The Effect of Montelukast Sodium on the Duration of Otitis Media with Effusion in Nonallergic Patients

Introduction: Otitis media with effusion (OME) is a very common clinical entity involving young patients, especially those aged less than 7 years. Although many predisposing factors have been studied, no medical treatment is currently available for OME. Montelukast sodium, a selective leukotriene receptor antagonist, has been reported to decrease the duration of the disease.

Aim and Scope: To test the effect of montelukast sodium on the duration of middle ear effusion in comparison with watchful waiting.

Patients and Methods: From April 2005 until December 2005, 80 patients (36 male, 44 female), median age 4.6 years, with OME and no history of allergy, were randomly assigned to receive montelukast sodium (40 patients) or no treatment (40 patients) for a 30-day period. The diagnosis of OME was set on the grounds of otoscopy, tympanometry, and acoustic reflectometry. The presence of allergy was excluded by in vitro assays.

Results: At the 30-day follow-up visit, data were available from 37 patients of the montelukast group and 35 patients of the watchful waiting group. Resolution was reported in 48% of ears in the montelukast sodium group and in 19% of ears in the watchful waiting group. The difference was significant.

Conclusion: Montelukast sodium may lead to more prompt resolution of middle ear effusion in nonallergic patients with OME.