Randomized comparison of 1-hour topical method vs. amoxycillin plus omeprazole for eradication of Helicobacter pylori in duodenal ulcer patients.
BACKGROUND
A novel 1-h topical method eradicated Helicobacter pylori in 96% of dyspeptic patients. The eradication rate of amoxycillin/omeprazole therapy varies from 0 to 93%.


OBJECTIVE
To compare both methods in patients with endoscopically proven duodenal ulcer.


METHODS
Eighty patients (59 males, 21 females; median age 43 years) were randomized into two therapeutic groups. The first group (group A) was treated with a 6-week course of ranitidine 300 mg/day, then omeprazole 20 mg b.d. with pronase 36000 units/day for 2 days, followed by 1-h topical therapy with a solution of bismuth, metronidazole, amoxycillin and pronase. The second group (group B) consisted of patients treated with omeprazole 20 mg b.d. and amoxycillin 2 g/day for 2 weeks, followed by a 4-week course of ranitidine 300 mg/day. Eradication of H. pylori was assessed by urease test, histology, a polymerase chain reaction and a 13C-urea breath test, all of which were performed 4 weeks after discontinuation of the antibacterial treatment.


RESULTS
Eradication rates in groups A and B were 2.5% and 35% in an intention-to-treat analysis, respectively. Side-effects were encountered in 40.5% and 12.5% of subjects in groups A and B, respectively. Treatment tolerance was rated as poor by 54% of patients in group A and 2.5% of patients in group B.


CONCLUSIONS
Both treatment regimens, the 1-h topical method and amoxycillin with omeprazole, have low eradication rates in patients with duodenal ulcer. In addition, the topical treatment is characterized by a high rate of side-effects and poor tolerance. Based on the results of our study, neither method can be recommended for eradication of H. pylori in patients with duodenal ulcer.
Department of Gastroenterology, Medical Centre for Postgraduate Education, Oncology Centre, Warsaw, Poland.
K
K
Przytulski
J
J
Regula
A
A
Dziurkowska-Marek
M
M
Kohut
E
E
Hennig
T
T
Marek
J
J
Ostrowski
A
A
Nowak
E
E
Butruk
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001729:Bismuth / Q000008:administration & dosage / Q000627:therapeutic use; D002985:Clinical Protocols; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016480:Helicobacter pylori / Q000737:chemistry / Q000187:drug effects*; D006801:Humans; D007441:Intubation, Gastrointestinal; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D010406:Penicillins / Q000008:administration & dosage / Q000627:therapeutic use*; D011402:Pronase / Q000008:administration & dosage / Q000627:therapeutic use; D011899:Ranitidine / Q000008:administration & dosage / Q000627:therapeutic use
D000897:Anti-Ulcer Agents; D010406:Penicillins; D008795:Metronidazole; D000658:Amoxicillin; D011899:Ranitidine; D011402:Pronase; D009853:Omeprazole; D001729:Bismuth