Use of a short course of prednisone for treating middle ear effusion. A double-blind crossover study.

This report presents findings of a double-blind crossover prospective study involving the use of a short course of prednisone for the treatment of otitis media with effusion (OME). Subjects were 41 children with persistent OME for three weeks or more despite the use of antimicrobial and/or decongestant therapy. Pulverized prednisone tablets (5 mg) or lactose powder (placebo) were packed in unmarked gelatin capsules and placed in identically coded vials. The dosage schedule was 1 mg/kg/day for the first two days in a divided dose; 0.75 mg/kg/day for the next two days; followed by 5-10 mg/kg/day as a single morning dose for the remaining three days. In addition, all children received concomitant sulfisoxazole suspension of 50 mg/kg/day twice daily. Results for 40 children treated with steroids either initially or following crossover revealed that 70% demonstrated resolution of OME via pneumo-otoscopy and 64% via tympanometry. In addition, we examined the relationship between the ability to resolve effusion with corticosteroids and six variables: 1) duration of OME prior to entry into study, 2) month of year at entry into study, 3) bilateral versus unilateral disease, 4) child's sex, 5) prior use of ventilating tubes and 6) personal or family history of allergy. The results of these comparisons are discussed.

RCT Entities:   Population Interventions Outcomes