Once or twice daily versus three times daily amoxicillin with or without clavulanate for the treatment of acute otitis media.

BACKGROUND: Acute otitis media (AOM) is a common problem in children, for which the antibiotic amoxicillin, with or without clavulanate, is frequently prescribed.

OBJECTIVES: To compare the effectiveness of one or two daily doses with three or four daily doses of amoxicillin, with or without clavulanate, for the treatment of AOM in children.

SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, issue 1), which contains the Acute Respiratory Infections (ARI) Group's Specialized Register; MEDLINE (January 1950 to March 2008); EMBASE (1974 to March 2008); the Science Citation Index (2001 to March 2008); and NLM Gateway (HSRProj) (March 2008).

SELECTION CRITERIA: We included studies if they met the following criteria: randomized controlled trials (RCTs) of children aged 12 years or younger with AOM, diagnosed by the following explicit criteria: acute ear pain (otalgia) and inflamed ear drum (confirmed by positive tympanocentesis or tympanogram of type B or C).

DATA COLLECTION AND ANALYSIS: We extracted data on treatment outcomes from individual trials. We assessed quality based on selection bias, performance bias, attrition bias and sample size calculation. The quality grading was defined as low risk of bias, moderate risk of bias or high risk of bias. The results were summarized as risk ratio (RR) and 95% confidence intervals (CI).

MAIN RESULTS: We included six studies with 1601 children in the review. Although the clinical cure rates at the end of therapy and at the follow-up periods of each study were shown to be comparable between the two groups, we did not perform pooled data analysis because of moderate to high risk of biases in the included studies. Most of the children were aged 2 months to 12 years. None of the studies had any consistently significant results either for benefit or harm. The outcomes were assessed at the end of therapy (often 10 days) and this may have been too late to measure any differences.

AUTHORS' CONCLUSIONS: This review showed insufficient evidence to judge whether once or twice daily doses of amoxicillin, with or without clavulanate, were comparable with three or four daily doses for the treatment of AOM. The evidence appears to be biased and therefore no firm conclusions can be drawn.