Medical management of chronic middle-ear effusion. Results of a clinical trial of prednisone combined with sulfamethoxazole and trimethoprim.

Prednisone for seven days plus the combination drug sulfamethoxazole and trimethoprim for 30 days was assessed in treating chronic middle-ear effusion present for at least eight weeks. Pneumatic otoscopy, tympanometry, and audiology at entry into the study, and one week and one month after therapy, documented the status of the middle-ear effusion. Clearing in both ears or in one when only one was involved was called complete resolution; clearing in one of two affected ears was called partial resolution. In the initial open trial, 13 of 24 patients experienced partial or complete resolution one month after therapy. Subsequently, 28 patients were enrolled in a randomized, double-blind, placebo-controlled clinical trial in which patients whose effusion failed to clear were crossed over to the alternative regimen. In this trial, ten treated children (71%) experienced partial or complete resolution one month after therapy compared with three (21%) in the control group. Patients enrolled in both trials whose effusion cleared were followed up monthly for six months. Seven of 29 patients required referral for ventilation tubes.