Cure of Helicobacter pylori-positive active duodenal ulcer patients: a double-blind, multicentre, 12-month study comparing a two-week dual vs a one-week triple therapy. GISU (Interdisciplinary Group for Ulcer Study).
OBJECTIVE
To compare a two-week dual therapy to a one-week triple therapy for the healing of duodenal ulcer and the eradication of the Helicobacter pylori infection.


METHODS
A total of 165 patients with active duodenal ulcer were enrolled in the study. At entry, endoscopy, clinical examination and laboratory tests were performed. Histology and the rapid urease test were used to diagnose Helicobacter pylori infection. Patients received either lansoprazole 30 mg plus amoxycillin 1 g bid for two weeks (two-week, dual therapy) or lansoprazole 30 mg plus amoxycillin 1 g plus tinidazole 500 mg bid for one week plus lansoprazole qd for an additional week (one-week, triple therapy). Two and twelve months after cessation of therapy, endoscopy and clinical assessments were repeated.


RESULTS
Duodenal ulcer healing and Helicobacter pylori eradication were both significantly greater (p<0.0001) in the triple therapy group (healing: 98.6%; Helicobacter pylori cure rate: 72.6%) than in the dual therapy group (healing: 77.3%; Helicobacter pylori cure rate: 33.3%). Ulcers healed more frequently in Helicobacter pyloricured than in Helicobacter pylori-not cured patients (94.9% vs. 77.2%; p<0.0022). After one year, Helicobacter pylori eradication was re-confirmed in 46/58 patients previously treated with the triple therapy and in 10/40 patients treated with the dual therapy [p<0.0001]. Only three duodenal ulcer relapses were observed throughout follow-up: all were in Helicobacter pylori-not cured patients.


CONCLUSIONS
Triple therapy was more effective than dual both in curing Helicobacter pylori infection and healing active duodenal ulcers. The speed of ulcer healing obtained after only 7 days of antibiotics and 14 days of proton pump inhibitors confirmed that longer periods of anti ulcer therapy were not necessary. Helicobacter pylori -not cured patients had more slowly healing ulcers which were more apt to relapse when left untreated.
Di Mario
F
F
Gastroenterology Unit, University of Padova, Italy.
Battaglia
F
F
Dal Bò
N
N
Leandro
G
G
Benedetti
E
E
Bottona
E
E
Caroli
A
A
Costan-Biedo
F
F
De Bastiani
R
R
Germanà
B
B
Andrea Grassi
S
S
Madia
D
D
Marcon
V
V
Marin
R
R
Monica
F
F
Olivieri
P
P
Orzes
N
N
Pilotto
A
A
Ronzani
G
G
Saggioro
A
A
Tafner
G
G
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D000994:Antitrichomonal Agents / Q000627:therapeutic use; D001706:Biopsy; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D016145:Endoscopy, Digestive System; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D010406:Penicillins / Q000627:therapeutic use; D054328:Proton Pump Inhibitors; D012008:Recurrence; D014011:Tinidazole / Q000627:therapeutic use*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D000994:Antitrichomonal Agents; D010406:Penicillins; D054328:Proton Pump Inhibitors; D014011:Tinidazole; D064747:Lansoprazole; D000658:Amoxicillin; D009853:Omeprazole