SANTA FE, N.M. – Treatment of bacterial vaginitis with tinidazole at 500 mg twice a day for 7 days was not significantly more efficacious than the standard dose of metronidazole, results from a single-center study demonstrated.
“BV is extremely common and has associated complications, but the therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV,” Dr. Jane R. Schwebke said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “Tinidazole was licensed in the U.S. for BV based on a placebo controlled study, so we really have no data to compare the efficacy of tinidazole for the treatment of BV ... with metronidazole.”
In what she described as the first study of its kind, Dr. Schwebke and her associates randomized 593 women with symptomatic BV who attended an STD clinic in Birmingham, Ala., over 4 years to one of three regimens: metronidazole 500 mg b.i.d. for 7 days, tinidazole 500 mg b.i.d. for 7 days, or tinidazole 1 g b.i.d. for 7 days. The researchers conducted follow-up visits at 14 and 28 days and then monthly for two additional visits. Cure was defined as a Nugent score of less than 7 among any of the treatment groups.
The mean age of the study participants was 28 years and most (92%) were black. Dr. Schwebke, professor of medicine at the University of Alabama, Birmingham, reported that there were no statistically significant differences between the cure rates at the day-14 visit or at the day-28 visit among any of the treatment groups. Cure rates at the day 14 visit for the metronidazole, tinidazole 1 g b.i.d., and tinidazole 500 mg b.i.d. were 82%, 73%, and 73%, respectively, while the cure rates at the day 28 visit were 64%, 68%, and 62%.
“Interestingly, neither baseline Nugent score, consistent use of condoms, sex with a new partner, nor sex with multiple partners were associated with treatment outcome,” Dr. Schwebke said. “However, women who engaged in sex during the study were more likely to have BV at follow-up, which has been a consistent finding among most studies of late.”
The side effect profiles were similar among treatment groups, with the most common side effects being yeast infections, nausea/vomiting, and a bad taste in the mouth.
The study was funded by the National Institute of Allergy and Infectious Diseases. Mission Pharmacal Co. provided the tinidazole.
Dr. Schwebke said that she had no relevant financial disclosures to make.