OT: Questions about Enzymes

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There was a posting yesterday, on this GFCFKids list, asking a question

about the use of the EnZymAid formulation to counter any infractions in the

diet when traveling. Another list mate (k.jorn) replied with a detailed

response suggesting reported ineffectiveness of the EnZymAid formulation,

despite acknowledging no personal experience with this product.

Unfortunately the information that was given was misleading and incorrect.

I work in the Professional Division of Kirkman Laboratories and have

experience with and knowledge about the EnZymAid product. I would like to

correct the misinformation given regarding the use and/or effectiveness of

this formulation. Following is a brief description of EnZymAid as well as a

clarification of Kirkman Laboratories position on the use of the EnZymAid as

it relates to the gluten-free and casein-free diet.

EnZymAid is a potent proteolytic enzyme with documented DPP-IV activity.

This enzyme was formulated by Mark Burdnak, Ph.D., N.D. with input from Jon

Pangborn, Ph.D. (Kirkman Labs Scientific Consultant). EnZymAid is

specifically designed to digest casein and gluten peptides as well as

proteins in soy. EnZymAid was part of a Pilot Study, co-sponsored by the

Autism Research Institute, involving five medical practitioners treating

children with autism spectrum disorders. The goal of the study was to

evaluate the clinical response of this formulation, on 13 different

parameters of function and behavior, in those with autism. Approximately 60%

of the children participating in study were liberally eating gluten and

casein containing foods and the remaining 40% were strictly GF/CF.

The results of this 12 week parent judged study (evaluation forms were

completed every two weeks and submitted to the ARI) indicated that moderate

to significant improvement was noted in function and behavior of the

participants. This included both those who were liberally eating gluten and

casein containing foods as well as those utilizing a strict GF/CF diet.

Kirkman Labs chose not to publicize or profit from these results and we have

not positioned this formulation in replacement of a GF/CF diet. Instead we

made these results available to researchers in autism encouraging additional

independent testing to confirm these results with rigorous clinical trials

and laboratory verification. Also a scientific article, inclusive of the

study design and outcome results, was submitted for publication in a Medical

Journal which included the following table.

SUMMARY OF THE DATABASE:

Following is a table providing the percentage of families that reported a

moderate, significant and/or great improvement rating in symptoms over a 12

week time period.

WEEK 1-2 WEEK 3-4 WEEK 5-6 WEEK 7-8 WEEK 9-10 WEEK 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/Compulsions 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 Sensitivity 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%

The observations from this study suggest that EnZymAid can be effectively

used to provide quite noticeable measures of improvement in function and

behavior of those children on the autism spectrum (both in those utilizing,

as well as strictly avoiding, gluten and casein). Despite these results

Kirkman Labs will not make any claims that these products alleviate, cure or

prevent any disease or condition in autism. We do not advocate the total

abandonment of the GF/CF diet, with liberal use of all gluten and dairy

containing foods in conjunction with enzymes, despite recognizing that this

is being done quite successively with our formulations.

Kirkman Laboratories supports the position of practitioners and researchers

who suggest there is no definitive scientific support guaranteeing that

enzymes completely (100%) breakdown casomorphin and gluteomorphin peptides.

We do support the use of these enzymes when there are accidental infractions

or planned exposures to gluten or casein in the diet, as we have had

confirmation of their effectiveness from countless families.

The suggestion that EnZymAid has not been effective for some that have tried

it may in part be related to the dosing of this enzyme. Those children in

the study who were ingesting gluten and casein containing foods utilized far

higher amounts of the formulation (2 to 4 capsules per meal) than those on a

strict GF/CF diet (using 1 to 2 capsules with food). Additionally it is

clear that each child responds differently to the introduction of enzymes.

The response by families to the combined use of EnZymAid and EnZym-Complete

(a multi-spectrum enzyme formulation) has provided support for undertaking

further studies evaluating the effectiveness of these enzymes in the health

and functioning of children with autism.

The position of Kirkman Laboratories remains consistent in supporting the

use of a GF/CF diet, which has been shown to be a crucial and effective

measure for many with autism spectrum disorders.

Ilene Buchholz, R.N.

Kirkman Laboratories

Professional Division