Traditional Chinese medicine versus western medicine as used in China in the management of rheumatoid arthritis: a randomized, single-blind, 24-week study.

This study is designed to compare the efficacy and safety of traditional Chinese medicine (TCM) with western medicine (WM) in the management of rheumatoid arthritis (RA). This is a 24-week, randomized, multicenter, single-blind study comparing TCM with WM (as used in China) carried out between June 2002 and December 2004 in nine research centers in China, involving 489 patients. Patients were randomized to receive TCM (n = 247), MTX and SSZ (n = 242). MTX was started at a dose of 5 mg to a final dose of 7.5-15 mg weekly. The maintenance dose was 2.5-7.5 mg weekly. The starting dose of SSZ was 0.25 g bid, increasing by 0.25 g a day once a week to a final dose of 0.5-1 g qid. The maintenance dose was 0.5 g tid to qid. Primary end point was the proportion of patients with response according to the American College of Rheumatology 20 % improvement criteria (ACR20) at weeks 24. At 24 weeks, ACR20 responses were 53.0 % in TCM group and 66.5 % in WM group, (P < 0.001) at 24 weeks. ACR 50 responses were 31.6 % of TCM group and 42.6 % in WM group, (P = 0.01). ACR70 responses were 12.6 % in TCM group and 17.4 % in WM group, (P = 0.14). Side effects were observed more frequently in WM group. In this study, ACR20, ACR50 responses at 24 weeks were significantly better in the WM treated group, by intention to treat (ITT) and per protocol analysis. The ACR 70 response showed no significant difference between the two groups. TCM, while effective in treating RA, appears to be less effective than WM in controlling symptoms, but TCM is associated with fewer side effects.

[Thinking about the key points in developing guidelines for Chinese and integrated medical clinical therapy].

The author offered in this paper that in developing the guidelines for Chinese and integrated medical clinical therapy, the specialties of Chinese medicine and clinical needs should be considered, and put stress on the following key points: (1) give priorities to the diseases on which plentiful evidences and practical experiences have been achieved in researches; (2) set up the clinical issues of diseases from an integral view, with Chinese medicine syndromes subordinated to diseases; (3) in making choice of clinical questions, problems that clinicians and researchers concerned should be taken in to consideration; (4) adopt the concepts and methods of complex intervention and reflect prominently the preponderant holistic thinking of Chinese medicine; (5) intensify the cognition-centered basic research of Chinese medicine through combining "disease diagnosis" and "syndrome differentiation" to acquaint the rules of disease/syndrome transformation from the integral dynamic views; (6) use the guidance establishing process of Western medicine as reference to collect, identify, review and classify the evidences from modern literature, while for those from ancient literature, the content analyzing method should be followed; (7) make the contents of design methods perfect and put emphasis on the control and guarantee of quality.

[Systematic evaluation on clinical literature related with treatment of Parkinson's disease with traditional Chinese medicine].

OBJECTIVE: To analyze the quality of scientific research design of clinical literature related with treatment of Parkinson's disease with traditional Chinese medicine, so as to objectively evaluate the therapeutic effect of TCM. METHODS: According to principles of evidence-based medicine, clinical epidemiology/design measurement evaluation (DME), the "Table of Systematic Evaluation of Quality and Information Collection for TCM Clinical Research Literature" were established and used to evaluate clinical control trial literature related with treatment of Parkinson's disease with TCM published during 1979 to 2000. RESULTS: The method of randomization was not described in 66.7% of the literature. Although randomized design was declared in 33.3 %, problems or mistakes of randomized allocation still existed in them. No record about the state of dropped out or absconded cases in follow-up study and without any record of samples screening presented in all literature. There were some problems of key links concerning samples' homogeneity, outcome indexes selection, conclusion deduction and so on, which could also influence the quality and reliability of randomized controlled trials. CONCLUSION: Methodological design of clinical research of TCM on Parkinson's disease should be strengthened.