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.
Przytulski
K
K
Department of Gastroenterology, Medical Centre for Postgraduate Education, Oncology Centre, Warsaw, Poland.
Regula
J
J
Dziurkowska-Marek
A
A
Kohut
M
M
Hennig
E
E
Marek
T
T
Ostrowski
J
J
Nowak
A
A
Butruk
E
E
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