Gastroenterology

Gastroenterology

Volume 121, Issue 5, November 2001, Pages 1120-1126
Gastroenterology

Clinical Research
Helicobacter pylori eradication does not exacerbate reflux symptoms in gastroesophageal reflux disease,☆☆,,★★

https://doi.org/10.1053/gast.2001.29332Get rights and content

Abstract

Background & Aims: Observational studies have suggested that Helicobacter pylori may protect against gastrointestinal reflux disease (GERD), but these results could be due to bias or confounding factors. We addressed this in a prospective, double blind, randomized, controlled trial. Methods: H. pylori–positive patients with at least a 1-year history of heartburn with a normal endoscopy or grade A esophagitis were recruited. Patients were randomized to 20 mg omeprazole, 250 mg clarithromycin, and 500 mg tinidazole twice a day for 1 week or 20 mg omeprazole twice a day and identical placebos. A second concurrently recruited control group of H. pylori–negative patients were given open label 20 mg omeprazole twice a day for 1 week. All patients received 20 mg omeprazole twice a day for the following 3 weeks and 20 mg omeprazole once daily for a further 4 weeks. Omeprazole was discontinued at 8 weeks and patients were followed up for a further 10 months. A relapse was defined as moderate or severe reflux symptoms. H. pylori eradication was determined by 13C-urea breath test. Results: The H. pylori–positive cases were randomized to antibiotics (n = 93) or placebo (n = 97). Relapse of GERD occurred in 83% of each of the antibiotic, placebo, and H. pylori–negative groups during the 12-month study period. Life tables revealed no statistical difference between the 2 H. pylori–positive groups (log rank test, P = 0.84) or between the 3 groups (log rank test, P = 0.94) in the time to first relapse. Two patients in each group developed grade B esophagitis at 12 months. Conclusions: H. pylori eradication therapy does not seem to influence relapse rates in GERD patients.

GASTROENTEROLOGY 2001;121:1120-1126

Section snippets

Materials and methods

This was a double blind, single dummy, parallel group randomized trial performed by 2 centers (Leeds and Rotherham) in the United Kingdom between July 1995 and August 1998. Patients over the age of 17 years were considered for recruitment if they had recurrent heartburn for at least 1 year as a dominant complaint and at least moderate symptoms for a minimum of 2 days each week for the previous 2 weeks. Subjects with grade A esophagitis or a normal endoscopy were enrolled. Exclusion criteria

Results

Two hundred fifty-one patients were recruited to the study; 190 were H. pylori positive and 61 were H. pylori negative. The H. pylori–positive cases were randomized to antibiotics (n = 93) or placebo antibiotics (n = 97). The baseline characteristics were similar between the 2 groups (Table 1).

. Baseline characteristics of the intention to treat antibiotic, placebo, and H. pylori–negative groups

VariablePlacebo group (n = 93)Antibiotic group (n = 85)H. pylori–negative group (n = 54)
No. of males (%)

Discussion

This is the first randomized controlled trial to evaluate the effect of H. pylori eradication on reflux symptoms and esophagitis in GERD patients. There was an 83% relapse rate in GERD symptoms at 12 months in the antibiotic and placebo groups. This relapse rate is consistent with the previous literature14 and was also seen in the H. pylori–negative controls. These data suggest that H. pylori infection does not have a clinically important impact on relapse rates in Los Angeles grade A

References (32)

Cited by (212)

  • Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States

    2018, Clinical Gastroenterology and Hepatology
    Citation Excerpt :

    If endoscopy is done for any reason such as to evaluate heartburn symptoms, it would be prudent to include gastric biopsy to exclude H pylori infection. Treatment of H pylori in patients with GERD does not alter the course or treatment of that disease.1,31 Gastric B cell lymphoma (also known as MALT lymphoma) and gastric cancer are both etiologically related to H pylori infection.32

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Address requests for reprints to: Paul Moayyedi, Ph.D., FRCP, Gastroenterology Unit, City Hospital NHS Trust, Dudley Road, Winson Green, Birmingham, B18 7QH England. e-mail: [email protected]; fax: (44) 121-414-6571.

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Supported by a research grant from AstraZeneca.

Dr. Moayyedi is currently funded by a UK Medical Research Council Training Fellowship in Health Services Research.

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Dr. Brown is an employee of AstraZeneca.

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