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Once or twice daily versus three times daily amoxicillin with or without clavulanate for the treatment of acute otitis mediaThanaviratananich S, Laopaiboon M, Vatanasapt P SummaryOnce or twice daily doses compared with three or four daily doses of amoxicillin, with or without clavulanate, for the treatment of acute otitis media in childrenAcute otitis media is very common disease in children and may cause pain and hearing loss. Amoxicillin, with or without clavulanate, is the most commonly used antibiotic for the treatment of acute otitis media. Currently one or two daily doses are increasingly used, in preference to three or four times daily doses, to aid compliance. We could not claim that the different dosage schedules have the same effectiveness, as the included studies were biased. To study whether both dosing schedules have the same effectiveness, a good quality equivalence trial is necessary.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2010 Issue 1, Copyright © 2010 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This version first published online:
October 08. 2008 AbstractBackgroundAcute otitis media (AOM) is a common problem in children, for which the antibiotic amoxicillin, with or without clavulanate, is frequently prescribed. ObjectivesTo 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 strategyWe 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 criteriaWe 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 analysisWe 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 resultsWe 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' conclusionsThis 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. |