Efficacy of clindamycin vaginal cream versus oral metronidazole in the treatment of bacterial vaginosis.

Author(s): Fischbach F, Petersen EE, Weissenbacher ER, Martius J, Hosmann J, Mayer H

Affiliation(s): Frauenklinik, TU Munchen, Germany.

Publication date & source: 1993-09, Obstet Gynecol., 82(3):405-10.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVE: To compare the efficacy and tolerance with 2% clindamycin vaginal cream versus oral metronidazole for the treatment of bacterial vaginosis. METHODS: This was a multicenter, randomized, double-blind study 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 (twice a day for 7 days) or metronidazole 500 mg (two 250-mg capsules orally twice a day for 7 days) plus placebo vaginal cream (5 g intravaginally 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 investigators, four in Germany, two in Austria, and one in Switzerland, enrolled 407 patients. Four patients never received either protocol drug, 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-related adverse medical events was approximately 12% in both groups. CONCLUSIONS: Oral metronidazole and intravaginal clindamycin cream had a similar efficacy of 78 to 83%. Both drugs were tolerated, with vaginal candidiasis developing in 8.5 and 4.7% of the patients in the clindamycin and metronidazole groups, respectively.