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Quality of Systematic Reviews of the Foods with Function Claims in Japan: Comparative Before- and After-Evaluation of Verification Reports by the Consumer Affairs Agency

机译：日本对具有功能声明的食品进行系统审查的质量：消费者事务管理局对验证报告进行的前后评估比较

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>Background: 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. >Methods: 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. >Results: 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 (p < 0.001). >Conclusion: 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.
机译：>背景：在日本，2015年4月推出了一种具有健康要求的新型食品，称为“具有功能声明的食品（FFC）”，以便提供更多带有某些特定健康功能标签的产品。关于证实产品有效性，必须通过系统评价（SR）来解释提议的功能声明的科学证据，但是SR的质量尚不清楚。此次审查的目的是根据在日本消费者事务管理局（CAA）网站上注册的FFC评估SR的质量，并确定CAA在2016年的验证报告是否与SR的质量提高相关。 >方法：我们通过AMSTAR方法学质量检查表评估了每个SR的报告质量。我们搜索了2015年4月1日至10月31日（SR之前）和2017年7月1日至2018年1月31日（SR之后）的数据库。 >结果：在所审查的104个SR中，包括96种最终产品：其中51种（53.1％）是补品，42种（43.8％）是不含补品的加工食品，其中3种（3.1％）是新鲜食品。在104份SR中，有92份（88.5％）是定性评价（即，未进行荟萃分析），有12份（11.5％）进行了荟萃分析。 SR前和SR后的平均质量得分分别为6.2±1.8和5.0±1.9，具有统计学意义的下降（p <0.001）。 >结论：总体而言，基于FFC的SR后的方法和报告质量要比SR前的差。特别是，对研究选择和数据提取，检索策略，偏倚风险评估方法，发表偏倚的评估以及基于方法严谨性和所纳入研究的科学质量得出结论的描述和/或实施情况非常差。

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