NEW YORK, April 28 (Reuters) -- An oral antibiotic that can be taken once daily may offer women a more rapid cure for bacterial vaginosis than do topical creams, according to a new study funded by the drug's manufacturer.
The drug, metronidazole (or Flagyl), may also help combat bacteria that has spread from the vagina into the uterus and fallopian tubes, unlike creams that are effective only in the vagina, according to Dr. James McGregor, a professor of obstetrics and gynecology at the University of Colorado School of Medicine in Denver.
The once-a-day formulation of the drug, called Flagyl MR, is not yet approved by the FDA for treatment of bacterial vaginosis. Flagyl MR is currently being reviewed by the FDA for treatment of trichomoniasis, a sexually transmitted disease. Studies on bacterial vaginosis will be submitted to the FDA later this year, according to its manufacturer, Searle and Co., a Skokie, Illinois-based subsidiary of Monsanto.
Bacterial vaginosis is a common infection -- affecting one in six women -- that occurs when the normal bacteria found in the vagina are overrun with other organisms, such as Gardnerella vaginalis or E. coli. A variety of health complications may result.
"Bacterial vaginosis doubles the risk of preterm birth and premature rupture of membranes when you are pregnant," said McGregor. And in women who are not pregnant, "the presence of bacterial vaginosis is abnormal. Not only is it associated with increased discharge and odor, but increased evidence of infection of lining of the womb called endometritis and salpingitis -- which is infection of the fallopian tubes," he said. In one study, those with bacterial vaginosis had nine times the risk of pelvic inflammatory disease, an infection that increases the risk of infertility.
"So this bacterial vaginosis goes along with chlamydia, gonorrhea and other anaerobic bacteria as a cause of ascending reproductive tract infection," he said. "It can be screened for and treated and prevented just like chlamydia."
McGregor and colleagues studied 709 women, aged 16 to 68, with bacterial vaginosis and found that more than half, or 58%, of those taking the oral drug metronidazole for five to seven days were cured of the bacterial infection a week after treatment. In contrast, only 32% of those using clindamycin vaginal cream were cured of the infection a week after treatment. The report was presented Saturday at the International Infectious Disease Society for Obstetrics and Gynecology meeting in Las Vegas.
However, a month after completion of treatment the cure rates were similar: 67% to 74% of women who had taken metronidazole had normal bacteria in the vagina, compared to 63% who had used clindamycin.
The risk of bacterial vaginosis is higher in women who smoke, have multiple sex partners, who use products such as tampons or douches, or who have taken antibiotics to treat other conditions.
"Overall, a good acronym to remember is STP -- screen, treat, and prevent this and other and reproductive tract infections," he said. Using condoms and limiting sex partners can help, McGregor said.
