Helicobacter pylori (H. pylori) is one of the most common bacterial infections in the world, associated with peptic ulcer disease and gastric cancer. We designed a study to compare the efficacy of 10-day vs. 12-day concomitant therapies for first-line H. pylori eradication in Iran.

Two hundred and eighteen patients with naïve H. pylori infection, were randomly divided into 2 groups to receive either 10-day or 12-day concomitant regimens, composed of Pantoprazole 40 mg, Amoxicillin 1 gr, Clarithromycin 500 mg and Metronidazole 500 mg, all given twice daily. Eight weeks after therapy, H. pylori eradication was assessed by 14C- Urea breath test.

Two hundred and twelve patients completed the study. According to intention to treat analysis, the eradication rates were 83.6% (95% confidence interval= 76.6 – 90.5) and 88.8% (95% CI= 82.8 – 94.7) in 10-day and 12-day concomitant groups, respectively (p = 0.24). Per-protocol eradication rates were 85.9% (95% CI= 79.3 – 92.4) and 92.6% (95% CI= 87.6 – 97.5), respectively (p= 0.19). The rates of severe side effects were not statistically different between the two groups (3.6% vs. 8.1%).

Twelve-day concomitant therapy could achieve ideal eradication rates by both intention to treat and per-protocol analyses. In order to reduce the cost of drugs and the rate of adverse effects of therapy and simultaneously to obtain ideal eradication rates, 12-day concomitant regimen seems to be a good alternative to previously suggested 14-day concomitant therapy.