School of Chinese Medicine
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 (Pâ ') 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/Pâ ' group (P = 0.0001) and in M&S/P+ group (P < 0.05), but not higher than in M&S/Pâ ' 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.
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This study was sponsored by the project from the National Eleventh Five Year Support Plan (115 Project, Project No. 2006BAI04A10) from the Ministry of Science and Technology of the People's Republic of China, and the projects from the National Science Foundation of China (Project No. 30825047).
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Jiang, Miao, Qinglin Zha, Chi Zhang, Cheng Lu, Xiaoping Yan, Wanhua Zhu, Wei Liu, Shenghao Tu, Liping Hou, Chengwu Wang, Wandong Zhang, Qinghua Liang, Bing Fan, Jiangping Yu, Weidong Zhang, Xinru Liu, Jing Yang, Xiaojuan He, Li Li, Xuyan Niu, Yan Liu, Hongtao Guo, Bing He, Ge Zhang, Zhaoxiang Bian, and Aiping Lu. "Predicting and verifying outcome of Tripterygium wilfordii Hook F. based therapy in rheumatoid arthritis: from open to double-blinded randomized trial." Scientific Reports 5 (2015): 9700.