Elsevier

The Lancet

Volume 357, Issue 9270, 2 June 2001, Pages 1738-1742
The Lancet

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

https://doi.org/10.1016/S0140-6736(00)04894-7Get rights and content

Summary

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.

Introduction

Gastro-oesophageal reflux disease (GORD) is a multifactorial disorder characterised by reflux of acidic gastric contents into the oesophagus leading to tissue damage and symptoms. Transient lower oesophageal-sphincter relaxation, a mechanically incompetent lower oesophageal sphincter,1 impaired motor function of the oesophageal body, and delayed gastric emptying2 could contribute to the disease.

The role of Helicobacter pylori in the pathogenesis of GORD is controversial. Some studies indicate a protective role,3, 4, 5, 6 whereas others fail to show different H pylori infection rates in patients with and without gastro-oesophageal reflux.7, 8, 9 Additionally, some researchers have reported an increased risk of developing GORD after eradication of H pylori in patients with duodenal ulcer,10 although others report an improvement of reflux symptoms after cure of infection.11

pH of gastric content is a major determinant of potential damage to the distal oesophageal mucosa. Hpylori has divergent effects on gastric secretory function dependent on intragastric distribution and severity of gastritis,12 and on strain of H pylori.6 Whereas antral predominant gastritis is associated with raised acid output, gastritis of the stomach body results in inhibition of acid secretion and might, therefore, prevent development of GORD.

Compared with studies13, 14 of patients with duodenal ulcers, data about the effects of H pylori eradication on relief and recurrence of symptoms in patients with established GORD are rare, are published only in abstract form,13 or lack a placebo control.14 Our aim was to investigate the effect of eradication of H pylori on relief of symptoms and the course of GORD.

Section snippets

Patients

Between January, 1996, and July, 1999, we enrolled patients with symptoms of GORD. Initial investigations included an upper endoscopy with two biopsies each of the gastric antrum and body, and a 24-h measurement of oesophageal and gastric pH. All patients had had heartburn, acid regurgitation, or both for more than 4 weeks, and had either endoscopically proven reflux oesophagitis according to the modified Savary-Miller-Monnier classification (grade ≥I)15, 16 or a pathological reflux pattern

Results

70 of 129 patients screened were eligible for study inclusion. Data from the 58 patients who completed our study are presented. Figure 1 shows the trial profile and table 1 shows baseline characteristics of the 58 patients. There were more patients who had had GORD symptoms for more than 1 year in the Hpylori-positive group than in the Hpylori-eradicated group, otherwise all characteristics were similar between groups. 53 patients reported symptoms of heartburn and regurgitation, and four

Discussion

Results of studies with duodenal ulcer patients indicate that H pylori eradication substantially raises the risk of development of GORD.10 However, H pylori-positive patients with duodenal ulcer show a different pattern of gastric acid secretion to those without ulcer disease.2122 Furthermore, previous studies do not support the view that eradication of H pylori aggravates or precipitates GORD symptoms in ulcer patients and in those with functional dyspepsia.2324 Our results show that

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