Lyszczyk Meagan, Karkhaneh Mohammad, Gladwin Kerri Kaiser, Funabashi Martha, Zorzela Liliane, Vohra Sunita
Department of Medicine, University of Alberta, Edmonton, AB T6G 2G3, Canada.
Institute of Health Economics, Edmonton, AB T5J 3N4, Canada.
Children (Basel). 2021 Apr 29;8(5):358. doi: 10.3390/children8050358.
Mind-body interventions (MBIs) are one of the top ten complementary approaches utilized in pediatrics, but there is limited knowledge on associated adverse events (AE). The objective of this review was to systematically review AEs reported in association with MBIs in children. In this systematic review the electronic databases MEDLINE, Embase, CINAHL, CDSR, and CCRCT were searched from inception to August 2018. We included primary studies on participants ≤ 21 years of age that used an MBI. Experimental studies were assessed for whether AEs were reported on or not, and all other study designs were included only if they reported an AE. A total of 441 were included as primary pediatric MBI studies. Of these, 377 (85.5%) did not explicitly report the presence/absence of AEs or a safety assessment. There were 64 included studies: 43 experimental studies reported that no AE occurred, and 21 studies reported AEs. There were 37 AEs found, of which the most serious were grade 3. Most of the studies reporting AEs did not report on severity (81.0%) or duration of AEs (52.4%). MBIs are popularly used in children; however associated harms are often not reported and lack important information for meaningful assessment.
身心干预（MBIs）是儿科中使用的十大补充疗法之一，但关于相关不良事件（AE）的了解有限。本综述的目的是系统回顾儿童中与身心干预相关的不良事件报告。在本系统综述中，检索了电子数据库MEDLINE、Embase、CINAHL、CDSR和CCRCT，检索时间从建库至2018年8月。我们纳入了针对年龄≤21岁参与者且使用身心干预的原始研究。对实验研究评估是否报告了不良事件，所有其他研究设计仅在报告了不良事件时才纳入。共有441项研究被纳入作为儿科身心干预的原始研究。其中，377项（85.5%）未明确报告不良事件的存在与否或安全性评估。纳入的研究有64项：43项实验研究报告未发生不良事件，21项研究报告了不良事件。共发现37例不良事件，其中最严重的为3级。大多数报告不良事件的研究未报告不良事件的严重程度（81.0%）或持续时间（52.4%）。身心干预在儿童中广泛使用；然而，相关危害往往未被报告，且缺乏进行有意义评估所需的重要信息。
