Lokale Verträglichkeit eines benzalkoniumchloridhaltigen homöopathischen Nasensprays

Abstract

spray Introduction: The German Federal Institute for Drugs and Medical Devices in the course of the graduated plan, grade II, for all benzalkonium chloride-containing intranasal drugs demands the limiation of their usage to a duration of 5- 7 days, as according to the Institute a potential of damage to the nasal mucosa by the preservative existed. Objective: We report the results of a double-blind, randomized, placebo-controlled study of the local tolerability of Euphorbium comp. Nasentropfen E (nasal pump spray) in healthy subjects. The study drugs of both treatment groups contained 0.02% benzalkonium chloride. Results are evaluated in the context of the currently available data. Methods: 24 healthy subjects for 4 weeks applied Euphorbium comp. Nasentropfen E or placebo (5 × 2 sprays per nostril daily). Before and after the application phase the following examinations regarding local tolerability were performed: measurement of saccharine transport time, anterior rhinomanometry, determination of nasal secretion performance, orientating smell test, anterior rhinoscopy. Local and systemic adverse events were documented during the application phase. Results: Data of 21 subjects could be used for analysis of the parameters of local tolerability. Clinically relevant differences or changes were not found, neither between the groups nor in pre-post comparison. Saccharine transport time always was in the normal range and in both groups was even slightly reduced. Conclusion: Neither the reported study nor the literature yield sufficient arguments to limit the duration of usage of benzalkonium chloride-containing intranasal drugs with active substances other than α-sympathomimetics to 5 - 7 days.