Mediterr J Otol 2005:1(1):20-23.

The efficacy and safety of local ciprofloxacin in patients with external otitis: A randomized comparative study

Psifidis A., Nikolaidis P., Tsona A., Koumentaki E., Kollaras P., Metallidis S., Daniilidis I. 

Department of Otorhinolaryngology, AHEPA Universtiy Hospital, Thessaloniki, Greece  apsifidi@auth.gr

OBJECTIVES: This study was designed to compare the efficacy and safety of  three regimens of local antibacterial treatment (ciprofloxacin with or without hydrocortisone, and a combination of polymyxin B, neomycin, and hydrocortisone) in the treatment of external otitis.

PATIENTS AND METHODS: Ninety-one patients (43 females, 48 males; mean age 35 years; range 22 to 61 years) who had external otitis for a duration of three weeks or less were included. The patients were randomly assigned to receive the following treatment regimens applied as an eardrop for seven days: (i) Group A (n=32) received a combination of polymyxin B (10,000 U/ml), neomycin (3.5 mg/ml), and hydrocortisone (10 mg/ml) given in a dose of three drops three times daily. (ii) Group B (n=29) received a combination of 0.2% ciprofloxacin (2 mg/ml) and hydrocortisone (10 mg/ml) in a dose of three drops twice daily. (iii) Group C (n=30) received 0.2% ciprofloxacin (2 mg/ml) alone in a dose of three drops twice daily. Ear swabs were obtained from the ear canal prior to (Day 1) and at the end of the therapy (Day 7) for microbiological examination. Clinical evaluations were made on Day 3, Day 7, and at the end of the follow-up period (mean 28 days; range 21 to 35 days).

RESULTS: On initial swab cultures, the most common pathogen was Pseudomonas aeruginosa, which was isolated in 18 patients (56.3%) in group A, in 13 patients (44.8%) in group B, and in 11 patients (36.7%) in group C. Bacteriological results were as follows: eradication 72%, 83.3% and 93.8%; persistence 12%, 5.6%, and 6.3%; and the occurrence of superinfection 16%, 11.1%, and 0%, in groups A, B, and C, respectively. All the persisting pathogens of P. aeruginosa were seen in group A. Superinfection was encountered in six cases; four being caused by fungi, and two by Gram-positive cocci. Clinically, complete resolution of external otitis was achieved in 84.4% in group A, 100% in group B, and 96.7% in group C. No adverse events were observed during or after treatment.

CONCLUSION: Our results suggest that ciprofloxacin is an efficacious and safe alternative for the local treatment of external otitis and that caution should be taken in the use of  hydrocortisone due to its association with a lower eradication rate.