Clinical Observation of Fuzheng Xiaoji Granule in the Treatment of Stage IIIC Colorectal Cancer.

Objective: This study aimed to evaluate the effectiveness and safety of Fuzheng Xiaoji granule in patients with stage IIIC colorectal cancer.

Methods: A total of 150 patients with stage IIIC colorectal cancer treated in Shanghai Ruijin Hospital from January 2019 to January 2022 were selected. They were divided into treatment and control groups according to a 2 : 1 random number table. There were 100 cases in the treatment group and 50 cases in the control group. The treatment group was administered Fuzheng Xiaoji (FZXJ) granule, and the control group was administered the placebo orally. The primary endpoint was disease-free survival (DFS). In addition, after 6 months, the changes in Traditional Chinese Medicine (TCM) symptom score (fatigue, emotional depression, chest tightness, insomnia, anorexia, abdominal distension, abdominal pain, soreness and weakness in the waist and legs, chills, and dysphoria in the chest, palm, and soles) were compared.

Results: The DFS was 34.37 ± 2.91 months in the control group and 37.0 ± 1.08 months in the treatment group ( < 0.05). Compared with the control group, the treatment group showed less fatigue, abdominal distension, and soreness and weakness in the waist and legs ( < 0.05), significantly. The scores of emotional depression and anorexia decreased obviously, with a significant difference between the control and treatment groups ( < 0.01). There were no significant differences between the control and treatment groups in the incidence of chest tightness, insomnia, abdominal pain, chills, and dysphoria in the chest, palm, and soles ( > 0.05).

Conclusion: Fuzheng Xiaoji granule can improve patients' symptoms and prolong the DFS.