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Cited by 708Helicobacter pylori-related gastroenterology studiesGastrointestinal Bleeding Diagnosis and TreatmentHepatitis C virus research

Effect of ranitidine and amoxicillin plus metronidazole on the eradication of Helicobacter pylori and the recurrence of duodenal ulcer

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Hentschel, Enno, Brandstatter, Gerald, Dragosics, Brigitte, Hirschl, Alexander M., Nemec, Heinz, Schutze, Kurt, Taufer, Margareta, Wurzer, Herbert·1993·New England Journal of Medicine
DOI 10.1056/nejm199302043280503
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Abstract

BACKGROUND: Persistent infection with Helicobacter pylori is associated with the recurrence of duodenal ulcer. Whether the efficacy of bismuth therapy in reducing the rate of recurrence of duodenal ulcer is due to its antimicrobial effects on H. pylori or to a direct protective action on the mucosa is still a matter of debate. METHODS: To study the effect of the eradication of H. pylori on the recurrence of duodenal ulcer, we treated 104 patients with H. pylori infection and recurrent duodenal ulcer with either amoxicillin (750 mg three times daily) plus metronidazole (500 mg three times daily) or identical-appearing placebos, given orally for 12 days. All patients also received ranitidine (300 mg each night) for 6 or 10 weeks. Endoscopy was performed before treatment and periodically during follow-up for up to 12 months after healing. RESULTS: Among the 52 patients given antibiotics, H. pylori was eradicated in 46, as compared with 1 of the 52 given placebo (89 percent vs. 2 percent, P < 0.001). After six weeks, the ulcers were healed in 48 patients given antibiotics and 39 given placebo (92 percent vs. 75 percent, P = 0.011). Side effects, mainly diarrhea, occurred in 15 percent of the patients given antibiotics. Among the patients followed up for 12 months, duodenal ulcers recurred in 4 of 50 patients given antibiotics and 42 of 49 given placebo (8 percent vs. 86 percent, P < 0.001). Ulcers recurred in 1 of 46 patients in whom H. pylori had been eradicated, as compared with 45 of 53 in whom H. pylori persisted (2 percent vs. 85 percent, P < 0.001). CONCLUSIONS: In patients with recurrent duodenal ulcer, eradication of H. pylori by a regimen that does not have any direct action on the mucosa is followed by a marked reduction in the rate of recurrence, suggesting a causal role for H. pylori in recurrent duodenal ulcer.

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  • Antibiotics alone, without H2 blockers or PPIs, could cure ulcers.

    “A final piece of evidence was demonstration that antibiotics alone, without H2 blockers or PPIs, could cure ulcers [17–20].”

    From What would it take to prove that a chronic infection is a causal agent in Alzheimer’s disease? (2025) · cites this paper as [18]

    The Methods (p. 1) state that all patients received ranitidine, an H2 blocker, whether they received antibiotics or placebo. The Treatment Period (p. 2) reports better ulcer healing with antibiotics plus ranitidine, but this trial did not demonstrate that antibiotics alone could cure ulcers. (LLM, conf=0.89)

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Research works printed but not linked: 20

  1. [1]1. Coghlan JG, Gilligan D, Humphries H, et al. Campylobacter pylori and recurrence of duodenal ulcers — a 12-month follow-up study. Lancet 1987; 2:1109-11.
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  7. [9]9. Hansky J, Lambert JR, Borromeo M, Korman MG, Eaves ER. Effect of colloidal bismuth (De-Nol) on healing and relapse of duodenal ulcers — role of Campylobacter pyloridis. Gastroenterology 1987;92:1489. abstract.
  8. [8]8. George LL, Borody TJ, Andrews P, et al. Cure of duodenal ulcer after eradication of Helicobacter pylori. Med J Aust 1990;153:145-9.
  9. [10]10. Smith AC, Price AB, Borriello P, Levi AJ. A comparison of ranitidine and tripotassium dicitratobismuth (T.D.B.) in relapse rates of duodenal ulcer (D.U.): the role of Campylobacter pylori. Gastroenterology 1988;94:A431. abstract.
  10. [15]15. Logan RPH, Walker MM, Misiewicz JJ, et al. The relationship between Helicobacter pylori recurrence and relapse of duodenal ulcer. Gastroenterology 1991;100:A112. abstract.
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  13. [19]19. Hirschl AM, Hentschel E, Schütze K, et al. The efficacy of antimicrobial treatment in Campylobacter pylori-associated gastritis and duodenal ulcer. Scand J Gastroenterol Suppl 1988;142:76-81.
  14. [20]20. Dent JC, McNulty CAM. Evaluation of a new selective medium for Campylobacter pylori. Éur J Clin Microbiol Infect Dis 1988;7:555-8.
  15. [22]22. Glupczynski Y, Burette A. Eradicating Helicobacter pylori. Lancet 1992; 339:54-5.
  16. [21]21. Graham DY, Ginger ML, Evans DG, Evans DJ Jr, Klein PD. Effect of triple therapy (antibiotics plus bismuth) on duodenal ulcer healing: a randomized controlled trial. Ann Intern Med 1991;115:266-9.
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Authors
Hentschel, E., Brandstatter, G., Dragosics, B., Hirschl, A. M., Nemec, H., Schutze, K., Taufer, M., & Wurzer, H.
Affiliations
  • Hanusch Hospital (AT)
  • University of Vienna (AT)
  • University of Graz (AT)
ORCID
Wurzer, Herbert
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
1993-02-04
Volume
328
Issue
5
Pages
308-312
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejm199302043280503
OpenAlex
W2329240046
Cited by
708
References
1
Citations by year
2025: 4 · 2024: 3 · 2023: 3 · 2022: 5 · 2021: 6 · 2020: 2 · 2019: 7 · 2018: 3 · 2017: 8 · 2016: 8 · 2015: 12 · 2014: 12 · 2013: 9 · 2012: 9
FWCI
99.57
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Helicobacter pylori-related gastroenterology studies
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal Bleeding Diagnosis and Treatment
  • Health Sciences › Medicine › Hepatology › Hepatitis C virus research
Keywords
Helicobacter pylori, duodenal ulcer, ulcer recurrence, Helicobacter pylori eradication, ranitidine, amoxicillin, metronidazole, triple therapy, Helicobacter pylori infection, ulcer healing
MeSH terms
Adult, Aged, Amoxicillin, Drug Administration Schedule, Drug Therapy, Combination, Duodenal Ulcer, Female, Follow-Up Studies, Gastric Mucosa, Humans, Intestinal Mucosa, Male, Metronidazole, Middle Aged, Prospective Studies, Ranitidine, Recurrence, Helicobacter pylori, Helicobacter Infections

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