In a prospective, placebo-controlled study, 74 women with recurrent
vulvovaginal candidiasis were treated with oral
ketoconazole (400 mg daily for two weeks) and were then randomly assigned to receive placebo (Group A), prophylactic
ketoconazole, 400 mg daily for five days beginning with the onset of menses for six menstrual cycles (Group B), or low-dose
ketoconazole, 100 mg daily for six months (Group C). Within a six-month follow-up period, 15 of 21 women (71.4 percent) treated with placebo had symptomatic recurrence of candidal
vaginitis. In contrast, candidal
vaginitis recurred in 6 of 21 (28.6 percent) and in 1 of 21 (4.8 percent) women in Groups B and C (P less than 0.01; P less than 0.001). After the prophylaxis was discontinued, the recurrence rates of candidal
vaginitis were high in women in Groups B and C. At the end of 12 months of follow-up, 23.8 percent of the women in Group A remained asymptomatic and attack-free, in contrast to 42.9 percent of the women in Group B (P greater than 0.05) and 52.4 percent in Group C (P less than 0.05). It appears that maintenance prophylactic
therapy with oral
ketoconazole is effective in preventing recurrent episodes of
vulvovaginal candidiasis, but that relapse is common after withdrawal of the
drug. Because of the risk of hepatotoxicity, caution is essential in selecting patients for long-term
ketoconazole therapy and in following patients undergoing such treatment.