Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, and Placebo-Controlled Trial

JIA Qing-yun; WANG Yi-ru; SUN Da-wei; MAO Jian-chun; XUE Luan; GU Xiao-hua; YU Xiang; PIAO Xue-mei; XU Hao; LIANG Qian-qian

doi:10.1007/s11655-024-3768-7

Your Location：

Home >

Browse articles >

Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, and Placebo-Controlled Trial

Original Article | Updated：2025-01-21

- Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, and Placebo-Controlled Trial
- Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, and Placebo-Controlled Trial
- 中国结合医学杂志（英文版） 2025年31卷第2期页码：99-107
- Affiliations：
  
  1.Spine Institute, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai (200032), China
  2.Spine Institute, Shanghai University of Traditional Chinese Medicine, Shanghai (200032), China
  3.Key Laboratory of Theory and Therapy of Muscles and Bones, Ministry of Education (Shanghai University of Traditional Chinese Medicine), Shanghai (201203), China
  4.Department of Orthopedics, Linyi People's Hospital, Linyi, Shandong Province (273000), China
  5.Department of Orthopedics, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai (200437), China
  6.Department of Orthopedics, the Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai (200137), China
- Author bio：
  
  Prof. LIANG Qian-qian, E-mail: liangqianqian@shutcm.edu.cn
- Funds：
  
  National Natural Science Foundation of China(81920108032;81822050);State Administration of Traditional Chinese Medicine Young Qi Huang Scholar, Shanghai Science and Technology Innovation Action Plan Medical Innovation Research Project(21Y11921400);Innovation Team Project of Scientific Research Project of Traditional Chinese Medicine of Shanghai Health Committee(2022CX001);the Program for Innovative Research Team of Ministry of Science and Technology of China(2015RA4002);"Innovation Team" Development Projects(IRT1270);Shanghai TCM Medical Center of Chronic Disease(2022ZZ01009);Shandong Provincial Natural Science Foundation(ZR2022LZY002;ZR2021QH230)
- DOI：10.1007/s11655-024-3768-7
  中图分类号：
- 纸质出版日期：2025-02，
  
  网络出版日期：2024-12-21，
  
  录用日期：2024-02-04
- Accepted：
Scan QR Code
Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, and Placebo-Controlled Trial[J]. 中国结合医学杂志（英文版）, 2025,31(2):99-107.

JIA QING-YUN, WANG YI-RU, SUN DA-WEI, et al. Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, and Placebo-Controlled Trial. [J]. Chinese journal of integrative medicine, 2025, 31(2): 99-107.
Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, and Placebo-Controlled Trial[J]. 中国结合医学杂志（英文版）, 2025,31(2):99-107. DOI： 10.1007/s11655-024-3768-7.

JIA QING-YUN, WANG YI-RU, SUN DA-WEI, et al. Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, and Placebo-Controlled Trial. [J]. Chinese journal of integrative medicine, 2025, 31(2): 99-107. DOI： 10.1007/s11655-024-3768-7.

摘要

Abstract

Objective:

To explore the efficacy and safety of Juan Bi Pill (JBP) in treatment of active rheumatoid arthritis (RA).

Methods:

From February 2017 to May 2018

115 participants from 4 centers were randomly divided into JBP group (57 cases) and placebo group (58 cases) in a 1:1 ratio using a random number table method. Participants received a dose of JBP (4 g

twice a day

orally) combined with methotrexate (MTX

10 mg per week) or placebo (4 g

twice a day

orally) combined with MTX for 12 weeks. Participants were required with follow-up visits at 24 and 48 weeks

attending 7 assessment visits. Participants were undergo disease activity assessment 7 times (at baseline and 2

48 weeks) and safety assessments 6 times (at baseline and 4

48 weeks). The primary endpoint was 28-joint Disease Activity Score (DAS28-ESR and DAS28-CRP). The secondary endpoints included American College of Rheumatology (ACR) criteria for 20% and 50% improvement (ACR20/50)

Health Assessment Questionnaire Disability Index (HAQ-DI)

clinical disease activity index (CDAI)

visual analog scale (VAS)

Short Form-36 (SF-36) score

Medial Outcomes Study (MOS) sleep scale score

serum erythrocyte sedimentation rate (ESR)

C-reactive protein (CRP)

tender joint count

swollen joint count

and morning stiffness. The adverse reactions were observed during the treatment.

Results:

After 12 weeks of treatment

DAS28-ESR and DAS28-CRP scores in both groups were lower than before treatment (both

0.01)

while the remission rate of DAS28-ESR and DAS28-CRP and low disease activity of JBP group were higher than those in the placebo group (both

0.01). JBP demonstrated better efficacy on ACR20 and ACR50 compliance rate at 12 and 48 weeks comparing to placebo (all

0.05). The CDAI and HAQ-DI score

pain VAS and global VAS change of RA patients and physicians

the serum ESR and CRP levels

and the number of tenderness and swelling joints were lower than before treatment at 4

48 weeks in both groups (

0.05 or

0.01)

while the reduction of above indices in the JBP group was more obvious than those in the placebo group at 12 weeks (ESR and CRP

both

0.05 ) or at 12 and 48 weeks (all

0.01). There was no difference in adverse reactions between the 2 groups during treatment (

=0.75).

Conclusion:

JBP combined with MTX could effectively reduce disease activity in patients with RA in active stage

reduce the symptoms of arthritis

and improve the quality of life

while ensuring safety

reliability

and fewer adverse effects. (Trial registration: ClinicalTrials.gov

No. NCT02885597)

关键词

Keywords

Chinese medicineJuan Bi Pillmethotrexateactive rheumatoid arthritisrandomized controlled trial

references

浏览量

Downloads

CSCD

文章被引用时，请邮件提醒。

Submit

工具集

关联资源

Efficacy and Safety of Zihua Wenfei Zhisou Granule in Treatment of Postinfectious Cough: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Trial

Efficacy and Safety of Ganyushu Granule in Treatment of Premenstrual Syndrome with Gan (Liver) Depression and Qi Stagnation Syndrome: A Randomized, Double-Blind, Multicenter, Phase-Ⅱ Clinical Trial

Efficacy and Safety of Sanjie Analgesic Capsule in Patients with Endometriosis-Associated Pain: A Multicenter, 3:1 Randomized, Double-Blind, Placebo-Controlled Trial

Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy: A Multicenter Double-Blind Randomized Controlled Trial

Reyanning Mixture on Asymptomatic or Mild SARS-CoV-2 Infection in Children and Adolescents:A Randomized Controlled Trial