AUTHOR=Ran Lei , Xu Bo , Han Hai-Hui , Wang Jian-Ye , A Xin-Yu , Cao Bo-Ran , Meng Xiao-Hui , Zhang Cheng-Bo , Xin Peng-Fei , Qiu Guo-Wei , Xiang Zheng , Pei Shao-Qiang , Gao Chen-Xin , Shen Jun , Zhong Sheng , Xu Xi-Rui , Bian Yan-Qin , Xie Jun , Shi Qi , Sun Song-Tao , Xiao Lian-Bo 

TITLE=The effect of JuanBiQiangGu granules in combination with methotrexate on joint inflammation in rheumatoid arthritis: a randomized controlled trial

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 14 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1132602

DOI=10.3389/fphar.2023.1132602

ISSN=1663-9812

ABSTRACT=Background: Rheumatoid arthritis (RA) joint inflammation severely affects joint function and quality of life in patients and leads to joint deformities and limb disability. Traditional Chinese medicine formula JuanBiQiangGu Granules (JBQG) is commonly used for the treatment of RA inflammation and delay of bone destruction, but has not been evaluated through high-quality clinical studies. There is a pressing need for well-designed, randomized, parallel, controlled clinical studies to evaluate the exact effect of JBQG on RA joint inflammation and improvement of patient quality of life.
Methods: This is a randomized, parallel, controlled clinical study in which 144 patients with rheumatoid arthritis who met the inclusion criteria were randomly assigned to 2 groups in a 1:1 ratio. The JBQG group received methotrexate 7.5 mg qw and JBQG granules 8 mg tid, while the MTX group received methotrexate 7.5 mg qw. The endpoint was 12 weeks after treatment. The patients' DAS28-ESR scores, HAQ-DI scores and Sharp scores were recorded at 4, 8 and 12 weeks after drug administration, and blood samples were collected to detect CRP, ESR, TNF-α, IL-1β, IL-6, IL-17, INF-γ, adverse effects and liver and kidney function (AST, ALT, Cr, BUN) indexes for safety evaluation.
Results: A total of 144 subjects completed treatment (71 in the JBQG group and 73 in the MTX group) and were included in the analysis. After treatment, the JBQG group had Remission of 45.07% and High of 5.63% compared to the MTX group. the MTX group had Remission of 12.33% and High of 17.81%. In addition, JBQG group can reduce the expression of CRP, ESR, TNF-α, IL-17, INF-γ, and β-CTX in the blood of RA patients and increase the expression of OPG (P<0.05), decreasing HAQ-DI, VSA scores, and Sharp score. The AST and ALT levels in the JBQG group were lower than those in the MTX group, with a statistically significant difference (P<0.05), but no statistical significance in Cr and BUN (P>0.05).
Conclusion: JuanBiQiangGu Granules can be used to treat patients with rheumatoid arthritis, alleviate joint inflammation, reduce the incidence of adverse reactions to methotrexate, and has good safety.