SEARCHCROSS-SECTIONALnutrition, epidemiology

cross-sectional·nutrition, epidemiology, public health, systematic review·PMC10180741

A Cross-Sectional Study Based on Forty Systematic Reviews of Foods with Function Claims (FFC) in Japan: Quality Assessment Using AMSTAR 2

Nutrients · 8 authors, 8 centres

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TL;DR

It found that the majority of the systematic reviews had critically low or low quality, indicating significant deficiencies in their research methodology.

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790 CHARS

This cross-sectional study used the AMSTAR 2 tool to evaluate the quality of 40 systematic reviews (36 qualitative, 4 with meta-analysis) submitted as scientific evidence for the Foods with Function Claims system in Japan. Independent assessment by four reviewers found that a high percentage of reviews had poor descriptions across key methodological items. The most common critical flaw was the lack of a registered or accessible review protocol. The study concludes that most of these industry-produced systematic reviews have critically low reliability, suggesting that notifications have increased without sufficient understanding of systematic review methodology. Limitations include potential publication bias and the inability to assess the functionality of the products themselves.

STUDY TYPE

cross-sectional

SPECIALTY

nutrition

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100% · A

ORIGINAL PAPER

PMC10180741

A Cross-Sectional Study Based on Forty Systematic Reviews of Foods with Function Claims (FFC) in Japan: Quality Assessment Using AMSTAR 2

Nutrients

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ABSTRACT

Abstract Background: The Foods with Function Claims (FFC) was introduced in Japan in April 2015 to make more products available that are labeled with health functions. The products’ functionality of function claims must be explained by scientific evidence presented in systematic reviews (SRs), but the quality of recent SRs is unclear. This study assessed the quality of SRs in the FFC registered on the Consumer Affairs Agency (CAA) website in Japan. Methods: We searched the database from 1 April to 31 October 2022. Confidence in the methodological quality of each SR was evaluated by the AMSTAR 2 checklist. Results: Forty SRs were randomly extracted on the basis of the eligibility criteria and recruitment procedures. Overall confidence was rated as “high” ( N = 0, 0%), “moderate” ( N = 0, 0%), “low” ( N = 2, 5%), or “critically low” ( N = 38, 95%). The mean AMSTAR 2 score was 51.1% (SD 12.1%; range 19–73%). Among the 40 SRs, the number of critical domain deficiencies was 4 in 7.5% of SRs, 3 in 52.5% of SRs, 2 in 35% of SRs, and 1 in 5% of SRs. Registering the review’s protocol and comprehensive search strategies were particularly common deficiencies. Additionally, the risk of bias (RoB) was insufficiently considered. Conclusion: Overall, the methodological quality of the SRs based on the FFC, introduced eight years earlier, was very poor. This was especially true in the interpretation and discussion of critical domains, which had many deficiencies in terms of protocol registration, a comprehensive literature search strategy, and accounting for the RoB. Keywords: food, supplement, randomized controlled trial, risk of bias, systematic review

CITATION EXPORT

Hiroharu Kamioka, Hideki Origasa, Kiichiro Tsutani et al.. A Cross-Sectional Study Based on Forty Systematic Reviews of Foods with Function Claims (FFC) in Japan: Quality Assessment Using AMSTAR 2. Nutrients. (2023). https://doi.org/10.3390/nu15092047

AUTHORS

8 · 8 CENTRES

Hiroharu Kamioka, Hideki Origasa, Kiichiro Tsutani, Jun Kitayuguchi, Takahiro Yoshizaki, Mikiko Shimada, Yasuyo Wada, Hiromi Takano-Ohmuro

1Faculty of Regional Environment Science, Tokyo University of Agriculture, 1-1-1 Sakuragaoka, Setagaya-ku, Tokyo 156-8502, Japan
2The Institute of Statistical Mathematics, 10-3 Midori-cho, Tachikawa, Tokyo 190-8562, Japan
3The Institute of Seizon and Life Sciences, 4-5-1 Ginza, Chuo-ku, Tokyo 104-0061, Japan
4Physical Education and Medicine Research Center Unnan, 328 Uji, Unnan City 699-1105, Japan
5Faculty of Food and Nutritional Sciences, Toyo University, 1-1-1 Izumino, Itakura Town 374-0193, Japan
6Department of Nutrition, Faculty of Health Care, Kiryu University, 606-7 Asami, Midori City 379-2329, Japan
7Department of Health Promotion, National Institute of Public Health, 2-3-6 Minami, Wako City 351-0197, Japan
8Research Institute of Pharmaceutical Sciences, Musashino University, 1-1-20 Aramachi, Nishitokyo, Tokyo 202-8585, Japan