Clinical outcomes of two-week sequential and concomitant therapies for Helicobacter pylori eradication: a randomized pilot study.

BACKGROUND: The eradication rate with PPI-based standard triple therapy for Helicobacter pylori infection has fallen considerably. One recent innovation is sequential therapy with PPI and three antibiotics, but the complexity of this regimen may reduce its usability. Concomitant administration of nonbismuth quadruple drugs (concomitant therapy) is also an effective treatment strategy. To investigate which regimen is a reasonable choice for Korean population, we performed two pilot studies with sequential and concomitant therapies.
METHODS: A total of 164 patients with proven H. pylori infection randomly received 14 days of sequential (n = 86) or concomitant (n = 78) therapies. The sequential group received 20 mg rabeprazole and 1 g amoxicillin (first week), followed by 20 mg rabeprazole, 500 mg clarithromycin, and 500 mg metronidazole (second week). The concomitant group received 20 mg rabeprazole, 1 g amoxicillin, 500 mg clarithromycin, and 500 mg metronidazole for 2 weeks. All drugs were administered BID. Helicobacter pylori status was confirmed 4 weeks later, after completion of treatment by (13) C-urea breath test.
RESULTS: The intention-to-treat and per-protocol eradication rates were 75.6% (95% CI, 66.3-84.9) and 76.8% (95% CI, 67.1-85.5) in the sequential group, and 80.8% (95% CI, 71.8-88.5) and 81.3% (95% CI, 71.6-90.7) in the concomitant group. There were no significant between-group differences, in regard to the eradication rates, compliance, or side effects. The most common side effects were bitter taste, epigastric soreness, and diarrhea.
CONCLUSIONS: Two-week concomitant and sequential therapies showed suboptimal efficacies. However, considering high antibiotics resistance, either of these two regimens may be a reasonable choice for Korean population.

RCT Entities:   Population Interventions Outcomes