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implement by keeping the same irst line antibiotic recommendation for treatment of AOM and non-severe pneumonia.
8.2.1 Evidence and summary of findings
here were no placebo-controlled trials from developing countries. A Cochrane review updated 2010 assessed 10 placebo controlled trials of oral
antibiotics conducted in developed countries with a total of 2928 children ranging in age from infancy to 15 years [Sanders S, 2004]. Enrolment in the trials was based
on clinical diagnosis, and primary outcomes included reported pain and health professional-determined clinical cure. he antibiotics used were mostly beta-lactams,
although macrolides and sulphonamides were also studied
see GRADE table A7.17 .
here is low-moderate quality evidence from the review for the equivalence of a range of antibiotics, although the studies that were included were small, and the outcome-
used, clinical response is likely to overestimate the efect of inefective antibiotics because of a high rate of spontaneous recovery
see GRADE table A7.18 .
Combined results of the trials showed that pain was not reduced at 24 hours from the start of treatment but it was reduced at 2 to 7 days, RR 0.72; 95 CI 0.62
to 0.83. Compared with delayed treatment, immediate antibiotic treatment was associated with decreased ear pain at day four RR 0.77; 95 CI 0.50 to 1.17. In
the four trials that measured tympanometry, there was no clinically or statistically signiicant diference in tympanometry results at 1 or 3 months ater the acute
episode, suggesting no efects on hearing. he review also found that antibiotics appeared to reduce the development of contralateral otitis, although the diference
was not statistically signiicant. Individual patient data meta-analysis of a subset of the included trials found antibiotics to be most beneicial in children aged less than 2
years or those with bilateral AOM and otorrhoea.
here are too few complications to be able to compare these across groups eg. one child out of 2928 children had mastoiditis. In applying these results to developing
countries with a higher frequent risk of more serious complications like mastoiditis, antibiotic treatment would be strongly advised.
A meta-analysis of 1643 children from six trials aged 6 months to 12 years looked at the efect of antibiotics on an extended episode of AOM lasting 3–7 days [Rovers,
2006]. Randomized placebo-controlled trials were included. hree of the six trials were included in the Cochrane review [Sanders S, 2004]. he relative risk of an extended
course of AOM at 3–7 days with antibiotics was 0.83 95 CI 0.78–0.89, for fever was 0.95 95 CI 0.92–98, and for pain was 0.86 95 CI 0.81–0.91. A signiicant reduction
in pain, fever, or both was noted in the treatment arm for those less than 2 years of age with bilateral disease 55 versus 30; RD -25; 95 CI -36,-15 with a NNT of 4 and
those with otorrhoea 60 versus 24; RD -36; 95 CI -53,-19; NNT 3.
In another systematic review, short-term clinical success was higher for immediate use of ampicillin or amoxicillin versus placebo respectively 73 versus 60; pooled
rate diference, 12; 95 CI 5–18; pooled rate diference, 12; 95 CI 5–18]; NNT, 9, 95 CI, 6-20 [Coker, 2010].
