Lansoprazole-based triple therapy versus ranitidine bismuth citrate-based dual therapy in the eradication of Helicobacter pylori in patients with duodenal ulcer: a multicenter, randomized, double-dummy study.
BACKGROUND
The optimal treatment regimen for eradication of Helicobacter pylori in patients with duodenal ulcer has yet to be determined. Based on a search of MEDLINE, no studies have been performed comparing a proton pump inhibitor-based triple therapy regimen with a ranitidine bismuth citrate (RBC)-based dual therapy regimen, both containing clarithromycin.


OBJECTIVE
This study was undertaken to compare the efficacy of lansoprazole (LAN)-based triple therapy with that of RBC-based dual therapy in H pylori-infected patients with duodenal ulcer.


METHODS
Patients were randomized to receive either 1 week of triple therapy with LAN 30 mg BID, clarithromycin 500 mg BID, and tinidazole 500 mg BID, followed by 3 weeks of LAN 30 mg BID, or 2 weeks of dual therapy with RBC 400 mg BID plus clarithromycin 500 mg BID, followed by 2 weeks of RBC 400 mg BID. Eradication of H pylori was defined as negative results on both the urease quick test and histologic examination > or =4 weeks after the end of treatment. Duodenal healing and recurrence rates were assessed endoscopically at 8 weeks and 6 months. A per-protocol (PP) analysis was conducted for each efficacy end point. Also conducted were an intent-to-treat (ITT) analysis in which patients with missing data were considered failures, and an observed analysis (OBS), which included patients with an evaluable result after treatment, regardless of compliance.


RESULTS
One hundred eighty-five patients (126 men, 59 women; age range, 18-76 years; mean age, 43 years) were enrolled and randomized to treatment. In the LAN and RBC groups, respectively, H. pylori eradication rates were 92.6%, 93.1%, and 72.8% versus 78.6%, 77.9%, and 64.5% in the PP (P = 0.02), OBS (P = 0.01), and ITT analyses. The corresponding duodenal ulcer healing rates were 98.6%, 98.7%, and 83.7% versus 90.8%, 91.5%, and 81.7%; these differences were not statistically significant. Side effects were mild, occurring in 20.7% of LAN patients and 17.2% of RBC patients. Ulcer recurred in 2 RBC patients. No difference was observed between treatments in terms of the occurrence of gastritis or improvement of symptoms.


CONCLUSIONS
Based on the results of the PP and OBS analyses, LAN-based triple therapy was superior to RBC-based dual therapy for the eradication of H. pylori in patients with duodenal ulcer.
Luzza
F
F
Dipartimento di Medicina Sperimentale e Clinica, Università di Catanzaro Magna Graecia, Italy. luzza@unicz.it
Giglio
A
A
Ciliberto
E
E
Belmonte
A
A
Cavaliere
C
C
Saccà
N
N
Frandina
C
C
Fiocca
R
R
Trimboli
V
V
Pallone
F
F
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000293:Adolescent; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001729:Bismuth / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy*; D004415:Dyspepsia; D005260:Female; D006261:Headache / Q000139:chemically induced; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D011537:Pruritus / Q000139:chemically induced; D011899:Ranitidine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D012008:Recurrence; D013651:Taste Disorders / Q000139:chemically induced; D014011:Tinidazole / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D014011:Tinidazole; D064747:Lansoprazole; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D017291:Clarithromycin; D009853:Omeprazole; D001729:Bismuth