Changes are occurring in the clinical research of TCM. Firstly, researchers are starting to emphasize the importance of clinical trials.⁵ Many experts including clinicians, pharmacologists, statisticians and epidemiologists are discussing and formulating clinical trial protocols for TCM. Secondly, quality control is being emphasized for the process of trials more than before.⁶ Thirdly, clinical researchers and journal editors are moving to accept CONSORT for TCM with the help of the support of EBM experts.⁷ Lastly, some experts of TCM are exploring evaluation methods suitable for TCM.⁸

While modern medicine has a well established system of clinical research applying evidence-based methods, traditional Chinese medicine has not developed its own system of research, despite its long history.

We suggest the introduction of a new pattern named as ‘Three Steps' in clinical research of TCM. The first is secondary study of literature; the second is original study; and the third is a methodology study.

After a clinical theme is defined, a researcher should search the medical literature to identify all relevant studies. According to the standard approach of EBM, the researcher should appraise the literature firstly and decide whether there is meaningful evidence. If the answer is reliable, evidence from the studies can be combined by means of meta-analysis. If there is no or insufficient evidence, the second step is to design and conduct a suitable study using high quality methods. On the basis of this second step, it is possible that some new methodology might emerge.

Randomized controlled trials have already been conducted in TCM. However, with the emerging of Circular Model,⁹ people begin to scan the hierarchy model again which emphasizes internal validity and experimental evidence. The circle method has no preferred orientation with the contrast of the hierarchy method. It might be a more fitting image for clinical research by balancing the weaknesses of one method with the strengths of another.

Chinese medicine is indeed different from western medicine, while TCM is an individual therapeutic method for diseases or conditions. The basic principles for evaluation are similar to western medicine although the special features in TCM should be highlighted. We also should consider the current possibilities for reporting the details of TCM studies. There should be a balance between what is ideal and what is feasible.

If the aim of a clinical trail is to evaluate the efficacy of treatment of a disease or symptom with TCM, the inclusion criteria should be internationally or nationally recognized and the criteria should be included. If the aim of a particular Chinese medicine is only to treat specific TCM symptoms it is important to report the TCM diagnostic criteria and this should also be related to the aim of the treatment. If the aim is to treat a disease or symptom, outcome measures should be patient related and internationally or nationally recognized. If the aim of a Chinese medicine is only to improve specific TCM symptom, it is necessary to report TCM outcome measures.

The best evidence which should be systematically evaluated, reviewed, summarized, and disseminated should lead to evidence based decision making instead of experience based decision making in traditional Chinese medicine.

References:

1.       Shang HC, Dai GH, Zhang JH, Xiang YZ, Wang Y, Zhang JP, et al. Myocardial infarction secondary prevention study. J Geriatr Cardiol 2006; 3: 116-119.

2.       Tran TH, Day NP, Nguyen HP, Nguyen TH, Tran TH, Pham PL, et al. A controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria. N Engl J Med 1996; 335: 76-83.

3.       Collaborative Group for China Coronary Secondary Prevention Using Xuezhikang. China coronary secondary prevention study (CCSPS). Chin J Cardiol (Chin) 2005; 33: 109-115.

4.       Chen KJ, Shi DZ, Xu H, Lü SZ, Li TC, Ke YN, et al. XS0601 reduces the incidence of restenosis: a prospective study of 335 patient s undergoing percutaneous coronary intervention in China. Chin Med J 2006; 119: 6-13.

5.       Zhang JH, Shang HC, Dai GH, Gao XM, Zhang BL. Key points of protocol design on clinical therapeutic research of traditional Chinese medicine. Chin J Integr Trad West Med (Chin) 2007; 27: 171-173.

6.       Shang HC, Zhang JH, Dai GH, Cao HB, Ren M, Xiang YZ, et al. Administration and quality control of large-scale clinical trials of traditional Chinese medicine. J Chin Integr Med (Chin) 2007; 5: 1-4.

7.       Wu TX, Li YP, Bian ZX, Chen KJ, Zhang BL, Shang HC, et al. Practice good publication practice to improve the transparence of clinical trials. Chin J Evid-Based Med (Chin) 2007; 7: 551-554.

8.       Shang HC, Li YP, Zhang BL, Zhang JH, Ren M, Cao HB. Individualized assessment method of evidence-based goal attainment scale produced in TCM. Chin J Evid-Based Med (Chin) 2007; 7: 537-541.

9.       Harald W, Torkel F, Vinjar F, George L, Wayne BJ. Circular instead of hierarchical: methodological principles for the evaluation of complex interventions. BMC Med Res Methodol 2006; 6: 29