Randomized clinical trial comparing 10- or 14-day sequential therapy and 10- or 14-day concomitant therapy for the first line empirical treatment of Helicobacter pylori infection.

BACKGROUND AND AIM: Whether concomitant therapy is superior to sequential therapy (ST) as first-line therapy of Helicobacter pylori in areas with high clarithromycin resistance remains controversial. The aim of this study was to compare the efficacy and tolerability of 10- or 14-day ST with 10- or 14-day concomitant therapy (CT).

METHODS: This was a prospective randomized study comparing 10- or 14-day ST with 10- or 14-day CT. The ST-10 and ST-14 groups received pantoprazole 40 mg and amoxicillin 1 g twice a day for the first 5 and 7 days followed by pantoprazole 40 mg, clarithromycin 500 mg, and metronidazole 500 mg twice a day for the remaining 5 and 7 days, respectively. The CT-10 and CT-14 groups received pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 10 and 14 days, respectively.

RESULTS: Three hundred forty-one patients were randomly allocated to the four groups. The modified intention-to-treat eradication rates of ST-10, ST-14, CT-10, and CT-14 were 91.7%, 91.2%, 94.2%, and 98.5%, respectively. The corresponding per protocol eradication rates were 91.4%, 91.0%, 95.6%, and 98.5%. There was no difference in compliance and adverse events in the four groups. Eradication rates increased sequentially with statistical significance in the following order: ST-10, ST-14, CT-10, and CT-14 (P = 0.044).

CONCLUSIONS: All four regimens achieved eradication rates >90% in per protocol analyses in a country with high clarithromycin resistance. There was no difference in tolerability among the four regimens.