Misleading presentations in functional food trials led by contract research organizations were frequently observed in Japan: meta-epidemiological study

Hidehiro Someko · Norio Yamamoto · Tatsuya Ito · Tomoharu Suzuki · Takahiro Tsuge · Hajime Yabuzaki +2 more

6 citations0/0 files storedJournal of Clinical Epidemiology

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Meta-analysis and systematic reviews Academic Publishing and Open Access Pharmaceutical industry and healthcare

Abstract

OBJECTIVES: The functional food market has experienced significant growth, leading to an uptick in clinical trials conducted by contract research organizations (CROs). Research focusing on CRO-managed trials and the communication of trial outcomes to the consumer market remains underexplored. This metaepidemiological study aims to evaluate the quality of randomized controlled trials (RCTs) facilitated by prominent CROs in Japan and to examine the quality of the representations used to convey their results to consumers. STUDY DESIGN AND SETTING: This study focused on the food trials that were registered in the University Hospital Medical Information Network Clinical Trial Registry or the International Clinical Trials Registry Platform by the top 5 CROs. Press releases of study results or advertisements of food products based on the study results were identified by conducting a Google search. The risk of bias in the RCT publications was independently assessed by 2 reviewers, who also evaluated the presence of "spin" in the abstracts and full texts. An assessment of "spin" in press releases/advertisements was undertaken. RESULTS: A total of 76 RCT registrations, 32 RCT publications, and 11 press releases/advertisements were included. Approximately 72% of the RCT publications exhibited a high risk of bias due to selective outcome reporting. "Spin" was present in the results of the abstract (72%), abstract conclusion (81%), full-text results (44%), and full-text conclusion (84%). "Spin" appeared in 73% of press releases/advertisements due to the selective outcome reporting. CONCLUSION: Functional food presentations in Japan frequently contained "spin." The Japanese government should more rigorously check whether food manufacturers report outcomes selectively.

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2019RoB 2: a revised tool for assessing risk of bias in randomised trials 2010Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes 2017Guidelines for reporting meta-epidemiological methodology research 2017Update on Trial Registration 11 Years after the ICMJE Policy Was Established 2018Effect of Heat-Killed Lactobacillus paracasei KW3110 Ingestion on Ocular Disorders Caused by Visual Display Terminal (VDT) Loads: A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study 2019Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions 2019Quality of Systematic Reviews of the Foods with Function Claims in Japan: Comparative Before- and After-Evaluation of Verification Reports by the Consumer Affairs Agency 2021Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports

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