5
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

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

      methods-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          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

          Related collections

          Most cited references45

          • Record: found
          • Abstract: found
          • Article: not found

          SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

          High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
            Bookmark
            • Record: found
            • Abstract: not found
            • Article: not found

            Global epidemiology of gout: prevalence, incidence, treatment patterns and risk factors

              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              2016 updated EULAR evidence-based recommendations for the management of gout.

              New drugs and new evidence concerning the use of established treatments have become available since the publication of the first European League Against Rheumatism (EULAR) recommendations for the management of gout, in 2006. This situation has prompted a systematic review and update of the 2006 recommendations.
                Bookmark

                Author and article information

                Contributors
                Journal
                Front Endocrinol (Lausanne)
                Front Endocrinol (Lausanne)
                Front. Endocrinol.
                Frontiers in Endocrinology
                Frontiers Media S.A.
                1664-2392
                13 October 2023
                2023
                : 14
                : 1218546
                Affiliations
                [1] 1 Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology , Wuhan, Hubei, China
                [2] 2 The Second School of Clinical Medicine, Tongji Medical College, Huazhong University of Science and Technology , Wuhan, Hubei, China
                [3] 3 Department of Rehabilitation Medicine, Wuhan No.1 Hospital, Tongji Medical College, Huazhong University of Science and Technology , Wuhan, Hubei, China
                [4] 4 Department of Endocrinology, Xianning Central Hospital, Hubei University of Science and Technology , Xianning, Hubei, China
                [5] 5 Clinical Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology , Wuhan, Hubei, China
                Author notes

                Edited by: James M Olcese, Florida State University, United States

                Reviewed by: Jian-Feng Tu, Beijing University of Chinese Medicine, China; Yuanjie Sun, China Academy of Chinese Medical Sciences, China

                *Correspondence: Yu Wang, wangyu2002628@ 123456163.com

                †These authors have contributed equally to this work

                Article
                10.3389/fendo.2023.1218546
                10611493
                37900149
                09b0d7ff-75a9-4840-b947-4c5f35d2e77a
                Copyright © 2023 Yu, Li, Fang, Ma, Wang, Lin, Liu, Tu, Chen, Xie, Zhang, Huang, Zheng and Wang

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 07 May 2023
                : 01 September 2023
                Page count
                Figures: 3, Tables: 2, Equations: 0, References: 46, Pages: 11, Words: 5229
                Funding
                This study was supported by the Traditional Chinese Medicine (TCM) Scientific Research Project of Hubei Provincial Health Commission (No. ZY2021Z002). The funder had no role in the study design; the collection, management, analysis, and interpretation of data; the reporting of results; or the decision to submit for publication.
                Categories
                Endocrinology
                Study Protocol
                Custom metadata
                Translational Endocrinology

                Endocrinology & Diabetes
                manual acupuncture,sham acupuncture,asymptomatic hyperuricemia,serum uric acid,randomized controlled trial,protocol

                Comments

                Comment on this article