S Romsaithong1, K Tomanakan2, W Tangsawad1, S Thanaviratananich3. 1. Department of Otolaryngology,Khon Kaen Hospital,Thailand. 2. Department of Medical Technology,Khon Kaen Hospital,Thailand. 3. Department of Otorhinolaryngology,Faculty of Medicine,Khon Kaen University,Thailand.
Abstract
OBJECTIVES: To compare the clinical effectiveness and adverse events for 3 per cent boric acid in 70 per cent alcohol versus 1 per cent clotrimazole solution in the treatment of otomycosis. METHODS:A total of 120 otomycosis patients were randomly assigned to receive either 1 per cent clotrimazole solution (intervention group) or 3 per cent boric acid in 70 per cent alcohol (control group) at the Khon Kaen Hospital ENT out-patient department. Treatment effectiveness was determined based on the otomicroscopic absence of fungus one week after therapy, following a single application of treatment. RESULTS: After 1 week of treatment, there were data for 109 participants, 54 in the clotrimazole group and 55 in the boric acid group. The absolute difference in cure rates between 1 per cent clotrimazole solution and 3 per cent boric acid in 70 per cent alcohol was 17.9 per cent (95 per cent confidence interval, 2.3 to 33.5; p = 0.028) and the number needed to treat was 6 (95 per cent confidence interval, 3.0 to 43.4). Adverse events for the two agents were comparable. CONCLUSION: One per cent clotrimazole solution is more effective than 3 per cent boric acid in 70 per cent alcohol for otomycosis treatment.
RCT Entities:
OBJECTIVES: To compare the clinical effectiveness and adverse events for 3 per cent boric acid in 70 per cent alcohol versus 1 per cent clotrimazole solution in the treatment of otomycosis. METHODS: A total of 120 otomycosispatients were randomly assigned to receive either 1 per cent clotrimazole solution (intervention group) or 3 per cent boric acid in 70 per cent alcohol (control group) at the Khon Kaen Hospital ENT out-patient department. Treatment effectiveness was determined based on the otomicroscopic absence of fungus one week after therapy, following a single application of treatment. RESULTS: After 1 week of treatment, there were data for 109 participants, 54 in the clotrimazole group and 55 in the boric acid group. The absolute difference in cure rates between 1 per cent clotrimazole solution and 3 per cent boric acid in 70 per cent alcohol was 17.9 per cent (95 per cent confidence interval, 2.3 to 33.5; p = 0.028) and the number needed to treat was 6 (95 per cent confidence interval, 3.0 to 43.4). Adverse events for the two agents were comparable. CONCLUSION: One per cent clotrimazole solution is more effective than 3 per cent boric acid in 70 per cent alcohol for otomycosis treatment.