I W Fong1. 1. Department of Medicine, St Michael's Hospital, University of Toronto, Ontario, Canada.
Abstract
OBJECTIVE: To determine the comparative efficacy of oral itraconazole versus intravaginal clotrimazole in suppressing recurrent episodes of vulvovaginal candidiasis. DESIGN: Prospective randomised open study of women with recurrent vulvovaginal candidiasis. Clinical and microbiological assessments were made monthly for 12 months. SETTING:Women's Clinic of a University teaching hospital. SUBJECTS:Forty-four otherwise healthy, non-pregnant women, with at least four proven episodes of candida vaginitis in the last year were enrolled into the study. INTERVENTION: After an acute episode of candida vaginitis, 22 women received oral itraconazole 200 mg daily for five days, then 200 mg twice weekly for six months; and 22 women received intra-vaginal clotrimazole 200 mg ovules daily for five days, then 200 mg twice weekly for six months. MAIN OUTCOME MEASURES: Symptomatic recurrent clinical vulvovaginal candidiasis during the first six months of suppressive therapy was the major endpoint. A secondary endpoint was recurrent candida vaginitis within six months after completion of therapy. RESULTS: Six patients did not complete the study, one in the itraconazole group and five in the clotrimazole group. Of the evaluable patients, seven of 21 patients (33.3%) in the itraconazole group versus none (0%) of 17 patients on clotrimazole were failures on suppressive therapy, p = 0.02. Following discontinuation of suppressive therapy, recurrences of candida vaginitis were similar, 10 (47.6%) of patients on itraconazole (95% confidence interval (CI) 27-67%), versus 11 (64%) patients on clotrimazole (CI 41-87%), p = 0.15. CONCLUSION: Intermittent suppressive therapy with clotrimazole was more effective than itraconazole in preventing recurrent candida vaginitis, provided patients adhered to the regimen. Recurrence of vaginitis was common with both regimens after stopping suppressive therapy.
RCT Entities:
OBJECTIVE: To determine the comparative efficacy of oral itraconazole versus intravaginal clotrimazole in suppressing recurrent episodes of vulvovaginal candidiasis. DESIGN: Prospective randomised open study of women with recurrent vulvovaginal candidiasis. Clinical and microbiological assessments were made monthly for 12 months. SETTING:Women's Clinic of a University teaching hospital. SUBJECTS: Forty-four otherwise healthy, non-pregnant women, with at least four proven episodes of candida vaginitis in the last year were enrolled into the study. INTERVENTION: After an acute episode of candida vaginitis, 22 women received oral itraconazole 200 mg daily for five days, then 200 mg twice weekly for six months; and 22 women received intra-vaginal clotrimazole 200 mg ovules daily for five days, then 200 mg twice weekly for six months. MAIN OUTCOME MEASURES: Symptomatic recurrent clinical vulvovaginal candidiasis during the first six months of suppressive therapy was the major endpoint. A secondary endpoint was recurrent candida vaginitis within six months after completion of therapy. RESULTS: Six patients did not complete the study, one in the itraconazole group and five in the clotrimazole group. Of the evaluable patients, seven of 21 patients (33.3%) in the itraconazole group versus none (0%) of 17 patients on clotrimazole were failures on suppressive therapy, p = 0.02. Following discontinuation of suppressive therapy, recurrences of candida vaginitis were similar, 10 (47.6%) of patients on itraconazole (95% confidence interval (CI) 27-67%), versus 11 (64%) patients on clotrimazole (CI 41-87%), p = 0.15. CONCLUSION: Intermittent suppressive therapy with clotrimazole was more effective than itraconazole in preventing recurrent candida vaginitis, provided patients adhered to the regimen. Recurrence of vaginitis was common with both regimens after stopping suppressive therapy.
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