Comparison of sequential therapy and amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori: a prospective, multi-center, randomized clinical trial

• Published in: BMC gastroenterology Vol. 16; no. 1; p. 79
• Main Authors: Lee, Ju Yup, Kim, Nayoung, Park, Kyung Sik, Kim, Hyun Jin, Park, Seon Mee, Baik, Gwang Ho, Shim, Ki-Nam, Oh, Jung Hwan, Choi, Suck Chei, Kim, Sung Eun, Kim, Won Hee, Park, Seon-Young, Kim, Gwang Ha, Lee, Bong Eun, Jo, Yunju, Hong, Su Jin
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 26.07.2016; BioMed Central
• Subjects: Amoxicillin; Amoxicillin - adverse effects; Amoxicillin - therapeutic use; Antacids - adverse effects; Antacids - therapeutic use; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Bismuth; Bismuth - adverse effects; Bismuth - therapeutic use; Drug Administration Schedule; Drug Resistance, Bacterial; Drug therapy; Drug Therapy, Combination; Female; Gastritis - drug therapy; Gastritis - microbiology; Gastroenterology; Health aspects; Helicobacter infections; Helicobacter Infections - drug therapy; Helicobacter Infections - microbiology; Helicobacter pylori - drug effects; Humans; Male; Medication Adherence; Middle Aged; Prospective Studies; Tetracycline - adverse effects; Tetracycline - therapeutic use; Treatment Failure; Quadruple; Bismuth; Helicobacter pylori; Eradication; Amoxicillin; Tetracycline
• DOI: 10.1186/s12876-016-0490-8
• ISSN: 1471-230X

The <80 % Helicobacter pylori eradication rate with sequential therapy is unsatisfactory. Modified bismuth quadruple therapy, replacing metronidazole with amoxicillin, could be promising because H. pylori resistance to tetracycline or to amoxicillin is relatively low. A 14-day modified bismuth quadruple protocol as first-line H. pylori treatment was compared with 10-day sequential therapy. In total, 390 H. pylori-infected subjects participated in the randomized clinical trial: 10-day sequential therapy (40 mg pantoprazole plus 1 g amoxicillin twice a day for 5 days, then 40 mg pantoprazole and 500 mg clarithromycin twice a day and 500 mg metronidazole three times a day for 5 days) or 14-day modified bismuth quadruple therapy (40 mg pantoprazole, 600 mg bismuth subcitrate, 1 g tetracycline, and 1 g amoxicillin, twice a day). (13)C-urea breath test, rapid urease testing, or histology was performed to check for eradication. Intention-to-treat (ITT) eradication rates of 10-day sequential and 14-day quadruple therapy were 74.6 % and 68.7 %, respectively, and the per-protocol (PP) rates were 84.2 and 76.5 %, respectively. The eradication rate was higher in the sequential therapy group, but neither the ITT nor the PP analyses had a significant difference (P = 0.240 and P = 0.099, respectively). However, the adverse events were significantly lower in the modified bismuth quadruple therapy group than the sequential therapy group (36.9 vs. 47.7 %, P = 0.040). Ten-day sequential therapy appears to be more effective despite frequent adverse events. However, both 10-day SQT and 14-day PBAT did not reach the excellent eradication rates that exceed 90 %. Additional trials are needed to identify a more satisfactory first-line eradication therapy. ClinicalTrials.gov ( NCT02159976 ); Registration date: 2014-06-03, CRIS ( KCT0001176 ); Registration date: 2014-07-23.