Liu Wei, Wu Yuan-Hao, Hu Si-Yuan, Zhong Cheng-Liang, Gao Ming-Li, Liu Dong-Wu, Wang Hai-Yun, Chen Mu-Zhi, Song Yue-Jin, Yang Ben-Zha-Xi, Zheng Qing-Shan, Yao Hua, Qi Xue-Bing, Li Gang
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, An-shan-xi Road #314, Nankai District, Tianjin, 300193, China.
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China.
Trials. 2016 Jul 27;17:359. doi: 10.1186/s13063-016-1481-3.
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.
通络化湿（TLHS）是传统藏药五味甘露的新配方，在中国已用于治疗类风湿性关节炎（RA）数百年。本研究旨在评估TLHS治疗RA患者的疗效和安全性。
这是一项在五个医疗中心对活动性RA患者进行的随机、双盲、安慰剂对照、剂量探索性研究。患者接受三剂（4.8、3.6或2.4克/天，口服）TLHS或安慰剂（每日三次，口服），持续8周。在开始治疗前及治疗后每2周进行血液采样、体格检查，并评估美国风湿病学会（ACR）20%改善（ACR20）标准。主要终点是ACR20。次要终点包括安全性。
共筛选出240名参与者，236名患者被随机分组（每组n = 59）；20名退出。8周后，TLHS 4.8克和3.6克组的ACR20改善显著高于安慰剂组（分别为P < 0.01和P < 0.05）。TLHS 4.8克组的ACR50改善显著高于安慰剂组（P < 0.01）。TLHS组的RA症状明显缓解。在TLHS组中，报告了失眠（n = 1）、胃肠反应（n = 2）、心律失常（n = 1）和轻度肝脏病变（n = 1）；在安慰剂组中，报告了肝功能障碍（n = 1）（P = 0.878）。
根据ACR20，TLHS改善了RA患者的症状。此外，TLHS是安全的。
中国临床试验注册中心：ChiCTR - TRC - 12003871。于2012年1月1日注册。
