THE TREATMENT OF BACTERIAL VAGINOSIS WITH A 3 DAY COURSE OF 2-PERCENTCLINDAMYCIN CREAM - RESULTS OF A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Objective-To evaluate the efficacy and safety of a 3 day course of int ravaginal clindamycin 2% cream for the treatment of bacterial vaginosi s. Design-A prospective, randomised, double-blind placebo controlled s tudy. Setting-Departments of genitourinary medicine at Birmingham, Not tingham, Liverpool, Swansea, Leeds, Walsall, Stoke Mandeville, Southam pton, Plymouth, Bishop)s Stortford and Glasgow. Subjects-Pre-menopausa l women aged 18 years and over, who had symptomatic bacterial vaginosi s were randomly allocated to receive either clindamycin 2% cream 5 gra ms (107 patients) or matching placebo cream (114 patients), daily for three days. Response to therapy was assessed at 7 days (Visit 2) and 2 8 days (Visit 3). Results-221 patients with symptomatic bacterial vagi nosis were enrolled to the study and of these 141 (63.8%) completed th e study. On the ''intent-to-treat'' (ITT) analysis, 75% of the clindam ycin group were classified as ''success'' or ''improved'' at visit 2 c ompared with 13% of the placebo group (p < 0.001). At Visit 3, 41% of the clindamycin group were classified as either ''(success)' or ''impr oved'' versus 4% in the placebo group (p < 0.001). Of the 80 patients who were recorded ''success'' or ''improved'' at visit 2, 20 (25%) wer e reported to have a ''recurrence'' of BV at Visit 3. The metaanalysis on those who were evaluable at Visit 2 and 3 also showed that clindam ycin cream 2% was an effective treatment for bacterial vaginosis, and the differences between the clindamycin group and the placebo group we re statistically significant. Conclusion-We conclude that a 3 day cour se of clindamycin 2% cream is an effective, and well tolerated treatme nt for bacterial vaginosis.