Safety and Efficacy of a topical combination of Neomycin, Clotrimazole, Beclomethasone and Lignocaine for management of Ear Infections: Phase IV Study
Journal Title: International Journal of Medical Science and Innovative Research (IJMSIR) - Year 2017, Vol 2, Issue 3
Abstract
Introduction: Otitis or ear infection is very common in developing countries like India and is often due mixed pathogens. Multi-drug therapy is often used in the treatment of Otitis. We studied the safety and efficacy of one such combination of anti-bacterial (Neomycin), anti-fungal (Clotrimaole), steroid (Beclomethasone) and local anaesthetic (Lignocaine) in the treatment of middle and external ear infections. Methodology: Total 196 patients were enrolled out of which 160 patients completed the study. Efficacy assessment was made by reduction in Total Symptom Score (TSS) of ear pain, ear discharge and ear itching related to Otitis media with perforation and Otitis Externa. Safety assessment was made by analysing the adverse events through the study. Results: Reduction in mean TSS score was done from 5.73(baseline) to 2.19(day 3) to 0.21(day 5) of ear pain, from 5.63 (baseline) to 1.73 (day 3) to 0.15(day 5) of ear discharge and from 4.84 (baseline) to 1.48(day 3) to 0.13(day 5) of ear itching. Nearly all the patients had >50% reduction in their TSS at all visits in all the parameters. 21 episodes of adverse events occurred and all of them were of mild intensity. Conclusion: A combination of Neomycin, Clotrimazole, Beclomethasone Dipropionate and Lignocaine is safe and effective in the treatment of mixed infection of the external and middle ear (with perforation).
Authors and Affiliations
Dr. Mayuresh Kiran
Keywords
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