Objectives-To assess the risks and benefits of antibiotic treatment in
children with symptoms of upper respiratory tract infection (URTI). D
esign-Quantitative systematic review of randomised trials that compare
antibiotic treatment with placebo. Data sources-Twelve trials retriev
ed from a systematic search (electronic databases, contact with author
s, contact with drug manufacturers, reference lists); no restriction o
n language. Main outcome measures-The proportion of children in whom t
he clinical outcome was worse or unchanged; the proportion of children
who suffered complications or progression of illness; the proportion
of children who had side effects. Results-1699 children were randomise
d in six trials that contributed to the meta-analysis. Six trials were
not used in the meta-analysis because of different outcomes or incomp
lete data. Clinical outcome was not improved by antibiotic treatment (
relative risk 1.01, 95% confidence interval (CI) 0.90 to 1.13), neithe
r was the proportion of children suffering from complications or progr
ession of illness (relative risk 0.71, 95% CI 0.45 to 1.12). Complicat
ions from URTI in the five trials that reported this outcome was low (
range 2-15%). Antibiotic treatment was not associated with an increase
in side effects compared with placebo (relative risk 0.8, 95% CI 0.54
to 1.21). Conclusions-In view of the lack of efficacy and low complic
ation rates, antibiotic treatment of children with URTI is not support
ed by current evidence from randomised trials.