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Prophylaxis of Recurrent Acute Otitis Media and Middle-Ear Effusion Comparison of Amoxicillin With Sulfamethoxazole and Trimethoprim

Nicola Principi, MD; Paola Marchisio, MD; Emilia Massironi, MD; Rosa Maria Grasso, MD; Gianfranco Filiberti, MD
Am J Dis Child. 1989;143(12):1414-1418. doi:10.1001/archpedi.1989.02150240036013.
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• We compared the efficacy of amoxicillin with that of the combination drug sulfamethoxazole and trimethoprim in reducing recurrences of acute otitis media (AOM) in a single-blind, randomized, placebo-controlled trial involving 96 children. Each of the children had had three or more episodes of AOM in the preceding 6 months, and 97% (93/96) of them still had unilateral or bilateral effusion at the beginning of the study. During the 6-month study period, 9 (27%) of 33 of the children in the amoxicillin group developed 9 episodes of AOM, 9(27%) of 33 of the children in the sulfamethoxazole and trimethoprim group experienced 11 episodes of AOM, and 19 (63%) of 30 of the children in the placebo group developed 25 episodes. Young age and day-care attendance characterized children for whom prophylaxis was more efficacious. Overall persistence of middle-ear effusion was shorter in treated children only as a consequence of the reduced number of new episodes of AOM.

(AJDC. 1989;143:1414-1418)


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