1. Immunogenic yeast-based fermentation product reduces allergic rhinitis-induced nasal congestion: a randomized, double-blind, placebo-controlled trial.
- Author
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Moyad MA, Robinson LE, Kittelsrud JM, Reeves SG, Weaver SE, Guzman AI, and Bubak ME
- Subjects
- Administration, Oral, Adolescent, Adult, Attitude to Health, Double-Blind Method, Female, Fermentation, Humans, Male, Middle Aged, Midwestern United States, Quality of Life psychology, Rhinitis, Allergic, Seasonal diagnosis, Rhinitis, Allergic, Seasonal epidemiology, Rhinitis, Allergic, Seasonal psychology, Safety, Severity of Illness Index, Statistics, Nonparametric, Surveys and Questionnaires, Treatment Outcome, Yeast, Dried immunology, Rhinitis, Allergic, Seasonal prevention & control, Saccharomyces cerevisiae, Yeast, Dried therapeutic use
- 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.
- Published
- 2009
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