Multicenter, randomized, double-blind comparison of erythromycin estolate versus amoxicillin for the treatment of acute otitis media in children

Abstract

Erythromycin is frequently prescribed in Germany for acute otitis media, but well-designed clinical trials under present epidemiological conditions are lacking. Therefore, a double-blind, randomized, multicenter trial was performed to compare the clinical efficacy and safety of erythromycin estolate versus amoxicillin in children with acute otitis media and to identify the risk factors associated with clinical failure. Investigators from 19 centers throughout Germany recruited 302 children with clinical, otoscopic, and tympanometric evidence of acute otitis 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 divided doses or amoxicillin at 50 mg/kg/day in two divided doses. Clinical examinations, otoscopy, and tympanometry were performed at baseline, 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 (erythromycin group, 141; amoxicillin group, 139). Both groups were comparable with respect to demographic data and severity of disease at entry. Treatment was successful in 94% of the erythromycin-treated patients and in 96% of the amoxicillin-treated patients. Clinical outcome was statistically equivalent between groups within a range of 7 percentage points. Clinical recurrence was seen in eight erythromycin-treated children (5.7%) and in seven amoxicillin-treated children (5.0%) (P=0.81). Patients with bilateral disease at entry were at higher risk of unfavourable outcome, whereas age and presence/absence of otorrhea at entry were not associated with outcome. Treatment-related adverse events were recorded in eight (5.3%) of 151 erythromycin-treated patients and in 11 (7.3%) of 151 amoxicillin-treated patients. In this study in an 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.

The use of macrolides in treatment of upper respiratory tract infections

“…Erythromycin was concluded to be as effective as amoxicillin in the treatment of AOM, producing success in 94% versus 96% of patients, respectively [51]. Although equally effective, erythromycin, however, is not the preferred treatment for upper RTIs, such as AOM, because of the marginal activity against H. influenzae and less convenient dosage, requiring multiple daily dosing for an average of 10 days, which may lead to poor compliance [2••].…”

“…Table 3 comprises selected clarithromycin studies involved in treatment of acute otitis media (AOM), bacterial pharyngitis, and acute sinusitis [2••,32-52]. The use of macrolides in the treatment of otitis media has been studied in many double-blinded, comparative trials [35,36,[42][43][44]46,48,49,51,53].…”

Effects of Otitis Media on the Eustachian Tube: An Animal Experiment

“…The most common four pathogens seen in AOM are Haemophilus influenzae, morexella catarrhalis, Streptococcus pneumoniae, and Staphylococcus aureus. Viruses, especially Rhinovirus and Adenoviruses, are identified as pathogens in up to 20% of patients [2]. Only if the balance is shifted inside, the eustachian will be used for these bacteria to colonize and invade the middle ear.…”

9. Treatment, Complications, and Sequelae

“…It also does not address the issue of whether treatment is justified at all, given the marginal benefits over placebo in blinded RCTs (about 14%) and the short-term nature of the efficacy achieved. 22. Van Balen et al 24 RCT of 149 children ages 6 months to 6 years with prospectively documented bilateral OME for 3 months or longer who were randomized to amoxicillin-clavulanate versus placebo for 14 days.…”