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

Abstract

Supplementation with twice the recommended dose of the DS was effective in reducing LDL-cholesterol and appeared safe, but according to the present results, no additional benefit could be achieved compared to the recommended dose.

A Meta-Analysis of Red Yeast Rice: An Effective and Relatively Safe Alternative Approach for Dyslipidemia

“…As presented in Table 1, 9 trials used compounds including red yeast rice (RYR), and 4 used RYR in intervention group, other ingredients and the doses of RYR and lovastatin (monacolin K) per day of every trial were also listed. Among the 13 included trials, 3 trials [18], [20], [25] adopted a three-armed group design. The 3 groups in Barrat 2012[18] were recommended daily dose group (6 tablets, including 1000 mg RYR), the typical dose group (3 tablets, including 500 mg RYR) or the placebo group; all groups were included in this meta-analysis.…”

“…Among the 13 included trials, 3 trials [18], [20], [25] adopted a three-armed group design. The 3 groups in Barrat 2012[18] were recommended daily dose group (6 tablets, including 1000 mg RYR), the typical dose group (3 tablets, including 500 mg RYR) or the placebo group; all groups were included in this meta-analysis. The 3 groups in Karl 2012[20] were the RYR + Nutrition group, the Nutrition group, and the placebo group; only the RYR + Nutrition group and the placebo group were included in this meta-analysis.…”

“…All included trials were randomized, placebo-controlled trials, and most of them were double-blinded trials except Marazzi 2011[22], which was single-blinded. Five [17], [18], [20], [21], [26] of the studies reported the methods of random sequence generation. Details of withdrawals and dropouts were reported in all studies.…”

“…Meta-analysis of 7 trials[18]–[20], [22], [25], [26], [28] reporting serum ALT level at baseline and after intervention showed that compared with placebo, serum ALT level was significantly higher in the intervention group but within the normal range (0 40 U/L) [Total WMD  = 1.55 (95% CI : 0.26, 2.84) U/L, I 2  = 0%, P  = 0.02, 7 trials (8 comparisons), n = 443]. (Figure S1A).…”

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

“…At a dosage of 3 tablets/d, the Natural Cholesterol-lowering Supplement provides 500 mg RYR with 2 mg monacolins, 11.1 mg SCdP and 600 mg ALEs with 36 mg caffeilquinic acid, together with minor constituents. Two small-sized randomized controlled trial showed a reduction of LDL-cholesterol concentrations (Ogier;Barrat, 2012). The primary aim of the present study was to confirm such an effect on a larger number of subjects, together with measurements of other parameters relevant to cardiovascular risk and safety assessments.…”