A pilot study of treatment of bacterial vaginosis with a buffering vaginal microbicide

Background: Bacterial vaginosis (BV) is an extremely common problem for women and is associated with adverse pregnancy outcomes and HIV infection. Currently available antibiotic treatments are moderately effective but may need to be repeated frequently because of the recurrent nature of the disease. We undertook a pilot study of a buffering vaginal microbicide in the treatment of BV. Methods: Women with clinically diagnosed BV were recruited to receive seven applications (5 g per application) of BufferGel(TM) (ReProtect, LLC, Baltimore, MD), a topical vaginal microbicide, and had clinical and gram stain evaluation of response. Subjects were evaluated at 2-3 days after the last application of BufferGel as a test of cure and again at 1 month to assess for relapse. Subjects with BV at test of cure were offered oral metronidazole. Results: Thirty-one women were screened, 16 were offered enrollment, and 10 completed the study. Treatment with BufferGel was clinically effective in 70% of women at 2-3 days after treatment and in 40% of women by 1-month follow-up. Conclusions: These results suggest that 5 g of BufferGel vaginally once a day appears to be a moderately effective treatment for BV.