中药临床研究中对照组选择存在的问题及对策

Problem and countermeasure of control group design in clinical research of Chinese materia medica

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。中药临床研究中阳性对照组选择存在以下问题:(1)效果难以评判;(2)容易引起偏倚;(3)对照不合适。虽然安慰剂对照仍存在伦理学和依从性的问题,但可以克服以上困难,得出更为科学的结论,所以,在中药临床试验中,应该在伦理学所能认可的最大限度内,最大可能并灵活地选择安慰剂对照。

It is necessary to have control group in randomized controlled trials （RCTs） on Chinese materia medica. But there are problems in the selection of positive control group： First, it is difficult to give the judgement about the effect of positive control group; second, it is apt to cause bias; last, the choice of control group is inappropriate. There are problems such as ethnics and compliableness associated with the use of a placebo control group, but the placebo control group can overcome the problems above. Therefore, it is necessary to use placebo reasonably in RCTs within the permission of ethnics.