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Safety of red yeast rice supplementation: A systematic review and meta-analysis of randomized controlled trials
F. Fogacci, M. Banach, DP. Mikhailidis, E. Bruckert, PP. Toth, GF. Watts, Ž. Reiner, J. Mancini, M. Rizzo, O. Mitchenko, D. Pella, Z. Fras, A. Sahebkar, M. Vrablik, AFG. Cicero, Lipid and Blood Pressure Meta-analysis Collaboration (LBPMC) Group,...
Jazyk angličtina Země Nizozemsko
Typ dokumentu časopisecké články, metaanalýza, systematický přehled
- MeSH
- biologické přípravky škodlivé účinky MeSH
- lidé MeSH
- muskuloskeletální nemoci MeSH
- potravní doplňky škodlivé účinky MeSH
- randomizované kontrolované studie jako téma MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- systematický přehled MeSH
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.
3rd Department of Internal Medicine 1st Medical Faculty Charles University Prague Czech Republic
Cardiovascular Research Centre University of Zielona Gora Zielona Gora Poland
Department of Hypertension Chair of Nephrology and Hypertension Medical University of Lodz Poland
Department of Medicine and Surgery Sciences University of Bologna Bologna Italy
Dyslipidaemia Department Institute of Cardiology AMS of Ukraine Ukraine
Neurogenic Inflammation Research Center Mashhad University of Medical Sciences Mashhad Iran
Polish Mother's Memorial Hospital Research Institute Lodz Poland
Preventive Cardiology CGH Medical Center Sterling IL USA
The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease Baltimore MD USA
Citace poskytuje Crossref.org
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- $a Fogacci, Federica $u Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy.
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- $a 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.
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- $a Banach, Maciej $u Department of Hypertension, Chair of Nephrology and Hypertension, Medical University of Lodz, Poland; Polish Mother's Memorial Hospital Research Institute (PMMHRI), Lodz, Poland; Cardiovascular Research Centre, University of Zielona Gora, Zielona Gora, Poland. Electronic address: maciejbanach77@gmail.com.
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- $a Mikhailidis, Dimitri P $u Department of Clinical Biochemistry, Royal Free Campus, University College London Medical School, University College London (UCL), London, UK.
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