A randomized controlled multicenter trial of Rebamipide on chronic non-atrophic gastritis / 中华消化内镜杂志

ABSTRACT

Objective To investigate the effect of rebamipide on chronic non-atrophic gastritis (NAG) with erosion and its protection of gastric mucosa from Helicobacter priori(Hp) associated lesions.Methods Patients(n=452)with endoscopically confirmed NAG with erosion from 11 hospitals in China were enrolled and randomly assigned at a ratio of 31 to receive either rebamipide(100 mg t.i.d.)or sucralfate(1.0 t.i.d.)for 8 weeks.Hp infected patients received eradication treatment before randomization.Symptoms,endoscopic scores and histological changes were recorded before and after therapy.Concentrations of serum prostaglandin E(PGE)and oxygen free radical(MDA)were measured in patients from 2 centers.Results Per-protocol analysis(n=415)showed that the dyspeptic symptom score in rebamipide group decreased significantly after eight weeks of treatment. The endoscopic inflammation score in rebamipide group also decreased from 2.65 ±0.09 to 0.60±0.10(P<0.001),which was,significantly better than that of sucralfate group(P<0.001).Histological findings were consistent with the endoscopic findings.There Was a significant elevation(P=0.002)in PGE2 concentration in mucesa from rebamipide-treated subjects [(225.4±18.3) pg/g vs.(266.7±14.7)Pg/g] compared with that in sucralfate group.The concentration of MDA significantly decreased from(325.9±65.6)mmoL/g to(216.5±61.5)mmol/g,which is markedly different from that of sucralfate group(P=0.046).No statistical difference was found between Hp eradication group,Hp infection group and Hp negative group,regarding the effect of Rebamipide.Conclusion Compared to sucralfate,Rebamipide demonstrates a superior effect on improvement of dyspepsia symptom and endoscopic findings in erosive NAG,which is not influenced by Hp infection.