Different bismuth-based therapies for eradicating Helicobacter pylori: Randomized clinical trial of efficacy and safety
Abstract
BACKGROUND AND OBJECTIVE: Bismuth salts are used for treating dyspepsia, and they exert antibacterial effects on Helicobacter pylori. This study aimed to compare the efficacy and safety of three bismuth-containing combination regimens for H. pylori eradication in a Turkish population.
METHODS: In this single-center study, 149 patients, who were diagnosed with H. pylori infection with urea breath test and histopathological examination, were randomized to receive the following therapies for 14 days: (1) bismuth-containing clarithromycin-based triple therapy (CBS-LAC), (2) bismuth-containing levofloxacin-based triple therapy (CBS-LAL), and (3) bismuth-containing quadruple therapy (BCQT). Eradication rates were evaluated six weeks after the treatment by performing intention to treat (ITT) and per protocol (PP) analyses. In addition, data on side effect profiles and patient compliance were collected.
RESULTS: PP and ITT analyses showed that eradication rates were 86% and 81.1%, respectively, with BCQT; 68.3% and 66.7%, respectively, with CBS-LAL therapy; and 65.3% and 59.3%, respectively, with CBS-LAC therapy. Eradication rates obtained using PP and ITT analyses were statistically significant for all the regimens.
CONCLUSION: Addition of bismuth to standard triple and levofloxacin-based regimen did not show an acceptable increase in eradication rates. Therefore, BCQT may be preferred for the first-line treatment of 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: 149 participants or records.
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