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Clinical Trial
. 2002 Sep;51(3):329-35.
doi: 10.1136/gut.51.3.329.

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

J Labenz  1 , A L Blum, W W Bolten, B Dragosics, W Rösch, M Stolte, H R Koelz
Affiliations
Clinical Trial

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

J Labenz et al. Gut. 2002 Sep.

Abstract

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<0.05 between placebo and all active treatment groups). Patients who received active treatment developed therapy requiring dyspeptic symptoms less frequently than those who received placebo (p<0.05 between placebo and all active treatment groups).

Conclusions: In H pylori infected patients, all three active therapies reduced the occurrence of NSAID associated peptic ulcer and dyspeptic symptoms requiring therapy.

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Figures

Figure 1
Figure 1
Numbers of patients enrolled in the study and analysed according to the intention to treat (ITT) and per protocol (PP) approaches.
Figure 2
Figure 2
Incidence of ulcers (A), erosions (B), dyspeptic complaints requiring therapy (C), and combined outcome criteria (D) consisting of ulcer or >10 erosions or dyspepsia requiring therapy in the intention to treat population (last value during diclofenac treatment). OAC-P, omeprazole+amoxicillin+clarithromycin, followed by placebo; OAC-O, omeprazole+amoxicillin+clarithromycin, followed by omeprazole; O-O, omeprazole followed by omeprazole; P-P, placebo followed by placebo.
Figure 3
Figure 3
Development of dyspepsia (A) and musculoskeletal pain (B) during the study, as assessed by the patients on a 100 mm visual analogue scale. OAC-P, amoxicillin+omeprazole+clarithromycin, followed by placebo; OAC-O, amoxicillin+omeprazole+clarithromycin, followed by omeprazole; O-O, omeprazole followed by omeprazole; P-P, placebo followed by placebo.
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Comment in

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