Metronidazole gel prevents recurrences of bacterial vaginosis

Journal of Family Practice, August, 2006 by J.D. Sobel, D. Ferris, J. Schwebke

* Clinical Question

Does suppressive therapy with metronidazole intravaginal gel prevent recurrences of bacterial vaginosis?

* Bottom Line

Metronidazole gel used twice weekly reduces recurrences of bacterial vaginosis. However, the benefit was largely offset by an increase in vaginal candidiasis and pain complaints. (Level of evidence [LOE]=2b)

Study Design

Randomized controlled trial (double-blinded)

Funding

Industry

Allocation

Concealed

Setting

Outpatient (specialty)

Synopsis

A total of 112 women with a history of recurrent bacterial vaginosis who had responded to a course of treatment with 0.75% metronidazole vaginal gel were randomized to receive additional 5-g doses twice weekly or placebo as suppressive therapy for 28 weeks. They were then followed-up for an additional 28 weeks. Women were evaluated every 4 weeks using Amsel criteria and Nugent score. Fifteen percent of women did not return for any follow-up visit.

The probability of remaining cured was 70% for the treated group and 39% for the control group during active treatment, which declined to 34% and 18% during the follow-up period. The mean number of recurrences during the study year was 1.6 in the treated group and 3.2 in the control group.

There were 2 adverse effects that occurred more frequently in the treated group: vaginal candidiasis (43% vs 21%; P=.02; number needed to treat to harm [NNTH]=5) and complaints of head, low back, abdominal, or leg pain (28% vs 9%; P=.023; NNTH=5).

FAST TRACK

The mean number of recurrences of bacterial vaginosis was 1.6 in the treatment group and 3.2 in the placebo group

Sobel JD, Ferris D, Schwebke J, et al. Suppressive antibacterial therapy with 0.75% metronidazole vaginal gel to prevent recurrent bacterial vaginosis. Am J Obstet Gynecol 2006; 194:1283-1289.