brompheniramine--pseudoephedrine-drug-combination and Otitis-Media

Acute otitis media is the most common bacterial infection of childhood. The effectiveness of oral antihistamine-decongestant mixtures in the treatment of this illness remains controversial in clinical practice. In a double-blind randomized study, 82 children (aged under 15 years) with acute otitis media were treated with amoxicillin and either a decongestant-antihistamine mixture (Dimetapp) or placebo. All diagnoses required agreement between a family practice resident and the supervising family physician. Clinical course was assessed by symptom diaries completed by parents and by follow-up examination at approximately two weeks, which included pneumatic otoscopy. No statistically significant benefit of the antihistamine-decongestant mixture was shown in terms of resolution of the symptoms or prevention of the complications of acute otitis media. It is recommended that antihistamine-decongestants not be routinely added to an antibiotic in the treatment of acute otitis media in children.

Topics: Adolescent; Amoxicillin; Brompheniramine; Child; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Drug Evaluation; Female; Humans; Infant; Male; Otitis Media; Phenylephrine; Phenylpropanolamine; Pseudoephedrine; Pyridines; Random Allocation; Sex Factors