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

ABSTRACT: 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 dyslipidemic patients with low to moderate cardiovascular risk.A total of 60 dyslipidemic patients with low to moderate cardiovascular risk were recruited and randomly assigned to receive either simvastatin (n = 33) or red yeast rice (n = 27) for 4 weeks. The muscle fatigue score, the physical activity, the serum lipid profile and the safety profile were then evaluated.At the end of study, the fatigue score was significantly increased in patients treated with simvastatin, whereas no significant change was observed in patients receiving red yeast rice. In addition, the physical activity level was significantly decreased in patients from simvastatin group when compared to those from red yeast rice group. Similar lipid-lowering effects were observed in two groups. The safety profile was not affected after the treatments.Among dyslipidemic patients with low to moderate cardiovascular risk, red yeast rice induced less fatigue side effect and exerted comparable lipid-lowering effects when compared to simvastatin in this pilot primary prevention study.NCT01686451 .

SUBMITTER: Xue Y

PROVIDER: S-EPMC5437665 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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

Xue Yangjing Y Tao Luyuan L Wu Shaoze S Wang Guoqiang G Qian Lu L Li Jiwu J Liao Lianming L Tang Jifei J Ji Kangting K

BMC cardiovascular disorders 20170518 1

<h4>Background</h4>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 dyslipidemic patients with low to moderate cardiovascular risk.<h4>Methods</h4>A total of 60 dyslipidemic patients with low to moderate cardiovasc ...[more]

PMID: 28521773

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Project description:Background and aimsA relevant role is emerging for functional foods in cardiovascular prevention. The aim of this study was to assess the effect of a nutraceutical multitargeted approach on lipid profile and inflammatory markers along with vascular remodelling in a cohort of dyslipidemic subjects without history of cardiovascular (CV) disease.Methods and resultsWe enrolled 25 subjects (mean age 48.2 years) with low to moderate CV risk profile and total cholesterol (TC) levels between 150 and 250 mg/dl. The patients were assigned to receive for one year a tablet/die of a nutraceutical combination containing red yeast rice (RYR) extract (Monacolin 3 mg/tablet) and coenzyme Q10 (30 mg/tablet). Treatment with the nutraceutical compounds led to a significant reduction of TC (from 227 to 201 mg/dl, p < 0.001), LDL-c (from 150 to 130 mg/dl, p = 0.001), triglycerides (from 121 to 109 mg/dl, p = 0.013), non-HDL-cholesterol (from 168 to 141 mg/dl, p < 0.001), hs-CRP (from 1.74 to 1.20 mg/l, p = 0.015), and osteoprotegerin (from 1488 to 1328 pg/ml, p = 0.045). Levels of HDL-c, Lp(a), glucose, liver enzyme, CPK, or creatinine did not change over time. An ultrasound study was performed to assess changes in mean carotid intima-media thickness (IMT) and maximum IMT (M-MAX) as well as modification in local carotid stiffness by means of determining the carotid compliance coefficient (CC) and distensibility coefficient (DC). At the end of the treatment, we observed small but significant reductions in both mean-IMT (from 0.62 to 0.57 mm, p = 0.022) and M-MAX (from 0.79 to 0.73 mm, p = 0.002), and an improvement in carotid elasticity (DC from 22.4 to 24.3 × 10-3/kPa, p = 0.006 and CC from 0.77 to 0.85 mm2/kPa, p = 0.019).ConclusionsA long-term treatment with a combination of RYR and coenzyme Q10 showed lipid-lowering activity along with a reduction of inflammatory mediators and an improvement of vascular properties in young subjects with a low-to-moderate CV risk profile.

Project description:While several studies have demonstrated the preventive and therapeutic effects of red yeast rice (RYR), a traditional Chinese medicine, on carotid atherosclerosis through the reduction of low-density lipoprotein cholesterol (LDL-C) level and other risk factors, the evidence remains inconsistent. This study aimed to further evaluate the effects of RYR in carotid atherosclerosis. Several databases were searched for original trials of RYR for the treatment of carotid atherosclerosis that reported plaque indicators. Carotid plaque area (AREA), carotid plaque score (SCORE), and intima-media thickness (IMT) were set as the primary outcomes, while lipid profile and safety indicators were set as the secondary outcomes. Meta-analyses were performed on the randomized controlled trials (RCTs) using Comprehensive Meta-analysis software. Heterogeneity was evaluated using the I 2 index and Q statistic. Subgroup, sensitivity, and dose-effect analyses were conducted. Twenty RCTs with 2217 patients were included. Compared to the control group, AREA (SMD = -0.855, 95%CI: -1.259 to -0.451, p < 0.001), IMT (SMD = -0.588, 95%CI: -0.792 to -0.384, p < 0.001), SCORE (SMD = -0.708, 95%CI: -1.135 to -0.282, p = 0.001), LDL-C (SMD = -0.938, 95%CI: -1.375 to -0.502, p < 0.001), triglyceride (SMD = -0.766, 95%CI: -0.980 to -0.551, p < 0.001), and total cholesterol (SMD = -0.858, 95%CI: -1.254 to -0.462, p < 0.001) were significantly decreased and HDL-C (SMD = 0.389, 95%CI: 0.044-0.733, p = 0.027) was significantly increased following RYR therapy. The indicators for safety were not significant and did not differ between the two groups (p > 0.050). Heterogeneities mainly existed for the treatment time or control group setting. Most results showed no changes in the sensitivity analysis. Dose-effect relationships were observed for all indicators except for TC and HDL-C. We concluded that RYR therapy showed considerable efficacy and an acceptable safety profile for the treatment of carotid atherosclerosis in the Chinese population.

Project description: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).

Project description:BackgroundFatigue is considered one of the most common symptoms of multiple sclerosis (MS) and lacks a current standardized treatment. Therefore, the aim of this study was to examine the feasibility and effectiveness of a cognition-targeted exercise versus symptom-targeted exercise for MS fatigue.MethodsIn this Pilot, parallel-group, randomized controlled trial, sixty participants with multiple sclerosis, were randomly assigned to either a Cognition-Targeted Exercise (CTE) (N = 30, mean age 41) or a Symptom-Targeted Exercise (STE) (N = 30, mean age 42). The participants in the experimental group received eight, 50-minute sessions of weekly Cognitive Behavior Therapy (CBT) in addition to a CTE Program; whereas, participants in the control group received eight, 50-minute sessions of weekly CBT in addition to the standardized physiotherapy program (STE Program). Feasibility was assessed through recruitment rate, participant retention, adherence and safety, in addition to clinical outcome measures, including: (1) Modified Fatigue Impact Scale (MFIS), (2) Work and Social Adjustment Scale (WSAS), (3) Hospital Anxiety and Depression Scale (HADS), and Perceived Stress Scale (PSS). All outcome measures were assessed at baseline (pretreatment), following completion of the eight visit intervention protocol, and at 3-months follow-up.ResultsThe recruitment rate was 60% and 93% of participants completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded. A Generalized Estimation Equation Model revealed a significant difference over time as an interaction term during the post and follow up visit for all clinical outcome measures (p < .001).ConclusionThe addition of CTE to CBT exhibited positive and more lasting influence on MS fatigue outcomes compared to Symptom-Targeted Exercise (STE). Feasibility and efficacy data from this pilot study provide support for a full-scale RCT of CTE as an integral component of Multiple Sclerosis fatigue management.

Dataset Information

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

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

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