title: [Clinical efficacy of a herbal drug combination in acute viral rhinosinusitis].
abstract: BACKGROUND
  Acute rhinosinusitis is a frequent inflammatory disease of the mucosa of the nose and paranasal sinuses, usually associated with substantial morbidity having considerable socioeconomic impact. A new herbal drug based on a dry extract of a combination of 5 medicinal drugs (Sinupret® extract Dragees) was tested in a confirmatory trial in patients with acute viral rhinosinusitis.
  
  
  METHODS
  386 patients with symptomatic acute viral rhinosinusitis have been treated with the herbal drug combination (daily dosage 3 × 160 mg) or placebo in a double-blind, randomised, placebo-controlled clinical trial for 15 days. Primary efficacy endpoint was the investigator assessed symptom score at the end of therapy (Major Symptom Score, MSSINV).
  
  
  RESULTS
  Treatment with verum lead to a statistically significant, clinically relevant improvement of the symptom score (2.07 ± 0.18 [SEM] vs. 3.47 ± 0.28 score points, p = 0.0001; PP: N = 300) compared to placebo at visit 5. The Number Needed to Treat (NNT) was 7 (PP). Adverse events occurred in 9.8% of the patients treated with verum and 14.1% of the patients treated with placebo. No serious adverse event was observed. The investigators assessed the tolerability of the herbal drug combination predominantly as good and very good (96.4% verum, 95.3% placebo).
  
  
  CONCLUSIONS
  The results prove the efficacy and tolerability of the herbal drug in the indication acute viral rhinosinusitis. Especially due to the favorable benefit-risk ratio the drug represents a suitable treatment alternative.
authors.affiliation: , Puchheim, Deutschland.
authors.forename: Rainer
authors.initials: R
authors.lastname: Jund
authors.forename: Martin
authors.initials: M
authors.lastname: Mondigler
authors.forename: Hubert
authors.initials: H
authors.lastname: Steindl
authors.forename: Holger
authors.initials: H
authors.lastname: Stammer
authors.forename: Pontus
authors.initials: P
authors.lastname: Stierna
authors.forename: Claus
authors.initials: C
authors.lastname: Bachert
mesh_terms: D000208:Acute Disease; D000258:Adenovirus Infections, Human / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010850:Picornaviridae Infections / Q000188:drug therapy*; D010936:Plant Extracts / Q000627:therapeutic use*; D012220:Rhinitis / Q000188:drug therapy*; D012229:Rhinovirus; D012852:Sinusitis / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010936:Plant Extracts; C028353:Sinupret