Abstract
Objectives: To compare efficacy, safety and patient preference of a single oral dose of 150 mg fluconazole with a single intravaginal dose of 1200 mg miconazole in vaginal candidosis. To investigate the effect of treatment on Candida colonization of throat and rectum.
Design: Double-blind, double-dummy, parallel, randomized trial. Ninety-nine patients with symptomatic and mycologically verified candidosis were given 150 mg fluconazole with an intravaginal dummy, or 1200 mg miconazole with an oral dummy. Patients with an inadequate short-term response were given a second dose.
Results: At each visit a patient self assessment and an invesigators’ global assess- ment were recorded, and cultures were set up. Adverse events were recorded and laboratory tests were performed. Clinical cure or improvement (investigators’ assessment) was obtained in 100% (short-term) and 95% (long term) of the fluconazole group and in 94% and 90%. respectively, of the miconazole group.
Patients considered the treatment excellent or good in 81 % (short-term) and 88% (long-term) in the fluconazole group and in 84% and 76%, respectively, of the miconazole group.
Mycological cure was achieved in 98% (short-term) and 73% (long-term) of the fluconazole group and in 96% and 82% respectively in the miconazole group. The differences in results were not significant.
Both treatments significantly reduced the number of positive rectal cultures; neither treatment had a significant effect on throat cultures. Four percent of the patients preferred intravaginal therapy.
Conclusion: A single dose fluconazole is as safe and effective as a single dose of miconazole.