Efficacy and safety of Azithromycin and Amoxicillin/clavulanate for otitis media in children: a systematic review and meta-analysis of randomized controlled trials
Abstract BackgroundResistance, prolonged therapy and more adverse reactions made amoxicillin less preferred for treating otitis media. The aim of this study was to compare the efficacy and safety of azithromycin and amoxicillin/clavulanate for treatment of otitis media in children.MethodologyThis study was a systematic review and meta-analysis. PubMed, Cochrane library and Google scholar databases were searched. Comparative RCT studies between azithromycin and amoxicillin/clavulanate to treat otitis media in children published up to 30 September 2019 were included. Risk of bias was assessed and Data was extracted by the first author and checked by second author. Meta-analysis was performed by STATA software version 16, and Mantel-Haenszel statistical method with effect measure odds ratio was employed for analysis.Result751 records were identified and 14 studies were eligible for analysis. In 12 studies azithromycin had equivalent clinical efficacy and 2 had less to amoxicillin/clavulanate. Meta-analysis results showed small statistical difference on efficacy in favor of amoxicillin/clavulanate after completion of treatment OR 0.75, 95% CI (0.62–0.91). On subgroup analysis for children less than 2 year (OR 0.96 95% CI (0.49–2.29), and greater than 2 year (OR 1.40 95% CI (0.93–2.11) and also efficacy on follow up (OR 0.97 95% CI (0.83–1.15) there is no statistical significant difference. The clinical adverse events are more in amoxicillin/clavulanate group than in azithromycin with statistical significant difference OR 0.46 95% CI (0.43–0.56).ConclusionAzithromycin is not inferior to amoxicillin/clavulanate to treat otitis media in children, and it is safer and more tolerable.