title: Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of the herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630) compared to placebo.
  
  
  METHODS
  Double-blind, randomized, placebo-controlled, parallel-group, multicenter trial with a group-sequential adaptive design.
  
  
  METHODS
  Patients with sinonasal symptoms of at least 7 days duration, and radiographically and clinically confirmed acute rhinosinusitis of presumably bacterial origin with a Sinusitis Severity Score (SSS) of at least 12 out of 24 points at inclusion.
  
  
  METHODS
  EPs 7630, a herbal drug preparation from the roots of Pelargonium sidoides (1: 8-10; extraction solvent: ethanol 11% (w/w)), or matching placebo at a dose of 60 drops three times daily for maximum 22 days.
  
  
  METHODS
  Change in the SSS after 7 days.
  
  
  RESULTS
  103 patients were recruited until the planned interim analysis. The mean decrease in the SSS was 5.5 points in the EPs 7630 group compared to 2.5 points in the placebo group, a difference of 3.0 points (95% confidence interval 2.0 to 3.9, p < 0.00001). This result was confirmed by all secondary parameters indicating a more favourable course of the disease and a faster recovery in the EPs 7630 group. According to the pre-specified decision rule, the study was stopped after obtaining proof of efficacy for EPs 7630.
  
  
  CONCLUSIONS
  EPs 7630 was well tolerated and superior in efficacy compared to placebo in the treatment of acute rhinosinusitis of presumably bacterial origin.
authors.affiliation: University of Ghent, ENT Department, Ghent, Belgium. claus.bachert@ugent.be
authors.forename: Claus
authors.initials: C
authors.lastname: Bachert
authors.forename: Andreas
authors.initials: A
authors.lastname: Schapowal
authors.forename: Petra
authors.initials: P
authors.lastname: Funk
authors.forename: Meinhard
authors.initials: M
authors.lastname: Kieser
mesh_terms: D000208:Acute Disease; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D018517:Plant Roots; D011859:Radiography; D012220:Rhinitis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology; D012852:Sinusitis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C476332:EPs 7630; D010936:Plant Extracts