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 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. 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.
RCT Entities:
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 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. 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.