Taha E Taha, Newton I Kumwenda, George Kafulafula, Bonus Makanani, Chiwawa Nkhoma, Shu Chen, Amy Tsui, Donald R Hoover
{"title":"Intermittent intravaginal antibiotic treatment of bacterial vaginosis in HIV-uninfected and -infected women: a randomized clinical trial.","authors":"Taha E Taha, Newton I Kumwenda, George Kafulafula, Bonus Makanani, Chiwawa Nkhoma, Shu Chen, Amy Tsui, Donald R Hoover","doi":"10.1371/journal.pctr.0020010","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Assess efficacy of intermittent intravaginal metronidazole gel treatment in reducing frequency of bacterial vaginosis (BV).</p><p><strong>Design: </strong>Randomized, double-masked, placebo-controlled phase 3 trial.</p><p><strong>Setting: </strong>Postnatal and family planning clinics of the Queen Elizabeth Central Hospital and two health centers in Blantyre, Malawi.</p><p><strong>Participants: </strong>Nonpregnant HIV-uninfected and -infected women.</p><p><strong>Intervention: </strong>Intravaginal metronidazole treatment and placebo gels provided at baseline and every 3 mo for 1 y.</p><p><strong>Outcome measures: </strong>PRIMARY: Cross-sectional and longitudinal comparisons of BV frequency at baseline, 1 mo after product dispensation (post-treatment evaluation [PTE]), and every quarterly visit. Secondary: Effect of treatment on BV clearance and recurrence.</p><p><strong>Results: </strong>BASELINE: 842 HIV-uninfected and 844 HIV-infected women were enrolled. The frequency of BV at baseline in treatment and placebo arms, respectively, was 45.9% and 46.8% among HIV-uninfected women, and 60.5% and 56.9% among HIV-infected women.</p><p><strong>Primary outcomes: </strong>At the PTEs the prevalence of BV was consistently lower in treatment than placebo arms irrespective of HIV status. The differences were statistically significant mainly in HIV-uninfected women. Prevalence of BV was also reduced over time in both treatment and placebo arms. In a multivariable analysis that controlled for other covariates, the effect of intravaginal metronidazole treatment gel compared with placebo was not substantial: adjusted relative risk (RR) 0.90, 95% confidence interval (CI) 0.83-0.97 in HIV-uninfected women and adjusted RR 0.95, 95% CI 0.89-1.01 in HIV-infected women.</p><p><strong>Secondary outcomes: </strong>Intravaginal metronidazole treatment gel significantly increased BV clearance (adjusted hazard ratio [HR] 1.34, 95% CI 1.07-1.67 among HIV-uninfected women and adjusted HR 1.29, 95% CI 1.06-1.58 among HIV-infected women) but was not associated with decreased BV recurrence.</p><p><strong>Safety: </strong>No serious adverse events were related to use of intravaginal gels.</p><p><strong>Conclusion: </strong>Intermittent microbicide treatment with intravaginal gels is an innovative approach that can reduce the frequency of vaginal infections such as BV.</p>","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2007-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1371/journal.pctr.0020010","citationCount":"34","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"PLoS clinical trials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1371/journal.pctr.0020010","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 34
Abstract
Objective: Assess efficacy of intermittent intravaginal metronidazole gel treatment in reducing frequency of bacterial vaginosis (BV).
Setting: Postnatal and family planning clinics of the Queen Elizabeth Central Hospital and two health centers in Blantyre, Malawi.
Participants: Nonpregnant HIV-uninfected and -infected women.
Intervention: Intravaginal metronidazole treatment and placebo gels provided at baseline and every 3 mo for 1 y.
Outcome measures: PRIMARY: Cross-sectional and longitudinal comparisons of BV frequency at baseline, 1 mo after product dispensation (post-treatment evaluation [PTE]), and every quarterly visit. Secondary: Effect of treatment on BV clearance and recurrence.
Results: BASELINE: 842 HIV-uninfected and 844 HIV-infected women were enrolled. The frequency of BV at baseline in treatment and placebo arms, respectively, was 45.9% and 46.8% among HIV-uninfected women, and 60.5% and 56.9% among HIV-infected women.
Primary outcomes: At the PTEs the prevalence of BV was consistently lower in treatment than placebo arms irrespective of HIV status. The differences were statistically significant mainly in HIV-uninfected women. Prevalence of BV was also reduced over time in both treatment and placebo arms. In a multivariable analysis that controlled for other covariates, the effect of intravaginal metronidazole treatment gel compared with placebo was not substantial: adjusted relative risk (RR) 0.90, 95% confidence interval (CI) 0.83-0.97 in HIV-uninfected women and adjusted RR 0.95, 95% CI 0.89-1.01 in HIV-infected women.
Secondary outcomes: Intravaginal metronidazole treatment gel significantly increased BV clearance (adjusted hazard ratio [HR] 1.34, 95% CI 1.07-1.67 among HIV-uninfected women and adjusted HR 1.29, 95% CI 1.06-1.58 among HIV-infected women) but was not associated with decreased BV recurrence.
Safety: No serious adverse events were related to use of intravaginal gels.
Conclusion: Intermittent microbicide treatment with intravaginal gels is an innovative approach that can reduce the frequency of vaginal infections such as BV.
目的:评价甲硝唑凝胶阴道间歇治疗降低细菌性阴道病(BV)发病率的疗效。设计:随机、双盲、安慰剂对照的3期试验。环境:伊丽莎白女王中心医院的产后和计划生育诊所以及马拉维布兰太尔的两个保健中心。参与者:未怀孕、未感染艾滋病毒和感染艾滋病毒的妇女。干预措施:在基线和每3个月提供阴道内甲硝唑治疗和安慰剂凝胶,为期1年。结果测量:主要:基线时、产品分配后1个月(治疗后评估[PTE])和每季度就诊时BV频率的横断面和纵向比较。次要:治疗对BV清除和复发的影响。结果:基线:842名未感染艾滋病毒的妇女和844名感染艾滋病毒的妇女入组。治疗组和安慰剂组基线时BV发生率在未感染艾滋病毒的妇女中分别为45.9%和46.8%,在感染艾滋病毒的妇女中分别为60.5%和56.9%。主要结局:在pte组,无论HIV状态如何,治疗组的BV患病率始终低于安慰剂组。这一差异主要在未感染艾滋病毒的妇女中具有统计学意义。治疗组和安慰剂组的细菌性阴道炎患病率也随着时间的推移而降低。在控制其他协变量的多变量分析中,阴道内甲硝唑治疗凝胶与安慰剂相比的效果并不显著:在未感染hiv的女性中,调整相对危险度(RR)为0.90,95%可信区间(CI)为0.83-0.97;在感染hiv的女性中,调整相对危险度(RR)为0.95,95%可信区间(CI)为0.89-1.01。次要结局:阴道内甲硝唑治疗凝胶显著增加了BV清除率(未感染hiv的女性校正风险比[HR] 1.34, 95% CI 1.07-1.67,感染hiv的女性校正风险比[HR] 1.29, 95% CI 1.06-1.58),但与BV复发率降低无关。安全性:未发现与阴道内凝胶使用相关的严重不良事件。结论:阴道内凝胶间歇杀菌剂治疗是一种降低阴道感染(如细菌性阴道炎)发生率的创新方法。