Comparative study of Helicobacter pylori eradication rates of concomitant therapy vs modified quadruple therapy comprising proton-pump inhibitor, bismuth, amoxicillin, and metronidazole in Korea

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Abstract

Background: The standard triple Helicobacter pylori regimen now shows unacceptably low treatment success in Korea. Administration of the concomitant therapy for 10 days, which has a high cure rate, is recommended as an alternative first-line treatment in areas of high clarithromycin resistance including Korea. Recently, modified bismuth-containing quadruple therapy with amoxicillin (PAM-B therapy) showed excellent results, regardless of dual clarithromycin and metronidazole resistance. This study compared the concomitant therapy with PAM-B therapy as a first-line treatment for H. pylori infection. Method: Subjects infected with H. pylori and naïve to treatment were performed a head-to-head comparison between 10-day concomitant therapy [rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily] and 14-day PAM-B therapy [rabeprazole 20 mg, amoxicillin 1 g, metronidazole 750 mg, and tripotassium dicitrato bismuthate 600 mg (elemental bismuth 240 mg) twice daily]. Six weeks after treatment, H. pylori eradication was assessed. Results: Two hundred and seventy subjects were randomized. Both regimens achieved high cure rates: 83.0% (112/135) and 88.1% (119/135) by the intention-to-treat analysis and 95.5% (106/111) and 96.6% (114/118) by the per-protocol analysis, respectively. The intention-to-treat and per-protocol analyses revealed no statistically significant difference in the eradication rate (P =.299 and P =.743, respectively). Rates of adverse events were similar between groups (25.2% vs 23.0%, P -value:.776) Adverse events, which resulted in poor compliance, occurred in six patients of each group, but there were no serious complications. Conclusions: PAM-B therapy is as effective as concomitant therapy for eradicating H. pylori with comparative safety. PAM-B therapy is regarded as a promising alternative to standard triple therapy for a first-line eradication in Korea.

Original languageEnglish
Article numbere12466
JournalHelicobacter
Volume23
Issue number2
DOIs
Publication statusPublished - 2018 Apr 1

Fingerprint

Bismuth
Proton Pump Inhibitors
Amoxicillin
Metronidazole
Korea
Helicobacter pylori
Pylorus
Therapeutics
Clarithromycin
Rabeprazole
Intention to Treat Analysis

Keywords

  • bismuth salts
  • concomitant therapy
  • eradication
  • Helicobacter pylori

ASJC Scopus subject areas

  • Gastroenterology
  • Infectious Diseases

Cite this

@article{c975a20760f84d94ba179d780b66748f,
title = "Comparative study of Helicobacter pylori eradication rates of concomitant therapy vs modified quadruple therapy comprising proton-pump inhibitor, bismuth, amoxicillin, and metronidazole in Korea",
abstract = "Background: The standard triple Helicobacter pylori regimen now shows unacceptably low treatment success in Korea. Administration of the concomitant therapy for 10 days, which has a high cure rate, is recommended as an alternative first-line treatment in areas of high clarithromycin resistance including Korea. Recently, modified bismuth-containing quadruple therapy with amoxicillin (PAM-B therapy) showed excellent results, regardless of dual clarithromycin and metronidazole resistance. This study compared the concomitant therapy with PAM-B therapy as a first-line treatment for H. pylori infection. Method: Subjects infected with H. pylori and na{\"i}ve to treatment were performed a head-to-head comparison between 10-day concomitant therapy [rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily] and 14-day PAM-B therapy [rabeprazole 20 mg, amoxicillin 1 g, metronidazole 750 mg, and tripotassium dicitrato bismuthate 600 mg (elemental bismuth 240 mg) twice daily]. Six weeks after treatment, H. pylori eradication was assessed. Results: Two hundred and seventy subjects were randomized. Both regimens achieved high cure rates: 83.0{\%} (112/135) and 88.1{\%} (119/135) by the intention-to-treat analysis and 95.5{\%} (106/111) and 96.6{\%} (114/118) by the per-protocol analysis, respectively. The intention-to-treat and per-protocol analyses revealed no statistically significant difference in the eradication rate (P =.299 and P =.743, respectively). Rates of adverse events were similar between groups (25.2{\%} vs 23.0{\%}, P -value:.776) Adverse events, which resulted in poor compliance, occurred in six patients of each group, but there were no serious complications. Conclusions: PAM-B therapy is as effective as concomitant therapy for eradicating H. pylori with comparative safety. PAM-B therapy is regarded as a promising alternative to standard triple therapy for a first-line eradication in Korea.",
keywords = "bismuth salts, concomitant therapy, eradication, Helicobacter pylori",
author = "Choe, {Jung Wan} and Jung, {Sung Woo} and Kim, {Seung Young} and Hyun, {Jong Jin} and Jung, {Young Kul} and Koo, {Ja Seol} and Yim, {Hyung Joon} and Lee, {Sang Woo}",
year = "2018",
month = "4",
day = "1",
doi = "10.1111/hel.12466",
language = "English",
volume = "23",
journal = "Helicobacter",
issn = "1083-4389",
publisher = "Wiley-Blackwell",
number = "2",

}

TY - JOUR

T1 - Comparative study of Helicobacter pylori eradication rates of concomitant therapy vs modified quadruple therapy comprising proton-pump inhibitor, bismuth, amoxicillin, and metronidazole in Korea

AU - Choe, Jung Wan

AU - Jung, Sung Woo

AU - Kim, Seung Young

AU - Hyun, Jong Jin

AU - Jung, Young Kul

AU - Koo, Ja Seol

AU - Yim, Hyung Joon

AU - Lee, Sang Woo

PY - 2018/4/1

Y1 - 2018/4/1

N2 - Background: The standard triple Helicobacter pylori regimen now shows unacceptably low treatment success in Korea. Administration of the concomitant therapy for 10 days, which has a high cure rate, is recommended as an alternative first-line treatment in areas of high clarithromycin resistance including Korea. Recently, modified bismuth-containing quadruple therapy with amoxicillin (PAM-B therapy) showed excellent results, regardless of dual clarithromycin and metronidazole resistance. This study compared the concomitant therapy with PAM-B therapy as a first-line treatment for H. pylori infection. Method: Subjects infected with H. pylori and naïve to treatment were performed a head-to-head comparison between 10-day concomitant therapy [rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily] and 14-day PAM-B therapy [rabeprazole 20 mg, amoxicillin 1 g, metronidazole 750 mg, and tripotassium dicitrato bismuthate 600 mg (elemental bismuth 240 mg) twice daily]. Six weeks after treatment, H. pylori eradication was assessed. Results: Two hundred and seventy subjects were randomized. Both regimens achieved high cure rates: 83.0% (112/135) and 88.1% (119/135) by the intention-to-treat analysis and 95.5% (106/111) and 96.6% (114/118) by the per-protocol analysis, respectively. The intention-to-treat and per-protocol analyses revealed no statistically significant difference in the eradication rate (P =.299 and P =.743, respectively). Rates of adverse events were similar between groups (25.2% vs 23.0%, P -value:.776) Adverse events, which resulted in poor compliance, occurred in six patients of each group, but there were no serious complications. Conclusions: PAM-B therapy is as effective as concomitant therapy for eradicating H. pylori with comparative safety. PAM-B therapy is regarded as a promising alternative to standard triple therapy for a first-line eradication in Korea.

AB - Background: The standard triple Helicobacter pylori regimen now shows unacceptably low treatment success in Korea. Administration of the concomitant therapy for 10 days, which has a high cure rate, is recommended as an alternative first-line treatment in areas of high clarithromycin resistance including Korea. Recently, modified bismuth-containing quadruple therapy with amoxicillin (PAM-B therapy) showed excellent results, regardless of dual clarithromycin and metronidazole resistance. This study compared the concomitant therapy with PAM-B therapy as a first-line treatment for H. pylori infection. Method: Subjects infected with H. pylori and naïve to treatment were performed a head-to-head comparison between 10-day concomitant therapy [rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily] and 14-day PAM-B therapy [rabeprazole 20 mg, amoxicillin 1 g, metronidazole 750 mg, and tripotassium dicitrato bismuthate 600 mg (elemental bismuth 240 mg) twice daily]. Six weeks after treatment, H. pylori eradication was assessed. Results: Two hundred and seventy subjects were randomized. Both regimens achieved high cure rates: 83.0% (112/135) and 88.1% (119/135) by the intention-to-treat analysis and 95.5% (106/111) and 96.6% (114/118) by the per-protocol analysis, respectively. The intention-to-treat and per-protocol analyses revealed no statistically significant difference in the eradication rate (P =.299 and P =.743, respectively). Rates of adverse events were similar between groups (25.2% vs 23.0%, P -value:.776) Adverse events, which resulted in poor compliance, occurred in six patients of each group, but there were no serious complications. Conclusions: PAM-B therapy is as effective as concomitant therapy for eradicating H. pylori with comparative safety. PAM-B therapy is regarded as a promising alternative to standard triple therapy for a first-line eradication in Korea.

KW - bismuth salts

KW - concomitant therapy

KW - eradication

KW - Helicobacter pylori

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DO - 10.1111/hel.12466

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AN - SCOPUS:85044384187

VL - 23

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