Combining Traditional Chinese Herbs and csDMARDs for the Treatment of Rheumatoid Arthritis Involves Tapering and Discontinuing Glucocorticoids: Protocol for a Two-Stage Non-Randomized Controlled Trial

Xingqiang Wang; Xianna Yang; Shiqi Wang; Xiaofang Tian; Jianmei Yin; Nian Liu; Pengtao Di; Jipeng Qi; Ya Li; Jimin Chen; Yang Wu; Jingjin Wu; Weiqing Zhao; Jiangyun Peng; Ling Zhang; Lingli Gu

doi:10.2147/IJGM.S444056

Combining Traditional Chinese Herbs and csDMARDs for the Treatment of Rheumatoid Arthritis Involves Tapering and Discontinuing Glucocorticoids: Protocol for a Two-Stage Non-Randomized Controlled Trial

Int J Gen Med. 2024 Mar 5:17:827-839. doi: 10.2147/IJGM.S444056. eCollection 2024.

Authors

Xingqiang Wang^#^{1

2}, Xianna Yang^#³, Shiqi Wang^#³, Xiaofang Tian¹, Jianmei Yin³, Nian Liu³, Pengtao Di¹, Jipeng Qi³, Ya Li³, Jimin Chen^{3

4}, Yang Wu¹, Jingjin Wu^{1

2}, Weiqing Zhao⁵, Jiangyun Peng^{1

2}, Ling Zhang^{1

2}, Lingli Gu¹

Affiliations

¹ Department of Rheumatology, The No. 1 Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, Kunming, Yunnan, 650021, People's Republic of China.
² Yunnan Provincial Clinical Medicine Research Center of Rheumatism in TCM, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, 650021, People's Republic of China.
³ The First School of Clinical Medicine, Yunnan University of Chinese Medicine, Kunming, Yunnan, 650021, People's Republic of China.
⁴ Department of Integrative Internal Medicine, The Lijiang Hospital of Traditional Chinese Medicine, Lijiang, Yunnan, 674100, People's Republic of China.
⁵ Department of Rheumatology and Immunology, The First People's Hospital of Yunnan Province and The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, 650034, People's Republic of China.

^# Contributed equally.

Abstract

Glucocorticoids (GC) are crucial in the treatment of rheumatoid arthritis (RA), but discontinuing GC effectively in RA patients poses a significant challenge for rheumatologists. In this two-stage, single-center, non-randomized controlled trial, we investigated the benefits of combining Chinese traditional herbal treatment with csDMARDs to aid GC discontinuation in terms of GC tapering, disease control, and safety. A total of 231 participants were enrolled, of which 150 eligible subjects were included in the first phase and allocated to three groups (control group, treatment group 1, and treatment group 2) based on their willingness to take traditional Chinese medicine and syndrome differentiation, in a 1:1:1 ratio. All groups received basic treatment consisting of methotrexate tablets (10 mg, qw), leflunomide (10 mg, qd), and stratified GC bridging therapy and tapering regimen (The intervention regimen was developed based on rigorous adherence to available evidence). Treatment group 1 received basic treatment combined with Juanbi Granule, while treatment group 2 received basic treatment combined with Yupingfeng Guizhi Decoction Granule. Efficacy was evaluated after a 12-week follow-up, with slightly adjustments to the treatment group based on efficacy and change of syndrome, followed by continued observation until 24 weeks to complete the study. The efficacy evaluation and data analysis were conducted in a blinded manner, including group label concealment, data cleaning, confounder and control regimen analysis, and outcome analysis. This project has received ethical approval from the Ethics Committee of Yunnan Provincial Hospital of Traditional Chinese Medicine (YLZ [2022] Ethical Review No. (006)-01) and has been registered with the China Clinical Trials Registry (Registration number: ChiCTR2300067676, Registered 17 January 2023, https://www.chictr.org.cn/showproj.html?proj=184908). This trial was the first to evaluate the clinical efficacy of combining Chinese herbal medicines with standard Western medicines to facilitate the discontinuation of glucocorticoid (GC) therapy in patients with rheumatoid arthritis (RA).

Keywords: Juanbi Decoction; Yupingfeng Guizhi Decoction; clinical trial; glucocorticoids tapering; rheumatoid arthritis; traditional Chinese medicine.

Grants and funding

This work is supported by grants from National Natural Science Foundation of China (81960863, 82160901, 82360924), the Construction Project of Yunnan Provincial Fund for Medical Research Center (202102AA310006), the Construction Project of National Traditional Chinese Medicine Clinical Research Base (2018 No. 131), the Construction Project for the focal branch of National Traditional Chinese Medicine (2023 No. 85), the Expert Workstation of zhangxuan in Yunnan Province (202305AF150175), the Yunnan Applied Basic Research Projects (202101AT070230), the Funding of Yunnan Applied Basic Research Projects-Union Foundation (2019FF002(−082), 2019FF002(−031), 202101AZ070001-072), Construction Project Funding of University Key Laboratories in Yunnan Province (2018TGZ01), and the Funding of Yunnan Provincial Health Science and Technology Plan (2018NS0045, 2018NS0046).