Efficacy of levofloxacin, omeprazole, nitazoxanide, and doxycycline (LOAD) regimen compared with standard triple therapy to eradicate Helicobacter pylori infection: a prospective randomized study from a tertiary hospital in India.

AIM: In this study, the efficacy of 14-day triple therapy was compared with that of a novel ten-day LOAD regimen to eradicate Helicobacter pylori infection in India.

BACKGROUND

Helicobacter pylorus infection is widespread in India. Resistance to antibiotics commonly used against Helicobacter pylori is increasing rapidly, leading to traditional triple therapy's lower success. Therefore, a search for a new regimen is needed.

METHODS

In this randomized trial, patients with Helicobacter pylori infection were randomized to a group receiving LOAD therapy (levofloxacin 250 mg OD, omeprazole 40 mg BD, nitazoxanide 500 mg BD, and doxycycline 100 mg OD) for ten days or a group receiving standard triple therapy (pantoprazole 80 mg, amoxicillin 2000 mg, and clarithromycin 1000 mg daily) in divided doses for 14 days). Gastric biopsy/RUT was done 10-12 weeks after completing therapy to confirm Helicobacter pylori eradication.

RESULTS

Eradication rates were significantly greater with the LOAD regimen than with standard triple therapy on both intention-to-treat analysis (82.75% vs. 60.26%, p = 0.001; difference, 22.49% [95% CI, 8.5-18%] and per-protocol analysis (83.3% vs. 62.75%, p = 0.002; difference, 20.55% [95% CI, 7.1-22.5%]). Both treatment regimens were well tolerated.

CONCLUSION

Although the rate of eradication of H. pylori infection was significantly higher with the LOAD regimen than triple therapy, the efficacy was still suboptimal, possibly because of fluoroquinolone resistance or the short course of treatment.