General Obstetrics and Gynecology: GynecologySuppressive antibacterial therapy with 0.75% metronidazole vaginal gel to prevent recurrent bacterial vaginosis
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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Supported by an educational grant from 3M Pharmaceuticals, St. Paul, MN.
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