Objective: Existing clinical data suggest that Huaier granules effectively improve the condition of PLC patients. However, their specific efficacy and safety in PLC patients remain unclear. This study aimed to investigate the effects of Huaier granules as an adjunctive therapy for PLC patients. Methods: This cohort study includes 4577 PLC patients, with data retrieved up to 2024. The patients were divided into the Huaier group (n = 2404) and a control group (n = 2173), and the treatment effects and safety between the two groups were compared. Review Manager 5.3 was used to analyze the clinical data. The fixed-effects and random-effects models were adopted. Stata 17.0 was used for sensitivity and bias analyses to evaluate publication bias. Results: Heterogeneity testing and analysis using a random-effects model showed that the combination of Huaier granules and conventional treatment significantly reduced the recurrence rate (OR = 0.65, 95% CI 0.50-0.85, p = 0.002) and improved the one-year survival rate (OR = 0.79, 95% CI 0.65-0.96, p = 0.02). Huaier granules also improved quality of life, reduced AFP levels (p < 0.00001), and significantly impacted immune function by altering the levels of the T lymphocyte subtypes CD3+, CD4+, CD8+ and the CD4+/CD8+ ratio. When Huaier granules were used in combination with other medications, no significant changes in side effects were observed. Conclusions: Huaier combination therapy shows good therapeutic efficacy and safety in PLC patients. However, this conclusion needs to be further validated through prospective clinical studies.
Keywords: Huaier granules; drug combination; immune indices; meta-analysis; primary liver cancer; traditional Chinese medicine.