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.
RCT Entities:
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.
Authors: Sarah K Wise; Sandra Y Lin; Elina Toskala; Richard R Orlandi; Cezmi A Akdis; Jeremiah A Alt; Antoine Azar; Fuad M Baroody; Claus Bachert; G Walter Canonica; Thomas Chacko; Cemal Cingi; Giorgio Ciprandi; Jacquelynne Corey; Linda S Cox; Peter Socrates Creticos; Adnan Custovic; Cecelia Damask; Adam DeConde; John M DelGaudio; Charles S Ebert; Jean Anderson Eloy; Carrie E Flanagan; Wytske J Fokkens; Christine Franzese; Jan Gosepath; Ashleigh Halderman; Robert G Hamilton; Hans Jürgen Hoffman; Jens M Hohlfeld; Steven M Houser; Peter H Hwang; Cristoforo Incorvaia; Deborah Jarvis; Ayesha N Khalid; Maritta Kilpeläinen; Todd T Kingdom; Helene Krouse; Desiree Larenas-Linnemann; Adrienne M Laury; Stella E Lee; Joshua M Levy; Amber U Luong; Bradley F Marple; Edward D McCoul; K Christopher McMains; Erik Melén; James W Mims; Gianna Moscato; Joaquim Mullol; Harold S Nelson; Monica Patadia; Ruby Pawankar; Oliver Pfaar; Michael P Platt; William Reisacher; Carmen Rondón; Luke Rudmik; Matthew Ryan; Joaquin Sastre; Rodney J Schlosser; Russell A Settipane; Hemant P Sharma; Aziz Sheikh; Timothy L Smith; Pongsakorn Tantilipikorn; Jody R Tversky; Maria C Veling; De Yun Wang; Marit Westman; Magnus Wickman; Mark Zacharek Journal: Int Forum Allergy Rhinol Date: 2018-02 Impact factor: 3.858