OBJECTIVE: To evaluate the efficacy of one-day, intermittent, monthly prophylaxis with 400 mg itraconazole in the management of recurrent vulvovaginal candidiasis. STUDY DESIGN: In a randomized trial, 57 patients and 57 controls with recurrent vulvovaginal candidiasis were assigned either to receive one-day monthly itraconazole prophylaxis for six months or no treatment. Clinical and mycologic evaluations were carried out 3, 6 and 12 months after enrollment. RESULTS: During the first six months of follow-up, the rate of symptomatic recurrences was 36.4% (20/55) among the treated women and 64.2% (34/53) in the controls. The mean time +/- SEM to symptomatic recurrence was 149 +/- 6 days among patients receiving prophylaxis and 120 +/- 6 days in the controls (P = .003 by log-rank test). These differences disappeared almost completely after the cessation of intermittent prophylaxis. In fact, the proportion of patients still asymptomatic after one year of follow-up was 38.9% (21/54) among treated women and 28.8% (15/53) in the controls (P = .83 by Fisher's exact test). CONCLUSION: One-day monthly, intermittent itraconazole prophylaxis reduced the rate of recurrence in patients with recurrent vulvovaginal candidiasis, but the beneficial effect of itraconazole was lost within a few months after cessation of prophylaxis.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of one-day, intermittent, monthly prophylaxis with 400 mg itraconazole in the management of recurrent vulvovaginal candidiasis. STUDY DESIGN: In a randomized trial, 57 patients and 57 controls with recurrent vulvovaginal candidiasis were assigned either to receive one-day monthly itraconazole prophylaxis for six months or no treatment. Clinical and mycologic evaluations were carried out 3, 6 and 12 months after enrollment. RESULTS: During the first six months of follow-up, the rate of symptomatic recurrences was 36.4% (20/55) among the treated women and 64.2% (34/53) in the controls. The mean time +/- SEM to symptomatic recurrence was 149 +/- 6 days among patients receiving prophylaxis and 120 +/- 6 days in the controls (P = .003 by log-rank test). These differences disappeared almost completely after the cessation of intermittent prophylaxis. In fact, the proportion of patients still asymptomatic after one year of follow-up was 38.9% (21/54) among treated women and 28.8% (15/53) in the controls (P = .83 by Fisher's exact test). CONCLUSION: One-day monthly, intermittent itraconazole prophylaxis reduced the rate of recurrence in patients with recurrent vulvovaginal candidiasis, but the beneficial effect of itraconazole was lost within a few months after cessation of prophylaxis.