Comparison between  daily single-dose triple therapy and conventional triple therapy on patient compliance and Helicobacter pylori eradication: A randomized controlled  trial.

OBJECTIVE

The poor compliance to treatment of Helicobacter pylori-infected patients is well-known. We evaluated the efficacy of daily single-dose triple therapy as compared to conventional triple therapy on patient compliance and eradication of H. pylori infection.

METHODS

In the study group, 105 patients received esomeprazole 40 mg, tinidazole 1 g, and levofloxacin 500 mg once-daily for 14 days. One hundred and seven patients in the control group received lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice-daily for 14 days. Four weeks after completing therapy, urea breath test was performed to assess the eradication of H. pylori infection.

RESULTS

The eradication rates by intention-to-treat analysis were 86% and 90.2% and by per-protocol analyses were 90.5% and 95.3% in the control and study groups, respectively, with no significant differences. Drug compliance was significantly better in the study group compared to the control group (p = 0.04). Overall, 44.7% of the patients in the study and 47.6% in the control groups had at least one adverse event. The most common adverse event was the dysgeusia in both the groups. The occurrence of diarrhea, nausea and vomiting was significantly higher in the control group and that of arthralgia was higher in the study group. The presence of periodontal disease and drug compliance was independently associated with treatment failure.

CONCLUSION

The use of single-dose PPI-based triple therapy improves drug compliance and eradication rate to standard PPI-based triple therapy. Presence of periodontal disease and drug compliance had negative influence on the eradication rate.

TRIAL REGISTRATION: NCT02711176 ᅟ ᅟ.