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A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Tong Luo Hua Shi capsule, a modernized Tibetan medicine, in patients with rheumatoid arthritis.
Trials
Short Title: Trials
Format: Journal Article
Publication Year: 2016
Pages: 1 - 7
Sources ID: 93766
Notes: Accession Number: 117060448; Wei Liu 1; Email Address: fengshiliuwei@163.com Yuan-Hao Wu 1 Si-Yuan Hu 1 Cheng-Liang Zhong 1 Ming-Li Gao 2 Dong-Wu Liu 2 Hai-Yun Wang 3 Mu-Zhi Chen 3 Yue-Jin Song 4 Ben-Zha-Xi Yang 5 Qing-Shan Zheng 6 Hua Yao 7 Xue-Bing Qi 8 Gang Li 8 Liu, Wei 9 Wu, Yuan-Hao 9 Hu, Si-Yuan 9 Zhong, Cheng-Liang 9 Gao, Ming-Li 2 Liu, Dong-Wu 2; Affiliation:  1: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, An-shan-xi Road #314, Nankai District, Tianjin 300193, China  2: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China  3: Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China  4: Hubei Hospital of Traditional Chinese Medicine, Wuhan, China  5: Tibetan Medicine Hospital of Qinghai Province, Xi'ning, China  6: Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China  7: Lanzhou Heshengtang Pharmaceutical Co. Ltd., Lanzhou, China  8: Beijing Highthink Pharmaceutical Service Technology Co. Ltd., Beijing, China  9: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, An-shan-xi Road #314, Nankai District, Tianjin, 300193, China; Source Info: 7/27/2016, Vol. 17, p1; Subject Term: RHEUMATOID arthritis treatment; Subject Term: TREATMENT of arthritis; Subject Term: JOINT disease treatment; Subject Term: TIBETAN medicine; Subject Term: ASIAN medicine; Subject Term: RHEUMATOID arthritis diagnosis; Subject Term: ANTIRHEUMATIC agents; Subject Term: CAPSULES (Pharmacy); Subject Term: COMPARATIVE studies; Subject Term: CONVALESCENCE; Subject Term: DISABILITY evaluation; Subject Term: HERBAL medicine; Subject Term: RESEARCH methodology; Subject Term: MEDICAL cooperation; Subject Term: CHINESE medicine; Subject Term: ORAL medication; Subject Term: RESEARCH; Subject Term: RHEUMATOID arthritis; Subject Term: TIME; Subject Term: EVALUATION research; Subject Term: PAIN measurement; Subject Term: RANDOMIZED controlled trials; Subject Term: TREATMENT effectiveness; Subject Term: BLIND experiment; Subject Term: DRUG administration; Subject Term: DRUG dosage; Subject Term: CHINA; Author-Supplied Keyword: Antirheumatic therapy; Author-Supplied Keyword: Rheumatoid arthritis; Author-Supplied Keyword: Tibetan medicine; Author-Supplied Keyword: Tong Luo Hua Shi capsules; Author-Supplied Keyword: Wu-weigan-lu decoction; Number of Pages: 7p; Illustrations: 1 Diagram, 4 Charts; Document Type: journal article
Visibility: Public (group default)
Abstract: (Show)
Background: Tong Luo Hua Shi (TLHS) is a new formulation of the traditional Tibetan medicine Wu-wei-gan-lu that has been used for the treatment of rheumatoid arthritis (RA) for hundreds of years in China. This study aimed to evaluate the efficacy and safety of TLHS in patients with RA.Methods: This was a randomized, double-blind, placebo-controlled, dose-finding study performed in patients with active RA from five medical centers. Patients received three doses (4.8, 3.6, or 2.4 g/day po) of TLHS or placebo (tid po) for 8 weeks. Blood sampling, physical examination, and assessment of the American College of Rheumatology (ACR) 20 % improvement (ACR20) criteria were performed before and every 2 weeks after starting treatment. The primary endpoint was the ACR20. The secondary endpoints included safety.Results: A total of 240 participants were screened and 236 patients were randomized (n = 59/group); 20 dropped out. After 8 weeks, ACR20 improvements in the TLHS 4.8 g and 3.6 g groups were significantly higher than in the placebo group (P < 0.01 and P < 0.05, respectively). ACR50 improvement in the TLHS 4.8 g group was significantly higher compared with the placebo group (P < 0.01). Symptoms of RA were significantly relieved in the TLHS groups. In the TLHS groups, insomnia (n = 1), gastroenteric reactions (n = 2), arrhythmia (n = 1), and minor hepatic lesion (n = 1) were reported; in the placebo group, hepatic dysfunction (n = 1) was reported (P = 0.878).Conclusions: TLHS improved the symptoms of patients with RA according to the ACR20. Moreover, TLHS was safe.Trial Registration: Chinese Clinical Trial Registry: ChiCTR-TRC-12003871 . Registered on 1 January 2012. [ABSTRACT FROM AUTHOR]