OBJECTIVES: One-week triple therapy, a combination of acid suppression with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. There is increasing evidence of H. pylori resistance to classical triple therapy. Recently, it was reported that the amoxicillin-clavulanate combination had a slightly higher activity than amoxicillin alone against H. pylori, and that beta-lactamase inhibitors had 'in-vitro' antibacterial activity against H. pylori. SETTING: To evaluate the efficacy of 1 week triple therapy omeprazole, clarithromycin and amoxicillin plus clavulanate compared with omeprazole, clarithromycin and amoxicillin for H. pylori eradication. The study was open randomized. SUBJECTS:Sixty dyspeptic patients (36 male, 24 female; mean age 53 +/- 9 years) with Helicobacter pylori infection never treated before, were enrolled and randomly assigned to two different 7-day triple therapies: (i) (n = 30) amoxicillin 875 mg plus clavulanic acid 125 mg b.i.d., clarithromycin 500 mg b.i.d., omeprazole 20 mg b.i.d. (ACCO); (ii) (n = 30) amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d., omeprazole 20 mg b.i.d. (ACO). Bacterial eradication was assessed by 13C-urea breath test 4-6 weeks after therapy. Information on gastrointestinal symptoms and antibiotic-related side-effects were recorded using a questionnaire. RESULTS: All patients completed the study. A significantly higher H. pylori eradication rate with ACCO compared with ACO: (26/30) 86.6 vs. (20/30) 66.6%, respectively (P < 0.05) were observed. No major side-effects were reported, whilst 8% patients complained of mild side-effects; no significant differences were noted between the two groups. CONCLUSIONS: Our results suggest that amoxicillin and clavulanate in combination achieve a higher H. pylori eradication rate than amoxicillin alone, without any increase in side-effects. The combination of amoxicillin and clavulanate may represent an alternative therapeutic scheme for the treatment of H. pylori infection.
RCT Entities:
OBJECTIVES: One-week triple therapy, a combination of acid suppression with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. There is increasing evidence of H. pylori resistance to classical triple therapy. Recently, it was reported that the amoxicillin-clavulanate combination had a slightly higher activity than amoxicillin alone against H. pylori, and that beta-lactamase inhibitors had 'in-vitro' antibacterial activity against H. pylori. SETTING: To evaluate the efficacy of 1 week triple therapy omeprazole, clarithromycin and amoxicillin plus clavulanate compared with omeprazole, clarithromycin and amoxicillin for H. pylori eradication. The study was open randomized. SUBJECTS: Sixty dyspeptic patients (36 male, 24 female; mean age 53 +/- 9 years) with Helicobacter pyloriinfection never treated before, were enrolled and randomly assigned to two different 7-day triple therapies: (i) (n = 30) amoxicillin 875 mg plus clavulanic acid 125 mg b.i.d., clarithromycin 500 mg b.i.d., omeprazole 20 mg b.i.d. (ACCO); (ii) (n = 30) amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d., omeprazole 20 mg b.i.d. (ACO). Bacterial eradication was assessed by 13C-urea breath test 4-6 weeks after therapy. Information on gastrointestinal symptoms and antibiotic-related side-effects were recorded using a questionnaire. RESULTS: All patients completed the study. A significantly higher H. pylori eradication rate with ACCO compared with ACO: (26/30) 86.6 vs. (20/30) 66.6%, respectively (P < 0.05) were observed. No major side-effects were reported, whilst 8% patients complained of mild side-effects; no significant differences were noted between the two groups. CONCLUSIONS: Our results suggest that amoxicillin and clavulanate in combination achieve a higher H. pylori eradication rate than amoxicillin alone, without any increase in side-effects. The combination of amoxicillin and clavulanate may represent an alternative therapeutic scheme for the treatment of H. pyloriinfection.