The effect of Helicobacter pylori infection and eradication in patients with gastro-oesophageal reflux disease: A parallel-group, double-blind, placebo-controlled multicentre study (original) (raw)
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Gastroenterology, 2001
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 13 C-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.
Arquivos de Gastroenterologia, 2012
CONTEXT: Helicobacter pylori has been associated with worsening of gastroesophageal reflux disease (GERD). OBJECTIVE: To evaluate the effect of H. pylori eradication in GERD patients. METHODS: We conducted a prospective, randomized, controlled trial performing symptom evaluation, endoscopy, histology, manometry and esophageal pH testing on GERD patients. Patients infected with H. pylori were randomized to: 1) eradication treatment plus proton pump inhibitors treatment, or 2) proton pump inhibitors alone. Patients not infected constituted a negative control group. After 3 months, patients were re-evaluated by symptom assessment, endoscopy, histology and manometry. RESULTS: GERD treatment resulted in significantly higher lower esophageal sphincter pressure, as measured by mean expiratory pressure, in H. pylori negative patients. There was significantly lower proportion of hypotensive waves and significantly higher proportion of normotensive waves in non-eradicated patients. All sympto...
The Lancet, 2001
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. 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. 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). 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.
European journal of gastroenterology & hepatology, 2004
Discussions concerning the increased incidence of gastro-oesophageal reflux disease (GORD) after Helicobacter pylori eradication continue. In this study we aimed to evaluate the presence of co-existing GORD in (1) duodenal ulcer patients after successful H. pylori eradication, (2) patients with persistent H. pylori infection after attempts at eradication, and (3) controls in whom H. pylori eradication had not been attempted. A prospective study of 255 patients with duodenal ulcer who were assigned to H. pylori eradication or to control treatment (omeprazole for 4 weeks) and followed up for 1 year or until peptic ulcer relapse. GORD was determined in the patients who had reflux oesophagitis on endoscopy at the beginning of the study and/or in patients without reflux oesophagitis if they experienced heartburn and/or regurgitation at least twice a week associated with impairment of daily activities. The study revealed a significant decrease (from 44.6% to 21.7%; P < 0.001) of patien...
Helicobacter, 2000
Background. It has been suggested that the incidence of gastroesophageal reflux disease (GERD) increases after successful eradication of Helicobacter pylori infection. We present data on development of GERD from a controlled study of H. pylori eradication in 165 duodenal ulcer patients. Methods. Patients (mean age, 55 years; 102 men; current smokers; n ϭ 74) were randomly assigned 2 : 1 to receive omeprazole, 40 mg twice daily, in combination with either amoxicillin, 750 mg twice daily, or placebo. Endoscopy and dyspeptic symptoms, including heartburn, were assessed at inclusion and at 6, 12, and 24 months after treatment. In addition, symptoms were assessed at 18 months. Patients with erosive esophagitis
Clinical Gastroenterology and Hepatology, 2004
Background & Aims: There has been significant controversy over the relationship between Helicobacter pylori infection and reflux esophagitis. We investigated the effects of eradicating H. pylori on the reflux esophagitis found in patients with peptic ulcers. Methods: Prospective posteradication evaluations were conducted yearly in 162 H. pylori-positive patients who had reflux esophagitis together with peptic ulcer disease (4 women and