Clinical Efficacy and Safety of Dahuang Zhechong Pills in the Treatment of Non-alcoholic Steatohepatitis with Syndrome of Intermingled Phlegm and Blood Stasis
Objective:To observe the clinical efficacy and safety of Dahuang Zhechong Pills in treating non-alcoholic steatohepati-tis(NASH)with a syndrome of intermingled phlegm and blood stasis.Methods:A total of 216 NASH patients with a syndrome of intermingled phlegm and blood stasis admitted to West China Hospital of Sichuan University between May 11,2020,and January 20,2022 were enrolled and randomly divided into a control group and an observation group by block randomization,with 108 pa-tients in each group.After accounting for dropouts(10 in the observation group and 9 in the control group),the control group re-ceived health education and standard treatments including antihypertensives,antidiabetics,lipid regulators,and liver enzyme reduc-ers according to conditions.The observation group received the same treatments with the addition of Dahuang Zhechong Pills.Out-comes were assessed before and after one year of treatment,including liver biopsy resolution rate,liver fibrosis improvement as measured by FibroScan,traditional Chinese medicine(TCM)syndrome scores,body mass index(BMI),liver function indicators[serum alanine aminotransferase(ALT),total bilirubin(TB),serum aspartate aminotransferase(AST)],lipid indicators[total cho-lesterol(TC),high-density lipoprotein cholesterol(HDL-C),triglycerides(TG),low-density lipoprotein cholesterol(LDL-C)],clin-ical efficacy,and safety.Results:The observation group showed higher liver biopsy resolution rates(x2=14.512,P=0.002)and liver fibrosis improvement rates(x2=15.550,P=0.001)than the control group.The total efficacy rate of TCM syndrome relief was also higher in the observation group than in the control group(x2=21.438,P<0.05).After treatment,both groups showed im-provements in BMI,liver function,and lipid profiles(P<0.05),with no significant differences in BMI and lipid profiles between groups(P>0.05).However,the observation group had lower liver function indicators(ALT,AST,TB)than the control group(P<0.05).A total of 37 mild adverse events occurred,which resolved with or without symptomatic treatment,with no significant differ-ence in adverse event rates between the groups(P>0.05).Conclusion:Dahuang Zhechong Pills can improve liver fibrosis,TCM syndrome,and liver function in NASH patients with intermingled phlegm and blood stasis syndrome,with good safety.
Dahuang Zhechong PillsNon-alcoholic steatohepatitisSyndrome of intermingled phlegm and blood stasisLiver fi-brosisInstantaneous elastographyRandomized controlled studyClinical efficacySafety