Suppressive antibacterial therapy with 0.75% metronidazole vaginal gel to prevent recurrent bacterial vaginosis.

Abstract

OBJECTIVE:

Efficacy study of suppressive vaginal metronidazole in reducing recurrent symptomatic episodes of bacterial vaginosis.

STUDY DESIGN:

Multicenter prospective study with initial 10-day open-label metronidazole gel in which asymptomatic responders randomly assigned to receive twice weekly metronidazole vaginal gel or placebo for 16 weeks and off therapy for 12 weeks.

RESULTS:

Of 157 eligible women with recurrent bacterial vaginosis, 112 of 127 returning evaluable women (88.2%) responded clinically and were randomly assigned. During suppressive therapy, recurrent bacterial vaginosis occurred in 13 women (25.5%) receiving metronidazole and 26 (59.1%) receiving placebo (MITT analysis, relative risk [RR] 0.43, CI = 0.25-0.73, P = .001). During the entire 28-week follow-up, recurrence occurred in 26 (51.0%) on treatment compared with 33 (75%) on placebo (RR 0.68, CI = 0.49-0.93, P = .02). Probability for remaining cured was 70% for metronidazole compared with 39% on placebo, which declined to 34% and 18%, respectively, by 28 weeks follow-up. Adverse effects were uncommon; however, secondary vaginal candidiasis occurred significantly more often in metronidazole-treated women (P = .02).

CONCLUSION:

Suppressive therapy with twice-weekly metronidazole gel achieves a significant reduction in the recurrence rate of bacterial vaginosis; however, secondary vaginal candidiasis is common.

• Authors: Jack D Sobel, Daron Ferris, Jane Schwebke, Paul Nyirjesy, Harold C Wiesenfeld, Jeffrey Peipert, David Soper, Suzanne E Ohmit, Sharon L Hillier
• Journal: American journal of obstetrics and gynecology (Am J Obstet Gynecol) Vol. 194 Issue 5 Pg. 1283-9 (May 2006) ISSN: 1097-6868 [Electronic] United States
• PMID: 16647911 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Gels
• Gram's stain
• Phenazines
• Metronidazole
• Gentian Violet

Topics

• Administration, Intravaginal
• Adult
• Anti-Bacterial Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Gels
• Gentian Violet
• Humans
• Metronidazole (administration & dosage, adverse effects, therapeutic use)
• Middle Aged
• Phenazines
• Risk Factors
• Secondary Prevention
• Staining and Labeling
• Treatment Outcome
• Vaginosis, Bacterial (diagnosis, etiology, prevention & control)