Syndrome differentiation (Bian Zheng) in traditional Chinese medicine (TCM) is the comprehensive analysis of clinical information gained by the four main diagnostic TCM procedures: observation, listening, questioning, and pulse analysis, and it is used to guide the choice of treatment either by acupuncture and/or TCM herbal formulae, that is, Fufang. TCM syndrome differentiation can be used for further stratification of the patients' conditions with certain disease, identified by orthodox medical diagnosis, which could help the improvement of efficacy of the selected intervention. In modern TCM research it is possible to integrate syndrome differentiation with orthodox medical diagnosis leading to new scientific findings in overall medical diagnosis and treatment. In this review, the focus is to screen published evidence on the role of syndrome differentiation in modern TCM research with particular emphasis on basic and clinical research as well as, pharmacological evaluation of TCM herbal formulary for drug discovery.

Traditional Chinese medicine (TCM) is currently considered a complementary or alternative medical system in most Western countries and has been increasingly accepted worldwide. More and more clinical trials on TCM have been conducted internationally, and scientists worldwide are becoming increasingly interested in the evaluation of clinical efficacy of TCM based on clinical trials. This paper reviews the situation of clinical trials on TCM in the past decade, including systematic reviews about clinical trials either focusing on the treatment of disease with TCM approaches or focusing on one herbal product, conduction of clinical trials on TCM either with randomization and controlled methods or general observation. Some general issues on the conduct of clinical trials on TCM, such as randomization, control, quality of life (QOL), patient reported outcomes (PROs) and biomarkers, quality control, safety evaluation and case studies, are discussed, and accordingly some suggestions are proposed.

Tripterygium wilfordii Hook F. (TwHF) based therapy has been proved as effective in treating rheumatoid arthritis (RA), yet the predictors to its response remains unclear. A two-stage trial was designed to identify and verify the baseline symptomatic predictors of this therapy. 167 patients with active RA were enrolled with a 24-week TwHF based therapy treatment and the symptomatic predictors were identified in an open trial; then in a randomized clinical trial (RCT) for verification, 218 RA patients were enrolled and classified into predictor positive (P+) and predictor negative (P−) group and were randomly assigned to accept the TwHF based therapy and Methotrexate and Sulfasalazine combination therapy (M&S) for 24 weeks, respectively. Five predictors were identified (diuresis, excessive sweating, night sweats for positive; and yellow tongue-coating, thermalgia in the joints for negative). In the RCT, The ACR 20 responses were 82.61% in TwHF/P+ group, significantly higher than that in TwHF/P− group (P = 0.0001) and in M&S/P+ group (P < 0.05), but not higher than in M&S/P− group. Similar results were yielded in ACR 50 yet not in ACR 70 response. No significant differences were detected in safety profiles among groups. The identified predictors enable the TwHF based therapy more efficiently in treating RA subpopulations.

Chinese medicine (CM) has a long history of experience and proven successful treatment for chronic diseases and has also played an important role in the provision of health care in China. Patients with chronic diseases are happy to accept CM and physicians are willing to use CM to relieve patients suffering from chronic illnesses. The Chinese health authorities encourage CM development to meet the requirements for the treatment of chronic diseases. CM products are an essential part of medications that have a predominant role in the prevention and treatment of chronic diseases in China. A large number of CM clinical studies, including a substantial number of available randomized controlled trials and systematic reviews, have shown that CM is effective and safe in the treatment of chronic diseases. Although the efficacies of some evaluated CM therapies remain uncertain, it is worth assessing them by using CM pattern (Zheng or syndrome) differentiation to verify treatment outcomes. CM is considered to have a better safety profile compared to pharmaceutical chemicals, but inappropriate applications of CM also makes the safety issues a hot discussed subject. As a medical system, CM should be able to provide worldwide contribution for the patients who are suffering from chronic diseases. The application of CM pattern classification in diagnosis with corresponding prescribed treatment using herbal formulae in the relief of chronic diseases can be linked with modern biomedical parameters (biomarkers) as treatment outcomes. These outcome parameters, together with the patients' reported quality of life assessment, can provide innovative approaches for evidence-based estimation of the efficacy of CM treatment in chronic diseases.