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Evaluation of outcomes reported in randomized controlled trials for herbal remedies for adults with chronic hepatitis C

机译：评估慢性丙型肝炎成人草药的随机对照试验中报告的结果

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Background:Herbal remedies have been widely utilized in treating chronic hepatitis C (CHC) worldwide.Selecting appropriate outcomes to reflect both beneficial and harmful effects is a crucial step in designing randomized controlled trials (RCTs).This study evaluated the outcomes reported in RCTs on herbal remedies for CHC with comparison to the core outcomes recommended by the Cochrane Hepato-Biliary Group (CHBG),to check the consistency of the outcomes and to provide recommendation for future researches.Methods:A systematic literature search was conducted in Western and Chinese databases to identify RCTs on herbal remedies for adults with CHC.For each trial,all the outcomes reported in the results section were collected.Comparison between trial outcomes and CHBG core outcomes were evaluated and summarized with descriptive statistics.Results:A total of 116 RCTs involving 9154 participants were included;27 outcomes were identified.Commonly reported outcomes included alanine aminotransferase (64 trials,55.2％),adverse events (58 trials,50.0％),and end-of-treatment virological response (50 trials,43.1％).All trials indicated that the herbal remedies under investigation had a positive effect and was markedly more effective than the control.Nearly half of the trials reported that the combination of herbal medicine and antiviral drugs could ameliorate adverse events.Very few trials reported primary core outcomes relating survival and quality of life.The most frequently reported core outcomes are non-serious adverse events (54 trials,46.6％),viral response (27 trials,23.3％),and biochemical response (24 trials,20.7％).Conclusion:The variation and inconsistency in trial outcomes impedes research synthesis efforts,and indicate the need for comparable outcomes through the development of core outcome sets in CHC.The low concordance of outcome reporting could be improved by following CHBG core outcomes recommendation.
机译：背景：草药在世界范围内已被广泛用于治疗慢性丙型肝炎（CHC）。选择适当的结果以反映有利和有害的影响是设计随机对照试验（RCT）的关键步骤。与Cochrane肝胆病小组（CHBG）推荐的核心结局比较，对CHC进行中草药治疗，以检查结局的一致性并为今后的研究提供建议。方法：在中西数据库中进行系统的文献检索目的是确定成人CHC用草药的RCT。每次试验均收集结果部分报告的所有结局，评估试验结局与CHBG核心结局之间的比较，并进行描述性统计总结。结果：共有116项RCT涉及包括9154名参与者;确定了27个结局。报告的常见结局包括丙氨酸氨基转移失败（64项试验，占55.2％），不良事件（58项试验，占50.0％）和治疗结束后的病毒学应答（50项试验，占43.1％）。所有试验均表明所研究的草药具有积极作用，并且明显比对照组有效。近一半的试验报告说，将草药和抗病毒药合用可以改善不良事件。很少有试验报告了与生存和生活质量有关的主要核心结果。严重不良事件（54项试验，占46.6％），病毒反应（27项试验，占23.3％）和生化反应（24项试验，占20.7％）。结论：试验结果的差异和不一致阻碍了研究的综合努力，并指出了必要性通过开发CHC核心结果集可比较可比较的结果。遵循CHBG核心结果建议可以改善结果报告的低一致性。

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  • 来源
    《中医科学杂志（英文）》 |2019年第002期|115-121|共7页
  • 作者

    Yuqian Yan; Ning Liang; Shibing Liang; Yuxin Sun; Nicola Robinson; Jianping Liu;

  • 作者单位

    Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029,China;

    Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029,China;

    Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029,China;

    Shanxi University of Chinese Medicine, Taiyuan 030619, China;

    Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029,China;

    School of Health and Social Care, London South Bank University, London SE10AA, United Kingdom;

    Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029,China;

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