One-week low-dose triple therapy without anti-acid treatment has sufficient efficacy on Helicobacter pylori eradication and ulcer healing

Abstract

Background/aims: The aim of this study was to determine the efficacy of a 1-week low-dose proton pump inhibitor-based triple therapy without further acid suppression for cure of Helicobacter pylori infection and the ulcer healing in peptic ulcer disease.

Methodology: Patients with endoscopically proven peptic ulcers who were H. pylori positive participated in this study. All patients were treated for 1 week with omeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d., then patients were treated randomly for another 4 weeks with either omeprazole 20 mg once daily (OCM-O group; n = 40) or without acid suppressing agents (OCM group; n = 39). Patients were investigated endoscopically for H. pylori and ulcer status before treatment, four weeks (week 5) and 8 weeks later (week 9) after anti-H. pylori treatment. H. pylori infection was assessed by rapid urease test and histology.

Results: The eradication rates of H. pylori were 72.5% (95% CI: 59-86%) and 76.3% (95% CI: 63-90%) by intention-to-treat analysis and by per protocol analysis respectively in the OCM-O group and were 87.2% (95% CI: 77-98%) and 97.1% (95% CI: 92-100%) by intention-to-treat analysis and by per protocol analysis respectively in the OCM group (p < 0.05 in per protocol analysis). In respect to ulcer healing status at week 5, 89.5% (34/38) of patients in the OCM-O group and 80% (28/35) of patients in the OCM group had healed ulcers; at week 9, 86.8% (33/38) of patients in the OCM-O group and 88.6% (31/35) of patients in the OCM group had healed ulcers (p = NS). When the ulcer status was analyzed in relation to the H. pylori status, at week 5 ulcer had healed in 84.4% (54/64) of patients with clearance of H. pylori infection and in 88.9% (8/9) of those with persistent infection. At week 9, ulcer healing increased up to 93.8% (60/64) of patients with clearance of H. pylori infection and decreased to 44.4% (4/9) of patients with persistent infection. The adverse events (20%) were mild in these two treatment groups and no patients required discontinuation of the study medications.

Conclusions: Continuation of antisecretory drug therapy beyond a one-week low-dose triple therapy consisting of omeprazole, clarithromycin and tinidazole is actually excessive regarding eradication efficacy and peptic ulcer healing.