OBJECTIVE: To evaluate the efficacy and safety of a 3 day course of intravaginal clindamycin 2% cream for the treatment of bacterial vaginosis. DESIGN: A prospective, randomised, double-blind placebo controlled study. SETTING: Departments of genitourinary medicine at Birmingham, Nottingham, Liverpool, Swansea, Leeds, Walsall, Stoke Mandeville, Southampton, Plymouth, Bishop's Stortford and Glasgow. SUBJECTS:Pre-menopausal women aged 18 years and over, who had symptomatic bacterial vaginosis were randomly allocated to receive either clindamycin 2% cream 5 grams (107 patients) ormatching placebo cream (114 patients), daily for three days. Response to therapy was assessed at 7 days (Visit 2) and 28 days (Visit 3). RESULTS:221 patients with symptomatic bacterial vaginosis were enrolled to the study and of these 141 (63.8%) completed the study. On the "intent-to-treat" (ITT) analysis, 75% of the clindamycin group were classified as "success" or "improved" at visit 2 compared with 13% of the placebo group (p < 0.001). At Visit 3, 41% of the clindamycin group were classified as either "success" or "improved" versus 4% in the placebo group (p < 0.001). Of the 80 patients who were recorded "success" or "improved" at visit 2, 20 (25%) were reported to have a "recurrence" of BV at Visit 3. The meta-analysis on those who were evaluable at Visit 2 and 3 also showed that clindamycin cream 2% was an effective treatment for bacterial vaginosis, and the differences between the clindamycin group and the placebo group were statistically significant. CONCLUSION: We conclude that a 3 day course of clindamycin 2% cream is an effective, and well tolerated treatment for bacterial vaginosis.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of a 3 day course of intravaginal clindamycin 2% cream for the treatment of bacterial vaginosis. DESIGN: A prospective, randomised, double-blind placebo controlled study. SETTING: Departments of genitourinary medicine at Birmingham, Nottingham, Liverpool, Swansea, Leeds, Walsall, Stoke Mandeville, Southampton, Plymouth, Bishop's Stortford and Glasgow. SUBJECTS: Pre-menopausal women aged 18 years and over, who had symptomatic bacterial vaginosis were randomly allocated to receive either clindamycin 2% cream 5 grams (107 patients) or matching placebo cream (114 patients), daily for three days. Response to therapy was assessed at 7 days (Visit 2) and 28 days (Visit 3). RESULTS: 221 patients with symptomatic bacterial vaginosis were enrolled to the study and of these 141 (63.8%) completed the study. On the "intent-to-treat" (ITT) analysis, 75% of the clindamycin group were classified as "success" or "improved" at visit 2 compared with 13% of the placebo group (p < 0.001). At Visit 3, 41% of the clindamycin group were classified as either "success" or "improved" versus 4% in the placebo group (p < 0.001). Of the 80 patients who were recorded "success" or "improved" at visit 2, 20 (25%) were reported to have a "recurrence" of BV at Visit 3. The meta-analysis on those who were evaluable at Visit 2 and 3 also showed that clindamycin cream 2% was an effective treatment for bacterial vaginosis, and the differences between the clindamycin group and the placebo group were statistically significant. CONCLUSION: We conclude that a 3 day course of clindamycin 2% cream is an effective, and well tolerated treatment for bacterial vaginosis.