Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study

Abstract

Background: Traditional Chinese Medicine is complementary and an alternative to modern medicine. The combination therapies of herbal products with disease-modifying anti-rheumatic drugs are gradually and widely adopted in the management of rheumatoid arthritis (RA) in China. Purpose: To evaluate the efficacy and safety of Huayu-Qiangshen-Tongbi (HQT) decoction, a Chinese medicine formula, combined with methotrexate (MTX) in the treatment of patients with active RA, in comparison with the combination therapy of MTX with leflunomide (LEF). Methods: This pilot study was a monocenter, open-label, randomized controlled trial with two parallel arms. Ninety patients with active RA were randomly allocated to receive either HQT at a dose of 250 ml twice daily or LEF at a dose of 20 mg once daily, and all participants received MTX at a dose of 10-15 mg once weekly. The primary efficacy endpoint was the proportion of patients who achieved a 20% improvement in the American College of Rheumatology criteria (ACR20) after a 24-week treatment. Results: 84.4% (76/90) patients completed the 24-week observation. In the intention-to-treat analysis, the percentage values of patients achieving the ACR20 response criteria were 72.1% (31/43) in MTX + HQT group and 74.4% (32/43) in MTX + LEF group (p = 0.808). No significant difference was observed in other parameters, Wu et al. A Pilot Study for HQT including ACR50, ACR70, clinical disease activity index good responses, European League Against Rheumatism good response, remission rate, and low disease activity rate. The results of the per-protocol analysis showed consistency with those of the intention-to-treat analysis. The mean change from baseline at week 24 for the van der Heijde modified total sharp score had no significant difference between two groups (3.59 ± 4.75 and 1.34 ± 8.67 in the MTX + HQT group and MTX + LEF group, respectively, p = 0.613). The frequency of adverse events was similar in both groups (11 cases in the MTX + HQT and 17 cases in the MTX + LEF, p > 0.05). Conclusions: In patients with active RA, treatment with the combination of HQT and MTX was associated with improvement in signs, symptoms, and physical function. With a beneficial clinical response and acceptable tolerability, HQT or other Chinese medicine formula may be a good therapeutic option in combination with MTX for RA treatment.

Sustained Drug Treatment Alters the Gut Microbiota in Rheumatoid Arthritis

“…All participants provided their written informed consent to participate in this study before baseline sample collection. The 22 RA patients were part of a clinical study published in September 2020 ( 16 ).…”

“…In the early stages, we implemented a retrospective clinical study and an investigator-initiated randomized clinical study with methotrexate (MTX) as the baseline drug and leflunomide (LEF) as the control, both of which suggested that “HQT+MTX” may have similar or even better clinical efficacy and tolerability than “LEF+MTX”. Importantly, the “HQT+MTX” group had fewer adverse events compared to the “HQT+LEF” group ( 15 , 16 ). Along with the successful clinical trial of HQT, we have also conducted in-depth research on the mechanism of HQT for the treatment of RA and found that the mechanisms underlying the therapeutic effects of HQT on RA are closely related to its modulation of lncRNA uc.477 and miR-19b ( 17 ).…”

“…In addition, pharmacological studies have also confirmed that HQT can treat RA by anti-inflammatory and regulating the body’s bone metabolism ( 18 ). In this study, the herbal composition and dosage of HQT were detailed in a previous study ( 16 , 18 ).…”

Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Attenuates Rheumatoid Arthritis through Upregulating miR-125b to Suppress NF-κB-Induced Inflammation by Targeting CK2

“…The Huayu-Qiangshen-Tongbi (HQT) decoction, a Chinese medical formula developed by the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, is composed of a total of 10 herbs and has been demonstrated to exert a potent therapeutic effect on RA [ 8 , 9 ]. Moreover, our previous study has revealed that the combined therapy of HQT and methotrexate (MTX) exerts definite clinical effects on RA with less adverse effects in 45 patients with RA [ 9 , 10 ]. MTX is an essential medicine that is applicated as a first-line treatment for RA [ 11 ].…”

Quantitative Proteomic Analysis of Bi Zhong Xiao Decoction Against Collagen-induced Arthritis Rats in the Early and Late Stages

“…(10,11) It is also considered valuable in treating RA because it can greatly improve the quality of life, prevent joint structural damage, and is highly tolerated by RA patients. (12,13) Bi Zhong Xiao decoction (BZXD), a traditional Chinese herbal formula, has been used clinically for many years in our department to treat RA and has no signi cant side effects. In our previous studies, it was found that BZXD can improve the active movement of the joint and the ability of daily life in RA patients.…”