FEAT DAILY NEWSLETTER
Sacramento, California http://www.feat.org
December 6, 2001
News Morgue Search www.feat.org/search/news.asp
·
Beneficial Effects of Enzyme-based Therapy for Autism
Spec Disorders
·
Peptizyde and HN-Zyme Prime 4-6 ½-Month Interim Update
http://www.gfcfdiet.com/Enzymes.htm#*
[This is to provide readers with some background
information on the
enzyme therapy referred to in the work of Dr. Timothy Buie,
a pediatric
gastroenterologist from Harvard/Mass General Hospital for
treatment for
autistic children with certain gastroinstestinal disorders.
See
http://www.feat.org/scripts/wa.exe?A2=ind0112&L=FEATNEWS&P=R1962
This pilot study is uncontrolled and is not peer reviewed
published. This means that the
information provided stands a higher risk of being inaccurate than from
peer-reviewed, controlled experiments.
Parents should be clear that when considering any
experimental medical treatment for a child, we are placing that child at some
risk. How much risk? Some answers to this can be obtained by
gathering information from other parents on the Internet who are already
experimenting with the same approach (try GFCFKids-subscribe@yahoogroups.com). However, the highest quality of information
comes from peer reviewed, controlled experiments. That’s why we need research, research, research… -LS]
Mark A. Brudnak Ph.D., N.D.* Bernard Rimland, Ph.D.†
John B. Pangborn Ph.D.‡
Ilene Buchholz R.N.††
Autism is a developmental disease usually manifesting
within the first three years of life. To date, no causative agent has been
found. Similarly, treatment options have been limited. Of the treatment options
available, a number of them have been nutritionally based in an attempt to
address one or more of the theories regarding the etiology of the disease.
A pilot study was undertaken to address the exorphin
(exogenous opiate-type peptides) theory of autism by treatment with dietary
enzyme therapy. Forty-six patients between the ages of 5 and 31 were selected
for inclusion in the study based on a diagnosis placing them in the category of
the autism spectrum disorders (ASD), some with and/or without attention deficit
disorder (ADD) or attention deficit hyperactivity disorder (ADHD). The diets were supplemented with a novel
dietary enzyme formulation, EnZymAid™, for a period of twelve weeks. Progress was tracked according to the
Symptom Outcome Survey (SOS1) form method of symptom charting and presented in
a table for further analysis.
Results: The novel enzyme formula, EnZymAid™, beneficially
and safely affected all thirteen of the parameters measured. Improvements
ranged from 50-90%, depending on the parameter measured, of the respondents who
completed the entire course of therapy. Statistical analysis revealed that even
assuming an extremely high baseline, twelve of the thirteen parameters were
significant improvements.
Conclusion: The novel enzyme formula EnZymAid™ was
effective at improving autistic symptoms such as socialization, hyperactivity,
attention, eye contact, comprehension, compulsions, etc. These results indicate
that further controlled studies are warranted.
Roy E. Kerry, M.D. and Margaret Dailey CRNP 17 6th Avenue Greenville
PA 16125 Bruce Stayton, M.D. 2116 South Sterling Ave
Independence, MO 64052
Robert Taylor, M.D. Triangle ENT Services 2909 N. Duke Street Ste 503
Durham, NC 27704
Frank Waickman, M.D. 2377 Thurmont Rd., Akron, OH
44313
Michael Waickman, M.D. 544 White Pond Dr., Ste B.
Akron, OH 44320
·
MAK Wood, Inc. Mark A. Brudnak, Ph.D., N.D., VP
Technology 235 Dakota Dr., Units E-F,
Grafton, WI 53024-9429 † Autism Research Institute 4182 Adams Avenue,
San Diego, CA 92116
‡ Bionostics,
42 W. 719 Bridle Ct., St Charles, IL 60175 †† Correspondence to:
Ilene Buchholz
Kirkman Laboratories, 9285 Dowdy Drive, Ste 105, San Diego, CA 92126
http://www.kirkmanlabs.com/disorders/autism/default.htm
It has been estimated that 5:10,000 to 1:300 suffer from
autism with an initial manifestation of symptoms by age three.2 While the exact
cause of autism remains elusive, considerable advances have been made in recent
years. These advances come from a study of the geographic localization, biological,
and psychological aspects of the disease. From these studies, several theories
have emerged.
One such theory is that autistics suffer from several
maladies with the accumulated symptoms being categorized into the autism
spectrum disorders, herein simply referred to as autism or ASD. Typically, the autistic’s
digestive tract is thought to function sub-optimally. Two important pioneers of
this work, Reichelt and Shattock, observed a significant correlation between
the symptoms of autism and an impaired ability to adequately digest
peptides/proteins from dairy (casein) and wheat (gluten).
During digestion, pre-opioid type compounds in the diet,
typically from casein and gluten, are thought to be activated due to an
incomplete breakdown of proteins.3,4 These exorphins (i.e., casomorphins and gluteomorphins
or gliadorphin) are then easily transferred across the lumen of the gut into
the circulation where they exert opioid-type action on the brain. The transfer
of peptides across the lumen of the gut is thought to occur at high levels due
to the “leaky” nature found to be associated with the autistic’s
gastrointestinal tract. According to the exorphin theory of autism, the
attenuated level of DPPIV could manifest as autistic symptoms. 5 The present
study was to determine the effectiveness of a more proactive enzyme formulation
on various parameters in ASD.
While previous attempts to address a nutritional based
therapy have tried to completely eliminate all contributions of exorphins from
the diet via exclusion of the causative agents, it has been determined that it
is not entirely practical or 100% guaranteed.6 Those that are not removed, may
go on to exert a neurotoxic effect. Previous attempts to deal with this situation
via enzyme therapy have been to digest the peptides after they are made, while
they are in the small intestines, via a strong peptidase enzyme.
In the present study, the enzyme formula was designed with
a very high acid stable protease to thoroughly digest the proteins to the
fullest extent possible in the shortest period of time. The idea being that if
the exorphins are going to form anyway from dietary constituents, driving the reaction
forward with large amounts of acid stable enzyme in the stomach allows more
time for the body’s endogenous enzymes, that have evolved to specifically
digest exorphins, to work.
Study Protocol and Human Subjects: The study protocol was
approved by a Medical/Scientific Review Board. The legal guardians of all
participants signed appropriate “informed consent” forms. The study was carried
out with the highest standards of ethics. Initially, forty-six patients between
the ages of two and twenty-one were chosen for the study. Of those that started
the study, twenty-two remained for the entire twelve-week period. For data analysis,
only those subjects who completed the entire course of therapy were
included. All raw data is kept on file
for public inspection at the Autism Research Institute (ARI), San Diego, CA.
Enzymes: All enzymes were manufactured by MAK Wood, Inc
(Grafton, WI). They were manufactured
specially for Kirkman Laboratories (Wilsonville, OR) to be free of milk,
casein, wheat, gluten, gliadin, corn, soy, egg, yeast, sugar, starch, MSG,
sterates, palmitates, artificial sweeteners, colors or flavors, preservatives,
salicylates and other common allergens. Kirkman Laboratories kindly supplied
all the enzymes. The following enzymes and activities were included:
CASO-GLUTENASE 10,000 AU; Bromelain 230 BTU; Acid Fast Protease 100 SAPU;
Lactase 330 LacU; Phytase 125 U; Galactose (as Genomeceutical) 100 mg.
Statistics of the participants: There was a predominance
of males (87%) compared to females (13%). Approximately 77% of the
participating children were diagnosed with autism spectrum disorders (autism,
PDD and Aspergers) and the remaining 23% were diagnosed with ADD and/or ADHD.
Of those with ADD/ADHD, four participants had an additional diagnosis of obsessive-compulsive
disorder (OCD), epilepsy, and/or Down’s syndrome. Of the 46 children who initially started the EnZymAid study a
total of 17 children dropped out within the first few weeks of this 12-week
pilot study. The families who withdrew
from the study reported a number of reasons including; needed to start other
therapies, child developed unrelated illness, family or personnel issues,
changed physicians, did not tolerate the taste of the supplement, experienced
adverse symptoms and/or no change in symptoms were noted.
Dietary Issues: Approximately 40% of the children were
strictly following a gluten-free and casein-free diet and 60% had liberal use
of wheat and dairy products in the diet. The criterion for inclusion in the EnZymAid
study was that participants would not make any changes in the diet during the
coarse of the study.
Dosing: The enzymes were to be taken at the beginning of
each meal (or early on into the meal). The capsules were swallowed whole or
pulled apart and the contents mixed with the first few bites of food or in
beverages. One half to one capsule with each meal was suggested with a gradual
increase to one or two capsules (in a couple of cases three capsules were
utilized) per meal.
Tolerance: The EnZymAid™ formulation was generally well
tolerated as only a small group of respondents reported adverse effects, which may
be directly attributed to the enzyme formulation.
Assay: Parents and/or guardians, with feedback from
teachers or therapists, were asked to complete a Symptom Outcome Survey form
every two weeks. They evaluated different parameters of function, behavior as
well as the gastrointestinal status of each child.
Evaluation: Participants evaluated thirteen different
parameters of function and behavior including: eye contact, socialization,
attention, mood, hyperactivity, anxiety/compulsions, stimming, comprehension,
speech, sound sensitivity, digestion (presence of constipation, diarrhea,
gassy, foul-smelling stools), sleep and perseveration.
Improvement Rating: Symptoms were assayed utilizing the
following 0 to 4 scale: 0=none; 1=possible; 2=moderate; 3=significant; 4=great.
The results in Table 1 list the percentage of patients that scored between a
moderate and great improvement by a guardian.
Summary: There were 22 children who completed the full
12-week trial on the EnZymAid. Out of this group there were three children
(12.5%) who experienced little change in symptoms categories being evaluated.
However 87.5% percent of the children were noted (by parent evaluation) to have
moderate to significant improvement, in one or more categories of function and/or
behavior, with use of this enzyme formulation. In greater then 90% of the
children the parents noted moderate to significant improvement in five or more
of the symptom categories being evaluated.
Statistical analysis: A statistical analysis of the data
revealed significant benefit/improvement in twelve of the thirteen parameters evaluated.
Results: The present study was undertaken to determine the
effectiveness of the rationale above as gauged by thirteen markers assessed in
twenty-two patients. The results of the application of EnZymAid™ to autistics
are presented below. Statistical analysis suggests that the enzyme formulation
is both sound and effective for the treatment of autism spectrum disorders.
Table I
Percentage of Participants Showing Improvement
WEEK 1-2 3-4 5-6
7-8 9-10 11-12
Eye Contact
37% 47% 43%
56% 67% 67%
Socialization
42% 67% 71%
76% 81% 90%
Attention 40%
54% 63% 59%
73% 68%
Mood 36%
52% 57% 60%
55% 59%
Hyperactivity
31% 31% 50%
75% 75% 80%
Anxiety/Compuls 20% 41% 46%
47% 41% 60%
Stimming 27%
38% 27% 38%
31% 50%
Comprehension
40% 45% 58%
55% 50% 63%
Speech/language 27% 41% 53%
47% 38% 44%
Sound Sensitiv
17% 17% 18%
42% 25% 50%
Digestion 35%
50% 56% 50%
56% 50%
Sleep
23% 36% 43%
50% 64% 57%
Perseveration
33% 38% 44%
50% 39% 53%
As an uncontrolled pilot clinical study the present work
has tremendous value. Not only did the overwhelming majority of parameters measured
show a significant benefit of the enzyme blend, but there were also very few
associated negative reactions. While the etiology of autism and the ASD’s still
remains elusive, clearly the present study advances the knowledge base for
efficacious treatment protocols.
References:
1. Personal
Communication. Dr. Bernard Rimland. Autism Research Institute.
San Diego CA.
2. Turner M, Barnby G,
Bailey A Genetic clues to the biological basis of autism. Mol Med Today 2000
Jun; 6(6):238-44
3. Haileselassie,
S.S., Lee, B.H., Gibbs, B.F., Purification and Identification of potentially
Bioactive Peptides from Enzyme-Modified Cheese. J. Dairy Sci. 1999.
82:1612-1617.
4. Reichelt KL, Hole
K, Hamberger A, Saelid G, Edminson PD, Braestrup CB, Lingjaerde O, Ledaal P,
Orbeck H Biologically active peptide-containing fractions in schizophrenia and
childhood autism. Adv Biochem Psychopharmacol 1981; 28:627-43.
5. Personal
Communication. Drs. Alan Friedman and Jon Pangborn.
6. Brudnak, MA
Application of Genomeceuticals to the Molecular and Immunological Aspects of
Autism. Medical Hypotheses. In Press. The EnZymAid™ Pilot Study was cosponsored
by the Autism Research Institute and Kirkman Laboratories.
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[The FEAT Newsletter has previously reprinted another
non-peer reviewed paper on the use of enzymes in the treatment of autism. This report has been compiled by
professional unpaid volunteer marketers of Houston Nutraceuticals products
Peptizyde and HN-Zyme Prime, rough equivalents to Kirkman Labs enzymes. See: http://www.feat.org/scripts/wa.exe?A2=ind0109&L=FEATNEWS&P=R1620
Below is an executive summary of an update to this report. –LS]
Karen L. DeFelice
November, 2001
Executive Summary
·
Of 109 new individuals (100%) using these products for
at least 3 weeks, 100 (92%) reported positive results, 6 (5%) reported negative
results, and 3 (3%) reported inconclusive results. The overwhelming majority of
respondents have continued to see significant improvements with Peptizyde and
HN-Zyme Prime.
·
Most individuals were higher functioning, 4-9 yrs old,
and on some type of restrictive diet.
·
Significant improvements continued to be seen in eye
contact, language, humor, foods tolerated, foods accepted, sleep, weight gain
or loss, digestion, stools/bowels, overall appearance, transitioning, socialization,
awareness, problem solving, short-term memory, flexibility in routine, range of
interests, sound and light tolerance, sensory integration, spontaneous
affection, and energy level among others. Significant decreases in aggression,
hyperness, anxiety, stimming, self-injurious behavior, pain, and headaches
among others.
·
After 6 months on enzymes, there have been no reports
of any regression after success is seen past the 3-week adjustment period, including
in those eating gluten/casein liberally.
·
25% of the children were ages 7-9 and showed just as
significant improvement just as quickly as younger children. Most positive
results were apparent within the first 3 weeks.
·
Significant improvements were seen whether people were
on or not on a restrictive diet.
·
The foods most problematic, even with enzymes, are nuts
and seeds, and highly phenolic foods in sensitive individuals.
·
The best results, including the Happy Child Effect, are
seen by those who take enzymes with foods all the time. This is thought to be
due to the gut healing and overall health benefits of enzymes beyond the
benefits of just breaking down food.
·
The new formulation of Peptizyde without the
L-glutamine significantly reduced the number of negative reactions and over
hyperness seen by some people before.
·
Hyperness continues to be the main side effect,
however, only sometimes is this a negative and there are several methods given
to assist in remedying hyperness with have helped many.
·
People with celiac disease tended to respond worse when
using proteases enzymes and gluten than when consuming gluten without enzymes.
·
It is currently recommended that enzymes and probiotics
be given at separate times.
·
Possible reasons some people see no results at all may
be due to heavy metals or overgrowth of undesirable gut flora.
·
The time for healing a leaky gut is about 3-6 months
and enzymes appear to facilitate this.
·
The longer on enzymes, the less expensive the program
becomes due to reduction in special food costs, supplements, and doctor visits
for most respondents.
·
The longer on enzymes, the more foods people tend to re-introduce
and the more positive results are seen.
·
People having difficulties or concerns when starting
enzymes were far more likely to achieve positive results when they posted their
concerns on the enzymesandautism board for assistance rather than attempt to
discern the problem themselves. This is attributed to getting more education
and information on using enzymes.
·
People having difficulty tolerating rice or rice bran
had no problem with Peptizyde and Zyme Prime. People intolerant of pineapple,
papaya or kiwi usually can not use any enzyme product containing these.
·
Reasons why several people previously seeing negative
results now see positive ones.
The 4-6 ½-month update was done in the same way as the
4-month summary report. Results from both will be combined into one document
called the 7-month Summary Report.
Both the previous 4 months summary and the complete
4-6 ½ month
summary are available through the FEAT Newsletter. Contact
FEAT@feat.org
Lenny Schafer, Editor@feat.org • CALENDAR EVENTS@feat.org
Michelle Guppy
Catherine Johnson PhD
• Ron Sleith •
Kay Stammers • Edward Decelie
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