Comparative Effectiveness of the Oral versus Topical Ofloxacin to Reduce the Discharge in Chronic Suppurative Otitis Media: A Randomized Control Trial

Abstract

Objective: The objective of the study was to assess the reduction rate of discharge in chronic suppurative otitis media with the use of oral vs topical Ofloxacin.

Methodology: It was a randomized control trial conducted in the Department of Otorhinolaryngology Head and Neck surgery PIMS Islamabad from 26-06-2019 to 26-12-2019. The study was commenced with the approval from the ERB (Ethical Review Board). Non-probability consecutive sampling technique was used. Sample size was calculated using WHO calculator which was 98 with 49 patients in each group A & B. Participants of group A received topical Ofloxacin whereas, in group B received oral/systemic Ofloxacin. Efficacy of oral and topical drug was compared after two weeks of the start of the treatment. Data analysis was done using SPSS version 23.

Results: According to gender distribution, there were 67.3% (n=33) males and 32.7% (n=16) were females in group A whereas, there were 61.2% (n=30) males and 38.8% (n=19) were females in group B. The mean age of the participants of group A was recorded as 27.0 years ± 9.4 and 26.6 years ± 10.1 in group B. Mean disease duration in group A was recorded as 2.6 years ± 2.1 and 2.4 years ± 1.9 in group B. A pus discharge was recorded in 73.5% (n=36) patients, pus and blood stained discharge in 26.5%, (n=12), 89.8% (n=44) had redness and 12.2% (n=6) had edema on examination. The values for group B were 95.9% (n=47), 4.1% (n=2), 46.9% (n=23) and 6.1% (n=3), respectively. After two weeks treatment, the outcomes were considerably enhanced in patients treated with topical ofloxacin in comparison to those treated with oral ofloxacin (p<0.05 across all groups).

Conclusion: Topical ofloxacin is a better agent as compared to orally available in resumption of discharge in CSOM. More, multicenter studies with an enlarged sample size are suggested to strengthen the evidence.