HELICOBACTER PYLORI

Treatment of Helicobacter pylori in functional dyspepsia resistant to conventional management: a double blind randomised trial with a six month follow up

H R Koelz¹, R Arnold², M Stolte³, M Fischer⁴, A L Blum⁵ the FROSCH Study Group

¹ Division of Gastroenterology, Department of Medicine, Triemli Hospital, Zurich, Switzerland
² Centre of Internal Medicine, Clinic of the Philipps University, Marburg, Germany
³ Department of Pathology, University of Bayreuth, Bayreuth, Germany
⁴ Institute for Numerical Statistics, Cologne, Germany
⁵ Division of Gastroenterology, Department of Medicine, University Hospital, Lausanne, Switzerland

Correspondence to:
Correspondence to:
Professor H R Koelz, Division of Gastroenterology, Department of Internal Medicine, Triemli Hospital, CH-8063 Zurich, Switzerland;
hrkoelz{at}hin.ch

Background: Previous studies on the treatment of Helicobacter pylori infection in functional dyspepsia have shown little, if any, effect on dyspeptic symptoms. However, whether such treatment might be of benefit in patients resistant to acid inhibitors has not been formally tested.

Aim: The present study investigated the effect of H pylori treatment in patients with functional dyspepsia resistant to conventional treatment.

Patients: A total of 181 H pylori positive patients with chronic functional dyspepsia who had not responded to a one week antacid run-in and two week double blind antisecretory or placebo treatment were included.

Methods: Patients were randomised to two weeks of treatment with omeprazole 40 mg twice daily combined with amoxicillin 1 g twice daily or omeprazole 20 mg once daily alone. The primary outcome variable ("response") was defined as no need for further therapy or investigations for dyspeptic symptoms 4–6 months after treatment.

Results: H pylori infection was healed in 10% of patients after omeprazole and in 52% after omeprazole plus amoxicillin. The respective "response" rates were 66% and 62% (NS). H pylori treatment and cure of H pylori infection had no effect on complete resolution of all dyspeptic symptoms, individual symptoms, or various aspects of quality of life.

Conclusion: In functional dyspepsia, H pylori treatment and cure of H pylori are no more effective for symptoms over six months than short term acid inhibition. These results do not support treatment of H pylori in functional dyspepsia.

Keywords: Helicobacter pylori; functional dyspepsia; omeprazole; amoxicillin; randomised clinical trial; gastric acid secretion

Abbreviations: ¹³C-UBT; ¹³C urea breath test; ITT, intention to treat; PP, per protocol

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