Clinical Study Of Shenlian Hewei Capsule In The Treatment Of Chronic Non-atrophic Gastritis (complex Syndrome Of Cold And Heat)

ObjectiveTo investigate the clinical effectiveness and safety of Shenlian Hewei Capsule in chronic non-atrophic gastritis(syndrome of the mixture of cold and heat).MethodA total of 240 subjects with chronic non-atrophic gastritis(syndrome of the mixture of cold and heat)who meet all of the inclusion and none of the exclusion criteria were enrolled to a randomized,double-blinded,parallel-controlled clinical trial.The subjects were allocated into three groups with 80 subjects in each,which were high dose group,low dose group and placebo-controlled group.After a treatment duration of 4 weeks,the following parameters in each group were evaluated,the score(pre and post treatment)of primary syndrome,the score(pre and post treatment)of secondary syndrome,the total score(pre and post treatment)of the syndrome,the improvement of gastric mucosal lesion with gastroscopy and the histopathological change of gastric mucosal.The safety and adverse events were also observed.Results1.After 4 weeks of treatment,control group is 4.1%in terms of the improvement of the total score of the syndrome,while the total effective rate is 43.2%;the total efficiency rate in high dose group is 26.9%for the primary syndrome,while the total effective rate is 82.1%;the total efficiency rate is 18.4%in the total efficiency rate in low dose group for primary syndrome,while the total effeetive rate is 81.6%.The difference between three groups is statistically significant(P<0.01).The total efficiency and effective rate in both high dose group and low dose group are higher than that in control group.However,there were no significant differences in terms of therapeutic effects between high dose group and low dose group(P>0.05).2.After 4 weeks of treatment,the total effective rates in control group in gastric mucosal erythema,erosion,bleeding and bile reflux are 58.6%,71.4%,56.3,and 60%respectively;the total effective rates in high dose group in gastric mucosal erythema,erosion,bleeding and bile reflux are 56.1%,75.0%,73.3%and 83.3%respectively;the total effective rates in low dose group are 61.9%,61.7%,89.5%and 84.2%respectively.There are no statistical significances between three groups after correcting the factors in all trial centers(P>0.05).3.After 4 weeks of treatment,the total effective rate in control group for active inflammation is 48%and 11.6%for chronic inflammation indicated by pathological examination;the total effective rate in high dose group for active inflammation is 30.4%and 11.8%for chronic inflammation indicated by pathological examination;the total effective rate in low dose group for active inflammation is 41.7%and 11.0%for chronic inflammation indicated by pathological examination;there were no statistical significance between three groups after correcting the factors in all trial centers(P>0.05)·ConclusionThe study preliminarily showed that Shenlian Hewei capsule is safe and effective for chronic non-atrophic gastritis(syndrome of the mixture of cold and heat).