Traditional Chinese Medicine Qingre Huoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis: A Multicenter, Double-Blind, Randomized Controlled Trial

作者：Xun Gong, Weixiang Liu, Xiaopo Tang, Jian Wang, Jian Liu, Qingchun Huang, Wei Liu, Yongfei Fang, Dongyi He, Ying Liu, Ming-Li Gao, Qingjun Wu, Shi Chen, Zhenbin Li, Yue Wang, Yan‐Ming Xie, Junli Zhang, Caiyun Zhou, Li Ma, Xinchang Wang, Chi Zhang, Quan Jiang · 发表于：Frontiers in Pharmacology · 年份：2021 · DOI：10.3389/fphar.2021.679588 · 被引用次数：17 · 研究领域：Rheumatoid Arthritis Research and Therapies、Pharmacological Effects of Natural Compounds、Chronic Lymphocytic Leukemia Research

Traditional Chinese medicine (TCM) has been used successfully to treat rheumatoid arthritis (RA). Qingre Huoxue treatment (Qingre Huoxue decoction (QRHXD)/Qingre Huoxue external preparation (QRHXEP)) is a therapeutic scheme of TCM for RA. To date, there have been few studies comparing the efficacy and safety of QRHXD and conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of active RA. This was investigated in a multicenter, double-blind, randomized controlled trial involving 468 Chinese patients with active RA [disease activity score (DAS)-28 > 3.2] treated with QRHXD/QRHXEP (TCM group), methotrexate plus hydroxychloroquine [Western medicine (WM) group], or both [integrative medicine (IM) group]. Patients were followed up for 24 weeks. The primary outcome measure was the change in DAS-28 from baseline to 24 weeks. The secondary outcome measures were treatment response rate according to American College of Rheumatology 20, 50, and 70% improvement criteria (ACR-20/50/70) and the rate of treatment-related adverse events (TRAEs). The trial was registered at ClinicalTrials.gov (NCT02551575). DAS-28 decreased in all three groups after treatment ( p < 0.0001); the score was lowest in the TCM group ( p < 0.05), while no difference was observed between the WM and IM groups ( p > 0.05). At week 24, ACR-20 response was 73.04% with TCM, 80.17% with WM, and 73.95% with IM (based on the full analysis set [FAS], p > 0...