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. 2013 Aug;1(4):226-35.
doi: 10.1177/2050640613484020.

The effect of Helicobacter pylori infection and eradication in patients with gastro-oesophageal reflux disease: A parallel-group, double-blind, placebo-controlled multicentre study

Werner Schwizer  1 , Dieter Menne  2 , Kurt Schütze  3 , Michael Vieth  4 , Reiner Goergens  4 , Peter Malfertheiner  5 , Andreas Leodolter  6 , Michael Fried  1 , Mark R Fox  7
Affiliations

The effect of Helicobacter pylori infection and eradication in patients with gastro-oesophageal reflux disease: A parallel-group, double-blind, placebo-controlled multicentre study

Werner Schwizer et al. United European Gastroenterol J. 2013 Aug.

Abstract

Objectives: This study aimed to resolve controversy regarding the effects of Helicobacter pylori eradication therapy and H. pylori infection in gastro-oesophageal reflux disease.

Design: A randomized, double-blind, multicentre trial was performed in patients presenting with reflux symptoms. H. pylori-positive patients were randomized to receive either antibiotics or placebo for 7 days. H. pylori-negative patient controls received placebo. All received esomeprazole 20 mg b.d. for 7 days, followed by 40 mg o.d. to complete an 8-week course, and were followed up for 32 weeks by telephone.

Results: In this study, 198/589 (34%) patients were H. pylori-positive and 113 H. pylori-negative patients served as controls. Baseline endoscopy revealed 63% Los Angeles grade 0A and 37% Los Angeles grade BCD oesophagitis with no difference between patient groups. Symptom improvement on esomeprazole was seen in 89%. H. pylori eradication was successful in 82%. H. pylori eradication had no effect on symptomatic relapse (hazard ratio 1.15, 95% CI 0.74-1.8; p = 0.5). Overall, H. pylori-positive patients had a lower probability of relapse compared to H. pylori-negative controls (hazard ratio 0.6, 95% CI 0.43-0.85; p = 0.004). Relapse hazard was modulated also by oesophagitis grade (BCD vs. 0A, hazard ratio 2.1, 95% CI 1.5-3.0).

Conclusion: Relapse of gastro-oesophageal reflux disease symptoms after a course of high dose acid suppression took longer for H. pylori-positive patients than H. pylori-negative controls; however eradication therapy had no effect on the risk of relapse; ClincialTrials.gov number, NCT00574925.

Keywords: H. pylori eradication therapy; Helicobacter pylori; esomeprazole; gastritis; gastro-oesophageal reflux disease; oesophagitis; symptomatic relapse.

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Figures

Figure 1.
Figure 1.
Schematic flow chart of Erastrat study procedures. PPI, proton pump inhibitor.
Figure 2.
Figure 2.
CONSORT diagram of Erastrat study: ITT analysis. Hp, H. pylori; RanEx, H. pylori-negative patients randomly excluded from study; No result, dropouts during treatment phase, treatment failures, and dropouts on follow up.
Figure 3.
Figure 3.
Cox regression. The proportion of patients with sustained remission of reflux symptoms after 8 weeks of PPI therapy was similar in H. pylori-positive patients irrespective of treatment allocation to antibiotic (Anti) or placebo (Pla), but greater in the H. pylori-negative control (Con) group.
Figure 4.
Figure 4.
Cox regression stratified according to endoscopic findings. The proportion of patients with sustained remission of reflux symptoms after 8 weeks of PPI therapy. H. pylori status had important effects on the risk of relapse in patients with endoscopy-negative reflux disease or LA grade-A reflux oesophagitis; however H. pylori status had no effect on the relatively high risk of relapse in patients with more severe, LA grade BCD reflux oesophagitis.
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