Triple therapy with azithromycin, omeprazole, and amoxicillin is highly effective in the eradication of Helicobacter pylori: a controlled trial versus omeprazole plus amoxicillin

Am J Gastroenterol. 1996 Feb;91(2):258-63.


Background: Azithromycin is a new-generation, acid-stable macrolide antibiotic that achieves remarkably high concentrations in gastric tissue, persisting above the MIC90 for Helicobacter pylori over a 5-day period after a single 500-mg oral dose.

Methods: We evaluated a new metronidazole-free triple therapy with omeprazole 20 mg b.i.d. plus amoxicillin 1 g b.i.d. (both for 14 days) and azithromycin 500 mg mane (for the first 3 days only) (group I) versus double therapy with omeprazole 20 mg b.i.d. plus amoxicillin 1 g t.i.d., both for 14 days (group II). H. pylori status was determined by urease test and histology before and 6 wk after completion of therapy.

Results: Ninety-two patients with peptic ulcer disease or nonulcer dyspepsia completed the study. H. pylori infection was eradicated in 44 (91.6%) of 48 patients randomized to receive triple therapy versus 26 (59.1%) of 44 who received double therapy (p < 0.001). Smoking, but not omeprazole pretreatment, proved to be a risk factor for treatment failure only in the double-therapy group (p = 0.05). All ulcers healed by the time of the 8-wk endoscopic control. Side effects, usually minor, were recorded in 12.5% and 9.1% of patients, respectively (NS), but therapy had to be discontinued in one patient in group I and in three in group II (NS).

Conclusions: Two-week triple therapy with omeprazole, amoxicillin, and (for the first 3 days) low-dose azithromycin is highly effective in eradicating H. pylori. This regimen is safe and well-tolerated, and we recommend that it be used as first-line treatment, as an alternative to less-effective omeprazole-amoxicillin double therapy. Moreover, azithromycin appears to be a new, promising antibiotic for future innovative anti-H. pylori combinations.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Amoxicillin / administration & dosage*
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Ulcer Agents / administration & dosage*
  • Azithromycin / administration & dosage*
  • Duodenal Ulcer / drug therapy
  • Dyspepsia / drug therapy
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori*
  • Humans
  • Male
  • Middle Aged
  • Omeprazole / administration & dosage*
  • Penicillins / administration & dosage*
  • Smoking
  • Stomach Ulcer / drug therapy
  • Time Factors


  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Penicillins
  • Amoxicillin
  • Azithromycin
  • Omeprazole