Advances in Therapy

, Volume 26, Issue 8, pp 795–804

Immunogenic yeast-based fermentation product reduces allergic rhinitis-induced nasal congestion: a randomized, double-blind, placebo-controlled trial

  • Mark A. Moyad
  • Larry E. Robinson
  • Julie M. Kittelsrud
  • Stuart G. Reeves
  • Susan E. Weaver
  • Aireen I. Guzman
  • Mark E. Bubak
Original Research

DOI: 10.1007/s12325-009-0057-y

Cite this article as:
Moyad, M.A., Robinson, L.E., Kittelsrud, J.M. et al. Adv Therapy (2009) 26: 795. doi:10.1007/s12325-009-0057-y

Abstract

Introduction

Allergic rhinitis (AR) impacts around 25% of the worldwide population. However, cost, safety, and a high dissatisfaction rate with numerous conventional medications continues to be an issue in the largest patient surveys, due primarily to a lack of efficacy on nasal congestion. Our previously published randomized trial demonstrated a significant reduction in cold and flu-like symptoms, and a secondary potential observation of a decrease in nasal congestion with an oral yeast-derived compound; therefore, the objective of this study was to test the effects of this same product on nasal congestion and other notable AR symptoms.

Methods

A 12-week, randomized, double-blind, placebo-controlled clinical trial of 96 healthy subjects with a recent clinically documented history of seasonal allergies and AR was conducted. Participants received once-daily supplementation with 500 mg of a dried, modified Saccharomyces cerevisiae oral fermentation product (EpiCor®, Embria Health Sciences, Ankeny, Iowa, USA) or placebo during the 12-week period of the highest recorded concentrations of total pollen counts for this Midwest geographic area. Clinical outcome measurements included in-clinic examinations, validated questionnaire and standard diary, and serologic analysis at baseline, 6 and 12 weeks.

Results

During the highest pollen count period (weeks 1–6), EpiCor significantly reduced the mean severity of specific AR symptoms, including a significant reduction in nasal congestion (P=0.04), rhinorrhea (P=0.005), and a nonsignificant reduction in ocular discharge symptoms. A significantly (P=0.04) reduced total number of days with nasal congestion (12.5 fewer days) favored EpiCor compared with placebo, as did the nasal congestion section of the quality of life questionnaire (P=0.04). Subjects receiving the intervention also experienced significantly (P=0.03) higher salivary IgA levels. Adverse events were similar to placebo.

Conclusion

This yeast-derived product appeared to be safe and efficacious, and should receive more clinical research with and without standard medications to reduce the impact of seasonal allergies, especially AR-induced nasal congestion.

Keywords

allergic rhinitisdietary supplementEpiCor®nasal congestionSaccharomyces cerevisiaeseasonal allergy

Copyright information

© Springer Healthcare Communications 2009

Authors and Affiliations

  • Mark A. Moyad
    • 1
  • Larry E. Robinson
    • 2
  • Julie M. Kittelsrud
    • 3
  • Stuart G. Reeves
    • 4
  • Susan E. Weaver
    • 3
  • Aireen I. Guzman
    • 5
  • Mark E. Bubak
    • 6
  1. 1.Preventive & Alternative MedicineUniversity of Michigan Medical Center, Department of UrologyAnn ArborUSA
  2. 2.Scientific AffairsEmbria Health SciencesAnkenyUSA
  3. 3.Avera Research InstituteSioux FallsUSA
  4. 4.Research and DevelopmentEmbria Health SciencesAnkenyUSA
  5. 5.Avera Research InstituteSioux FallsUSA
  6. 6.Allergy, Department of Internal MedicineUSD Sanford School of MedicineSioux FallsUSA