OBJECTIVE:To assess the lipid-lowering activity and safety of a dietary supplement containing monacolin Kβ-hydroxy acid form(MKA),Heye(Folium Nelumbinis),and Cangzhu(Rhizoma Atractylodis Lanceae),compared to lifestyl...OBJECTIVE:To assess the lipid-lowering activity and safety of a dietary supplement containing monacolin Kβ-hydroxy acid form(MKA),Heye(Folium Nelumbinis),and Cangzhu(Rhizoma Atractylodis Lanceae),compared to lifestyle modifications.METHODS:Totally 117 subjects with moderate to severe dyslipidemia(according to Chinese guidelines)and low CV risk were randomly assigned into three treatment groups:lifestyle modification(LM),LM plus a low dosage of MKA,LM plus a high dosage of MKA,and treated for 60 d.The primary endpoint was the reduction of low density lipoprotein cholesterol(LDL-C)and total cholesterol(TC).Safeties along with Traditional Chinese Medicine Syndromes were assessed through the study.RESULTS:A low dosage of MKA along with lifestyle modifications caused a significant decrease in LDL-C by 15.6%on average(95%CI,9.6%to 21%)with,a decrease in TC by 15.3%on average(95%CI,9.26%to 21.4%),and a decrease in non-HDL-C by 35.4%(95%CI,25.76%to 41.34%).Weak evidence of a reduction of triglycerides but an increment of HDL-C was observed in patients with severe hyperlipidemia.No severe adverse events occurred during the study.CONCLUSION:Our results confirm the LDL-C and TC lowering properties of MKA is clinically meaningful.It also produces a significant reduction of non-HDL-C,and slightly effects on TG and HDL-C as well.展开更多
基金Supported by Guangzhou Science and Technology Plan project(No.201710010107)Joint Innovation Specific Project in Key areas from Guangdong Branch Institute of China Academy of Chinese Medical Sciences(No.ZZ0908065)Project of Administration of Traditional Chinese Medicine of Guangdong Province of China(No.201811389)。
文摘OBJECTIVE:To assess the lipid-lowering activity and safety of a dietary supplement containing monacolin Kβ-hydroxy acid form(MKA),Heye(Folium Nelumbinis),and Cangzhu(Rhizoma Atractylodis Lanceae),compared to lifestyle modifications.METHODS:Totally 117 subjects with moderate to severe dyslipidemia(according to Chinese guidelines)and low CV risk were randomly assigned into three treatment groups:lifestyle modification(LM),LM plus a low dosage of MKA,LM plus a high dosage of MKA,and treated for 60 d.The primary endpoint was the reduction of low density lipoprotein cholesterol(LDL-C)and total cholesterol(TC).Safeties along with Traditional Chinese Medicine Syndromes were assessed through the study.RESULTS:A low dosage of MKA along with lifestyle modifications caused a significant decrease in LDL-C by 15.6%on average(95%CI,9.6%to 21%)with,a decrease in TC by 15.3%on average(95%CI,9.26%to 21.4%),and a decrease in non-HDL-C by 35.4%(95%CI,25.76%to 41.34%).Weak evidence of a reduction of triglycerides but an increment of HDL-C was observed in patients with severe hyperlipidemia.No severe adverse events occurred during the study.CONCLUSION:Our results confirm the LDL-C and TC lowering properties of MKA is clinically meaningful.It also produces a significant reduction of non-HDL-C,and slightly effects on TG and HDL-C as well.