摘要
Objectives: Evaluating the quality of systematic reviews/meta-analysis of Wenxin granule in treating cardiac arrhythmia to provide evidence for clinical practice, and analyzing the problems in the research to identify potential research priorities for researchers. Method: The systematic reviews of Wenxin granule in treating cardiac arrhythmia were searched from 8 databases. The methodological quality and evidence quality were assessed by AMSTAR and GRADE respectively. Results: Nineteen eligible systematic reviews with 52,905 participants were included. The overall scores of AMSTAR ranged from 3 to 10 with a mean score of 6.5, the median score was 6. There were 9 (9/19, 47.37%) systematic reviews had the score of 7 or more. 6 of them with appropriate information were assessed the quality of evidence by GRADE. The results showed that the overall quality of evidence was limited (range from “very low” to “low”), no “moderate” or “high” quality of evidence existed. For the outcome reporting, no systematic reviews reported endpoints and limited evidence showed that there is causality between Wenxin granule and adverse effects/events. The outcome matrix showed that there are obvious heterogeneity and incompleteness for the outcome reporting in included systematic reviews, so that some included studies cannot be conducted meta-analysis. Meanwhile, there were studies excluded because of inappropriate outcome measures, such as outcome measures did not meet inclusion criteria, treatment time did not meet inclusion criteria, treatment time was unclear, incomplete data or the data cannot be extracted. Conclusions: Wenxin granule have limited efficacy and safety for treating arrhythmia. In the future, high quality of RCTs and systematic reviews should be conducted. Core outcome set for cardiac arrhythmia is needed to improve outcome reporting and decrease waste.
目的:对稳心颗粒治疗心律失常的系统评价/meta分析进行再评价,为临床应用提供证据;分析目前研究中存在的问题,为研究者提供可能的优先研究主题。方法:从8 个数据库中检索稳心颗粒治疗心律失常的系统评价。分别用AMSTAR和GRADE评估系统评价的方法学质量和证据质量。结果:共纳入1 9 项系统评价,涉及52, 9 0 5 个参与者。AMSTAR评分3-10分,平均6 .5 分,中位数为6 分, 9 (9/19, 47.37°%)项系统评价的AMSTAR得分大于7 分,对其中的6 项研究采用GRADE评估其证据质量。结果显示,所有研究的证据质量都在极低和低之间,无中、高质量证存在。从结局指标报告来看,没有系统评价评估终点指标,虽然有部分研究报告了不良反应/事件,但很少有研究进行因果关系判断。系统评价结局指标矩阵显示,结局指标报告存在明显的异质性及不完全报告的情况,导致有些研究不能进行m eta分析。同时,一些原始研究由于结局指标报告不合理而被不能纳入系统评价(如未报告相关结局指标,治疗时间不合适/不清楚,数据不完全或无法提取)。结论:稳心颗粒治疗心律失常的疗效和安全性证据有限,未来需要更多的高质量R C T s和系统评价提供证据。在未来的研究中,有必要构建心律失常核心指标集,以提高结局指标报告水平,减少由于结局指标报告不合理而造成的浪费。
基金
National Natural Science Foundation of China [No: 81430098].
