A randomized placebo controlled trial of an innovative herbal formula in the prevention of atherosclerosis in postmenopausal women with borderline hypercholesterolemia

Summary 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 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.