Comparison of 7-day and 14-day proton pump inhibitor-containing triple therapy for Helicobacter pylori eradication: neither treatment duration provides acceptable eradication rate in Korea.
OBJECTIVE
Although triple combination therapy containing a proton pump inhibitor (PPI) and two antibiotics is considered as a standard regimen for the first-line anti-Helicobacter pylori treatment, there are still debates on the ideal duration of treatment. The aim of this study was to compare the efficacies of 7-day and 14-day PPI-containing triple therapy.


METHODS
This study was performed in a randomized, multicenter, prospective manner. After upper gastrointestinal endoscopy, H. pylori-infected patients with a gastric ulcer and/or a duodenal ulcer were randomly assigned to a PAC7 group (omeprazole 20 mg or equivalent dose of other PPIs, amoxicillin 1000 mg, and clarithromycin 500 mg twice daily for 7 days) or to a PAC14 group (the same regimen as the PAC7 group but for 14 days). H. pylori status was evaluated by (13)C urea breath test 5 weeks after anti-ulcer treatment completion.


RESULTS
A total of 598 patients were enrolled; 337 were randomized to the PAC7 group and 261 to the PAC14 group. The two groups were comparable in terms of baseline characteristics. The eradication rates of the PAC7 group were not inferior to those of the PAC14 group in both intention-to-treat analysis (71.2% vs. 75.5%) and per-protocol analysis (83.6% vs. 86.6%). Incidences of adverse events were comparable.


CONCLUSIONS
Although the 7-day PPI-containing triple anti-H. pylori therapy is not inferior to the 14-day therapy, neither treatment duration provides acceptable eradication rate reaching 90% in per-protocol analysis. New combination regimen with higher efficacy should be developed as a first-line eradication therapy for H. pylori in Korea.
Kim
Byeong Gwan
BG
Department of Internal Medicine, Seoul National University Boramae Hospital, Seoul, Korea.
Lee
Dong Ho
DH
Ye
Byong Duk
BD
Lee
Kwang Hyuck
KH
Kim
Beung Wook
BW
Kim
Sang Gyun
SG
Kim
Sang Woo
SW
Kim
Sung Kook
SK
Kim
Jae J
JJ
Kim
Hak Yang
HY
Park
Jong Jae
JJ
Park
Chang Young
CY
Baik
Gwang Ho
GH
Lee
Yong Chan
YC
Lee
Jun Haeng
JH
Lee
Jin Hyug
JH
Chun
Hoon Jai
HJ
Hahm
Ki Baik
KB
Hong
Su Jin
SJ
Lee
Sang Woo
SW
Jung
Hyun Chae
HC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D007723:Korea; D008297:Male; D008875:Middle Aged; D009853:Omeprazole; D054328:Proton Pump Inhibitors; D017494:Proton Pumps / Q000627:therapeutic use*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D017494:Proton Pumps; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole