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Open Access 01-12-2022 | Colchicine | Study protocol

Effect of Baihu and Guizhi decoction in acute gouty arthritis: study protocol for a randomized controlled trial

Authors: Yikun He, Chaoran Dai, Jiaying Shen, Qianwen Chen, Jiandong Gao, Xin Pan, Jing Gan

Published in: Trials | Issue 1/2022

Abstract

Background

The prevalence rates of gout worldwide have increased annually. Acute gouty arthritis (AGA) accounts for a large proportion of gout patients and causes severe physical and mental pain in patients. Controlling the occurrence and development of gout inflammation is the first step in the treatment of gout. The main treatment drugs in gout are non-steroid anti-inflammatory drugs (NSAIDs), colchicine, and glucocorticoids, but these treatments have many adverse reactions which limit their clinical application. Baihu and Guizhi decoction (BHGZ) is one of the classic prescriptions in the Synopsis of the Golden Chamber and is a good prescription for AGA. Previous clinical studies have shown that BHGZ confers a strong benefit for treating AGA. However, the literature shows a lack of high-quality RCT research on BHGZ with respect to AGA. Therefore, in this study, we use a randomized, double-blind, controlled study with a placebo to evaluate the clinical efficacy and safety of BHGZ on the AGA of moist heat arthralgia spasm syndrome.

Methods

This study is a randomized, double-blind, controlled clinical trial. A total of 102 adult participants with AGA of moist heat arthralgia spasm syndrome will be enrolled, with balanced treatment allocation (1:1). The experimental intervention will be BHGZ plus the low-dose colchicine, and the control intervention will be placebo plus the low-dose colchicine for 10 days. To study the clinical efficacy (including VAS score; joint tenderness, joint swelling, joint movement disorder; TCM evidence efficacy score) and the changes of inflammatory indexes. At the same time, the improvement of joint inflammation in patients with AGA will be observed from musculoskeletal ultrasound imaging, and the safety evaluation will be carried out.

Discussion

This study will be the first placebo-controlled RCT to assess whether BHGZ plus low-dose colchicine have beneficial effects on changing reducing inflammation of joints for patients with AGA of moist heat arthralgia spasm syndrome. The results of this trial will help to provide evidence-based recommendations for clinicians.

Trial registration

Chinese Clinical Trials Register ChiCTR1900024974. Registered on 5 August 2019

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Title: Effect of Baihu and Guizhi decoction in acute gouty arthritis: study protocol for a randomized controlled trial
Authors: Yikun He
Chaoran Dai
Jiaying Shen
Qianwen Chen
Jiandong Gao
Xin Pan
Jing Gan
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Colchicine
Gout
Joint Pain
Arthritis
Joint Swelling
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06194-z

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effect of Baihu and Guizhi decoction in acute gouty arthritis: study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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