AIM: Triple therapy consisting of a proton pump inhibitor (PPI) and two antibiotics is used as first choice in treating Helicobacter pylori (H. pylori) infection. Since in the North Italian population, metronidazole resistance is less than 40%, this antibiotic would be preferable as first approach. The aim of this randomized study was to assess the efficacy of a metronidazole-based versus a tinidazole-based treatment, in naïve patients with H. pylori infection. METHODS:Diagnosis and eradication of H. pylori infection were assessed by 13C-urea breath test, and by histology when an endoscopic examination was necessary. A total of 171 patients was treated: 91 (47 males, mean age 50+/-3 years) with metronidazole 250 mg q.i.d., amoxicilline 1 gr b.i.d. and PPI standard dose (MAO), and 80 (36 males, mean age 52+/-3.8 years) withtinidazole 500 mg b.i.d., amoxicilline 1 gr b.i.d. and PPI standard dose (TAO) regimen for 7, 10 or 14 days. RESULTS: Three patients suspended MAO treatment due to side effects. H. pylori eradication was obtained as follow indicated. After 7 days, in 23/30 (76.6%) patients in MAO versus 20/27 (74.0%) in TAO regimen. After 10 days, in 20/26 (76.9%) patients in MAO versus 20/26 (76.9%) in TAO regimen. After 14 days, in 25/32 subjects (78.1%) in MAO versus 21/27 (77.7%) in TAO treatment. The differences among durations or between metronidazole-versus tinidazole-based triple therapy were not statistically different. CONCLUSION: Treatment with metronidazole is as effective as that with tinidazole in terms of efficacy. Moreover, duration did not influence efficacy of treatment.
RCT Entities:
AIM: Triple therapy consisting of a proton pump inhibitor (PPI) and two antibiotics is used as first choice in treating Helicobacter pylori (H. pylori) infection. Since in the North Italian population, metronidazole resistance is less than 40%, this antibiotic would be preferable as first approach. The aim of this randomized study was to assess the efficacy of a metronidazole-based versus a tinidazole-based treatment, in naïve patients with H. pyloriinfection. METHODS: Diagnosis and eradication of H. pyloriinfection were assessed by 13C-urea breath test, and by histology when an endoscopic examination was necessary. A total of 171 patients was treated: 91 (47 males, mean age 50+/-3 years) with metronidazole 250 mg q.i.d., amoxicilline 1 gr b.i.d. and PPI standard dose (MAO), and 80 (36 males, mean age 52+/-3.8 years) with tinidazole 500 mg b.i.d., amoxicilline 1 gr b.i.d. and PPI standard dose (TAO) regimen for 7, 10 or 14 days. RESULTS: Three patients suspended MAO treatment due to side effects. H. pylori eradication was obtained as follow indicated. After 7 days, in 23/30 (76.6%) patients in MAO versus 20/27 (74.0%) in TAO regimen. After 10 days, in 20/26 (76.9%) patients in MAO versus 20/26 (76.9%) in TAO regimen. After 14 days, in 25/32 subjects (78.1%) in MAO versus 21/27 (77.7%) in TAO treatment. The differences among durations or between metronidazole-versus tinidazole-based triple therapy were not statistically different. CONCLUSION: Treatment with metronidazole is as effective as that with tinidazole in terms of efficacy. Moreover, duration did not influence efficacy of treatment.