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

Ling-ling Yu; Chen-nan Li; Meng-yue Fang; Yan Ma; Bo Wang; Feng-ping Lin; Wen-Hua Liu; Sheng-hao Tu; Zhe Chen; Wen-xi Xie; Rui-Yuan Zhang; Yao Huang; Cui-Hong Zheng

doi:10.3389/fendo.2023.1218546

journal article Open Access Oct 13, 2023

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

Ling-ling Yu Chen-nan Li Meng-yue Fang Yan Ma

Bo Wang

Feng-ping Lin Wen-Hua Liu

Sheng-hao Tu Zhe Chen

Wen-xi Xie Rui-Yuan Zhang Yao Huang

Cui-Hong Zheng

Frontiers in Endocrinology Vol. 14 · Frontiers Media SA

View at Publisher Save 10.3389/fendo.2023.1218546

Abstract

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

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Details

Published: Oct 13, 2023
Vol/Issue: 14
License: View

Authors

China National GeneBank, Beijing Genomics Institute (BGI)–Shenzhen, Shenzhen, 518083, China.

Jiangsu University

Cite This Article

Ling-ling Yu, Chen-nan Li, Meng-yue Fang, et al. (2023). 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, 14. https://doi.org/10.3389/fendo.2023.1218546

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

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