title: A prospective open-label study to assess the efficacy and safety of a herbal medicinal product (Sinupret) in patients with acute rhinosinusitis.
abstract: OBJECTIVE
  We present a multicenter, prospective, open-label study to assess the efficacy and safety of a phytomedicine. The aim of the research was to evaluate the efficacy and safety of 14 days of treatment with Sinupret for acute rhinosinusitis. Sinupret is a herbal preparation used to restore and maintain the physiological function of the membranes in the sinus cavity.
  
  
  METHODS
  Sixty patients with acute rhinosinusitis based on the EPOS guidelines were enrolled in the study. Thirty patients were treated with Sinupret Forte, while 30 patients were treated with intranasal fluticasone furoate. The criteria for the evaluation of efficacy were the major symptom scores according to the investigator and the Health-Related Quality of Life score. The criteria used to evaluate safety were the number of patients with adverse events, the patients' vital signs, and laboratory safety.
  
  
  RESULTS
  All patients considered showed significant improvements in symptoms. Among the patients treated with Sinupret, none had an adverse event, while 3 patients treated with fluticasone furoate had minor adverse events. The patients' vital signs and laboratory values were normal.
  
  
  CONCLUSIONS
  The results of this study suggest that this phytomedicinal preparation has a significant level of efficacy in acute rhinosinusitis and that treatment is safe.
authors: ENT Department, University of Medicine and Surgery, Siena, Italy.
authors: Desiderio
authors: D
authors: Passali
authors: Michele
authors: M
authors: Loglisci
authors: Giulio Cesare
authors: GC
authors: Passali
authors: Pasquale
authors: P
authors: Cassano
authors: Hugo Anibal
authors: HA
authors: Rodriguez
authors: Luisa Maria
authors: LM
authors: Bellussi
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D012220:Rhinitis / Q000188:drug therapy*; D012852:Sinusitis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts; C028353:Sinupret