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Abstract
Objective
A systematic review of animal and human studies was conducted on genetically modified (GM) food consumption to assess its safety in terms of adverse effects/events to inform public concerns and future research.
Methods
Seven electronic databases were searched from January 1st 1983 till July 11th 2020 for in vivo, animal and human studies on the incidence of adverse effects/events of GM products consumption. Two authors independently identified eligible studies, assessed the study quality, and extracted data on the name of the periodical, author and affiliation, literature type, the theme of the study, publication year, funding, sample size, target population characteristics, type of the intervention/exposure, outcomes and outcome measures, and details of adverse effects/events. We used the Chi-square test to compare the adverse event reporting rates in articles funded by industry funding, government funding or unfunded articles.
Results
One crossover trial in humans and 203 animal studies from 179 articles met the inclusion criteria. The study quality was all assessed as being unclear or having a high risk of bias. Minor illnesses were reported in the human trial. Among the 204 studies, 59.46% of adverse events (22 of 37) were serious adverse events from 16 animal studies (7.84%). No significant differences were found in the adverse event reporting rates either between industry and government funding (χ2 = 2.286, P = 0.131), industry and non-industry funding (χ2 = 1.761, P = 0.185) or funded and non-funded articles (χ2 = 0.491, P = 0.483). We finally identified 21 GM food-related adverse events involving 7 GM events (NK603 × MON810 maize, GTS 40-3-2 soybean, NK603 maize, MON863 maize, MON810 maize, MON863 × MON810 × NK603 maize and GM Shanyou 63 rice), which had all been on regulatory approval in some countries/regions.
Conclusion
Serious adverse events of GM consumption include mortality, tumour or cancer, significant low fertility, decreased learning and reaction abilities, and some organ abnormalities. Further clinical trials and long-term cohort studies in human populations, especially on GM food-related adverse events and the corresponding GM events, are still warranted. It suggests the necessity of labelling GM food so that consumers can make their own choice.
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Details

1 Beijing University of Chinese Medicine, Centre for Evidence-Based Chinese Medicine, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176)
2 Beijing Institute of Radiation Medicine, Beijing, China (GRID:grid.410740.6) (ISNI:0000 0004 1803 4911)
3 Beijing University of Chinese Medicine, School of Chinese Medicine, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176)
4 China National Research Institute of Food & Fermentation Industries Co,. Ltd, Beijing Key Laboratory of the Innovative Development of Functional Staple and the Nutritional Intervention for Chronic Disease, Beijing, China (GRID:grid.464225.3)
5 Beijing University of Chinese Medicine, School of Life Sciences, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176)
6 Beijing University of Chinese Medicine, School of Chinese Materia Medica, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176)
7 Ruikang Hospital, Guangxi University of Chinese Medicine, Guangxi, China (GRID:grid.411858.1) (ISNI:0000 0004 1759 3543)
8 Beijing University of Chinese Medicine, Centre for Evidence-Based Chinese Medicine, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176); London South Bank University, School of Health and Social Care, London, UK (GRID:grid.4756.0) (ISNI:0000 0001 2112 2291)
9 Beijing University of Chinese Medicine, Centre for Evidence-Based Chinese Medicine, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176); Beijing University of Chinese Medicine, Institute for Excellence in Evidence-Based Chinese Medicine, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176)