Cod Liver Oil)

Immunity is complex and impacts

every system in the body. It

isn’t surprising that it effects

child behavior and development.

Immune System

 TH1 TH2 type of WBC

 Viral Stimulation

 Inappropriate antibody formation

– Auto-antibodies

– Food antibodies

 Frequent Infections - Especially Ear

 Related Yeast Overgrowth in Intestinal

Tract w/ Clostridia and Parasites

IMMUNIZATIONS

 I am not suggesting that we abandon our

vaccination policy

 I am concerned about the growing number

of chronically ill children

 There are more children with learning

disabilities and autoimmune disorders then

there has ever been in the history of

medicine.

Concerns about Vaccines

 Are we unnaturally stressing underdeveloped

immune systems beyond their capabilities in our

effort to keep the children from becoming ill?

 There are inadequate safety studies for the

vaccines that are currently on the market

 Are we giving too many vaccines over a short

time span?

 We do not have a clear understanding of the

effects of some of the vaccine components such as

thimerosal, aluminum, formaldehyde, and human

fetal tissue.

What’s Going On?

 Social deficits, shyness, social withdrawal

 Repetitive, perseverative, stereotypic behaviors; obsessive-compulsive

tendencies

 Irritability, aggression, temper tantrums

 Lacks eye contact; impaired visual fixation

 Loss of speech, delayed language, failure to develop speech

 Speech comprehension deficits

 Sound sensitivity; mild to profound hearing loss

 Abnormal touch sensations; touch aversion

 Flapping, myoclonal jerks, choreiform movements, circling, rocking, toe

walking, unusual postures

 Poor concentration, attention, response inhibition

 Self injurious behavior, e.g. head banging

 ADHD traits

 Sleep difficulties

 Diarrhea; abdominal pain/discomfort, constipation

ALL SIGNS AND SYMPTOMS OF…

MERCURY TOXICITY

MERCURY

Statement:Pediatrics 2001 Jul, American Academy of Pediatrics: Committee on

Environmental Health.



The developing fetus and young children are thought to be disproportionately

affected by mercury exposure, because many aspects of development,

particularly brain maturation, can be disturbed by the presence of mercury.

Minimizing mercury exposure is, therefore, essential to optimal child

health…..Mercury in all of its forms is toxic to the fetus and children, and

efforts should be made to reduce exposure to the extent possible to

pregnant women and children as well as the general population.

_______________________________________________________________

Vaccine inserts would typically say “0.01% thimerosal as a preservative”, which

to anyone would sound like an extremely small amount. When called to testify

in front of the Institute of Medicine, an independent group formed by our

government to monitor safety issues, Dr. Neil Halsey of Johns Hopkins

University, and head of the vaccine recommendation committee that reports to

the CDC, went on record as saying “No one ever did the math…. No one

knows what dose of mercury, if any, from vaccines is safe. We can say there is

no evidence of harm but the truth is no one has looked”

Mercury/Thimerosal

 Thimerosal is Ethylmercury, a neurotoxin

 Mercury was found in the blood of

newborns even before Hepatitis B shot, and

higher levels after the shot.

• Journal of Pediatrics, May 2000

 In some pre-term infants, mercury levels

were 10 times that of term infants

 Pre-term babies are vaccinated according to

chronological age, not gestational age.

Mercury/Thimerosal

 Intrauterine sources may include:





• maternal fish consumption

• mercury amalgam fillings

•Rhogam (given to Rh (-) mothers, no longer present)

•Influenza vaccine (still present)

Mercury/Thimerosal

 Hepatitis B vaccine was introduced in 1991-

with most newborns getting the first dose

before leaving the hospital

 Hep B vaccine had contained 12.5 mcg of

thimerosal = 6.25mcg mercury

 EPA established the “safe limit” at 0.1

mcg/kg/day, approximately 0.4 mcg/day for

an 8 pound newborn

Mercury/Thimerosal

Typical Thimerosal Exposure for 2 month old infant:

Hep B 12.5 mcg

DTaP 25 mcg

Hib 25 mcg

Total 62.5 mcg

of which 50% is ethylmercury = 31.25mcg



Total “safe” dose for 10 pound (2 month old) baby

by EPA standards: 0.5 mcg. The average 2 month

old received ~60x the EPA limit

Mercury/Thimerosal

 By 6 months of age, a fully vaccinated infant

would have received:

– 3 DTP 75 mcg thimerosal

– 3 Hib 75 mcg thimerosal

– 3 Hep B 37.5 mcg thimerosal



Total 187.5 mcg thimerosal

93.75 mcg mercury



1999 FDA Center for Biologics Evaluation and Research

Heavy Metal Exposures

After exposure to mercury, the length of time to be eliminated

varies for different organs:



 Blood and Hair: 4-6 months

 Non CNS organs: several years

 Brain: 20 years

(Boyd Haley, PhD, University of Kentucky, Dept of

Chemistry)



Lead typically deposits into brain and bone. After exposure to

lead, within several months the blood and urine levels will

be normal even if the lead is still in the bone and brain

(Clarkson, 2002)

Who’s looking into all of this?

Boyd Haley, PhD, Department of Chemistry Chairman,

University of Kentucky. Dr Haley is considered one of the

leading researchers in America on Heavy Metal toxicity

• He reports that exposing neurons to thimerosal rapidly

results in the stripping of tubuluin from the nerve axon,

and also reduces the viability of actin. Actin and tubulin

are proteins that are critically important for the growth of

dendrites and to maintain the structure of the axon.

•On exposing neurons grown in culture for 24 hours, then

exposed to vaccines with thimerosal and thimerosal-free

vaccines. There was significantly more cell death in those

exposed to thimerosal vaccines. The most concerning part

about this was that there was an extremely low amount of

thimerosal used in the study, 10K less then the

concentration found in most vaccines

Who’s looking into this (cont)

•Holloway et al, Arizona State:Oral antibiotics have been shown in rats

to increase the half-life for excretion of mercury from 10 days to over

100 days. (Doctors have been told it is OK to vaccinate children as

long as they are not seriously sick, with high fevers, and there is no

recommendations not to vaccinate children on antibiotics)

•Holloway et all, Arizona State 2002 carried out a DMSA challenge

study involving 15 children with autism and 15 typical children. The

children received a single dose of meso-2,3-dimercaptosuccinic acid

(DMSA), at a dose of 10 mg/kg, followed by a 10-hour urine collection.

The DMSA resulted in a much greater increase in heavy metal

excretion in the children with autism compared to the controls. Many

of the children with autism excreted high levels of one or more heavy

metals, although there was wide variation in the amount and type of

metal excreted. (The data suggests that many children with autism

have a greatly diminished ability to excrete heavy metals, and thus

would be unusually vulnerable to exposures to those metals)

Mercury Testing

 As there is a relative short half life of mercury in serum,

blood and urine testing will often be negative if more then

6 months have passed between exposure and testing

 Hair tests can be falsely positive if there are metals in

shampoos, conditioners, or water. Also, there is evidence

that mercury levels in the hair of autistic children is less

than in controls (Cave and Holmes)



 For me, the best test is an oral chelation challenge,

extracting the heavy metal and excreting it in the urine.

This can document that the metal is present, it is not being

excreted under normal circumstances, AND that the

chelation agent and the route of administration given

works for the individual

Mercury Removal: Chelation

Agents

EDTA, Dimercaprol (BAL), DMSA, DMPS, and DMPA all have

heavy metal binding activity

Marked specificity for heavy metals, but also can cause decreases in

trace elements and micronutrients (and these should be tested for

periodically)

Mercury is essentially irreversibly bound to DMSA, so mercury is

not deposited in other tissues, even the kidney.

DMSA/DMPS works through increasing urinary excretion.

DMSA/DMPS does not cross the blood-brain barrier, so no risk of

delivering bound mercury to the brain

Very low toxicity. Side effects may include anorexia, nausea,

vomiting, diarrhea, rash and a transient increase in liver enzymes.

There are no known adverse drug interactions with DMSA/DMPS.

EDTA: disodium vs Calcium disodium. Disodium EDTA given

rapidly by IV can suddenly drop serum calcium levels. Only

should use CaNa2 EDTA

Mercury Removal: Chelation

• oral (DMPS and DMSA)

• IV (DMPS and CaNa2 EDTA)

• Rectal (DMPS, DMSA, CaNa2 EDTA

[detoxamin]).

– best to have stool passage before insertion

– CaNa2 EDTA seems to cause less yeast

exacerbation

• TD – emu oil seems the best vehicle

– seen very little benefit/movement with DMPS

– seen some positive excretions with DMSA

– CaNa2 very difficult to keep in suspension without

precipitation

Single dose chelation challenge

– baseline urine taken before dose given

– 8 hour urine collection regardless of

type/route

– empty bladder before giving dose

– DMSA (oral or rectal 25mg/kg)

– DMPS (3mg/kg for IV, 10mg/kg for

rectal, 5-10mg/kg oral)

– CaNA2 EDTA (25-50mg/kg regardless

of rout, maximum of 1500mg)

– May need to do more than 1 challenge

with different agents/routes

(DAN! 2005 Consensus Paper)

Antonio (7 y/o) on first chelation challenge with DMSA

Antonio, after 4 cycles of DMSA

Antonio, after 8 cycles of DMSA

Antonio After Chelation with DMSA





Has bad gas during the DMSA days, and is moody,

then this goes away when the DMSA is finished.

Doing better and better in speech therapy

If he does not want to do things he cries.

Teachers are reporting improvements seen on a

month-to-month basis

More hand gesturing

In a more advanced class. The mimicry behavior has

stopped.

At this point language is the major barrier, behaviors

and stemming are under control

Richard (6 y/o) on first DMSA Challenge

Richard after 2 mo of DMSA

Richard Before Chelation

•No self help skills

•No bathroom skills

•No attention span

•No learning anything at school







Richard After Chelation

•Using the bathroom appropriately

•Will sit still for haircuts

•Focus and attention significantly improved

•Knows his letter, numbers and colors

•Excelling in all areas of education except for verbal speech, though is

vocalizing more then every before

Baseline

DMPS/Glutathione-IV

DMPS/Glutathione-Rectal

Urine Porphyrins

Porphyrins represent a group of uniquely

structured compounds that can surround

different types of ions/metals. Each has a

specific biological function

– Hemoglobin

– Myoglobin

– Chlorophyll

Biochemistry 101

Enzymes – the keys to life





A+B 0 C 0 D

A & B are substrates, the ingredients being

“mixed” together

0 is the enzyme, the catalyst that makes the

reaction proceed.

C & D are products made by the reaction,

which can then go on to be substrates

(ingredients) in other reactions

Some enzyme reactions can go both directions

Biochemistry 101

A+B 0 C 0 D

What can cause an enzyme not to work?

•Not enough or particular substrate

•The genes that code for the enzyme are

abnormal, creating a damaged or inefficient

enzyme

•Something “poisons” the enzyme so it won’t

work

•Too much of a product (D) drives the reaction

in the other direction

Urine Porphyrins

 Certain toxins, such as heavy metals and pesticides can inhibit

certain enzymes in the heme porphyrin pathway, leading to

specific porphyrin profiles being excreted into the urine. If an

enzyme is inhibited, the substrate “upstream” can build up.

 Aluminum and dioxin inhibit uropophyrin decaboxylase.

 Mercury inhibits coproporphyrinogen oxidase.

 Lead inhibits coproporphyrinogen oxidase and aminolevulinic

acid dehydratase.

(Woods, 1996)



Second urine void of the day is the best collection, as supplements

that cause oxidation if mixed with the porphyrins overnight in

the bladder can change the structure of the porphyrin lead to

false values (Martin, 1996)

Urine Porphyrins

 Coproporphyrin (copro) is a general marker for

overall toxic metal burden. It is seen elevated in

the presence of mercury, lead and arsenic

 Precoproporphyrin (preco) – an atypical porphyrin

that only appears in the presence of mercury

 Heptacarboxyporhyrin and uroporphyrin is high

on exposure to pesticides, PCBs, arsenic and

aluminum

(Woods, 2005)

Urine Porphyrins

 Children with autism have significantly higher

levels of copro and preco porphyrins compared to

controls (Nataf, 2006; Geier, 2006)

 Nataf also found that the severity of autistic

symptoms correlated with the copro level, and that

children with autism and seizures had the highest

copro levels.

 Urine porphyrin levels decrease with chelation

(Pingree, 2001)

Urine Porphyrins

(how/when I use the test)

 I only send to Dr Nataf’s lab in France. They are the only

commercial lab that has ranges for children and that autistic

children has been studied at. The large US labs are not

calibrated to test for levels under that which is seen in genetic

porphyrin diseases which produce much higher porphyrin levels

 I prefer using the chelation challenge test, as it also tells me if

the chelation agent/route of administration is working, not just if

the metals are present.

 I order this test for:

– families who do not wish to expose their children to a

chelation agent unless there is proof of metals.

– If chelation challenge tests are negative but we still suspect

metals are present

– Once chelation challenge tests are negative after cycles of

chelation, if we still suspect metals are present

Overview of The Methylation / Transsulfuration Pathway

Methionine Protein synthesis

MAT

THF

SAM

Methylation of DNA, RNA,

MTase

proteins, membrane

MS BHMT phospholipids, creatine,

MTHFR

MB12 SAH neurotransmittors

Betaine

SAHH AK

5-CH3THF Choline Adenosine AMP



Homocysteine ADA



B6 CBS

Inosine

THF: tetrahydrofolate

Betaine:TMG Cystathionine

B6



Cysteine



Glutathione

The Methylation / Transsulfuration Pathway



The Enzymes:





MS: Methionine synthase

MAT: Methionine adenosyltransferase

MTase:Methyltransferase

MTHFR: Methylenetetrahydrofolate Reductase

SAHH: S-adenosylhomocysteine Hydrolase

CBS: Cystathione beta synthase

BHMT: betaine-homocysteine methyltransferase

The Methionine Cycle: Remethylation of Homocysteine



Methionine Protein synthesis

MAT

THF Methylation of DNA, RNA,

SAM

proteins, histones,

MTase membrane phospholipids,

MS neurotransmitters

MB12 SAH



SAHH AK

5-CH3THF Adenosine AMP



Homocysteine ADA

Inosine

THF: tetrahydrofolate

The Methionine Cycle: Remethylation of Homocysteine

Methionine Protein synthesis

MAT

THF

SAM

Methylation of DNA, RNA,

MTase proteins, histones,

MS membrane phospholipids,

B12 SAH neurotransmitters



SAHH AK

5-CH3THF Adenosine AMP



Homocysteine ADA

Inosine

THF: tetrahydrofolate

Effect of Oxidative Stress on Methionine Transsulfuration



Methionine Protein synthesis

MAT

THF

SAM

MTase Methylation of DNA, RNA,

MS proteins, membrane

BHMT

phospholipids, creatine,

B12 SAH neurotransmittors

Betaine



5-CH3THF Choline SAHH Adenosine ( AK and/or ADA)



Homocysteine



B6 CBS

THF: tetrahydrofolate

Cystathionine

B6

Cysteine



GSH GSSG

Neurotoxicity of Thimerosal in Human Brain Cells

is Associated with Glutathione Depletion:



Protective Effect of Cysteine or Glutathione

Supplementation





S. Jill James, William Slikker, Elizabeth New,

Stefanie Jernigan, Stepan Melnyk

Department of Pediatrics

University of Arkansas for Medical Sciences

Little Rock, AR

Neurotoxicity of Thimerosal in Human Brain Cells

is Associated with Glutathione Depletion:



Protective Effect of Cysteine or Glutathione

Supplementation





WORKING HYPOTHESIS

• Ethyl mercury in Thimerosal binds to cysteine thiol (–

SH) groups on intracellular proteins and inactivates

function.



• The cysteine-rich antioxidant, glutathione, binds

mercury and protects essential proteins from functional

inactivation.



• The neurotoxicity of Thimerosal is associated with

depletion of glutathione, the major intracellular

antioxidant.

VIABILITY OF GLIOBLASTOMA AND NEUROBLASTOMA

CELLS WITH INCREASING DOSE OF THIMEROSAL

Viability (MTT OD)









1.2 Glioblastoma Cells Neuroblastoma Cells

0.5

(48 hr Exposure) (3 hr Exposure)

1.0

0.4

0.8

0.3

0.6

0.2

0.4



0.1

0.2



0.0 0.0

0 2.5 5 10 20 0 0 2.52.5 5 510 10 20

20

M Thimerosal M Thimerosal

Viability of Glioblastoma cells exposed to 15 M

Thimerasol in the presence of GSH-ester, Cystine, N-

acetylcysteine (NAC), or Methionine



0.9

0.8

0.7

0.6

O.D. (Viability)









0.5

0.4

0.3

0.2

0.1

0

Control Thimerosal +GSH + Cystine +NAC + Methionine

Methyl-B12, Folinic Acid, and Betaine

Supplementation in 8 Children with Autism





Injectible Methyl-B12 (75 µg/Kg b.i.d.) was given to the 8

children who had been taking folinic and and betaine

supplements for 3-4 months



Plasma thiol profile was repeated in the 8 children after

4 weeks of combined folinic acid, betaine, and methyl

B12

Transmethyation Metabolites after addition of Methyl-B12 to

Folinic Acid and Betaine Supplementation in 8 Autistic Children



Methionine S-Adenosylmethionine

50 140

40 120

100

30

80

20 60

Control Before Folinic Folinic 40

10 Control Before Folinic Folinic

Betaine Betaine Betaine Betaine

Me-B12 20

Me-B12

0

0



S-Adenosylhomocysteine Adenosine

0.6

40

0.5

30 0.4

0.3

20

0.2

Control Before Folinic Folinic

10 Control Before Folinic Folinic

Betaine Betaine 0.1 Betaine Betaine

Me-B12 Me-B12

0 0

Transsulfuration Metabolites after addition of Methyl-B12 to

Folinic Acid and Betaine Supplementation in 8 Autistic Children



Homocysteine Cysteine

10 250



8 200



6 150



4 100

Control Before Folinic Folinic

Control Before Folinic Folinic 50

2 Betaine Betaine

Betaine Betaine

Me-B12

Me-B12

0 0



Cystinyl-Glycine 12 Total Glutathione tGSH)

70

60 10

50 8

40

6

30

4

20 Control Before Folinic Folinic

Control Before Folinic Folinic

10 Betaine Betaine 2 Betaine Betaine

Me-B12

Me-B12

0 0

Glutathione Redox Potential after addition of Methyl-B12 to

Folinic Acid and Betaine Supplementation in 8 Autistic Children



Total Glutathione (tGSH) 0.8

Oxidized Glutathione (fGSSG)

12

10

0.6

8

6 0.4

4 Control Before Folinic Folinic 0.2 Control Before Folinic Folinic

2 Betaine Betaine Betaine Betaine

Me-B12 Me-B12

0 0

GSH/GSSG Ratio

40



30



20



10 Control Folinic Folinic

Before Betaine Betaine

Me-B12

0

So, Why is this happening?

 Certain toxins such as mercury can inhibit the

enzymes of this pathway.

 Dr James has looked at the DNA sequences that

code for the proteins that make up these enzymes

and has found that autistic children have up to 3

times as many single DNA mutations

(polymorphisms, SNPs) as do children without

autism

 We have identified these SNPs in children with

other neurodevelopmental disorders

OPEN CLINICAL TRIAL

METHYLCOBALAMIN STUDY









JAMES A. NEUBRANDER, M.D.,

F.A.A.E.M.

EDISON, N.J. 08837

OPEN CLINICAL TRIAL

METHYLCOBALAMIN STUDY



Total number of children included in the data: 85





•71 males 51 males responded

•14 females 12 females responded



•84% males

74.1 % of the

•16 % females

children

responded

positively!

OPEN CLINICAL TRIAL

METHYLCOBALAMIN STUDY



THE TOP TEN

Symptoms Parents Reported Were Helped Most Often





Language 71% Better Behavior 35%

Awareness 65% More Focused 35%

Cognition 52% Understanding 35%

Engagement 43% Vocalization 35%

Eye Contact 37% Trying“New Things” 33%

OPEN CLINICAL TRIAL

METHYLCOBALAMIN STUDY

Side Effects Parents Reported

Hyperactivity 10%

Sleep Patterns Disrupted Or Worsened 6%

Uncontrolled Or Unusual Laughter 3%

Increased Aggression 2%

Biting Objects 2%

More Distractible 2%

Eczematous Symptoms Worse 2%

Increased Stimming 2%

Silliness, Unusual And Unexplained 2%

Teeth Grinding 2%

Tongue Tingles 2%



•All reported side effects faded upon stopping therapy

• Most parents chose to resume therapy b/c benefits

outweighed the side-effects

Oxalates

 Oxalates are small carbon and oxygen containing molecules that

are found in certain types of fruits and vegetables. Also most

nuts and seeds have oxalates.









 For most people, oxalates in the diet are not absorbed in great

amounts into the bloodstream. They are usually metabolized by

intestinal flora and excreted in the feces.

 In the presence of intestinal inflammation and leaky gut, larger

amounts of oxalates can get into the bloodstream and be

transported to tissues

 Under certain conditions they can crystallize and become

deposited in tissues. The crystals can grow and become stones

(kidney stones are calcium oxalate)

 When lodged in tissues, these crystals can produce irritation and

pain.

Oxalates

 Oxalates seem to accumulate more in conditions of

glutathione deficiency and oxidative stress.

 Vitamin B6 (pyridoxine) is a necessary cofactor for

enzymes that help prevent the formation of oxalates

 When sulfur is deficient, it becomes extremely difficult to

keep the body from making excess oxalates.

 High oxalates are associated with certain conditions like

vulvodynia, prostatitis, irritable bowel syndrome,

fibromyalgia, interstitial cystitis, and skin sensitivity. Some

people may get a sense of urinary urgency and frequent

urination, and sometimes the patient would have trouble

urinating (Solomon, VP Foundation)

 High oxalates are often seen in patients with

recurrent/resistant yeast infections and glycine intolerance.

Testing for High Oxalates

 There is no perfect test right now.

 Urine testing is most often used. If high values are seen

then this is a strong indicator, but people secrete oxalates

in their urine at different times of the day (it may be most

accurate to collect multiple urine specimens during the

day), and relative to food intake so there can be false

negatives.

 Great Plains Lab full organic acid test reports a spot oxalic

acid value. They also report other substances that are high

when there are oxalate issues: glyceric and glycolic acid

 Quest Labs has both random and 24 hour urine oxalate

tests, both as an individual value as well as relative to

oxalate. I usually get 24 hour collection with oxalate.

Treating High Oxalates

 The low oxalate diet. Full information can

be found at several sources:

– Yahoo Group: Trying_Low_Oxalates



Treating High Oxalates

 The Low Oxalate Cookbook is published by the Vulvar

Pain Foundation, contains over 250 recipes.

 The book has lists of foods with actual amount of oxate per

serving of a food.

 Aim to keep oxalate intake down to under 40-60mg oxalate

a day.

 Food Lists and summary can be found on “Medical

Topics” section of my webpage

 Probiotics: VSL#3: 1/2 to 1 capsule daily or ¼ to ½

packet of the unflavored powder daily

 Reduce vitamin C to 250mg or less a day, including foods

(oxalates can be converted to vitamin C)

 Calcium citrate supplementation - given with meals to

help bind and excrete the oxalates.

Elevated Male Hormones/Androgens

 Several studies have demonstrated that children with

Autism Spectrum Disorders have elevated androgens,

including testosterone, dihydrotestosterone,

androstendione and DHEA (Torjman, 1997; Knickmeyer,

2005; Geier,2006)

 Although not exclusive, increased androgens have been

associated with increased masturbation and genital

rubbing, aggressiveness, hyperactivity, self-stimming, and

increased body hair (legs and back),

 Elevations have been seen in male and female patients

 I use LabCorp for my testing. They have the most specific

reference ranges for both sex and age of patient.

Elevated Male Hormones/Androgens









The enzyme that converts DHEA to DHEA-S

(storage hormone) is sulfotransferase, which is

glutathione dependant. When this enzyme is not

working, there is a build up of DHEA which then

gets sent to androstenedione and then

testosterone

Treating elevated Androgens

 Geier – Lupron.

– belongs to a class of drugs called gonadotropin-releasing

hormone (GnRH) agonists.

– It is used to decrease the body’s production of specific

hormones, natural chemicals that influence the behavior of

certain cells. Because Lupron Depot can reduce the

production of both male and female hormones, it is used to

treat specific conditions in men, women, and children

(www.lupron.com)

 Bradstreet – Spironolactone,

– a potassium sparing diuretic, also has action of blocking the

receptor for dihydrotestosterone.

– Androgen levels should not go down with this treatment, but

the effects of the hormone are blocked.

Treating elevated Androgens

 Berger (VERY NEW)

– Glycyrrhizin – the active ingredient in licorice root

– decreases testosterone level by inhibiting the enzyme which

converts of 17-OH progesterone to DHEA (Armanini, 1999)

– Inhibits the enzyme that converts Androstendiaone to Testosterone

(Fukui, 2003).

– High doses can affect blood pressure and fluid retention, but doses

21%)



 Traditional HBOT – a hard walled chamber that

exposes the patient to a maximum of 3ATA

(monoplace-1 patient) or 6ATA (multiplace - >1

patient) at 100% oxygen

 Mild HBOT (mHBOT) - a soft walled chamber

that exposes the patient to a maximum of 1.3ATA

and <100% oxygen

Hyperbaric Oxygen Therapy

Laws of Physics

 Henry’s Law - the amount of a gas absorbed by a

liquid is in proportion to the pressure of the gas

above the liquid, provided that no chemical action

occurs.

 Boyle’s Law - at a constant temperature, the

volume and the pressure of a gas are inversely

proportional. In other words, a gas will compress

proportionately to the amount of pressure exerted

on it.

 Examples of these laws:

– a bottle of soda

– A scuba diver

Hyperbaric Oxygen Therapy

History

 In 1662, British Physician Dr. Henshaw first used

compressed air in an attempt to treat pulmonary disease.

His first chamber was called the “Domicilium”. Chamber

pressure was either raised or lowered with organ bellows

 In 1879, French surgeon Fontaine created a mobile

chamber. He was able to increase the amount of oxygen

carried in the blood during the administration of nitrous

oxide anesthesia. This prevented blood oxygen levels from

decreasing, which typically happened from surgical

anesthesia

 In 1921 Cunningham constructed a 20 meter round ball

that was the largest Hyperbaric Chamber ever built. It

contained a smoking lounge, dining facilities, rich

carpeting, and private quarters.

Hyperbaric Oxygen Therapy

Cunningham’s Sanitarium -1921









Later it was scraped for metal during World War II.

Hyperbaric Oxygen Therapy

History

 In 1934, US Naval Submarine Officer, Dr. Behnke

proposed using oxygen plus recompression for

Decompression Sickness (the bends). This information was

ignored until 1967

 In 1955, Dutch thoracic surgeon, Dr. Boerma removed the

red blood cells from pigs and found they could survive

with oxygen dissolved in plasma by use of hyperbaric

Oxygen.

 In 1961 Danish Dr. Brummelkamp, Published on the

ability of HBOT to inhibit the growth of anaerobic

bacteria - organisms that live where there is low or no

oxygen, such as gangrene or tetanus.

 In June 2006 Tampa Pediatrician David Berger obtained

his first mHBOT chamber, getting a second one the month

later. The world has never been the same since.

Hyperbaric Oxygen Therapy

Official Medical Indications

• Air or Gas Embolism • Exceptional Blood Loss

• Carbon Monoxide (Anemia)

Poisoning and Smoke • Necrotizing Soft Tissue

Inhalation Infections

• Carbon Monoxide • Osteomyelitis

Poisoning Complicated (Refractory)

by Cyanide Poisoning • Radiation Tissue

• Clostridial Myonecrosis Damage

(Gas Gangrene) (Osteoradionecrosis)

• Crush Injury, • Skin Grafts and Flaps

Compartment (Compromised)

Syndrome, and other • Thermal Burns

Acute Traumatic

Ischemias

• Decompression Sickness

(the "Bends")

• Enhancement of Healing

in Selected Problem

Wounds

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action

• Correct Cerebral hypoperfusion (low blood flow)

• Correct Cerebral Hypoxia (low oxygen levels)

• Decrease Neuroinflammation

• Decrease Intestinal Inflammation

• Improve Immune Function

• Reduce Oxidative Stress

• Correct Neurotransmitter Abnormalities

• Treat Intestinal Dysbiosis



Rossignol DA, Hyperbaric oxygen therapy might improve certain

pathophysiological findings in autism. Med Hypotheses (2006)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Rossignol DA, Hyperbaric oxygen therapy might

improve certain pathophysiological findings in

autism. Med Hypotheses (2006)

• Differing levels of pressure and oxygen were used in

the various studies that are discussed

• Some may be at pressures that are not being

recommended for children with Neurodevelomental

disorders

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action

Cerebral Hypoperfusion and Hypoxia in Autism



• Multiple studies have shown hypoperfusion to areas of the

brain of children with autism, especially the temporal lobes.

(Rye, 1999; Zilbovicius, 2000; Ohnishi, 2000)

• The low blood flow was more profound the older a child is.

(Wilcox, 2002)

• Autistic children often do not increase their cerebral blood

flow when doing tasks and when listening and trying to

speak, as seen in neurotypical children. (Critchley 2000,

Allen 2003).

• Decreased blood flow to the thalamus as seen on SPECT

scans has been associated with repetitive and self-stimming

behaviors (Starkstein, 2000)

• Decreased blood flow to Wernicke’s and Brodmann’s areas

(speech areas of the brain) has been associated with

decreased auditory processing (Bodaert, 2002) and

language development (Wilcox, 2002)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action

Treating Hypoperfusion with HBOT

• HBOT may overcome the effects of the hypoperfusion by

providing the brain with more oxygen (Sheffield, 1976;

Neubauer, 1998)

• HBOT may increase new blood vessel growth (Al-Waili,

2006)

• Hypoperfusion may be due to inflammation. Inflamed

vascular cells can lead to diminished blood flow, and

inflammation in tissue prevents maximal uptake of oxygen

by cells

• HBOT can increase the distance that Oxygen can travel

between cells (Williams, 1997)

• Increased blood flow to the brain also means increased

blood flow from the brain, potentially increasing the flow of

toxins away from the brain. This could bring a synergistic

effect with chelation.

SPECT Scans in a 4 year old autistic child

after 10 dives mHBOT at 1.3 atm and 24% oxygen









Before After Mild HBO





Heuser et al., 2002

Best Publications; 2002:109-15

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Neuroinflammation and Autism

• Of recent, several studies have demonstrated

evidence that children with autism have increased

neuroinflammation.

• Increased inflammatory cells and pro-

inflammatory chemical mediators (cytokines)

have been found in the CSF of Autistic Children

(Weizman, 1982; Vargas, 2005).

• Increased brain auto-antibodies have been

demonstrated in children with Autism (Connolly,

1999; Singh, 1997; Vojdani, 2002; Singer, 2006)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Gastrointestinal Inflammation and Autism

• A subset of children with Autism have demonstratable

inflammation of their stomach, small intestine and colon

(Furlano, 2001; Uhlmann, 2002; Balzola, 2005; Wakefield,

2005)

• Both inflammatory cell and cytokines (TNF-ά, IL-1Β, IL-6)

have been seen in increased amounts in the gastrointestinal

lining in some children with Autism (Jyonouchi, 2001;

Ashwood, 2003 & 2004)

• Many children with autism have increased serum antibodies

directed against casein and gluten based peptides (Vojdani,

2003; & 2004)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Treating Inflammation with HBOT

• HBOT had been demonstrated to have anti-inflammatory

affects on tissues (Al-Waili, 2006)

• HBOT can decrease the production of the cyctokines that

are pro-inflammatory such as IL-6 and IL-1(Weisz, 1997)

and TNF-ά, (Yang, 2006)

• HBOT can increase the production of cytokines that

decrease inflammation such as IL-10 (Buras, 2006)

• HBOT has been shown in animal studies to reduce

symptoms and inflammation of arthritis (Warren, 1979) and

peritonitis (Tokar, 2003)

• There is evidence that HBOT can facilitate remission for

non-responsive Crohn’s Disease (Brady, 1989; Columbel,

1995) and Ulcerative Colitis (Buchman, 2001; Gurbuz,

2003)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Abnormal Immune Function and Autism



• 5% of Children with Autism have low serum IgA levels

(Gupta, 1996)

• Compared to typical children, many Autistic children have

elevated IgE levels (Gupta, 1996; Lucarelli, 1995)

• Some children with Autism have reduced levels of T-helper

cells (Warren, 1986)

• Some children with Autism have decreased lymphocyte

activity/responsiveness (Stubbs, 1977)

• Warren (1987) demonstrated decreased Natural Killer Cells

in Autistic Children compared to controls

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Treating Immune Abnormalities with HBOT



• In patients with MS, HBOT significantly

increased the production in total an helper T-

Lymphocyte levels as well as IgA serum levels

(Nyland, 1989)

• In patients with atopic dermatitis, HBOT

decreased IGE levels as well as symptoms

(Olszanski, 1992).

• In mice studies, Lymphocyte activity and

lymphocyte counts were increased by HBOT

(Lee, 1993&1994)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action

Increased Oxidative Stress and Autism



• Many children with Autism show the presence of increased

oxidative stress/free radicals

• They have lower levels of glutathione (James, 2004)

• Increased RBC nitric oxide has been seen in some Autistic

children. This is a free radical and is a neurotoxin. (Sogut,

2003)

• Children with Autism demonstrate increased markers of

oxidative stress and lipid peroxidation such as

malondialdehyde (Chauhan, 2004)

• Children with Autism often have decreased activity of the

enzymes that produce antioxidants such as glutathione

peroxidase and superoxide dismutase (Yorbik, 2002)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Treating Oxidative Stress with HBOT



• There has been concern that HBOT could, thought increased

production of reactive oxygen species, increase oxidative

stress, and that taking alpha-liopic acid (an antioxidant)

could ameliorate this problem (Alleva, 2005).

• In animal studies, there is evidence that oxidative stress is

less of a concern at pressures < 2.0 ATA (Wada, 2001).

• Other animal studies have shown that at < 2.0 ATA, HBOT

may reduce oxidative stress by decreasing the peroxidation

of lipids (Ozden, 2004, Kudchakar, 2000).

• In other animal studies, HBOT has been demonstrated to

increase superoxide dismutase (Gregorevic, 2001) and

glutathione peroxidase (Gulec, 2004)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Abnormalities in Neurotransmitters and Autism



• Serotonin levels man be lower in children with autism

(Chugani, 1999; Connors, 2006)

• Compared to controls, children with Autism have lower

plasma tryptophan levels. Tryptophan is the amino acid

precursor of serotonin.

• Tryptophan uptake into brain cells was decreased in children

with Autism compared to controls when studies with PET

scans (Chugani, 1999)

• Some children with Autism may have increased dopamine

activity (Gillberg, 1997)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Correcting Neurotransmitter Abnormalities with

HBOT



• Serotonin uptake by endothelial cells of the lung

has been shown to be reduced [the same

mechanism as SSRIs] when HBOT was used

(Fisher, 1980; Block, 1981)

• Following brain injury, HBOT was demonstrated

to decrease dopamine release (Yang, 2002)

• Oxygen alone, without increased pressure, may

decrease brain extracellular dopamine levels

(Adachi, 2001)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Intestinal Dysbiosis and Autism



• Overgrowth of certain abnormal bacteria, and in particular

clostridia (anaerobic) bacteria, have been seen in many

children with autism compared to controls (Feingold, 2002;

Song, 2004; Parracho, 2005)

• An increased clostridial byproduct (HPHPA) is often seen

on urine organic acid testing of children with Autism.

• Improvements in Autistic symptoms have been

demonstrated in serial blinded psychological evaluations

after the administration of oral Vancomycin (Sandler, 2000)

• Intestinal overgrowth of yeast, viruses and parasites have

been documented in children with Autism (Cave, 2001)

Hyperbaric Oxygen Therapy

Proposed Mechanisms of Action



Treating Intestinal Dysbiosis with HBOT



• HBOT has been shown to decrease levels of

atypical bacteria overgrowth in the distal ileum

(Akin, 2001).

• HBOT has been demonstrated to be able to kill

many different types of bacteria, including

clostridia (Gotleib, 1971;Unsworth, 1984)

• Phagocytes, white blood cells that engulf bacteria,

depend on oxygen to kill the bacteria (Babior,

1978). Killing of Staph Aureus by these

leukocytes is enhanced by HBOT (Mader, 1980)

Hyperbaric Oxygen Therapy

Hard vs. Soft Chamber

• Cost: Hard chamber dives cost 2-6x that of mHBOT

• Time to depressurize if need to get out quickly. The higher

the pressure, the longer it takes to depressurize

• Oxygen Dangers/Flammability/fire and building codes

• Oxygen Delivery

– 100% in Hard Chamber. In most units, no special masks or

tubes are needed. Compliance may be easier with the Hard

Chamber

– 24 – 40% in mHBOT depending on how O2 is delivered

• Breaks vs. no breaks in therapy

• Accessibility/home use approval

• Is more better?

• Some may respond to hard but not soft (often see 1.75ATA

used for ASD, never more than 2.0ATA)

– certain conditions such as crush injuries, CP, anaerobic bone

infections

Hyperbaric Oxygen Therapy

And Seizure Risk

• There is a known entity called Oxygen seizures.

• Incidence of seizures has never been reported with

pressures <2.0ATA for 1 hour or less

• Davis (1989): In chart review, Overall incidence

of seizures was 0.01%, looking at 1505 patients

who did a total of 52,700 dives. 5 patients

developed seizures, all recovered completely.

Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy

Our Proposed Study

 This would be the first University based,

placebo-controlled, blinded study ever

performed using HBOT on children with

Autism

 Joint project between Wholistic Pediatrics and

USF Child Psychiatry, Child Neurology and

Child Development teams

Hyperbaric Oxygen Therapy

Our Proposed Study

 Subjects:

– Children with formal diagnosis of Autism

– Selecting kids that have not done any biomedical/dietary

interventions, only educational interventions

– Only educational changes allowed during treatment

period

– 10 children to receive treatment, 10 placebo. Will cross-

over the placebo group.

– 6-8 year old

– Must be able to comply with use of non-rebreather mask

Hyperbaric Oxygen Therapy

Our Proposed Study

 Outcome measures:

• ADOS

• full neuropsychological evaluation

• Single subject design – since multiple N=1

• GI checklist



Will do evaluations at:

3 months prior to starting mHBOT

The week before starting mHBOT (to determine what a typical

3 months bring in terms of symptom changes)

At the end of 3 months of dives

3 months after dives start

Also will take selected data during 1-2 week intervals during

the dive phase for the single subject design

The Bottom Line:

We Need More

Research!







----The Bottom Line----The Bottom Line----The Bottom Line----The Bottom Line---


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