What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials.

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials.
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DOI:
10.1016/j.apmr.2014.05.005
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发表时间:
2014-12
影响因子:
4.3
通讯作者:
Yeh, Gloria Y.
Yeh, Gloria Y.
中科院分区:
医学1区
文献类型:
--
作者:
Wayne, Peter M.;Berkowitz, Danielle L.;Litrownik, Daniel. E.;Buring, Julie E.;Yeh, Gloria Y.

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系统审查太极拳(TC)随机临床试验(RCTs)中不良事件(AE)报告的频率和质量。电子检索PubMed/MEDLINE和其他数据库,从开始到2013年3月的英文RCT。搜索词是太极,太极,太极拳。数据由两名研究人员独立提取。我们纳入了所有可用的随机对照试验(RCT),这些试验以英文发表,并使用太极拳作为干预措施。根据系统性综述和荟萃分析首选报告项目(PRISMA)指南报告研究的入选和排除。符合条件的RCT根据AE报告进行分类:1)未提及监测AE的方案或AE报告; 2)有或无明确监测AE的方案的AE报告。确定了153项合格的RCT,大多数针对老年人。只有50项合格试验(33%)报告了AE,其中只有18项试验(12%)还报告了明确的AE监测方案。方案不同方面的严谨性,系统监测太极和对照组。报告的AE通常为轻微和预期事件,主要与肌肉骨骼相关(例如,膝关节和背痛);未报告干预相关严重AE。太极不太可能导致严重的不良事件,但可能与轻微的肌肉骨骼疼痛有关。然而,不良事件的报告不佳和不一致极大地限制了关于太极拳安全性的结论。
Systematically review frequency and quality of adverse event (AE) reports in randomized clinical trials (RCTs) of Tai Chi (TC). Electronic searches of PubMed/MEDLINE and additional databases from inception through March 2013 of English-language RCTs. Search terms were tai chi, taiji, tai chi chuan. Data were independently extracted by two investigators. We included all available randomized controlled trials (RCTs) that were published in English and used Tai Chi as an intervention. Inclusion and exclusion of studies were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligible RCTs were categorized with respect to AE reporting: 1) No mention of protocols for monitoring AEs or reports of AEs; 2) Reports of AEs either with or without explicit protocols for monitoring AEs. 153 eligible RCTs were identified, most targeting older adults. Only 50 eligible trials (33%) included reporting of AEs, and of these, only 18 trials (12% overall) also reported an explicit AE monitoring protocol. Protocols varied with respect to rigor of systematic monitoring in both Tai Chi and comparison groups. Reported AEs were typically minor and expected, and primarily musculoskeletal related (e.g., knee and back pain); no intervention-related serious AEs were reported. Tai Chi is unlikely to result in serious adverse events, but may be associated with minor musculoskeletal aches and pains. However, poor and inconsistent reporting of AEs greatly limits the conclusions that can be drawn regarding the safety of Tai Chi.
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