Background: The introduction of the triazole antifungal agent fluconazole, which can be used via an oral route and single dose, has had a significant impact on patient compliance.
Goal of this study: To compare the efficacy and safety of a single oral dose of 150 mg fluconazole with that of a 100-mg clotrimazole vaginal suppository twice a day in the morning and at bedtime for 3 days in the treatment of vulvovaginal candidiasis.
Study design: A single-blind, randomized controlled trial was conducted at Ramathibodi Hospital between June 1 and September 30, 1993.
Results: There were 53 women in the group treated with fluconazole and 50 in the group treated with clotrimazole. There was no significant difference between the two groups regarding clinical characteristics (age and length of follow-up period). Mycological cure rates approximately 1 week after treatment were 79.2% in the fluconazole group and 80.0% in the clotrimazole group. Approximately 4 weeks after treatment, these rates were 60.4% and 66.0%, respectively. The side effects were minimal and did not warrant any treatment. The differences in the results were not statistically significant.
Conclusion: We recommend that a single oral dose of 150 mg of fluconazole be given as an alternative method of treating vulvovaginal candidiasis, but the cost is higher than for clotrimazole.
PIP: The efficacy and safety associated with use of a single oral dose of 150 mg of fluconazole compared to administration of a 100 mg clotrimazole vaginal suppository twice a day for three days in the treatment of vulvovaginal candidiasis were investigated. Involved in the prospective, double-blind, controlled trial conducted at a Bangkok hospital were 103 women with a confirmed diagnosis of vulvovaginal candidiasis who were randomly assigned to a treatment group. Self-assessed clinical improvement was obtained within 1 week in 88.7% of women in the fluconazole group and 90.0% of those in the clotrimazole group. The mycologic cure rate at the 1-week follow-up visit was 79.2% in the fluconazole group and 80.0% in the clotrimazole group; at 4 weeks, these rates were 60.4% and 68.0%, respectively. 3 (5.7%) fluconazole users experienced nausea and 1 (1.9%) reported dizziness, while 11 (22.0%) clotrimazole acceptors had vaginal burning. This study suggests that fluconazole is equally as effective as the traditionally used antifungal agent clotrimazole. Although the former drug has the advantages of oral administration, single dosage, and minimal side effects, it is more expensive.