AIM: To explore the efficacy and mechanism of a novel therapeutic method of traditional Chinese medicine in patients with refractory cirrhotic ascites complicated with azotemia.METHODS: Seventy-five cases of refractory cirrhotic ascites complicated with azotemia were randomly divided into 3 groups: comprehensive treatment (n =29), simple treatment (n = 24), and control (n = 22).The basic treatment methods were the same in all groups, including liver protecting medicines, diuretics and supportive drugs. The control group underwent only the basic treatment. Shehuang Paste (SHP) was applied to the navels of the two treatment groups once a day for 30 d. Colon dialysis with Chinese herbs was administered to the comprehensive treatment group once every two days. Before and after treatment, we measured abdominal circumference, BUN, Cr, serum Na+,urine Na+/K+, liver function, endotoxin content, NO, and ET-1. Color Doppler ultrasonography was conducted to measure the portal vein blood flow.RESULTS: The total effective rate for ascites was 72.4% in the comprehensive treatment group, 45.8% in the simple treatment, contrasting with 18.2% in the controls.Between the two treatment groups and the controls,there were significant differences in the effective rates (P ＜ 0.01, and P ＜ 0.05). There was also a significant difference (P ＜ 0.05) between the two treatment groups. Measurements of Cr and BUN showed higher values for the treatment groups, with the comprehensive better than the simple group (P ＜ 0.05). Sera Na, urine Na/K were different, P ＜ 0.01 between pre- and posttreatment in the comprehensive group, and P ＜ 0.05 in the simple group. The treatment groups endotoxin content was also significantly reduced (P ＜ 0.01, and P ＜ 0.05), with the comprehensive group better than the simple group (P ＜ 0.05). Portal vein blood flow and NO content significantly reduced (P ＜ 0.05), as did ET-1 content (P ＜ 0.01). There were no significant changes in the control group (P ＞ 0.05). The comprehensive treatment groups pre- and post-treatment portal vein and splenic vein blood flows showed a positive correlation to NO, ET-1 and endotoxin contents.CONCLUSION: When treating refractory cirrhotic ascites complicated with azotemia, Shehuang Paste combined with Chinese herbal dialysis is better than Shehuang Paste alone for ascites resolution, azotemia,and endotoxin elimination. However, both methods on their own were also effective for reducing portal and splenic vein blood flow, and lowering the contents of NO,ET-1 in the two treatment groups.