Efficacy and safety of sequential therapy versus standard triple therapy in Helicobacter pylori eradication in Kashmir India: a randomized comparative trial.

BACKGROUND: Increasing resistance against Helicobacter pylori has resulted in reduced eradication rates.
OBJECTIVE: This study aims to determine whether eradication rates for H. pylori infection with sequential therapy is better than standard triple therapy. PATIENTS: Patients with endoscopy documented peptic ulcer and H. pylori infection confirmed by histology and rapid urease test. INTERVENTION: Patients were randomized into two groups; 134 received standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg and amoxicillin 1 g each administered twice daily) for 10 days and 138 received sequential regimen (pantoprazole 40 mg plus amoxicillin 1 g twice daily for 5 days followed by 40 mg pantoprazole, 500 mg clarithromycin, and 500 mg tinidazole each administered twice daily for 5 days). Eradication was confirmed by histology and rapid urease test. Compliance and adverse effects were determined by the recovery of empty medicine strips and questioning.
RESULTS: The eradication rates with sequential therapy were significantly greater than with standard therapy on both intention-to-treat analysis (76.0 % vs. 61.9 %, p = 0.005; difference, 14.1 % [95 % CI, 6.5-19 %] and per protocol analysis (84.6 % vs. 67.4 %, p = 0.002; difference, 17.2 % [95 % CI, 8.5-23.5 %]). The incidence of side effects did not differ between the two therapy groups. One patient in standard therapy discontinued treatment due to side effects. LIMITATION: Cultures were not performed. Loss to follow up was 5.2 % in standard therapy and 6.5 % in sequential therapy.
CONCLUSION: Sequential therapy was significantly more effective than standard therapy for eradicating H. pylori infection in peptic ulcer disease in Asian patients. Side effects were similar.

RCT Entities:   Population Interventions Outcomes