RESUMO
We conducted a prospective, randomized, placebo-controlled, double-blind study to determine if the leukotriene inhibitor montelukast is effective in eliminating persistent middle ear drainage in patients with otitis media with effusion (OME). Our study population was made up of patients aged 2 to 6 years who had had confirmed OME in one or both ears for at least 2 months. Patients were randomized to receive either placebo or 4 mg of montelukast daily for 1 month. The main outcome measure was clearance of middle ear effusion as demonstrated by otoscopy and tympanometry 1 month after the initiation of treatment. Our goal was to recruit 120 patients; however, an interim analysis was conducted after 38 patients had completed their regimen (19 patients in each group) when it became apparent that montelukast was not having any effect in clearing the effusions. Indeed, the OME had cleared in only 3 montelukast patients (15.8%) and 4 controls (21.1%); the difference was not statistically significant (p > 0.90). Based on this early trend, the study was terminated at this point. We conclude that montelukast appears to be no more effective than placebo in eliminating persistent middle ear effusion.
Assuntos
Acetatos/uso terapêutico , Antagonistas de Leucotrienos/uso terapêutico , Otite Média com Derrame/tratamento farmacológico , Quinolinas/uso terapêutico , Criança , Pré-Escolar , Doença Crônica , Ciclopropanos , Método Duplo-Cego , Humanos , Sulfetos , Falha de TratamentoRESUMO
This study tests the hypothesis that montelukast sodium, a selective leukotriene receptor antagonist, will decrease the duration of the effusion of otitis media. Tympanometry and spectral gradient acoustic reflectometry were used to confirm the effusion of otitis media in patients between 2 and 12 years of age. Patients were treated with amoxicillin for 10 days and montelukast sodium or placebo for 30 days in a random, double-blind manner. Sixty patients completed the study: 31 received placebo and 29 received montelukast sodium. At a 4-week follow-up visit, 5 ears (16%) were free of effusion in the placebo group and 17 (58%) in the montelukast sodium group. The difference was significant. The efficacy of montelukast sodium in clearing the effusion was 49%.