Clinical outcome and influencing factors of a new short-term quadruple therapy for Helicobacter pylori eradication: a randomized controlled trial (MACLOR study)

Arch Intern Med. 2002 Jan 28;162(2):153-60. doi: 10.1001/archinte.162.2.153.


Background: Short-term therapies for eradicating Helicobacter pylori in selected patients might offer advantages in terms of costs, compliance, and adverse effects in contrast to standard 1-week triple therapy.

Methods: To determine eradication success and influencing factors in a new short-term quadruple therapy, a total of 243 patients positive for H pylori were randomly assigned to 1 of 3 regimens according to age, smoking status, and diagnosis: a 5-day treatment with 3 antibiotics (amoxicillin, 1 g twice daily [bid]; clarithromycin, 250 mg bid; and metronidazole, 400 mg bid) and lansoprazole (30 mg bid [L5; reference treatment]) or ranitidine hydrochloride (300 mg bid [R5]), or the same 3-day antibiotic-lansoprazole combination (L3) with a 2-day pretreatment with lansoprazole.

Results: A total of 234 patients completed the study. On an intention-to-treat basis, overall eradication of H pylori was confirmed in 86.4%: 89.2% in the L5 group vs 81.2% in the L3 group vs 88.8% in the R5 group; differences were not significant. Multiple logistic regression analysis showed that younger age (<55 years; P =.03), history of peptic ulcer disease (P =.04), smoking (P =.03), metronidazole resistance (P =.003), low ranitidine trough serum concentrations (P =.005), cytotoxin-associated gene A-negative strains in peptic ulcer disease (P =.04), and outer inflammatory protein A-positive strains (P =.02) were associated with eradication failure.

Conclusions: This new quadruple H pylori eradication regimen is efficacious, safe, well tolerated, and cost saving, and may be a treatment option for patients older than 55 years with no history of peptic ulcer disease. Furthermore, strains that are sensitive to all antibiotics, cytotoxin-associated gene A-positive, and outer inflammatory protein A-negative could be suitable for short-term quadruple therapy. Patients with an unfavorable combination of characteristics should be treated for a minimum of 7 days.

Publication types

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

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Adult
  • Aged
  • Amoxicillin / therapeutic use
  • Anti-Bacterial Agents / therapeutic use*
  • Anti-Ulcer Agents / therapeutic use*
  • Clarithromycin / therapeutic use
  • Drug Therapy, Combination / therapeutic use*
  • Enzyme Inhibitors / therapeutic use*
  • Female
  • Gastritis / drug therapy
  • Gastritis / microbiology
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori*
  • Histamine H2 Antagonists / therapeutic use*
  • Humans
  • Lansoprazole
  • Male
  • Metronidazole / therapeutic use
  • Middle Aged
  • Omeprazole / analogs & derivatives*
  • Omeprazole / therapeutic use*
  • Peptic Ulcer / drug therapy*
  • Peptic Ulcer / microbiology
  • Proton Pump Inhibitors*
  • Ranitidine / therapeutic use*
  • Regression Analysis
  • Treatment Outcome


  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Enzyme Inhibitors
  • Histamine H2 Antagonists
  • Proton Pump Inhibitors
  • Lansoprazole
  • Metronidazole
  • Amoxicillin
  • Ranitidine
  • Clarithromycin
  • Omeprazole