Department of Acupuncture and Moxibustion, Affiliated hospital of Gansu University of Traditional Chinese Medicine, Lanzhou, Gansu Province.
College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province.
Medicine (Baltimore). 2021 Feb 12;100(6):e24279. doi: 10.1097/MD.0000000000024279.
BACKGROUND: Ankylosing spondylitis (AS) is a common infammatory rheumatic disease that affects the axial skeleton. Traditional Chinese medicine (TCM) nonpharmacological interventions are gaining an increasing popularity for AS. Nevertheless, the evidence of efficacy and safety of random controlled trials (RCTs) remains controversial. This study aims to evaluate the efficacy and acceptability of different TCM nonpharmacological therapies by systematic review and network meta-analysis. METHODS: According to the strategy, the authors will retrieve a total of 7 electronic databases by December 2020, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chongqing VIP, and Wan-fang databases After a series of screening, 2 researchers will use Aggregate Data Drug Information System and Stata software to analyze the data extracted from the randomized controlled trials of TCM nonpharmacological interventions for AS. The primary outcome will be the improvement of Pain intensity and functional status/disability and the secondary outcomes will include lobal improvement, health-related quality of life, satisfaction with treatment, and adverse events. Both classical meta-analysis and network meta-analysis will be implemented to investigate direct and indirect evidences on this topic. The quality of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation instrument. RESULTS: This study will provide a reliable evidence for the selection of TCM nonpharmacological therapies in the treatment of AS. CONCLUSION: This study will generate evidence for different TCM nonpharmacological therapies for AS and provide a decision-making reference for clinical research. ETHICS AND DISSEMINATION: This study does not require ethical approval. The results will be disseminated through a peer-reviewed publication. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/FHD2U.
背景:强直性脊柱炎(AS)是一种常见的炎性风湿性疾病,影响中轴骨骼。传统的中医(TCM)非药物干预措施在 AS 中的应用越来越受到关注。然而,随机对照试验(RCT)的疗效和安全性证据仍然存在争议。本研究旨在通过系统评价和网络荟萃分析评估不同 TCM 非药物疗法的疗效和可接受性。
方法:根据策略,作者将在 2020 年 12 月前通过 7 个电子数据库(包括 PubMed、Cochrane 图书馆、EMbase、中国知网、中国生物医学文献数据库、重庆维普和万方数据库)检索总共 7 个电子数据库。经过一系列筛选,2 名研究人员将使用聚合数据药物信息系统和 Stata 软件分析从中提取的 TCM 非药物干预 AS 的随机对照试验的数据。主要结局将是疼痛强度和功能状态/残疾的改善,次要结局将包括整体改善、健康相关生活质量、对治疗的满意度和不良事件。将采用经典荟萃分析和网络荟萃分析来调查该主题的直接和间接证据。使用推荐评估、制定和评价工具评估证据的质量。
结果:本研究将为 TCM 非药物疗法治疗 AS 的选择提供可靠的证据。
结论:本研究将为 AS 的不同 TCM 非药物疗法提供证据,并为临床研究提供决策参考。
伦理和传播:本研究不需要伦理批准。结果将通过同行评审出版物进行传播。
OSF 注册号:DOI 10.17605/OSF.IO/FHD2U。
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