UNASSIGNED: Significant challenges are associated with the pharmacological management of dyslipidemia, an important risk factor for cardiovascular disease. Limited reliable evidence exists regarding the efficacy of red yeast rice (RYR)-containing commercial Chinese polyherbal preparation (CCPP), despite their widespread use in China.
UNASSIGNED: We aimed to investigate the efficacy of RYR-containing CCPPs combined with statins in treating dyslipidemia.
UNASSIGNED: Eight databases were searched for relevant randomized controlled trials (RCTs) from database inception date to November 2023. Outcome measures, including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglyceride (TG), clinical efficacy, and adverse reactions, were assessed. The Cochrane Handbook for Systematic Reviews of Interventions was used for quality evaluation, and the meta-analysis was conducted using RevMan 5.3 and Stata 15.1.
UNASSIGNED: Thirty-three studies involving 4,098 participants were included. The combination of RYR-containing CCPP, such as Xuezhikang (XZK), Zhibitai (ZBTAI), or Zhibituo (ZBTUO) with statins had a significant effect on the increase in clinical efficacy [RR:1.16, 95%CI (1.13, 1.19), p < 0.00001]. In addition, they also improved blood lipid profile parameters by increasing HDL-C levels [MD:0.21, 95%CI(0.17, 0.25), p < 0.00001], and decreasing TC [MD: 0.60, 95%CI(-0.76, -0.45), p < 0.00001], TG [MD: 0.33, 95%CI(-0.39, -0.26), p < 0.00001] and LDL-C levels [MD: 0.45, 95%CI(-0.54, -0.36), p < 0.00001]. No significant adverse reactions was observed in the RYR-containing CCPPs. Notably, ZBTAI and XZK significantly reduced the incidence of gastrointestinal disturbances and muscular adverse reactions. However, subgroup analyses suggested that the type of CCPPs, dose, and treatment duration might affect the efficacy of RYR-containing CCPPs.
UNASSIGNED: RYR-containing CCPPs combined with statins appears to improve lipid profiles and clinical efficacy in patients with dyslipidemia. However, due to the poor quality of the included studies, and some studied showing negative findings was unpublished. The results should be interpreted with caution until further confirmation by well-designed RCTs.
UNASSIGNED: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=487402, identifier CRD42023487402.

BACKGROUND: Red yeast rice (RYR), a natural lipid-lowering agent, is widely used in clinical practice. However, the existing meta-analyses concerning the safety of RYR preparations have yielded inconsistent results, and the credibility of the evidence has not been quantified.
OBJECTIVE: This study was designed to evaluate the existing evidence and offer a comprehensive understanding of the associations between the use of RYR preparations and various adverse health outcomes.
METHODS: Seven literature databases were searched from inception to May 5, 2023, using medical subject headings and free-text terms (e.g., \"red yeast rice,\" \"Xuezhikang,\" and \"Zhibitai\").
METHODS: Meta-analyses that investigated and quantitatively estimated associations between the use of RYR preparations and adverse health outcomes were included in this study.
METHODS: Two researchers independently extracted data using a standardized data collection table; any disagreements were resolved by consulting a third researcher. Based on the participant, intervention, comparator and outcome (PICO) framework in each eligible meta-analysis, a series of unique associations between the use of RYR preparations and adverse health outcomes were determined. The associations\' effect estimates were re-evaluated using random-effect models.
RESULTS: Fifteen meta-analyses, comprising 186 (164 unique) randomized controlled trials, were identified. Based on A MeaSurement Tool to Assess Systematic Reviews version 2, 3 (20%) and 12 (80%) of these meta-analyses had low and critically low confidence, respectively. A total of 61 unique associations between the use of RYR preparations and adverse health outcomes were extracted from eligible meta-analyses. Based on the random-effect models, 10 (16.4%) associations indicated a significant protective effect of RYR preparations against adverse health outcomes, while 5 (8.2%) indicated an increased risk of adverse health outcomes related to uric acid, alanine transaminase and aspartate transaminase levels. The other 46 (75.4%) associations showed no significant difference between the use of RYR preparations and control treatments. Regarding the credibility of the evidence, 21 (34.4%), 34 (55.7%) and 6 (9.8%) associations showed moderate, low and very low credibility, respectively.
CONCLUSIONS: The evidence examined in this study suggests that RYR preparations are safe; however, the credibility of the evidence was not high. Further high-quality evidence is required. Please cite this article as: Ma ZY, Yang SP, Li Y, Xu TT, Yang YL, Yang HY, Li HB, Zhou LJ, Diao Y, Li SY. Associations between the use of red yeast rice preparations and adverse health outcomes: An umbrella review of meta-analyses of randomized controlled trials. J Integr Med. 2024; 22(2): 126-136.

Monacolin K is the major active component in red yeast rice (RYR) which is structurally identical to lovastatin and has the most powerful effect, in terms of reducing blood cholesterol levels. This review aimed to examine the effect and safety of different doses of monacolin K on blood cholesterol levels. PubMed and Cochrane were searched for articles published between 2012 and 2023 for clinical-trials and randomized-controlled-trials. Eligible studies included participants>18-years-old, of any gender and ethnicity. The intervention/exposure of interest was monacolin K. Hypercholesterolemia was considered the outcome of interest defined as the elevated total or low-density-lipoprotein (LDL) cholesterol levels. 12 randomized-controlled-trials were eligible for inclusion in the analysis including 769 participants>18-years-old. 11 out of 12 studies were assessed with high methodological quality and one study with low methodological quality. Monacolin K supplementation varied between 2mg and 10mg per day and the maximum period of supplementation was 12 weeks. All studies indicated a beneficial effect of monacolin supplementation on LDL and total cholesterol levels (p<0.05) regardless the dose and period of supplementation. Also, 3 of the included studies reported adverse side effects after treatment with monacolin K. Low doses of monacolin K equal to 3mg/day exert potential cholesterol-lowering effects although the number of relative studies is limited. Regarding the safety of monacolin K supplementation, findings seem to be more controversial and therefore, it is suggested for all patients treated with monacolin K to be routinely monitored regardless the dose of supplementation.

Red yeast rice (RYR) is an entirely natural product that originates from the fermentation of white rice (Oryza sativa) with a yeast, mainly Monascus Purpureus, and has been part of traditional Chinese medicine and diet since ancient times. It has generated great interest in recent years in the context of cardiovascular (CV) prevention due to its ability to inhibit endogenous cholesterol production, helping to achieve and maintain optimal plasma lipid concentrations. This review aims to make an extensive 360-degree assessment and summary of the whole currently available scientific evidence about RYR, starting with its biochemical composition, passing through a historical reconstruction of all the studies that have evaluated its efficacy and safety in cholesterol-lowering action, with a focus on CV outcomes, and ultimately addressing its other relevant clinical effects. We also discuss its possible therapeutic role, alone or in combination with other nutraceuticals, in different clinical scenarios, taking into account the positions of major scientific documents on the issue, and describe the articulate legal controversies that have characterized the regulation of its use up to the present day. RYR preparations have been proven safe and effective in improving lipid profile, with a potential role in reducing cardiovascular risk. They can be considered as additional supportive agents in the armamentarium of lipid-modifying therapies.

UNASSIGNED: Dyslipidemia/hyperlipidemia are among the risk factors for chronic diseases, especially cardiovascular diseases. Red Yeast Rice (RYR) herbal supplement may be helpful in improving serum fat levels due to some mechanisms. Therefore, the aim of this study was to evaluate the effects of RYR consumption on total serum cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels in adults.
UNASSIGNED: Four comprehensive databases (SCOPUS, PubMed/MEDLINE, EMBASE, and Web of Science) were employed until 23 December 2021 RCTs, with 24 treatment arms included after screening 3623 articles.
UNASSIGNED: Pooled data showed significant effectiveness in lowering TC (WMD: -33.16 mg/dl, 95% CI: -37.69, -28.63, P < 0.001), LDL-C (WMD: -28.94 mg/dl, 95% CI: -32.90, -24.99, P < 0.001), and TG (WMD: -23.36 mg/dl, 95% CI: -31.30, -15.43, P < 0.001) concentration and increasing HDL-C concentration (WMD: 2.49 mg/dl, 95% CI: 1.48, 3.49, P < 0.001) following RYR supplementation. Furthermore, the effect of this herbal drug in doses less than 1200 mg and with an intervention duration of less than 12 weeks was more in individuals with dyslipidemia.
UNASSIGNED: In conclusion, this comprehensive article and meta-analysis showed that RYR significantly decreases TC, TG, and LDL-C as well as increases HDL-C.

Background: Metabolic syndrome (MetS) is characterized by the cooccurrence of obesity, insulin resistance, dyslipidaemia, and hypertension. Red yeast rice (RYR) preparations might be beneficial for the prevention and treatment of MetS. Objective: To implement a systematic review and meta-analysis to determine whether RYR preparations improve clinical endpoints and reduce risk factors for MetS. Methods: The PubMed, Cochrane Library, EMBASE, Scopus, China National Knowledge Infrastructure, Chinese VIP Information, and WanFang databases were searched for randomized controlled trials (published up to September 2020), and a meta-analysis was performed using fixed- or random-effects models. The primary outcome measures were mortality and major adverse cardiovascular events (MACEs), and the secondary outcome measures were biochemical parameters of blood glucose, blood lipids, and blood pressure. The registration number is CRD42020209186. Results: A total of 921 articles were identified, of which 30 articles were included in this article. RYR preparations group demonstrated significant improvements in MetS compared with control group. RYR preparations reduced the mortality and MACEs (RR = 0.62, 95% CI [0.49, 0.78]; RR = 0.54, 95% CI [0.43, 0.66]). In terms of blood glucose metabolism, fasting plasma glucose (FPG) (MD = -0.46 mmol/L, 95% CI [-0.71, -0.22]), haemoglobin A1c (HbA1c) (MD = -0.49, 95% CI [-0.71, -0.26]) and the homeostasis model assessment of insulin resistance (HOMA-IR) (MD = -0.93, 95% CI [-1.64, -0.21]) were decreased. Regarding the lipid metabolism, total cholesterol (TC) (MD = -0.74 mmol/L, 95% CI [-1.02, -0.46]), triglycerides (TG) (MD = -0.45 mmol/L, 95% CI [-0.70, -0.21]), and low-density lipoprotein cholesterol (LDL) (MD = -0.42 mmol/L, 95% CI [-0.78, -0.06]) were decreased, while high-density lipoprotein cholesterol (HDL) (MD = 0.14 mmol/L, 95% CI [0.09, 0.20]) was increased. Regarding blood pressure, the mean arterial pressure (MAP) (MD = -3.79 mmHg, 95% CI [-5.01, -2.57]) was decreased. In addition, RYR preparations did not increase the incidence of adverse reactions (RR = 1.00, 95% CI [0.69, 1.43]). Conclusion: RYR preparations reduce mortality, MACEs, and multiple risk factors for MetS without compromising safety, which supports its application for the prevention and treatment of MetS. However, additional high-quality studies are needed to provide more evidence for the effect of RYR on MetS due to the heterogeneity in this study. Systematic Review Registration: www.crd.york.ac.uk/PROSPERO, identifier CRD42020209186.

Red yeast rice has been used to produce alcoholic beverages and various fermented foods in China and Korea since ancient times; it has also been used to produce tofuyo (Okinawan-style fermented tofu) in Japan since the 18th century. Recently, monacolin K (lovastatin) which has cholesterol-lowering effects, was found in some strains of Monascus fungi. Since statins have been used world-wide as a cholesterol-lowering agent, processed foods containing natural statins are drawing attention as materials for primary prevention of life-style related diseases. In recent years, large-scale commercial production of red yeast rice using traditional solid-state fermentation has become possible, and various useful materials, including a variety of monascus pigments (polyketides) that spread as natural pigments, in addition to statins, are produced in the fermentation process. Red yeast rice has a lot of potential as a medicinal food. In this paper, we describe the history of red yeast rice as food, especially in Japan and East Asia, its production methods, use, and the ingredients with pharmacological activity. We then review evidence of the beneficial effects of red yeast rice in improving lipid metabolism and the circulatory system and its safety as a functional food.

Armolipid Plus® is a multi-constituent nutraceutical that claims to improve lipid profiles. The aim of this PRISMA compliant systematic review and meta-analysis was to globally evaluate the efficacy and safety of Armolipid Plus® on the basis of the available randomized, blinded, controlled clinical trials (RCTs). A systematic literature search in several databases was conducted in order to identify RCTs assessing the efficacy and safety of dietary supplementation with Armolipid Plus®. Two review authors independently identified 12 eligible studies (1050 included subjects overall) and extracted data on study characteristics, methods, and outcomes. Meta-analysis of the data suggested that dietary supplementation with Armolipid Plus® exerted a significant effect on body mass index (mean difference (MD) = -0.25 kg/m2, p = 0.008) and serum levels of total cholesterol (MD = -25.07 mg/dL, p < 0.001), triglycerides (MD = -11.47 mg/dL, p < 0.001), high-density lipoprotein cholesterol (MD = 1.84 mg/dL, p < 0.001), low-density lipoprotein cholesterol (MD = -26.67 mg/dL, p < 0.001), high sensitivity C reactive protein (hs-CRP, MD = -0.61 mg/L, p = 0.022), and fasting glucose (MD = -3.52 mg/dL, p < 0.001). Armolipid Plus® was well tolerated. This meta-analysis demonstrates that dietary supplementation with Armolipid Plus® is associated with clinically meaningful improvements in serum lipids, glucose, and hs-CRP. These changes are consistent with improved cardiometabolic health.

Metabolic diseases constitute a major public health burden and are linked with high morbidity and mortality. They comprise atherosclerosis dyslipidemia, diabetes, hypertension, and obesity. However, there is no single drug that can simultaneously treat multiple diseases with complex underlying mechanisms. Therefore, it is necessary to identify a class of adjuvant drugs that block the development of metabolic diseases from a preventive perspective. Red yeast rice is a food fermentation product widely used to promote blood circulation and remove blood stasis. Modern pharmacology has shown that red yeast rice exerts potential protective effects on the liver, pancreas, blood vessels, and intestines. Therefore, this study was carried out to analyze and summarize the effect of red yeast rice on several metabolic diseases and the mechanisms of action involved. It was found that red yeast rice may be beneficial in the prevention and treatment of metabolic diseases.

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.