General Obstetrics and Gynecology: Gynecology
Suppressive antibacterial therapy with 0.75% metronidazole vaginal gel to prevent recurrent bacterial vaginosis

https://doi.org/10.1016/j.ajog.2005.11.041Get rights and content

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.

Section snippets

Methods

Eligible women with a current symptomatic bacterial vaginosis infection (≥3 signs Amsel criteria) and a history of at least 2 previous episodes of bacterial vaginosis in the past year were enrolled in the open-label treatment phase of the study.17 A positive Amsel requires the presence of at least 3 or 4 signs or examination—homogenous vaginal discharge, vaginal pH greater than 4.5, amine odor, and clue cells.17 All women were treated with 0.75% metronidazole gel, 5 gm intravaginally at bedtime

Results

A total of 157 eligible women were enrolled in the metronidazole vaginal gel open-label treatment study at 7 US clinical care sites between June 2000 and January 2003. Of these, 131 (83%) participants returned for evaluation after completion (3-5 days post) of open-label treatment. Of 127 returning and evaluable women, 112 (88.2%) had responded clinically to treatment (asymptomatic and ≤2 signs Amsel criteria) and were randomly assigned to receive maintenance therapy with metronidazole vaginal

Comment

Previously considered a nuisance infection, there is now widespread recognition that bacterial vaginosis is associated with a growing list of major morbidities, especially preterm labor, prematurity, acquisition of sexually transmitted infections, and enhanced HIV transmission.2, 3, 4, 5, 6, 7, 8, 9, 10, 11 To nongravid women, the greatest concern relates to the propensity for symptomatic infection to recur frequently.1, 14, 15, 16 Recurrence rates are estimated to be as high as 30% at 3 months

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  • Cited by (0)

    Supported by an educational grant from 3M Pharmaceuticals, St. Paul, MN.

    Reprints not available from the authors.

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