A Double-Blind Comparison of the Effectiveness of Itraconazole Oral Capsules with Econazole Vaginal Capsules in the Treatment of Vaginal Candidosis

Abstract

To assess the effectiveness and convenience of use of itraconazole oral capsules in comparison with econazole vaginal capsules, a total of 81 patients with vaginal candidosis were treated for 3 days. The itraconazole group received active itraconazole capsules and placebo vaginal capsules, and the econazole group received active econazole vaginal capsules and placebo capsules in a double-blind (double-dummy) randomised parallel group study. Patients were instructed to both take 2 oral capsules and place 1 vaginal capsule deep into the vagina each evening. Only outpatients with symptomatic vaginal candidosis proven by yeast culture were included in this trial. Endpoints for evaluation of effectiveness of treatment included mycological cure (the primary variable) at weeks 1 and 2, symptoms present at weeks 1 and 2, and counts of the total number of symptomatic days during the treatment and follow-up periods. Significantly more patients in the itraconazole group responded well to the treatment compared with the econazole group at week 1 after the treatment (p = 0.014). At week 2, the difference was not statistically significant, but approached a significant level in favour of itraconazole (p = 0.093). Also, the proportion of asymptomatic patients at week 1 was higher in the itraconazole group (72.5%) than in the econazole group (63.5%); however, this difference did not reach statistical significance. At week 2, the proportions were similar. The total number of symptomatic days during the study was lower in the itraconazole group compared with the econazole group for all individual symptoms. 80% of patients preferred oral treatment and 5% preferred topical vaginal capsules (p < 0.001). Oral itraconazole was a more effective and more convenient treatment than topical econazole. Both drugs were safe and well tolerated.