H2-antagonist maintenance therapy versus Helicobacter pylori eradication in patients with chronic duodenal ulcer disease: a prospective study.
BACKGROUND
Few outcome studies directly compare Helicobacter pylori eradication therapy with maintenance H2-antagonist therapy in duodenal ulcer disease.


OBJECTIVE
To examine prospectively the efficacy of H. pylori eradication therapy with ranitidine maintenance therapy over 1 year in patients with confirmed chronic duodenal ulcer.


METHODS
One hundred and nineteen patients with active H. pylori infection were randomized to receive ranitidine, 150 mg/day initially (58 patients), or omeprazole, 40 mg/day, amoxycillin 2 g/day and metronidazole 1.2 g/day for 14 days, or omeprazole 40 mg/day and clarithromycin 1.5 g/day, for 14 days (if penicillin-allergic). Symptoms were assessed using the Gastrointestinal System Rating Scale (GSRS) and SF36 quality of life index.


RESULTS
13C urea breath testing confirmed overall treatment success in 100% of patients (58/58) per protocol and 95.1% (58/61) on an intention-to-treat basis. At 4 and 12 months there were no differences in any GSRS symptoms between treatment groups. SF36 analysis showed a perceived health improvement at 4 and 12 months in patients who received H. pylori eradication. However, despite successful H. pylori eradication, one-fifth of patients still required antisecretory therapy.


CONCLUSIONS
Following successful H. pylori eradication, chronic duodenal ulcer patients were at least as well symptomatically as when taking maintenance ranitidine. They perceived that their health had improved, but a subgroup was still acid-suppression dependent.
Department of Clinical Pharmacology, University of Dundee, Ninewells Hospital and Medical School, UK. andrzej@memo.dundee.ac.uk
A T
AT
Prach
M
M
Malek
M
M
Tavakoli
D
D
Hopwood
B W
BW
Senior
F E
FE
Murray
D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004064:Digestive System / Q000187:drug effects; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006635:Histamine H2 Antagonists / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011899:Ranitidine / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D017211:Treatment Failure
D006635:Histamine H2 Antagonists; D011899:Ranitidine