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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.

AbstractOBJECTIVE:
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.
AuthorsI H Ahmed-Jushuf, M Shahmanesh, O P Arya
JournalGenitourinary medicine (Genitourin Med) Vol. 71 Issue 4 Pg. 254-6 (Aug 1995) ISSN: 0266-4348 [Print] ENGLAND
PMID7590720 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Aminoglycosides
  • Anti-Bacterial Agents
  • Ointments
  • Clindamycin
Topics
  • Administration, Intravaginal
  • Adolescent
  • Adult
  • Aminoglycosides
  • Anti-Bacterial Agents (administration & dosage)
  • Clindamycin (administration & dosage)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Ointments
  • Prospective Studies
  • Treatment Outcome
  • Vaginosis, Bacterial (drug therapy)

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