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Vaginal Clindamycin and Oral Metronidazole for Bacterial Vaginosis: A Randomized Trial

From the Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland; Clinica Ostetrica e Ginecologica, Ospedale S. Gerardo di Monza, Milan, Italy; and Pharmacia & Upjohn, Kalamazoo, Michigan.

Address reprint requests to: Jorma Paavonen, MD Department of Obstetrics and Gynecology University of Helsinki Haartmaninkatu 2 00290 Helsinki Finland E-mail: jpaavone{at}cc.helsinki.fi

Objective: To compare the efficacy and safety of clindamycin vaginal ovules with oral metronidazole for treatment of bacterial vaginosis.

Methods: Women with bacterial vaginosis received either 100-mg ovules of clindamycin (intravaginally for 3 consecutive days) plus placebo capsules (orally twice daily for 7 days) or metronidazole 500 mg (two 250-mg capsules orally twice daily for 7 days) plus placebo ovules (intravaginally for 3 consecutive days). The sample was determined prospectively to provide a probability of .84 of correctly concluding that the rate of success for clindamycin is not more than 15% less than the expected 75% success rate for metronidazole. Clinical outcome was determined on the basis of vaginal fluid amine odor and clue cells.

Results: Of the 399 patients enrolled, 233 could be evaluated for efficacy. Of those, 77 (68.1%) of 113 patients were cured with clindamycin, compared with 80 (66.7%) of 120 who were cured with metronidazole (95% confidence interval -10.6%, 13.4%; P = .810). Treatment-related adverse events were reported more frequently in the metronidazole treatment group. Systemic symptoms, such as nausea and taste perversion, accounted for most of the difference between groups.

Conclusion: A 3-day regimen of clindamycin, given as intravaginal ovules, was as effective as and better tolerated than a 7-day regimen of oral metronidazole 500 mg, given twice daily, for treatment of bacterial vaginosis.