The Efficacy of Phytonutritional Dietary Supplements for the Treatment of Autism

William Zollweg, Ph. D., William Deering, M. D., Patrick Scott, M. D., Kirby Lentz, M.Ed

La Crosse, Wisconsin: Chileda, University of Wisconsin-La Crosse, Franciscan Mayo Medical Center, January, 1997.

Introduction

The Chileda in La Crosse, Wisconsin has undertaken a bold effort to help inform and educate the parents and professionals associated with persons with autism spectrum disorders. Because of the ambiguous etiology, cures, and treatments are constantly falling into and out of the accepted range of intervention. Parents and practitioners are plagued by the need to provide or offer the treatment in vogue. Many of the treatments have little or no scientific basis to support the tremendous level of hope generated. Furthermore, many of the treatments available for persons with autism spectrum disorders are expensive, time consuming, and potentially harmful.

As part of the overall commitment of Chileda to offer its insights to the growing field of autism, this study was conducted to examine the effect of phytonutritional supplements on the symptoms associated with the condition of autism. Phytonutritional dietary supplements are naturally occurring, food grade polysaccharides, combined with flash freeze-dried, vine ripened fruits and vegetables. Basic polysaccharides are known to be important in cell communication. The etiologies of the the spectrum of autistic behaviors have not been clearly identified, but inter-cellular communication has been hypothesized as one of the contributing factors in the severity of autistic behavioral characterizations. Recently, some anecdotal evidence has been presented suggesting children with autism show significant improvement in the level of functioning after taking phytonutritional supplements.

Protocol

Twenty-three individuals participated in this study. All of the subjects had a primary diagnosis of autism (19) or pervasive developmental disability (PDD) (4). Subject selection was made by DSM-IV criteria, and all subjects required a current diagnosis of Autistic Disorder (299.0) or Pervasive Developmental Disorder (299.8). Subjects with other autism spectrum disorders, Rett Syndrome, Asperger, uncontrolled seizure disorders, or those individuals with substantial changes in psychotropic medications were excluded from the study.

Subjects were randomly assigned to either the experimental or control group. The composition of each group was matched on the basis of age, sex, weight, and primary diagnosis. Baseline measures of autistic behavioral symptoms were collected prior to the introduction of phytonutrients. Each subject was observed over a two-day period. Each subject's period of observation lasted approximately 20 minutes. Measurements were taken before treatment exposure at the baseline (T), and at 3 weeks (T1), 6 weeks (T2), 9 weeks (T3), and at 12 weeks (T4) post treatment.

The Autistic Behavior Checklist (ABC) (Krug,. Arick & Almond, 1988) was the measuring instrument used. The ABC is an instrument that measures autistic symptoms in five different dimensions: Sensory, Relating, Body and Object Use, Language, and Social/Self-Help. To administer the ABC, observers note which of the 57 listed behavioral symptoms are subject performs. Each specific behavior is coded with a specific point value. All behavior values are totaled in each of the five dimensions. Each evaluator was assigned the same subject to observe for each ABC measurement. The observer's were blinded to the group assignment of the subject.

A sensitivity-screening week was conducted where each subject received either treatment Phyto-Bears (Mannatech, Inc.) or a placebo Gummy-Bear (Hershey, Inc.) to test the feasibility of the subject accepting the consumption of either product. After the sensitivity week the subjects were given 20 treatment or placebo chewable products each day. The experimental stimuli were distributed to the subjects in an arbitrary fashion throughout the day. Only the subjects immediate care giver administered the products.

Findings

Twenty-four subjects began the study. Twelve subjects were randomly assigned to the treatment group and twelve subjects were assigned to the control group. However, one subject from the control group dropped out of the study after baseline data were collected. This data was dropped from the study. The 23 remaining subjects were predominantly male (19), with a mean age of 13.2 years (range 6-19). Nineteen subjects had a primary diagnosis of autism, and four subjects had a primary diagnosis of pervasive developmental disorder.

Measures of complete blood count (CBC) and a comprehensive metabolic panel (CMET) including blood sugar, liver, kidney and nutritional status were obtained at the beginning and end of the study for all participants. There were no systematic changes of any kind.

While the collected data reveals some interesting insights into the changes that took place in the study population, most noteworthy was the similarity between the changes that occurred between the two groups.

No significant differences were found between the treatment and control in this study. Therefore, some more specific analysis were conducted in order to investigate some of the potential intervening variables. Further analysis indicated little change between the two groups.

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