安慰剂对照在中药临床研究中的作用探讨

如何选择对照组是临床随机对照试验设计的关键环节之一。中药临床研究中对照组选择存在以下问题:1、由于历史原因,阳性对照药的有效性及安全性尚待质疑;2、难于找到合适的中药对照药;3、由于理论体系、治病机理不同,以化学药物作对照进行疗效评价,意义有待斟酌。安慰剂对照可以克服研究者和受试者由于心理因素所形成的偏倚,能够直接量度在试验条件下,试验药物和安慰剂之间的差别。提倡在伦理学所能认可的最大限度内,在临床试验中广泛应用安慰剂作对照。

Discussion of the effect of placebo control in randomized controlled trials(RCTs)

Control group is very important in randomized controlled trials(RCTs)of Chinese herbal medicine (CHM ) .But there is some problem:First, because of the history,the effect of active control group is doubtful.Second,it is difficult to find a fit control group of CHM. Last, the chemical drug is doubtful to work as a control group of CHM becouse its different theory and mechanism.The placebo control can reduce the bias made of mentality of the investigators and subjects .It can distinguish the difference from the treatment control. It is necessary to enhance the use of placebo in RCTs under the permission of Ethnics.