Objective: to compare the effectiveness, safety and tolerability of Hibiscus sabadariffa extract (SHE) versus pravastatin in hypercholesterolemia.
Methods: double blind and controlled clinical trial. Men and women with hypercholesterolemia ≥ 220 mg/dL, and over 30 years without previous treatment were included.
Treatments: Experimental I, SHE standardized 10 mg of anthocyanins, control, 20 mg of pravastatin; Experimental II, extract of H. sabdariffa, standardized to 20 mg of anthocyanins for 12 weeks. SHE Data analysis with Anova and χ(2) tests were used.
Results: we included 104 patients, at baseline there were no significant differences in age, weight, BMI, total cholesterol, HDL, LDL, VLDL or triglycerides. At the end of the study, the experimental I group reduced triglycerides (p ≤0.0001), the control treatment reduced triglycerides, total cholesterol and its fractions (p = 0.02), and finally, the experimental treatment II reduced triglycerides (p = 0.0001). The three treatments showed high percentages (> 96) of safety and tolerability, without showing significant differences (p ≥ 0.57).
Conclusions: the treatments, with 10 and 20 mg of anthocyanins reduce triglycerides. The control treatment showed the greatest effect on lowering total cholesterol and fractions compared to experimental treatments.