OBJECTIVE--To determine whether treatment of the sexual partners of women with chronic vulvovaginal candidiasis with oral ketoconazole can reduce the recurrence rate of candida vaginitis. DESIGN--Single blind randomised study where all the women were treated with ketoconazole 400 mg daily for 7 days after an acute episode of candida vaginitis and half the male partners were treated with ketoconazole 200 mg daily for 5 days. SETTING--Women's Candida Clinic of St. Michael's Hospital, a University of Toronto teaching Hospital, Toronto, Ontario, Canada. SUBJECTS--Fifty-four women attending the clinic with at least four proven episodes of candida vaginitis and their male sex partners (stable monogamous relationships) were enrolled in the study. MAIN OUTCOME MEASURES--Clinical recurrence of candida vaginitis with confirmation by smear and culture. Follow-up was obtained one to two weeks after initial treatment, then monthly for one year. RESULTS--In the control group (untreated partners), 20 of 28 (71%) patients had recurrences in six months, versus 17 of 26 (65%) patients in the treated group (treated partners) (95% Confidence Interval (CI) for the difference in recurrence rate = -19% to 31%). At one year, 23 of 28 (82%) patients in the control group had recurrences, versus 22 of 26 (85%) in the treated group (CI = -23% to 17%). CONCLUSION--Treatment of the male partners, with a brief course of ketoconazole, is not of value in reducing the incidence of relapse in women with recurrent vaginal candidiasis. It is unlikely that a larger study would show a clinical important difference.
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