Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years.

OBJECTIVE To determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age. DESIGN Practice based, double blind, randomised, placebo controlled trial. SETTING 53 general practices in the Netherlands. SUBJECTS 240 children aged 6 months to 2 years with the diagnosis of acute otitis media. INTERVENTION Amoxicillin 40 mg/kg/day in three doses. MAIN OUTCOME MEASURES Persistent symptoms at day four and duration of fever and pain or crying, or both. Otoscopy at days four and 11, tympanometry at six weeks, and use of analgesic. RESULTS Persistent symptoms at day four were less common in the amoxicillin group (risk difference 13%; 95% confidence interval 1% to 25%). The median duration of fever was two days in the amoxicillin group versus three in the placebo group (P=0.004). No significant difference was observed in duration of pain or crying, but analgesic consumption was higher in the placebo group during the first 10 days (4.1 v 2.3 doses, P=0.004). In addition, no otoscopic differences were observed at days four and 11, and tympanometric findings at six weeks were similar in both groups. CONCLUSIONS Seven to eight children aged 6 to 24 months with acute otitis media needed to be treated with antibiotics to improve symptomatic outcome at day four in one child. This modest effect does not justify prescription of antibiotics at the first visit, provided close surveillance can be guaranteed.