Since consistently higher cure rates of Helicobacter pylori have been reported with the use of proton pump inhibitor–based triple therapy, this therapy is recommended over dual therapy. However, the ideal duration for triple therapy, from seven to 14 days, is still being evaluated. Studies showing more than than 90 percent H. pylori eradication using triple therapy for seven days have been reported. Fennerty and associates compared a 10-day treatment regimen with a 14-day treatment regimen in patients with H. pylori infection and active duodenal ulcer disease or a history of duodenal ulcer.
A total of 284 patients were randomized to receive 30 mg of lansoprazole, 250 mg of amoxicillin and 500 mg of clarithromycin twice daily for 10 or 14 days. The primary efficacy outcome was eradication of H. pylori, confirmed by histologic and culture results four to six weeks after completion of therapy. Because of various protocol violations, only 236 patients were included in the final analysis.
H. pylori was eradicated in 103 patients (84 percent) in the 10-day treatment group and in 96 patients (85 percent) in the 14-day treatment group. Even in the worst-case scenario, in which patients who failed to return for follow-up were considered to have persistent infection, the H. pylori eradication rates were 81 percent in the 10-day group and 82 percent in the 14-day treatment group. No significant differences were found between the two groups in overall treatment outcomes. Of the 228 patients with an active ulcer, 166 patients did not have an ulcer at the final endoscopy, conducted four weeks after the completion of therapy. No difference in ulcer status was noted between the two treatment groups, and the same percentage of patients showed resolution or improvement of acute and chronic inflammation.
No differences were observed between the treatment groups in either the frequency or the mean severity of daytime or nighttime abdominal pain during the treatment period. There was, however, a significant observed difference in the frequency and mean severity of daytime abdominal pain during the follow-up period. Adverse events did not differ between treatment groups. The most commonly reported events were diarrhea and taste disturbance. Nine patients discontinued taking the study medication prematurely, at least in part because of drug-related adverse events.
The results of this study are similar for the 10- and 14-day triple regimens. The treatment groups were found to be comparable based on cure rates of H. pylori infection, resolution or improvement of gastritis, frequency and mean severity of daytime or nighttime abdominal pain, and tolerability. The authors conclude that triple therapy twice daily for 10 days results in high rates of H. pylori eradication, tolerability and compliance.