Chinese patent medicine for atherosclerosis: a systematic review and Meta-analysis of randomized controlled trials.

X U Jian, Liu Yuntao, Luo Zhihao, Zhao Zhen, Wang Dawei, Liu Qing
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Abstract

Objective: To synthesize the evidence from randomized controlled trials (RCTs) to assess the efficacy and safety of Chinese patent medicine (CPM) on atherosclerosis (AS) or with a high risk of atherosclerosis.

Methods: All RCTs in three databases (PubMed, EMBASE, and Cochrane Library) were included from the inception of the database to September 20, 2019. The methodological evaluation of the included trials was carried out using the Cochrane Collaboration Risk of Bias Tool. Meta-analysis was conducted using RevMan 5.3 software. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to evaluate the quality of evidence.

Results: Eighteen RCTs were included, involving a total of 3885 patients with AS or with a high risk of AS. Most trials had favorable methodology. Meta-analysis suggested significant differences in clinical endpoint (n = 1938, RR 0.53; 95% CI 0.40 to 0.69, P < 0.00001; I 2 = 0%); the change in carotid artery IMT (n = 1723, MD -0.09, 95% CI -0.14 to -0.04, P < 0.001; I 2 = 40%); change in FMD (n = 239, MD 0.87, 95% CI 0.52 to 1.21, P < 0.00001; I 2 = 0%); change in high sensitive C-reactive protein (hs-CRP) (n = 1527, MD -1.89, 95% CI -3.36 to -0.42, P = 0.01; I 2 = 94%) and incidence of total adverse events (RR 0.76, 95% CI 0.62 to 0.93, P = 0.009; I 2 = 40%) in favor of the experimental group. However, meta-analysis showed no significant differences in the change in low-density lipoprotein-C (LDL-C) (n = 2419, MD -0.19, 95% CI -0.50 to 0.12, P = 0.22, I 2 = 94%) between the experimental and control groups.

Conclusion: CPM could have certain clinical efficacy in the treatment of AS. However, more double-blinded placebo-controlled RCTs are required in further evaluations to provide stronger evidence.

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中成药治疗动脉粥样硬化:随机对照试验的系统评价和meta分析。
目的:综合随机对照试验(RCTs)的证据,评价中成药(CPM)治疗动脉粥样硬化(AS)或动脉粥样硬化高危患者的疗效和安全性。方法:纳入三个数据库(PubMed、EMBASE和Cochrane Library)中自数据库建立至2019年9月20日的所有随机对照试验。采用Cochrane协作偏倚风险工具对纳入的试验进行方法学评价。采用RevMan 5.3软件进行meta分析。采用建议分级、评估、发展和评价(GRADE)方法评价证据质量。结果:纳入18项随机对照试验,共纳入3885例AS或高危AS患者。大多数试验采用有利的方法。meta分析显示两组临床终点差异有统计学意义(n = 1938, RR 0.53;95% CI 0.40 ~ 0.69, P 0.00001;I 2 = 0%);颈动脉IMT变化(n = 1723, MD -0.09, 95% CI -0.14 ~ -0.04, P 0.001;I 2 = 40%);FMD变化(n = 239, MD 0.87, 95% CI 0.52 ~ 1.21, P 0.00001;I 2 = 0%);高敏c反应蛋白(hs-CRP)变化(n = 1527, MD -1.89, 95% CI -3.36 ~ -0.42, P = 0.01;I 2 = 94%)和总不良事件发生率(RR 0.76, 95% CI 0.62 ~ 0.93, P = 0.009;I 2 = 40%),有利于实验组。然而,荟萃分析显示,实验组和对照组之间低密度脂蛋白c (LDL-C)的变化无显著差异(n = 2419, MD -0.19, 95% CI -0.50 ~ 0.12, P = 0.22, i2 = 94%)。结论:CPM治疗AS有一定的临床疗效。然而,进一步的评估需要更多的双盲安慰剂对照随机对照试验来提供更有力的证据。
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