Clinical trial to evaluate the efficacy and safety of Tongxinluo in high risk group of cardiovascular diseases

심혈관질환 고위험군에 대한 통심락(通心絡)의 유효성 및 안전성 평가를 위한 임상시험

Background and purpose: Arterial stiffness is an important, independent determinant of cardiovascular risk. Pulse wave velocity (PWV) has been used as a valuable index of arterial stiffness and as a surrogate marker for atherosclerosis. The Framingham risk score was developed using categorized risk factors to predict the 10 year absolute risk of developing coronary heart disease (CHD). This algorithm is established using recommended guidelines for blood pressure, total cholesterol, and high density lipoprotein cholesterol in addition to age, smoking history and history of diabetes. Tongxinluo(TXL) has been shown to have anti hyperlipidemic activity and anti atherogenic effects. To determine its efficacy and safety, we examined whether TXL improves PWV, ABI, Framingham score, blood pressure, and lipid profile in high risk group of cardiovascular diseases. Subjects and methods: 49 subjects with the high risk of cardiovascular diseases were recruited. Subjects were administered TXL with the dose of 1110mg three times a day for 8 weeks. baPWV, ABI, Framingham risk score, Blood pressure and serum lipid profile were assessed at baseline and after 4 and 8weeks. Results: Total cholesterol, LDL cholesterol, triglyceride, total lipid and phospolipid significantly decreased after 4 weeks of medication. Total cholesterol, total lipid and phospolipid significantly decreased after 8 weeks of medication. There were no significant changes in Framingham risk scores, ABI, PWV and blood pressure. On safety assessment, there were no adverse effects, hepatic or renal toxicity. Conclusion: We suggest that TXL is a safe and useful herbal medicine for hyperlipidemia and as for anti-atherognic effects, further research would be necessary.