Prevention and treatment of serous otitis media with an oral antihistamine. A double-blind study in pediatric practice.

Serous otitis media (SOM) is a common and troublesome disease in childhood. Although antihistamines are commonly prescribed to prevent or treat SOM, there have been no controlled clinical trials to determine the efficacy of such interventions. This study was designed to determine if antihistamines are of value in the prevention or treatment of SOM. Using a randomized double-blind method, 206 children with acute otitis media were treated with antibiotics and either brompheniramine maleate or placebo. The children were evaluated two weeks later by tympanometry and, independently, by combined pneumatoscopy and otoscopy. There were no significant differences overall between the treatment and control groups in terms of preventing SOM: 44% of those on antihistamine and 41% of those on placebo had SOM after two weeks of therapy. However, children with a history of serous otitis media did significantly better on placebo than did those on antihistamine, and children without a history of serous otitis media did significantly better on antihistamine than did those on placebo. One hundred children continued to use antihistamine or placebo for four more weeks. There were no significant differences between the treatment and control groups in terms of resolution of SOM (64% versus 68%).

RCT Entities:   Population Interventions Outcomes