Objective: To observe the curative effect of Huazhuo granule prepared with traditional Chinese medicine(TCM) turbidity toxin theory on type 2-diabetes mellitus(T2DM) combined with nonalcoholic fatty liver(phlegm-dampness accumulating spleen type). Method: The 90 cases were randomly divided into treatment group(45 cases) and control group(45 cases). Both groups received basic therapy plus western medicine hypoglycemic therapy

while treatment group also received Huazhuo granule for 2 treatment courses

3 months a course. Changes in TCM clinical symptoms before and after treatment in two groups

and changes in blood glucose

glycosylated hemoglobin(HbA1c)

blood lipid

liver enzymes

fasting insulin(FINS) release level

insulin resistance index(HOMA IR)

body mass index(BMI) and other indicators were observed. Result: Comparison of clinical effect between two groups:the total effective rate was 87.80% in treatment group and 53.84% in control group(P<0.05). Comparison of TCM symptoms:the total effective rate was 78.04% in treatment group and 64.10% in control group(P<0.05). Comparison of the conditions before and after treatment:P<0.05 for fasting plasma glucose(FPG)

2-hour postprandial blood glucose(2 hPBG)

and HbA1c;P<0.01 for fasting insulin(FINS)

HOMA-IR;P<0.05 for cholesterol(TC)

triglyceride(TG)

low density lipoprotein cholesterol(LDL-C)

high-density lipoprotein cholesterol(HDL-C);P<0.01 for alanine aminotransferase(ALT)

aspartate amino transferase(AST) in treatment group;P<0.05 for ALT and AST in control group;P<0.05 for body mass index(BMI). Comparison between treatment group and control group after treatment:P<0.05 for FPG and HbA1c

P<0.05 for FINS and HOMA-IR

P<0.05 for ALT and AST

P<0.05 for BMI. Conclusion: Compared with the treatment with western medicine alone

treatment with Huazhuo granule combined with western hypoglycemic medicine achieves better efficacy for T2DM of phlegm-dampness accumulating spleen type combined with nonalcoholic fatty liver.