Summary of EpiCor Effects on Allergy Symptoms

Larry E. Robinson, Ph.D. and Stuart Reeves, Ph.D., ARCS, Scientific Affairs

Summary: This human clinical trial, published in a MEDLINE-indexed journal, used a double-blinded, placebo-controlled model on subjects who tested positive for allergies. The purpose of this trial was to confirm earlier pilot work finding seasonal allergies increased in the placebo group, but were not observed in the EpiCor group; this was reflected by increased serum IgE in the placebo group compared to the EpiCor group (p<0.13) (Jensen et al., 2008). Results include:

  • Significant reduction in runny nose and nasal congestion compared to placebo

  • 43% reduction in days with nasal congestion compared to placebo

  • Significant reduction in use of rescue allergy medication compared to placebo

  • Trend towards reduction in ichiness and sneezing compared to placebo

  • Demonstration of balanced immune response by significant increases in slgA while significantly decreasing allergy symptoms compared to placebo

In a previous study, EpiCor was shown to strengthen and balance the immune system by simultaneously increasing sIgA while reducing IgE as compared to placebo (Jensen et al., 2008). Animal studies also suggested EpiCor’s ability to balance immune response by significantly reducing inflammation (Evans et al, 2012). Results from these previous studies led to this trial examining EpiCor’s ability to balance immune response by relieving symptoms from common allergens or seasonal allergies.

In this double-blinded, placebo-controlled trial, subjects had to test positive for allergies to pollen in order to participate. This protocol was used to reduce the possibility that benefits would come from EpiCor’s effects on spring-time colds. Over 80 healthy subjects, ages 18-65, and were randomized to take EpiCor (500 mg) or a placebo. The 90-day trial took place in South Dakota during the 2008 spring allergy season when total pollen counts were high.

The highest total pollen counts occurred during the first six weeks of the clinical trial. During this high pollen count period, the EpiCor group showed statistically significant reductions in several symptoms commonly associated with seasonal allergies. The EpiCor group had the greatest reductions in symptom incidence and severity when total pollen counts were highest. Since allergy symptoms and cold and flu symptoms are often similar, these high pollen count results strongly suggest anti-allergy effects of EpiCor and not anti-cold or flu effects of EpiCor. The largest symptomatic impact occurred with nasal congestion showing a 43% reduction in days with symptoms compared to placebo (Figure 1). The most significant symptom reductions were:

Reduction in nasal symptoms

  • Reduction mean severity (p=0.03)

  • Runny nose (p=0.005)

  • Nasal congestion (p=0.04)

Trend toward reduction in itchiness and sneezing

Subjects were also asked to record when they used rescue medication for severe allergies. The EpiCor group utilized statistically significantly less rescue medication for allergies compared to the placebo group. Biochemical data mirrored the effectiveness observed in the allergy diary and questionnaire comparing EpiCor to Placebo:

  • The number of selective allergy producing lymphocytes was reduced in the nasal smears (p<0.05)

  • Downward trend of mean eosinophil percentage in nasal smears (p=0.056)

  • Downward trend of mean serum basophil percentage (p=0.082)

During the trial sIgA levels were measured for both groups. Subjects taking EpiCor had significantly increased levels of sIgA compared to placebo, showing improved defense against pathogens while at the same time having reduced allergy symptoms.

A strong immune system is one that responds appropriately to stressors. The results from this study build upon earlier biochemical and clinical work showing EpiCor helps the body respond appropriately to upper respiratory challenges. This study demonstrates that EpiCor helps allergy sufferers not to over-respond to pollen and thereby benefit from reduced allergy symptoms.

Moyad, M.A., Robinson, L.E., Kittelsrud, J.M., Reeves, S.G., Weaver, S.E., Guzman, A.I., and Bubak, M.E., (2009), Immunogenic yeast-based fermentation product reduces allergic rhinitis-induced nasal congestion: a randomized, double-blind, placebo-controlled trial, Advances in Therapy, v. 26, p. 795-804.

Jensen, G.S., Patterson, K.M., Barnes, J., Schauss, A.E., Beaman, R., Reeves, S.G., and Robinson, L.E., (2008), A double-blind placebo-controlled, randomized pilot study: Consumption of a high-metabolite immunogen from yeast culture has beneficial effects on erythrocyte health and mucosal immune protection in healthy subjects, Open Nutrition Journal, v. 2, p. 68-75

Evans, M., Reeves, S.G. and Robinson, L.E., (2012), a dried yeast fermentate prevents and reduces inflammation in two separate experimental immune models, Evidence-Based Complementary and Alternative Medicine, Volume 2012, Article ID 973041