Vaginitis, most often due to bacterial vaginosis or Candida species, remains the most common reason for visiting a gynecologist. The diagnosis may be difficult because the clinical findings are not specific for different causative agents and because some of the responsible pathogens are part of the vaginal flora. This randomized, double-blind, controlled, multicenter trial compared Clo-Met, a vaginal tablet containing 100 mg each of clotrimazole and metronidazole, with clotrimazole alone in 165 women presenting with vaginal discharge who were diagnosed as having vaginitis caused by Trichomonas vaginalis, bacterial vaginosis, Candida albicans, or any combination of these agents. Participants had not been treated for vaginitis during the past month.
Eighty-four women taking part in this study were assigned to combined treatment and 81 to clotrimazole alone. The 2 groups were similar in age, educational level, and marital status. Women in both groups reported having had an average of about 5 past episodes of vaginitis. The only diagnosis made frequently enough to analyze was C. albicans vaginitis and, in these women, treatment with Clo-Met proved to be more effective than clotrimazole alone. The therapeutic cure rate, comprising both clinical and microbiologic cures, was 89.5% with Clo-Met and 64.7%, a statistically significant difference. Logistic regression analysis yielded an odds ratio for a beneficial response to Clo-Met 4.6 times greater than with clotrimazole alone. Among women with candidal growth at baseline, 83% of those given Clo-Met and 65.5% of those treated with clotrimazole alone had negative cultures 30 days after starting treatment. The patients, in general, regarded both treatments as being effective. One patient taking clotrimazole had a strong vaginal burning sensation that led her to discontinue medication.
The Clo-Met vaginal table appears to be an effective and safe treatment for vaginitis. In this trial, Clo-Met was significantly more effective than clotrimazole alone in eliminating C albicans infection.