Antibiotics for acute otitis media: a meta-analysis with individual patient data.
BACKGROUND
Individual trials to test effectiveness of antibiotics in children with acute otitis media have been too small for valid subgroup analyses. We aimed to identify subgroups of children who would and would not benefit more than others from treatment with antibiotics.


METHODS
We did a meta-analysis of data from six randomised trials of the effects of antibiotics in children with acute otitis media. Individual patient data from 1643 children aged from 6 months to 12 years were validated and re-analysed. We defined the primary outcome as an extended course of acute otitis media, consisting of pain, fever, or both at 3-7 days.


RESULTS
Significant effect modifications were noted for otorrhoea, and for age and bilateral acute otitis media. In children younger than 2 years of age with bilateral acute otitis media, 55% of controls and 30% on antibiotics still had pain, fever, or both at 3-7 days, with a rate difference between these groups of -25% (95% CI -36% to -14%), resulting in a number-needed-to-treat (NNT) of four children. We identified no significant differences for age alone. In children with otorrhoea the rate difference and NNT, respectively, were -36% (-53% to -19%) and three, whereas in children without otorrhoea the equivalent values were -14% (-23% to -5%) and eight.


CONCLUSIONS
Antibiotics seem to be most beneficial in children younger than 2 years of age with bilateral acute otitis media, and in children with both acute otitis media and otorrhoea. For most other children with mild disease an observational policy seems justified.
Rovers
Maroeska M
MM
Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, the Netherlands. M.Rovers@umcutrecht.nl
Glasziou
Paul
P
Appelman
Cees L
CL
Burke
Peter
P
McCormick
David P
DP
Damoiseaux
Roger A
RA
Gaboury
Isabelle
I
Little
Paul
P
Hoes
Arno W
AW
D000208:Acute Disease; D000367:Age Factors; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D016015:Logistic Models; D008297:Male; D010033:Otitis Media / Q000145:classification / Q000188:drug therapy* / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index
D000900:Anti-Bacterial Agents