Efficacy and Tolerability of Brodimoprim in Otitis

Abstract

Eighty adult patients affected by acute bacterial otitis media were selected and randomized into two balanced groups of treatment: 1) brodimoprim 200 mg tablets at the dosage of 2 tablets in single dose on the first day and one tablet on the following days; 2) josamycin 500 mg tablets at the dosage of 3 tablets/day. The average duration of treatment was 8 days: all patients completed the trial. The symptoms were evaluated by score method (on the 3rd, 7th and on the last day of therapy) and a thermometric curve was made daily. Microbiological examination of the exudate was performed in the patients with auricular discharge (28), at the beginning of the treatment and 7 days after the end of therapy. The tolerability was assessed through registration of side effects. Brodimoprim resulted more effective in the reduction of hypoacusis and tinnitus; other symptoms demonstrated higher percentage reductions in the group under brodimoprim therapy. Bacteriological exams were negative at the second checkup, except in 6 patients (3 per group). Side effects were reported in 5 patients (12.5%) treated with brodimoprim and in 9 (22.5%) treated with josamycin. Abnormal values in laboratory tests were not observed.