There is increasing research support for an association between food hypersensitivities and ADHD symptoms. Eleven clinical trials of the Few Foods Diet therapy have been published using within subject crossover or controlled designs. Each trial reported statistically significant symptom improvement across a variety of measures. Egger treated children with hyperactive food reactions using Enzyme Potentiated Desensitization (EPD). A statistically significant ability to reintroduce previously reactive foods, using double blind placebo controlled protocols, was demonstrated after 3 EPD Treatments.
EPD is a cell mediated immunotherapy utilizing injections of very low dose antigen mixtures combined with a complex protocol of environmental exposure management, including diet restrictions. The American Clinical Trial of Enzyme Potentiated Desensitization (ACTEPD) provided EPD Treatment for a variety of symptoms. The outcome measure of Satisfaction was defined as a minimum of 50% improvement in symptom severity.
The purpose of this study was to explore the longitudinal trends of Satisfaction with ADHD symptom severity specific to children in the ACTEPD. A maximum of 12 Treatments were analyzed per subject, including modeling of Minimal, Moderate and Long Term Treatment periods. Generalized Estimating Equation (GEE) methods were used to develop predicted probabilities of Satisfaction, which adjusted for Treatment Level, Initial Severity, Gender and Stimulant Medications. Statistical tests of Satisfaction were highly significant within each treatment period, including Treatment 6 (p < 0.002), Treatment 9 (p < 0.0001) and Treatment 12 (p < 0.0007).
Satisfaction increased with an increase in the Number of Treatments. There was a highly significant association of Satisfaction at Last Treatment with an increase in Treatment Levels (p < 0.0008). Repeat measures of Satisfaction increased with an increase in Treatment Number during the Minimal (p < 0.05) and Moderate (p < 0.006) Treatment periods. The Long Term Treatment period was expected to represent treatment maintenance, and as anticipated, there were no statistically significant variables.
Treatment Level was a statistically significant confounder in the GEE model of Treatment Numbers 1-6 (p < 0.02). Odds ratios indicated that subjects who completed only Minimal Treatment were approximately 52% as likely to be Satisfied as subjects who completed Long Term Treatment. In contrast, subjects who completed Moderate Treatment were 89% as likely to be Satisfied as Long Term Treatment subjects.
Initial Severity was a statistically significant covariate in the Logistic Regression model (p < 0.03) and in the GEE model of Moderate Treatment (p < 0.02). Frequency distributions indicated that Maximum Severity subjects experienced greater variability in Treatment Response. Stimulant Medication use was not a statistically significant covariate in any of the statistical models.
Cross-sectional survey data indicated that prior to EPD, the rates of reported ADHD symptoms were different between ADHD subjects and Controls across all 3 ADHD symptom categories, including Behavioral (83% vs. 14%), Social (67% vs. 10%) and Academic (63% vs. 14%) symptoms. ADHD subjects were approximately twice as likely as Controls to report Behavioral Reactions to Environmental Exposures (84% vs. 37%). Foods or Food Additives was the Environmental Exposure category most frequently reported as associated with Behavioral Reactions.