ABSTRACT
The aim of this study was to compare the efficacy of antireflux therapy with both conventional management and those with no treatment in children with chronic otitis media with effusion [COME]. In this prospective randomized clinical trial ninety children with COME which lasted more than 3 months or more, documented by physical examination and Type B tympanogram in at least one ear without clinical signs and symptoms of active infection that were refractory to 3 period of antibacterial treatment, were randomly allocated to receive a 3 month course in three groups of antireflux treatment [AR group, Cisapride 1 mg/kg/day], conventional antibacterial treatment [AB group, Co-amoxiclave 40 mg/kg/day TID] and those with no treatment [Control group, no medication]. All patients were followed every month. The favorable response was considered as complete resolution of effusion clinically and type A or more than -200 peak in tympanometry. Of the 30 patients assigned to AR group, 10 [33.3%] were judged to be clinically cured and in AB group 12 [40%] were cured while only 3 [10%] in control group were cured. The cure rate in AR and AB groups was significantly higher compared with control group but there was no significant difference between cure rates in AR and AB groups [P=0.59]. No subjects experienced complications during or after the study. There may be a possible role for GER medical management in patients with COME. Further investigations are necessary in order to confirm this hypothesis