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Comparison of the lipid-lowering efficacies of simvastatin and red yeast rice; a & b Comparison of lipid levels at week 4 and baseline in the simvastatin and red yeast rice groups (mean ± SD). No significant changes in TG or HDL levels were observed in either arm; c Comparison of the percentage changes in the lipid (TC and LDL) levels from baseline to week 4 (mean ± SD). The decrease in both the TC and LDL levels were comparable between the two groups.* TC levels, P < .001 vs. baseline in simvastatin group. ** LDL levels, P < .001 vs. baseline in simvastatin group. # TC levels, P < .001 vs. baseline in red yeast rice group. ## LDL levels, P < .001 vs. baseline in red yeast rice group
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Background
About 10–15% patients who take statins experience skeletal muscle problems. Red yeast rice has a good safety profile could provide a compromise therapeutic strategy. Therefore, the aim of this study was to evaluate the effects of red yeast rice, when compared to simvastatin, on the muscle fatigue symptom and the serum lipid level in dysl...
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... Clinical trials comparing RYR with other statin preparations [56][57][58][59][60][61][62][63][64][65][66] have reported reductions in LDL-C from baseline of up to 33.4%, generally similar to the statin comparator in each study. However, most of these studies were performed in China and are not of high quality. ...
... This formulation is discussed further in Section 2.7. Certain studies have also reported that RYR significantly reduced TC [59][60][61][62][63]65,66] and triglycerides [56][57][58]62,65,66], while effects on HDL-C were generally small and inconsistent [57][58][59][60][62][63][64][65][66] (Supplemental Table S2). ...
... Overall, RYR has been well tolerated in clinical trials with 4-24 weeks of treatment in diverse populations with dyslipidemia, including those who are intolerant to statins [44,47,49,[51][52][53][54][55]93]. AEs reported in randomized controlled trials have included musculoskeletal, gastrointestinal, hepatic, and general AEs, such as fatigue and dizziness, and laboratory observations such as elevated transaminases, which are rarely serious (Table 5) [44,[47][48][49]51,52,54,55,57,60,63,64,66]. Many of these studies, including those with the greatest numbers of participants, have been conducted in China, and these have shown no increase in the incidence of AEs compared with control groups [73,86]. ...
Reducing low-density lipoprotein cholesterol (LDL-C) levels is a key target for lowering cardiovascular risk and preventing atherosclerotic cardiovascular disease (ASCVD). Red yeast rice (RYR) is a nutraceutical widely used as a lipid-lowering dietary supplement. The main cholesterol-lowering components of RYR are monacolins, particularly monacolin K, which is structurally identical to lovastatin and targets the same key enzyme of cholesterol biosynthesis. RYR supplementation reduces LDL-C levels by approximately 15–34% versus placebo, with a similar effect to low-dose, first-generation statins in subjects with mild-to-moderate dyslipidemia. RYR has also demonstrated beneficial reductions of up to 45% versus placebo in the risk of ASCVD events in secondary prevention studies. RYR at a dose that provides about 3 mg/d of monacolin K is well tolerated, with an adverse event profile similar to that of low-dose statins. RYR is therefore a treatment option for lowering LDL-C levels and ASCVD risk for people with mild-to-moderate hypercholesterolemia who are ineligible for statin therapy, particularly those who are unable to implement lifestyle modifications, and also for people who are eligible for statin therapy but who are unwilling to take a pharmacologic therapy.
... Це явище гальмує застосування функціонального RYR, і, що більш важливо, тривале вживання ловастатину може спричинити виснаження, шлунковокишкові реакції, міалгію тощо. Близько 10-15 % пацієнтів із дисліпідемією, які приймають статини, мають проблеми зі скелетними м'язами [11,23]. ...
... Екстракти RYR виявляють здатність діяти проти втоми. Встановлено, що пероральне введення RYR пацієнтам з дисліпідемією протягом 4 тижнів значно зменшує м'язову втому й зберігає фізичну активність [23]. У моделі щурів Wistar введення порошкоподібного RYR протягом 4 тижнів значно подовжувало час плавання щурів, ефективно затримувало зниження рівня глюкози в крові, запобігало збільшенню концентрації лактату й азоту сечовини в крові, а також сприяло зниженню спричиненого фізичними навантаженнями окиснювального стресу. ...
Червоний дріжджовий, або ферментований, рис (RYR) виготовляється шляхом ферментації пропареного рису (Oryza sativa) їстівним грибом (Monascus purpureus та ін.). До складу RYR входять різні хімічні компоненти, що включають монаколіни,
пігменти, органічні кислоти, амінокислоти, стерини, похідні декаліну, флавоноїди, лігнани, кумарин, терпеноїди та інші. Крім того, з RYR були виділені полісахариди й монаскан. Монаколіни й пігменти є найбільш поширеними й біологічно активними
складовими RYR. RYR демонструє широкий спектр біологічних властивостей, що включають гіполіпідемічні, антиатеросклеротичні, антидіабетичні, антиадипогенні, гепатопротекторні, імуномодулюючі, протизапальні, антигіпертензивні, протиракові, нейроцитопротекторні й антиостеопоротичні ефекти. Серед них гіполіпідемічна й
антиатеросклеротична активність є найбільш вираженою. У результаті численних аналізів були зроблені надійні висновки про те, що препарати RYR впливають на фактори ризику метаболічного синдрому (МС). Докази свідчать, що препарати RYR
суттєво знижують частоту смерті й серцево-судинних подій при МС, покращують рівень глюкози в крові, ліпідний профіль і артеріальний тиск. Отже, препарати RYR можуть бути ефективним засобом лікування — зменшують фактори ризику МС і
запобігають прогресуванню серцево-судинних захворювань. Завдяки складній системі компонентів RYR, які взаємодіють між собою і підсилюють один одного, препарати RYR більш ефективні, ніж комерційні статини, рідко викликають нетолерантність у пацієнтів і рідше призводять до діабету. Ще більш перспективним є використання сумішей ліпідознижуючих препаратів,
таких як бергамот, артишок, берберин тощо. Хоча хронічне застосування монаколінів може спричинити легкі побічні ефекти, вони зазвичай безпечні й добре переносяться.
Ключевые слова: червоний дріжджовий (ферментований) рис; статини; дисліпідемія; метаболічний синдром; діабет; атеросклероз
... Improve the quality of eggs for human consumption: (a) Decreasing the level of serum and egg yolk cholesterol (b) Enhance the egg quality in laying hens without disablement of laying production (Pengnoi et al., 2018;Sun et al., 2015;Zhu et al., 2019) Anticarcinogenic compounds against liver, colon, breast, and prostate cancer (Chiu et al., 2013;Klingelhöfer and Morlock, 2019) Inhibitors of cholesterol biosynthesis (Man et al., 2002) Lipid and cholesterol-lowering properties (Becker et al., 2009;Bogsrud et al., 2010;Heber et al., 1999;Ma et al., 2009;Wei et al., 2003;Yang et al., 2021;Zhou et al., 2019) Prevent the build-up of fats, cholesterol, and other substances in and on the artery walls (Lin et al., 2008;Lin et al., 2011;Liu et al., 2017;Shen et al., 2017;Wu et al., 2017) Neurocytoprotective activity (Lee et al., 2009;Lee et al., 2007b;Lee et al., 2010;Lin et al., 2015) Preventing osteoporosis (Cho et al., 2010;Gutierrez et al., 2006;Wang et al., 2015;Wong and Rabie, 2008) Anti-obesity activity Anti-fatigue effects Xue et al., 2017) Anti-diabetic benefits (Chen and Liu, 2006;Chen et al., 2008) Regulatory effects on the immune system (Patakova, 2013) Anti-microbial activities (Ferdeş et al., 2009;Milanda et al., 2021) Anti-inflammatory effects (Ding et al., 2014;Hsu et al., 2010) Anti-hypertensive benefits Anti-cancer activity (Hong et al., 2011;Hsu et al., 2010;Lee et al., 2013;Lin et al., 2007;Xue et al., 2017) Prevent damage to the liver (Cheng and Pan, 2011;Hong et al., 2007;Lee et al., 2012) NM: not mentioned. NA: not applicable. ...
... Improve the quality of eggs for human consumption: (a) Decreasing the level of serum and egg yolk cholesterol (b) Enhance the egg quality in laying hens without disablement of laying production (Pengnoi et al., 2018;Sun et al., 2015;Zhu et al., 2019) Anticarcinogenic compounds against liver, colon, breast, and prostate cancer (Chiu et al., 2013;Klingelhöfer and Morlock, 2019) Inhibitors of cholesterol biosynthesis (Man et al., 2002) Lipid and cholesterol-lowering properties (Becker et al., 2009;Bogsrud et al., 2010;Heber et al., 1999;Ma et al., 2009;Wei et al., 2003;Yang et al., 2021;Zhou et al., 2019) Prevent the build-up of fats, cholesterol, and other substances in and on the artery walls (Lin et al., 2008;Lin et al., 2011;Liu et al., 2017;Shen et al., 2017;Wu et al., 2017) Neurocytoprotective activity (Lee et al., 2009;Lee et al., 2007b;Lee et al., 2010;Lin et al., 2015) Preventing osteoporosis (Cho et al., 2010;Gutierrez et al., 2006;Wang et al., 2015;Wong and Rabie, 2008) Anti-obesity activity Anti-fatigue effects Xue et al., 2017) Anti-diabetic benefits (Chen and Liu, 2006;Chen et al., 2008) Regulatory effects on the immune system (Patakova, 2013) Anti-microbial activities (Ferdeş et al., 2009;Milanda et al., 2021) Anti-inflammatory effects (Ding et al., 2014;Hsu et al., 2010) Anti-hypertensive benefits Anti-cancer activity (Hong et al., 2011;Hsu et al., 2010;Lee et al., 2013;Lin et al., 2007;Xue et al., 2017) Prevent damage to the liver (Cheng and Pan, 2011;Hong et al., 2007;Lee et al., 2012) NM: not mentioned. NA: not applicable. ...
Red fermented rice (RFR) is rice fermented using Monascus spp. This product contains monacolin K, providing health benefits including mitigation of diarrhoea and improving blood circulation. RFR can produce pigments that can act as natural colour and flavouring agents. However, Monascus spp. (a fungal starter to ferment RFR) can also produce the mycotoxin, citrinin (CIT) which is believed to have adverse effects on human health. CIT in RFR has been reported worldwide by using different methods of detection. This review focuses on the production of RFR by solid-state fermentation (SSF) and submerged fermentation (SmF), the occurrence of CIT in RFR, CIT quantification, the factors affecting the growth of Monascus spp., pigments and CIT production in RFR, and possible methods to reduce CIT in RFR. This review will help the food industry, researchers, and consumers understand the risk of consuming RFR, and the possibility of controlling CIT in RFR.
... Red yeast rice wine is produced by mixing cooked white glutinous rice with RFR and incubating for a month. RFR has health benefits such as improved blood circulation, as an anti-hypercholesterolemic agent (Cicero et al., 2019), produces hypolipidemic effects (Zhou et al., 2019), has anti-fatigue and anti-cancer (Xue et al., 2017) benefits, and antiinflammatory activity (Hsu et al., 2010). RFR is available in traditional Chinese shops and is in high demand (Samsudin and Abdullah, 2014). ...
Red fermented rice (RFR) is produced using Monascus spp. This product has some health benefits. However, RFR can also contain the mycotoxin, citrinin (CIT) and that has adverse effects on human health. The objective of the study was to develop a simple and rapid screening method for the detection of Monascus spp. isolates that can produce CIT by using Coconut Cream Agar (CCA). RFR was spread onto CCA and other media and incubated at 30 °C for 7 days. All the media were observed daily under ultraviolet (UV) light and any Monascus spp. colony that produced light blue fluorescence was recorded as a CIT-producer. Two different isolates (MF1 and MS1) isolated from CCA were selected for further analysis. All (100%; 10/10 plates) of CCA inoculated with MF1 produced light blue fluorescence after incubation for 4 days, meanwhile 30% (3/10 plates) of MS1 produced weak fluorescence on CCA after incubation for 7 days. Isolates MF1 and MS1 were identified as M. purpureus with the ability to produce CIT by having polyketide synthase (pksCT) and transcriptional regulator (ctnA) genes. CIT was quantified by high-performance liquid chromatography (HPLC). CCA is a simple and rapid method to detect CIT-producers of Monascus spp.
... There are, at present, a small number of well-designed randomized controlled studies indicating the likelihood of decreasing cholesterol using red yeast rice (Spigoni et al., 2017). However, the primary care clinicians recognize possible adverse reactions by administrating red yeast rice, and unfavorable effects have also been documented (Xue et al., 2017). Barrios et al. (2017) reported the current drugs therapy to be inclined to lesser serum lipid in hyperlipidemic patients and associated with adverse reactions, as well as a development of resistance of medicine (Barrios et al., 2017). ...
Hyperlipidemia, the most common form of dyslipidemia, is the main source of cardiovascular disorders, characterized by elevated level of total cholesterol (TC), triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C) with high-density lipoprotein cholesterol (HDL-C) in peripheral blood. It is caused by a defect in lipid metabolism in the surface of Apoprotein C-II or a defect in lipoprotein lipase activity as well as reported in genetic, dietary and environmental factors. Several electronic databases were investigated as information sources, including Google Scholar, PubMed, Web of Science, Scopus, ScienceDirect, SpringerLink, Semantic Scholar, MEDLINE and CNKI Scholar. The current review focused on the risk factors of dyslipidemia, synthetic medication with their side effects and different types of medicinal plants having significant potential for the management of hyperlipidemia. The management of hyperlipidemia mostly involves a constant decrease in lipid level using different remedial drugs like statin, fibrate, bile acid sequestrates and niacin. However, this extensive review suggested that the consequences of these drugs are arguable, due to their numerous adverse effects. The selected parts of herb plants are used intact or their extracts containing active phytoconstituents to regulate the lipids in blood level. It was also noted that the Chinese herbal medicine and combination therapy is promising for the lowering of hyperlipidemia. This review intends to provide a scientific base for future endeavors, such as in-depth biological and chemical investigations into previously researched topics.
... Lovastatin and several other statins are marketed as drugs whereas FRMR is offered as a food supplement. Statins can cause side effects such as muscle damage and kidney failure, hence the side effects of FRMR need a critical consideration (Xue et al., 2017). In addition, the quantities of MK in FRMR remain widely variable (Yang and Mousa, 2012). ...
... As of date, some side effects of FRMR have been reported, such as myopathy, erectile dysfunction, and liver injury, etc. (Polsani et al., 2008;Childress et al., 2013;Mazzanti et al., 2017;Liu and Chen, 2018). On the other hand, among dyslipidemic patients with low to moderate cardiovascular risk, FRMR induces less muscle fatigue symptoms and exerts comparable lipid-lowering effects, when compared with simvastatin in single-center randomized pilot trials (Xue et al., 2017). Therefore, safety evaluation of FRMR is an urgent and important subject. ...
Monacolin K (MK) is a secondary metabolite of the Monascus species that can inhibit cholesterol synthesis. Functional red mold rice (FRMR) is the fermentation product of Monascus spp., which is rich in MK. FRMR is usually employed to regulate serum cholesterol, especially for hypercholesterolemic patients who refuse statins or face statin intolerance. The present perspective summarized the bioactive components of FRMR and their functions. Subsequently, efficient strategies for FRMR production, future challenges of FRMR application, and possible directions were proposed. This perspective helps to understand the present situation and developmental prospects of FRMR.
... RYR extracts exhibit strong anti-fatigue capability. The oral administration of RYR (24 mg/kg) to dyslipidemia patients for 4 weeks was found to significantly reduce muscle fatigue and preserve physical activity (Xue et al., 2017). Nevertheless, only a single dose of RYR was used in this study. ...
Red yeast rice (RYR), a Chinese traditional folk medicine produced by the fermentation of cooked rice kernels with a Monascaceae mold, Monascus purpureus, has long been used to treat blood circulation stasis, indigestion, diarrhea, and limb weakness in East Asian countries. This article provides a systematic review of the traditional uses, chemistry, biological activities, and toxicology of RYR to highlight its future prospects in the field of medicine. The literature reviewed for this article was obtained from the Web of Science, Elsevier, SciFinder, PubMed, CNKI, ScienceDirect, and Google Scholar, as well as Ph.D. and M.Sc. dissertations, published prior to July 2019. More than 101 chemical constituents have been isolated from RYR, mainly consisting of monacolins, pigments, organic acids, sterols, decalin derivatives, flavonoids, polysaccharides, and other compounds. Crude extracts of RYR, as well as its isolated compounds, possess broad pharmacological properties with hypolipidemic, anti-atherosclerotic, anti-cancer, neurocytoprotective, anti-osteoporotic, anti-fatigue, anti-diabetic, and anti-hypertensive activities. However, further studies are needed to characterize its diverse chemical constituents and the toxicological actions of the main bioactive compounds. New pharmacological trials addressing the overlooked traditional uses of RYR, such as in the treatment of indigestion and diarrhea, are required.
... For example, Red yeast rice (RYR) use as a lipid-lowering dietary supplement seems to be overall tolerable and safe in a large group of moderately hypercholesterolemic subjects [18]. It has been reported that herbal medicine could result in fewer side effects such as fatigue [19]. Although there is sufficient evidence of their efficacy in lipid disorders, the mechanisms of action are not very clear. ...
Dyslipidemia is a key risk factor for cardiovascular diseases, which are a major cause of morbidity and mortality worldwide. However, despite the advancement of the treatment and prevention of dyslipidemia, medications used to treat dyslipidemia are limited to chemical drugs. Herbal medicine, as an alternative treatment, has a long history of usage and provides more treatment options, and related studies have revealed intervention targets for dyslipidemia. Four lipid-lowering mechanisms of herbal medicines have been proposed and are discussed in this paper. These mechanisms are the inhibition of cholesterol absorption in enterocytes, reduction of cholesterol synthesis, elevation of reverse cholesterol transport, and promotion of cholesterol excretion in the liver. This review elaborates on the underlying molecular pathways involved in plasma lipid balance via bioactive compounds from herbal medicines.
... This phenomenon has inhibited the development of functional RYR, and more important, long-term use of lovastatin probably can cause burnout, gastrointestinal reactions, myalgia, etc. About 10-15% patients with dyslipidemia who take statins experience skeletal muscle problems [11]. Molecules 2019, 24, x 9 of 29 ...
Red yeast rice (RYR) is made by fermenting the rice with Monascus. It is commonly used in food colorants, dyeing, and wine making in China and its neighboring countries. Nowadays RYR has two forms on the market: common RYR is used for food products, the other form is functional RYR for medicine. However, some researchers reported that commercial lovastatin (structure is consistent with monacolin K) is illegally added to common RYR to meet drug quality standards, so as to imitate functional RYR and sell the imitation at a higher price. Based on current detection methods, it is impossible to accurately distinguish whether functional RYR is adulterated. Therefore, it is especially important to find a way to authenticate functional RYR. In the current review, the advances in history, applications, components (especially monacolins, monacolins detection methods), quality standards, authentication methods and perspectives for the future study of RYR are systematically reviewed.
... requiring urgent medical procedures and/or hospitalization, life-threatening or leading to death). If one or more outcomes could not be extracted from a study, [23] 2019 L L L L L U Derosa, G [24] 2018 L L L L L U Cicero, AF [25] 2017 L L L L L L Cicero, AF [8] 2017 L L L L L L Cicero, AF [26] 2017 L L L L L L D'Addato, S [27] 2017 L L L L L L Derosa, G [28] 2017 U U L L L U Marazzi, G [29] 2017 H H H U U U Spigoni, V [30] 2017 L L L L L L Xue, Y [31] 2017 U U L L L H Zheng, J [32] 2017 U U H L L U Cicero, AF [11] 2016 L L H L L L Cicero, AF [33] 2016 L L L L L L Cicero, AF [34] 2016 L L L L L L Cicero, AF [35] 2016 L L L U U L Heinz, T [36] 2016 L L L L L L Kasliwal, RR [37] 2016 L L L L L H Gentile, M [38] 2015 L L L U U U Verhoeven, V [39] 2015 L L L L L L Derosa, G [40] 2014 L L L L L H Gonnelli, S [41] 2014 L L L L L L Moriarty, PM [42] 2014 L L L L L U Ruscica, M [43] 2014 L L L L L L Solà, R [44] 2014 L L L L L L Barrat, E [45] 2013 L U L L L L Barrat, E [46] 2013 L U L L L L Cicero, AF [47] 2013 L L L L L L Ogier, N [48] 2013 L L L L L L Verhoeven, V [49] 2013 L L L L L U Affuso, F [50] 2012 L L L L L L Cicero, AF [51] 2012 U U U L L U Karl, M [52] 2012 L L L L L L Lee, IT [53] 2012 U U H L L H Guardamagna, O [54] 2011 L L L L L L Marazzi, G [55] 2011 H H H L L U Affuso, F [10] 2010 L L L L L L Bogsrud, MP [56] 2010 L L L L L L Halbert, SC [57] 2010 L L L L L L Becker, DJ [58] 2009 L U L L L L Yang, NC [59] 2009 U U L L L H Ye, P [60] 2009 U U H U L U Geith, O [61] 2008 L U L L L H Lu, Z [62] 2008 L L L H H L Cicero, AF [63] 2007 L L H L L U Huang, CF [64] 2007 U L U U U U Li, JJ [65] 2007 L U U U U U Shang, XB [66] 2007 U U U L L U Hu, [67] 2006 L L L U H U Zhao, SP [9] 2004 U L H L L L Liu, L [68] 2003 U L H L L U Keithley, JK [69] 2002 L L L L L L Yu, H [70] 2002 U U U L L U Heber, D [71] 1999 L L L L L L L = Low risk of bias; H= High risk of bias; U = Unclear risk of bias. the study was removed only from the analysis involving those outcomes. ...
... Follow-up periods ranged between 4 weeks and 4.5 years and several daily doses of monacolin K were tested. Selected trials were designed with crossover [26,33,35,43,47,54] or parallel groups [8,10,11,[23][24][25][27][28][29][30][31][32]34,[36][37][38][39][40][41][42][44][45][46][48][49][50][51][52][53][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70][71]. Enrolled subjects were adults and children without any major disease [8,10,11,[23][24][25][26][27][28]63,64,69,71], individuals with documented CVD [9,29,62,[65][66][67][68]70], statin intolerant patients [55,57,58] patients with HIV-1 infection [69] or idiopathic nephrotic syndrome [61]. ...
Recently, concerns regarding the safety of red yeast rice (RYR) have been raised after the publication of some case reports claiming toxicity. Since the previous meta-analyses on the effects of RYR were mainly focused on its efficacy to improve lipid profile and other cardiovascular parameters, we carried out a meta-analysis on safety data derived from the available randomized controlled clinical trials (RCTs). Primary outcomes were musculoskeletal disorders (MuD). Secondary outcomes were non-musculoskeletal adverse events (Non-MuD) and serious adverse events (SAE). Subgroups analyses were carried out considering the intervention (RYR alone or in association with other nutraceutical compounds), monacolin K administered daily dose (≤3, 3.1-5 or >5 mg/day), follow-up (>12 or ≤12 weeks), with statin therapy or statin-intolerance and type of control treatment (placebo or statin treatment). Data were pooled from 53 RCTs comprising 112 treatment arms, which included 8535 subjects, with 4437 in the RYR arm and 4303 in the control one. Monacolin K administration was not associated with increased risk of MuD (odds ratio (OR) = 0.94, 95% confidence interval (CI) 0.53,1.65). Moreover, we showed reduced risk of Non-MuD (OR = 0.59, 95%CI 0.50, 0.69) and SAE (OR = 0.54, 95%CI 0.46, 0.64) vs. control. Subgroups analyses confirmed the high tolerability profile of RYR. Furthermore, increasing daily doses of monacolin K were negatively associated with increasing risk of Non-MuD (slope: -0.10; 95%CI: -0.17, -0.03; two-tailed p < 0.01). Based on our data, RYR use as lipid-lowering dietary supplement seems to be overall tolerable and safe in a large kind of moderately hypercolesterolaemic subjects.
