More on LDN for Dr. McCandless

[Guest guest]

Here is a summary of LDN from the author of " Children with Starving Brains, "

Dr. McCandless (permission to forward granted). I highlighted certain parts

that seemed relevant to recent discussions.

LDN - LOW-DOSE NALTREXONE FOR IMMUNOMODULATION

Naltrexone is an FDA-approved drug used as an opiate antagonist for treating

opiate drug and alcohol addiction since the 1970's, available in generic

form as well as ReVia in 50mg tablets. At regular dosing, usually 50mg a

day, it blocks the euphoric response to opiate drugs such as heroin or

morphine. I as well as many other DAN! doctors have tried Naltrexone with

our ASD children hoping to offset the " opioid " effects of the large peptides

in wheat, milk and soy. I found it mostly ineffective and abandoned this

therapy long ago. Naltrexone has always been considered very safe and has

never been reported as being addicting.

Opioids are known to operate as cytokines, the principal communication

signalers of the immune system, creating immunomodulatory effects through

opioid receptors on immune cells. A popular immune classification method is

referred to as the Th1/Th2 balance; Th1 cells promote cell-mediated immunity

while Th2 cells induce humoral immunity. The inability to respond adequately

with a Th1 response can result in chronic infection and cancer; an

overactive Th2 response can contribute to allergies and various syndromes

and play a role in autoimmune disease, which most ASD children show on

immune testing.

Bernard Bihari, MD, a New York physician studying the immune responses in

AIDs patients, discovered that a very low dose of naltrexone in less than

one-tenth the usual dosage boosts the immune system and helps fight diseases

characterized by inadequate immune function. Low-Dose Naltrexone (LDN) tends

to normalize the immune system by elevating the body's endorphin levels and

accomplishes its results with virtually no side effects or toxicity. Since

endorphins are an integral part of the immune system, when a tiny dose of

naltrexone is given between 9-12pm at night the body attempts to overcome

the opioid block and the endorphins rise, to stay elevated throughout the

next 18 hours.

LDN had been studied in ASD children using from 5-12.5mg daily or every

other day in the early 90s; researchers were looking for opioid antagonism.

Results were equivocal with non-compliance because of the bitterness of the

drug. Dr. Tyrus at Coastal Compounding agreed to create a transdermal

cream for my study; that way we could adjust the dose easily (some of the

smaller kids did better with only 1-1/2mg), the bitter taste was no problem,

and it could be put on their bodies while they slept. The cream is put into

syringes, ? cc providing 3mg, with a month's supply of the child dose (3mg)

costing $19, the adult dose (4.5mg) $30, plus shipping, no refrigeration

required. Dr. has offered to share this very effective formula with

any compounding pharmacist who wishes to call him, 912-354-5188.

I have completed an 8-week informal clinical study on 15 of my ASD patients

using 3mg of LDN transdermally between 9-12pm. Several adults participated

also, one with Crohn's Disease and one with Chronic Fatigue Syndrome using

4.5mg nightly. Parents reported weekly; 8 of the 15 children had positive

responses, with five of these 8 having results considered quite phenomenal

according to their parents. The primary positive responses have been in the

area of mood, cognition, language, and socialization. 5 of the children had

equivocal results and three children dropped out, one because of no response

after 4 weeks, the other two for personal family reasons. Two very small

children did better when changed to 1-1/2mg dosing. No allergic reactions

were noted to the cream, with the primary negative side effect being

insomnia and earlier awakening when first taking it, usually lasting 3-5

days. The two adults in the study, one with Crohn's and the other with

Chronic Fatigue Syndrome, have had very positive responses; the Crohn's

participant says she has been in remission since starting LDN (almost 3

months now). All participants who completed my study have indicated they

wish to continue, and hundreds of other ASD kids have started this

non-toxic, non-invasive, inexpensive intervention by now.

All my study children were on well-controlled dietary restriction. I am

receiving reports from the e-lists I monitor of about 5% of other children

besides those in my study having side effects such as irritability,

agitation, and restlessness. Side effects subside as soon as the drug is

withdrawn. I am querying these parents about gluten/casein/soy in diet, as

this could be withdrawal symptoms of opioid block. I suspect that children

on a strict GF/CF/SF diet may demonstrate the positive immune modulation

effect sooner than the child who needs to go through opioid withdrawal

first, but I assume it is possible for the block to stimulate withdrawal

effects and also have the endorphin rush if parents want to stick out the

side effects.

It may be a while before a formal study can be conducted, so although I

assume the positive effects are due to up-regulation of the immune system, I

do not yet have studies to prove it. I suspect we will get lots of informal

clinical data long before we can get a formal study conducted. I am hoping

this will be another weapon in our ever-expanding arsenal to help the

children get as immune-efficient as possible. I want to thank those who

participated in the study for being trusting enough to go along with me in

trying something new, and I thank Dr. Tyrus at Coastal Compounding for

helping devise a successful form to use in our children. Jaquelyn

McCandless, M.D. 7-18-05