10-day vs a 14-day Standard PPI-based Therapy for H. Pylori
10-day vs a 14-day Standard PPI-based Therapy for H. Pylori
Background The eradication rates of Helicobacter pylori (H. pylori) using a proton pump inhibitor (PPI)-based triple therapy have declined due to antibiotic resistance worldwide.
Aim To compare the eradication rate of the 10-day sequential therapy for H. pylori infection with that of the 14-day standard PPI-based triple therapy.
Methods This was a prospective, randomised, controlled study. A total of 409 patients with H. pylori infection were randomly assigned to receive either the 10-day sequential therapy regimen, which consisted of pantoprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then pantoprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for another five consecutive days or the 14-day PPI-based triple therapy regimen, which consisted of pantoprazole (40 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice a day for 14 days. The pre- and post-treatment H. pylori status were assessed by rapid urease test, urea breath test, or histology. Successful eradication was confirmed at least 4 weeks after finishing the treatment.
Results In the intention-to-treat analysis, the eradication rates of the 10-day sequential therapy and of the 14-day PPI-based triple therapy were 85.9% (176/205) and 75.0% (153/205), respectively (P = 0.006). In the per-protocol analysis, the eradication rates were 92.6% (175/205) and 85% (153/204), respectively (P = 0.019). There was no statistically significant difference between the two investigated groups regarding the occurrence of adverse event rates (18.9% vs. 13.3%, P = 0.143).
Conclusion The 10-day sequential therapy achieved significantly higher eradication rates than the 14-day standard PPI-based triple therapy in Korea.
Since the first discovery of Warren and Marshall, it has been demonstrated that Helicobacter pylori (H. pylori) infection is the cause of many upper gastrointestinal diseases. Therefore, the eradication of H. pylori becomes an effective strategy for the treatment and prevention of H. pylori-associated diseases such as H. pylori-related peptic ulcers and low-grade gastric mucosa-associated lymphoid tissue lymphomas. The standard therapy for H. pylori infection in both the United States and Europe consists of a proton pump inhibitor (PPI)-based triple regimen containing a PPI and chlarithromycin, with either amoxicillin or metronidazole. In the United States, the Food and Drug Administration has approved the PPI-based triple regimens of 7, 10 or 14 days. Among them, the 7-day PPI-based triple therapy is currently the most popular in the world. The same regimen applies to Korea. However, the prevalence of clarithromycin and metronidazole resistance has increased substantially in recent years, and there has been a corresponding decrease in the eradication rate for H. pylori infection. The Third Maastricht Consensus Report agreed that effective treatment for H. pylori should achieve an intention-to-treat eradication rate of >80%. Unfortunately, eradication therapy using the standard PPI-based triple regimen fails in approximately one in five patients recently. A 10-day sequential therapy, which was introduced in year 2000, consists of 5 days of treatment with a PPI and amoxicillin followed by 5-day triple therapy with a PPI and two other antibiotics (usually clarithromycin and metronidazole). In several studies, this 10-day sequential therapy has achieved the high eradication rate with more than 90% in the intention-to-treat analysis. The aim of this study was to determine the efficacy of the 10-day sequential treatment regimen compared with the 14-day standard PPI-based triple treatment regimen for the eradication of H. pylori in Korea.
Abstract and Introduction
Abstract
Background The eradication rates of Helicobacter pylori (H. pylori) using a proton pump inhibitor (PPI)-based triple therapy have declined due to antibiotic resistance worldwide.
Aim To compare the eradication rate of the 10-day sequential therapy for H. pylori infection with that of the 14-day standard PPI-based triple therapy.
Methods This was a prospective, randomised, controlled study. A total of 409 patients with H. pylori infection were randomly assigned to receive either the 10-day sequential therapy regimen, which consisted of pantoprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then pantoprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for another five consecutive days or the 14-day PPI-based triple therapy regimen, which consisted of pantoprazole (40 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice a day for 14 days. The pre- and post-treatment H. pylori status were assessed by rapid urease test, urea breath test, or histology. Successful eradication was confirmed at least 4 weeks after finishing the treatment.
Results In the intention-to-treat analysis, the eradication rates of the 10-day sequential therapy and of the 14-day PPI-based triple therapy were 85.9% (176/205) and 75.0% (153/205), respectively (P = 0.006). In the per-protocol analysis, the eradication rates were 92.6% (175/205) and 85% (153/204), respectively (P = 0.019). There was no statistically significant difference between the two investigated groups regarding the occurrence of adverse event rates (18.9% vs. 13.3%, P = 0.143).
Conclusion The 10-day sequential therapy achieved significantly higher eradication rates than the 14-day standard PPI-based triple therapy in Korea.
Introduction
Since the first discovery of Warren and Marshall, it has been demonstrated that Helicobacter pylori (H. pylori) infection is the cause of many upper gastrointestinal diseases. Therefore, the eradication of H. pylori becomes an effective strategy for the treatment and prevention of H. pylori-associated diseases such as H. pylori-related peptic ulcers and low-grade gastric mucosa-associated lymphoid tissue lymphomas. The standard therapy for H. pylori infection in both the United States and Europe consists of a proton pump inhibitor (PPI)-based triple regimen containing a PPI and chlarithromycin, with either amoxicillin or metronidazole. In the United States, the Food and Drug Administration has approved the PPI-based triple regimens of 7, 10 or 14 days. Among them, the 7-day PPI-based triple therapy is currently the most popular in the world. The same regimen applies to Korea. However, the prevalence of clarithromycin and metronidazole resistance has increased substantially in recent years, and there has been a corresponding decrease in the eradication rate for H. pylori infection. The Third Maastricht Consensus Report agreed that effective treatment for H. pylori should achieve an intention-to-treat eradication rate of >80%. Unfortunately, eradication therapy using the standard PPI-based triple regimen fails in approximately one in five patients recently. A 10-day sequential therapy, which was introduced in year 2000, consists of 5 days of treatment with a PPI and amoxicillin followed by 5-day triple therapy with a PPI and two other antibiotics (usually clarithromycin and metronidazole). In several studies, this 10-day sequential therapy has achieved the high eradication rate with more than 90% in the intention-to-treat analysis. The aim of this study was to determine the efficacy of the 10-day sequential treatment regimen compared with the 14-day standard PPI-based triple treatment regimen for the eradication of H. pylori in Korea.