Randomized prospective comparative study: short-term treatment with ciclopiroxolamine (cream and solution) versus boric acid in the treatment of otomycosis.

Sixty-four patients with symptomatic otomycosis (80 infected ears) confirmed by direct microscopy and culture were randomly treated for I week with ciclopiroxolamine cream 11% (group A, 20 infected ears, 17 patients), ciclopiroxolamine solution 1% (group B, 20 infected ears, 17 patients) and boric acid (group C, 40 infected ears, 30 patients) and daily mechanical suction aspiration of the debris. An attempt was made to match 11 clinical parameters with both the mycological and bacteriological findings. There was no significant association between the fungal species cultured and the clinical parameters did not vary with the presence or absence of different bacteria; pus was never present in fungal otitis externa (Fisher's test, P < 0.001). Before therapy, a significant number of ears had completely sterile bacterial cultures (p < 0.01, chi2 test); saprophytic Gram-positive bacteria increased after treatment, whilst Gram-negative bacteria, Pseudomonas aeruginosa and Proteus species, decreased after treatment. Clinical total cure rates 3 days after the end of therapy ranged from 50% in group A, 25% in group B to 22.5% in group C. Mycological cure rates were 80% (group A), 95% (group B) and 72.5% (group C). Two weeks after the end of therapy the clinical cure rates were 60% (group A), 65% (group B) and 80% (group C) and the mycological cure rates was 65% for group A and 75% for both group B and C. Eleven patients relapsed with otitis externa: four (20%) in groups A and C and three (15%) in group B. In four cases the infection was due to bacteria and the remaining seven were due to fungi. Six sites relapsed with the same fungal species as that isolated at the start of the study. In this short-term assessment the relapse rate was not significantly associated with predisposing conditions. The tolerance was excellent in group A. Four patients (20%) in group B had mild (two patients) or moderate (two patients) burning and itching with each application. Twelve patients (30%) in group C had severe stinging and five of these patients who had perforated tympanic membranes also experienced pain. In terms of clinical and mycological effectiveness, there were no significant differences between the three treatment groups, although group A (ciclopiroxolamine cream 1%) and B (ciclopiroxolamine solution 1%) both showed significantly better tolerance (Fisher's test, P < 0.05) when compared with boric acid (group C).

RCT Entities:   Population Interventions Outcomes