Metronidazole gel bests placebo for recurrent BV: ongoing study.(Gynecology)

PLAYA HERRADURA, COSTA RICA -- Women with bacterial vaginosis treated with vaginal metronidazole gel had a lower recurrence rate and prolonged time to recurrence compared with those on placebo, according to initial results of an ongoing study.

Recurrent bacterial vaginosis (BV) should be distinguished from refractory BV. The refractory condition is more rare, occurring in an estimated 10%-20% of women with BV in studies that use Amsel criteria to define clinical failure. "As clinicians, we occasionally see patients who are refractory and have persistent symptoms--these are uncommon cases," Dr. Jack D. Sobel said at a conference on vaginitis sponsored by Imedex.

Recurrent BV implies an initial clinical response and is defined as at least three episodes in 12 months separated by asymptomatic periods. There is no consensus on the prevalence of recurrent vaginosis in the literature. "There are different rates in different studies, but suffice it to say that recurrent bacterial vaginosis is a major problem," said Dr. Sobel, professor and chief, division of infectious diseases, Wayne State University School of Medicine, Detroit.

Encouraged by the success of 0.75% metronidazole vaginal gel in a small pilot study (one of six women using the gel failed to respond during 3 months of treatment, compared with four of six women using a placebo), Dr. Sobel launched a randomized, controlled trial to assess the suppressive action of metronidazole gel.

A total of 157 women were enrolled in the study. The women applied 5 g metronidazole gel at bedtime during a 10-day, open-label evaluation.

The subjects' mean age was 29.5 years: 74% were African American, 22% were white, and 4% were from other racial groups.

Their ...