Evidence map›Paper›PMID 40661225›Full record

ArticleJournal of pain research2025

Efficacy and Safety of Bushen Jiedu Tongluo Decoction in Active Rheumatoid Arthritis: Study Protocol for a Multi-Center, Randomized, Double-Blind, Controlled Trial.

Yikun He, Jiaying Shen, Huihui Wu, Lan Chen, Qian Zhou, Qi Wang, Yafang Guo, Fan Wu, Xin Pan

Abstract read
In one paragraph

Article in Journal of pain research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Yikun He *Department of Rheumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.
Jiaying Shen *Department of Rheumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.
Huihui Wu *Department of Rheumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.
Lan ChenDepartment of Traditional Chinese Medicine, Shanghai Sanlin Kangde Community Health Service Center, Shanghai, 200124, People's Republic of China.
Qian ZhouDepartment of Traditional Chinese Medicine, Shanghai Nanmatou Community Health Service Center, Shanghai, 200127, People's Republic of China.
Qi WangDepartment of Traditional Chinese Medicine, Shanghai Punan Hospital of Pudong New District, Shanghai, 200125, People's Republic of China.
Yafang GuoDepartment of Traditional Chinese Medicine, Shanghai Pudong Hospital Affiliated to Fudan University, Shanghai, 201399, People's Republic of China.
Fan WuUltrasound Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.
Xin PanDepartment of Rheumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with the primary clinical symptoms of joint swelling and pain. Among the currently available therapeutic agents, methotrexate (MTX) is an internationally recognized first-line disease-modifying antirheumatic drug (DMARD) for RA and is widely used as a basic drug in combination therapies. The Bushen Jiedu Tongluo Decoction (BSJDTL), an herbal formula, has been used for the treatment of RA for more than ten years with a better curative effect. Therefore, we designed a multi-center, randomized, double-blind, placebo-controlled study, to scientifically evaluate the clinical efficacy and safety of BSJDTL for active RA. Methods: This was a multi-center, randomized, double-blind placebo-controlled trial. A total of 120 adult participants with active RA will be enrolled, with a balanced treatment allocation (1:1). The treatment intervention will be BSJDTL plus the conventional medicine methotrexate, and the control intervention will be placebo plus the conventional drug methotrexate for 24 weeks. In addition, both groups received folic acid during treatment to prevent side effects of methotrexate. The primary outcome was DAS28-ESR. Secondary outcomes included changes in joint symptoms and signs, ESR, CRP, MIF, MMP2, CD147, ICAM-1, VCAM-1, and HIF-1α levels, and joint evaluation via musculoskeletal ultrasound and X-ray. Discussion: We designed this multi-center, randomized, double-blind, placebo-controlled clinical trial, utilizing assessment of RA activity and imaging techniques (musculoskeletal ultrasound and X-ray) to scientifically evaluate the clinical efficacy and safety of BSJDTL for active RA. The results of this trial may provide insights into improving the clinical symptoms of patients with RA. We hope that this trial will provide preliminary evidence of the efficacy of BSJDTL in treating RA patients and that these results will aid researchers, practitioners, and patients alike. Aim: This study aimed to clarify the efficacy and safety of BSJDTL in patients with active RA. Trial Registration: International Traditional Medicine Clinical Trial Registry, ITMCTR2025000194.

Indexed as

Bushen Jiedu Tongluo Decoctionefficacyrandomized double-blind controlled clinical trialrheumatoid arthritis

Identifiers

PMID40661225
PMCPMC12258239

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.