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Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols, and Berberine) in Patients with Low-Moderate Risk Hypercholesterolemia: A Double-Blind, Placebo-Controlled Study.

Gonnelli S, Caffarelli C, Stolakis K, Cuda C, Giordano N, Nuti R - Curr Ther Res Clin Exp (2014)

Bottom Line: In the MBP-NC group both total cholesterol and LDL-C already showed a significant reduction at Week 4 (-30.3% ± 33.9% and -29.4% ± 35.3%, respectively) that remained substantially unchanged at Week 12 (-26.7% ± 33.1% and -25.6% ± 31.5%, respectively) and at Week 24 (-24.6% ± 32.1% and -23.7% ± 32.6%, respectively).There were no significant changes in HDL-C, fasting glucose, and triglyceride serum levels in either group.MBP-NC was also safe and well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Surgery, and Neuroscience, University of Siena, Italy.

ABSTRACT

Background: Statins are at the forefront of strategies to manage hypercholesterolemia. However 10% to 15% of patients are intolerant to any statin drugs, even at low daily doses and almost one-third of statin users discontinue therapy within 1 year. Some nutraceuticals are prescribed as lipid-lowering substances, but doubts remain about their efficacy and tolerability.

Objectives: We aimed to investigate the efficacy and the safety of a nutraceutical combination consisting mainly of 200 mg red yeast rice extract (equivalent to 3 mg monacolins), 500 mg berberine, and 10 mg policosanols (MBP-NC) in patients with low-moderate risk hypercholesterolemia.

Methods: In this single centre, randomized, double-blind, placebo-controlled study 60 consecutive outpatients (29 men and 31 women; age range = 18-60 years), with newly diagnosed primary hypercholesterolemia not previously treated, after a run-in period of 3 weeks on a stable hypolipidic diet, were randomized to receive a pill of MBP-NC (n = 30) or placebo (n = 30) once a day after dinner, in addition to the hypolipidic diet. The efficacy and the tolerability of the proposed nutraceutical treatment were fully assessed after 4, 12, and 24 weeks of treatment.

Results: In the MBP-NC group both total cholesterol and LDL-C already showed a significant reduction at Week 4 (-30.3% ± 33.9% and -29.4% ± 35.3%, respectively) that remained substantially unchanged at Week 12 (-26.7% ± 33.1% and -25.6% ± 31.5%, respectively) and at Week 24 (-24.6% ± 32.1% and -23.7% ± 32.6%, respectively). The between-groups differences were significant at all time points for both total cholesterol and LDL-C. There were no significant changes in HDL-C, fasting glucose, and triglyceride serum levels in either group. MBP-NC was also safe and well tolerated.

Conclusions: In patients with low- to moderate-risk hypercholesterolemia a nutraceutical combination in association with a hypolipidic diet significantly reduced total cholesterol and LDL-C levels and may favor the reaching the recommended cholesterol targets. ClinicalTrials.gov identifier: NCT02078167.

No MeSH data available.


Related in: MedlinePlus

Flow diagram of the study population. MBP-NC = nutraceutical combination consisting mainly of 200 mg red yeast rice extract (equivalent to 3 mg monacolins), 500 mg berberine, and 10 mg policosanols.
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f0005: Flow diagram of the study population. MBP-NC = nutraceutical combination consisting mainly of 200 mg red yeast rice extract (equivalent to 3 mg monacolins), 500 mg berberine, and 10 mg policosanols.

Mentions: The demographic and clinical characteristics of the 60 patients with hypercholesterolemia who were stable on the hypolipidic diet, 30 assigned to MBP-NC and 30 to placebo, are shown in Table I. There were no significant differences between the 2 groups in baseline characteristics. Fifty-seven patients (28 in the MBP-NC group and 29 in the placebo group) completed the 24-week study period. One patient in the MBP-NC group withdrew from the study for problems unrelated to the study drugs, whereas 2 patients (1 in the MBP-NC group and 1 in the placebo group) withdrew for not serious adverse events (Figure 1). All outcome variables were distributed normally and there was no need for log transformation. The percentage changes of lipid parameters with respect to baseline in the 2 study groups are shown in Figure 1. In the MBP-NC group both total cholesterol and LDL-C levels already showed a significant reduction at Week 4 (–30.3% ± 33.9% and –29.4% ± 35.3%, respectively), which remained substantially unchanged at Week 12 (–26.7% ± 33.1% and –25.6% ± 31.5%, respectively) and at Week 24 (–24.6% ± 32.1% and –23.7% ± 32.6%, respectively), whereas there were no significant changes in the placebo arm. The between-groups differences were significant at all time points for both total cholesterol and LDL-C (Figure 2). There were no significant changes in HDL-C and triglyceride serum levels in either group, although at the end of the study period triglyceride levels were more reduced in patients treated with MBP-NC than in those treated with placebo (–22.9% ± 62.3% and –4.1% ± 35.3%, respectively) (Figure 1). A 24-week treatment with either MBP-NC plus diet or placebo plus diet showed similar effect on body weight (–2.8 kg and –3.5 kg, respectively) and on waist circumference (–2.2 cm and –2.6 cm, respectively) (Table II). No significant differences were observed between groups at all time points for anthropometric or body composition parameters and for systolic and diastolic blood pressure (Table II). MBP-NC treatment showed a tendency to reduce serum levels of fasting glucose and of uric acid but without reaching statistical significance.


Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols, and Berberine) in Patients with Low-Moderate Risk Hypercholesterolemia: A Double-Blind, Placebo-Controlled Study.

Gonnelli S, Caffarelli C, Stolakis K, Cuda C, Giordano N, Nuti R - Curr Ther Res Clin Exp (2014)

Flow diagram of the study population. MBP-NC = nutraceutical combination consisting mainly of 200 mg red yeast rice extract (equivalent to 3 mg monacolins), 500 mg berberine, and 10 mg policosanols.
© Copyright Policy - CC BY-NC-ND
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4644239&req=5

f0005: Flow diagram of the study population. MBP-NC = nutraceutical combination consisting mainly of 200 mg red yeast rice extract (equivalent to 3 mg monacolins), 500 mg berberine, and 10 mg policosanols.
Mentions: The demographic and clinical characteristics of the 60 patients with hypercholesterolemia who were stable on the hypolipidic diet, 30 assigned to MBP-NC and 30 to placebo, are shown in Table I. There were no significant differences between the 2 groups in baseline characteristics. Fifty-seven patients (28 in the MBP-NC group and 29 in the placebo group) completed the 24-week study period. One patient in the MBP-NC group withdrew from the study for problems unrelated to the study drugs, whereas 2 patients (1 in the MBP-NC group and 1 in the placebo group) withdrew for not serious adverse events (Figure 1). All outcome variables were distributed normally and there was no need for log transformation. The percentage changes of lipid parameters with respect to baseline in the 2 study groups are shown in Figure 1. In the MBP-NC group both total cholesterol and LDL-C levels already showed a significant reduction at Week 4 (–30.3% ± 33.9% and –29.4% ± 35.3%, respectively), which remained substantially unchanged at Week 12 (–26.7% ± 33.1% and –25.6% ± 31.5%, respectively) and at Week 24 (–24.6% ± 32.1% and –23.7% ± 32.6%, respectively), whereas there were no significant changes in the placebo arm. The between-groups differences were significant at all time points for both total cholesterol and LDL-C (Figure 2). There were no significant changes in HDL-C and triglyceride serum levels in either group, although at the end of the study period triglyceride levels were more reduced in patients treated with MBP-NC than in those treated with placebo (–22.9% ± 62.3% and –4.1% ± 35.3%, respectively) (Figure 1). A 24-week treatment with either MBP-NC plus diet or placebo plus diet showed similar effect on body weight (–2.8 kg and –3.5 kg, respectively) and on waist circumference (–2.2 cm and –2.6 cm, respectively) (Table II). No significant differences were observed between groups at all time points for anthropometric or body composition parameters and for systolic and diastolic blood pressure (Table II). MBP-NC treatment showed a tendency to reduce serum levels of fasting glucose and of uric acid but without reaching statistical significance.

Bottom Line: In the MBP-NC group both total cholesterol and LDL-C already showed a significant reduction at Week 4 (-30.3% ± 33.9% and -29.4% ± 35.3%, respectively) that remained substantially unchanged at Week 12 (-26.7% ± 33.1% and -25.6% ± 31.5%, respectively) and at Week 24 (-24.6% ± 32.1% and -23.7% ± 32.6%, respectively).There were no significant changes in HDL-C, fasting glucose, and triglyceride serum levels in either group.MBP-NC was also safe and well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Surgery, and Neuroscience, University of Siena, Italy.

ABSTRACT

Background: Statins are at the forefront of strategies to manage hypercholesterolemia. However 10% to 15% of patients are intolerant to any statin drugs, even at low daily doses and almost one-third of statin users discontinue therapy within 1 year. Some nutraceuticals are prescribed as lipid-lowering substances, but doubts remain about their efficacy and tolerability.

Objectives: We aimed to investigate the efficacy and the safety of a nutraceutical combination consisting mainly of 200 mg red yeast rice extract (equivalent to 3 mg monacolins), 500 mg berberine, and 10 mg policosanols (MBP-NC) in patients with low-moderate risk hypercholesterolemia.

Methods: In this single centre, randomized, double-blind, placebo-controlled study 60 consecutive outpatients (29 men and 31 women; age range = 18-60 years), with newly diagnosed primary hypercholesterolemia not previously treated, after a run-in period of 3 weeks on a stable hypolipidic diet, were randomized to receive a pill of MBP-NC (n = 30) or placebo (n = 30) once a day after dinner, in addition to the hypolipidic diet. The efficacy and the tolerability of the proposed nutraceutical treatment were fully assessed after 4, 12, and 24 weeks of treatment.

Results: In the MBP-NC group both total cholesterol and LDL-C already showed a significant reduction at Week 4 (-30.3% ± 33.9% and -29.4% ± 35.3%, respectively) that remained substantially unchanged at Week 12 (-26.7% ± 33.1% and -25.6% ± 31.5%, respectively) and at Week 24 (-24.6% ± 32.1% and -23.7% ± 32.6%, respectively). The between-groups differences were significant at all time points for both total cholesterol and LDL-C. There were no significant changes in HDL-C, fasting glucose, and triglyceride serum levels in either group. MBP-NC was also safe and well tolerated.

Conclusions: In patients with low- to moderate-risk hypercholesterolemia a nutraceutical combination in association with a hypolipidic diet significantly reduced total cholesterol and LDL-C levels and may favor the reaching the recommended cholesterol targets. ClinicalTrials.gov identifier: NCT02078167.

No MeSH data available.


Related in: MedlinePlus