The treatment of bacterial vaginosis with a 3 day course of 2% clindamycin cream: results of a multicentre, double blind, placebo controlled trial. B V Investigators Group.
OBJECTIVE
To evaluate the efficacy and safety of a 3 day course of intravaginal clindamycin 2% cream for the treatment of bacterial vaginosis.


METHODS
A prospective, randomised, double-blind placebo controlled study.


METHODS
Departments of genitourinary medicine at Birmingham, Nottingham, Liverpool, Swansea, Leeds, Walsall, Stoke Mandeville, Southampton, Plymouth, Bishop's Stortford and Glasgow.


METHODS
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.


CONCLUSIONS
We conclude that a 3 day course of clindamycin 2% cream is an effective, and well tolerated treatment for bacterial vaginosis.
Ahmed-Jushuf
I H
IH
Department of Genitourinary Medicine, Nottingham City Hospital.
Shahmanesh
M
M
Arya
O P
OP
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000617:Aminoglycosides; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002981:Clindamycin / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D009824:Ointments; D011446:Prospective Studies; D016896:Treatment Outcome; D016585:Vaginosis, Bacterial / Q000188:drug therapy*
D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D009824:Ointments; D002981:Clindamycin