Long Term Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols and Berberine) in Low-moderate Risk Hypercholesterolemic Patients: a Double-blind, Placebo Controlled Study
Background: Statins are at the forefront of strategies to manage hypercholesterolemia. However, 10-15% of patients result to be intolerant to any statins, even at low daily doses and almost one- third of statin users discontinue therapy within one year. Some nutraceuticals are prescribed as lipid- lowering substances, but doubts remain about their efficacy and tolerability. In this study we investigated the effects of a nutraceutical combination consisting mainly of red yeast rice extract 200 mg (equivalent to 3 mg monacolins), berberine 500 mg and policosanols 10 mg (MBP-NC).
Methods: In this single centre, randomized, double-blind, placebo-controlled study 60 consecutive outpatients (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.
|Hypercholesterolemia||Other: nutraceutical combination (red yeast rice, policosanols and berberine)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Long Term Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols and Berberine) in Low-moderate Risk Hypercholesterolemic Patients: a Double-blind, Placebo Controlled Study|
- level of cholesterol [ Time Frame: 24 weeks ]
- level of tryglicerides [ Time Frame: 24 weeks ]
|Study Start Date:||January 2009|
|Study Completion Date:||December 2013|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Other: nutraceutical combination (red yeast rice, policosanols and berberine)