Topical antifungal treatment of chronic rhinosinusitis with nasal polyps: a randomized, double-blind clinical trial.
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.
Weschta
Michael
M
Department of Otorhinolaryngology and Head and Neck Surgery, University of Ulm, Prittwitzstrasse 43, D-89075 Ulm, Germany. michael.weschta@medizin.uni-ulm.de
Rimek
Dagmar
D
Formanek
Marc
M
Polzehl
Doreen
D
Podbielski
Andreas
A
Riechelmann
Herbert
H
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
D000935:Antifungal Agents; D000666:Amphotericin B