Abstract： [OBJECTIVE]:To investigate the clinical effects of Weining Granules on gastric precancerous lesions (GPLs).[METHODS]:120 patients with GPLs were randomly assigned in a 1:1 ratio to receive Weining Granules (trial group) or the comparator Weifuchun tablets (control group) for 6 months.Outcomes were compared between the two groups including:overall response;gastroscopically-determined response;pathologically-confirmed response;eradication of Helicobacter pylori (HP);microvessel density (MVD)in the gastric mucosa;expression of vascular endothelial growth factor (VEGF);interleukin 2 (IL-2);interleukin 6 (IL-6);T lymphocyte subsets;immunoglobulins;symptom scores;quality of life (QOL);and adverse reactions.[RESULTS]:Patients in the trial group had a signifi-cantly higher (P＜0.05) overall response rate (81.7％)as compared with those in the control group (63.3％).Relative to treatment with Weifuchun tablets treatment with Weining Granules resulted in a significant improvement (P＜0.05) in the scores for gastric pain,distension and stuffiness in the hypochondrium,and anorexia.As compared with the tablets the Granules were associated with a significantly higher overall gastroscopically-determined response rate (78.3％;P＜0.05).Pathological examination of tissue samples indicated that 61.7％ of patients receiving the granules were cured with an overall response rate of 75.5％;these rates were significantly higher than in the control group (P＜0.05).In comparison with patients receiving the tablets,those given the granules were significantly more likely to have their HP eradicated (75.0％ vs.51.4％;P＜0.05).Improvements in MVD,VEGF,CD4+,CD4+/CD8+,IL-2,IL-6 and lgG were significantly greater with the Weining Granules than with the Weifuc-hun tablets (P＜0.05 or P＜0.01).After follow-up of 1 year,17.5％ of patients in the trial group relapsed as compared with 39.5％ in the control group (P＜0.05).Relative to the control group,the trial group showed significantly greater improvements in physical,psychological and social relationships,and in environmental domains (P＜0.05 or P＜0.01),No significant adverse reactions were observed during treatment.[CONCLUSION]:The Weining Granules appear to be effective in improving the gastric precancerous state and the main symptoms,in inhibiting angiogenesis,enhancing immune function and QOL,and in reducing 1-year relapses.In addition,this preparation seems to be associated with a low risk of adverse events,making it a safe and efficacious option for the treatment of GPLs.