Suppressive Antibacterial Therapy with 0.75% Metronidazole Vaginal Gel to Prevent Recurrent Bacterial Vaginosis.
From: Department of Medicine, Wayne State University School of Medicine, Detroit, MI, USA.
American journal of obstetrics and gynecology
- Publish Date: May 2006
- ISSN: 1097-6868
- Volume: 194
- Issue: 5
- Pages: 1283-9
- Medium: Internet
- Language: English
- Citation (JAMA): Sobel Jack D, Ferris Daron, Schwebke Jane, et al. Suppressive Antibacterial Therapy with 0.75% Metronidazole Vaginal Gel to Prevent Recurrent Bacterial Vaginosis.. Am. J. Obstet. Gynecol. May 2006;194:1283-9
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.
Mesh Headings (Keywords): Administration, Intravaginal, Adult, Anti-Bacterial Agents, Double-Blind Method, Drug Administration Schedule, Female, Follow-Up Studies, Gels, Gentian Violet, Humans, Metronidazole, Middle Aged, Phenazines, Recurrence, Risk Factors, Staining and Labeling, Treatment Outcome, Vaginosis, Bacterial
Check for Full Text / PubMed Unique Identifier (PMID): 16647911
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