Sequential Therapy versus Triple Therapy for the First Line Treatment of Helicobacter pylori in Korea: A Nationwide Randomized Trial

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Authors: Joon Sung Kim ; Byung-Wook Kim ; Su Jin Hong ; Jin Il Kim ; Ki-Nam Shim ; Jie-Hyun Kim ; Gwang Ho Baik ; Sang Wook Kim ; Hyun Joo Song ; Ji Hyun Kim

MeSH: Adult ; Aged ; Amoxicillin/administration & dosage ; Anti-Bacterial Agents/administration & dosage* ; Clarithromycin/administration & dosage ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Helicobacter Infections/drug therapy* ; Helicobacter pylori/drug effects* ; Humans ; Intention to Treat Analysis ; Male ; Medication Adherence ; Metronidazole/administration & dosage ; Middle Aged ; Proton Pump Inhibitors/administration & dosage* ; Republic of Korea ; Treatment Outcome

Abstract: BACKGROUND/AIMS: Eradication of Helicobacter pylori infection with standard triple therapy (TT) has declined primarily because of increased antibiotic resistance. Sequential therapy (ST) has been suggested as an alternative to TT for the first-line treatment of H. pylori. The purpose of this study was to compare the efficacy of ST with TT.

METHODS: This was a multicenter, randomized open-label trial performed at nine centers in Korea. Patients with H. pylori infection were randomly assigned to receive either 7 day TT or 10 day ST. Eradication rates, drug compliance, and adverse events were compared among the two regimens.

RESULTS: A total of 601 patients were enrolled between March 2011 and September 2014. The intention-to-treat eradication rates were 70.8% for TT and 82.4% for ST (p=0.001). The corresponding per protocol eradication rates were 76.9% and 88.8% for TT and ST, respectively (p=0.000). There were no statistically significant differences between the two regimens with respect to drug compliance and adverse events.

CONCLUSIONS: ST achieved better eradication rates than TT as a first-line therapy for H. pylori eradication in Korea.