Treatment of bacterial vaginosis with an acidic buffering gel (BufferGel): pilot study

Abstract

Background Bacterial Vaginosis (BV) is a highly prevalent and frequently recurring vaginal infection that increases women's risk for HIV-acquisition. BV is caused by a replacement of the normal lactobacillus-dominated flora with a complex mixture of anaerobes and other organisms. Vaginal pH characteristically rises in BV, perhaps enhancing the survival of BV organisms, which are inhibited at acid pH. Objective To determine if an acid-buffering gel would improve symptoms and clinical findings in women with BV. Methods HIV-negative women with symptomatic vaginal discharge were screened for BV using Amsel's criteria. Women positive for BV received a 5ml dose of BufferGel™ (ReProtect, LLC) in the clinic, subsequently applied an evening dose nightly for a total of 7 doses in 6 days, and completed a study diary and acceptability form. Women returned to the clinic 2-3 days after last BufferGel application, and again at one-month. Results 31 women were screened for BV from Mar-Jun 1999. 16 had BV by Amsel's criteria. 10/16 were evaluable. 100% of women reported abnormal vaginal discharge and 50% reported abnormal odor on study entry. At 2-3 days after last application, 7/10 (70%) were negative for BV. At one month, 4 women (40% of the original 10 evaluable women, 57% of the original 7 responders) remained negative for BV, 70% had no reported discharge and 80% no abnormal odor. Nine women had evaluable Gram's stain. 9/9 (100%) were BV(+) by Gram's stain at baseline. 6/9 (67%) were positive at first follow-up and 5/9 (56%) were positive at one month by Gram's stain. No women reported any adverse event. All women completed the prescribed 6-day course of BufferGel. 10/10 women (100%) would use BufferGel again. Conclusions BufferGel can improve symptoms and clinical findings in women with BV and may provide a non-antibiotic therapy or prophylaxis. However, relapse was common with the regimen used, and studies of alternative regimens (extended, intermittent, or prophylactic rather than therapeutic) are planned.