A comparison of single-dose oral fluconazole with 3-day intravaginal clotrimazole in the treatment of vaginal candidiasis. Report of an international multicentre trial.

A total of 369 women with clinical and mycological evidence of vaginal candidiasis received treatment, after random allocation, with either a single oral 150-mg dose of fluconazole (188 women) or 200 mg of intravaginal clotrimazole given daily for 3 consecutive days (181 women). They were assessed at 5-16 days and again at 27-62 days after treatment. Candida species were completely eradicated from the vagina in 72% of the fluconazole group and in 62% of the clotrimazole group at the long-term assessment (P = 0.07). Favourable clinical responses were obtained in 99% of the fluconazole group and in 97% of the clotrimazole group at the short-term assessment and in 93% and 84% respectively at the long-term assessment when there was a significant advantage for fluconazole treatment (P = 0.02). Symptoms in patients receiving fluconazole were relieved more rapidly (P less than 0.001). Treatment-related side-effects were few and minor in both groups. It is concluded that treatment of vaginal candidiasis with fluconazole, as a single oral dose, was more effective in the long term, relieved symptoms more rapidly, and was as safe as treatment with intravaginal clotrimazole.

RCT Entities:   Population Interventions Outcomes