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A multicenter, double‐blind, randomized, placebo‐controlled study of rifaximin for the treatment of bacterial vaginosis
Author(s) -
Donders Gilbert G.G.,
Guaschino Secondo,
Peters Klaus,
Tacchi Raffaella,
Lauro Vittoria
Publication year - 2013
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2012.08.022
Subject(s) - medicine , rifaximin , placebo , bacterial vaginosis , tolerability , metronidazole , adverse effect , randomization , randomized controlled trial , surgery , gastroenterology , antibiotics , gynecology , alternative medicine , pathology , microbiology and biotechnology , biology
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.