Three-day intravenous triple therapy is not effective for the eradication of Helicobacter pylori infection in patients with bleeding gastro-duodenal ulcer.
OBJECTIVE
To test the efficacy of an ultra-short intravenous triple therapy against Helicobacter pylori infection in patients with bleeding peptic ulcer against standard oral 1-week triple therapy in a randomised, double-blind prospective trial.


METHODS



METHODS
(n = 75) with haemorrhagic peptic ulcer and H. pylori infection were randomised into: an Intravenous Group to receive omeprazole, clarithromycin and amoxicillin-clavulanic acid intravenously b.d. for 3 days followed by 7 days of oral omeprazole plus placebo of clarithromycin and amoxicillin; an Oral Group to receive intravenous omeprazole plus placebo of clarithromycin and amoxicillin-clavulanic acid followed by 7 days of oral omeprazole, clarithromycin and amoxicillin b.d. Gastric biopsies were obtained for urease test. A 13C-urea breath test was performed to check for H. pylori eradication.


RESULTS
Intention-to-treat eradication was 50% (19/38) in the Intravenous Group and 78% (29/37) in the Oral Group (odds ratio 3.63; 95% confidence interval 1.32-9.94; P < 0.01; number needed to treat (NNT) = 4). Per protocol eradication was 50% (14/28) in the Intravenous Group and 86% (24/28) in the Oral Group (P < 0.005). There were no statistically significant differences in adverse events between the two treatment groups.


CONCLUSIONS
An ultra-short, 3-day, intravenous, triple therapy containing omeprazole, clarithromycin and amoxicillin-clavulanic acid cannot be recommended as an effective eradication regimen for H. pylori infection related to haemorrhagic gastro-duodenal ulcer.
Romero-Gómez
M
M
Digestive and Hepatology Unit, Hospital Universitario de Valme, Seville, Spain. mromerog@supercable.es
Martínez-Delgado
C
C
Hergueta
P
P
Navarro
J-M
JM
Garrido-Serrano
A
A
Santos
O
O
Montojo
C
C
D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D017291:Clarithromycin / Q000008:administration & dosage; D002969:Clavulanic Acids / Q000008:administration & dosage; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004381:Duodenal Ulcer / Q000188:drug therapy; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage; D010438:Peptic Ulcer Hemorrhage / Q000188:drug therapy*; D012008:Recurrence; D013276:Stomach Ulcer / Q000188:drug therapy; D017211:Treatment Failure
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D002969:Clavulanic Acids; D004338:Drug Combinations; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole