Evaluating the effectiveness and safety of acupuncture on serum uric acid in asymptomatic hyperuricemia population: a randomized controlled clinical trial study protocol
Background The 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.Methods This 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 dissemination Ethics 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 registration ClinicalTrials.gov identifier, NCT05406830
基金:
This study was supported by the Traditional Chinese Medicine
(TCM) Scientific Research Project of Hubei Provincial Health
Commission (No. ZY2021Z002).
第一作者单位:[1]Huazhong Univ Sci & Technol,Tongji Hosp,Tongji Med Coll,Inst Integrated Tradit Chinese & Western Med,Wuhan,Hubei,Peoples R China
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推荐引用方式(GB/T 7714):
Yu Ling-ling,Li Chen-nan,Fang Meng-yue,et al.Evaluating the effectiveness and safety of acupuncture on serum uric acid in asymptomatic hyperuricemia population: a randomized controlled clinical trial study protocol[J].FRONTIERS IN ENDOCRINOLOGY.2023,14:doi:10.3389/fendo.2023.1218546.
APA:
Yu, Ling-ling,Li, Chen-nan,Fang, Meng-yue,Ma, Yan,Wang, Bo...&Wang, Yu.(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,
MLA:
Yu, Ling-ling,et al."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.(2023)