背景:具有功能要求的食品于2015年4月在日本推出,以提供更多标有健康功能的产品。产品功能声明的功能必须通过临床试验(CT)或系统评价中提供的科学证据来解释,但近期CT的质量尚不清楚.这项研究的目的是使用2018年发布的“评估风险的修订工具(RoB2)”来评估偏见风险(RoB),该通知基于消费者事务机构网站上发布的所有最新CT。
方法:在2023年1月1日至2024年6月30日期间,在消费者事务机构网站上发布的基于CT的总共38篇论文符合资格。RoB2工具提供了一个框架,用于在任何类型的随机试验的结果中考虑偏倚的风险。该工具具有五个领域,用于评估研究方法的质量。
结果:合格的CT被评估为“低风险”(11%,n=4),“中等风险”(13%,n=5),和“高风险”(76%,n=29)。发表了许多高度偏见的论文。偏差发生在所有五个领域,特别是“报告结果(域5)选择的偏差”,这是最严重的(“高风险”;75%)。对于与RoB相关的元素,作者所属组织的营利性和学术研究的RoB2评分无显著差异(p=0.785)。2000-2019年和2020-2024年发布的年份类别之间的RoB得分没有显着差异(p=0.498),英语和日语出版物之间的RoB得分没有显着差异(p=0.643)。
结论:总体而言,2023年后提交的最新CT的质量非常低,发生在所有五个领域,并且对于“报告结果(域5)的选择偏差”最为严重。
BACKGROUND: The Foods with Function Claim was introduced in Japan in April 2015 to make more products available that are labeled with health functions. A product\'s functionality of function claims must be explained by the scientific evidence presented in clinical trials (CTs) or systematic reviews, but the quality of recent CTs is unclear. The purpose of this study was to evaluate the risk of bias (RoB) using \"a revised tool to assess risk (RoB 2)\" published in 2018 for notifications based on all recent CTs published on the Consumer Affairs Agency website.
METHODS: A total of 38 submitted papers based on CTs that were published on the Consumer Affairs Agency website during the period from 1 January 2023 to 30 June 2024 were eligible. The RoB 2 tool provides a framework for considering the risk of bias in the findings of any type of randomized trial. This tool with five domains was used to evaluate the quality of research methods.
RESULTS: Eligible CTs were assessed as \"low risk\" (11%, n = 4), \"medium risk\" (13%, n = 5), and \"high risk\" (76%, n = 29). A number of highly biased papers were published. Bias occurred in all five domains, especially \"bias in selection of the reported result (Domain 5)\", which was the most serious (\"high risk\"; 75%). For elements correlated with RoB, there was no significant difference (p = 0.785) in the RoB 2 score between for-profit and academic research in the author\'s affiliated organization. There was no significant difference (p = 0.498) in the RoB score between the published year categories of 2000-2019 and 2020-2024, and no significant difference (p = 0.643) in the RoB score between English and Japanese language publications.
CONCLUSIONS: Overall, the quality of the latest CTs submitted after 2023 was very low, occurring in all five domains, and was most serious for \"bias in selection of the reported result (Domain 5)\".