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The importance and necessity of establishing technical specifications for the registration of traditional chinese medicine clinical studies

机译:建立中药临床研究注册技术规范的重要性和必要性

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Dear Editor:Registration of clinical trials can prevent bias and make their reporting transparent, thus also improving their quality. As an illustration, JAMA, New England Journal of Medicine, and The Lancet stipulate that researchers must register their clinical trials before they submit their articles. This is also supported by the World Health Organization (WHO) and is written in the declaration of Helsinki. We propose that registration provides an opportunity for Traditional Chinese Medicine (TCM) to solve some of the current problems in TCM clinical studies.As the number of TCM studies has increased greatly in recent years, their quality has been the focus of researchers' attention, with the finding that there is a large gap between the quantity and quality of TCM clinical studies. In the evaluation of 1452 randomized controlled trials (RCTs) of TCM, published between 1995 and 2005, it was reported that 103 (7.3%) had a correct randomization method and only 9 (0.6%) conformed to more than 50% of the items of the Consolidated Standards of Reporting Trials (CONSORT).1 Another report, based on searching the Chinese biomedical database and the Cochrane library, found that only 100 (3%) of 31,590 RCTs had appropriate randomizing, concealing, and blinding.2 Evidence-based medicine was introduced to TCM more than 20 years ago, and the quantity of systematic reviews has steadily increased. However, almost all systematic reviews conclude that there is insufficient evidence to draw conclusions and the studies are of poor quality. Similarly, in Chinese journals it has been found that international standards for methodological descriptions are not being met.3 Therefore, it is necessary when conducting RCTs for attention to be paid to improve the quality.
机译:尊敬的编辑:临床试验注册可以防止偏见并使报告透明化,从而提高质量。作为说明,《美国医学会杂志》,《新英格兰医学杂志》和《柳叶刀》均规定,研究人员必须在提交文章之前注册其临床试验。世界卫生组织(WHO)也对此提供了支持,并将其写在赫尔辛基宣言中。我们建议注册为中药(TCM)提供解决中医药临床研究中一些当前问题的机会。由于近年来中药研究的数量大大增加,其质量一直是研究人员关注的焦点,发现中医临床研究的数量和质量之间存在很大差距。在1995年至2005年间发布的1452项中药随机对照试验(RCT)评估中,有103份(7.3%)的随机方法正确,只有9份(0.6%)符合50%以上的标准1另一份报告基于对中国生物医学数据库和Cochrane库的搜索,发现31,590个RCT中只有100个(3%)具有适当的随机化,隐蔽性和盲目性。2证据-二十多年来,基于医学的药物被引入中医领域,系统评价的数量稳步增长。但是,几乎所有的系统评价都得出结论:没有足够的证据得出结论,并且研究质量较差。同样,在中国期刊中也发现未满足方法学描述的国际标准。3因此,进行RCT时有必要注意提高质量。

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