Clinical trial on ecabet sodium-based quadruple therapy for Helicobacter pylori eradication: a multicenter clinical study / 中华消化杂志

ABSTRACT

Objective To assess and compare the efficacy and safety of ecabet sodium-based quadruple therapy versus bismuth-based quadruple therapy for Helicobacter pylori (Hp) eradication.Methods A multicenter,randomized,positive controlled clinical trial was carried out.The object of the study were chronic gastritis patients at 8 hospitals in Xi'an,Beijing,Shanghai and Guangzhou from June 2009 to June 2011.All patients were divided into treatment group and control group.In treatment group,patients received ecabet sodium-based quadruple therapy (two times per day,omeprazole magnesium 20 mg,amoxicillin 1000 mg,clarithromycin 500 mg and ecabet sodium 1.0 g each time for 10 days.In control group,patients were assigned to receive bismuth-based quadruple therapy (two times per day; omeprazole magnesium 20 mg,amoxicillin 1000 mg,clarithromycin 500 mg and bismuth potassium citrate 220 mg each time) for 10 days.The Hp eradication was determined by 13C or 14C urea breath test at the 38th day after the treatment and the eradication rate was calculated.Side effects were recorded and analyzed.The data were analyzed by chi square test and Fisher's exact test.Results A total of 311 patients were recruited,and 155 patients were allatted in treatment group and 156 in control group.The per-protocol (PP) analysis indicated that the eradication rates of treatment group arid control group were 75.71％(106/140) and 77.37％(106/137) respectively,and there was no significant difference x2 =0.106,P=0.745).The intention-to-treat (ITT) analysis indicated that the eradication rates of treatment group and control group were 68.39％ (106/155) and 67.95％ (106/156) respectively,and there was no significant difference x2 =0.007,P=0.934).The side effects rates of treatment group and control group were 20.00％ (31/155) and 25.64％(40/156) respectively,and the difference was not statistically significant (Fisher's exact test,P=0.280).No serious side effect was observed in two groups.Conclusion The efficacy and safety of ecabet sodium-based quadruple therapy for Hp eradication in chronic gastritis patients may be the same as bismuth-based quadruple therapy.