Adding Bismuth to Rabeprazole-Based First-Line Triple Therapy Does Not Improve the Eradication of Helicobacter pylori

Abstract EN

This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori.

A total of 162 patients with Helicobacter pylori infection were randomly assigned to either the 7-day triple therapy group (RAK regimen: rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg bid; n=81) or the bismuth plus triple therapy group (n=81).

In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen.

A follow-up endoscopy or urea breath test was performed at least 4 weeks after eradication to confirm the treatment efficacy.

Comparable compliance and Helicobacter pylori eradication rates were observed in both groups in either intention-to-treat [RAK 72.8% (59/81) versus RBAK 77.8% (63/81); p=0.47] or per protocol analysis [RAK 74.7% (59/79) versus RBAK 81.8% (63/77); p=0.26].

Adverse effects were commonly reported (50.6% for both groups) although most of these did not cause cessation of treatment.

The resistance rate was 27.2% for metronidazole and 12.3% for clarithromycin.

Adding bismuth to the standard 7-day triple therapy did not substantially increase the eradication rate.

Further study is needed clarifying whether extending the duration of RBAK regimen to 10–14 days can lead to a better result.