Red Yeast Rice for Hyperlipidemia: A Meta-Analysis of 15 High-Quality Randomized Controlled Trials

Abstract

Background: RYR is a commonly used lipid-lowering dietary supplements in Asian and European countries, showing considerable benefits and low toxicity. This quantitative study aims to present high-quality evidence regarding the efficacy and safety of RYR in treating hyperlipidemia, in order to promote its clinical application.Methods: PubMed, embase, and Cochrane Central Register of Controlled Trials databases were systematically searched, and high-quality randomized controlled trials comparing RYR with non-RYR interventions were included. RevMan5.3 software was used to conduct the meta-analysis.Results: A total of 1,012 individuals participated in this study (481 in the experimental and 531 in the control group). In comparison to statins, RYR was more effective in lowering TG (MD, −19.90; 95% CI, −32.22 to −7.58; p = 0.002), comparable in lowering LDL-C and elevating HDL-C, and less effective in lowering TC (MD, 12.24; 95% CI, 2.19 to 22.29; p = 0.02). Compared with nutraceutical, RYR significantly reduced TC (MD, −17.80; 95% CI, −27.12 to −8.48; p = 0.0002) and LDL-C (MD, −14.40; 95% CI, −22.71 to −6.09; p = 0.0007), and elevated HDL-C (MD, 7.60; 95% CI, 4.33 to 10.87; p < 0.00001). Moreover, RYR effectively synergized nutraceutical to further reduce TC (MD, −31.10; 95% CI, −38.83 to −23.36; p < 0.00001), LDL-C (MD, −27.91; 95% CI, −36.58 to −19.24; p < 0.00001), and TG (MD, −26.32; 95% CI, −34.05 to −18.59; p < 0.00001). Additionally, RYR significantly reduced apoB (MD, −27.98; 95% CI, −35.51 to −20.45; p < 0.00001) and, whether alone or in combination, did not increase the risk of adverse events in patients with hyperlipidemia.Conclusion: RYR at 200–4800 mg daily appears to be a safe and effective treatment for hyperlipidemia, effectively regulating blood lipid levels with an exceptional impact on TG. Looking forward, high-quality clinical trials with longer observation periods are required to evaluate the efficacy and safety of RYR as a long-term medication.Systematic Review Registration: (https://www.crd.york.ac.uk/PROSPERO/), identifier (CRD4202128450).

Red Yeast Rice for the Improvement of Lipid Profiles in Mild-to-Moderate Hypercholesterolemia: A Narrative Review

“…A 2021 meta-analysis of 15 high-quality randomized controlled trials (mostly using doses of 600–2400 mg twice daily) involving 1012 subjects showed that RYR significantly decreased LDL-C versus placebo (mean difference [MD] −35.82 mg/dL; 95% confidence interval [CI] −43.36, −28.29 [ p < 0.00001]), with no significant difference versus other statins (simvastatin 20 mg/d, pravastatin 40 mg/d, or rosuvastatin 10 mg/d) with an MD of 1.89 mg/dL (95% CI −7.93, 11.71 [ p = 0.71]) [ 11 ]. RYR significantly increased HDL-C versus placebo (MD 3.47 mg/dL; 95% CI 0.94, 6.00 [ p = 0.007]) to a similar degree as other statins (MD 2.50 mg/dL; 95% CI −4.21, 9.22 [ p = 0.46]).…”

“…While RYR significantly reduced TC versus placebo (MD −37.43 mg/dL; 95% CI −47.08, −27.79 [ p < 0.00001]), it was less effective than other statins (MD 12.24 mg/dL; 95% CI 2.19, 22.29 [ p = 0.02]). For triglycerides, significant decreases were seen for RYR versus placebo (MD −20.65 mg/dL; 95% CI −35.60, −5.70 [ p = 0.007]) and versus other statins (MD −19.90 mg/dL; 95% CI −32.22, −7.58 [ p = 0.002]) [ 11 ].…”

“…Despite meta-analyses of randomized trials indicating that RYR reduces LDL-C levels versus placebo, with similar effects to low-dose, first-generation statins [ 10 , 11 ], international guidelines for the management of dyslipidemia and ASCVD prevention vary in their recommendations relating to RYR. The 2016 Joint Position Statement of the Italian Society of Diabetology and the Italian Society for the Study of Arteriosclerosis on nutraceuticals for the treatment of hypercholesterolemia states: “On the basis of current knowledge, the use of RYR preparations containing up to 10 mg/day monacolin K can be advised for patients with mild-to-moderate ASCVD risk and LDL-C levels exceeding the recommended therapeutic targets by up to 20–25% despite the implementation of adequate lifestyle changes” [ 12 ].…”

The impact of botanical fermented foods on obesity, metabolic syndrome and type 2 diabetes: a systematic review of randomised controlled trials

“…Meta-analyses of red yeast rice identified significant improvements in LDL-C, TC and TG compared to placebo in dyslipidaemic patients. [36,37,95] Our review also found that some lactofermented foods, [53,63,76] jangs, [67,72,74] tempeh, [58][59][60] brown rice lees [64] and fermented soy powder [69] significantly improved lipid parameters compared to controls.…”

“…[18,33,34] However, as these reviews did not use systematic review methodology, many existing clinical trials of BFFs were not identified. On the other hand, we found several up-to-date systematic reviews/ meta-analyses of randomised controlled trials (RCTs) investigating the impact of red yeast rice/ monacolin/ xuezhikang [35][36][37][38][39] or vinegar [40][41][42][43][44][45] on metabolic parameters; these RCTs were thus excluded during abstract screening to prevent the waste of resources. [46] We have undertaken a systematic review of RCTs administering other BFFs to participants with T2DM, MetS, obesity, or other MetS components.…”