Efficacy of Empirical Co-Amoxiclav Vs Culture Directed Treatment in Chronic Suppurative Otitis Media. A Double Blind Randomized Controlled Trial

Abstract

Background: Chronic suppurative otitis media (CSOM) is common middle ear inflammatory condition secondary to tympanic membrane perforation and superimposed infection, which causes increased discharge from middle ear mucosa. This is a common condition seen in relatively low socioeconomic status and in younger population. The effective treatment of this disease is essential as un-treated patients often lead to various complications like mastoiditis, facial nerve paralysis, labyrinthitis and abscess formation. A huge number of hearing loss in paediatric population is due to this condition. The treatment of CSOM includes aural toilet, topical antibiotics and in some cases systemic antibiotics. In this study we will compare the results of patients who were given culture sensitivity directed antibiotics with the ones who were given Co-Amoxiclav as an empiric treatment Methodology: A two-year observational cross-sectional study was conducted at PIMS, a total of 396 patients were enrolled and randomly divided into two group i.e., Group A and Group B with 198 patients in each. Group A included those who were given culture specific antibiotics and group B included those who were given Co-Amoxiclav as a part of empiric therapy. Their results were compared after 12 days of treatment in terms of response seen as clean and dried, external auditory canal along with middle ear mucosa. Results: Out of 198 patients in Group A, 177 patients had clean and dried middle ear mucosa which shows success rate of 89.39% and in Group B 170 patients out of 198 (85.85%) showed positive response. Conclusion: Empiric treatment of CSOM (Tubotympanic Type) with co-amoxiclav must be considered as its response is comparable to culture sensitivity directed treatment in terms of clean and dried external auditory canal and middle ear mucosa.