Comparison of Two Common Quadruple Therapy Protocols for Eradication of Helicobacter Pylori in Iran: an Open Label, Randomized, Non-inferiority, Clinical Trial

Abstract

Background:

Helicobacter pylori (H. pylori) is located in the digestive tract. This bacterium has a tendency to attack the stomach surface layer, mucosal changing, and eventually may involve in developing gastric cancer. In this regard, the main remaining issue is antibiotic resistance, which influences the efficacy of eradication regimens.

Aim:

To assess the efficacy of two frequent anti-H. Pylori quadruple treatments consisting of omeprazole, bismuth, amoxicillin, and clarithromycin (OBAC) or tetracycline (OBMT). Materials and Methods:

Patients infected with H. pylori were assigned to receive omeprazole 20 mg, bismuth subcitrate 240 mg, metronidazole 500 mg, and tetracycline 500 mg twice a day versus omeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and bismuth subcitrate 240 mg twice a day. Non-inferiority analyses were conducted according to both intention-to-treat and per-protocol principles.

Results:

100 patients in each group were enrolled. The intention-to-treat eradication rate was 82% (82/100) in the group receiving OBMT and 85% (85/100) in the OBAC group. Per protocol, eradication rates were 88.1% (82/93) for the group receiving OBMT and 89.4% (85/95) for patients in the OBAC group. When considering non-inferiority analysis, there were no differences between the two groups in both methods of analysis.

Conclusion:

The eradication rate of OBMT is not inferior to OABC, and both are effective in eradicating H. pylori in areas with high metronidazole resistance. OBMT is a good alternative against the increasing resistance to clarithromycin.