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Bismuth, lansoprazole, amoxicillin and metronidazole or clarithromycin as first-line Helicobacter pylori therapy
  1. Wei Zhang1,2,
  2. Qi Chen1,2,
  3. Xiao Liang1,2,
  4. Wenzhong Liu1,2,
  5. Shudong Xiao1,2,
  6. David Y Graham3,
  7. Hong Lu1,2
  1. 1GI Division, Renji Hospital, School of Medicine, Shanghai Jiao-Tong University, Shanghai Institution of Digestive Disease, Shanghai, China
  2. 2Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Shanghai, China
  3. 3Michael E. DeBakey VA Medical Center, and Baylor College of Medicine Houston, Houston, Texas, USA
  1. Correspondence to Dr Hong Lu, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, 145 Middle Shandong Rd, Shanghai 200001, China; hlu{at}sjtu.edu.cn

Abstract

Objective To evaluate the efficacy and tolerability of replacing tetracycline with amoxicillin in bismuth quadruple therapy.

Design Subjects who were infected with Helicobacter pylori and naïve to treatment were randomly (1:1) assigned to receive a 14-day modified bismuth quadruple therapy: lansoprazole 30 mg, amoxicillin 1 g, bismuth potassium citrate 220 mg (elemental bismuth), twice a day with metronidazole 400 mg four times a day (metronidazole group) or clarithromycin 500 mg twice a day (clarithromycin group). Six weeks after treatment, H. pylori eradication was assessed by 13C-urea breath test. Antimicrobial susceptibility was assessed by the twofold agar dilution method. This was a non-inferiority trial.

Results Two hundred and fifteen subjects were randomised. Metronidazole and clarithromycin containing regimens achieved high cure rates: 94 of 97 (96.9%, 95% CI 93.5% to 100%) and 93 of 98 (94.9%, 95% CI 90.5% to 99.3%) by per-protocol and 88.9% (95% CI 83.0% to 94.8%) and 88.8% (95% CI 82.8% to 94.8%) by intention-to-treat, respectively. Amoxicillin, metronidazole and clarithromycin resistance rates were 1.5%, 45.5% and 26.5%, respectively. Only clarithromycin resistance reduced treatment success (eg, susceptible 98.6%, resistant 76.9%, p=0.001). Adverse events were more common in the metronidazole group.

Conclusions These results suggest that amoxicillin can substitute for tetracycline in modified 14 day bismuth quadruple therapy as first-line treatment and still overcome metronidazole resistance in areas with high prevalence of metronidazole and clarithromycin resistance. Using clarithromycin instead of metronidazole was only effective in the presence of susceptible strains.

Trial registration number NCT02175901.

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