title: Topical antifungal treatment of chronic rhinosinusitis with nasal polyps: a randomized, double-blind clinical trial.
abstract: BACKGROUND
  Recently, fungal elements were suspected to be the causative agent of chronic rhinosinusitis, and benefits of topical amphotericin B therapy have been reported.
  
  
  OBJECTIVE
  The effects of amphotericin B versus control nasal spray on chronic rhinosinusitis were compared in a double-blind, randomized clinical trial.
  
  
  METHODS
  Patients with chronic rhinosinusitis were administered 200 microL per nostril amphotericin B (3 mg/mL) or saline nasal spray 4 times daily over a period of 8 weeks. The response rate, defined as a 50% reduction of pretreatment computed tomography score, was the primary outcome variable. Additional outcome variables included a symptom score, a quality of life score, and an endoscopy score. Before and after treatment, nasal lavages were pretreated with dithiothreitol and examined for fungal elements by PCR and standard culture techniques.
  
  
  RESULTS
  Seventy-eight patients were included, and 60 patients finished the study per protocol. In the control group, no positive response (0 of 32) was observed, and 2 of 28 patients responded in the amphotericin B group (P>.2). The symptom scores were distinctly worse after amphotericin B therapy (P <.005). The other parameters investigated did not differ remarkably between the treatment groups.
  
  
  CONCLUSIONS
  Nasal amphotericin B spray in the described dosing and time schedule is ineffective and deteriorates patient symptoms.
authors.affiliation: Department of Otorhinolaryngology and Head and Neck Surgery, University of Ulm, Prittwitzstrasse 43, D-89075 Ulm, Germany. michael.weschta@medizin.uni-ulm.de
authors.forename: Michael
authors.initials: M
authors.lastname: Weschta
authors.forename: Dagmar
authors.initials: D
authors.lastname: Rimek
authors.forename: Marc
authors.initials: M
authors.lastname: Formanek
authors.forename: Doreen
authors.initials: D
authors.lastname: Polzehl
authors.forename: Andreas
authors.initials: A
authors.lastname: Podbielski
authors.forename: Herbert
authors.initials: H
authors.lastname: Riechelmann
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage*; D000935:Antifungal Agents / Q000008:administration & dosage*; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009298:Nasal Polyps / Q000382:microbiology*; D011446:Prospective Studies; D012220:Rhinitis / Q000188:drug therapy* / Q000382:microbiology; D012852:Sinusitis / Q000188:drug therapy* / Q000382:microbiology; D014057:Tomography, X-Ray Computed
chemical_list: D000935:Antifungal Agents; D000666:Amphotericin B