Department of Herbal Pharmacology, College of Korean Medicine, Gachon University, Seongnam, Republic of Korea.
Naturalis Inc., Seongnam, Republic of Korea.
Medicine (Baltimore). 2023 Jun 9;102(23):e33903. doi: 10.1097/MD.0000000000033903.
BACKGROUND: Rheumatoid arthritis is a chronic inflammatory autoimmune disease characterized by a wide range of clinical symptoms affecting various bodily functions, including skeletal, vascular, metabolic, and cognitive functions. This review aimed to evaluate the efficacy and safety of integrative medicine (East Asian herbal medicine combined with conventional medicine) used for the treatment of inflammatory pain in rheumatoid arthritis and to identify key candidate drugs based on the data. METHODS: A comprehensive literature search will be conducted in 4 core databases (PubMed, Excerpta Medica database, Cochrane Library, and Cumulative Index to Nursing & Allied Health Literature) 4 Korean databases (Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, Research Information Service System, and Korea Citation Index), 2 Chinese databases (Chinese National Knowledge Infrastructure Database and Wanfang data), and 1 Japanese database (Citation Information by National Institute of Informatics) for randomized controlled trials from December 13, 2022. Statistical analysis will be performed using R version 4.1.2 and R Studio program. The American College of Rheumatology 20/50/70 score and rate of adverse events will be the primary outcomes. All outcomes will be analyzed using a random-effects model to produce more statistically conservative results. Sensitivity, meta-regression, and subgroup analyses will be used to identify the sources of any heterogeneity in the study. The revised tool for assessing the risk of bias in randomized trials, version 2.0, will be used to evaluate methodological quality. The overall quality of evidence will be assessed according to the Grading of Recommendations Assessment, Development, and Evaluation Pro Framework. ETHICS AND DISSEMINATION: There are no ethical issues, as no primary data will be collected directly from the participants. The results of this review will be reported in a peer-reviewed scientific journal. TRIAL REGISTRATION: PROSPERO registration number: CRD42023412385.
背景:类风湿关节炎是一种慢性炎症性自身免疫性疾病,其临床症状广泛,影响多种身体功能,包括骨骼、血管、代谢和认知功能。本综述旨在评估东亚草药联合常规药物治疗类风湿关节炎炎症性疼痛的疗效和安全性,并根据数据确定关键候选药物。
方法:我们将对 4 个核心数据库(PubMed、Excerpta Medica 数据库、Cochrane 图书馆和 Cumulative Index to Nursing & Allied Health Literature)、4 个韩国数据库(Oriental Medicine Advanced Searching Integrated System、Korean Studies Information Service System、Research Information Service System 和 Korea Citation Index)、2 个中国数据库(中国国家知识基础设施数据库和万方数据)和 1 个日本数据库(国立情报学研究所的引文信息)进行全面的文献检索,以查找 2022 年 12 月 13 日以后发表的随机对照试验。使用 R 版本 4.1.2 和 R Studio 程序进行统计分析。美国风湿病学会 20/50/70 评分和不良事件发生率将作为主要结局。所有结局都将使用随机效应模型进行分析,以产生更具统计学稳健性的结果。敏感性分析、Meta 回归和亚组分析将用于确定研究中任何异质性的来源。将使用修订版随机试验偏倚风险评估工具(version 2.0)评估方法学质量。根据 Grading of Recommendations Assessment, Development, and Evaluation Pro 框架,评估证据的总体质量。
伦理和传播:由于不会直接从参与者那里收集原始数据,因此不存在伦理问题。本综述的结果将在同行评议的科学期刊上报告。
试验注册:PROSPERO 注册号:CRD42023412385。
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