A new vaginal antifungal agent--butoconazole nitrate.

The continuously increasing incidence of vulvovaginal candidiasis necessitated a search for novel therapeutic modalities. Butoconazole nitrate (BN) a new imidazole, has been singled out for clinical studies since, in experimental vaginal candidiasis, it proved more effective than either miconazole nitrate (MN) or clotrimazole. One hundred and thirty volunteers with vaginal candidiasis, verified by wet mount and positive fungal culture, were randomly assigned to receive daily, for 6 days, either 1% BN (44 patients), or 2% BN (45 patients) vaginal cream or 2% MN (41 patients) vaginal cream. The patients were comparable regarding age (85% were 18-39 years of age), gravidity and parity. Twenty-five per cent had a recent history of unsuccessfully treated fungal vaginitis. Eight days after completion of treatment, negative fungal cultures were found in 98% of the patients using 2% BN, in 91% of patients using 1% BN and in 83% using 2% MN. The recurrence rate of the disease was low; about 80% of patients using 1% and 2% BN and 68% of those using 2% MN were culture-negative 30 days after conclusion of treatment. Rapid relief of clinical symptoms was experienced by patients in all three treatment groups. No significant side effects of the treatment were observed in any of the treatment groups.

RCT Entities:   Population Interventions Outcomes