BACKGROUND: The high cost and complexity of therapeutic schemes for the eradication of Helicobacter pylori has stimulated the search of simpler and cheaper treatment options. AIM: To evaluate the efficacy of 3 days of azithromycin 500 mg od, 7 days of amoxycillin 750 mg tid and omeprazole, 20 (Group A) or 40 mg (Group B) on randomization, as a treatment for Helicobacter pylori infection in patients with endoscopically diagnosed peptic ulcer. METHODS:H. pylori status of peptic ulcer patients was pathologically confirmed by the examination of five gastric biopsies using the Giemsa stain and by rapid urease testing in two gastric biopsies. H. pylori status was reassessed not less than 28 days after completing treatment. Adverse events and compliance were evaluated. RESULTS:Fifty four patients (29 men, 25 women, mean age 48 years) were enrolled, 28 in Group A and 27 in Group B. Per protocol the infection was cured in 58.8% of patients (30/51; 95% CI: 45-73%). On an intention to treat basis, H pylori infection was cured in 55%. Minor side effects including diarrhea and nausea were reported by 32% of patients. Ninety-five per cent of patients consumed more than 95% of prescribed medications. H. pylori was successfully eradicated in 61% of group A and 57% of group B patients (p = NS). CONCLUSION: Short term therapy with azithromycin was poorly effective in curing H. pylori infection. The compliance was excellent. Increasing Omeprazole from 20 to 40 mg/day did not improve treatment effectiveness.
RCT Entities:
BACKGROUND: The high cost and complexity of therapeutic schemes for the eradication of Helicobacter pylori has stimulated the search of simpler and cheaper treatment options. AIM: To evaluate the efficacy of 3 days of azithromycin 500 mg od, 7 days of amoxycillin 750 mg tid and omeprazole, 20 (Group A) or 40 mg (Group B) on randomization, as a treatment for Helicobacter pylori infection in patients with endoscopically diagnosed peptic ulcer. METHODS:H. pylori status of peptic ulcerpatients was pathologically confirmed by the examination of five gastric biopsies using the Giemsa stain and by rapid urease testing in two gastric biopsies. H. pylori status was reassessed not less than 28 days after completing treatment. Adverse events and compliance were evaluated. RESULTS: Fifty four patients (29 men, 25 women, mean age 48 years) were enrolled, 28 in Group A and 27 in Group B. Per protocol the infection was cured in 58.8% of patients (30/51; 95% CI: 45-73%). On an intention to treat basis, H pylori infection was cured in 55%. Minor side effects including diarrhea and nausea were reported by 32% of patients. Ninety-five per cent of patients consumed more than 95% of prescribed medications. H. pylori was successfully eradicated in 61% of group A and 57% of group B patients (p = NS). CONCLUSION: Short term therapy with azithromycin was poorly effective in curing H. pyloriinfection. The compliance was excellent. Increasing Omeprazole from 20 to 40 mg/day did not improve treatment effectiveness.
Authors: Arnoldo Riquelme; Alejandro Soza; Cesar Pedreros; Andrea Bustamante; Felipe Valenzuela; Francisco Otarola; Eduardo Abbott; Marco Arellano; Brenda Medina; Alejandro Pattillo; Douglas Greig; Marco Arrese; Antonio Rollan Journal: World J Gastroenterol Date: 2007-06-07 Impact factor: 5.742