Two-week bismuth-containing quadruple therapy and concomitant therapy are effective first-line treatments for Helicobacter pylori eradication: A prospective open-label randomized trial

Abstract

BACKGROUND Increasing levels of antibiotic resistance have reduced the Helicobacter pylori (H. pylori) eradication rates afforded by the standard triple therapy. Thus, 2-wk first-line four-drug regimens must be considered. AIM To analyze the eradication rates of modified bismuth-containing quadruple therapy (mBCQT) and concomitant therapy (CT), the associated adverse events, and compliance. METHODS Patients infected with H. pylori were prospectively randomized to receive mBCQT or CT for 2 wk. mBCQT featured a proton pump inhibitor (PPI), bismuth, metronidazole, and tetracycline, taken twice daily. CT included a PPI, clarithromycin, metronidazole, and amoxicillin, taken twice daily. The C-13-urea breath test was performed no earlier than 4 wk after therapy concluded to confirm eradication. If either the histological or rapid urease test was positive, H. pylori infection was diagnosed. RESULTS The demographic characteristics of 68 patients who received mBCQT and 68 who received CT did not differ significantly. On intention-to-treat analysis, the eradication rate was 88.2% (60/68) in the mBCQT group and 79.4% (54/68) in the CT group (P = 0.162). By per-protocol analysis, the respective eradication rates were 98.4% (60/61) and 93.1% (54/58) (P = 0.199). More CT than mBCQT patients experienced adverse events [33.8% (23/68) mBCQT vs 51.5% (35/58) CT patients, respectively, P = 0.037]. All patients showed good compliance [85.3% (58/68) mBCQT vs 82.4% (56/68) CT patients, P = 0.641]. CONCLUSION The H. pylori eradication rates of the 2-wk mBCQT and CT regimens are high. Most patients show good compliance, and more CT than mBCQT patients experience adverse events.