The objectives of the study were to determine the effectiveness and incidence of adverse events of
ofloxacin otic
solution for
suppurative otitis media compared with other treatments. All randomized controlled trials and nonrandomized comparative clinical trials published from 1966 to 2000 using
ofloxacin otic
solution as one of the interventions were reviewed and data were extracted and analyzed. Eleven clinical trials (9 randomized and 2 nonrandomized) enrolling 1,484 adults and children were finally included in the analysis. Five studies employed clear concealment procedure in the allocation of treatment whereas evaluation of outcome was at least single-blinded in 6 trials. The probability of overall cure rate was higher with 0.3%
ofloxacin otic
solution than with other topical or systemic
antibiotics in 9 of the studies analyzed (OR = 2.67; 95% CI = 2.04, 3.50). Resolution of secondary outcome parameters evaluated at least 1 week
after treatment was higher with 0.3%
ofloxacin otic
solution: resolution of
otalgia (4 trials; OR = 2.41; 95% CI = 1.2, 4.82); resolution of otorrhea (11 trials; OR = 2.78; 95% CI = 2.12, 3.65), and bacterial eradication rate (6 trials; OR = 3.86; 95% CI = 2.54, 5.87). A subgroup analysis of 4 studies comparing
ofloxacin otic
solution with
antibiotic- and
steroid-containing otic
solution showed a higher cure rate for
ofloxacin otic
solution (OR = 2.73; 95% CI = 1.52, 4.90). Another subgroup analysis on 3 studies comparing
ofloxacin otic
solution with oral systemic
antibiotics showed higher resolution of otorrhea with
ofloxacin otic
solution (OR = 2.78; 95% CI = 2.12, 3.65). Of 4 studies with data on adverse events, the probability of adverse events was lower with
ofloxacin otic
solution than with other topical
antibiotics (OR = 0.28; 95% CI = 0.19, 0.42). Subgroup analysis showed that 0.3%
ofloxacin otic
solution showed better results in terms of overall cure rate, resolution of otorrhea,
otalgia, bacterial eradication rate and incidence of adverse events. Whether due to chronic
suppurative otitis media (CSOM) or draining
tympanostomy tube, the overall cure rate (CSOM OR = 4.86; with
tympanostomy tube OR = 2.13) and resolution of otorrhea (CSOM OR = 4.42; with
tympanostomy tube OR = 1.66) were likewise in favor of 0.3%
ofloxacin otic
solution. The studies included in this meta-analysis showed generally homogenous results in all clinical and laboratory outcomes analyzed, except for the evaluation of adverse events. The authors conclude that 0.3%
ofloxacin otic
solution is better than other otic
antibiotic drops and other oral
antibiotics in terms of overall cure rate and resolution of secondary outcome parameters. Estimates on the beneficial effects of
ofloxacin otic
solution are limited to the period of study included in this review.