Efficacy and safety of ofloxacin and its combination with dexamethasone in chronic suppurative otitis media. A randomised, double blind, parallel group, comparative study

The role of corticosteroid in patients of chronic suppurative otitis media (CSOM) is unknown. In the present study, the efficacy and safety of ofloxacin alone (OA) and the ofloxacin + dexamethasone combination (ODC) is compared by studying clinical cure rates and adverse drug reactions in patients with CSOM. After prior permission from the Institutional Review Board and written informed consent from patients, pre-treatment clinical assessment and bacteriology of the middle ear discharge were done. The middle ear was categorised into active, mucoid or inactive according to the type of discharge. Grades of otorrhoea and size of tympanic membrane perforation were noted. CSOM with organisms sensitive to ofloxacin were treated either with OA or ODC eardrops for a period of 15 days. Post-treatment clinical cure (when grade of otorrhoea become 0) was recorded on the 5(th), 10(th) and 15(th) days and bacteriological assessment was recorded at the last visit. All parameters were analysed using Fisher's exact test. A total 110 patients were randomised. The most common microorganism associated with CSOM was Pseudomonas aeruginosa (45.45 %). Clinical improvement was seen in 84.61% and 86.79% of cases, but bacteriological improvement in only 82.69% and 77.35% of cases treated with OA and ODC, respectively. Shift of middle ear discharge from active to inactive was noted in 71.15% and 64.15% patients by the 10th day in the OA and ODC groups, respectively. As there was no difference in clinical or bacteriological improvement, it may be unnecessary to combine steroids with topical antibiotic preparations for management of CSOM.