A multicenter, double-blind, randomized, placebo-controlled study of rifaximin for the treatment of bacterial vaginosis

作者：Donders Gilbert G G^*; Guaschino Secondo; Peters Klaus; Tacchi Raffaella; Lauro Vittoria

来源：International Journal of Gynecology & Obstetrics, 2013, 120(2): 131-136.

DOI：10.1016/j.ijgo.2012.08.022

• Bacterial vaginosis
• Efficacy
• Placebo
• Randomized
• Recurrence
• Rifaximin

Objective: To compare efficacy and tolerability between different regimens of rifaximin vaginal tablets and a placebo for treatment of bacterial vaginosis. Methods: In a prospective study carried out at 13 sites in 3 European countries between August 2009 and October 2010, White, non-pregnant, premenopausal women with bacterial vaginosis were randomly assigned to receive rifaximin at 100 mg for 5 days (100 mg/5 days), 25 mg/5 days, or 100 mg/2 days, or placebo. Women were assessed at 7-10 and 28-35 days. Diagnosis and cure were based on Amsel criteria and Nugent score. Fisher exact test was used to compare cure rates. Results: Among 114 women recruited, 103 were evaluable for drug efficacy. Therapeutic cure rate at first follow-up was higher in the rifaximin 25 mg/5 days (48%, P = 0.04), 100 mg/2 days (36.0%), and 100 mg/5 days (25.9%) groups than in the placebo group (19.0%). At second follow-up, therapeutic cure rate was 28.0%, 14.8%, and 4.0% in the respective groups versus 7.7% in the placebo group. No difference in adverse events was observed. Conclusion: Rifaximin at 25 mg/5 days showed better therapeutic cure rates and maintenance of therapeutic cure after 1 month versus placebo. All treatment regimens were well tolerated. EudraCT number: 2009-011826-32.

• 出版日期2013-2