Clinical efficacy of Fuzheng Jiedu Xiaoyong granules in advanced colorectal cancer (spleen deficiency and stasis toxin syndrome)

BACKGROUND: The management of advanced colorectal cancer (CRC) is challenging due to limited treatment efficacy and the significant toxicities and resistance associated with chemotherapy. Traditional Chinese medicine offers potential therapeutic benefits through mechanisms such as inhibiting tumor proliferation, modulating immunity, and preventing angiogenesis. Fuzheng Jiedu Xiaoyong granules (FZJDXYG) has shown promising clinical results, including enhanced immune function and reduced chemotherapy‐related toxicities. AIM: To validate the efficacy and safety of FZJDXYG and determine its effects on immune function in patients with advanced CRC. METHODS: In this multi‐center, double‐blind, randomized, placebo‐controlled trial, 78 eligible patients were randomly assigned at a ratio of 1:1 to the treatment group (receiving FZJDXYG plus standard care) or the control group (receiving placebo plus standard care) for 12 weeks. RESULTS: The treatment group experienced significant reductions in carcinoembryonic antigen and carbohydrate antigen 19‐9 levels (both P < 0.05), with significantly greater reductions in these two markers compared to the control group (both P < 0.05). Immunologically, the treatment group exhibited significant increases in CD3+ and CD4+ cell counts and CD4+/CD8+ ratio, and decreased CD8+ levels, with all changes superior to those in the control group (all P < 0.05). The Karnofsky Performance Status score was also significantly higher in the treatment group (P < 0.05). Crucially, the incidence of adverse events was significantly lower in the treatment group than in the control group (P < 0.05). CONCLUSION: FZJDXYG effectively ameliorates clinical symptoms, enhances immune function, and reduces chemotherapy‐induced toxicities in patients with advanced CRC with spleen deficiency and stasis toxin syndrome.