EFFICACY OF CLINDAMYCIN VAGINAL CREAM VERSUS ORAL METRONIDAZOLE IN THE TREATMENT OF BACTERIAL VAGINOSIS

Objective: To compare the efficacy and tolerance with 2% clindamycin v aginal cream versus oral metronidazole for the treatment of bacterial vaginosis. Methods: This was a multicenter, randomized, double-blind s tudy in which patients were randomly assigned to one of the following two regimens in a 1:1 ratio: clindamycin phosphate vaginal cream 2% (5 g intravaginally at bedtime for 7 days) plus two placebo capsules (tw ice a day for 7 days) or metronidazole 500 mg (two 250-mg capsules ora lly twice a day for 7 days) plus placebo vaginal cream (5 g intravagin ally at bedtime for 7 days). The patients were seen for follow-up at 5 -10 days and 25-39 days after completion of therapy. Results: Seven in vestigators, four in Germany, two in Austria, and one in Switzerland, enrolled 407 patients. Four patients never received either protocol dr ug, leaving 403 evaluable for safety. Two hundred thirty-four patients were evaluable for efficacy. The analysis for all evaluable patients showed no significant difference between treatment groups. The cure or improvement rate at 1 month after therapy was 83% in the clindamycin group versus 78% in the metronidazole group. The incidence of drug-rel ated adverse medical events was approximately 12% in both groups. Conc lusions: Oral metronidazole and intravaginal clindamycin cream had a s imilar efficacy of 78 to 83%. Both drugs were tolerated, with vaginal candidiasis developing in 8.5 and 4.7% of the patients in the clindamy cin and metronidazole groups, respectively.