Recurrent vulvovaginal candidiasis. A prospective study of the efficacy of maintenance ketoconazole therapy

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.