Fourteen-day vonoprazan-amoxicillin dual therapy versus 14-day bismuth-based quadruple therapy for treatment: a randomized clinical trial
Background: Potassium-competitive acid blockers (P-CABs) have shown potential in Helicobacter pylori ( H. pylori ) eradication, but the efficacy of dual therapy with P-CABs and amoxicillin remains underexplored. Objectives: This study evaluated the efficacy, safety, and compliance of a 14-day vonopr...
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| Format: | Article |
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SAGE Publishing
2025-07-01
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| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/17562848251354868 |
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| author | Jin-Yan Zhang Jin-Hai Chen Yu-Lin Huang Ji Li Dong Xu Zhong Xu Xiao-Yi Lei |
| author_facet | Jin-Yan Zhang Jin-Hai Chen Yu-Lin Huang Ji Li Dong Xu Zhong Xu Xiao-Yi Lei |
| author_sort | Jin-Yan Zhang |
| collection | DOAJ |
| description | Background: Potassium-competitive acid blockers (P-CABs) have shown potential in Helicobacter pylori ( H. pylori ) eradication, but the efficacy of dual therapy with P-CABs and amoxicillin remains underexplored. Objectives: This study evaluated the efficacy, safety, and compliance of a 14-day vonoprazan-amoxicillin (VA) dual therapy compared to a bismuth-based quadruple therapy (BQT) in treatment-naive patients. Design: A randomized clinical trial. Methods: This single-center, prospective, randomized controlled trial enrolled 250 H. pylori -positive patients from November 2022 to April 2024. Participants were randomly assigned (1:1) to receive 14-day VA dual therapy or BQT (lansoprazole, bismuth, amoxicillin, and clarithromycin). The primary outcomes were eradication rates in intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary outcomes included adverse events and treatment compliance. Results: Eradication rates in the ITT analysis were 92.0% for the VA dual group and 88.0% for the BQT group ( p = 0.292). In the PP analysis, eradication rates were 95.8% and 91.7%, respectively ( p = 0.188). The VA dual group demonstrated statistically significant non-inferiority to the BQT group in both the ITT and PP analyses (both p < 0.001). The incidence of adverse events was significantly lower in the VA dual group compared to the BQT group (11.2% vs 20.8%, p = 0.038), with no severe adverse events reported. The compliance rates of both groups were 97.6%. Conclusion: The 14-day VA dual therapy is highly effective and well-tolerated, demonstrating non-inferiority to BQT. Given its reduced antibiotic usage and lower adverse events, it may be a viable first-line alternative for H. pylori in southern China. Trial registration: This trial was registered on the Chinese Clinical Trial Registry with the registration number ChiCTR2200055752. |
| format | Article |
| id | doaj-art-ddad3dd4b09a40bfa442c0e49e56355f |
| institution | Kabale University |
| issn | 1756-2848 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj-art-ddad3dd4b09a40bfa442c0e49e56355f2025-08-20T03:50:00ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-28482025-07-011810.1177/17562848251354868Fourteen-day vonoprazan-amoxicillin dual therapy versus 14-day bismuth-based quadruple therapy for treatment: a randomized clinical trialJin-Yan ZhangJin-Hai ChenYu-Lin HuangJi LiDong XuZhong XuXiao-Yi LeiBackground: Potassium-competitive acid blockers (P-CABs) have shown potential in Helicobacter pylori ( H. pylori ) eradication, but the efficacy of dual therapy with P-CABs and amoxicillin remains underexplored. Objectives: This study evaluated the efficacy, safety, and compliance of a 14-day vonoprazan-amoxicillin (VA) dual therapy compared to a bismuth-based quadruple therapy (BQT) in treatment-naive patients. Design: A randomized clinical trial. Methods: This single-center, prospective, randomized controlled trial enrolled 250 H. pylori -positive patients from November 2022 to April 2024. Participants were randomly assigned (1:1) to receive 14-day VA dual therapy or BQT (lansoprazole, bismuth, amoxicillin, and clarithromycin). The primary outcomes were eradication rates in intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary outcomes included adverse events and treatment compliance. Results: Eradication rates in the ITT analysis were 92.0% for the VA dual group and 88.0% for the BQT group ( p = 0.292). In the PP analysis, eradication rates were 95.8% and 91.7%, respectively ( p = 0.188). The VA dual group demonstrated statistically significant non-inferiority to the BQT group in both the ITT and PP analyses (both p < 0.001). The incidence of adverse events was significantly lower in the VA dual group compared to the BQT group (11.2% vs 20.8%, p = 0.038), with no severe adverse events reported. The compliance rates of both groups were 97.6%. Conclusion: The 14-day VA dual therapy is highly effective and well-tolerated, demonstrating non-inferiority to BQT. Given its reduced antibiotic usage and lower adverse events, it may be a viable first-line alternative for H. pylori in southern China. Trial registration: This trial was registered on the Chinese Clinical Trial Registry with the registration number ChiCTR2200055752.https://doi.org/10.1177/17562848251354868 |
| spellingShingle | Jin-Yan Zhang Jin-Hai Chen Yu-Lin Huang Ji Li Dong Xu Zhong Xu Xiao-Yi Lei Fourteen-day vonoprazan-amoxicillin dual therapy versus 14-day bismuth-based quadruple therapy for treatment: a randomized clinical trial Therapeutic Advances in Gastroenterology |
| title | Fourteen-day vonoprazan-amoxicillin dual therapy versus 14-day bismuth-based quadruple therapy for treatment: a randomized clinical trial |
| title_full | Fourteen-day vonoprazan-amoxicillin dual therapy versus 14-day bismuth-based quadruple therapy for treatment: a randomized clinical trial |
| title_fullStr | Fourteen-day vonoprazan-amoxicillin dual therapy versus 14-day bismuth-based quadruple therapy for treatment: a randomized clinical trial |
| title_full_unstemmed | Fourteen-day vonoprazan-amoxicillin dual therapy versus 14-day bismuth-based quadruple therapy for treatment: a randomized clinical trial |
| title_short | Fourteen-day vonoprazan-amoxicillin dual therapy versus 14-day bismuth-based quadruple therapy for treatment: a randomized clinical trial |
| title_sort | fourteen day vonoprazan amoxicillin dual therapy versus 14 day bismuth based quadruple therapy for treatment a randomized clinical trial |
| url | https://doi.org/10.1177/17562848251354868 |
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