Boric Acid, Better Evidence (BABE) Study, Comparing Intravaginal Metronidazole to Boric Acid in Women Symptomatic for Bacterial Vaginosis

• Main Authors: Wood, Teresa, Zeron Mullins, Melinda, Cohen, Trevor
• Format: Article in Journal/Newspaper
• Language: English
• Published: UBC Journal of Family Practice Research and Scholarship 2015
• Subjects: Anti-bacterial agents; HIV; BV; Treatment Outcome; Victoria Island
• Online Access: http://ojs.library.ubc.ca/index.php/familypractice/article/view/187155

Introduction: Bacterial vaginosis (BV), the world’s most common vaginal infection, continues to cost patients time, energy, comfort and money. BV is associated with increased incidence of sexually transmitted infections (including HIV), spontaneous abortion, pre-term labour, post-surgical infections, and endometritis. Current treatment for those women symptomatic for BV includes both oral and intravaginal antibiotics, such as metronidazole, which have success rates of 70-80 % at 1 month after treatment. These treatments also have high recurrence rates (49-66 % at one year after treatment) and side effects (10-20 % of women) that include secondary vaginal infection with candida. Intravaginal boric acid has been used for >100 years for the treatment of vaginal infections and is quite commonly prescribed today as a treatment for BV. It is cheap, easily accessible, easy to use, and is an effective treatment of other vaginal infections, such as candida. To date, there are no clinical trials studying the effectiveness of boric acid in the treatment of BV. Objectives: To determine whether boric acid is at least as effective and as safe as metronidazole for treating women with symptomatic BV, our study will compare intravaginal boric acid to the current standard intravaginal treatment, metronidazole, and to a placebo. Our goal is to expand women’s options for the treatment of BV.Hypothesis: Boric acid is an effective treatment of bacterial vaginosis as compared to placebo. Boric acid is at least as effective and as safe in the treatment of bacterial vaginosis as compared to metronidazole. Methods: We are proposing a volunteer based, randomized, double-blinded, placebo controlled, multi-center (including: several private GP offices, Victoria Youth Clinics, Victoria Island Sexual Health Clinic, and Victoria STI Clinic) study for women symptomatic of a BV infection, confirmed with gram stain using the Nugent score. The volunteers would take either 600 mg boric acid, or 37.5 mg metronidazole, or an inert substance ...