Concomitant versus reverse hybrid therapy for eradication of Helicobacter pylori infection-An open-label randomized controlled trial.

BACKGROUND

Due to the declining efficacy of the earlier regimens for Helicobacter pylori eradication because of anti-microbial resistance, non-bismuth quadruple (concomitant) and reverse-hybrid regimens are emerging as a new regimen. We compared eradication efficacy, compliance and adverse effects of concomitant therapy (CT) vs. reverse-hybrid therapy (RHT).

METHODS

This was a prospective, single-centre, parallel-arm, open-label, non-inferiority randomized controlled study. Clinical Trials Registry-India: CTRI/2021/10/047865. Patients with peptic ulcer disease and gastritis found to be H. pylori positive were randomized 1:1 to concomitant therapy: omeprazole 20 mg twice daily (BD), amoxicillin 1 gm BD, clarithromycin 500 mg BD, metronidazole 400 mg thrice daily (TDS) for 14 days and reverse hybrid therapy groups omeprazole 20 mg BD and amoxicillin 1 g BD for 14 days plus clarithromycin 500 mg BD and metronidazole 400 mg TDS for the first seven days. Eradication was assessed six weeks post-therapy and compliance and adverse effects were noted.

RESULTS

Total 148 patients were randomized to 74 in CT and RHT groups. Baseline features were comparable; mean age 44.5 ± 13.9 vs. 43.7 ± 13.5 years; males 56.8% vs. 58.1%. Eradication (CT vs. RHT) was 59 (79.7%) vs. 62 (83.7%) (intention-to-treat [ITT], p = 0.52), 59 (86.7%) vs. 62 (88.5%) (modified ITT, p = 0.74) and 59 (92.2%) vs. 62 (92.5%) (per-protocol, p = 0.94) analysis. Compliance was good and similar in both groups by per-protocol 64/70 (91.4%) vs. 67/71 (94.4%) (p = 0.497) and ITT 64/74 (86.5%) vs. 67/74 (90.5%) (p = 0.439) analysis. Adverse effects occurred at similar frequencies; the most common was altered taste 33/68 (48.5%) vs. 30/70 (42.9%) (p = 0.50). Overall, 98 adverse events were recorded in CT and 75 in RHT (1.44 vs. 1.07 events/patient; rate ratio 1.35, 95% CI 1.00-1.82; p = 0.053).

CONCLUSION

Fourteen-day concomitant and reverse-hybrid regimens achieved comparable eradication, with similar compliance and no difference in overall adverse events.