THE VALUE OF PROPHYLACTIC (MONTHLY) CLOTRIMAZOLE VERSUS EMPIRIC SELF-TREATMENT IN RECURRENT VAGINAL CANDIDIASIS

Objective-To determine the comparative efficacy and cost benefit of pr ophylactic monthly (perimenstrual) clotrimazole, versus empiric self-t reatment with the same agent at the onset of symptoms in recurrent vul vovaginal candidiasis. Design-Prospective, randomised, open cross-over study of women with proven recurrent vulvovaginal candidiasis. Clinic al and microbiological assessments were done every two months for 12 m onths. Setting-Women's Clinic of a University Teaching Hospital. Subje cts-Twenty-three otherwise healthy, non-pregnant women with greater th an four proven episodes of candida vaginitis in the last year were enr olled into the study. Intervention-Patients were randomised to receive : (1) a single dose of prophylactic clotrimazole 500 mg ovule just bef ore 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 recurr ent vulvovaginitis during each period, and number of clotrimazole ovul es used for each 6 month period. The personal preference of the patien ts for the two different regimens were assessed at the end of study. R esults-During the prophylactic 6 months period of the study, 23 patien ts had 50 episodes of symptomatic vaginitis (mean 2.2 episodes per pat ient), versus 86 episodes (mean 3.7 episodes/patient) during the empir ic self-treatment 6 months period (P = 0.05). However, during the prop hylactic period a total of 168 clotrimazole ovules were used (mean 7.3 per patient), versus 84 ovules (mean 3.6 per patient) during the empi ric self-treatment period, p < 0.001. The personal preference of the p atients for the type of regimen employed were 17 (73.9%) in favour of the empirical treatment, versus 4 (17.4%) in favour of the prophylacti c treatment and 2 (8.7%) no personal preference, p < 0.01. Conclusion- Empiric self-treatment is more cost-effective and preferable to patien ts than cyclical monthly prophylactic use of 500 mg clotrimazole vagin al ovules.