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High-dose dual therapy versus culture-based susceptibility-guided therapy as a rescue regimen for Helicobacter pylori infection: a randomized controlled trial

BACKGROUND: Although the Maastricht VI/Florence consensus report recommended high-dose proton pump inhibitor–amoxicillin dual therapy as possible rescue therapy for Helicobacter pylori infection, clinical evidence of its efficacy was lacking. OBJECTIVES: To compare the efficacy, safety, patient comp...

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Autores principales: Zhao, Zhe, Zou, Pei-Ying, Su, Na-Yun, Guo, Yan, Wang, Xing-Wei, Zhao, Jing-Tao, Mei, Hao, Shi, Qing, Wang, Bin, Chen, Dong-Feng, Lan, Chun-Hui
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9806367/
https://www.ncbi.nlm.nih.gov/pubmed/36600682
http://dx.doi.org/10.1177/17562848221145566
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author Zhao, Zhe
Zou, Pei-Ying
Su, Na-Yun
Guo, Yan
Wang, Xing-Wei
Zhao, Jing-Tao
Mei, Hao
Shi, Qing
Wang, Bin
Chen, Dong-Feng
Lan, Chun-Hui
author_facet Zhao, Zhe
Zou, Pei-Ying
Su, Na-Yun
Guo, Yan
Wang, Xing-Wei
Zhao, Jing-Tao
Mei, Hao
Shi, Qing
Wang, Bin
Chen, Dong-Feng
Lan, Chun-Hui
author_sort Zhao, Zhe
collection PubMed
description BACKGROUND: Although the Maastricht VI/Florence consensus report recommended high-dose proton pump inhibitor–amoxicillin dual therapy as possible rescue therapy for Helicobacter pylori infection, clinical evidence of its efficacy was lacking. OBJECTIVES: To compare the efficacy, safety, patient compliance, and cost between high-dose dual therapy (HDDT) and culture-based susceptibility-guided therapy (CB-SGT) as a rescue regimen for H. pylori infection. DESIGN: A single-center, open-label, randomized controlled clinical trial. METHODS: In all, 146 patients with a history of eradication failure were enrolled and randomly assigned to receive HDDT or CB-SGT. HDDT consisted of esomeprazole 20 mg and amoxicillin 750 mg, both given four times per day (qid). CB-SGT consisted of esomeprazole 20 mg twice daily (bid), amoxicillin 1000 mg bid plus clarithromycin 500 mg bid, metronidazole 400 mg bid, or levofloxacin 500 mg daily (qd) for sensitive patients, in that order. For patients with triple resistance, a bismuth-containing regimen with a high dose of metronidazole was chosen, including esomeprazole 20 mg bid, bismuth 220 mg bid, amoxicillin 1000 mg bid, and metronidazole 400 mg qid. All regimens were given for 14 days. RESULTS: The eradication H. pylori rates achieved with HDDT in the intention-to-treat (ITT), per-protocol, and modified ITT analyses were all 84.9% [62/73, 95% confidence interval (CI): 76.5–93.9%], compared with 83.6% (61/73, 95% CI: 74.9–92.3%), 84.7% (61/72, 95% CI: 76.2–93.2%), and 84.7% (61/72, 95% CI: 76.2–93.2%) with CB-SGT, respectively. For patients with CYP2C19 polymorphisms of intermediate/poor metabolizers, the eradication rates of HDDT and CB-SGT were 90.70% (39/43, 95% CI: 77.86–97.41%) and 84.21% (32/38, 95% CI: 68.75–93.98%), respectively. The difference between groups was 6.49% (95% CI: −8.00% to 20.97%), and the non-inferiority p value was 0.0128. For patients with a treatment interval of more than 3 months, the eradication rates of the two regimens reached 88.71% (95% CI: 78.11–95.34%) and 71.97% (95% CI: 70.02–90.64%). The difference between groups was 6.74% (95% CI: −5.71% to 19.20%), with a non-inferiority p value of 0.0042. Patient adherence was high in both groups. The HDDT had a lower cost and rate of side effects (p < 0.001) compared with CB-SGT. CONCLUSIONS: HDDT can reach an eradication rate of 85% in treatment-experienced patients of H. pylori infection and 91% in patients with CYP2C19 polymorphisms of intermediate/poor metabolizers, with good compliance, lower side effects and costs, and less use of antibiotics. In conclusion, HDDT offers an effective rescue regimen for H. pylori infection. REGISTRATION: This clinical trial was registered at the Chinese Clinical Trail Registry (trail registration number: ChiCTR1900025044)
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spelling pubmed-98063672023-01-03 High-dose dual therapy versus culture-based susceptibility-guided therapy as a rescue regimen for Helicobacter pylori infection: a randomized controlled trial Zhao, Zhe Zou, Pei-Ying Su, Na-Yun Guo, Yan Wang, Xing-Wei Zhao, Jing-Tao Mei, Hao Shi, Qing Wang, Bin Chen, Dong-Feng Lan, Chun-Hui Therap Adv Gastroenterol Helicobacter pylori Infection — pathogenesis, management and prevention BACKGROUND: Although the Maastricht VI/Florence consensus report recommended high-dose proton pump inhibitor–amoxicillin dual therapy as possible rescue therapy for Helicobacter pylori infection, clinical evidence of its efficacy was lacking. OBJECTIVES: To compare the efficacy, safety, patient compliance, and cost between high-dose dual therapy (HDDT) and culture-based susceptibility-guided therapy (CB-SGT) as a rescue regimen for H. pylori infection. DESIGN: A single-center, open-label, randomized controlled clinical trial. METHODS: In all, 146 patients with a history of eradication failure were enrolled and randomly assigned to receive HDDT or CB-SGT. HDDT consisted of esomeprazole 20 mg and amoxicillin 750 mg, both given four times per day (qid). CB-SGT consisted of esomeprazole 20 mg twice daily (bid), amoxicillin 1000 mg bid plus clarithromycin 500 mg bid, metronidazole 400 mg bid, or levofloxacin 500 mg daily (qd) for sensitive patients, in that order. For patients with triple resistance, a bismuth-containing regimen with a high dose of metronidazole was chosen, including esomeprazole 20 mg bid, bismuth 220 mg bid, amoxicillin 1000 mg bid, and metronidazole 400 mg qid. All regimens were given for 14 days. RESULTS: The eradication H. pylori rates achieved with HDDT in the intention-to-treat (ITT), per-protocol, and modified ITT analyses were all 84.9% [62/73, 95% confidence interval (CI): 76.5–93.9%], compared with 83.6% (61/73, 95% CI: 74.9–92.3%), 84.7% (61/72, 95% CI: 76.2–93.2%), and 84.7% (61/72, 95% CI: 76.2–93.2%) with CB-SGT, respectively. For patients with CYP2C19 polymorphisms of intermediate/poor metabolizers, the eradication rates of HDDT and CB-SGT were 90.70% (39/43, 95% CI: 77.86–97.41%) and 84.21% (32/38, 95% CI: 68.75–93.98%), respectively. The difference between groups was 6.49% (95% CI: −8.00% to 20.97%), and the non-inferiority p value was 0.0128. For patients with a treatment interval of more than 3 months, the eradication rates of the two regimens reached 88.71% (95% CI: 78.11–95.34%) and 71.97% (95% CI: 70.02–90.64%). The difference between groups was 6.74% (95% CI: −5.71% to 19.20%), with a non-inferiority p value of 0.0042. Patient adherence was high in both groups. The HDDT had a lower cost and rate of side effects (p < 0.001) compared with CB-SGT. CONCLUSIONS: HDDT can reach an eradication rate of 85% in treatment-experienced patients of H. pylori infection and 91% in patients with CYP2C19 polymorphisms of intermediate/poor metabolizers, with good compliance, lower side effects and costs, and less use of antibiotics. In conclusion, HDDT offers an effective rescue regimen for H. pylori infection. REGISTRATION: This clinical trial was registered at the Chinese Clinical Trail Registry (trail registration number: ChiCTR1900025044) SAGE Publications 2022-12-26 /pmc/articles/PMC9806367/ /pubmed/36600682 http://dx.doi.org/10.1177/17562848221145566 Text en © The Author(s), 2022 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Helicobacter pylori Infection — pathogenesis, management and prevention
Zhao, Zhe
Zou, Pei-Ying
Su, Na-Yun
Guo, Yan
Wang, Xing-Wei
Zhao, Jing-Tao
Mei, Hao
Shi, Qing
Wang, Bin
Chen, Dong-Feng
Lan, Chun-Hui
High-dose dual therapy versus culture-based susceptibility-guided therapy as a rescue regimen for Helicobacter pylori infection: a randomized controlled trial
title High-dose dual therapy versus culture-based susceptibility-guided therapy as a rescue regimen for Helicobacter pylori infection: a randomized controlled trial
title_full High-dose dual therapy versus culture-based susceptibility-guided therapy as a rescue regimen for Helicobacter pylori infection: a randomized controlled trial
title_fullStr High-dose dual therapy versus culture-based susceptibility-guided therapy as a rescue regimen for Helicobacter pylori infection: a randomized controlled trial
title_full_unstemmed High-dose dual therapy versus culture-based susceptibility-guided therapy as a rescue regimen for Helicobacter pylori infection: a randomized controlled trial
title_short High-dose dual therapy versus culture-based susceptibility-guided therapy as a rescue regimen for Helicobacter pylori infection: a randomized controlled trial
title_sort high-dose dual therapy versus culture-based susceptibility-guided therapy as a rescue regimen for helicobacter pylori infection: a randomized controlled trial
topic Helicobacter pylori Infection — pathogenesis, management and prevention
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9806367/
https://www.ncbi.nlm.nih.gov/pubmed/36600682
http://dx.doi.org/10.1177/17562848221145566
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