Primary prevention of diclofenac associated ulcers and dyspepsia by omeprazole or triple therapy in Helicobacter pylori positive patients: a randomised, double blind, placebo controlled, clinical trial

• Published in: Gut 2002-09, Vol.51 (3), p.329-335
• Main Authors: Labenz, J, Blum, A L, Bolten, W W, Dragosics, B, Rösch, W, Stolte, M, Koelz, H R
• Format: Article
• Language: English
• Subjects: Adult; Amoxicillin - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Ulcer Agents - therapeutic use; Biological and medical sciences; Clarithromycin - therapeutic use; COX-2; cyclooxygenase 2; Diclofenac; Diclofenac - adverse effects; Digestive system; Double-Blind Method; Drug dosages; Drug therapy; Drug Therapy, Combination - therapeutic use; dyspepsia; Dyspepsia - chemically induced; Dyspepsia - prevention & control; Dysplasia; Endoscopy; Female; followed by omeprazole; followed by placebo; Helicobacter infections; Helicobacter Infections - drug therapy; Helicobacter pylori; Humans; Infections; Male; Medical sciences; Middle Aged; Musculoskeletal system; non-steroidal anti-inflammatory drug; non-steroidal anti-inflammatory drugs; Nonsteroidal anti-inflammatory drugs; NSAID; O-O; OAC-O; OAC-P; Omeprazole; Omeprazole - therapeutic use; omeprazole followed by omeprazole; omeprazole+amoxicillin+clarithromycin; P-P; Pain - drug therapy; Patients; Peptic ulcer; Peptic Ulcer - chemically induced; Peptic Ulcer - prevention & control; Pharmacology. Drug treatments; Physiological aspects; placebo followed by placebo; PPI; Prevention; proton pump inhibitor; relative risk; Stomach; Studies; Treatment Outcome; Ulcers
• ISSN: 0017-5749; 1468-3288; 1458-3288
• DOI: 10.1136/gut.51.3.329

Background: There is much controversy as to whether or not treatment of Helicobacter pylori reduces the occurrence of peptic ulcers during therapy with a non-steroidal anti-inflammatory drug (NSAID). Aim: To assess the efficacy of triple therapy or omeprazole on the occurrence of diclofenac associated ulcers in H pylori positive patients. Methods: This was a randomised, double blind, placebo controlled, multicentre trial in H pylori positive patients requiring NSAID therapy who had no past or current peptic ulcer. They received diclofenac 50 mg twice daily for five weeks in combination with one of the four randomly assigned treatments: anti-H pylori treatment for one week (omeprazole 20 mg+clarithromycin 500 mg+amoxicillin 1 g, all twice daily) followed by placebo for four weeks (OAC-P); anti-H pylori treatment for one week followed by antisecretory treatment with omeprazole 20 mg once daily for four weeks (OAC-O); omeprazole 20 mg once daily for five weeks (O-O); or placebo for five weeks (P-P). Patients were endoscoped before and after treatment. Results: Data from 660 patients were included in an intention to treat analysis. The occurrence of peptic ulcers in the four treatment groups during the study period was: 1.2% for OAC-P, 1.2% for OAC-O, 0% for O-O, and 5.8% for P-P (p