Efficacy and safety of the use of rebamipide in the scheme of triple eradication therapy of Helicobacter pylori infection: a prospective randomized comparative study.

AIM: To evaluate the effectiveness and safety of the use of rebamipide as part of the triple eradication therapy (ET) scheme of Helicobacter pylori infection.

MATERIALS AND METHODS: A prospective, randomized comparative study included 94 patients with uncomplicated H. pylori-associated stomach / duodenal ulcer. In the process of randomization, patients are divided into three groups depending on the intended therapy. The first group (n=36) received a classical triple scheme of the first-line ET (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day) for 10 days. Patients of the second group (n=33) were assigned a classical triple scheme of ET with the inclusion of rebamipide (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day, rebamipide 100 mg 3 times a day day) for 10 days. Patients of the third group (n=25) were assigned a classical triple scheme of ET with the inclusion of rebamipide (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day, rebamipide 100 mg 3 times a day) in for 10 days, with the prolongation of the administration of rebamipide for the next 20 days. The effectiveness of ET was determined by the respiratory test after 6 weeks after the end of treatment. Adverse events were recorded by patients in specially developed diaries. All patients with gastric ulcer at the 6th week underwent a histological examination of the biopsy specimens of the antrum and the body of the stomach, assessing the inflammatory activity of the process on a point system in accordance with the updated Sydney system.

RESULTS: Efficiency of H. pylori eradication in the first group was 77.7% (ITT), 82.3% (PP), in the second group - 81.8% (ITT), 84.4% (PP), and in the third group - 84% (ITT), 87.5% (PP). The use of rebamipide in the triple ET regimen was associated with an increase in H. pylori eradication efficiency, both with simultaneous use with the scheme [odds ratio (OR) 1.16; 95% confidence interval (CI) 0.32-4.24], and with subsequent prolonged admission (OR 1.5, 95% CI 0.34-6.7). A somewhat more pronounced dynamics of the epithelization of erosive and ulcerative changes in the mucous membrane of the stomach and duodenum to the 21st and 28th days in the third group of patients was noted. The incidence of adverse events between the groups was comparable: 22.2% in the first group, 24.2% in the second group and 20% in the third group. In the pathomorphological evaluation of biopsy specimens of patients with gastric ulcer at the 6th week after the treatment, significant differences were revealed between the first and third groups in terms of the inflammatory activity in the antrum stomach (2±0.63 vs. 1.4±0.52; p=0,0399).

CONCLUSION: The inclusion of rebamipide in the classical triple scheme of H. pylori ET increases the effectiveness of treatment and does not affect the safety profile. In the post-eradication period, it is advisable to continue the use of rebamipide to potentiate the repair of the gastric mucosa and regress the inflammatory processes.