Objective: To observe the clinical efficacy of Guishao Huoxue Decoction combined with ursodeoxycholic acid on primary biliary cirrhosis.Methods: 44 patients with primary biliary cirrhosis were randomly divided into an observation group and a control group, 22 cases in each group. Patients in the observation group were treated with Guishao Huoxue Decoction combined with ursodeoxycholic acid, while patients in the control group were treated with ursodeoxycholic acid. The improvement of clinical symptoms and liver function indexes were observed. Results: After 1 month of treatment, there was no significant difference between the two groups; after 6 months, there were significant differences between the two groups. The clinical symptoms including fatigue, itching, jaundice, hepatosplenomegaly of the observation group were improved, the routine examination blood, urine, stool showed no abnormality. The efficacy of the treatment group was obviously better than that of the control group. The AST, ALT, GGT, ALP of the two groups had significant differences. Conclusion: Guishao Huoxue Decoction combined with ursodeoxycholic acid has significant effect on the treatment of primary biliary cirrhosis with high safety which is worthy of clinical application.