Objective: To investigate the effect and mechanism of Jianpi Yishen method on improving the cancer-related fatigue in patients with advanced colorectal cancer

and to provide objective evidence for the traditional Chinese medicine (TCM) treatment of cancer-related fatigue. Method: Totally 150 cases of colorectal cancer patients with the spleen and kidney deficiency were collected and randomly divided into Chinese medicine treatment group and control group by using random number table method. They were asked to fill out a spleen and kidney deficiency symptoms rating table

Piper Fatigue Scale and Karnofsky (KPS) scale before and after treatment. The serum cytokines content was detected

then the relationship between cytokines and the cancer-related fatigue was investigated. The degree of fatigue

TCM clinical symptoms

quality of life

serum cytokines changes

and the degree of adverse reactions were compared between the two groups before and after treatment. Result: There were significantly positive correlations between the fatigue scores and symptom scores

and these two items were negatively correlated to the levels of interferon-γ (IFN-γ)

interleukin-2 (IL-2)

and Th1/Th2 in serum

but were positively correlated to IL-4 and IL-5 levels in colorectal cancer patients (P<0.05). No obvious adverse reactions were found in patients of both groups during the treatment

and the improvement in fatigue and the quality of life in the Chinese medicine treatment group was significantly better than that in the control group (P<0.05). The levels of Th1/Th2

IL-2 and IFN-γ in serum were significantly increased after treatment in two groups

and the increase degree in the Chinese medicine treatment group was higher than that in the control group (P<0.05);however the levels of IL-4 and IL-5 in serum were significantly decreased after treatment in both groups and the decrease degree in Chinese medicine treatment group was more obvious than that in the control group (P<0.05). Conclusion: The Jianpi Yishen method can redress the imbalance of Th1/Th2

and effectively improve the symptoms and the quality of life in the patients with advanced colorectal cancer.