HelicobacterPub Date : 2024-08-15DOI: 10.1111/hel.13126
Joon Sung Kim, Byung-Wook Kim, Jin Il Kim, Woo Chul Chung, Sung Woo Jung, Chang Seok Bang, Gwang Ha Kim, Seon Woo Jeon, Moon Kyoung Joo, Si Hyung Lee, Yun Jeong Lim, Jae Kyu Sung, Seung Young Seo, Sun Young Park, Wan Sik Lee, Hang Lak Lee, Ki Bae Kim, Heung Up Kim
{"title":"Empirical Therapy Versus Tailored Therapy of Helicobacter pylori in Korea: Results of the K-CREATE Study","authors":"Joon Sung Kim, Byung-Wook Kim, Jin Il Kim, Woo Chul Chung, Sung Woo Jung, Chang Seok Bang, Gwang Ha Kim, Seon Woo Jeon, Moon Kyoung Joo, Si Hyung Lee, Yun Jeong Lim, Jae Kyu Sung, Seung Young Seo, Sun Young Park, Wan Sik Lee, Hang Lak Lee, Ki Bae Kim, Heung Up Kim","doi":"10.1111/hel.13126","DOIUrl":"10.1111/hel.13126","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The optimal duration of regimens for tailored therapy based on genotypic resistance for clarithromycin has yet to be established.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>This study was a nationwide, multicenter, randomized trial comparing empirical therapy with tailored therapy based on genotypic resistance for first-line eradication of <i>Helicobacter pylori</i>. We also compared the eradication rates of 7- and 14-day regimens for each group.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Patients and Methods</h3>\u0000 \u0000 <p>Patients with <i>H. pylori</i> infection were first randomized to receive empirical or tailored therapy. Patients in each group were further randomized into 7- or 14-day regimens. Empirical therapy consisted of a triple therapy (TT) regimen (twice-daily doses of pantoprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg) for 7 or 14 days. Tailored therapy consisted of TT of 7 or 14 days in patients without genotypic resistance. Patients with genotypic resistance were treated with bismuth quadruple therapy (BQT) regimens (twice-daily doses of pantoprazole 40 mg, three daily doses of metronidazole 500 mg, and four times daily doses of bismuth 300 mg and tetracycline 500 mg) for 7 or 14 days. A <sup>13</sup>C-urea breath test assessed eradication rates. The primary outcome was eradication rates of each group.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 593 patients were included in the study. The eradication rates were 65.7% (201/306) in the empirical therapy group and 81.9% (235/287) in the tailored therapy group for intention-to-treat analysis (<i>p</i> < 0.001). In the per-protocol analysis, the eradication rates of the empirical therapy and tailored groups were 70.3% (201/286) and 85.5% (235/274) (<i>p</i> < 0.001), respectively. There was no difference in compliance between the two groups. The rate of adverse events was higher in the tailored group compared to the empirical group (<i>p</i> < 0.001).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Our study confirmed that tailored therapy based on genotypic resistance was more effective than empirical therapy for <i>H. pylori</i> eradication in Korea. However, no significant difference was found between 7- and 14-day regimens for each group. Future studies are needed to determine the optimal duration of therapy for empirical and tailored therapy regimens.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.13126","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141982117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HelicobacterPub Date : 2024-08-15DOI: 10.1111/hel.13131
Pingping Yang, Jiuliang Jiang
{"title":"Letter to the Editor Regarding the Article: “Exploring the Capacities of ChatGPT: A Comprehensive Evaluation of Its Accuracy and Repeatability in Addressing Helicobacter pylori-Related Queries”","authors":"Pingping Yang, Jiuliang Jiang","doi":"10.1111/hel.13131","DOIUrl":"10.1111/hel.13131","url":null,"abstract":"","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141982177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HelicobacterPub Date : 2024-08-13DOI: 10.1111/hel.13120
Akiko Kowada
{"title":"Cost-Effectiveness of Population-Based Helicobacter pylori Screening With Eradication for Optimal Age of Implementation","authors":"Akiko Kowada","doi":"10.1111/hel.13120","DOIUrl":"10.1111/hel.13120","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p><i>Helicobacter pylori</i> screening with eradication reduces gastric cancer (GC) development. However, it was unknown at what age the <i>H</i>. <i>pylori</i> screening should be implemented to achieve the greatest benefits at the least cost. This study aimed to determine the optimal age of <i>H</i>. <i>pylori</i> screening for primary GC prevention.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>A state transition model for a hypothetical cohort of 15-year-olds from a healthcare payer perspective on a lifetime horizon was developed. Nine ages for <i>H</i>. <i>pylori</i> testing were considered: 15, 18, 20, 30, 40, 50, 60, 70, and 80 years. <i>H</i>. <i>pylori</i> screening was compared with no screening and annual, biennial, and triennial endoscopies starting at age 50. The main outcomes were costs, quality-adjusted life-years (QALYs), life expectancy life-years (LYs), incremental cost-effectiveness ratios, GC cases, stage I GC cases, and GC-related deaths. One-way, two-way, and probabilistic sensitivity analyses were performed to assess the uncertainty of the parameters.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>All <i>H</i>. <i>pylori</i> screenings at ages 15–80 were more cost-effective than all endoscopies and no screening. <i>H</i>. <i>pylori</i> screening at age 15 yielded the greatest cost-saving and benefits. The cost-effectiveness was sensitive to the adherence rate of <i>H</i>. <i>pylori</i> screening at age 15. Cost-effectiveness acceptability curves showed that <i>H</i>. <i>pylori</i> screening at age 15 was 99.6% cost-effective at a willingness-to-pay threshold of US$50,000 per QALY gained. Compared with no screening and biennial endoscopy in 15.6 million 15-year-olds from 2022 to 2037, respectively, <i>H</i>. <i>pylori</i> screening at age 15 saves US$9.70 million and US$2.39 billion, increases 1.26 million QALYs with 1312 LYs and 651 LYs, prevents 436 GC cases with 254 stage I GC cases and 305 stage I GC cases, and avoids 176 GC-related deaths and 72 GC-related deaths.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The optimal age for population-based <i>H</i>. <i>pylori</i> screening at ages 15–80 is the youngest, 15 years old. Shifting population-based <i>H</i>. <i>pylori</i> screening to younger people will reduce GC morbidity and mortality worldwide, along with a detailed investigation of the feasibility and long-term consequences of <i>H</i>. <i>pylori</i> eradication at a young age.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.13120","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HelicobacterPub Date : 2024-08-07DOI: 10.1111/hel.13119
Zhili Liu, He Li, Xiaotian Huang, Qiong Liu
{"title":"Animal Models of Helicobacter pylori Infection and Vaccines: Current Status and Future Prospects","authors":"Zhili Liu, He Li, Xiaotian Huang, Qiong Liu","doi":"10.1111/hel.13119","DOIUrl":"10.1111/hel.13119","url":null,"abstract":"<div>\u0000 \u0000 <p><i>Helicobacter pylori</i> infection causes chronic gastritis, ulcers, and gastric cancer, making it a threat to human health. Despite the use of antibiotic therapy, the global prevalence of <i>H. pylori</i> infection remains high, necessitating early eradication measures. Immunotherapy, especially vaccine development, is a promising solution in this direction, albeit the selection of an appropriate animal model is critical in efficient vaccine production. Accordingly, we conducted a literature, search and summarized the commonly used <i>H. pylori</i> strains, <i>H. pylori</i> infection-related animal models, and models for evaluating <i>H. pylori</i> vaccines. Based on factors such as the ability to replicate human diseases, strain compatibility, vaccine types, and eliciting of immune responses, we systematically compared the advantages and disadvantages of different animal models, to obtain the informed recommendations. In addition, we have proposed novel perspectives on <i>H. pylori</i>–related animal models to advance research and vaccine evaluation for the prevention and treatment of diseases such as gastric cancer.</p>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HelicobacterPub Date : 2024-08-07DOI: 10.1111/hel.13124
{"title":"Correction to Indications of Helicobacter pylori Eradication Treatment and Its Influence on Prescriptions and Effectiveness (Hp-EuReg)","authors":"","doi":"10.1111/hel.13124","DOIUrl":"10.1111/hel.13124","url":null,"abstract":"<p>S. J. Martínez-Domínguez, O. P. Nyssen, A. Lanas, et al., “Indications of <i>Helicobacter pylori</i> Eradication Treatment and Its Influence on Prescriptions and Effectiveness (Hp-EuReg),” <i>Helicobacter</i> 29, no. 4 (2024): e13111.</p><p>The corresponding author email was incorrect. The correct corresponding author email is <span>[email protected]</span>.</p><p>We apologize for this error.</p>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.13124","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correlation of FUT3 and FUT6 Gene Polymorphisms With Helicobacter pylori Infection","authors":"Shihang Zhou, Ziwei Zheng, Liying Wang, Wenqian Song, Yuexin Xia, Linnan Shao, Xiaohua Liang","doi":"10.1111/hel.13122","DOIUrl":"10.1111/hel.13122","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p><i>Helicobacter pylori</i> infection is a significant pathogen in gastrointestinal diseases. Previous studies have identified single-nucleotide polymorphisms (SNPs) are factors associated with <i>H. pylori</i> infection. Notably, Le<sup>b</sup> and Sialyl-Le<sup>x</sup> antigens, regulated by the <i>FUT3</i> and <i>FUT6</i> genes, play a crucial role in <i>H. pylori</i> infection. This study aimed to investigate the correlation between <i>FUT3</i> and <i>FUT6</i> gene polymorphisms and <i>H. pylori</i> infection in the Han population of northern China.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>An immunoturbidimetric assay was employed to detect <i>H. pylori</i> infection, categorizing subjects into infected and noninfected groups. Gene variants were identified through sequencing. Finally, <i>FUT3</i> and <i>FUT6</i> gene polymorphisms were analyzed to assess their association with <i>H. pylori</i> infection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The frequency of the T allele (rs778805) and the G allele (rs61147939) in the infection group was significantly higher than that in the noninfection group (63.4% vs. 55.1%, <i>p</i> = 0.045; 55.2% vs. 47.0%, <i>p</i> = 0.042, respectively). In the infection group, the frequency of the AA genotype (rs3745635) in the recessive model, the TT genotype (rs778805) in the recessive model, and the GG genotype (rs61147939) in the recessive model were significantly higher than the noninfection group (5.8% vs. 2.3%, <i>p</i> = 0.042; 41.9% vs. 29.3%, <i>p</i> = 0.022; 34.9% vs. 20.5%, <i>p</i> = 0.0068, respectively). The frequency of the A13 haplotype and the A13/A13 diplotype of the FUT6 gene was significantly higher in the infection group than in the noninfection group (55.56% vs. 46.32%, <i>p</i> = 0.019; 34.94% vs. 20.30%, <i>p</i> = 0.045, respectively). The rs778805-rs17855739-rs28362459-rs3745635 combination was identified as the best interaction model (<i>p</i> < 0.05).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study suggests that <i>FUT3</i> and <i>FUT6</i> gene polymorphisms are significantly associated with <i>H. pylori</i> infection in the Han Chinese from northern China.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HelicobacterPub Date : 2024-08-07DOI: 10.1111/hel.13123
Yue Ma, Xianzhu Zhou, Yashi Liu, Shihan Xu, Aixia Ma, Yiqi Du, Hongchao Li
{"title":"An Economic Evaluation of Family-Based Versus Traditional Helicobacter pylori Screen-and-Treat Strategy: Based on Real-World Data and Microsimulation Model","authors":"Yue Ma, Xianzhu Zhou, Yashi Liu, Shihan Xu, Aixia Ma, Yiqi Du, Hongchao Li","doi":"10.1111/hel.13123","DOIUrl":"10.1111/hel.13123","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>There is an economic evaluation on the family-based <i>Helicobacter pylori</i> screen-and-treat strategy (FBHS) in China. This study aimed to compare the cost-effectiveness of the FBHS with the traditional <i>H. pylori</i> screen-and-treat strategy (TBHS).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>A seven-state microsimulation model, including <i>H. pylori</i> infection and gastric cancer states, was constructed on the basis of the target family samples from 29 provinces in China. Taking a lifetime horizon from a healthcare system perspective, the long-term costs and health outcomes of the FBHS and TBHS screening strategies were simulated separately, and economic evaluations were performed. The model parameters were primarily derived from real-world data, published literature, and expert opinions. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed as cost/quality-adjusted life-year (QALY) gained. One-way sensitivity analysis, probabilistic sensitivity analysis, and scenario analysis were performed to assess the uncertainty of the results.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The base-case analysis revealed that the average costs for FBHS and TBHS were 563.67 CNY and 574.08 CNY, respectively, with corresponding average QALYs of 14.83 and 14.79. The ICER for the comparison between the two strategies was −214.07, indicating that FBHS was an absolutely dominant strategy with better cost-effectiveness. The results of both one-way sensitivity analysis and probabilistic sensitivity analysis were robust. When taking into account the added benefit of the higher <i>H. pylori</i> eradication rate in FBHS, the average costs were further reduced, and the average QALYs were increased, solidifying its position as an unequivocally dominant strategy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The FBHS is an absolutely dominant and cost-effective strategy that enables an optimized allocation of screening resources. Decision-makers should prioritize FBHS when developing <i>H. pylori</i> prevention and control strategies.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Artificial Intelligence-Generated Patient Education Materials for Helicobacter pylori Infection: A Comparative Analysis","authors":"Shuyan Zeng, Qingzhou Kong, Xiaoqi Wu, Tian Ma, Limei Wang, Leiqi Xu, Guanjun Kou, Mingming Zhang, Xiaoyun Yang, Xiuli Zuo, Yueyue Li, Yanqing Li","doi":"10.1111/hel.13115","DOIUrl":"10.1111/hel.13115","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Patient education contributes to improve public awareness of <i>Helicobacter pylori</i>. Large language models (LLMs) offer opportunities to revolutionize patient education transformatively. This study aimed to assess the quality of patient educational materials (PEMs) generated by LLMs and compared with physician sourced.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>Unified instruction about composing a PEM about <i>H. pylori</i> at a sixth-grade reading level in both English and Chinese were given to physician and five LLMs (Bing Copilot, Claude 3 Opus, Gemini Pro, ChatGPT-4, and ERNIE Bot 4.0). The assessments of the completeness and comprehensibility of the Chinese PEMs were conducted by five gastroenterologists and 50 patients according to three-point Likert scale. Gastroenterologists were asked to evaluate both English and Chinese PEMs and determine the accuracy and safety. The accuracy was assessed by six-point Likert scale. The minimum acceptable scores were 4, 2, and 2 for accuracy, completeness, and comprehensibility, respectively. The Flesch–Kincaid and Simple Measure of Gobbledygook scoring systems were employed as readability assessment tools.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Accuracy and comprehensibility were acceptable for English PEMs of all sources, while completence was not satisfactory. Physician-sourced PEM had the highest accuracy mean score of 5.60 and LLM-generated English PEMs ranged from 4.00 to 5.40. The completeness score was comparable between physician-sourced PEM and LLM-generated PEMs in English. Chinese PEMs from LLMs proned to have lower score in accuracy and completeness assessment than English PEMs. The mean score for completeness of five LLM-generated Chinese PEMs was 1.82–2.70 in patients' perspective, which was higher than gastroenterologists' assessment. Comprehensibility was satisfactory for all PEMs. No PEM met the recommended sixth-grade reading level.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>LLMs have potential in assisting patient education. The accuracy and comprehensibility of LLM-generated PEMs were acceptable, but further optimization on improving completeness and accounting for a variety of linguistic contexts are essential for enhancing the feasibility.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141889041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Tetracycline Three Times Daily Versus Four Times Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Multicenter, Noninferiority, Randomized Controlled Trial","authors":"Yu-Ming Ding, Qiu-Mei Zhang, Rui-Li Li, Zhong-Xue Han, Qing Zhao, Li-Dong Xu, Ke-Yu Wang, Xue-Ping Nan, Miao Duan, Shu-Yan Zeng, Qing-Zhou Kong, Hui Wang, Xiao-Qi Wu, Ning Zhang, Yan-Qing Li, Xiu-Li Zuo, Yue-Yue Li","doi":"10.1111/hel.13121","DOIUrl":"10.1111/hel.13121","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Current guidelines recommend bismuth-containing quadruple therapy for patients newly diagnosed with <i>Helicobacter pylori</i> (<i>H. pylori</i>) infection. We aimed to compare the efficacy and safety of tetracycline administered three times daily versus four times daily in bismuth-containing quadruple therapy for first-line treatment of <i>H. pylori</i> infection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This multicenter, noninferiority, randomized controlled study, conducted in China, recruited treatment-naïve adults with <i>H. pylori</i> infection, randomized 1:1 into two treatment groups to receive either of the following bismuth-containing quadruple therapies: esomeprazole 20 mg twice-daily; bismuth 220 mg twice-daily; amoxicillin 1000 mg twice-daily; and tetracycline 500 mg three times daily (TET-T) versus 500 mg four times daily (TET-F). At least 6 weeks post-treatment, a <sup>13</sup>C-urea breath test was performed to evaluate <i>H. pylori</i> eradication.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In total, 406 patients were randomly assigned to the two treatment groups. Intention-to-treat eradication rates were 91.63% (186/203; 95% confidence interval [CI] 87.82%–95.44%) versus 90.15% (183/203; 95% CI 86.05%–94.25%) (<i>p</i> = 0.0005) and per-protocol eradication rates were 95.34% (184/193; 95% CI 92.36%–98.31%) versus 95.72% (179/187; 95% CI 92.82%–98.62%) (<i>p</i> = 0.0002) for the TET-T and TET-F group, respectively. TET-T-treated patients had a lower incidence of adverse effects than TET-F-treated patients (21.61% vs. 31.63%, <i>p</i> = 0.024), with no significant differences in compliance to treatment between the groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>As a first-line therapy for <i>H. pylori</i> infection, the eradication rate of the TET-T therapy was noninferior to that of the TET-F therapy while significantly reducing the incidence of adverse reactions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>ClinicalTrials.gov identifier: NCT05431075</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141889042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HelicobacterPub Date : 2024-08-01DOI: 10.1111/hel.13118
Shuhan Qiu, Yu Huang, Jinnan Chen, Yixian Guo, Meixuan Li, Zhaohui Ding, Xiao Liang, Hong Lu
{"title":"Vonoprazan–Amoxicillin Dual Therapy With Different Amoxicillin Administration Regimens for Helicobacter pylori Treatment: A Randomized Controlled Trial","authors":"Shuhan Qiu, Yu Huang, Jinnan Chen, Yixian Guo, Meixuan Li, Zhaohui Ding, Xiao Liang, Hong Lu","doi":"10.1111/hel.13118","DOIUrl":"10.1111/hel.13118","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The effect of preprandial or postprandial administration of amoxicillin on the efficacy of vonoprazan–amoxicillin dual therapy (VA-dual therapy) for <i>Helicobacter pylori</i> treatment has not been studied. It is also unclear whether amoxicillin dosing four times daily is more effective than three times daily. We aimed to investigate the effect of different amoxicillin administration regimens on the efficacy of VA-dual therapy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p><i>H. pylori</i>-infected subjects were randomly assigned to three groups in a 1:1:1 ratio to receive a 14-day dual therapy consisting of vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily before meals (BM-TID) or 1000 mg three times daily after meals (AM-TID) or 750 mg four times daily after meals (AM-QID). <i>H. pylori</i> eradication rates, adverse events rates, compliance, and antibiotic resistance were compared.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Between May 2021 to April 2023, 327 subjects were enrolled. The eradication rates of BM-TID, AM-TID, and AM-QID dual therapy were 88.1%, 89.9%, and 93.6% in intention-to-treat (ITT) analysis, 90.6%, 94.2%, and 99.0% in modified ITT (MITT) analysis, and 90.4%, 94.1%, and 99.0% in per-protocol (PP) analysis. Although there was non-inferiority between BM-TID and AM-TID, as well as between AM-TID and AM-QID, AM-QID was significantly more effective than BM-TID. There were no significant differences in adverse event rates, compliance, and antibiotic resistance among the three groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Postprandial administration and the increased frequency of administration of amoxicillin may contribute to a better efficacy of VA-dual therapy, especially for rescue therapy. All VA-dual therapy in our study could achieve good efficacy for first-line treatment.</p>\u0000 \u0000 <p><b>Trial Registration:</b> clinicaltrials.gov: NCT05901051.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}