The value of prophylactic (monthly) clotrimazole versus empiric self-treatment in recurrent vaginal candidiasis.

OBJECTIVE To determine the comparative efficacy and cost benefit of prophylactic monthly (perimenstrual) clotrimazole, versus empiric self-treatment with the same agent at the onset of symptoms in recurrent vulvovaginal candidiasis. DESIGN Prospective, randomised, open cross-over study of women with proven recurrent vulvovaginal candidiasis. Clinical and microbiological assessments were done every two months for 12 months. SETTING Women's Clinic of a University Teaching Hospital. SUBJECTS Twenty-three otherwise healthy, non-pregnant women with greater than four proven episodes of candida vaginitis in the last year were enrolled into the study. INTERVENTION Patients were randomised to receive: (1) a single dose of prophylactic clotrimazole 500 mg ovule just before or on the last day of the menses each month for 6 months; (2) or a single dose of clotrimazole 500 mg ovule empirically at the onset of symptoms for 6 months. After the first 6 months patients were crossed-over to the opposite regimen. MAIN OUTCOME MEASURES Symptoms of recurrent vulvovaginitis during each period, and number of clotrimazole ovules used for each 6 month period. The personal preference of the patients for the two different regimens were assessed at the end of study. RESULTS During the prophylactic 6 months period of the study, 23 patients had 50 episodes of symptomatic vaginitis (mean 2.2 episodes per patient), versus 86 episodes (mean 3.7 episodes/patient) during the empiric self-treatment 6 months period (P = 0.05). However, during the prophylactic period a total of 168 clotrimazole ovules were used (mean 7.3 per patient), versus 84 ovules (mean 3.6 per patient) during the empiric self-treatment period, p < 0.001. The personal preference of the patients for the type of regimen employed were 17 (73.9%) in favour of the empirical treatment, versus 4 (17.4%) in favour of the prophylactic treatment and 2 (8.7%) no personal preference, p < 0.01. CONCLUSION Empiric self-treatment is more cost-effective and preferable to patients than cyclical monthly prophylactic use of 500 mg clotrimazole vaginal ovules.