Clinical outcome and influencing factors of a new short-term quadruple therapy for Helicobacter pylori eradication: a randomized controlled trial (MACLOR study).
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.
Treiber
Gerhard
G
Department of Gastroenterology/Hepatology, University Hospital of Magdeburg, Leipziger Str 44, D-39120 Magdeburg, Germany. gerhard.treiber@medizin.uni-magdeburg.de
Wittig
Joachim
J
Ammon
Susanne
S
Walker
Siegfried
S
van Doorn
Leen-Jan
LJ
Klotz
Ulrich
U
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D005756:Gastritis / Q000188:drug therapy / Q000382:microbiology; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D010437:Peptic Ulcer / Q000188:drug therapy* / Q000382:microbiology; D054328:Proton Pump Inhibitors; D011899:Ranitidine / Q000627:therapeutic use*; D012044:Regression Analysis; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D004791:Enzyme Inhibitors; D006635:Histamine H2 Antagonists; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D011899:Ranitidine; D017291:Clarithromycin; D009853:Omeprazole