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首页> 外文期刊>Statistics in medicine >Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: Application to a randomized controlled acupuncture trial
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Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: Application to a randomized controlled acupuncture trial

机译：使用现代临床试验设计和统计方法评估中药：在随机对照针灸试验中的应用

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摘要

Traditional Chinese medicine (TCM), used in China and other Asian counties for thousands of years, is increasingly utilized in Western countries. However, due to inherent differences in how Western medicine and this ancient modality are practiced, employing the so-called Western medicine-based gold standard research methods to evaluate TCM is challenging. This paper is a discussion of the obstacles inherent in the design and statistical analysis of clinical trials of TCM. It is based on our experience in designing and conducting a randomized controlled clinical trial of acupuncture for post-operative dental pain control in which acupuncture was shown to be statistically and significantly better than placebo in lengthening the median survival time to rescue drug. We demonstrate here that PH assumptions in the common Cox model did not hold in that trial and that TCM trials warrant more thoughtful modeling and more sophisticated models of statistical analysis. TCM study design entails all the challenges encountered in trials of drugs, devices, and surgical procedures in the Western medicine. We present possible solutions to some but leave many issues unresolved.
机译：在中国和其他亚洲县使用了数千年的中药（TCM），在西方国家越来越多地被使用。但是，由于西医和这种古老疗法的内在差异，采用所谓的基于西医的金标准研究方法来评估中医具有挑战性。本文讨论了中医临床试验设计和统计分析中固有的障碍。它是基于我们在设计和进行针灸以控制术后牙痛的随机对照临床试验中的经验而得出的，在该试验中，针灸在统计学上显着优于安慰剂，从而延长了挽救药物的平均生存时间。我们在这里证明普通Cox模型中的PH假设在该试验中不成立，而TCM试验则需要更周到的建模和更复杂的统计分析模型。中医研究设计需要在西药的药物，器械和外科手术试验中遇到的所有挑战。我们提供了一些解决方案，但许多问题尚未解决。

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