Clinical outcome and influencing factors of a new short-term quadruple therapy for Helicobacter pylori eradication: a randomized controlled trial (MACLOR study)
Treiber, G.; Wittig, J.; Ammon, S.; Walker, S.; van Doorn, L-Jan.; Klotz, U.
Archives of Internal Medicine 162(2): 153-160
2002
ISSN/ISBN: 0003-9926 PMID: 11802748 Document Number: 547715
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.