Kwok Timothy, Leung Ping Chung, Lam Christopher, Ho Suzanne, Wong Chun Kwok, Cheng King Fai, Chook Ping
Department of Medicine & Therapeutics, Prince of Wales Hospital, CUHK, Hong Kong.
Institute of Chinese Medicine, CUHK, Hong Kong.
Complement Ther Med. 2014 Jun;22(3):473-80. doi: 10.1016/j.ctim.2014.03.010. Epub 2014 Apr 6.
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.
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.
The study was designed as a randomized, double-blinded, placebo-controlled trial with a 12-month treatment period.
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.
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.
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.
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.
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.
丹参（Salvia miltiorrhiza）和葛根（Radix puerariae）（丹葛）是中药中常用于治疗心绞痛和其他心脏症状的两味草药。近期研究已证实它们具有心脏保护和抗动脉粥样硬化作用。早些时候我们在2004年和2007年进行了两项临床试验，在极高风险患者中证实了这些作用。
本研究旨在证明丹葛在预防绝经后早期高胆固醇血症女性动脉粥样硬化方面的安全性和有效性。
本研究设计为一项随机、双盲、安慰剂对照试验，治疗期为12个月。
试验纳入了165名年龄在47 - 65岁的绝经后女性，以人群为基础的样本。仅招募绝经超过12个月的女性。
符合条件的受试者被随机分配，以双盲和平行方式每日服用丹葛制剂（两粒胶囊）或外观相同的安慰剂胶囊（两粒胶囊），为期12个月。
将轻度高胆固醇血症的绝经后女性（治疗组平均年龄56.5±4.1岁，安慰剂组平均年龄56.0±3.8岁）随机分为丹葛组或安慰剂组进行试验治疗。使用高分辨率超声测量颈动脉内膜中层厚度（IMT）作为替代指标。同时检测血脂谱。
两组的基线特征具有可比性。12个月后，两组的血压和一般生化指标均无显著变化，然而，与安慰剂组（分别为-3.21%和-3.42%）相比，丹葛组的血清低密度脂蛋白（LDL）胆固醇（-6.92%）和总胆固醇（TC）（-5.85%）较基线有显著下降。治疗12个月后，丹葛组的颈动脉内膜中层厚度（IMT）较基线下降了1.52%（p<0.004），而安慰剂治疗组仅下降了1.13%（p = 0.009）。共报告了12例不良事件（安慰剂组6例，丹葛组6例），但均与研究用草药制剂无直接关联。
绝经后早期高胆固醇血症女性对丹葛耐受性良好。丹葛可改善颈动脉内膜厚度，降低LDL和总胆固醇。因此，丹葛可推荐用于预防绝经后高胆固醇血症女性的动脉粥样硬化。
