[Application of non-randomized study in the field of traditional Chinese medicine or integrated traditional Chinese and Western medicine].

Non-randomized studies (NRS) have gradually attracted people's attention in the field of clinical medicine. In this paper, the importance of NRS was emphasized on the viewpoints of the coherence of scientific research, the limitation of randomized control trials (RCTs), the immanent characteristics of TCM clinical practice and the actual requirement of complex intervention in clinical practice. And two main points in evaluation and implementation of NRS differed to those in RCTs were put forward, i.e. the first, the full-scale design of the study with the professional characteristics should be described very explicitly, especially the speciality of the objects, intervention elements and indexes for effectiveness evaluation, etc.; the second, the control of bias and evaluation of effectiveness, and their influence on conclusion induction should be fully taken into consideration. At the same time, the key step in improving the quality of NRS of TCM and integrative medicine was preliminary discussed in this paper.