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A Randomized Controlled Trial (MACLOR Study)

Gerhard Treiber, MD; Joachim Wittig, MD; Susanne Ammon, MD; Siegfried Walker, MD; Leen-Jan van Doorn, PhD; Ulrich Klotz, PhD

Arch Intern Med. 2002;162:153-160.

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.

From the Department of Gastroenterology, Robert Bosch Hospital, Stuttgart, Germany (Dr Treiber); Department of Gastroenterology, Hospital of Bietigheim, Bietigheim, Germany (Drs Wittig and Walker); Dr Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart (Drs Ammon and Klotz); and Delft Diagnostic Centre R.deGraaf Group (SSDZ), Delft, the Netherlands (Dr van Doorn). Dr Treiber is now with the Department of Gastroenterology/Hepatology, University Hospital of Magdeburg, Magdeburg, Germany.

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