title: Herbal drug BNO 1016 is safe and effective in the treatment of acute viral rhinosinusitis.
abstract: CONCLUSIONS
  Daily intake of 480 mg of BNO 1016 for 15 days is an effective treatment in acute viral rhinosinusitis.
  
  
  OBJECTIVE
  The pooled efficacy data of two similar randomized placebo-controlled clinical trials were analyzed. Safety was evaluated on the basis of the individual trials.
  
  
  METHODS
  The efficacy analysis was based on 589 patients. Treatment was performed orally with either 3 × 160 mg BNO 1016 (n = 294) or 3 × placebo (n = 295) for 15 days. In both trials patients underwent five visits to the investigational sites. Symptoms were evaluated according to the EPOS 2012 guideline. Ultrasonography was used to confirm the diagnosis at onset of treatment and the remission of symptoms at the last visit. Efficacy was evaluated by the investigator as the mean major symptom score (MSS) at the end of treatment (visit 5, day 14). Patients reported symptoms and social/emotional consequences of rhinosinusitis using a quality of life questionnaire (SNOT-20 GAV).
  
  
  RESULTS
  MSS improved during the treatment period by a mean of 10.02 ± 1.61 score points to 2.47 ± 2.55 for BNO 1016 and of 9.87 ± 1.52 to 3.63 ± 3.63 for placebo. Differences between treatment groups at end of therapy (1.16 ± 3.14 score points; p < 0.0001) and patient-assessed quality of life (p = 0.0015) were statistically significant in favor of BNO 1016.
authors.affiliation: 1Department of Oto-Rhino-Laryngology, Ghent University Hospital , Ghent , Belgium.
authors.forename: Rainer
authors.initials: R
authors.lastname: Jund
authors.forename: Martin
authors.initials: M
authors.lastname: Mondigler
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; D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D012220:Rhinitis / Q000150:complications / Q000188:drug therapy* / Q000821:virology*; D012852:Sinusitis / Q000150:complications / Q000188:drug therapy* / Q000821:virology*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C578474:BNO 1016; D010936:Plant Extracts
keywords: Dry extract; EPOS 2012; MSS; Sino-Nasal Outcome Test (SNOT-20); major symptom score; ultrasonography