Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study. Helicobacter Eradication for Lesion Prevention

The effect of Helicobacter pylori in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. We investigated the effects of H. pylori eradication in patients with current or previous peptic ulceration, dyspepsia, or both who continued to use NSAIDs. 285 patients were randomly a...

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Bibliographic Details
Published in:The Lancet (British edition) 1998-09, Vol.352 (9133), p.1016-1021
Main Authors: Hawkey, C J, Tulassay, Z, Szczepanski, L, van Rensburg, C J, Filipowicz-Sosnowska, A, Lanas, A, Wason, C M, Peacock, R A, Gillon, K R
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Amoxicillin - therapeutic use
Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
Clarithromycin - therapeutic use
Dyspepsia - etiology
Dyspepsia - microbiology
Female
Helicobacter Infections - drug therapy
Helicobacter pylori
Humans
Life Tables
Male
Middle Aged
Omeprazole - therapeutic use
Peptic Ulcer - complications
Peptic Ulcer - drug therapy
Peptic Ulcer - microbiology
Recurrence
Risk Factors
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Summary:The effect of Helicobacter pylori in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. We investigated the effects of H. pylori eradication in patients with current or previous peptic ulceration, dyspepsia, or both who continued to use NSAIDs. 285 patients were randomly assigned omeprazole 20 mg, amoxycillin 1000 mg, and clarithromycin 500 mg, twice daily (n=142, H. pylori eradication treatment), or omeprazole with placebo antibiotics (n=143, controls) for 1 week. All patients received omeprazole 20 mg once daily for 3 weeks until endoscopy, and, if the ulcer was not healed, 40 mg once daily until repeat endoscopy at 8 weeks. Ulcer-free patients with mild dyspepsia continued NSAIDs but not antiulcer treatment. We investigated ulcers with endoscopy at 1, 3, and 6 months and with carbon-13-labelled urea breath test at 3 months. The estimated probability of being ulcer-free at 6 months was 0.56 (95% CI 0.47-0.65) on eradication treatment and 0.53 (0.44-0.62) on on control treatment (p=0.80). Time to treatment failure did not differ between groups for ulcers or dyspepsia alone, per-protocol analysis, or final H. pylori status. 66% (58-74) of the eradication group compared with 14% (8-20) of the control group had a final negative H. pylori result (p
ISSN:0140-6736