Abstract
Thirty-five patients with symptomatic otomycosis (40 infected ears) confirmed by direct microscopy and culture were randomly treated for 1 week with either bifonazole 1% cream or solution, and daily mechanical suction aspiration of the debris. An attempt was made to match 10 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. Before therapy, a considerable number of ears had completely sterile bacterial cultures; after treatment, saprophytic Gram-positive bacilli, Proteus species and Pseudomonas aeruginosa colonized all the ears (P=0·000030). Clinical cure rates 3 days after the end of therapy ranged from 65% to 60% with the cream and solution, respectively. Mycological cure was achieved in 70% of the cream group and in 95% of the solution treated sites. Two weeks after the end of therapy the clinical cure rate was 72·5% and mycological cure rate 57·5% of the sites. In 17 patients (85%) there was an irritant reaction to the solution, whilst the cream was tolerated well. During long-term follow-up (2·5 years) 36 sites were examined; 10 ears had otitis externa: in four cases the infection was due to bacteria, the remaining six were fungal. Four of the six organisms were different to those isolated at the start of the study. The relapse rate was significantly associated with predisposing conditions such as eczema (P=0·0073).