1. Correction to: Immunogenic Yeast-Based Fermentation Product Reduces Allergic Rhinitis-Induced Nasal Congestion: A Randomized, Double-Blind, Placebo-Controlled Trial
- Author
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Mark A. Moyad, Larry E. Robinson, Julie M. Kittelsrud, Stuart G. Reeves, Susan E. Weaver, Aireen I. Guzman, and Mark E. Bubak
- Subjects
Adult ,Male ,Adolescent ,Correction ,Administration, Oral ,Rhinitis, Allergic, Seasonal ,General Medicine ,Saccharomyces cerevisiae ,Middle Aged ,Severity of Illness Index ,Statistics, Nonparametric ,Midwestern United States ,Treatment Outcome ,Double-Blind Method ,Yeast, Dried ,Surveys and Questionnaires ,Fermentation ,Quality of Life ,Humans ,Pharmacology (medical) ,Female ,Safety ,Attitude to Health - Abstract
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.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.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.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. more...
- Published
- 2019