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  • Title: A randomized placebo controlled trial of an innovative herbal formula in the prevention of atherosclerosis in postmenopausal women with borderline hypercholesterolemia.
    Author: Kwok T, Leung PC, Lam C, Ho S, Wong CK, Cheng KF, Chook P.
    Journal: Complement Ther Med; 2014 Jun; 22(3):473-80. PubMed ID: 24906587.
    Abstract:
    BACKGROUND: Danshen (Salvia miltiorrhiza) and Gegen (Radix puerariae) (D&G) are two herbs frequently used for the treatment of angina and other cardiac symptoms in Chinese materia medica. Recent studies have demonstrated their cardio-protective and anti-atherosclerosis effects. Earlier we have conducted two clinical trials in 2004 and 2007 which demonstrated such effects in extremely high risk patients. STUDY OBJECTIVE: The aim of the study was to demonstrate the safety and effectiveness of D&G in the prevention of atherosclerosis in postmenopausal women with early hypercholesterolemia. DESIGN: The study was designed as a randomized, double-blinded, placebo-controlled trial with a 12-month treatment period. SUBJECT: A population based sample of 165 postmenopausal women aged 47-65 were included in the trial. Only women who experienced menopause for more than 12 months were recruited. INTERVENTIONS: The eligible subjects were randomized to take the D&G preparation (two capsules), or image-identical placebo capsules (two capsules) daily, in a double-blind and parallel fashion for 12 month. MEASUREMENTS: The postmenopausal women with mild hypercholesterolemia (mean age 56.5 ± 4.1 of treatment group and 56.0 ± 3.8 years of placebo group) were randomized to the D&G group or placebo group for trial treatment. Carotid intima-media thickness (IMT) was used as the surrogate marker and was measured using high resolution ultrasound. Lipid profile was also tested. RESULTS: Baseline characteristics were comparable between the two groups. After 12 months, there were no significant changes in the blood pressures and general biochemical profiles in both groups, however, there was a remarkable decrease in serum low density lipoprotein (LDL) cholesterol (-6.92%) and total cholesterol (TC) (-5.85%) in the D&G group compared with the placebo group (-3.21% and -3.42%) when compared with the baseline. The carotid intima-media thickness (IMT) decreased 1.52% from baseline in the D&G group (p < 0.004) but the decrease was only 1.13% in the placebo treatment group (p = 0.009) after 12 months treatment. Twelve adverse events were reported (six in placebo group and six in D&G group) but none of them was directly relevant to the study herbal preparation. CONCLUSIONS: Postmenopausal women with early hypercholesterolemia tolerated D&G well. D&G improved the carotid intima thickness, lowered LDL and total cholesterol. D&G therefore can be recommended for the prevention of atherosclerosis in postmenopausal women with hypercholesterolemia.
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