Evaluating the effectiveness and safety of acupuncture on serum uric acid in asymptomatic hyperuricemia population: a randomized controlled clinical trial study protocol

Frontiers in Endocrinology

Endocrinology

Wen-hua Liu¹  Feng-ping Lin²  Bo Wang³  Yan Ma³  Wen-xi Xie⁴  Zhe Chen⁴  Rui-yuan Zhang⁴  Yao Huang⁴  Sheng-hao Tu⁴  Cui-hong Zheng⁴  Yu Wang⁴  Ling-ling Yu⁴  Meng-yue Fang⁵  Chen-nan Li⁵ 

[1] Clinical Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China;Department of Endocrinology, Xianning Central Hospital, Hubei University of Science and Technology, Xianning, Hubei, China;Department of Rehabilitation Medicine, Wuhan No.1 Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China;Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China;The Second School of Clinical Medicine, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China;

关键词: manual acupuncture;    sham acupuncture;    asymptomatic hyperuricemia;    serum uric acid;    randomized controlled trial;    protocol;   

DOI  :  10.3389/fendo.2023.1218546

 received in 2023-05-07, accepted in 2023-09-01,  发布年份 2023

来源: Frontiers

【 摘 要 】

BackgroundThe clinical dangers of asymptomatic hyperuricemia to human health have become increasingly prominent over the past 20 years. Previous studies have shown the potential benefits of acupuncture on uric acid levels in the body. However, definitive evidence is lacking. Our objective is to evaluate the efficacy and safety of acupuncture on serum uric acid (SUA) in individuals with asymptomatic hyperuricemia.MethodsThis is a randomized, single-blind, sham-controlled trial. A total of 180 eligible patients with asymptomatic hyperuricemia will be recruited at three hospitals in China. Patients will be randomly assigned in a 1:1 ratio to receive 16 sessions of manual acupuncture or sham acupuncture for 8 weeks. Patients will be followed up for 12 weeks. The primary outcome will be the change in SUA levels at week 8 after randomization. Secondary outcomes will include dynamic changes in SUA levels, efficacy rates, proportion of gout flare, body weight, and acute medication intake. The MGH Acupuncture Sensation Scale and adverse events related to acupuncture will be measured after each treatment. A blinding assessment will be performed on patients who receive at least one session of acupuncture. Data analyses will be performed on a full analysis set and a per-protocol set.Ethics and disseminationEthics approval has been obtained from the Clinical Trial Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology (approval no. 2021-S135). Written informed consent will be obtained from enrolled patients. The findings will be disseminated in a peer-reviewed journal.Clinical trial registrationClinicalTrials.gov identifier, NCT05406830

【 授权许可】

Unknown   
Copyright © 2023 Yu, Li, Fang, Ma, Wang, Lin, Liu, Tu, Chen, Xie, Zhang, Huang, Zheng and Wang