Fluconazole 150 mg single dose versus itraconazole 200 mg per day for 3 days in the treatment of acute vaginal candidiasis: a double-blind randomized study.

Author(s): De Punzio C, Garutti P, Mollica G, Nappi C, Piccoli R, Genazzani AR

Affiliation(s): Dipartimento di Medicina della Procreazione e dell'Eta Evolutiva, Divisione di Ginecologia ed Ostetricia, Universita degli Studi di Pisa, via Roma, 67-56100 Pisa, Italy.

Publication date & source: 2003-02-10, Eur J Obstet Gynecol Reprod Biol., 106(2):193-7.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVE: To compare the safety and efficacy of fluconazole 150mg single dose and itraconazole 200mg per day for 3 days in the treatment of the acute episode of vulvovaginal candidiasis (VVC). METHODS: Double-blind randomized study conducted in three University centers. Patients with acute clinically and mycologically confirmed VVC were enrolled. RESULTS: A total of 86 patients were enrolled; of them, 38 fluconazole and 32 itraconazole patients were evaluable. At the Day 7 visit, all but one fluconazole patients were cured or improved with eradication of the baseline pathogen obtained in all but two itraconazole patients. At the Day 21 visit, a 13% relapse rate was observed in both groups with all other patients cured or improved; eradication rates were 76% for fluconazole and 66% for itraconazole. Global symptom scores (GSS) were significantly more severe at baseline in fluconazole patients (P=0.003). Nevertheless, the slope of the GSS decrease between baseline and Day 7 was similar for both groups whilst GSS were identical at the last visit. Nineteen fluconazole patients reported 31 adverse events and 15 itraconazole patients reported 30 adverse events. CONCLUSIONS: Both oral antifungal treatments showed good clinical and mycological efficacy on the acute episode of VVC with a dramatic decrease of signs and symptoms 7 days after treatment initiation. Fluconazole in single dose warrants optimal compliance in patients who frequently experience more than one episode of VVC.