An RCT included children aged 6-35 months with acute otitis media (AOM), and studied the effect of amoxicillin-clavulanate 40 mg/kg/day (n=161) compared to placebo (n=158) for 7 days on the time to the resolution of middle-ear effusion (MEE) as a secondary objective. The median time to resolution of MEE was 20 days (95% CI 16-24 days) in the amoxicillin-clavulanate group and 29 days (95% CI 26-32 days) in the placebo group. In multivariable analysis, the resolution of MEE was prolonged most significantly by at least 1 recurrence of AOM during follow-up: MEE resolved in 65% of children with a recurrence of AOM during follow-up and in 94% among those without a recurrence (p<0.001). Median times to resolution were 67 vs 15 days, respectively.
Another RCT2 included a total of 84 children between 6 months and 15 years of age with acute otitis media. Children received either amoxicillin-clavulanate or a placebo for 7 days. The primary outcome measure was the time to the disappearance of middle ear effusion (MEE) as defined by a normal tympanogram finding from both ears on 2 consecutive measurements. Middle ear effusion disappeared 2.0 weeks (13.7 days) earlier (p =0.02) in the antimicrobial group (mean time, 2.7 weeks; 95% CI, 1.7-3.7) than in the placebo group (4.7 weeks; 95% CI, 3.6-5.7). Normal otoscopy findings were observed 1.4 weeks sooner in the antimicrobial group (p =0.02). On day 14, 69% of children in the antimicrobial group and 38% in the placebo group had normal tympanometry findings (NNT 3.2; 95% CI, 2.0-10.5). On day 60, 2 children (5%) in the antimicrobial group and 10 children (24%) in the placebo group had persistent MEE (p = 0.01).
Third study3 included 90 children with acute otitis. The children were treated with either oral amoxicillin or cefuroxime-axetil for 10 days. Their parents monitored the disappearance of effusion with tympanometry daily for 14 days or until the tympanogram was normal (curve A or C) in both ears. Pneumatic otoscopy was carried out every 2 weeks. Normal tympanograms were obtained after a median time of 7.5 days (range 1-58 days) among 75 successfully monitored patients. In 69% of them, effusion resolved in 14 days. The median duration of effusion did not differ significantly between the two treatment groups (8 vs 7 days, p=0.7). The children who had unilateral otitis cured more rapidly than those with bilateral otitis (5 vs 19 days, p<0.001). Bilaterality explained treatment failure at 2 weeks (OR 28.1; 95% CI 4.6-169.5).
Primary/Secondary Keywords