Safety of red yeast rice supplementation: a systematic review and meta-analysis of randomized controlled trials

Publication date: Available online 4 March 2019Source: Pharmacological ResearchAuthor(s): Federica Fogacci, Maciej Banach, Dimitri P. Mikhailidis, Eric Bruckert, Peter P. Toth, Gerald F. Watts, Željko Reiner, John Mancini, Manfredi Rizzo, Olena Mitchenko, Daniel Pella, Zlatko Fras, Amirhossein Sahebkar, Michal Vrablik, Arrigo F.G. Cicero, on behalf of the Lipid and Blood Pressure Meta-analysis Collaboration (LBPMC) Group the International Lipid Expert Panel (ILEP)AbstractRecently, 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, <3-5 and>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 a...
Source: Pharmacological Research - Category: Drugs & Pharmacology Source Type: research