Buzhong Tiaogan Dispersant For Intervening Incidence Of Liver Metastases After Colorectal Cancer Surgery: A Randomized Controlled Trial

Objective The objective of this study was to testify whether Buzhong Tiaogan Formula(BTF)could decrease the rate of occurrence of colorectal liver metastasis(CRLM)(deficiency of qi in middle jiao and the discord of the spleen and the liver type).Methods This study adopted a randomized,controlled trial method,including treatment group and control group,with 55 cases in every group.Treatment: Control group: postoperative adjuvant chemotherapy(XELOX chemotherapy: CAPE+OXA).Treatment group: postoperative adjuvant chemotherapy plus orally BTF,two bags for oral administration in the morning and evening before meals.Both groups treat six chemotherapy cycles as a course of treatment.Both groups followed up every three months,totally one year or the ending of this study.BTF was provided by Shanxi Province Hospital of Traditional Chinese Medicine(TCM).The rate of the occurrence of liver metastasis in the first year,and disease free survivl(DFS)in two groups were recorded before the treatment and in every three months.TCM clinical syndrome table,the score of Karnofsky(KPS),CEA,CA19-9 and T cell subset in two groups were recorded before the treatment and in sixth month.To establish a database,Spss28.0 statistical software was used for statistical analysis.Results In the ending of this study,104 cases were recorded,51 cases in treatment group and 53 ones in other group.There was no significant difference between the treatment group and the control group at baseline(P>0.05),indicating comparability.The rate of the occurrence of liver metastasis in the first year of the treatment group and the control group was 0 and 5.7%;DFS of the treatment group was 11.87 months(95%CI:11.83-11.92),and the other group was 11.69 months(95%CI:11.61-11.78),indicating no statistical difference(P>0.05).The scores and indicators of each scale were compared as follows: 1.Comparations before treatment: TCM syndrome score,KPS score,CEA,CA19-9 T cell subset in two groups were compared,showing no statistical difference(P>0.05).2.Comparations within groups: Inter-group comparison of the two groups in TCM syndrome score,KPS score,CEA,CA19-9 T cell subset after six months’ treatment showed statistical significance(P<0.05),compared to the time before treatment.3.Comparations among groups:The TCM clinical syndrome scores,KPS scores,CEA,CA19-9 T cell subset between the treatment group after six months’ treatment showed statistical significance(P<0.05),compared to the other group.Conclusion BTF may decrease the rate of occurrence of colorectal cancer liver metastasis(CRLM)in the first year,improve TCM syndrome score,KPS score and immunologic function,reduce CEA and CA19-9 to a certain extent.