Abstract

The aim of this prospective, multicenter, randomized, case-control study was to investigate the efficacy of a nonspecific mucosal antiseptic (octenidine dihydrochloride, phenoxyethanol) with proven antifungal effects, in patients with acute symptomatic vaginal candidosis, in comparison with a specific topical antifungal agent (clotrimazole), particularly in respect to non-Candida albicans yeasts. A total of 491 patients from 29 gynecological practices, who had new clinical vaginal mycosis, not treated with antifungal agents in the last 12 months, were included in the study. The diagnosis in each case was confirmed by microscopy or positive culture. The majority of the vaginal mycoses were infections with C. albicans (72%). In 28% of patients a non- Candida species (mainly C. glabrata) contributed to the infection. Except for vaginal discharge, the success of treatment was between 71% and 91% for both clinical and subjective parameters. The control preparation was significantly better than the treatment in the test group. Mycological cure rate on the basis of cultures was 78% in the test group and 87% in the control group. These results were also significantly different. The relatively high proportion of C. glabrata isolates in this study tended to be more successfully treated by the antiseptic (to 72%) than by the administration of clotrimazole (59%). Even though therapeutic success with clotrimazole was overall significantly better than with the test preparation, the success of treatment with the antiseptic used was within the range between 70% and 90% described for topical antifungal agents. Both the good efficacy of the topical antiseptic and the increased prevalence of non-Candida albicans species causing vaginal infections mean that the use of an antiseptic may be considered a suitable alternative therapeutic concept to an appropriate topical antifungal agent in the treatment of acute vaginal candidosis.

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