Randomized comparison of differing periods of twice-a-day triple therapy for the eradication of Helicobacter pylori.
BACKGROUND
We assessed the efficacy, compliance, and tolerability of the twice-a-day triple therapy, amoxycillin, omeprazole, and clarithromycin, for Helicobacter pylori and studied the effect of treatment duration (7, 10 or 14 days) on these factors.


METHODS
One-hundred and fifty subjects with H. pylori infection documented by 13C-urea breath test were randomly assigned to a 7, 10 or 14-day course of amoxycillin 1 g b.d., omeprazole 20 mg b.d. and clarithromycin 500 mg b.d. Subjects returned at the end of therapy for pill count and assessment of side-effects. Subjects returned for a repeat 13C-urea breath test 4 weeks after the end of therapy.


RESULTS
Poor compliance (< 80% of medications taken) was seen in 0 subjects at 7 days, 6% at 10 days, and 10% at 14 days (P = 0.03 by chi 2 test for trend; difference for 7 vs. 14 days = 10%; 95% CI, -2% to 18%; P = 0.056). Intention-to-treat eradication rates were 86% at 7 days, 90% at 10 days and 92% at 14 days. Per-protocol eradication rates were 86% at 7 days, 91% at 10 days, and 95% at 14 days (P = 0.11; difference for 7 vs. 14 days = 9%; 95% CI, -2% to 21%; P = 0.17).


CONCLUSIONS
One week of twice-a-day amoxycillin, omeprazole and clarithromycin is well tolerated and provides a good rate of H. pylori eradication. Increasing the duration of therapy decreases compliance but has the potential to modestly improve efficacy if the patient takes the full complement of medication.
Laine
L
L
University of Southern California School of Medicine, Department of Medicine, Los Angeles 90033, USA.
Estrada
R
R
Trujillo
M
M
Fukanaga
K
K
Neil
G
G
D000328:Adult; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D010406:Penicillins / Q000009:adverse effects / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D004791:Enzyme Inhibitors; D010406:Penicillins; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole