J Korean Med Sci.  2020 Feb;35(5):e33. 10.3346/jkms.2020.35.e33.

Comparison of 7- and 14-Day Eradication Therapy for Helicobacter pylori with First- and Second-Line Regimen: Randomized Clinical Trial

• Kim TH
• Park JM
• Cheung DY
• Oh JH

• KMID: 2469349
• DOI: http://doi.org/10.3346/jkms.2020.35.e33

Abstract

BACKGROUND
Although Helicobacter pylori is a key cause of gastric cancer development, its eradication rate has been decreasing by standard regimens. For successful eradication, duration of treatment has been issued for overcoming antibiotics resistance. We were to compare the eradication rate of 7-day vs. 14-day treatment in first- and second-line regimens.
METHODS
This study was an open-label randomized controlled trial. A total of 369 H. pylori-infected patients were enrolled and assigned either to 7-day or 14-day proton pump inhibitor (PPI)-based standard triple therapy (STT; PPI-clarithromycin-amoxicillin). Bismuth-containing quadruple therapy was used as second-line therapy. Eradication success was defined as a negative ¹³C-urea breath test.
RESULTS
In first-line treatment, eradication rate was 78.5% (106/135) and 78.6% (114/143) in the 7-day and 14-day treatment in per-protocol (PP) analysis (P = 0.805). In intention-to-treat (ITT) analysis, eradication rate was 64.0% (114/178) and 66.0% (126/191), respectively (P = 0.924). There was no significant difference in drug compliance (81.5% vs. 84.3%, P = 0.320). In second-line therapy, eradication rate was not significantly different in both treatments of PP analysis (91.7% [33/36] vs. 100% [45/45], P = 0.084). In the ITT analysis, eradication rate was 79.6% (35/44) and 90.4% (47/52), respectively (P = 0.080). Drug compliances were not significantly different between the two groups (95.5% vs. 98.1%, P = 0.728).
CONCLUSION
PPI-based STT for H. pylori is not efficient as a first-line therapy both in 7 days and 14 days in Korea. Although bismuth-containing quadruple therapy for 14 days as a second line therapy tend to show higher eradication rate compared to 7-day therapy, this should be elucidated by further larger scaled studies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02487511

Keyword

Drug Resistance; Helicobacter pylori; Proton Pump Inhibitors; Stomach Neoplasms; Treatment Outcome

MeSH Terms

Anti-Bacterial Agents
Breath Tests
Compliance
Drug Resistance
Helicobacter pylori*
Helicobacter*
Humans
Korea
Proton Pump Inhibitors
Proton Pumps
Stomach Neoplasms
Treatment Outcome
Anti-Bacterial Agents
Proton Pump Inhibitors
Proton Pumps