MULTICENTER RANDOMIZED, DOUBLE-BLIND COMPARISON OF ERYTHROMYCIN ESTOLATE VERSUS AMOXICILLIN FOR THE TREATMENT OF ACUTE OTITIS-MEDIA IN CHILDREN

Erythromycin is frequently prescribed in Germany for acute otitis medi a, but well-designed clinical trials under present epidemiological con ditions are lacking. Therefore, a double-blind, randomized. multicente r trial was performed to compare the clinical efficacy and safety of e rythromycin estolate versus amoxicillin in children with acute otitis media and to identify the risk factors associated with clinical failur e. Investigators from 19 centers throughout Germany recruited 302 chil dren with clinical, otoscopic, and tympanometric evidence of acute oti tis media. In a double-blind fashion, patients were allocated randomly to a 10-day course of erythromycin estolate at 40 mg/kg/day in two di vided doses or amoxicillin at 50 mg/kg/day in two divided doses. Clini cal examinations, otoscopy, and tympanometry were performed at baselin e, day 3-5, day 9-11, and at 5 weeks. Clinical outcome was assessed on day 9-11. Two-hundred eighty children were evaluable for efficacy (er ythromycin group, 141; amoxicillin group, 139). Both groups were compa rable with respect to demographic data and severity of disease at entr y. Treatment was successful in 94% of the erythromycin-treated patient s and in 96% of the amoxicillin-treated patients. Clinical outcome was statistically equivalent between groups within a range of 7 percentag e points. Clinical recurrence was seen in eight erythromycin-treated c hildren (5.7%) and in seven amoxicillin-treated children (5.0%) (P=0.8 1). Patients with bilateral disease at entry were at higher risk of un favourable outcome, whereas age and presence/absence of otorrhea at en try were not associated with outcome. Treatment-related adverse events were recorded in eight (5.3%) of 151 erythromycin-treated patients an d in 11 (7.3%) of 151 amoxicillin-treated patients. In this study in a n outpatient setting in Germany, erythromycin estolate was as safe and effective as amoxicillin in the treatment of acute otitis media. Both drugs can be administered in a convenient twice-daily dosage schedule .