With Helicobacter pylori infections becoming nonresponsive to traditional therapy, a team of Italian doctors tested a new approach: five days of a proton-pump inhibitor (PPI) and amoxicillin followed by five days on a PPI, clarithromycin, and tinidazole. The results: the sequential regimen proved superior to traditional care.
The team of researchers—from hospitals in Bologna and Rome—recruited 300 patients with dyspepsia or peptic ulcers who had never been treated for H. pylori and randomized them to either the novel sequential regimen or standard 10-day therapy with pantoprazole, clarithromycin, and amoxicillin. A placebo identical to the clarithromycin capsule was used during the first five days of sequential therapy to maintain blinding. The drugs were given for two weeks, and the patients took the urea breath test four and eight weeks later.
Results showed that the eradication rate of H. pylori was 89% in the sequential group and 77% in the standard-therapy group, a statistically significant difference. Among those patients with clarithromycin-resistant strains, the results were more pronounced—89% eradication in the experimental group vs. 29% in the control group.
Seventeen percent of patients in each group experienced side-effects, most of which were relatively mild.
The researchers note that in addition to being more effective, the sequential regimen is less expensive than conventional therapy. Therefore, they conclude: “Our data suggest that sequential therapy may have a role as a first-line treatment for H. pylori bacterium infection” (Ann Intern Med. 2007; 146:556-562).