Study On The Availability And Safety Of Sanhuangdan Shenyin In Treating Metabolic Syndrome (Phlegm And Stasis Type)

Objective:To observe the clinical efficacy and safety of Sanhuandanshen docoction in the treatmen of metabolic syndrome (pattern of phlegm-dampness stasis syndrome) preliminarily and provide new and effective clinical intervention in the treatmen of metabolic syndrome with the Traditional Chinese Medicine.Methods:80patients who met the diagnostic criteria of metabolic syndrome (pattern of phlegm-dampness stasis syndrome) were divided randomly into two groups.40cases,the trail group,were treated by Sanhuangdanshen Decoction and comprehensive therapy while the other40cases,the control group,were treated only with the comprehensive therapy.12weeks later,observed the change of indexes including body weight,body mass index(BMI), waistline and waist to height ratio(WHtR), blood glucose(FPG,2hPG), glycosylated hemoglobin(HbAlc),fasting insulin (FINS), HOMA insulin resistance index(HOMA-IR), insulin sensitivity index (ISI), total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) and the TCM syndrome score.At the same time,four vital signs,the blood routine, urine and stool routine, the hepatic and renal function, electrocardiogram (ECG),the adverse reactions were also recorded.At last, we evaluated Sanhuangdanshen Decoction’s efficacy and safety by analyzing the above indicators.Results:1.Weight,BMI,Waistline and WHtR decreased significantly after treatment (P<0.05) in the trial group,but not in the control group (P>0.05).The trial group decreased statistically more significant than the control group after treatment (P<0.05).2.FPG,2hPG and HbAlc decreased in both groups(P<0.05).There was no statistically difference on the level of FPG and2hPG between the two groups after treatment (P>0.05),while the the difference of HbAlc was statistically significant(P<0.05).3.FINS and Ln(HOMA-IR) decreased (P<0.05) while Ln(ISI) were increased (P<0.05) in trail group,but not in the control group (P>0.05) after treatment. There was a statistically significant difference between the two groups (P<0.05).4.TC,TG decreased significantly in trail group(P<0.05),but HDL-C,LDL-C were exactly the opposite (P>0.05).The difference of the former was statistically significant between the two groups after treatment (P>0.05),but the latter was exactly the opposite (P>0.05).5.TCM symptoms were improved after treatment in both groups (P<0.05), but the trail group was better than the control group (P<0.05).6.There was no abnormal in safety index in the testing process and the incidence of adverse reactions was low.Conclusion:In the treatment of metabolic syndrome (pattern of phlegm-dampness stasis syndrome),Sanhuangdanshen decoction could effectively improve the patients’ clinical symptoms,decrease the waistline, lose weight, improve insulin resistance and regulate blood lipids, while the incidence of adverse reactions was low.