The effectiveness and safety of Yi Guan Jian decoction in the treatment of primary liver cancer: A systematic review and meta-analysis of randomized controlled trials.

[BACKGROUND] Yi Guan Jian decoction (YGJ) is a well-known traditional Chinese medicine (TCM) formula that has been widely used in the clinical treatment of primary liver cancer (PLC). The primary objective of this study is to systematically evaluate the clinical efficacy and safety of YGJ decoction in the treatment of PLC.

[METHODS] We searched China National Knowledge Infrastructure, Wanfang Data, Chinese Science and Technology Journal Database (VIP), PubMed, Sinomed, Web of Science, and Cochrane Library from inception to March 2025. Randomized controlled trials involving YGJ or its modified formulations for PLC treatment were included. Study quality was assessed using RevMan 5.4. Count data were analyzed using relative risk and odds ratio; continuous data were analyzed using mean difference (MD) and standardized MD. All statistical indicators were calculated with 95% confidence intervals (CI) and P values. Data were grouped and analyzed based on intervention duration and control group treatment methods.

[RESULTS] A total of 10 randomized controlled trials were included, involving 745 patients. Meta-analysis showed that YGJ or its modified versions, combined with Western medical supportive treatments, significantly increased treatment effectiveness (OR = 1.84, 95% CI: 1.32-2.58), improved Karnofsky performance status score (MD = 7.00, 95% CI: 4.80-9.21), decreased serum alpha-fetoprotein (AFP) (SMD = -0.36, 95% CI: -0.58 to -0.14), improved TCM syndrome scores (MD = -3.10, 95% CI: -3.78 to -2.42), reduced total bilirubin (MD = -1.52, 95% CI: -2.25 to -0.78), and lowered gastrointestinal adverse reactions (OR = 0.53, 95% CI: 0.33-0.84).

[CONCLUSION] The combination of YGJ or its modified versions with modern medical therapies significantly enhances treatment effectiveness, Karnofsky performance status scores, and TCM syndrome scores, reduces AFP levels, and decreases gastrointestinal adverse reactions compared to modern medical therapies alone. These results suggest that YGJ may be a valuable addition to clinical treatment strategies. However, the included studies had small sample sizes, were geographically limited, and mostly lacked blinding. Future research should involve larger, more diverse samples and rigorous study designs to confirm these findings.