Randomised double blind controlled study of recurrence of gastric ulcer after treatment for eradication of Helicobacter pylori infection

Abstract

Objective: To determine whether eradication of Helicobacter pylori infection reduces recurrence of benign gastric ulceration. Design: Randomised, double blind, controlled study. Patients were randomised in a 1:2 ratio to either omeprazole 40 mg once daily for eight weeks or the same treatment plus amoxycillin 750 mg twice daily for weeks 7 and 8. A 12 month untreated follow up ensued. Setting: Teaching and district general hospitals between 1991 and 1994. Subjects: 107 patients with benign gastric ulcer associated with H pylori. Main outcome measures: Endoscopically confirmed relapse with gastric ulcer (analysed with life table methods), H pylori eradication, and healing of gastric ulcers (Mantel-Haenszel test). Results: 172 patients were enrolled. Malignancy was diagnosed in 19; 24 were not infected with H pylori; four withdrew because of adverse events; and 18 failed to attend for start of treatment, leaving 107 patients eligible for analysis (35 omeprazole alone; 72 omeprazole plus amoxycillin). In the omeprazole/amoxycillin group 93% (67/72; 95% confidence interval 84% to 98%) of gastric ulcers healed and 83% (29/35; 66% to 94%) in the omeprazole group (P=0.103). Eradication of H pylori was 58% (42/72; 46% to 70%) and 6% (2/35; 1% to 19%) (P<0.001) and relapse after treatment was 22% (16/72) and 49% (17/35) (life table analysis, P<0.001), in the two groups, respectively. The recurrence rates were 7% (3/44) after successful H pylori eradication and 48% (30/63) in those who continued to be infected (P<0.001). Conclusions: Eradication of H pylori reduces relapse with gastric ulcer over one year. Eradication rates achieved with this regimen, however, are too low for it to be recommended for routine use.

Key messages

The occurrence of gastric ulcer is positively associated with H pylori infection Treatment to eradicate H pylori (omeprazole 40 mg once daily and amoxycillin 750 mg twice daily) reduces recurrence of gastric ulcers compared with omeprazole treatment alone Regardless of the treatment given, rates of recurrence of gastric ulcers were lower in patients with successful H pylori eradication compared with those who continued to be infected The rate of eradication of H pylori was 58% in the omeprazole/amoxycillin treatment group Rates of healing of gastric ulcers were not significantly higher in those patients who received eradication treatment