A nationwide questionnaire study evaluated kidney injury associated with Beni-koji tablets in Japan

Shinzawa, Maki; Matsui, Isao; Doi, Yohei; Matsumoto, Ayumi; Takahashi, Atsushi; Nangaku, Masaomi; Isaka, Yoshitaka; Collaborators

doi:https://doi.org/10.1016/j.kint.2024.11.027

A nationwide questionnaire study evaluated kidney injury associated with Beni-koji tablets in Japan

Shinzawa, Maki; Matsui, Isao; Doi, Yohei et al.

Kidney International, 2025, 107(3), 530-540

アクセス数:1,331件（2025-09-07 17:48 集計）

固定URL: https://hdl.handle.net/11094/100703

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タイトル	A nationwide questionnaire study evaluated kidney injury associated with Beni-koji tablets in Japan
著者	NRID 1000030704788 1000030704788 researchmap permalink 7000009447 7000009447 Scopus Author ID 47661817400 47661817400 著者名 Shinzawa, Maki
	NRID 1000060456986 1000060456986 ORCID 0000-0001-8378-6130 0000-0001-8378-6130 researchmap permalink matsui-handai3857 matsui-handai3857 Scopus Author ID 24488796300 24488796300 著者名 Matsui, Isao
	NRID 1000030846382 1000030846382 ORCID 0000-0002-5165-291X 0000-0002-5165-291X researchmap permalink DOI-YOHEI DOI-YOHEI 著者名 Doi, Yohei
	NRID 1000040794053 1000040794053 著者名 Matsumoto, Ayumi
	NRID 1000010704786 1000010704786 researchmap permalink takahashi-handai3857 takahashi-handai3857 Scopus Author ID 55728349700 55728349700 著者名 Takahashi, Atsushi
	NRID 1000090311620 1000090311620 著者名 Nangaku, Masaomi
	NRID 1000000379166 1000000379166 researchmap permalink isaka-handai3857 isaka-handai3857 Scopus Author ID 16207611100 16207611100 ORCID 0000-0002-0820-7167 0000-0002-0820-7167 著者名 Isaka, Yoshitaka
	著者名 Collaborators
キーワード等	Beni-koji (red yeast rice)
	Fanconi syndrome
	kidney injury
内容	Shinzawa M., Matsui I., Doi Y., et al. A nationwide questionnaire study evaluated kidney injury associated with Beni-koji tablets in Japan. Kidney International 107, 530 (2025); https://doi.org/10.1016/j.kint.2024.11.027.
抄録	Red yeast rice, traditionally used in Asian cuisine and increasingly marketed as a dietary supplement for cholesterol management, has recently been linked to kidney dysfunction in Japan. In late 2023 to early 2024, multiple cases involving specific Beni-koji (red yeast rice) tablets from three different Beni-koji preparations, prompted a safety reevaluation. Although citrinin, a known nephrotoxin of red yeast rice, was not produced by the implicated strains, new safety concerns emerged. Here, we aimed to investigate the clinical, laboratory, and pathological features of affected patients with a two-phase nationwide survey of Japanese nephrologists. The initial survey captured clinical presentations, while the follow-up survey tracked changes in kidney function and gathered pathological data. Statistical analyses included trend assessments across estimated glomerular filtration rate (eGFR) categories and mixed-effects models for eGFR trajectories. Of 192 patients, 94.1% presented with low eGFR (under 60 ml/min/1.73m2). Laboratory findings revealed characteristics of Fanconi syndrome, including hypokalemia, hypophosphatemia, hypouricemia, glycosuria, and metabolic acidosis. Creatine kinase levels were not elevated suggesting no rhabdomyolysis related kidney injury. Kidney biopsies showed predominant tubulointerstitial changes, with 50% exhibiting tubulointerstitial nephritis and 32% showing tubular necrosis. Glomerular changes were less prominent. Following product discontinuation and treatment, Fanconi syndrome-related parameters improved significantly. However, 87% of patients still had eGFR under 60 ml/min/1.73m2 at the last observation. Our findings underscore the need for long-term follow-up of affected individuals and highlight the importance of rigorous safety evaluations for dietary supplements. Further research is necessary to establish definitive causal relationships and long-term outcomes.
出版者	Elsevier B.V.
収録物名	Kidney International
巻(号)	107(3)
ページ	530-540
刊行年月	2025-03-01
言語	英語
ハンドルURL	https://hdl.handle.net/11094/100703
PISSN	00852538
eISSN	15231755
関連情報 (isIdenticalTo)	DOI (出版社版) https://doi.org/10.1016/j.kint.2024.11.027
アクセス権	open access
権利情報	This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
出版タイプ	Version of Record
カテゴリ	学術雑誌論文 Journal Article

資源タイプ	学術雑誌論文
ローカル資源タイプ	学術雑誌論文
DCTERMS.bibliographicCitation	Kidney International. 2025, 107(3), p. 530-540
DC.title	A nationwide questionnaire study evaluated kidney injury associated with Beni-koji tablets in Japan
DC.creator	Shinzawa, Maki
	Matsui, Isao
	Doi, Yohei
	Matsumoto, Ayumi
	Takahashi, Atsushi
	Nangaku, Masaomi
	Isaka, Yoshitaka
	Collaborators
DC.publisher	Elsevier B.V.
DC.language' scheme='DCTERMS.RFC1766	英語
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2025-03-01
DC.identifier	https://doi.org/10.1016/j.kint.2024.11.027
DC.subject	Beni-koji (red yeast rice)
	Fanconi syndrome
	kidney injury
DC.description	Shinzawa M., Matsui I., Doi Y., et al. A nationwide questionnaire study evaluated kidney injury associated with Beni-koji tablets in Japan. Kidney International 107, 530 (2025); https://doi.org/10.1016/j.kint.2024.11.027.
DCTERMS.abstract	Red yeast rice, traditionally used in Asian cuisine and increasingly marketed as a dietary supplement for cholesterol management, has recently been linked to kidney dysfunction in Japan. In late 2023 to early 2024, multiple cases involving specific Beni-koji (red yeast rice) tablets from three different Beni-koji preparations, prompted a safety reevaluation. Although citrinin, a known nephrotoxin of red yeast rice, was not produced by the implicated strains, new safety concerns emerged. Here, we aimed to investigate the clinical, laboratory, and pathological features of affected patients with a two-phase nationwide survey of Japanese nephrologists. The initial survey captured clinical presentations, while the follow-up survey tracked changes in kidney function and gathered pathological data. Statistical analyses included trend assessments across estimated glomerular filtration rate (eGFR) categories and mixed-effects models for eGFR trajectories. Of 192 patients, 94.1% presented with low eGFR (under 60 ml/min/1.73m2). Laboratory findings revealed characteristics of Fanconi syndrome, including hypokalemia, hypophosphatemia, hypouricemia, glycosuria, and metabolic acidosis. Creatine kinase levels were not elevated suggesting no rhabdomyolysis related kidney injury. Kidney biopsies showed predominant tubulointerstitial changes, with 50% exhibiting tubulointerstitial nephritis and 32% showing tubular necrosis. Glomerular changes were less prominent. Following product discontinuation and treatment, Fanconi syndrome-related parameters improved significantly. However, 87% of patients still had eGFR under 60 ml/min/1.73m2 at the last observation. Our findings underscore the need for long-term follow-up of affected individuals and highlight the importance of rigorous safety evaluations for dietary supplements. Further research is necessary to establish definitive causal relationships and long-term outcomes.
DC.rights	This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
DC.format	100703
citation_title	A nationwide questionnaire study evaluated kidney injury associated with Beni-koji tablets in Japan
citation_author	Shinzawa, Maki
	Matsui, Isao
	Doi, Yohei
	Matsumoto, Ayumi
	Takahashi, Atsushi
	Nangaku, Masaomi
	Isaka, Yoshitaka
	Collaborators
citation_publisher	Elsevier B.V.
citation_language	英語
citation_date	2025-03-01
citation_journal_title	Kidney International
citation_volume	107
citation_issue	3
citation_firstpage	530
citation_lastpage	540
citation_doi	https://doi.org/10.1016/j.kint.2024.11.027
citation_public_url	https://hdl.handle.net/11094/100703

A nationwide questionnaire study evaluated kidney injury associated with Beni-koji tablets in Japan

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