Duodenal ulcer healing with 1‐week eradication triple therapy followed, or not, by anti‐secretory treatment: a multicentre double‐blind placebo‐controlled trial

Abstract

Background: In the management of Helicobacter pylori induced duodenal ulcer, it is still controversial whether anti‐secretory treatment needs to be continued following a 1‐week course of eradication therapy. Methods: 150 patients with H. pylori active duodenal ulcer (diameter ≥ 5 mm) were included. After a 1‐week eradication treatment combining omeprazole 20 mg b.d., amoxicillin 1000 mg b.d. and clarithromycin 500 mg b.d. (OAC), patients were randomized to omeprazole 20 mg or placebo for 3 additional weeks. The primary variable was ulcer healing assessed at 4 weeks. Eradication was verified 4 weeks after cessation of study drugs by 13C‐urea breath test. Intention‐to‐treat analysis (ITT) included 131 patients with positive histopathology at inclusion. Results: Healing rates were not statistically different, at 89% and 87%, respectively, in the OAC–omeprazole and OAC–placebo groups (95% CI: –8.7; 13.7). Numerically, healing rates in patients with successful eradication was higher [94/104 (90%)] than in patients with failed eradication [21/27 (78%)]. However, the difference was not statistically significant (P < 0.1). Conclusions: One‐week OAC eradication triple therapy achieves excellent healing rates in patients with uncomplicated duodenal ulcer disease. Although the confidence interval of the difference in healing suggests little or no benefit of continued omeprazole treatment after 1 week, larger studies are needed to address this issue definitively.

Diagnosis and treatment of Helicobacter: a 2002 updated review

“…were assigned to two groups to receive either a placebo or a further 3 weeks of omeprazole. In this study the duodenal ulcer healing rate was the same in both groups suggesting that the proton pump inhibitor need not be continued beyond the antibiotic regimen 50 . A further factor that may influence the outcome is the metaboliser status of the patients.…”

Systematic review and meta‐analysis: is 1‐week proton pump inhibitor‐based triple therapy sufficient to heal peptic ulcer?

“…Studies assessing ulcer healing with a 7‐day combination of PPI plus two antibiotics are summarized in Table 1 11–34 . In total, 24 studies (2342 patients) were included.…”

“…Healing rate (weighted mean) was 86% (95% CI, 84–87%) in all patients (both with H. pylori eradication success and failure), and it was 95% (95% CI, 94–96%) when only patients with H. pylori eradication success were considered. The characteristics of studies included in the meta‐analysis comparing the efficacy on ulcer healing of a 7‐day combination of PPI plus two antibiotics vs. this same regimen but prolonging the PPI for several more weeks are summarized in Table 2 12, 23, 25, 26, 32, 33 . Six studies identified with the defined search strategy fulfilled the inclusion criteria and contained data for the planned comparison.…”

“… Meta‐analysis comparing the efficacy on ulcer healing of 7‐day combination of a proton pump inhibitor (PPI) plus two antibiotics vs. this same regimen but prolonging the PPI for several more weeks 12, 23, 25, 26, 32, 33 …”

“…With respect to the ulcer type, 13 studies 12, 13, 15, 18, 21, 25–28, 30–33 evaluated patients with duodenal ulcer only (Table 1), and the ulcer healing rate after 7‐day PPI‐based triple therapy was 87% (95% CI, 85–89%) overall, and 94% (95% CI, 92–96%) when only patients with H. pylori eradication success were considered. Ten studies 11, 14, 16, 17, 19, 20, 23, 24, 29, 34 included both patients with duodenal and/or gastric ulcer disease, and the corresponding healing rates for all patients and for those with H. pylori eradication success were 86% (95% CI, 84–88%) and 97% (95% CI, 95–98%).…”