Faculty of Regional Environment Science, Tokyo University of Agriculture, 1-1-1 Sakuragaoka, Setagaya-ku 156-8502, Tokyo, Japan.
Physical Education and Medicine Research Center Unnan, 328 Uji, Unnan City 699-1105, Shimane, Japan.
Nutrients. 2024 Aug 17;16(16):2744. doi: 10.3390/nu16162744.
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.
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.
Eligible CTs were assessed as "low risk" (11%, = 4), "medium risk" (13%, = 5), and "high risk" (76%, = 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 ( = 0.785) in the RoB 2 score between for-profit and academic research in the author's affiliated organization. There was no significant difference ( = 0.498) in the RoB score between the published year categories of 2000-2019 and 2020-2024, and no significant difference ( = 0.643) in the RoB score between English and Japanese language publications.
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)".
功能声称食品于 2015 年 4 月在日本推出，目的是让更多具有健康功能的产品能够贴上标签。产品的功能声称必须通过临床试验（CT）或系统评价中提供的科学证据来解释，但最近 CT 的质量尚不清楚。本研究的目的是使用 2018 年发布的“评估风险偏倚（RoB）的修订工具（RoB 2）”，对基于所有最近在消费者厅网站上发布的 CT 的通知进行风险偏倚评估。
2023 年 1 月 1 日至 2024 年 6 月 30 日期间，从消费者厅网站上发布的 CT 中筛选出共 38 篇符合条件的论文。RoB 2 工具为评估任何类型的随机试验结果的风险偏倚提供了一个框架。该工具使用五个领域来评估研究方法的质量。
符合条件的 CT 被评估为“低风险”（11%， = 4）、“中风险”（13%， = 5）和“高风险”（76%， = 29）。许多高度有偏倚的论文发表了。偏倚发生在所有五个领域，特别是“报告结果选择的偏倚（领域 5）”最为严重（“高风险”；75%）。对于与 RoB 相关的因素，在作者所属机构的营利性和学术研究之间，RoB 2 评分没有显著差异（ = 0.785）。在 2000-2019 年和 2020-2024 年出版年份类别之间，RoB 评分没有显著差异（ = 0.498），在英语和日语出版物之间，RoB 评分也没有显著差异（ = 0.643）。
总体而言，2023 年后提交的最新 CT 质量非常低，所有五个领域都存在偏倚，“报告结果选择的偏倚（领域 5）”最为严重。
