Three-day treatment of patients with vulvovaginal candidiasis: A comparison of butoconazole inserts with econazole ovules

Abstract

The safety and efficacy of butoconazole nitrate 100-mg pessaries was compared with that of econazole nitrate 150-mg ovules in a three-day regimen in nonpregnant patients with vulvovaginal candidiasis. Follow-up visits occurred approximately 11 and 32 days after the completion of treatment. In microbiologic assessments of the elimination of the pathogenic Candida sp from vaginal secretions (wet-mount and culture), butoconazole was superior to econazole, both at visit 2 (89% versus 52%, respectively; P = 0.006) and at visit 3 (100% versus 67%, respectively; P = 0.014). Among patients treated with butoconazole who had a microbiologic cure at visit 2, no cases of relapse were detected a month after treatment ended. In contrast, 33.3% of econazole-treated patients experienced relapse. Clinical cures (absence of vulval and vaginal signs and/or symptoms) were comparable for the two treatment groups at visit 2 (69% for butoconazole and 82% for econazole) and also at visit 3 (80% for butoconazole and 83% for econazole). Therapeutic cures (simultaneous clinical and microbiologic cures) were numerically but not statistically superior for butoconazole at visit 2 (62% versus 48%) and at visit 3 (80% versus 58%). No serious adverse events were reported or observed with the use of either drug.