Once or twice daily versus three times daily amoxicillin with or without clavulanate for the treatment of acute otitis media
Abstract
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 methods
We searched (CENTRAL 2010, issue 3), which contains the Acute Respiratory Infections (ARI) Group's Specialised Register, MEDLINE (January 1950 to July 2010), EMBASE (1974 to July 2010), the Science Citation Index (2001 to July 2010) and NLM Gateway (HSRProj) (July 2010).
Selection criteria
We included randomized controlled trials (RCTs) of children aged 12 years or younger with AOM, diagnosed by the following 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. We defined the quality grading as low risk of bias, moderate risk of bias or high risk of bias. We summarised the results as risk ratio (RR) and 95% confidence intervals (CI).
Main results
We included five 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 two 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.
PICOs
Plain language summary
Dosage intervals of amoxicillin for the treatment of acute middle ear infection
Acute middle ear infection (acute otitis media) is a very common disease in children and may cause pain and hearing loss. Delayed or ineffective treatment may lead to serious complications such as ear drum perforation, sensorineural hearing loss or the disease becoming chronic. Amoxicillin, with or without clavulanate, is the most commonly used antibiotic for treating acute otitis media. Currently, reducing the dosing interval to using one or two daily doses is being used, in preference to the conventional three or four daily doses, to aid compliance. Although we included five randomized, double‐blinded clinical studies (1640 participants) comparing these two dosing schedules, these studies were of poor quality and were poorly conducted. They could therefore not be analyzed together to evaluate the effectiveness of the different dosage schedules. A good quality equivalence trial is needed to evaluate whether both dosing schedules have the same effectiveness.
