Evaluation of the clinical efficacy and safety of grapeseed extract in the treatment of fall seasonal allergic rhinitis: a pilot study.
BACKGROUND
Herbal products are widely used by consumers as alternatives to prescription drugs in treating symptoms of allergic rhinitis. However, there have been few placebo-controlled clinical trials that have examined the efficacy or safety of these products. Although grapeseed extract (GSE) is an herbal that is marketed for treating allergic rhinitis, its efficacy is unproven.


OBJECTIVE
The aim of this study was to compare the efficacy and safety of GSE with placebo in the treatment of seasonal allergic rhinitis (SAR).


METHODS
This was a randomized, double-blind, placebo-controlled study of GSE 100 mg, twice daily, versus placebo. Patients with SAR and skin prick test sensitivity to ragweed were randomized to 8 weeks of active treatment or placebo which was begun before the ragweed pollen season. Outcomes included: daily symptom diary scores recorded by patients, rhinitis quality of life scores at baseline and after 4 and 8 weeks of treatment; and requirements for rescue chlorpheniramine. Safety was monitored with routine laboratory studies.


RESULTS
Over 8 weeks of treatment, no significant differences were observed between active and placebo groups in rhinitis quality of life assessments, symptom diary scores, or requirements for rescue antihistamine. No significant laboratory abnormalities were detected.


CONCLUSIONS
This study did not show trends supporting the efficacy of GSE in the treatment of SAR.
Bernstein
David I
DI
Division of Immunology, University of Cincinnati College of Medicine, Ohio 45267, USA.
Bernstein
Cheryl K
CK
Deng
Chunqin
C
Murphy
Karen J
KJ
Bernstein
I Leonard
IL
Bernstein
Jonathan A
JA
Shukla
Rakesh
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D027843:Vitis
D010936:Plant Extracts