[Double-blind comparative trial of trimethoprim-polymyxin B and trimethoprim-sulphacetamide-polymyxin B ear drops in the treatment of otorrhoea (author's transl)]

Abstract

The purpose of his double-blind, randomized trial was to compare ear drops containing either trimethoprim and polymyxin B (TP) or trimethoprim, sulphacetamide and polymyxin B (TSP) from the points of view of effectiveness and safety. The 68 patients treated had otitis externa or recurrent otitis media with perforated ear-drum, or mastoid cavity with post-tympanoplasty infection. Satisfactory results were obtained in 60.6% of the cases with TP and in 88.6% with TSP. When evaluated by the Chi-square method with Yates' correction, the difference was statistically significant. There was no evidence of ototoxicity, fungal infection or local hypersensitivity with either preparation. The trial demonstrated that both ear drops were active and that TSP was much more effective than TP in the treatment of otorrhea.