Ma Zhen-Yu, Yang Shu-Ping, Li Ying, Xu Tian-Tian, Yang Ya-Lin, Yang Hui-Yong, Li Heng-Bing, Zhou Le-Jin, Diao Yong, Li Su-Yun
School of Medicine, Huaqiao University, Quanzhou 362021, Fujian Province, China.
School of Medicine, Huaqiao University, Quanzhou 362021, Fujian Province, China.
J Integr Med. 2024 Mar;22(2):126-136. doi: 10.1016/j.joim.2024.01.008. Epub 2024 Feb 2.
Red yeast rice (RYR), a natural lipid-lowering agent, is widely used in clinical practice. However, the existing meta-analyses concerning the safety of RYR preparations have yielded inconsistent results, and the credibility of the evidence has not been quantified.
This study was designed to evaluate the existing evidence and offer a comprehensive understanding of the associations between the use of RYR preparations and various adverse health outcomes.
Seven literature databases were searched from inception to May 5, 2023, using medical subject headings and free-text terms (e.g., "red yeast rice," "Xuezhikang," and "Zhibitai").
Meta-analyses that investigated and quantitatively estimated associations between the use of RYR preparations and adverse health outcomes were included in this study.
Two researchers independently extracted data using a standardized data collection table; any disagreements were resolved by consulting a third researcher. Based on the participant, intervention, comparator and outcome (PICO) framework in each eligible meta-analysis, a series of unique associations between the use of RYR preparations and adverse health outcomes were determined. The associations' effect estimates were re-evaluated using random-effect models.
Fifteen meta-analyses, comprising 186 (164 unique) randomized controlled trials, were identified. Based on A MeaSurement Tool to Assess Systematic Reviews version 2, 3 (20%) and 12 (80%) of these meta-analyses had low and critically low confidence, respectively. A total of 61 unique associations between the use of RYR preparations and adverse health outcomes were extracted from eligible meta-analyses. Based on the random-effect models, 10 (16.4%) associations indicated a significant protective effect of RYR preparations against adverse health outcomes, while 5 (8.2%) indicated an increased risk of adverse health outcomes related to uric acid, alanine transaminase and aspartate transaminase levels. The other 46 (75.4%) associations showed no significant difference between the use of RYR preparations and control treatments. Regarding the credibility of the evidence, 21 (34.4%), 34 (55.7%) and 6 (9.8%) associations showed moderate, low and very low credibility, respectively.
The evidence examined in this study suggests that RYR preparations are safe; however, the credibility of the evidence was not high. Further high-quality evidence is required. Please cite this article as: Ma ZY, Yang SP, Li Y, Xu TT, Yang YL, Yang HY, Li HB, Zhou LJ, Diao Y, Li SY. Associations between the use of red yeast rice preparations and adverse health outcomes: An umbrella review of meta-analyses of randomized controlled trials. J Integr Med. 2024; 22(2): 126-136.
红曲米是一种天然降脂药物，在临床实践中广泛应用。然而，关于红曲米制剂安全性的现有荟萃分析结果并不一致，且证据的可信度尚未量化。
本研究旨在评估现有证据，并全面了解红曲米制剂的使用与各种不良健康结局之间的关联。
从各数据库建库至2023年5月5日，使用医学主题词和自由文本词（如“红曲米”“血脂康”和“脂必泰”）检索了7个文献数据库。
本研究纳入了调查并定量估计红曲米制剂使用与不良健康结局之间关联的荟萃分析。
两名研究人员使用标准化数据收集表独立提取数据；如有分歧，则通过咨询第三名研究人员解决。基于每项合格荟萃分析中的参与者、干预措施、对照和结局（PICO）框架，确定了红曲米制剂使用与不良健康结局之间的一系列独特关联。使用随机效应模型重新评估关联的效应估计值。
共识别出15项荟萃分析，包括186项（164项独特的）随机对照试验。根据《系统评价的测量工具》第2版，这些荟萃分析中分别有3项（20%）和12项（80%）的可信度低和极低。从合格的荟萃分析中总共提取了61项红曲米制剂使用与不良健康结局之间的独特关联。基于随机效应模型，10项（16.4%）关联表明红曲米制剂对不良健康结局有显著保护作用，而5项（8.2%）关联表明与尿酸、丙氨酸转氨酶和天冬氨酸转氨酶水平相关的不良健康结局风险增加。其他46项（75.4%）关联显示红曲米制剂使用与对照治疗之间无显著差异。关于证据的可信度，21项（34.4%）、34项（55.7%）和6项（9.8%）关联的可信度分别为中等、低和极低。
本研究审查的证据表明红曲米制剂是安全的；然而，证据的可信度不高。需要进一步的高质量证据。请引用本文：马子跃, 杨思平, 李毅, 徐婷婷, 杨艳丽, 杨慧勇, 李海波, 周立军, 刁勇, 李淑媛. 红曲米制剂使用与不良健康结局的关联：随机对照试验荟萃分析的伞状综述. 中西医结合学报. 年; 22(2): 126 - 136. （注：原文中“J Integr Med. 2024; 22(2): 126 - 136.”部分内容的年份缺失，译文按照原文保留了该格式）
