P O-Prasertsawat1, A Bourlert. 1. Department of Obstetrics and Gynecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Abstract
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.
RCT Entities:
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.
Entities:
Keywords:
Asia; Bacterial And Fungal Diseases; Candidiasis; Clinical Research; Comparative Studies; Developing Countries; Diseases; Drugs--administraction and dosage; Infections; Research Methodology; Research Report; Southeastern Asia; Studies; Thailand; Treatment
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