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根据国际通行的标准,对中医临床研究提出以下建议。(1)一定要随机分组,而不是人为分组以均衡组间的基线特征。(2)用国际通行的标准衡量疗效,而不是简单地采用治愈率、显效率和有效率。(3)注意记录并用适当的方法处理缺失的数据。(4)客观地描述研究结果,特别要避免选择性偏倚。此外,在评估中医治疗疑难杂症的效果时,应避免低限效应。同时,还要考虑到伦理上的问题。

英文摘要:

According to the international accepted criteria, some suggestions were provided in this paper on the clinical study of traditional Chinese medicine. Firstly, allocate the participants randomly, rather than deliberately perform that to balance the baseline characteristics in groups. Secondly, use the international standard to evaluate the clinical effectiveness, rather than just use the simple criteria as cure rate, markedly effective rate, and effective rate. Thirdly, record and manage the missing data with proper statistical methods. Fourthly, objectively report the results of study, especially avoiding selective bias. In addition, the low limit effects should be avoided when assessing the effects of TCM in treating difficult and uncertain diseases; furthermore, the ethical problems should also be considered.

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