Preliminary study on a novel quadruple eradication therapy with a mucoprotective drug, sofalcone, for Helicobacter pylori infection

To assess the effects of the mucoprotective drug sofalcone, which has direc t and indirect effects on Helicobacter pylori in vitro, the eradication rat e, adverse effects, and the quality of healing peptic ulcers were evaluated . Each study patient was given 500 mg t.i.d. amoxicillin and 200 mg t.i.d. clarithromycin. In addition, three different treatment regimens were compar ed: a standard dose (20 mg q.d.) of the proton pump inhibitor omeprazole (O AC), a double dose (20 mg b.i.d.) of omeprazole (Ox2AC), and a standard dos e of omeprazole and a standard dose (100 mg t.i.d.) of sofalcone (OACS). Th irty-one H. pylori-positive patients were treated with OAC, 37 with Ox2AC, and 41 with OACS therapy. With an intention-to-treat analysis, the eradicat ion rates were 74.2% for OAC, 86.2% for Ox2AC, and 85.0% for OACS therapy. The incidence of side effects was 9.6% for patients given OAC therapy, 86.5 % for Ox2AC, and only 7.5% for OACS-treated patients, which was significant ly lower than the incidence in the Ox2AC group. High-quality peptic ulcer s cars were observed after eradication therapy which included solfacone. Alth ough it is necessary to conduct a randomized double-blind study to obtain d efinitive conclusions, our results indicate that this novel quadruple eradi cation therapy with solfacone is an efficacious regimen with a high eradica tion rate and positive effects on ulcer healing, combined with a low incide nce of adverse events.