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Evidence summaries

Persistence of Effusion in the Middle Ear after an Acute Otitis

After acute otitis effusion is found in the middle ear for several weeks but disappears sooner when treated with antibiotics compared to placebo, at least in some children. Level of evidence: "A"

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).

    References

    • Ruohola A, Laine MK, Tähtinen PA. Effect of Antimicrobial Treatment on the Resolution of Middle-Ear Effusion After Acute Otitis Media. J Pediatric Infect Dis Soc 2018;7(1):64-70. [PubMed]
    • Tapiainen T, Kujala T, Renko M et al. Effect of antimicrobial treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial. JAMA Pediatr 2014;168(7):635-41. [PubMed]
    • Renko M, Kontiokari T, Jounio-Ervasti K et al. Disappearance of middle ear effusion in acute otitis media monitored daily with tympanometry. Acta Paediatr 2006;95(3):359-63. [PubMed]

Primary/Secondary Keywords