Yiwei Xiaoyu granules for treatment of chronic atrophic gastritis with deficiency syndrome of the spleen and stomach

BACKGROUND The Correa sequence,initiated by Helicobacter pylori(H.pylori),commonly progresses to gastric cancer through the stage of chronic atrophic gastritis(CAG).Although eradication of H.pylori only reduces the risk of gastric cancer,it does not eliminate the risk for neoplastic progression.Yiwei Xiaoyu granules(YWXY)are a commonly used composite preparation in Chinese clinics.However,the pursuit of excellence in clinical trials and the establishment of standardized animal experiments are still needed to contribute to full understanding and application of traditional Chinese medicine in the treatment of CAG.AIM To demonstrate the effectiveness of YWXY in patients with CAG and spleenstomach deficiency syndrome(DSSS),by alleviating histological scores,improving response rates for pathological lesions,and achieving clinical efficacy in relieving DSSS symptoms.METHODS We designed a double-blind,randomized,controlled trial.The study enrolled seventy-two H.pylori-negative patients(mean age,52.3 years;38 men)who were randomly allocated to either the treatment group or control group in a 1:1 ratio,and treated with 15 g YWXY or 0.36 g Weifuchun(WFC)tablet combined with the respective dummy for 24 wk.The pre-randomization phase resulted in the exclusion of 72 patients:50 participants did not meet the inclusion criteria,12 participants declined to participate,and 10 participants were excluded for various other reasons.Seven visits were conducted during the study,and histopathological examination with target endoscopic biopsy of narrow-band imaging was requested before the first and seventh visits.We also evaluated endoscopic performance scores,total symptom scores,serum pepsinogen and gastrin-17.RESULTS Six patients did not complete the trial procedures.Treatment with YWXY improved the Operative Link on Gastric Intestinal Metaplasia Assessment(OLGIM)stage,compared with WFC(P<0.05).YWXY provided better relief from symptoms of DSSS and better improvement in serum gastric function,compared with WFC(P<0.05).CONCLUSION YWXY compared with WFC significantly reduced the risk of mild or moderate atrophic disease,according to OLGIM stage,significantly relieved symptoms of DSSS,and improved serum gastric function.

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

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.