Department of Pharmacological and Biomolecular Sciences, University of Milan, 20133 Milan, Italy.
Center for the Study of Atherosclerosis, Bassini Hospital, 20092 Cinisello Balsamo, Italy.
Nutrients. 2024 Feb 2;16(3):444. doi: 10.3390/nu16030444.
Red yeast rice (RYR) has a cholesterol-lowering effect due to the presence of bioactive components (monacolins, mainly monacolin K) that act by inhibiting the activity of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. The European Food Safety Authority (EFSA) assessed the use of RYR and, while pointing out several uncertainties regarding the available data, raised a warning related to the safety of RYR when used as a food supplement at a dose of monacolin as low as 3 mg/day. In their decision in June 2023, EFSA approved the use of monacolins from RYR at doses less than 3 mg/day. We therefore decided to interrogate the different adverse event reporting systems (FAERS and CAERS) and analyse the characteristics of the cases reported to be associated with RYR supplements, and we reviewed the most recent meta-analyses with a focus on the occurrence of muscle symptoms and liver dysfunction. In terms of all musculoskeletal disorders from September 2013 (when the first case related to RYR consumption was recorded) to 30 September 2023, 363,879 cases were reported in the FAERS, with the number of cases related to RYR consumption being very small and accounting for 0.008% of cases. In the same time frame, 27,032 cases of hepatobiliary disorders were reported, and the cases attributable to RYR ingestion accounted for 0.01% of all cases. A low rate of muscle symptoms and liver dysfunction attributed to RYR ingestion was also observed in the CAERS database, where only 34 cases of adverse muscle events and 10 cases of adverse liver events reported RYR as the suspect product, while 19 cases of both muscle events and 10 cases of adverse liver events reported it as a concomitant product. This profile mirrors that of meta-analyses of randomised clinical trials of RYR, in which RYR use was not associated with either liver dysfunction or muscular adverse symptoms.
红曲米（RYR）含有生物活性成分（主要为洛伐他汀），具有降低胆固醇的作用，这些成分通过抑制 3-羟基-3-甲基戊二酰基辅酶 A（HMG-CoA）还原酶的活性来发挥作用。欧洲食品安全局（EFSA）评估了 RYR 的使用情况，虽然指出了关于现有数据的几个不确定性，但对 RYR 作为膳食补充剂使用时提出了安全警告，当剂量低至 3 毫克/天时，其安全性存在问题。在 2023 年 6 月的决定中，EFSA 批准了 RYR 中的洛伐他汀在低于 3 毫克/天的剂量下使用。因此，我们决定查询不同的不良事件报告系统（FAERS 和 CAERS），并分析与 RYR 补充剂相关的报告病例的特征，我们还回顾了最近的荟萃分析，重点关注肌肉症状和肝功能障碍的发生情况。从 2013 年 9 月（记录到第一例与 RYR 消费相关的病例）到 2023 年 9 月 30 日，FAERS 报告了 363879 例与所有肌肉骨骼疾病相关的病例，与 RYR 消费相关的病例数量非常少，占病例的 0.008%。在同一时期，报告了 27032 例肝胆疾病病例，归因于 RYR 摄入的病例占所有病例的 0.01%。在 CAERS 数据库中，也观察到归因于 RYR 摄入的肌肉症状和肝功能障碍的低发生率，其中只有 34 例不良肌肉事件和 10 例不良肝脏事件报告 RYR 为可疑产品，而 19 例同时报告了肌肉事件和 10 例不良肝脏事件报告 RYR 为伴随产品。这一特征与 RYR 随机临床试验的荟萃分析相吻合，其中 RYR 的使用与肝功能障碍或肌肉不良症状无关。
