title: Effect of antimicrobial treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial.
abstract: OBJECTIVE
  Antimicrobial treatment reduces the symptoms of acute otitis media (AOM). The effect of antimicrobial treatment on the duration of middle ear effusion (MEE) and concomitant hearing impairment is not known.
  
  
  OBJECTIVE
  To determine whether the antimicrobial treatment of AOM reduces the duration of MEE.
  
  
  METHODS
  This randomized, double-blind, placebo-controlled trial involved a total of 84 children with AOM between 6 months and 15 years of age. Participants were recruited from September 14, 1999, to January 4, 2000; October 10, 2005, to December 16, 2005; and September 22, 2009, to June 4, 2012, from among children attending an AOM prevention trial and children visiting local outpatient clinics in Oulu, Finland.
  
  
  METHODS
  Children were randomly allocated to receive either 40 mg/kg of amoxicillin-clavulanate or a placebo mixture per day for 7 days.
  
  
  METHODS
  The primary outcome measure was the time to the disappearance of MEE as defined by a normal tympanogram finding (A curve) from both ears on 2 consecutive measurement days. Parents performed daily tympanometry at home. The study physician performed tympanometry and otoscopy at study entry, after 3 and 7 days, and then weekly until both ears were healthy. The main secondary outcome measures were the time to normal otoscopy findings and the proportion of children without persistent MEE at 14 days and 2 months.
  
  
  RESULTS
  Middle ear effusion disappeared 2.0 weeks (13.7 days) earlier (P = .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 than in the placebo group (P = .02). On day 14, 69% of children in the antimicrobial group and 38% in the placebo group had normal tympanometry findings (number needed to treat, 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 = .01).
  
  
  CONCLUSIONS
  Antimicrobial treatment effectively reduced the duration of MEE and possible concomitant hearing impairment in children with AOM. Antimicrobial treatment also reduced the risk for persistent MEE.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01244581.
authors.affiliation: Department of Pediatrics, Oulu University Hospital, Oulu, Finland2Institute of Clinical Medicine, University of Oulu, Oulu, Finland.
authors.forename: Terhi
authors.initials: T
authors.lastname: Tapiainen
authors.affiliation: Department of Otolaryngology, Oulu University Hospital and Institute of Clinical Medicine, University of Oulu, Oulu, Finland.
authors.forename: Tiia
authors.initials: T
authors.lastname: Kujala
authors.affiliation: Department of Pediatrics, Oulu University Hospital, Oulu, Finland2Institute of Clinical Medicine, University of Oulu, Oulu, Finland.
authors.forename: Marjo
authors.initials: M
authors.lastname: Renko
authors.affiliation: Department of Otolaryngology, Oulu University Hospital and Institute of Clinical Medicine, University of Oulu, Oulu, Finland.
authors.forename: Petri
authors.initials: P
authors.lastname: Koivunen
authors.affiliation: Institute of Clinical Medicine, University of Oulu, Oulu, Finland.
authors.forename: Tero
authors.initials: T
authors.lastname: Kontiokari
authors.affiliation: Department of Otolaryngology, Oulu University Hospital and Institute of Clinical Medicine, University of Oulu, Oulu, Finland.
authors.forename: Aila
authors.initials: A
authors.lastname: Kristo
authors.affiliation: Department of Pediatrics, Oulu University Hospital, Oulu, Finland2Institute of Clinical Medicine, University of Oulu, Oulu, Finland.
authors.forename: Tytti
authors.initials: T
authors.lastname: Pokka
authors.affiliation: Department of Otolaryngology, Oulu University Hospital and Institute of Clinical Medicine, University of Oulu, Oulu, Finland.
authors.forename: Olli-Pekka
authors.initials: OP
authors.lastname: Alho
authors.affiliation: Department of Pediatrics, Oulu University Hospital, Oulu, Finland2Institute of Clinical Medicine, University of Oulu, Oulu, Finland.
authors.forename: Matti
authors.initials: M
authors.lastname: Uhari
mesh_terms: D000158:Acoustic Impedance Tests; D000208:Acute Disease; D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D019818:Clavulanic Acid / Q000627:therapeutic use*; D004311:Double-Blind Method; D005387:Finland; D006801:Humans; D007223:Infant; D010034:Otitis Media with Effusion / Q000188:drug therapy*; D038781:Otoscopy; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D019818:Clavulanic Acid; D000658:Amoxicillin