Low- versus high-dose azithromycin triple therapy for Helicobacter pylori infection.
BACKGROUND
We report a clinical trial which evaluated the effectiveness of triple therapy containing low- and high-dose azithromycin to treat Helicobacter pylori infection.


METHODS
From March 1997 to March 1998, patients infected with H. pylori were assigned to receive either: Treatment 1: ranitidine bismuth citrate (RBC) (400 mg b.d.) and amoxycillin (1 g b.d.) for 10 days with azithromycin 500 mg o.m. for 3 days: or Treatment 2: RBC and amoxycillin for 10 days with azithromycin 1 g o.m. for 3 days. H. pylori eradication was established by a urea breath test at least 4 weeks after therapy. Side-effects and compliance were assessed using a diary.


RESULTS
Sixty-eight patients were enrolled. Fifty-seven per cent of patients were treated for active peptic ulcer disease or a history of peptic ulcer disease. Treatment 1 cured H. pylori in 44% and 44% by per protocol and intention-to-treat analysis, respectively. The corresponding eradication rates for Treatment 2 were 79% and 75%. Two patients taking Treatment 2 dropped out of the study because of side-effects.


CONCLUSIONS
With RBC and amoxycillin for 10 days, azithromycin at a dose of 1 g/day for 3 days was significantly better at curing H. pylori infection than azithromycin 500 mg/day for 3 days.
Chey
W D
WD
Department of Internal Medicine, University of Michigan, Ann Arbor, USA. wchey@uv1.im.med.umich.edu
Fisher
L
L
Barnett
J
J
Delvalle
J
J
Elta
G H
GH
Hasler
W L
WL
Nostrant
T
T
Palaniappan
J
J
Scheiman
J
J
D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage* / Q000009:adverse effects; D001729:Bismuth / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination / Q000008:administration & dosage*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D011899:Ranitidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000897:Anti-Ulcer Agents; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D017963:Azithromycin; D011899:Ranitidine; D001729:Bismuth