Eradication of Helicobacter pylori in functional dyspepsia: Randomised double blind placebo controlled trial with 12 months' follow up

Nicholas J. Talley, Jef Janssens, Karsten Lauritsen, István Rácz, Elisabeth Bolling-Sternevald

Research output: Contribution to journalArticle

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Abstract

Objectives. To determine whether eradication of Helicobacter pylori relieves the symptoms of functional dyspepsia. Design. Multicentre randomised double blind placebo controlled trial. Subjects. 278 patients infected with H pylori who had functional dyspepsia. Setting. Predominantly secondary care centres in Australia, New Zealand, and Europe. Intervention. Patients randomised to receive omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily or placebo for 7 days. Patients were followed up for 12 months. Main outcome measures. Symptom status (assessed by diary cards) and presence of H pylori (assessed by gastric biopsies and 18C-urea breath testing using urea labelled with carbon-13). Results. H pylori was eradicated in 113 patients (85%) in the treatment group and 6 patients (4%) in the placebo group. At 12 month follow up there was no significant difference between the proportion of patients treated successfully by injection to treat in the eradication arm (24%, 95% confidence interval 17% to 32%) and the proportion of patients treated successfully by intention to treat in the placebo group (22%, 15%, to 30%). Changes in symptom scores and quality of life did not significantly differ between the treatment and placebo groups. When the groups were combined, there was a significant association between treatment success and chronic gastritis score at 12 months; 41/127 (32%) patients with no or mild gastritis were successfully treated compared with 21/123 (17%) patients with persistent gastritis (P = 0.008). Conclusion. No convincing evidence was found that eradication of H pylori relieves the symptoms of functional dyspepsia 12 months after treatment.

Original languageEnglish
Pages (from-to)833-837
Number of pages5
JournalBritish Medical Journal
Volume318
Issue number7187
Publication statusPublished - Mar 27 1999

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Dyspepsia
Helicobacter pylori
Placebos
Pylorus
Gastritis
Urea
Secondary Care Centers
Clarithromycin
Omeprazole
Amoxicillin
Therapeutics
New Zealand
Stomach
Carbon
Quality of Life
Outcome Assessment (Health Care)
Confidence Intervals
Biopsy
Injections

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Eradication of Helicobacter pylori in functional dyspepsia : Randomised double blind placebo controlled trial with 12 months' follow up. / Talley, Nicholas J.; Janssens, Jef; Lauritsen, Karsten; Rácz, István; Bolling-Sternevald, Elisabeth.

In: British Medical Journal, Vol. 318, No. 7187, 27.03.1999, p. 833-837.

Research output: Contribution to journalArticle

Talley, Nicholas J. ; Janssens, Jef ; Lauritsen, Karsten ; Rácz, István ; Bolling-Sternevald, Elisabeth. / Eradication of Helicobacter pylori in functional dyspepsia : Randomised double blind placebo controlled trial with 12 months' follow up. In: British Medical Journal. 1999 ; Vol. 318, No. 7187. pp. 833-837.
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abstract = "Objectives. To determine whether eradication of Helicobacter pylori relieves the symptoms of functional dyspepsia. Design. Multicentre randomised double blind placebo controlled trial. Subjects. 278 patients infected with H pylori who had functional dyspepsia. Setting. Predominantly secondary care centres in Australia, New Zealand, and Europe. Intervention. Patients randomised to receive omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily or placebo for 7 days. Patients were followed up for 12 months. Main outcome measures. Symptom status (assessed by diary cards) and presence of H pylori (assessed by gastric biopsies and 18C-urea breath testing using urea labelled with carbon-13). Results. H pylori was eradicated in 113 patients (85{\%}) in the treatment group and 6 patients (4{\%}) in the placebo group. At 12 month follow up there was no significant difference between the proportion of patients treated successfully by injection to treat in the eradication arm (24{\%}, 95{\%} confidence interval 17{\%} to 32{\%}) and the proportion of patients treated successfully by intention to treat in the placebo group (22{\%}, 15{\%}, to 30{\%}). Changes in symptom scores and quality of life did not significantly differ between the treatment and placebo groups. When the groups were combined, there was a significant association between treatment success and chronic gastritis score at 12 months; 41/127 (32{\%}) patients with no or mild gastritis were successfully treated compared with 21/123 (17{\%}) patients with persistent gastritis (P = 0.008). Conclusion. No convincing evidence was found that eradication of H pylori relieves the symptoms of functional dyspepsia 12 months after treatment.",
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