The use of an antihistamine-decongestant in conjunction with an anti-infective drug in the treatment of acute otitis media.

We evaluated the efficacy of an antihistamine-decongestant combination as adjunctive therapy in the treatment of acute otitis media with effusion. In a randomized study, 53 children were treated for acute otitis media with antibiotics and either Naldecon or placebo. Subjects were evaluated by tympanometry and pneumotoscopy. Follow-up evaluation was performed at days seven and 14 of therapy. The antihistamine-decongestant prescription was found to influence both the duration of nasal congestion and the course of middle ear effusion: Naldecon-treated subjects were symptomatic with nasal congestion for an average of six days compared to nine days reported by those given placebo, and the risk of persisting middle ear effusion was approximately two times greater in the placebo-treated group when evaluated by tympanometry.

RCT Entities:   Population Interventions Outcomes