Abstract:Objective To observe the clinical efficacy of Shugan Jianpi Jiedu recipe for treatment of liver stagnation and spleen deficiency syndrome after surgical excision of intrahepatic cholangiocarcinoma (ICC). Methods A single center, prospective, randomized controlled trial was conducted. Seventy patients with liver stagnation and spleen deficiency syndrome after surgical excision of ICC were evenly randomized into two groups (n=35):treatment group and control group. Patients with hepatitis B or hepatitis C history continued antiviral treatment and liver protection treatment if necessary. The treatment group was treated with Shugan Jianpi Jiedu recipe once a day for at least 3 months. The control group was not given oral traditional Chinese medicine. After 3 months of treatment, the clinical symptoms and Karnofsky performance score (KPS) were evaluated. The patients were followed up for 4 months to 1 year to calculate the progression-free survival. Results There were no significant differences in gender, age, clinical stage or Child-Pugh classification between the two groups (all P>0.05). After 3 months of treatment, the main clinical symptoms of the treatment group were improved significantly compared with the control group, including flank swelling, abdominal distension, anorexia and fatigue (all P<0.05), and the KPS was significantly higher than that of the control group (P<0.01). After 4 months to 1 year follow-up, the average progression-free survival was (48.20±7.34) weeks and the progression-free survival rate was 80.00% in the treatment group, while those in the control group were (38.30±16.73) weeks and 57.14%, respectively, with significant difference found in the progression-free survival rates between the two groups (P<0.05). Conclusion Shugan Jianpi Jiedu recipe can improve the clinical symptoms, quality of life and progression-free survival rate of patients with liver stagnation and spleen deficiency syndrome after surgical excision of ICC.