title: A randomized, double-blind, placebo-controlled trial to evaluate efficacy and tolerability of an optimized botanical combination in the management of patients with primary hypercholesterolemia and mixed dyslipidemia.
abstract: This study compared the efficacy and tolerability of an optimized botanical combination containing policosanol, tomato extract, orally bioavailable grape procyanidins and Oenothera biennis oil against placebo in the management of patients with primary hypercholesterolemia and mixed dyslipidemia. Such a combination is endowed with biological properties targeted to cholesterol control and vasoprotection. This randomized, double-blind, parallel-group trial consisted of a 6 week treatment period following 4 week baseline period, and a 2 week post-treatment follow-up. At baseline, both the groups were comparable to each other. Both the active treatment and the placebo group included 30 patients (active treatment: mean age 46.80 ± 7.43 years, nine males; placebo: mean age 45.50 ± 6.76 years, eight males). Significant reductions in the LDL-cholesterol (LDL-C; -17.33% from baseline, p < 0.001) and total cholesterol (TC; -13.38% from baseline, p < 0.0001) values over the treatment period were observed with the tested product. The treatment also resulted in reductions in C-reactive protein (CRP), malondialdehyde (MDA) and superoxide dismutase (SOD) values, which are indices of oxidative stress. This rational combination of different compounds is effective and safe in lowering the elevated LDL-C and TC values. It is also effective in the modulation of the oxidation indices values; however, a further long term study in a larger population would be needed in order to confirm these preliminary findings.
authors.affiliation: Department of Medicine, Grant Medical College Mumbai, Mumbai, India.
authors.forename: H
authors.initials: H
authors.lastname: Gupta
authors.forename: D
authors.initials: D
authors.lastname: Pawar
authors.forename: A
authors.initials: A
authors.lastname: Riva
authors.forename: E
authors.initials: E
authors.lastname: Bombardelli
authors.forename: P
authors.initials: P
authors.lastname: Morazzoni
mesh_terms: D000328:Adult; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000032:analysis; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008297:Male; D008315:Malondialdehyde / Q000032:analysis; D008875:Middle Aged; D018384:Oxidative Stress / Q000187:drug effects; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D011446:Prospective Studies; D013482:Superoxide Dismutase / Q000032:analysis
chemical_list: D000924:Anticholesteremic Agents; D028321:Plant Preparations; D008315:Malondialdehyde; D002097:C-Reactive Protein; D002784:Cholesterol; D013482:Superoxide Dismutase