Prophylaxis of recurrent acute otitis media and middle-ear effusion. Comparison of amoxicillin with sulfamethoxazole and trimethoprim
N. Principi, P. Marchisio, E. Massironi, R. M. Grasso and G. Filiberti
Department of Pediatrics, University of Milan, Italy.
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.
