A group III steroid solution without antibiotic components: an effective cure for external otitis.

The present study was undertaken to compare the clinical benefits of prescribing ear drops containing 0.05% solution of betamethasone dipropionate (BD), and ear drops containing hydrocortisone with oxytetracycline hydrochloride and polymyxin B (HCPB), for topical treatment of external otitis. Fifty-one patients were enrolled in this open randomized, parallel-group, multicentre study, performed in eight different ENT departments. The patients were randomly assigned to one of the two treatment groups: BD (n = 26) and HCPB (n = 25). Only ENT specialists investigated the patients. Bacterial and fungal cultures were raised on days 1 and 11, using swabbed material from ear canals. Twice daily the patients recorded their symptoms during the acute phase, using special diary cards.BD proved a significantly more effective cure than HCPB during the acute phase of external otitis and afforded a lower relapse frequency during a six-month follow-up period. The patients of the BD group were significantly less troubled by itching (p < 0.01) than those in the HCPB group. On day 11, at the end of the acute phase, growth of bacteria (p = 0.03) and fungi (p < 0.01) was less frequent in the BD group than in the HCPB group. No serious adverse events occurred, and those minor events observed were comparable between the two groups.Our conclusion is that the group III steroid solution, BD, cured the external otitis more effectively than did the HCPB solution, whether infected by bacteria or by fungi. No difference was evident regarding adverse effects. Furthermore, price favours a solution without any antibiotic component. In view of these observations, a group III steroid solution ought to be the preferred remedy for external otitis, whether infected or not.

RCT Entities:   Population Interventions Outcomes