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


METHODS
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.
Division of Gastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung Medical Center, 123 Ta Pei Road, Niao Sung Hsiang, Kaohsiung Hsien, Taiwan. pipi0755@ms23.hinet.net
Chia-Chang
CC
Hsu
Sheng-Nan
SN
Lu
Chi-Sin
CS
Changchien
D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D017291:Clarithromycin / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010437:Peptic Ulcer / Q000188:drug therapy*; D011446:Prospective Studies; D014011:Tinidazole / Q000008:administration & dosage* / Q000627:therapeutic use
D000897:Anti-Ulcer Agents; D014011:Tinidazole; D017291:Clarithromycin; D009853:Omeprazole