Research

Red Yeast Rice (Monascus purpureus)

76 peer-reviewed studies curated from PubMed and Semantic Scholar.

12
Meta-analyses
3
Systematic reviews
55
RCTs
6
Other studies
Meta-analyses (16%)
Systematic reviews (4%)
RCTs (72%)
Observational (1%)

Studies

Sorted by quality and recency

2024·Semergen·E Liasi, M Kantilafti, E Hadjimbei, et al

Monacolin K supplementation in patients with hypercholesterolemia: A systematic review of clinical trials.

Systematic reviewn = 769Heart Health

Systematic review of 12 randomized-controlled-trials with 769 participants examining the effect and safety of monacolin K supplementation on blood cholesterol levels. Monacolin K showed a beneficial effect on LDL and total cholesterol levels, though some studies reported adverse side effects. Routine monitoring is suggested for patients treated with monacolin K.

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2024·Nutrients·Efstratios Trogkanis, Maria A Karalexi, Theodoros N Sergentanis, et al

Safety and Efficacy of the Consumption of the Nutraceutical "Red Yeast Rice Extract" for the Reduction of Hypercholesterolemia in Humans: A Systematic Review and Meta-Analysis.

Meta-analysisHeart Health

Systematic review and meta-analysis of 14 double-blinded clinical trials on red yeast rice extract for hypercholesterolemia. RYR extract significantly reduced total cholesterol and LDL-C without increasing life-threatening side effects.

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2024·Journal of integrative medicine·Zhen-Yu Ma, Shu-Ping Yang, Ying Li, et al

Associations between the use of red yeast rice preparations and adverse health outcomes: An umbrella review of meta-analyses of randomized controlled trials.

Meta-analysis

Umbrella review of meta-analyses evaluating the associations between red yeast rice preparations and adverse health outcomes. The review included 15 meta-analyses with 186 randomized controlled trials. It found that 10 associations indicated a protective effect, 5 indicated increased risk related to uric acid and liver enzymes, and 46 showed no significant difference. The credibility of the evidence was generally low.

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2022·Expert review of clinical pharmacology·Parisa Rahmani, Ebru Melekoglu, Sogand Tavakoli, et al

Impact of red yeast rice supplementation on lipid profile: a systematic review and meta-analysis of randomized-controlled trials.

Meta-analysisHeart Health

Systematic review and meta-analysis of RCTs evaluating the effects of red yeast rice supplementation on lipid profiles. RYR significantly decreased total cholesterol, triglycerides, and LDL-C, and increased HDL-C, particularly effective in individuals with dyslipidemia.

PubMedRead on PubMed
2021·Endocrinology, diabetes & metabolism·Guiqin Xu, Mingxin Lin, Xueli Dai, et al

Comparing the effectiveness of Chinese patent medicines containing red yeast rice on hyperlipidaemia: A network meta-analysis of randomized controlled trials.

Meta-analysisn = 4,824Heart Health

Network meta-analysis of 47 randomized controlled trials involving 4824 subjects evaluated the effectiveness of Chinese patent medicines containing red yeast rice for hyperlipidaemia. Xuezhikang was most effective in reducing total cholesterol and low-density lipoprotein cholesterol levels, while Zhibituo was most effective for controlling triglyceride and high-density lipoprotein cholesterol levels.

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2020·Scientific reports·Bunleu Sungthong, Chenchira Yoothaekool, Sornsalak Promphamorn, et al

Efficacy of red yeast rice extract on myocardial infarction patients with borderline hypercholesterolemia: A meta-analysis of randomized controlled trials.

Meta-analysisn = 10,699Heart Health Inflammation

Meta-analysis of seven studies with 10,699 myocardial infarction patients with borderline hypercholesterolemia. Red yeast rice extract (1,200 mg/day) reduced nonfatal MI, revascularization, and sudden death, and improved lipid profiles by lowering LDL, TC, TG, and increasing HDL levels.

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2020·BioMed research international·Bin Wu, Jie-Feng Huang, Bang-Jian He, et al

Promotion of Bone Formation by Red Yeast Rice in Experimental Animals: A Systematic Review and Meta-Analysis.

Meta-analysisJoint Bone Health

Systematic review and meta-analysis of 11 animal studies evaluating the effects of red yeast rice on bone formation. Results showed significant improvements in bone mineral density, osteoblast proliferation, and alkaline phosphatase expression, suggesting potential benefits for osteoporosis treatment.

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2019·Pharmacological Research·F. Fogacci, M. Banach, D. Mikhailidis, et al

Safety of red yeast rice supplementation: A systematic review and meta‐analysis of randomized controlled trials

Meta-analysisn = 8,535

Systematic review and meta-analysis of 53 RCTs with 8535 subjects assessing the safety of red yeast rice (RYR) supplementation. Monacolin K administration was not associated with increased risk of musculoskeletal disorders and showed reduced risk of non-musculoskeletal adverse events and serious adverse events compared to control.

Semantic ScholarRead on Semantic Scholar
2017·The American journal of nursing·Diane Peng, Amy Fong, Amanda van Pelt

Original Research: The Effects of Red Yeast Rice Supplementation on Cholesterol Levels in Adults.

Meta-analysisn = 8,713Heart Health

This state-of-the-science review extends a previous meta-analysis to explore the effectiveness and safety of red yeast rice (RYR) supplementation in treating dyslipidemic adults. The review included 15 articles, with significant reductions in LDL and total cholesterol levels observed in all trials. No significant changes in liver and kidney function or creatine kinase levels were noted. Despite positive findings, further research is needed to support RYR supplementation recommendations.

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2017·Critical reviews in food science and nutrition·Xingjiang Xiong, Pengqian Wang, Xiaoke Li, et al

The effects of red yeast rice dietary supplement on blood pressure, lipid profile, and C-reactive protein in hypertension: A systematic review.

Systematic reviewn = 4,558Heart Health Inflammation

Systematic review of 21 trials with 4558 patients evaluating red yeast rice (RYR) for hypertension. RYR plus conventional therapy significantly lowered total cholesterol, LDL-C, and CRP but had no significant effect on systolic BP, diastolic BP, triglycerides, and HDL-C compared to placebo. RYR plus statins was more effective in lowering BP, TC, TG, and LDL-C compared to statins alone. No serious adverse events were reported.

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2016·Pharmacological research·Matteo Pirro, Massimo Raffaele Mannarino, Vanessa Bianconi, et al

The effects of a nutraceutical combination on plasma lipids and glucose: A systematic review and meta-analysis of randomized controlled trials.

Meta-analysisn = 1,670Heart Health Nutrition

Systematic review and meta-analysis of randomized controlled trials assessing the effects of a nutraceutical combination (NComb) on plasma lipids and glucose levels. NComb, comprising red yeast rice, berberine, policosanol, astaxanthin, coenzyme Q10, and folic acid, significantly improved total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, and glucose levels.

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2016·Journal of clinical pharmacy and therapeutics·Yi Chin Ong, Zoriah Aziz

Systematic review of red yeast rice compared with simvastatin in dyslipidaemia.

Systematic reviewn = 905Heart Health -

Systematic review of 10 RCTs involving 905 Chinese subjects with dyslipidaemia comparing red yeast rice and simvastatin. No statistically significant difference was found in lipid-lowering effects between the two treatments.

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2014·PloS one·Yinhua Li, Long Jiang, Zhangrong Jia, et al

A meta-analysis of red yeast rice: an effective and relatively safe alternative approach for dyslipidemia.

Meta-analysisn = 804Heart Health

Meta-analysis of 13 randomized, placebo-controlled trials with 804 participants assessing red yeast rice for dyslipidemia. Red yeast rice significantly lowered serum total cholesterol, triglycerides, and LDL-C, but had no significant effect on HDL-C. No serious side effects were reported.

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2011·The Cochrane database of systematic reviews·Zhao Lan Liu, Jian Ping Liu, Anthony Lin Zhang, et al

Chinese herbal medicines for hypercholesterolemia.

Meta-analysisn = 2,130Heart Health

Meta-analysis of 22 randomized trials with 2130 participants assessing Chinese herbal medicines for hypercholesterolemia. Xuezhikang showed a significant cholesterol-lowering effect compared to inositol nicotinate. The risk of bias in included trials was high or unclear.

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2010·Clinical and experimental hypertension (New York, N.Y. : 1993)·Jian-Jun Li, Zong-Liang Lu, Wen-Rong Kou, et al

Long-term effects of Xuezhikang on blood pressure in hypertensive patients with previous myocardial infarction: data from the Chinese Coronary Secondary Prevention Study (CCSPS).

RCTn = 2,704Heart Health -

Post-hoc subgroup analysis of a randomized, double-blinded, placebo-controlled trial assessing the effects of Xuezhikang on blood pressure in 2704 hypertensive patients with previous myocardial infarction over 4.5 years. The study found no significant differences in blood pressure changes between Xuezhikang and placebo groups.

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2009·Journal of clinical pharmacology·Jian-Jun Li, Zong-Liang Lu, Wen-Rong Kou, et al

Beneficial impact of Xuezhikang on cardiovascular events and mortality in elderly hypertensive patients with previous myocardial infarction from the China Coronary Secondary Prevention Study (CCSPS).

RCTn = 1,530Heart Health Longevity

RCT of 1530 elderly hypertensive patients with previous myocardial infarction comparing Xuezhikang to placebo over 4.5 years. Xuezhikang significantly reduced coronary events by 38.2% and CHD death by 29.2%, demonstrating its effectiveness in reducing cardiovascular events and all-cause mortality.

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2008·The American journal of cardiology·Zongliang Lu, Wenrong Kou, Baomin Du, et al

Effect of Xuezhikang, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction.

RCTn = 5,000Heart Health Longevity

Multicenter RCT of nearly 5,000 Chinese patients with previous myocardial infarction, comparing Xuezhikang (XZK) to placebo over 4.5 years. XZK significantly decreased major coronary events, CV and total mortality, and improved lipoprotein profiles.

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2023·Nutrients·Nicholas Angelopoulos, Rodis D Paparodis, Ioannis Androulakis, et al

Low Dose Monacolin K Combined with Coenzyme Q10, Grape Seed, and Olive Leaf Extracts Lowers LDL Cholesterol in Patients with Mild Dyslipidemia: A Multicenter, Randomized Controlled Trial.

RCTn = 105Heart Health

RCT assessing the lipid-lowering activity and safety of a dietary supplement containing monacolin K, coenzyme Q10, grape seed, and olive leaf extracts in 105 patients with mild hypercholesterolemia. LDL-C decreased by 26.46% with 10 mg and by 16.77% with 3 mg of monacolin K. No severe adverse events occurred.

PubMedRead on PubMed
2023·Archives of Medical Sciences. Atherosclerotic Diseases·F. Fogacci, M. Giovannini, Valentina Di Micoli, et al

Evaluation of the effect of a dietary supplementation with a red yeast rice and fish oil-containing nutraceutical on lipid pattern, high sensitivity C-reactive protein, and endothelial function in moderately hypercholesterolaemic subjects: a double-blind, placebo-controlled, randomized clinical tria

RCTHeart Health Inflammation

Double-blind, randomized, placebo-controlled clinical trial testing 8 weeks of supplementation with red yeast rice and PUFAs in moderately hypercholesterolaemic subjects. The supplement significantly improved LDL-C, TC, apoB, hsCRP, and endothelial function.

Semantic ScholarRead on Semantic Scholar
2022·Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan·Chen Benjian, Huang Xiaodan, Peng Huiting, et al

Effectiveness and safety of red yeast rice predominated by monacolin K β-hydroxy acid form for hyperlipidemia treatment and management.

RCTn = 117Heart Health

RCT assessing the lipid-lowering activity and safety of a dietary supplement containing monacolin K β-hydroxy acid form (MKA) in 117 subjects with dyslipidemia. MKA significantly decreased LDL-C, TC, and non-HDL-C, with weak evidence of triglyceride reduction and HDL-C increment. No severe adverse events were reported.

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2021·Chinese journal of integrative medicine·Yan Feng, Shu-Li Lu, Xiang-Gong Jin, et al

Effect of "Natural Polypill", Xuezhikang on Serum Cholesterol Metabolism Markers in Early Menopausal Women with Hypercholesterolemia.

RCTn = 90Heart Health

RCT of 90 early menopausal women with hypercholesterolemia comparing Xuezhikang to atorvastatin over 8 weeks. Both treatments significantly reduced total cholesterol, triglycerides, and low-density cholesterol. Xuezhikang showed more comprehensive effects on cholesterol synthesis markers compared to atorvastatin.

PubMedRead on PubMed
2020·Nutrients·Arrigo F G Cicero, Sergio D'Addato, Claudio Borghi

A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUO) on LDL Cholesterol Levels and Lipid Pattern in Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study).

RCTn = 88Heart Health

A randomized, double-blind, placebo-controlled clinical trial tested the effects of a nutraceutical combination containing phytosterols, red yeast rice, niacin, and policosanols on lipid profiles in 88 moderately hypercholesterolemic subjects. The nutraceutical significantly reduced LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C, and LDL-C/HDL-C ratios compared to placebo, indicating a positive effect on heart health.

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2015·Atherosclerosis·Maaike C Gerards, Ruben J Terlou, Huixin Yu, et al

Traditional Chinese lipid-lowering agent red yeast rice results in significant LDL reduction but safety is uncertain - a systematic review and meta-analysis.

Meta-analysisHeart Health

Systematic review and meta-analysis of 20 studies evaluating red yeast rice (RYR) for LDL cholesterol reduction. RYR significantly lowered LDL cholesterol by 1.02 mmol/L compared to placebo, with a safety profile similar to statins. However, the quality of safety assessment was low in most studies.

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2009·Lipids·Claudia Stefanutti, Fabio Mazza, Antonio Vivenzio, et al

Combined treatment with Dif1stat and diet reduce plasma lipid indicators of moderate hypercholesterolemia more effectively than diet alone: a randomized trial in parallel groups.

RCTn = 240Heart Health

An open-labeled randomized trial studied the effects of Dif1stat (Monascus purpureus-Linear aliphatic alcohols-Niacin) combined with diet on primary moderate hypercholesterolemia over 8 months. Group B, receiving Dif1stat and diet, showed significant reductions in cholesterol and triglycerides compared to diet alone, indicating an anti-atherogenic effect.

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2021·Nutrients·Rafael Guerrero-Bonmatty, Guadalupe Gil-Fernández, Francisco José Rodríguez-Velasco, et al

A Combination ofStrains CECT7527, CECT7528, and CECT7529 Plus Monacolin K Reduces Blood Cholesterol: Results from a Randomized, Double-Blind, Placebo-Controlled Study.

RCTn = 39Heart Health

A 12-week randomized, double-blind, placebo-controlled trial evaluated the efficacy of red yeast rice containing 10 mg of monacolin K combined with three probiotic strains in 39 adults with high cholesterol. The intervention group showed a significant reduction in LDL and total cholesterol compared to placebo, with no adverse effects reported.

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2021·Nutrients·Stefania Cicolari, Chiara Pavanello, Elena Olmastroni, et al

Interactions of Oxysterols with Atherosclerosis Biomarkers in Subjects with Moderate Hypercholesterolemia and Effects of a Nutraceutical Combination (BB536, Red Yeast Rice Extract) (Randomized, Double-Blind, Placebo-Controlled Study).

RCTn = 33Heart Health

This randomized, double-blind, placebo-controlled study evaluated the effects of a nutraceutical combination (BB536, red yeast rice extract) on oxysterol levels in subjects with moderate hypercholesterolemia. The study found that 27-OHC levels were significantly reduced by 10.4% in the nutraceutical group, while other oxysterol levels remained unchanged.

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2021·Asia Pacific journal of clinical nutrition·Takuya Minamizuka, Masaya Koshizaka, Mayumi Shoji, et al

Low dose red yeast rice with monacolin K lowers LDL cholesterol and blood pressure in Japanese with mild dyslipidemia: A multicenter, randomized trial.

RCTn = 18Heart Health

A multicenter randomized trial with 18 patients with mild dyslipidemia comparing low dose red yeast rice (200 mg/day) containing 2 mg monacolin K to diet therapy alone for 8 weeks. The red yeast rice group showed significant reductions in low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and blood pressure without severe adverse effects.

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2019·High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension·Alberto Mazza, Laura Schiavon, Gianluca Rigatelli, et al

The Effects of a New Generation of Nutraceutical Compounds on Lipid Profile and Glycaemia in Subjects with Pre-hypertension.

RCTn = 131Heart Health Nutrition

RCT of 131 subjects with pre-hypertension comparing a nutraceutical compound (red yeast rice, berberine, coenzyme Q10, folic acid, and chrome) to diet alone for 3 months. The treatment group showed significant reductions in total cholesterol, LDL cholesterol, triglycerides, and glucose levels, with increased HDL cholesterol, indicating improved lipid and metabolic profiles.

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2019·BioMed research international·Francesco Landi, Anna Maria Martone, Sara Salini, et al

Effects of a New Combination of Medical Food on Endothelial Function and Lipid Profile in Dyslipidemic Subjects: A Pilot Randomized Trial.

RCTn = 50Heart Health Nutrition

Pilot randomized trial evaluating the effects of two nutraceutical combinations on endothelial function, lipid profile, and glucose metabolism in 50 dyslipidemic subjects. Both combinations improved lipid profiles, with one combination showing significant improvement in endothelial function and cholesterol lowering.

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2019·The American journal of Chinese medicine·Tien-Ju Wang, Angela Shin-Yu Lien, Jiun-Liang Chen, et al

A Randomized Clinical Efficacy Trial of Red Yeast Rice (Monascus pilosus) Against Hyperlipidemia.

RCTn = 50Heart Health

RCT examining the efficacy of monacolin K-rich and GABA-rich red yeast rice (Monascus pilosus) on hyperlipidemia. Monacolin K-rich RYR significantly reduced serum TC and LDL-C levels compared to baseline and other groups, while GABA-rich RYR showed non-significant reduction on serum triglyceride. Two subjects reported elevated liver enzymes.

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2019·Complementary therapies in medicine·Irene Iskandar, Yahdiana Harahap, Tri Rahayu Wijayanti, et al

Efficacy and tolerability of a nutraceutical combination of red yeast rice, guggulipid, and chromium picolinate evaluated in a randomized, placebo-controlled, double-blind study.

RCTHeart Health

RCT evaluating the efficacy and tolerability of NutraforChol, a nutraceutical containing red yeast rice, guggulipid, and chromium picolinate, in subjects with mild dyslipidemia. The study found significant reductions in total cholesterol and LDL levels after 8 weeks, with no significant changes in renal and liver function parameters.

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2018·The American journal of cardiology·Giuseppe Marazzi, Giuseppe Campolongo, Francesco Pelliccia, et al

Usefulness of Low-Dose Statin Plus Ezetimibe and/or Nutraceuticals in Patients With Coronary Artery Disease Intolerant to High-Dose Statin Treatment.

RCTn = 100Heart Health

This randomized, prospective, parallel-group, single-blind study evaluated the efficacy of low-dose statin plus ezetimibe or low-dose statin plus nutraceutical (Armolipid Plus containing red yeast rice, policosanol, and berberine) in achieving target LDL-C levels in coronary artery disease patients intolerant to high-dose statin. 66% of patients treated with LDS + EZE and 62% with LDS + ALP achieved target LDL-C after 3 months, with 92% reaching target at 6 months. The combination was effective and well-tolerated.

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2018·Phytomedicine : international journal of phytotherapy and phytopharmacology·Giuseppe Derosa, Gabriele Catena, Riccardo Raddino, et al

Effects on oral fat load of a nutraceutical combination of fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols: A randomized, placebo controlled trial.

RCTn = 80Heart Health Inflammation

RCT of 80 Caucasian patients with low cardiovascular risk comparing a nutraceutical combination of fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols to placebo. The combination improved lipid profile and markers of endothelial damage both at fasting and after an oral fat load.

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2017·The American journal of cardiology·Giuseppe Marazzi, Giuseppe Campolongo, Francesco Pelliccia, et al

Comparison of Low-Dose Statin Versus Low-Dose Statin + Armolipid Plus in High-Intensity Statin-Intolerant Patients With a Previous Coronary Event and Percutaneous Coronary Intervention (ADHERENCE Trial).

RCTn = 100Heart Health

RCT comparing low-dose statin therapy versus combined therapy of low-dose statin plus Armolipid Plus in 100 high-risk patients with coronary artery disease and high-dose statin intolerance. The Armolipid Plus group showed a significantly greater reduction in LDL-C and total cholesterol, with 70% achieving the therapeutic target.

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2017·Advances in therapy·Arrigo F G Cicero, Federica Fogacci, Marilisa Bove, et al

Short-Term Effects of a Combined Nutraceutical on Lipid Level, Fatty Liver Biomarkers, Hemodynamic Parameters, and Estimated Cardiovascular Disease Risk: A Double-Blind, Placebo-Controlled Randomized Clinical Trial.

RCTn = 60Heart Health Inflammation

This double-blind, placebo-controlled randomized clinical trial studied the effects of a nutraceutical containing red yeast rice, phytosterols, and L-tyrosol on lipid profile, blood pressure, and cardiovascular risk in 60 patients with polygenic hypercholesterolemia. The nutraceutical improved total cholesterol, LDL-C, hepatic steatosis index, ALT, AST, serum uric acid, systolic blood pressure, endothelial reactivity, and estimated 10-year cardiovascular risk score compared to placebo.

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2017·BMC cardiovascular disorders·Yangjing Xue, Luyuan Tao, Shaoze Wu, et al

Red yeast rice induces less muscle fatigue symptom than simvastatin in dyslipidemic patients: a single center randomized pilot trial.

RCTn = 60Physical Performance

RCT comparing red yeast rice to simvastatin in 60 dyslipidemic patients with low to moderate cardiovascular risk over 4 weeks. Red yeast rice induced less muscle fatigue and maintained physical activity levels better than simvastatin, with similar lipid-lowering effects.

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2016·Nutrition (Burbank, Los Angeles County, Calif.)·Ravi R Kasliwal, Manish Bansal, Rajeev Gupta, et al

ESSENS dyslipidemia: A placebo-controlled, randomized study of a nutritional supplement containing red yeast rice in subjects with newly diagnosed dyslipidemia.

RCTn = 191Heart Health

This multicenter, double-blind RCT studied the effects of a nutritional supplement containing red yeast rice, grape-seed, niacinamide, and folic acid (RYR-NS) on LDL-C levels in 191 statin-free subjects with newly-diagnosed hyperlipidemia. The RYR-NS group showed a significant reduction in LDL-C and non-HDL-C levels compared to placebo after 12 weeks, with no safety issues observed.

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2016·Nutrition research (New York, N.Y.)·Tina Heinz, Jan Philipp Schuchardt, Katharina Möller, et al

Low daily dose of 3 mg monacolin K from RYR reduces the concentration of LDL-C in a randomized, placebo-controlled intervention.

RCTn = 142Heart Health

RCT of 142 nonstatin-treated participants with hypercholesterolemia comparing 3 mg monacolin K from red yeast rice and 200 μg folic acid to placebo. The supplement group showed significant reductions in LDL-C, total cholesterol, and homocysteine after 12 weeks, with no significant changes in the placebo group.

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2016·Chinese journal of integrative medicine·Chien-Ying Lee, Min-Chien Yu, Wu-Tsun Perng, et al

No additional cholesterol-lowering effect observed in the combined treatment of red yeast rice and Lactobacillus casei in hyperlipidemic patients: A double-blind randomized controlled clinical trial.

RCTn = 60Heart Health -

Double-blind RCT evaluating the cholesterol-lowering effect of combining red yeast rice and Lactobacillus casei in 60 hyperlipidemic patients. No additional cholesterol-lowering effect was observed with the combination compared to red yeast rice alone. A significant difference in diastolic pressure was noted, potentially linked to L. casei.

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2015·Journal of medicinal food·Arrigo F G Cicero, Giuseppe Derosa, Livia Pisciotta, et al

Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study.

RCTn = 137Heart Health

Multicenter open study comparing the effects of a combined nutraceutical containing red yeast rice and PUFAs versus phytosterols in subjects with primary polygenic hypercholesterolemia and metabolic syndrome. The combined nutraceutical group showed a significant decrease in total cholesterol, LDL-C, triglycerides, and non-HDL-C compared to baseline and the phytosterol group.

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2015·The American journal of cardiology·Giuseppe Marazzi, Francesco Pelliccia, Giuseppe Campolongo, et al

Usefulness of Nutraceuticals (Armolipid Plus) Versus Ezetimibe and Combination in Statin-Intolerant Patients With Dyslipidemia With Coronary Heart Disease.

RCTn = 100Heart Health

A single-blind, single-center, randomized trial compared the efficacy and tolerability of Armolipid Plus (a combination of nutraceuticals) versus ezetimibe in statin-intolerant patients with dyslipidemia and coronary heart disease. After 3 months, 14 patients in the nutraceutical group achieved their therapeutic target, whereas none in the ezetimibe group did. At 1-year follow-up, 72.5% of the combined therapy group and 100% of the nutraceutical group reached the therapeutic goal. No significant adverse effects were reported.

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2015·Advances in therapy·Alberto Mazza, Salvatore Lenti, Laura Schiavon, et al

Nutraceuticals for Serum Lipid and Blood Pressure Control in Hypertensive and Hypercholesterolemic Subjects at Low Cardiovascular Risk.

RCTn = 66Heart Health Inflammation

RCT of 66 patients with hypertension and hypercholesterolemia testing a nutraceutical compound containing red yeast rice, policosanol, berberine, folic acid, and coenzyme Q10. The treatment group showed significant reductions in systolic and pulse pressure, total cholesterol, LDL-C, and triglycerides, with no changes in HDL-C.

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2015·BMC complementary and alternative medicine·Veronique Verhoeven, Anastasia Van der Auwera, Luc Van Gaal, et al

Can red yeast rice and olive extract improve lipid profile and cardiovascular risk in metabolic syndrome?: A double blind, placebo controlled randomized trial.

RCTn = 50Heart Health Inflammation

Double blind placebo controlled randomized trial of 50 persons with metabolic syndrome testing a supplement combining red yeast rice and olive extract. The intervention group showed significant reductions in LDL cholesterol, total cholesterol, apolipoprotein B, triglycerides, and oxidized LDL, as well as decreased systolic and diastolic blood pressure compared to the control group.

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2015·High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension·Valentina Trimarco, Raffaele Izzo, Eugenio Stabile, et al

Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic subjects. A cross-over, randomized, double-blind trial.

RCTHeart Health Hormone Health

Double-blind randomized cross-over trial comparing two nutraceutical combinations in dyslipidemic patients. Combination B, which includes Morus alba, showed greater reductions in LDL cholesterol, glycated hemoglobin, fasting glucose, and insulin levels compared to Combination A.

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2014·Journal of biological regulators and homeostatic agents·G Derosa, A Bonaventura, L Bianchi, et al

A randomized, placebo-controlled study on the effects of a nutraceutical combination of red yeast rice, silybum marianum and octasonol on lipid profile, endothelial and inflammatory parameters.

RCTn = 134Heart Health Inflammation

A double-blind, placebo-controlled RCT with 134 dislipidemic patients evaluated the effects of a nutraceutical combination of red yeast rice, Silybum marianum, and octasonol on lipid profile, endothelial, and inflammatory parameters. The combination improved total cholesterol, LDL cholesterol, and reduced various inflammatory markers compared to placebo.

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2014·Journal of clinical lipidology·Patrick M Moriarty, Eli M Roth, Adam Karns, et al

Effects of Xuezhikang in patients with dyslipidemia: a multicenter, randomized, placebo-controlled study.

RCTn = 116Heart Health

RCT of 116 adults with dyslipidemia comparing placebo to Xuezhikang (XZK) 1200 or 2400 mg daily for 12 weeks. XZK significantly reduced non-HDL-C and LDL-C levels, with additional benefits on total cholesterol, apolipoprotein B, triglycerides, and HDL-C. XZK was safe and well tolerated.

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2014·PloS one·Rosa Solà, Rosa-M Valls, José Puzo, et al

Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial.

RCTn = 102Heart Health Physique

A multicenter randomized trial assessed the effects of Armolipid Plus, a supplement containing red yeast rice extract, policosanol, berberine, folic acid, coenzyme Q10, and asthaxantine, on cardiovascular biomarkers in 102 participants with moderate hypercholesterolemia. The supplement reduced LDL-c, ApoB-100, and cholesterol ratios while increasing ApoA1, and was associated with modest weight loss compared to placebo.

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2013·American heart journal·David J Becker, Benjamin French, Patti B Morris, et al

Phytosterols, red yeast rice, and lifestyle changes instead of statins: a randomized, double-blinded, placebo-controlled trial.

RCTn = 187Heart Health Inflammation Physique

RCT of 187 participants with statin intolerance comparing red yeast rice with and without phytosterols, alongside lifestyle changes. Phytosterols did not significantly improve LDL-C compared to placebo. Lifestyle changes led to greater LDL-C reduction and weight loss. Red yeast rice significantly decreased LDL-C, total cholesterol, triglycerides, and increased HDL cholesterol.

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2013·International journal of food sciences and nutrition·Emmanuel Barrat, Yassine Zaïr, Nicolas Ogier, et al

A combined natural supplement lowers LDL cholesterol in subjects with moderate untreated hypercholesterolemia: a randomized placebo-controlled trial.

RCTn = 100Heart Health

RCT of a natural cholesterol-lowering supplement (NCLS) containing red yeast rice, policosanols, and artichoke leaf extracts in 100 volunteers with untreated moderate hypercholesterolemia. The supplement reduced LDL cholesterol and apolipoprotein B100 without affecting safety parameters over 16 weeks.

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2013·BMC complementary and alternative medicine·Veronique Verhoeven, Maja Lopez Hartmann, Roy Remmen, et al

Red yeast rice lowers cholesterol in physicians - a double blind, placebo controlled randomized trial.

RCTn = 52Heart Health

Double blind placebo controlled randomized trial of red yeast rice (RYR) in 52 physicians and their spouses with high cholesterol. RYR significantly lowered LDL cholesterol by 36 mg/dL (22%) and total cholesterol by 37 mg/dL (15%) compared to placebo. No significant difference in side-effects or CK elevation was observed.

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2013·International journal of pharmaceutics·Chia-Hao Chen, Jyh-Chin Yang, Yow-Shieng Uang, et al

Improved dissolution rate and oral bioavailability of lovastatin in red yeast rice products.

RCTHeart Health

The study compared the dissolution rate, physical state, and oral bioavailability of lovastatin in three red yeast rice (RYR) products to lovastatin tablets. Results showed that RYR products had a faster and higher dissolution rate, reduced crystallinity, and significantly improved oral bioavailability of lovastatin compared to lovastatin tablets.

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2012·Nutrition research (New York, N.Y.)·I-Te Lee, Wen-Jane Lee, Ching-Min Tsai, et al

Combined extractives of red yeast rice, bitter gourd, chlorella, soy protein, and licorice improve total cholesterol, low-density lipoprotein cholesterol, and triglyceride in subjects with metabolic syndrome.

RCTHeart Health Nutrition

Double-blinded RCT examining the effects of a plant-extractive compound on lipid profiles in subjects with metabolic syndrome. The compound, including red yeast rice, bitter gourd, chlorella, soy protein, and licorice, significantly reduced total cholesterol, low-density lipoprotein cholesterol, and triglycerides compared to placebo. It also reduced the proportion of subjects with hypertensive criteria.

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2011·Journal of clinical lipidology·Mitchell Karl, Mark Rubenstein, Chad Rudnick, et al

A multicenter study of nutraceutical drinks for cholesterol (evaluating effectiveness and tolerability).

RCTn = 79Heart Health

This multicenter RCT evaluated the effects of nutraceutical drinks with and without red yeast rice (RYR) on cholesterol levels in 79 subjects. The drink containing RYR significantly reduced total and LDL cholesterol at 4 and 8 weeks, while the drink without RYR showed no change. The RYR drink was well-tolerated, with only one subject experiencing a headache.

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2009·Annals of internal medicine·David J Becker, Ram Y Gordon, Steven C Halbert, et al

Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial.

RCTn = 62Heart Health

RCT of 62 statin-intolerant patients with dyslipidemia comparing red yeast rice to placebo over 24 weeks. Red yeast rice significantly decreased LDL cholesterol levels compared to placebo, without increasing CPK or pain levels.

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2008·Mayo Clinic proceedings·David J Becker, Ram Y Gordon, Patti B Morris, et al

Simvastatin vs therapeutic lifestyle changes and supplements: randomized primary prevention trial.

RCTn = 74Heart Health

This randomized trial compared the lipid-lowering effects of an alternative regimen (lifestyle changes, red yeast rice, and fish oil) with simvastatin in 74 patients with hypercholesterolemia. Both groups showed significant reductions in LDL-C levels, with the alternative group also showing significant reductions in triglycerides and weight.

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2024·Clinical Diabetes and Endocrinology·Alessia Izzo, R. Costanzo, L. De Martino, et al

Does EFSA statement on Monacolin content of nutraceutical combinations impair their lipid lowering effect? The LopiGLIK experience

StudyHeart Health

The study compares the cholesterol-lowering effects of Armolipid Plus® and LopiGLIK®, focusing on Monacolin-K, the active component of red yeast rice. Despite reducing Monacolin-K content to comply with EFSA guidelines, LopiGLIK® maintained its efficacy, suggesting other ingredients like Morus alba may enhance its effectiveness.

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2019·Acta medica Indonesiana·Nafrialdi Nafrialdi, Johannes Hudyono, Frans D Suyatna, et al

Safety and Efficacy of NC120 for Improving Lipid Profile: A Double Blind Randomized Controlled Trial.

RCTn = 49Heart Health

Double blind randomized controlled trial comparing NC120, containing red yeast rice, guggulipid, and chromium picolinate, with placebo in subjects with hypercholesterolemia. NC120 significantly reduced total cholesterol and LDL-cholesterol but not triglycerides. Side effects were minor and comparable between groups.

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2019·Nutrients·Mònica Domenech, Rosa Casas, Ana Maria Ruiz-León, et al

Effects of a Novel Nutraceutical Combination (Aquilea Colesterol) on the Lipid Profile and Inflammatory Biomarkers: A Randomized Control Trial.

RCTn = 40Heart Health Inflammation

RCT evaluating the effects of a nutraceutical combination (Aquilea Colesterol) containing phytosterols, red yeast rice, and hydroxytyrosol on lipid profile and inflammatory biomarkers in individuals with moderate hypercholesterolemia. The nutraceutical significantly reduced total cholesterol, LDL-c, apolipoprotein B, and hs-CRP compared to placebo over one and three months.

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2018·Atherosclerosis·Matteo Pirro, Daniela Francisci, Vanessa Bianconi, et al

NUtraceutical TReatment for hYpercholesterolemia in HIV-infected patients: The NU-TRY(HIV) randomized cross-over trial.

RCTn = 30Heart Health Inflammation

This randomized cross-over trial investigated the effects of a nutraceutical combination containing red yeast rice and berberine on lipid profile, PCSK9, subclinical inflammation, and arterial stiffness in 30 ART-treated HIV-infected patients. The nutraceutical significantly reduced total cholesterol, LDL-C, PCSK9 levels, and hs-CRP, and improved arterial stiffness without significant side effects.

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2018·Food & function·A. Mazza, L. Schiavon, G. Rigatelli, et al

The short-term supplementation of monacolin K improves the lipid and metabolic patterns of hypertensive and hypercholesterolemic subjects at low cardiovascular risk.

RCTn = 30Heart Health Nutrition

RCT investigating the efficacy and safety of a nutraceutical compound containing high doses of monacolin K in improving lipid profile and glucose metabolism in hypertensive and hypercholesterolemic subjects. The treatment group showed significant reductions in total cholesterol, LDL cholesterol, and blood glucose compared to the control group.

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2017·Complementary therapies in medicine·Christian Tshongo Muhindo, Sylvie A Ahn, Michel F Rousseau, et al

Efficacy and safety of a combination of red yeast rice and olive extract in hypercholesterolemic patients with and without statin-associated myalgia.

Observationaln = 642Heart Health

An observational study evaluated the efficacy, tolerance, and safety of Cholesfytol, a combination of red yeast rice and olive extract, in 642 hypercholesterolemic patients. The study found significant reductions in total cholesterol and LDL-C levels, with greater reductions in patients with higher baseline values. Minor side effects were reported by 13 patients, and 4 patients with antecedent SAMS reported myalgia.

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2017·Trials·Nina Hermans, Anastasia Van der Auwera, Annelies Breynaert, et al

A red yeast rice-olive extract supplement reduces biomarkers of oxidative stress, OxLDL and Lp-PLA, in subjects with metabolic syndrome: a randomised, double-blind, placebo-controlled trial.

RCTn = 49Heart Health

A double-blind, placebo-controlled, randomised trial with 49 patients with metabolic syndrome tested the effects of a red yeast rice-olive extract supplement. The supplement significantly reduced Lp-PLA by 7% and OxLDL by 20%, suggesting a potential reduced risk for cardiovascular disease.

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2016·Annals of nutrition & metabolism·Arrigo F G Cicero, Martino Morbini, Martina Rosticci, et al

Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects.

RCTn = 40Heart Health

This double-blind, placebo-controlled RCT investigated the effects of red yeast rice plus Coenzyme Q10 supplementation on lipid patterns, endothelial reactivity, and arterial stiffness in 40 moderately hypercholesterolemic subjects. The treatment group showed significant improvements in LDL-cholesterol, endothelial reactivity, and arterial stiffness compared to placebo.

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2013·Journal of clinical lipidology·Massimiliano Ruscica, Monica Gomaraschi, Giuliana Mombelli, et al

Nutraceutical approach to moderate cardiometabolic risk: results of a randomized, double-blind and crossover study with Armolipid Plus.

RCTn = 30Heart Health

RCT of 30 patients with moderate dyslipidemia and metabolic syndrome comparing Armolipid Plus to placebo and pravastatin. Armolipid Plus significantly reduced total and LDL cholesterol and increased HDL cholesterol, showing lipid-lowering activity comparable to pravastatin.

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2013·Forschende Komplementarmedizin (2006)·Chien-Ying Lee, Ming-Shiou Jan, Min-Chien Yu, et al

Relationship between adiponectin and leptin, and blood lipids in hyperlipidemia patients treated with red yeast rice.

RCTn = 30Heart Health Inflammation

RCT of 30 hyperlipidemia patients treated with red yeast rice capsules 600 mg twice a day for 8 weeks. Significant decreases in LDL-C and total cholesterol were observed, along with an increase in adiponectin. Adiponectin correlated positively with HDL-C, and leptin correlated negatively with TG.

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2013·Nutrition research (New York, N.Y.)·Arrigo F G Cicero, Giuseppe Derosa, Angelo Parini, et al

Red yeast rice improves lipid pattern, high-sensitivity C-reactive protein, and vascular remodeling parameters in moderately hypercholesterolemic Italian subjects.

RCTn = 25Heart Health Inflammation

A crossover, double-blind, placebo-controlled RCT tested the effects of 10 mg monacolins from red yeast rice on lipid patterns, hs-CRP, and vascular remodeling biomarkers in 25 mildly hypercholesterolemic Italian subjects. Monacolins significantly improved total cholesterol, LDL cholesterol, non-HDL cholesterol, matrix metalloproteinases 2 and 9, and hs-CRP compared to placebo, with no significant differences in triglycerides, HDL cholesterol, and safety parameters.

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2012·European journal of nutrition·Emmanuel Barrat, Yassine Zaïr, Pascal Sirvent, et al

Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study.

RCTn = 45Heart Health

RCT of 45 subjects with untreated hypercholesterolaemia comparing a dietary supplement containing red yeast rice extract, policosanol, and artichoke leaf extract at two doses to placebo. Both doses significantly reduced LDL-cholesterol compared to placebo, with no additional benefit from the higher dose. No adverse effects on muscle, liver, or renal biomarkers were observed.

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2012·European journal of nutrition·Nicolas Ogier, Marie-Josèphe Amiot, Stéphane Georgé, et al

LDL-cholesterol-lowering effect of a dietary supplement with plant extracts in subjects with moderate hypercholesterolemia.

RCTn = 39Heart Health

Double-blind, randomized controlled trial of a dietary supplement containing red yeast rice, sugar cane-derived policosanols, and artichoke leaf extracts in 39 subjects with moderate hypercholesterolemia. The supplement reduced LDL-cholesterol by 21.4% and total cholesterol by 14.1% after 16 weeks, suggesting it may aid in managing mild to moderate hypercholesterolemia.

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2012·High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension·Valentina Trimarco, Claudia Sara Cimmino, Mario Santoro, et al

Nutraceuticals for blood pressure control in patients with high-normal or grade 1 hypertension.

RCTn = 30Heart Health

RCT comparing two nutraceutical combinations in 30 patients with grade 1 hypertension. The combination including Orthosiphon stamineus significantly reduced mean 24-hour systolic and diastolic BP levels, while the combination without it did not show significant BP reduction.

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2010·Scandinavian cardiovascular journal : SCJ·Martin Prøven Bogsrud, Leiv Ose, Gisle Langslet, et al

HypoCol (red yeast rice) lowers plasma cholesterol - a randomized placebo controlled study.

RCTn = 42Heart Health

A randomized, double-blind, placebo-controlled study of 42 patients assessed the effect of red yeast rice (HypoCol) on plasma lipids over 16 weeks. The RYR group showed significant reductions in LDL-cholesterol (23.0%) and total cholesterol (15.5%) compared to placebo.

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2010·Nutrition, metabolism, and cardiovascular diseases : NMCD·O Guardamagna, F Abello, V Baracco, et al

The treatment of hypercholesterolemic children: efficacy and safety of a combination of red yeast rice extract and policosanols.

RCTn = 40Heart Health

Double-blind, randomized, placebo-controlled, cross-over trial in 40 hypercholesterolemic children evaluating a dietary supplement containing red yeast rice extract and policosanols. The supplement significantly reduced total cholesterol, LDL-C, and apolipoprotein B levels compared to placebo, with no adverse effects detected.

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2009·The American journal of cardiology·Steven C Halbert, Benjamin French, Ram Y Gordon, et al

Tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance.

RCTn = 43Heart Health

RCT comparing the tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in 43 patients with previous statin intolerance due to myalgia. Red yeast rice was tolerated as well as pravastatin and achieved a comparable reduction in low-density lipoprotein cholesterol.

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2019·Journal of clinical psychopharmacology·Antonio Bruno, Gianluca Pandolfo, Manuela Crucitti, et al

Effect of Red Yeast Rice on Cognitive Functioning in Schizophrenia: Data From a Pilot Study.

Studyn = 35Mental Clarity

Pilot study of 35 schizophrenia outpatients receiving 200 mg/day red yeast rice for 12 weeks. Red yeast rice supplementation significantly improved cognitive functioning, specifically WCST 'perseverative errors' and phonemic fluency test, with small effect sizes. No significant changes in clinical symptoms or adverse effects were reported.

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2014·Alternative therapies in health and medicine·Thomas Hobbs, Richard Caso, David McMahon, et al

A novel, multi-ingredient supplement to manage elevated blood lipids in patients with no evidence of cardiovascular disease: a pilot study.

Studyn = 16Heart Health

Pilot study of a multi-ingredient supplement (MIS) featuring red yeast rice (RYR) and omega-3 fatty acids in 19 patients with hypercholesterolemia. The MIS significantly decreased total cholesterol and LDL levels. The addition of omega-3s decreased triglycerides in a subgroup, though not significantly. No side effects were reported.

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2012·Journal of dietary supplements·Joseph Stefon Feuerstein, Wendy Sue Bjerke

Powdered red yeast rice and plant stanols and sterols to lower cholesterol.

Case reportn = 18Heart Health

Case series of 18 patients with hypercholesterolemia using a proprietary product combining red yeast rice and phytosterols. Significant reductions in total cholesterol (19%) and LDL cholesterol (33%) were observed after 6 weeks, with no significant side effects reported.

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2011·Journal of postgraduate medicine·P. Sikka, S. Kapoor, Bindra Vk, et al

Statin intolerance: now a solved problem.

Review

The paper discusses strategies for managing statin intolerance in hyperlipidemic patients, including lower and intermittent dosing of statins, alternate hypolipidemic drugs, and supplementation with red yeast rice, coenzyme Q10, and vitamin D.

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