Zeron Mullins Melinda, Trouton Konia M
Department of Family Practice, University of British Columbia, 3rd Floor David Strangway Building, 5950 University Boulevard, Vancouver, British Columbia, BC V6T 1Z3, Canada.
Trials. 2015 Jul 26;16:315. doi: 10.1186/s13063-015-0852-5.
Bacterial vaginosis is associated with increased transmission of sexually transmitted infections, preterm labor, post-surgical infections, and endometritis. Current treatment for symptomatic bacterial vaginosis includes antibiotics, such as metronidazole, which are 70-80 % effective at one month after treatment and result in high recurrence rates and secondary candida infections. Intravaginal boric acid has been used for over a hundred years to treat vaginal infections, such as bacterial vaginosis. Boric acid is inexpensive, accessible, and has shown to be an effective treatment for other infections, such as vaginal candidiasis. To date, there has been no clinical trial evaluation of boric acid effectiveness to treat bacterial vaginosis.
METHODS/DESIGN: The BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) trial is a randomized, double-blinded, multicenter study. The study will enroll a minimum of 240 women of 16-50 years of age who are symptomatic with bacterial vaginosis. Eligible participants will have Amsel and Nugent scores confirming bacterial vaginosis. Women who are pregnant or menopausal or have other active co-infections will be excluded. Consenting participants who meet exclusion and inclusion criteria will be randomly assigned to one of three treatment groups: boric acid, metronidazole, or an inert placebo. Self-administration of treatment intravaginally for 10 days will be followed by clinical assessment at 7 and 30 days (days 17 and 40, respectively) after the end of the treatment phase. Primary outcome is a non-inferiority, per-protocol comparison of the effectiveness of boric acid with that of metronidazole at day 17, as measured by the Nugent score in 16-50 year olds. Secondary outcomes include: non-inferiority, intention-to-treat comparison of effectiveness of boric acid with that of metronidazole at day 17, analysis for both per-protocol and intention-to-treat at day 40, and safety considerations, including adverse effects requiring patient discontinuation of treatment.
This study will be the first to determine whether intravaginal boric acid is non-inferior to metronidazole in the treatment of bacterial vaginosis in symptomatic women.
ClinicalTrials.gov NCT00799214, registered online Nov 10, 2008.
细菌性阴道病与性传播感染、早产、术后感染及子宫内膜炎的传播增加有关。目前，有症状的细菌性阴道病的治疗方法包括使用抗生素，如甲硝唑，治疗后一个月的有效率为70%-80%，但复发率高且会引发继发性念珠菌感染。阴道内使用硼酸治疗阴道感染（如细菌性阴道病）已有一百多年的历史。硼酸价格低廉、容易获得，且已证明对其他感染（如阴道念珠菌病）有效。迄今为止，尚无关于硼酸治疗细菌性阴道病有效性的临床试验评估。
方法/设计：BASIC（硼酸，阴道定植的替代溶液）试验是一项随机、双盲、多中心研究。该研究将招募至少240名年龄在16至50岁之间、有细菌性阴道病症状的女性。符合条件的参与者将通过阿姆斯尔和纽金特评分确诊为细菌性阴道病。怀孕、绝经或患有其他活动性合并感染的女性将被排除。符合排除和纳入标准且同意参与的参与者将被随机分配到三个治疗组之一：硼酸组、甲硝唑组或惰性安慰剂组。阴道内自行给药10天，治疗阶段结束后第7天和第30天（分别为第17天和第40天）进行临床评估。主要结局是按照符合方案集，在第17天通过纽金特评分比较16至50岁女性中硼酸与甲硝唑有效性的非劣效性。次要结局包括：按照意向性分析集，在第17天比较硼酸与甲硝唑有效性的非劣效性，在第40天对符合方案集和意向性分析集进行分析，以及安全性考量，包括需要患者停药的不良反应。
本研究将首次确定阴道内使用硼酸治疗有症状女性的细菌性阴道病是否不劣于甲硝唑。
ClinicalTrials.gov NCT00799214，于2008年11月10日在线注册。
