Faculty of Regional Environment Science, Tokyo University of Agriculture, 1-1-1 Sakuragaoka, Setagaya-ku, Tokyo 156-8502, Japan.
Tokyo Ariake Medical and Health Sciences University, 2-9-1 Ariake, Kouto-ku, Tokyo 135-0063, Japan.
Nutrients. 2019 Jul 12;11(7):1583. doi: 10.3390/nu11071583.
In Japan, a new type of foods with health claims, called Foods with Function Claims (FFC), was introduced in April 2015 in order to make more products available that are clearly labeled with certain health functions. Regarding substantiating product effectiveness, scientific evidence for the proposed function claims must be explained by systematic reviews (SRs), but the quality of SRs was not clear. The objectives of this review were to assess the quality of SRs based on the FFC registered on the Consumer Affairs Agency (CAA) website in Japan, and to determine whether the CAA's verification report in 2016 was associated with improvement in the quality of SRs. We evaluated the reporting quality of each SR by the AMSTAR checklist on methodological quality. We searched the database from 1 April to 31 October 2015 as the before-SR and from 1 July 2017 to 31 January 2018 as the after-SR. Among the 104 SRs reviewed, 96 final products were included: 51 (53.1%) were supplements, 42 (43.8%) were processed foods without supplements, and 3 (3.1%) were fresh foods. Of the 104 SRs, 92 (88.5%) were qualitative reviews (i.e., without meta-analysis) and 12 (11.5%) performed a meta-analysis. The average quality score of before-SRs and after-SRs was 6.2 ± 1.8 and 5.0 ± 1.9, respectively, a statistically significant decrease ( < 0.001). Overall, the methodology and reporting quality of after-SRs based on the FFC were poorer than those of before-SRs. In particular, there were very poor descriptions and/or implementations of study selection and data extraction, search strategy, evaluation methods for risk of bias, assessment of publication bias, and formulating conclusions based on methodological rigor and scientific quality of the included studies.
在日本，为了推出更多明确标注特定健康功能的产品，2015 年 4 月引入了一种新型具有保健功能声称的食品，称为“特定保健用食品”（FFC）。关于证实产品功效，必须通过系统评价（SR）来解释拟议功能声称的科学证据，但 SR 的质量并不明确。本次审查的目的是根据日本消费者事务局（CAA）网站上注册的 FFC 评估 SR 的质量，并确定 2016 年 CAA 的验证报告是否与 SR 质量的提高有关。我们使用 AMSTAR 清单评估了每个 SR 的报告质量，以评估方法质量。我们从 2015 年 4 月 1 日至 10 月 31 日作为 SR 前检索数据库，从 2017 年 7 月 1 日至 2018 年 1 月 31 日作为 SR 后检索数据库。在审查的 104 篇 SR 中，有 96 项最终产品被纳入：51 项（53.1%）为补充剂，42 项（43.8%）为无补充剂的加工食品，3 项（3.1%）为新鲜食品。在 104 篇 SR 中，92 篇（88.5%）为定性综述（即无荟萃分析），12 篇（11.5%）进行了荟萃分析。SR 前和 SR 后的平均质量评分为 6.2±1.8 和 5.0±1.9，有统计学显著下降（<0.001）。总体而言，基于 FFC 的 SR 后方法学和报告质量不如 SR 前。特别是，研究选择和数据提取、搜索策略、偏倚风险评估方法、发表偏倚评估以及基于纳入研究的方法严谨性和科学质量制定结论的描述和/或实施都非常差。
