Prospective, randomized, comparative trial of ciprofloxacin otic drops, with or without hydrocortisone, vs. polymyxin B-neomycin-hydrocortisone otic suspension in the treatment of acute diffuse otitis externa

In a prospective, multicenter, randomized trial, the efficacy and safety of a 1-week treatment regimen of ciprofloxacin otic drops (0.2%), with or without hydrocortisone, or polymyxin B-neomycin-hydrocortisone otic suspension (PNH) were compared in patients with acute diffuse otitis externa of less than 3 weeks' duration. Eight hundred forty-two patients aged greater than or equal to 2 years were enrolled. Of 703 patients valid for efficacy analysis (239 ciprofloxacin alone [CIP Soln], 236 ciprofloxacin plus hydrocortisone [CIP/HC Susp], 228 PNH), clinical resolution or improvement was observed in 93%, 90%, and 87% of CIP Soln-, CIP/HC Susp-, and PNH-treated patients, respectively. Estimated median time-to-end of ear pain was 4.7 days (CIP Soln), 3.8 days (CIP/HC Susp), and 4.1 days (PNH). CIP/HC Susp-treated patients had a significantly shorter time-to-end of ear pain than did CIP Soln-treated patients (P = .039). Pseudomonas aeruginosa was the most common pathogen in all three treatment groups (67%). Bacteriologic eradication at the end of therapy was achieved in 92%, 95%, and 87% of CIP Soln-, CIP/HC Susp-, and PNH-treated patients, respectively. All treatments were well tolerated with similar rates of drug-related adverse events, ranging from 5% to 6%. Ciprofloxacin otic drops, with or without hydrocortisone, were as effective as PNH in the treatment of acute otitis externa. The addition of hydrocortisone to ciprofloxacin resulted in a statistically significant reduction in the time-to-end of ear pain when compared with ciprofloxacin alone.