title: Prophylaxis of recurrent acute otitis media and middle-ear effusion. Comparison of amoxicillin with sulfamethoxazole and trimethoprim.
abstract: 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.
authors.affiliation: Department of Pediatrics, University of Milan, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Principi
authors.forename: P
authors.initials: P
authors.lastname: Marchisio
authors.forename: E
authors.initials: E
authors.lastname: Massironi
authors.forename: R M
authors.initials: RM
authors.lastname: Grasso
authors.forename: G
authors.initials: G
authors.lastname: Filiberti
mesh_terms: D000658:Amoxicillin / Q000627:therapeutic use*; D002675:Child, Preschool; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D010034:Otitis Media with Effusion / Q000188:drug therapy; D011897:Random Allocation; D012008:Recurrence; D012621:Seasons; D016037:Single-Blind Method; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000627:therapeutic use*
chemical_list: D000658:Amoxicillin; D015662:Trimethoprim, Sulfamethoxazole Drug Combination