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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.
See this image and copyright information in PMC

References

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