Comparison of the efficacy of 1-day high-dose quadruple therapy versus 7-day triple therapy for treatment of Helicobacter pylori infection.
BACKGROUND
The proton pump inhibitor (PPI)-based 7-day triple therapy is the regimen with the highest cure rates for eradication of Helicobacter pylori infection and has been recommended as the first-line regimen in the world. It had been reported that a 1-day quadruple therapy could also successfully cure 95% of the H. pylori infected patients.


OBJECTIVE
To observe the efficacy of 1-day high-dose quadruple therapy versus 7-day triple therapy for treatment of H. pylori infection, and to observe side-effects of the two different regimens.


METHODS
This randomized, open, parallel-controlled study was conducted at Renji Hospital between November 2004 to March 2005. A total of 80 consecutive patients with non-ulcer dyspepsia, who were H. pylori positive proven by both rapid urease test and histology were included and randomly assigned to 1-day quadruple therapy or 7-day triple therapy. Thirty-nine patients were administered with 1-day high-dose quadruple therapy including esomeprazole 40 mg b.i.d., colloidal bismuth subcitrate 440 mg q.i.d., amoxicillin 2 g q.i.d. and metronidazole (400 mg q.i.d.) for 1 day. Forty-one patients received a standard 7-day triple therapy consisting of esomeprazole 20 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxicillin 1 g b.i.d. for 7 days. The eradication rates were evaluated by the (13)C-urea breath test at least 4 weeks after completion of a course treatment.


RESULTS
Seventy-seven patients completed the trial and three patients dropped out. The eradication rates in the 1-day therapeutic group and the 7-day therapeutic group were 39.5% (15/38) and 84.6% (33/39), respectively. There was a statistically significant difference between the two groups (P < 0.0001). Short-lasting and self-limiting side effects including thirst, a metallic taste, diarrhea and abdominal pain were reported in three patients (7.9%) in the 1-day group and seven patients (18%) in the 7-day group (P = 0.31).


CONCLUSIONS
A 1-day high-dose quadruple therapy with amoxicillin, metronidazole, bismuth salt, and esomeprazole is not effective for eradication of H. pylori compared with the standard 7-day triple therapy.
Zheng
Qing
Q
Shanghai Institute of Digestive Disease, Shanghai Second Medical University, Renji Hospital, Shanghai, China.
Pan
Yan
Y
Zhang
Lin
L
Xiao
Shu Dong
SD
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001729:Bismuth / Q000008:administration & dosage / Q000009:adverse effects; D001944:Breath Tests; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy*; D064098:Esomeprazole / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects; D054328:Proton Pump Inhibitors
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; C002791:bismuth tripotassium dicitrate; D064098:Esomeprazole; D001729:Bismuth