A comparison of fluconazole and ketoconazole in the oral treatment of vaginal candidiasis; report of a double-blind multicentre trial.

One hundred and eighty three patients with vaginal candidiasis were randomly allocated to treatment with either fluconazole in a single oral 150 mg dose, or ketoconazole, 200 mg twice daily for 5 days. Favourable clinical responses were obtained in 92% of the patients in the fluconazole group and in 89% of those in the ketoconazole group after 5-16 days. Long-term evaluation at 27-62 days showed favourable clinical responses in 86 and 88%, respectively. Candida was eradicated from the vagina in 77% of both treatment groups at the long-term evaluation. The relapse or reinfection rate was similar for both groups, ranging between 4-8%. One hundred and thirty two of the 160 patients who had rectal swabs cultured for yeast at baseline, gave positive results. Of the 27 patients in the fluconazole group whose rectal cultures remained negative at the long-term evaluation, 26 maintained mycological cure of their vaginal candidiasis. In contrast, patients with positive rectal cultures at this time were much less frequently associated with mycological cure. The results were similar for the patients in the ketoconazole group. Treatment-related side effects in both groups were few and minor. This double-blind multicentre study showed that a single oral 150 mg dose of fluconazole was as effective as 5 days of oral ketoconazole medication in the treatment of vaginal candidiasis.