Abstract:Traditional Chinese medicine rating scale of Parkinson's disease has been developed, it includes major symptom score sheet, liver and kidney deficiency score sheet In this study, its validity and responsiveness were evaluated to examine its applicability of clinical evaluation of traditional Chinese medicine (TCM).Methods:Between September 2008 and December 2009, traditional Chinese medicine rating scale of Parkinson's disease was used to investigate 121 patients from three clinical research centers (Xuanwu Hospital of Capital Medical University, the Second Hospital of Guangdong Province, Beijing Hospital of Integrated Traditional and Western Medicine), all patients in this investigation were given informed consent. The unified Parkinson disease rating scale (UPDRS) was used as the criterion, and correlation analysis was conducted to evaluate the criterion validity; subjects were grouped into mild group and moderate group by Hoehn &Yah grade to evaluate the discriminant validity. Paired ttest, effect size (ES) and standard response mean (SRM) were used to evaluate the responsiveness. Results:1) the Spearman rank correlation coefficient between traditional Chinese medicine rating scale Parkinson's disease and UPDRS Ⅱ was 0.38 ~ 0.47, the Spearman rank correlation coefficient between traditional Chinese medicine rating scale of Parkinson's disease and the UPDRS Ⅲ was 0.25~0.46. 2) Subjects were grouped into mild group and moderate group by Hoehn &Yah grade to compare their scores of traditional Chinese medicine rating scale of Parkinson's disease. Total score of the major symptom score sheet and the score of its mixed symptoms were significantly different(P<0.05). 3)Comparing the score difference of traditional Chinese medicine rating scale of Parkinson's disease of treatment group and control group respectively six months ago and after the intervention, except the total score of the major symptom score sheet of the control group had no statistical significance, the scores of the main symptom and mixed symptoms of the major symptom score sheet and the score of liver and kidney deficiency score sheet had varying degrees of statistical significance (P<0.01~P<0.001). Both effect size (ES) and standard response mean (SRM) of treatment group were more than 0.8. Conclusion:Traditional Chinese medicine rating scale of Parkinson's disease has good validity and responsiveness,and can be used for TCM clinical evaluation of Parkinson's disease.