BACKGROUND:Rabeprazole is a new proton pump inhibitor, which has been reported to induce a faster acid suppression than other drugs of the same category. This might be useful to reduce the duration of anti-Helicobacter therapies. AIMS: The aim of this study was to assess whether there is the possibility of shortening a rabeprazole-based triple therapy from 7 to 4 days without compromising its efficacy in the eradication of Helicobacter pylori infection. PATIENTS: A total of 128 consecutive dyspeptic patients with H. pylori infection were recruited for this controlled, randomized, open and parallel-group trial comparing the efficacy of two durations of the same rabeprazole-based triple therapy. METHODS: All patients were subdivided to receive a combination of rabeprazole 20 mg twice daily, clarithromycin 250 mg twice daily and metronidazole 500 mg twice daily (RCM) for 4 days (n = 63) and for 7 days (n = 65). At baseline, they underwent breath 13C-urea test and endoscopy with biopsies for rapid urease testing and histology to confirm infection with H. pylori. Eradication was determined by a negative 13C-urea breath test within 28-32 days after the end of therapy. RESULTS:Overall eradication rates were similar for patients treated with the 4- and the 7-day periods (intention-to-treat and per-protocol analyses showed a success rate of 81% versus 78% and 88% versus 85%, respectively; P = NS). Tolerance was similar in both groups. Most adverse events were mild to moderate, and only two patients were withdrawn because of them. CONCLUSIONS: The eradication rate of the 4-day regimen was equivalent to that of the same 7-day regimen based on rabeprazole plus clarithromycin and metronidazole. Therefore, the 4-day regimen of RCM seems to give us the possibility of adopting a shorter-than-usual duration of therapy against H. pylori.
RCT Entities:
BACKGROUND:Rabeprazole is a new proton pump inhibitor, which has been reported to induce a faster acid suppression than other drugs of the same category. This might be useful to reduce the duration of anti-Helicobacter therapies. AIMS: The aim of this study was to assess whether there is the possibility of shortening a rabeprazole-based triple therapy from 7 to 4 days without compromising its efficacy in the eradication of Helicobacter pylori infection. PATIENTS: A total of 128 consecutive dyspeptic patients with H. pyloriinfection were recruited for this controlled, randomized, open and parallel-group trial comparing the efficacy of two durations of the same rabeprazole-based triple therapy. METHODS: All patients were subdivided to receive a combination of rabeprazole 20 mg twice daily, clarithromycin 250 mg twice daily and metronidazole 500 mg twice daily (RCM) for 4 days (n = 63) and for 7 days (n = 65). At baseline, they underwent breath 13C-urea test and endoscopy with biopsies for rapid urease testing and histology to confirm infection with H. pylori. Eradication was determined by a negative 13C-urea breath test within 28-32 days after the end of therapy. RESULTS: Overall eradication rates were similar for patients treated with the 4- and the 7-day periods (intention-to-treat and per-protocol analyses showed a success rate of 81% versus 78% and 88% versus 85%, respectively; P = NS). Tolerance was similar in both groups. Most adverse events were mild to moderate, and only two patients were withdrawn because of them. CONCLUSIONS: The eradication rate of the 4-day regimen was equivalent to that of the same 7-day regimen based on rabeprazole plus clarithromycin and metronidazole. Therefore, the 4-day regimen of RCM seems to give us the possibility of adopting a shorter-than-usual duration of therapy against H. pylori.