“Zhigan Pill”for the treatment of nonalcoholic fatty liver disease of phlegm and blood stasis pattern: a randomized placebo-controlled trial

Objective To observe the clinical efficacy ofZhigan Pillfor the treatment of nonalcoholic fatty liver disease( NAFLD) and its correlation with TCM syndromes. Methods One hundred and sixty cases with NAFLD were randomized into treatment group( 120 cases) and control group( 60 cases). Treatment group was treated withZhigan Pillorally and control group was treated by placebo,with the course of 3 months. The changes of liver ultrasound disease indexing,syndrome effectiveness and total score of TCM syndromes were observed and compared. Results ① One hundred and fifty-eight cases were observed,with 120 cases in treatment group and 38 cases in control group. ② In each group,there was a significant difference in liver ultrasound disease indexing in treatment group( P 0. 05),while without significant difference in control group between before and after treatment( P 0. 05); After the treatment,there was a significant difference in the liver ultrasound disease indexing between the two groups( P 0. 05),the changes in treatment group was superior to that of the control group. ③ The total effective rate was 85. 83% in the treatment group and 63. 16% in the control group,with a difference in TCM syndrome scores between the two groups( P 0. 05). ④ In each group,there was a significant difference in total TCM syndrome scores in treatment group after treatment( P 0. 05),while without significant difference in control group( P 0. 05); After treatment,there were significant differences in scores of TCM syndrome and difference value between the two groups( P 0. 05). ⑤ There was a significant positive correlation between the syndrome effectiveness( recovery,markedly,effective,invalid)and changes of liver ultrasound disease indexing( normal,mild,moderate,severe)( P 0. 05). Conclusion Zhigan Pillhas curative effect on NAFLD of phlegm and blood stasis pattern. Ultrasound examination can be the main method and indicator to evaluate the therapeutic effects in the treatment.