PLACEBO-CONTROLLED TRIAL OF INTRAVAGINAL CLINDAMYCIN 2-PERCENT CREAM FOR THE TREATMENT OF BACTERIAL VAGINOSIS

OBJECTIVE: To compare the safety and efficacy of intravaginal clindamy cin 2% cream with placebo in nonpregnant women with bacterial vaginosi s. DESIGN: A randomized, double-blind, placebo-controlled clinical tri al. SETTING: Ambulatory patients in the general community. PATIENTS: T wo hundred fifteen nonpregnant outpatients with a diagnosis of bacteri al vaginosis were entered into this study. Of the 134 evaluable patien ts, 65 received clindamycin and 69 placebo. Demographic parameters wer e comparable between the two treatment groups. INTERVENTION: Study sub jects were equally randomized to receive either 5 g of clindamycin 2% vaginal cream or placebo cream for seven nights. MAIN OUTCOME MEASURES : Clinical and microbiologic follow-up evaluations were scheduled for 5-10 days and 25-39 days posttreatment. Patients were interviewed abou t signs and symptoms, adverse events, and compliance. Diagnostic exami nations were performed. RESULTS: Clinical success rates (cure and impr ovement) occurred in 50 of 65 patients who received clindamycin (77 pe rcent) and 17 of 69 patients who received placebo (25 percent) by the first posttreatment visit (p<0.001). Microbiologic cures or improvemen t were observed in 59 of the 65 patients treated with clindamycin (91 percent) compared with 20 of 69 placebo-treated patients (29 percent) (p<0.001). At the end of the study, clinical and microbiologic cures o r improvement were evident in 45 of 57 (79 percent) and 37 of 57 clind amycin-treated patients (65 percent), respectively, and 18 of 51 (35 p ercent) and 14 of 51 (28 percent) of the placebo-treated patients, res pectively. The success rates with clindamycin 2% cream were statistica lly higher than those with placebo. The adverse-effect profiles in the two groups were similar and no serious adverse effects were reported. Patients who received clindamycin had a statistically higher incidenc e of nonbacterial vaginitis/cervicitis (18.5 vs. 7.5 percent, p=0.003) . CONCLUSIONS: Intravaginal clindamycin 2% cream appears to be an effe ctive and safe treatment of symptomatic bacterial vaginosis in nonpreg nant women.