A clinical study of Weining Granules in the treatment of gastric precancerous lesions

ObjectiveTo investigate the clinical effects of Weining Granules on gastric precancerous lesions (GPLs).Methods120 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.ResultsPatients in the trial group had a significantly 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 IgG were significantly greater with the Weining Granules than with the Weifuchun 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.ConclusionThe 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.