Helicobacter pylori and symptomatic relapse of gastro-oesophageal reflux disease: a randomised controlled trial

Lancet. 2001 Jun 2;357(9270):1738-42. doi: 10.1016/S0140-6736(00)04894-7.


Background: There is little information on the effects of Helicobacter pylori eradication in patients with a primary diagnosis of gastro-oesophageal reflux disease (GORD). Our aim was to investigate the effect of H pylori eradication in this group of patients.

Methods: We did a double-blind, randomised, placebo-controlled study in 70 patients with GORD. We assigned individuals to three groups. All patients received lansoprazole 30 mg twice daily for 10 days, followed by 30 mg once daily for 8 weeks. Patients infected with H pylori received either antibiotics (clarithromycin 500 mg and amoxicillin 1000 mg twice daily) or placebo for the first 10 days. Controls were patients not infected with H pylori. Patients were followed up for 6 months at 2-week intervals for GORD symptoms. At the end of the study we repeated endoscopy and oesophageal and gastric 24 h-pH monitoring.

Findings: 58 of 70 patients completed our study. At the end of the study 16 of these patients were H pylori-positive (14 placebo and two eradication failures), 13 were negative because of successful H pylori eradication, and 29 were controls. H pylori-positive patients relapsed earlier (54 days) than did those in whom H pylori was eradicated (100 days) (p=0.046). The H pylori-negative control group relapsed after the longest period (110 days). However, time to relapse was also affected by oesophagitis grade (no oesophagitis 127 days, grade III or IV oesophagitis 18 days). When results were corrected for the affect of oesophagitis grade, H pylori-positive patients relapsed earlier (p=0.086) than H pylori-eradiated patients and controls (p=0.001).

Interpretation: H pylori infection positively affects the relapse rate of GORD. Eradication of H pylori could, therefore, help to prolong disease-free interval in patients with GORD.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Amoxicillin / administration & dosage
  • Amoxicillin / therapeutic use*
  • Analysis of Variance
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / therapeutic use*
  • Anti-Ulcer Agents / therapeutic use*
  • Clarithromycin / administration & dosage
  • Clarithromycin / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Gastroesophageal Reflux / drug therapy*
  • Gastroesophageal Reflux / etiology
  • Helicobacter Infections / complications
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori*
  • Humans
  • Hydrogen-Ion Concentration
  • Lansoprazole
  • Male
  • Middle Aged
  • Omeprazole / analogs & derivatives*
  • Omeprazole / therapeutic use*
  • Recurrence
  • Treatment Outcome


  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Lansoprazole
  • Amoxicillin
  • Clarithromycin
  • Omeprazole