Comparison of ofloxacin otic solution with oral amoxycillin plus chloramphenicol ear drop in treatment of chronic suppurative otitis media with acute exacerbation.

The efficacy and safety of 0.3 per cent Ofloxacin otic solution (OFLX) 6 drops twice daily was compared with those of oral Amoxycillin 500 mg three times daily plus 1 per cent Chloramphenicol ear drop at 3 drops three times daily (AMOX + CRP) in a two-week treatment of chronic suppurative otitis media (CSOM) with acute exacerbation. 80 adult patients were enrolled in a prospective, randomized, investigator-blind study at the outpatient ENT service of Chulalongkorn University Hospital. The most common pathogens isolated at the pretreatment visit were Staphylococcus aureus (30.3%) and Pseudomonas aeruginosa (24.7%). The susceptibility of all the pathogenic isolates to ofloxacin, amoxycillin and chloramphenicol were 96.4, 57.1 and 51.8 per cent respectively. The overall response expressed as an improvement or cure of otalgia, otorrhea and middle ear mucosal inflammation was recorded. It revealed that the improvement rate of the OFLX-treated patients was better than that of AMOX + CRP-treated, but was not statistically significant. However, the cure rate was significantly better in OFLX-treated than in AMOX + CRP-treated groups in terms of painless (p = 0.05) and dry (p < 0.001) ears. Ototoxicity was assessed by an elevation in bone conduction threshold (BC) and/or speech reception threshold (SRT) of greater than 5 dB or a presence of high tone hearing loss resulting from treatments. A significant decrease in BC and SRT was revealed in OFLX-treated ears (p < 0.0001; p = 0.002 respectively) but a significant elevation of BC was found in AMOX + CRP-treated ears (p = 0.007). The ototoxic rate was significantly higher in AMOX + CRP-treated than in OFLX-treated ears whether assessed by BC (p < 0.001) or SRT (p = 0.03). In conclusion, OFLX was more effective and safer than AMOX + CRP in the treatment of CSOM with acute exacerbation.

RCT Entities:   Population Interventions Outcomes