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


CONCLUSIONS
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.
Moyad
Mark A
MA
Preventive & Alternative Medicine, University of Michigan Medical Center, Department of Urology, Ann Arbor, Michigan 48109-0330, USA. mmmoyad@aol.com
Robinson
Larry E
LE
Kittelsrud
Julie M
JM
Reeves
Stuart G
SG
Weaver
Susan E
SE
Guzman
Aireen I
AI
Bubak
Mark E
ME
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001294:Attitude to Health; D004311:Double-Blind Method; D005260:Female; D005285:Fermentation; D006801:Humans; D008297:Male; D008875:Middle Aged; D015146:Midwestern United States; D011788:Quality of Life / Q000523:psychology; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control* / Q000523:psychology; D012441:Saccharomyces cerevisiae; D012449:Safety; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D015002:Yeast, Dried / Q000276:immunology / Q000627:therapeutic use*