A new quadruple therapy for the eradication of Helicobacter pylori . Effect of pretreatment with omeprazole on the cure rate

Abstract

To elucidate whether pretreatment with omeprazole decreases the cure rate of Helicobacter pylori infection with a new quadruple therapy, and thus, whether this pretreatment should not be used in clinical practice, we conducted a randomized trial. Ninety patients with chronic peptic ulcer disease and nonulcer dyspepsia, with biopsy-proven H. pylori infection were randomly assigned to the two following regimens: Group 1 (n = 45) received omeprazole 20 mg once daily for 2 weeks (days 1-14), and 500 mg amoxicillin granules and 250 mg metronidazole thrice daily, and roxithromycin 150 mg twice daily for 1 week (days 8-14), Group 2 (n = 45) received the same antibiotic treatment as group 1 for 1 week (days 1-7), in addition to omeprazole treatment for 2 weeks (days 1-14). Four weeks after the treatment ended, endoscopy was repeated, with two biopsy specimens each taken from the antrum and the corpus (total of four specimens) for a urease test, histological analysis, and culture to establish cure of infection. A patient was regarded as cured only if all three methods gave negative results for H. pylori. In the intention-to-treat analysis, 42 of 45 patients (93.3%; 95% confidence intervals [CI], 81.7%-98.6%) in group 1 were cured compared with 43 of 45 patients (95.6%; 95% CI, 84.9%-99.5%) in group 2. In the per-protocol analysis, the corresponding figures were 42/44 (95.5%; 95% CI 84.5%-99.4%) and 43/44 (97.7%; 95% CI, 88.0%-99.9%). There were no significant differences in the cure rate between the two groups on either analysis. All patients, except for one who had an allergic reaction, completed the treatment regimens. Fifty to sixty percent of the patients had no side effects while the rest had mild to moderate side effects. The new quadruple therapy consisting of omeprazole, amoxicillin, metronidazole, and roxithromycin appears suitable for use in clinical practice, as the cure rate was 95% and no severe side effects were observed. Pretreatment with omeprazole did not reduce the cure rate for this new quadruple therapy.

Does Pretreatment with Lansoprazole Influence Helicobacter pylori Eradication Rate and Quality of Life?

“…The authors theorized that PPIs might induce coccoid-persistent forms of H. pylori in a direct or indirect manner and that H. pylori exposed to PPIs were in a less active, dormant state and therefore less vulnerable to the actions of antibiotics. Other studies have reported that pretreatment with a PPI did not reduce the rate of eradication [5,6,7,17]. Janssen et al [8] have reported the results of a meta-analysis indicating that pretreatment did not influence eradication, but this meta-analysis did not include the regimen recommended in Japan (lansoprazole, amoxicillin and clarithromycin).…”

“…However, it was subsequently reported that initial treatment with a proton pump inhibitor (PPI), either with triple therapy (pantoprazole, clarithromycin and metronidazole; or omeprazole, amoxicillin and metronidazole) or with quadruple therapy (omeprazole, amoxicillin, metronidazole and roxithromycin) did not reduce the H. pylori eradication rate [5,6,7]. Furthermore, based on a meta-analysis, Janssen et al reported that pretreatment with a PPI did not influence H. pylori eradication [8].…”

New concepts of resistance in the treatment of Helicobacter pylori infections

“…It consists of all four drugs (the PPI, clarithromycin, metronidazole/ tinidazole, and amoxicillin being given b.i.d.. The duration has ranged from 3 to 7 days and it has resulted in Grade B results similar to those obtained with sequential therapy [59][60][61][62][63][64][65][66][67] ( Figure 3). As with sequential therapy, studies are needed to test whether extending the duration of therapy will improve the results.…”

“…From reference 14 , with permission. Weight mean and 95% confidence intervals for 16 studies of sequential therapy (n = 1805) for 10 days(modified intention-to-treat) 57 and 9 studies of concomitant therapy (n = 715) ranging from 3 to 7 days (intention-to-treat) [59][60][61][62][63][64][65][66][67] .…”

Meta-Analysis of Sequential, Concomitant and Hybrid Therapy for <i>Helicobacter pylori</i> Eradication

“…The superiority of this therapy over standard triple therapy has been widely documented (7). Meanwhile, concomitant therapy, first introduced in 1998 (8,9), is now being reconsidered as a firstline H. pylori eradication therapy (10). The concomitant regimen includes quadruple therapy with standard triple therapy (PPI, clarithromycin, amoxicillin) plus metronidazole or tinidazole.…”