Evaluation of the lipid lowering ability, anti-inflammatory effects and clinical safety of intensive therapy with Zhibitai, a Chinese traditional medicine☆
Received 28 August 2009; received in revised form 27 January 2010; accepted 27 January 2010. published online 02 March 2010.
Abstract
Objectives
To evaluate the lipid lowering ability, anti-inflammatory effects and clinical safety of intensive therapy of the Chinese traditional medicine Zhibitai in subjects with moderate to high cardiovascular risk.
Methods
A total of 169 subjects (96 males and 73 females, aged 55–72) having moderate to high cardiovascular risk were recruited and randomly divided into Zhibitai group (n=85), which received 480mg of Zhibitai orally twice daily, and atorvastatin group (n=84), which received 10mg of atorvastatin orally once a day. Blood lipoproteins, myocardial enzymes, liver and renal functions were measured before treatment started, and after 4 and 8 weeks of the treatment. High sensitivity C-reactive protein (hs-CRP), P-selectin, matrix metalloproteinase-9 (MMP-9) and soluble intercellular adhesion molecule-1 (sICAM-1) were measured before and after the treatment.
Results
Plasma total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) were significantly decreased, and high-density lipoprotein cholesterol (HDL-C) was increased in both groups, after 4 and 8 weeks of treatment (p<0.05 for all pairs). Interestingly, plasma triglycerides (TG) decreased in the Zhibitai group after 4 weeks of treatment but only decreased in the atorvastatin group after 8 weeks. Inflammatory factors such as hs-CRP, P-selectin, MMP-9 and sICAM-1 were significantly decreased in both groups after 8 weeks (p<0.01 for all pairs). Furthermore, there was no difference in myocardial enzymes, hepatic and renal function test parameters, incidence of myopathy or gastrointestinal tract symptoms in either group.
Conclusion
Zhibitai therapy is a good alternative to statin therapy to reduce plasma cholesterol levels in subjects with moderate to high cardiovascular risk. Most importantly, Zhibitai is safe to use.
aDepartment of Internal Cardiovascular Medicine, Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, PR China
bDepartment of Respiratory Medicine, Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, PR China
Corresponding authors at: 139 Middle Renming Road, Department of Cardiology, Internal Medicine, Second Xiangya Hospital, Changsha, Hunan 410011, PR China. Tel.: +86 731 5292100; fax: +86 731 4895989.
☆ This work was supported by 2008 National Nature Scientific Funding of China (No. 30770856), 2008 Program for New Century Excellent Talents in University (NCET-08-0566) and Grant of Institute of Metabolism and Endocrine of Central South University of 2008 (DY-2008-02-04).