少药肝草汤治疗不宁腿综合征的疗效和安全性:系统综述和荟萃分析

Zhining Tian, Rong Li, Jingwen Wei, Wenying Huai, Jun Xia, Hua Jiang, Ying Xiong, Yunhui Chen
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引用次数: 3

摘要

不宁腿综合征(RLS)是一种常见的慢性神经系统疾病,其特征是无法抗拒和压倒性的冲动移动腿。近年来,越来越多的临床试验表明,中药少药干草汤(SG-Tang)可以改善RLS。然而,有必要对现有证据进行严格审查。本研究旨在评价SG-Tang治疗RLS的疗效和安全性。本研究的方案已注册并发表在国际前瞻性系统评价登记册(PROSPERO;CRD42020173520)。通过检索Cochrane图书馆、PubMed、EMBASE、Web of Science、中国生物医药数据库、中国国家知识基础设施、万方数据库、VIP信息库等自成立至2022年2月14日期间的文献,确定了SG-Tang治疗RLS疗效和安全性的随机临床试验(rct)。主要结局测量指标为总有效率,次要结局测量指标包括国际不宁腿综合征研究组不宁腿综合征严重程度评定量表(IRLS)、匹兹堡睡眠质量指数(PSQI)和不良事件发生率。使用Review Manager 5.3软件根据Cochrane干预措施系统评价手册和系统评价和meta分析指南的首选报告项目进行定量综合。本荟萃分析纳入了6项符合条件的随机对照试验。与常规药物相比,SG-Tang干预在总有效率(风险比[RR] = 1.22, 95%可信区间[CI] (1.09,1.36), P = 0.004)、IRLS(平均差[MD] = - 4.74, 95% CI (- 8.65, - 0.83), P = 0.02)、PSQI (MD = - 2.54, 95% CI (- 4.34, - 0.74), P = 0.006)、不良事件发生率(RR = 0.21, 95% CI (0.09, 0.31), P = 0.0005)方面均有显著改善。SG-Tang作为缓解RLS的补充和替代疗法可能是有效和安全的。然而,由于数据有限和纳入研究的方法学质量不理想,结果需要谨慎解释。需要进行更多设计良好、大规模、高质量、多中心的随机对照试验来进一步验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of Shaoyao Gancao Tang for restless leg syndrome: A systematic review and meta-analysis
Restless leg syndrome (RLS) is a common and chronic neurological disease characterized by an irresistible and overwhelming urge to move the legs. In recent years, a growing body of clinical trials has demonstrated that -traditional Chinese herbal medicine Shaoyao Gancao Tang (SG-Tang) may improve RLS. However, a critical examination of the available evidence is warranted. This study aimed to evaluate the efficacy and safety of SG-Tang in the treatment of RLS. The protocol of this study was registered and published at International Prospective Register of Systematic Reviews (PROSPERO; CRD42020173520). Randomized clinical trials (RCTs) on the efficacy and safety of SG-Tang in the treatment of RLS were identified by searching the Cochrane Library, PubMed, EMBASE, Web of Science, the Chinese Biological Medicine Database, China National Knowledge Infrastructure, Wanfang Database, and VIP Information Database from inception to February 14, 2022. The primary outcome measurements were the total effective rate, and the secondary outcome measurements included the International Restless Legs Syndrome Study Group Rating Scale for Severity of Restless Legs Syndrome (IRLS), the Pittsburgh Sleep Quality Index (PSQI), and the incidence of adverse events. The Review Manager 5.3 software was utilized to conduct quantitative synthesis according to the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Six eligible RCTs were included in this meta-analysis. Compared to conventional medications, SG-Tang intervention showed significant improvements in the total effective rate (risk ratio [RR] = 1.22, 95% confidence interval [CI] (1.09,1.36), P = 0.004), the IRLS (mean difference [MD] = −4.74, 95% CI (−8.65, −0.83), P = 0.02), and the PSQI (MD = −2.54, 95% CI (−4.34, −0.74), P = 0.006) with less incidence of adverse events (RR = 0.21, 95% CI (0.09, 0.31), P = 0.0005). SG-Tang may be effective and safe as a complementary and alternative treatment to relieve RLS. However, the results need to be interpreted with caution because of limited data and the undesirable methodological quality of the included studies. More well-designed, large-scale, high-quality, and multi-center RCTs are required to be performed for further verification.
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