Single-dose 500-mg clotrimazole vaginal tablets compared with placebo in the treatment of Candida vaginitis.

In a double-blind controlled clinical trial, 29 practitioners randomized 55 women with culture-proven Candida vaginitis to treatment with single-dose 500-mg clotrimazole vaginal tablets, and 40 to placebo. At a follow-up visit 7 to 10 days after treatment, Candida was present in 21 (38%) of those treated with clotrimazole and in 30 (75%) in the placebo group (P less than .05). Symptoms had improved or disappeared in 38 (69%) treated with clotrimazole, compared with 22 (55%) in the placebo group (P greater than .05). In 10 (23%) of the mycologically cured women, symptoms were unchanged or worse, whereas symptoms had improved or disappeared in 26 (51%) in whom Candida was isolated at the follow-up visit (P = .015). Questionnaires sent to the 95 women 4 weeks after the follow-up visit were returned by 62. Vaginal symptoms were reported by 50% in both groups. Further clinical trials including placebo are needed in general practice in the evaluation of the treatment of Candida vaginitis.