OBJECTIVES:Oral metronidazole is still the drug of choice in the treatment of bacterial vaginosis. Yet, side effects have been reported, and dosage as well as duration of therapy are still controversial. This study presents a possible alternative treatment using a single dose of metronidazole administered in a vaginal bioadhesive tablet. STUDY DESIGN: Double blind, randomised, placebo-controlled trial. SUBJECTS: The 116 patients were allocated to placebo; metronidazole 100; 250; 500mg in a 1:1:1:1 ratio. RESULTS: A cure rate of 64% was obtained with a single 100mg dose of metronidazole formulated in a bioadhesive vaginal tablet compared to a cure rate of 29% in the placebo group. The cure rates with the higher doses were similar 61.5% for 250mg dose and 68% for the 500mg dose. No side effects were reported. CONCLUSIONS: Treatment of bacterial vaginosis with a single application of 100mg metronidazole in a bioadhesive vaginal tablet was found to be a valid alternative. Further research in relation to tablet shaping and optimal dose finding might increase the cure rate.
RCT Entities:
OBJECTIVES: Oral metronidazole is still the drug of choice in the treatment of bacterial vaginosis. Yet, side effects have been reported, and dosage as well as duration of therapy are still controversial. This study presents a possible alternative treatment using a single dose of metronidazole administered in a vaginal bioadhesive tablet. STUDY DESIGN: Double blind, randomised, placebo-controlled trial. SUBJECTS: The 116 patients were allocated to placebo; metronidazole 100; 250; 500mg in a 1:1:1:1 ratio. RESULTS: A cure rate of 64% was obtained with a single 100mg dose of metronidazole formulated in a bioadhesive vaginal tablet compared to a cure rate of 29% in the placebo group. The cure rates with the higher doses were similar 61.5% for 250mg dose and 68% for the 500mg dose. No side effects were reported. CONCLUSIONS: Treatment of bacterial vaginosis with a single application of 100mg metronidazole in a bioadhesive vaginal tablet was found to be a valid alternative. Further research in relation to tablet shaping and optimal dose finding might increase the cure rate.