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Use of mixed-treatment-comparison methods in estimating efficacy of treatments for heavy menstrual bleeding

机译:混合治疗比较法在估计月经严重出血的治疗效果中的应用

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Background: A variety of pharmacological and surgical treatments have been developed for heavy menstrual bleeding (HMB), which can have negative physical, social, psychological, and economic consequences. We conducted a systematic literature review and mixed-treatment-comparison (MTC) meta-analysis of available data from randomized controlled trials (RCTs) to derive estimates of efficacy for 8 classes of treatments for HMB, to inform health-economic analysis and future studies. Methods. A systematic review identified RCTs that reported data on menstrual blood loss (MBL) at baseline and one or more follow-up times. Eight treatment classes were considered: COCs, danazol, endometrial ablation, LNG-IUS, placebo, progestogens given for less than 2 weeks out of 4 during the menstrual cycle, progestogens given for close to 3 weeks out of 4, and TXA. The primary measure of efficacy was the proportion of women who achieved MBL < 80 mL per cycle (month), as measured by the alkaline hematin method. A score less than 100 on an established pictorial blood-loss assessment chart (PBAC) was considered an acceptable substitute for MBL < 80 mL. Estimates of efficacy by treatment class and time were obtained from a Bayesian MTC model. The model also included effects for treatment class, study, and the combination of treatment class and study and an adjustment for baseline mean MBL. Several methodological challenges complicated the analysis. Some trials reported various summary statistics for MBL or PBAC, requiring estimation (with less precision) of % MBL < 80 mL or % PBAC < 100. Also, reported follow-up times varied substantially. Results: The evidence network involved 34 RCTs, with follow-up times from 1 to 36 months. Efficacy at 3 months of follow-up (estimated as the posterior median) ranged from 87.5% for the levonorgestrel-releasing intrauterine system (LNG-IUS) to 14.2% for progestogens administered for less than 2 weeks out of 4 in the menstrual cycle. The 95% credible intervals for most estimates were quite wide, mainly because of the limited evidence for many combinations of treatment class and follow-up time and the uncertainty from estimating % MBL < 80 mL or % PBAC < 100 from summary statistics. Conclusions: LNG-IUS and endometrial ablation are very efficacious in treating HMB. The study yielded useful insights on using MTC in sparse evidence networks. Diversity of outcome measures and follow-up times in the HMB literature presented considerable challenges. The Bayesian credible intervals reflected the various sources of uncertainty.
机译:背景:针对严重的月经出血(HMB),已经开发出多种药物和外科治疗方法,这些方法可能会对身体,社会,心理和经济造成负面影响。我们对来自随机对照试验(RCT)的可用数据进行了系统的文献综述和混合治疗比较(MTC)荟萃分析,以得出8种HMB治疗效果的估计值,为健康经济分析和未来研究提供参考。方法。一项系统的审查确定了RCT,这些RCT报告了基线和一个或多个随访时间的月经失血(MBL)数据。考虑了八种治疗类别:COC,达那唑,子宫内膜消融,LNG-IUS,安慰剂,在月经周期中少于4个2周的孕激素,在4个问题中将近3周的孕激素和TXA。疗效的主要衡量指标是每个周期(月)达到MBL <80 mL的女性比例,这是通过碱性血红素法测定的。在已建立的图形失血量评估图(PBAC)上评分小于100的分数被认为是MBL <80 mL的可接受替代品。从贝叶斯MTC模型获得按治疗类别和时间估算的疗效。该模型还包括治疗类别,研究的效果,以及治疗类别和研究的组合以及基线平均MBL的调整。几个方法上的挑战使分析变得复杂。一些试验报告了MBL或PBAC的各种汇总统计数据,需要估计(精度较低)MBL <80 mL或PBAC%<100。此外,报告的随访时间也有很大差异。结果:证据网络涉及34个RCT,随访时间为1到36个月。随访3个月时的效率(估计为后中位数)范围从左炔诺孕酮释放子宫内系统(LNG-IUS)的87.5%到在月经周期中少于4周的2周内服用的孕激素的14.2%。大多数估计值的95%可信区间相当宽,主要是因为治疗类别和随访时间的许多组合的证据有限,以及根据汇总统计数据估算MBL <80 mL或PBAC%<100所带来的不确定性。结论:LNG-IUS和子宫内膜消融治疗HMB非常有效。该研究产生了在稀疏证据网络中使用MTC的有用见解。 HMB文献中成果指标和随访时间的多样性提出了相当大的挑战。贝叶斯可信区间反映了各种不确定性来源。

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