title: Predicting and verifying outcome of Tripterygium wilfordii Hook F. based therapy in rheumatoid arthritis: from open to double-blinded randomized trial.
abstract: 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) 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.
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.|School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon 999077, Hong Kong.
authors.forename: Miao
authors.initials: M
authors.lastname: Jiang
authors.affiliation: School of Computer, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, P.R. China.
authors.forename: Qinglin
authors.initials: Q
authors.lastname: Zha
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.
authors.forename: Chi
authors.initials: C
authors.lastname: Zhang
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.
authors.forename: Cheng
authors.initials: C
authors.lastname: Lu
authors.affiliation: Department of Rheumatism, Beijing China-Japan Hospital, Beijing 100621, P.R. China.
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Yan
authors.affiliation: Nantong Liangchun Rheumatology Hospital, Nantong, Jiangsu 226009, P.R. China.
authors.forename: Wanhua
authors.initials: W
authors.lastname: Zhu
authors.affiliation: Department of Rheumatism, The first affiliated hospital of Tianjin University of TCM, Tianjin 300193, P.R. China.
authors.forename: Wei
authors.initials: W
authors.lastname: Liu
authors.affiliation: Department of Rheumatism, Hubei Tongji Hospital, Wuhan, Hubei 430030, P.R. China.
authors.forename: Shenghao
authors.initials: S
authors.lastname: Tu
authors.affiliation: Shanxi Taiyuan Rheumatology Hospital, Taiyuan 030006, Shanxi, P.R. China.
authors.forename: Liping
authors.initials: L
authors.lastname: Hou
authors.affiliation: Department of Rheumatism, The first hospital affiliated to Jilin Changchun University of TCM, Changchun, Jilin 130021, P.R. China.
authors.forename: Chengwu
authors.initials: C
authors.lastname: Wang
authors.affiliation: Department of Rheumatism, The first hospital affiliated to Anhui University of TCM, Hefei, Anhui 230031, P.R. China.
authors.forename: Wandong
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Department of Rheumatism, Hunan Xiangya Hopital, Changsha, Hunan 410008, P.R. China.
authors.forename: Qinghua
authors.initials: Q
authors.lastname: Liang
authors.affiliation: Department of Rheumatism, Affiliated Hospital to Shandong University of TCM, Jinan, Shandong 250011, P.R. China.
authors.forename: Bing
authors.initials: B
authors.lastname: Fan
authors.affiliation: Department of Rheumatism, The first hospital affiliated to Jiangxi University of TCM, Nanchang 330020, Jiangxi, P.R. China.
authors.forename: Jiangping
authors.initials: J
authors.lastname: Yu
authors.affiliation: College of Pharmacy, The Second Military Medical University, Shanghai 200433, P.R. China.
authors.forename: Weidong
authors.initials: W
authors.lastname: Zhang
authors.affiliation: College of Pharmacy, The Second Military Medical University, Shanghai 200433, P.R. China.
authors.forename: Xinru
authors.initials: X
authors.lastname: Liu
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.
authors.forename: Jing
authors.initials: J
authors.lastname: Yang
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.
authors.forename: Xiaojuan
authors.initials: X
authors.lastname: He
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.
authors.forename: Xuyan
authors.initials: X
authors.lastname: Niu
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Rheumatism, The first hospital affiliated to Henan College of Chinese medicine, Zhengzhou, Henan, 450000, P.R. China.
authors.forename: Hongtao
authors.initials: H
authors.lastname: Guo
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon 999077, Hong Kong.
authors.forename: Bing
authors.initials: B
authors.lastname: He
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon 999077, Hong Kong.
authors.forename: Ge
authors.initials: G
authors.lastname: Zhang
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon 999077, Hong Kong.
authors.forename: Zhaoxiang
authors.initials: Z
authors.lastname: Bian
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R. China.|School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon 999077, Hong Kong.
authors.forename: Aiping
authors.initials: A
authors.lastname: Lu
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis* / Q000188:drug therapy*; D015897:Comorbidity; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D011379:Prognosis; D012720:Severity of Illness Index; D016896:Treatment Outcome; D029757:Tripterygium / Q000737:chemistry*; D055815:Young Adult
chemical_list: D018501:Antirheumatic Agents; D010936:Plant Extracts
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