Objective: Helicobacter pylori is a bacterial pathogen associated with chronic gastritis, peptic ulcer disease, gastric adenocarcinoma, and gastric mucosa associated lymphoid tissue lymphoma. Current treatment guidelines support a 7- to 14-day, triple-drug protocol consisting of a proton-pump inhibitor (PPI), clarithromycin, and either amoxicillin or an imidazole. The initial eradication rates for this regimen were 80 to 90%. Nevertheless its effectiveness has declined as the antibiotic resistance to clarithromycin and metronidazole has emerged. In Puerto Rico the reported resistance of H. pylori to clarithromycin is 16% and to metronidazole, 3.7%. Sequential therapy for H. pylori eradication, 5 days of treatment with a PPI and amoxicillin followed by 5 days of treatment with the PPI and 2 other antibiotics (clarithromycin and an imidazole), was introduced as an effective alternate regimen. This is a prospective clinical trial intended to compare the efficacy of first-line, standard 10-day tripledrug therapy with those of both 10- and 14-day sequential therapy in eradicating H. pylori at the San Juan Veterans Affairs Hospital in a population that is naïve to previous treatment.
Methods: This was a prospective, open-label, randomized clinical trial.
Results: Based on the intention-to-treat analysis, the eradication rate was 83.7% (72 of 86 patients) in the standard triple-therapy group, 80.0% (68/85) in the 10- day sequential-therapy group, and 79.1% (68/86) in the 14-day sequential-therapy group. There were no significant statistical differences between the eradication rates among therapies.
Conclusion: Sequential-therapy treatment regimens are not better than standard triple therapy for the eradication of H. pylori infection, regardless of the treatment duration.
Keywords: Amoxicillin; Breath test; Helicobacter pylori; Proton pump inhibitors; Veterans.