P Graf1, J Enerdal, H Hallén. 1. Department of Otorhinolaryngology, Huddinge University Hospital, Karolinska Institute, Stockholm, Sweden.
Abstract
CONTEXT: In most countries, the use of topical nasal decongestants is limited to a maximum of 10 days because of the risk of developing rebound mucosal swelling and rhinitis medicamentosa. OBJECTIVE: To determine whether topical nasal decongestants can be safely used for 10 days in patients with chronic inflammation of the nasal mucosa. DESIGN: Double-blind, randomized, controlled, parallel study. PATIENTS: Thirty-five patients with vasomotor rhinitis selected from our outpatient department. INTERVENTION: Eighteen patients received oxymetazoline hydrochloride (0.5 mg/mL) nasal spray containing the preservative benzalkonium chloride (0.1 mg/mL), and the other 17 were treated with oxymetazoline nasal spray without benzalkonium chloride. Before and after the treatment, recordings of the nasal mucosa and minimal cross-sectional area were made with rhinostereometry and acoustic rhinometry, followed by histamine hydrochloride challenge tests. Symptoms of nasal stuffiness were estimated on visual analog scales (0-100) in the morning and the evening, just before the nasal spray was used. RESULTS: No rebound swelling was found after the 10-day treatment in the 2 groups with either of the methods or as estimated by symptom scores. In the group receiving oxymetazoline containing benzalkonium chloride, but not in the other group, the histamine sensitivity was significantly reduced after treatment (P<.001). CONCLUSIONS: It is safe to use topical nasal oxymetazoline with or without benzalkonium chloride for 10 days in patients with vasomotor rhinitis. However, this study indicates that benzalkonium chloride in nasal decongestant sprays affects the nasal mucosa also after short-term use.
RCT Entities:
CONTEXT: In most countries, the use of topical nasal decongestants is limited to a maximum of 10 days because of the risk of developing rebound mucosal swelling and rhinitis medicamentosa. OBJECTIVE: To determine whether topical nasal decongestants can be safely used for 10 days in patients with chronic inflammation of the nasal mucosa. DESIGN: Double-blind, randomized, controlled, parallel study. PATIENTS: Thirty-five patients with vasomotor rhinitis selected from our outpatient department. INTERVENTION: Eighteen patients received oxymetazoline hydrochloride (0.5 mg/mL) nasal spray containing the preservative benzalkonium chloride (0.1 mg/mL), and the other 17 were treated with oxymetazoline nasal spray without benzalkonium chloride. Before and after the treatment, recordings of the nasal mucosa and minimal cross-sectional area were made with rhinostereometry and acoustic rhinometry, followed by histamine hydrochloride challenge tests. Symptoms of nasal stuffiness were estimated on visual analog scales (0-100) in the morning and the evening, just before the nasal spray was used. RESULTS: No rebound swelling was found after the 10-day treatment in the 2 groups with either of the methods or as estimated by symptom scores. In the group receiving oxymetazoline containing benzalkonium chloride, but not in the other group, the histamine sensitivity was significantly reduced after treatment (P<.001). CONCLUSIONS: It is safe to use topical nasal oxymetazoline with or without benzalkonium chloride for 10 days in patients with vasomotor rhinitis. However, this study indicates that benzalkonium chloride in nasal decongestant sprays affects the nasal mucosa also after short-term use.
Authors: Martin Desrosiers; Gerald A Evans; Paul K Keith; Erin D Wright; Alan Kaplan; Jacques Bouchard; Anthony Ciavarella; Patrick W Doyle; Amin R Javer; Eric S Leith; Atreyi Mukherji; R Robert Schellenberg; Peter Small; Ian J Witterick Journal: Allergy Asthma Clin Immunol Date: 2011-02-10 Impact factor: 3.406