The Effect of Using Ofloxacin Ear Drops in Traumatic Tympanic Membrane Healing: A Systematic Review and Meta-Analysis.

ABSTRACT

Objectives: To evaluate the effectiveness of ofloxacin ear drops versus no intervention in the repair of traumatic tympanic membrane (TM) perforations from randomized controlled trials (RCTs). Data Sources Medline/PubMed, CENTRAL, Clinical Trials.Gov, and Google Scholar. Study Selection Inclusion criteria (1) English language; (2) RCT studies; (3) reported the outcomes on the application of ofloxacin and outcomes of spontaneous healing. Exclusion criteria (1) studies without a control group; (2) patient with severe otologic disease such as chronic suppurative otitis media or ossicular disruption or patients with craniocerebral injury; (3) studies with no pretreatment values or single-arm clinical studies. Data Extraction Country, year of publication, number of participants in each arm, patient characteristics such as age, sex, intervention details, laterality, cause of TM perforation, position of perforation, follow-up time, hearing gain, rate of TM closure, and closure time. Results: A total of 6 RCTs studies were analyzed. A total of 502 participants were included; the relative risk for closure rate of ofloxacin treatment was 1.18 [95% confidence interval (CI), 1.08 to 1.28, P < .001] and the mean difference (MD) for healing time was -18.4 (95% CI, -19.96 to -16.82, P < .001), suggesting ofloxacin has a significant effect on closure of TM perforations. However, no clinically significant effect in hearing (SMD 0.21, 95% CI, 0.02 to 0.40, P = .03) was seen in ofloxacin group. Also, patients in the ofloxacin group were associated with a 13% reduction in the risk of infections compared to their observation-assigned counterparts, but this estimate was not statistically significant. Conclusion: Ofloxacin use in patients with traumatic TM perforation is effective in reducing healing time and increasing rate of TM perforation closure. No evidence of increased risk of hearing loss or infection rates are encountered when ofloxacin is prescribed to patients with traumatic TM perforation.