Randomized trial of a quadruple-drug regimen and a triple-drug regimen for eradication of Helicobacter pylori: long-term follow-up study
Abstract
BACKGROUND: In developing countries, H. pylori eradication rates are suboptimal. A quadruple-drug regimen may improve on the eradication rate achieved with triple-drug regimen.
METHODS: 64 consecutive patients with active duodenal ulcer associated with H. pylori infection were randomized to receive either a one-week triple-drug regimen (lansoprazole, clarithromycin, secnidazole) or a one-week quadruple-drug regimen (lansoprazole, amoxycillin, colloidal bismuth subcitrate, secnidazole). H. pylori eradication and ulcer healing were assessed 4 weeks after completion of therapy. Patients were followed up at 24 weeks and 52 weeks for H. pylori recurrence.
RESULTS: Both the regimens eradicated H. pylori in 75% (95% CI 0.6-0.9) of patients. The ulcer-healing rate with the triple-drug regimen was 97% (95% CI 0.91-1.0) and 91% (95% CI 0.91-1.0) with the quadruple-drug regimen. No ulcer or H. pylori recurrence occurred in patients eradicated with the triple-drug regimen, whereas 8.3% of patients eradicated with the quadruple-drug regimen had ulcer as well as H. pylori recurrence during the 52-week follow up.
CONCLUSION: Triple-drug regimen achieves similar eradication rates as quadruple-drug regimen in H. pylori infection.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 64 participants or records.
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