title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  TLHS improved the symptoms of patients with RA according to the ACR20. Moreover, TLHS was safe.
  
  
  
  Chinese Clinical Trial Registry: ChiCTR-TRC-12003871 . Registered on 1 January 2012.
authors.affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, An-shan-xi Road #314, Nankai District, Tianjin, 300193, China. fengshiliuwei@163.com.
authors.forename: Wei
authors.initials: W
authors.lastname: Liu
authors.affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, An-shan-xi Road #314, Nankai District, Tianjin, 300193, China.
authors.forename: Yuan-Hao
authors.initials: YH
authors.lastname: Wu
authors.affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, An-shan-xi Road #314, Nankai District, Tianjin, 300193, China.
authors.forename: Si-Yuan
authors.initials: SY
authors.lastname: Hu
authors.affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, An-shan-xi Road #314, Nankai District, Tianjin, 300193, China.
authors.forename: Cheng-Liang
authors.initials: CL
authors.lastname: Zhong
authors.affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China.
authors.forename: Ming-Li
authors.initials: ML
authors.lastname: Gao
authors.affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China.
authors.forename: Dong-Wu
authors.initials: DW
authors.lastname: Liu
authors.affiliation: Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.
authors.forename: Hai-Yun
authors.initials: HY
authors.lastname: Wang
authors.affiliation: Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.
authors.forename: Mu-Zhi
authors.initials: MZ
authors.lastname: Chen
authors.affiliation: Hubei Hospital of Traditional Chinese Medicine, Wuhan, China.
authors.forename: Yue-Jin
authors.initials: YJ
authors.lastname: Song
authors.affiliation: Tibetan Medicine Hospital of Qinghai Province, Xi'ning, China.
authors.forename: Ben-Zha-Xi
authors.initials: BZ
authors.lastname: Yang
authors.affiliation: Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
authors.forename: Qing-Shan
authors.initials: QS
authors.lastname: Zheng
authors.affiliation: Lanzhou Heshengtang Pharmaceutical Co. Ltd., Lanzhou, China.
authors.forename: Hua
authors.initials: H
authors.lastname: Yao
authors.affiliation: Beijing Highthink Pharmaceutical Service Technology Co. Ltd., Beijing, China.
authors.forename: Xue-Bing
authors.initials: XB
authors.lastname: Qi
authors.affiliation: Beijing Highthink Pharmaceutical Service Technology Co. Ltd., Beijing, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Li
mesh_terms: D000284:Administration, Oral; D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D002214:Capsules; D002681:China; D004185:Disability Evaluation; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D020127:Recovery of Function; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D002214:Capsules; D004365:Drugs, Chinese Herbal; C000626149:tong luo hua shi
keywords: Antirheumatic therapy; Rheumatoid arthritis; Tibetan medicine; Tong Luo Hua Shi capsules; Wu-wei-gan-lu decoction