Population-based Helicobacter pylori screening is a promising strategy for gastric cancer prevention in high-prevalence regions. Although serology is recommended for treatment-naïve individuals, its accuracy in large-scale screening remains uncertain. This multicenter study evaluated serology against biopsy-based tests and assessed the influence of age and atrophic status to inform stratified screening policies.
Materials and Methods
In this multicenter diagnostic study, 8497 treatment-naïve adults undergoing upper endoscopy across nine hospitals in Taiwan were tested for H. pylori using serology, rapid urease test (RUT), histology, and culture. Serum pepsinogen I and II levels were measured to define serological atrophic gastritis (AG). Diagnostic performance was assessed against a composite reference standard (≥ 2 positive results among RUT, histology, and culture), with subgroup analyses by age and AG status.
Results
Serology showed a sensitivity of 94.5% (95% CI: 93.7–95.4) and specificity of 86.0% (95% CI: 85.0–87.0), with a diagnostic odds ratio (DOR) of 106.4. RUT, histology, and culture had higher specificities (97.1%, 94.3%, and 98.2%, respectively) but lower sensitivities (88.6%, 92.3%, and 90.2%, respectively). In individuals aged ≤ 45 years, serology demonstrated 95.2% sensitivity, 93.1% specificity, and a DOR of 268.9 (95% CI: 183.4–394.3). Among participants with AG, serologic specificity declined to 62.4% (95% CI: 53.3–71.5) versus 87.2% (95% CI: 86.0–88.5) in those without AG. The overall negative likelihood ratio was 0.06, and 0.05 among younger adults.
Conclusions
Serology is an accurate, non-invasive tool for H. pylori detection in younger, treatment-naïve adults without gastric atrophy in high-prevalence regions. In older individuals or those with atrophic gastritis, confirmatory testing is warranted, supporting age-atrophy–based algorithms to optimize screening strategies.
{"title":"Overall and Stratified Accuracies of H. pylori Serology Testing: A Multicenter Study of 8497 Screening-Naïve Adults","authors":"Mei-Jyh Chen, Yu-Jen Fang, Chien-Chuan Chen, Chieh-Chang Chen, Jiing-Chyuan Luo, Ming-Jong Bair, Po-Yueh Chen, Chu-Kuang Chou, Ji-Yuh Lee, Tsung-Hua Yang, Jian-Jyun Yu, Chia-Chi Kuo, Min-Chin Chiu, Chi-Yi Chen, Chia-Tung Shun, Wen-Hao Hu, Min-Horn Tsai, Yao-Chun Hsu, Cheng-Hao Tseng, Chi-Yang Chang, Jaw-Town Lin, Emad M. El-Omar, Yi-Chia Lee, Ming-Shiang Wu, Jyh-Ming Liou, the Taiwan Gastrointestinal Disease and Helicobacter Consortium","doi":"10.1111/hel.70074","DOIUrl":"https://doi.org/10.1111/hel.70074","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Population-based <i>Helicobacter pylori</i> screening is a promising strategy for gastric cancer prevention in high-prevalence regions. Although serology is recommended for treatment-naïve individuals, its accuracy in large-scale screening remains uncertain. This multicenter study evaluated serology against biopsy-based tests and assessed the influence of age and atrophic status to inform stratified screening policies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>In this multicenter diagnostic study, 8497 treatment-naïve adults undergoing upper endoscopy across nine hospitals in Taiwan were tested for <i>H. pylori</i> using serology, rapid urease test (RUT), histology, and culture. Serum pepsinogen I and II levels were measured to define serological atrophic gastritis (AG). Diagnostic performance was assessed against a composite reference standard (≥ 2 positive results among RUT, histology, and culture), with subgroup analyses by age and AG status.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Serology showed a sensitivity of 94.5% (95% CI: 93.7–95.4) and specificity of 86.0% (95% CI: 85.0–87.0), with a diagnostic odds ratio (DOR) of 106.4. RUT, histology, and culture had higher specificities (97.1%, 94.3%, and 98.2%, respectively) but lower sensitivities (88.6%, 92.3%, and 90.2%, respectively). In individuals aged ≤ 45 years, serology demonstrated 95.2% sensitivity, 93.1% specificity, and a DOR of 268.9 (95% CI: 183.4–394.3). Among participants with AG, serologic specificity declined to 62.4% (95% CI: 53.3–71.5) versus 87.2% (95% CI: 86.0–88.5) in those without AG. The overall negative likelihood ratio was 0.06, and 0.05 among younger adults.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Serology is an accurate, non-invasive tool for <i>H. pylori</i> detection in younger, treatment-naïve adults without gastric atrophy in high-prevalence regions. In older individuals or those with atrophic gastritis, confirmatory testing is warranted, supporting age-atrophy–based algorithms to optimize screening strategies.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 5","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145110707","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}
Variations in Helicobacter pylori infection rates and pathogenicity do not explain the global gastric cancer incidence, indicating that other bacteria may play a role. We investigated the pathogenic factors of H. pylori and their interactions with the gastric microbiome in a population with low gastric cancer but high gastritis rates in Indonesia.
Methods
The study included 66 H. pylori-positive gastric biopsies. DNA was extracted from the bacterial cultures to examine the pathogenic factors of H. pylori. The 16S rRNA V3–V4 region was sequenced using next-generation sequencing. The microbiome analysis concentrated on α-diversity and β-diversity, along with absolute and relative abundances. Correlation analysis and predicted functional inference were conducted using SECOM and PICRUSt2.
Results
Helicobacter predominates in H. pylori-infected stomachs, limiting other bacteria. Although α-diversity was non-significant, virulent H. pylori genotypes showed greater microbial diversity, suggesting co-colonization by other taxa. Some taxa were notably abundant across pathogenic subtypes (p < 0.05), such as Veillonella sp. in East Asian-type CagA H. pylori and Klebsiella without babB. The β-diversity results indicated that microbial diversity and abundance varied according to polymorphisms in patients with different H. pylori CagA types, sabA status, homA/B, and iceA subtypes (PERMANOVA test; p < 0.05). H. pylori dominance remains unchanged when atrophy worsens, alongside decreased microbial diversity (p < 0.05 for atrophy stage 0 vs. stages 1 and 2). Microbial correlation analysis revealed that Helicobacter only had a positive linear relationship with Veillonella (SECOM(Pearson2) = 0.51, SECOM(Distance) = 0.60), whereas Streptococcus sp. correlated with several gastric taxa. Predicted functional inference showed several pathways to be depleted when atrophy progresses.
Conclusion
Various pathogenic factors impact microbial diversity, and bacteria cohabiting in the gastric environment might shape disease outcomes. Additionally, our study uncovers relationships among genera present in the stomach. More research is needed to explore how non-Helicobacter species induce or possibly safeguard against gastric pathologies.
{"title":"Helicobacter pylori Pathogenic Factors and Their Interactions With the Gastric Microbiome","authors":"Camilia Metadea Aji Savitri, Takashi Matsumoto, Kartika Afrida Fauzia, Ricky Indra Alfaray, Langgeng Agung Waskito, Yudith Annisa Ayu Rezkitha, Tomohisa Uchida, Muhammad Miftahussurur, Yoshio Yamaoka","doi":"10.1111/hel.70072","DOIUrl":"https://doi.org/10.1111/hel.70072","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Variations in <i>Helicobacter pylori</i> infection rates and pathogenicity do not explain the global gastric cancer incidence, indicating that other bacteria may play a role. We investigated the pathogenic factors of <i>H. pylori</i> and their interactions with the gastric microbiome in a population with low gastric cancer but high gastritis rates in Indonesia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The study included 66 <i>H. pylori</i>-positive gastric biopsies. DNA was extracted from the bacterial cultures to examine the pathogenic factors of <i>H. pylori</i>. The 16S rRNA V3–V4 region was sequenced using next-generation sequencing. The microbiome analysis concentrated on α-diversity and β-diversity, along with absolute and relative abundances. Correlation analysis and predicted functional inference were conducted using SECOM and PICRUSt2.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p><i>Helicobacter</i> predominates in <i>H. pylori</i>-infected stomachs, limiting other bacteria. Although α-diversity was non-significant, virulent <i>H. pylori</i> genotypes showed greater microbial diversity, suggesting co-colonization by other taxa. Some taxa were notably abundant across pathogenic subtypes (<i>p</i> < 0.05), such as <i>Veillonella</i> sp. in East Asian-type CagA <i>H. pylori</i> and <i>Klebsiella</i> without <i>babB</i>. The β-diversity results indicated that microbial diversity and abundance varied according to polymorphisms in patients with different <i>H. pylori</i> CagA types, <i>sabA</i> status, <i>homA/B</i>, and <i>iceA</i> subtypes (PERMANOVA test; <i>p</i> < 0.05). <i>H. pylori</i> dominance remains unchanged when atrophy worsens, alongside decreased microbial diversity (<i>p</i> < 0.05 for atrophy stage 0 vs. stages 1 and 2). Microbial correlation analysis revealed that <i>Helicobacter</i> only had a positive linear relationship with <i>Veillonella</i> (SECOM(Pearson2) = 0.51, SECOM(Distance) = 0.60), whereas <i>Streptococcus</i> sp. correlated with several gastric taxa. Predicted functional inference showed several pathways to be depleted when atrophy progresses.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Various pathogenic factors impact microbial diversity, and bacteria cohabiting in the gastric environment might shape disease outcomes. Additionally, our study uncovers relationships among genera present in the stomach. More research is needed to explore how non-<i>Helicobacter</i> species induce or possibly safeguard against gastric pathologies.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 5","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145110706","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}
João Carlos Silva, Pedro Leite-Silva, Fernando Tavares, Maria José Bento, Diogo Libânio, Mário Dinis-Ribeiro
Background and Aims
In countries with an intermediate incidence of gastric cancer (GC), it has been suggested that offering an upper gastrointestinal endoscopy (UGIE) to individuals referred for a screening colonoscopy following a positive result in the fecal immunochemical test (FIT) may be cost-effective. This study was designed to evaluate the impact of a FIT-based screening program on GC incidence, early diagnosis, and mortality.
Methods
Population-based retrospective cohort study in northern Portugal. Data on GC cases were retrieved from the Portuguese National Cancer Registry (RON). GC stage at diagnosis (with early stages defined as T1) and net survival estimates were compared between 2014 and 2016 and the first 3 years of the FIT-based screening program (2018–2020), during which 165,967 tests were performed.
Results
The odds of GC detection were significantly higher among FIT-positive individuals compared to those with a negative result (OR = 2.87; 95% CI: 1.76–4.49). Of the 10,372 individuals who completed FIT screening and underwent colonoscopy, 51% (n = 5281) also underwent UGIE. The proportion of early-stage diagnoses increased by 14% (95% CI: 12–15), and 3-year net survival improved from 42% (95% CI: 40–43) to 48% (95% CI: 47–50).
Discussion
Despite the absence of a formal GC screening program, more than half of FIT-screened individuals who underwent colonoscopy also underwent UGIE. The period following the implementation of FIT-based screening was associated with increased early-stage detection and improved survival. These findings support the potential value of offering UGIE combined with colonoscopy for FIT-positive individuals, at least in regions with intermediate GC incidence.
{"title":"Impact of a FIT Based Colorectal Cancer Screening Program on Gastric Cancer Incidence, Early Diagnosis and Patients' Survival","authors":"João Carlos Silva, Pedro Leite-Silva, Fernando Tavares, Maria José Bento, Diogo Libânio, Mário Dinis-Ribeiro","doi":"10.1111/hel.70071","DOIUrl":"https://doi.org/10.1111/hel.70071","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background and Aims</h3>\u0000 \u0000 <p>In countries with an intermediate incidence of gastric cancer (GC), it has been suggested that offering an upper gastrointestinal endoscopy (UGIE) to individuals referred for a screening colonoscopy following a positive result in the fecal immunochemical test (FIT) may be cost-effective. This study was designed to evaluate the impact of a FIT-based screening program on GC incidence, early diagnosis, and mortality.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Population-based retrospective cohort study in northern Portugal. Data on GC cases were retrieved from the Portuguese National Cancer Registry (RON). GC stage at diagnosis (with early stages defined as T1) and net survival estimates were compared between 2014 and 2016 and the first 3 years of the FIT-based screening program (2018–2020), during which 165,967 tests were performed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The odds of GC detection were significantly higher among FIT-positive individuals compared to those with a negative result (OR = 2.87; 95% CI: 1.76–4.49). Of the 10,372 individuals who completed FIT screening and underwent colonoscopy, 51% (<i>n</i> = 5281) also underwent UGIE. The proportion of early-stage diagnoses increased by 14% (95% CI: 12–15), and 3-year net survival improved from 42% (95% CI: 40–43) to 48% (95% CI: 47–50).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Despite the absence of a formal GC screening program, more than half of FIT-screened individuals who underwent colonoscopy also underwent UGIE. The period following the implementation of FIT-based screening was associated with increased early-stage detection and improved survival. These findings support the potential value of offering UGIE combined with colonoscopy for FIT-positive individuals, at least in regions with intermediate GC incidence.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 5","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145038446","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}
Han Chen, Yan Wang, Yuting Shao, Wei Su, Shuo Li, Yun Liu, Xiaoying Zhou
Background
Several clinical studies have demonstrated that Helicobacter pylori (Hp) infection may exacerbate the progression of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD); however, the underlying mechanisms remain unclear. This study aims to investigate the characterization of the gastric microbiome and metabolome in relation to the progression of MASLD induced by Hp infection.
Methods
We established a high-fat diet (HFD) obese mouse model, both with and without Hp infection, to compare alterations in serum and liver metabolic phenotypes. Subsequently, a multi-omics analysis was performed, combining gastric 16S rRNA amplicon sequencing, targeted energy metabolomics, and liver metabolomics sequencing to investigate the correlations among gastric microbiota, energy metabolism, and hepatic metabolism following Hp infection.
Results
HFD mice infected with Hp exhibited a more severe liver steatosis phenotype compared with Hp-negative controls. Hp infection triggers gastric dysbiosis, resulting in a notable enrichment of the Helicobacter genus, which subsequently becomes the dominant bacterial community. This shift leads to a significant rise in the abundance of other bacteria, such as Enterococcus, Streptococcus, and Staphylococcus, while concurrently reducing beneficial bacterial taxa such as Bifidobacterium. Analysis of bacterial functional enrichment and gastric energy metabolomics consistently reveals elevated glycolytic pathway activity in gastric tissue following Hp infection. Furthermore, liver metabolomics indicate increased activities of both glycolytic and lipid metabolic pathways in the liver. The disturbance of the gastric microbiota–metabolism axis is significantly and positively correlated with the hepatic lactate content and severity of hepatic steatosis and inflammation.
Conclusion
Hp infection may influence liver metabolism through microbial-metabolic interactions within the gastrohepatic axis, potentially exacerbating the progression of hepatic steatosis. Further studies are necessary to verify these potential causal relationships.
{"title":"Multi-Omics Analysis Revealed Characterization of Gastric Microbiome and Metabolome in Helicobacter pylori-Induced Progression of MASLD","authors":"Han Chen, Yan Wang, Yuting Shao, Wei Su, Shuo Li, Yun Liu, Xiaoying Zhou","doi":"10.1111/hel.70069","DOIUrl":"https://doi.org/10.1111/hel.70069","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Several clinical studies have demonstrated that <i>Helicobacter pylori</i> (Hp) infection may exacerbate the progression of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD); however, the underlying mechanisms remain unclear. This study aims to investigate the characterization of the gastric microbiome and metabolome in relation to the progression of MASLD induced by Hp infection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We established a high-fat diet (HFD) obese mouse model, both with and without Hp infection, to compare alterations in serum and liver metabolic phenotypes. Subsequently, a multi-omics analysis was performed, combining gastric 16S rRNA amplicon sequencing, targeted energy metabolomics, and liver metabolomics sequencing to investigate the correlations among gastric microbiota, energy metabolism, and hepatic metabolism following Hp infection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>HFD mice infected with Hp exhibited a more severe liver steatosis phenotype compared with Hp-negative controls. Hp infection triggers gastric dysbiosis, resulting in a notable enrichment of the <i>Helicobacter</i> genus, which subsequently becomes the dominant bacterial community. This shift leads to a significant rise in the abundance of other bacteria, such as <i>Enterococcus, Streptococcus</i>, and <i>Staphylococcus</i>, while concurrently reducing beneficial bacterial taxa such as <i>Bifidobacterium</i>. Analysis of bacterial functional enrichment and gastric energy metabolomics consistently reveals elevated glycolytic pathway activity in gastric tissue following Hp infection. Furthermore, liver metabolomics indicate increased activities of both glycolytic and lipid metabolic pathways in the liver. The disturbance of the gastric microbiota–metabolism axis is significantly and positively correlated with the hepatic lactate content and severity of hepatic steatosis and inflammation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Hp infection may influence liver metabolism through microbial-metabolic interactions within the gastrohepatic axis, potentially exacerbating the progression of hepatic steatosis. Further studies are necessary to verify these potential causal relationships.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 5","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145012439","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}
The optimal duration for vonoprazan and amoxicillin dual therapy (VA-DT) remains unclear, and studies on gastric acid suppression of vonoprazan during eradication are still lacking.
Objective
This study conducted a multicenter, randomized controlled trial to compare the eradication efficacy between 10 and 14-day VA-DT, and to identify the dynamic changes of gastric pH during treatment.
Methods
This study included 418 naïve adult patients with Helicobacter pylori infection, who were randomly divided into 10 or 14-day VA-DT groups (vonoprazan 20 mg twice daily and amoxicillin 1000 mg thrice daily). 13C-urea breath tests were conducted at 4–8 weeks after eradication to evaluate the success of treatment. 24-h intragastric pH was monitored in 22 patients.
Results
Ten and 14-day VA-DT demonstrated eradication rates of 83.3% vs. 88.0% (rate difference: −4.8%, 95% confidence interval: −11.6% to −2.0%) in intention-to-treat analysis, 87.9% vs. 93.9% (−6.0%, −11.9% to −0.3%) in modified intention-to-treat analysis, and 89.1% vs. 95.3% (−6.1%, −11.8% to −0.7%) in per-protocol analysis, respectively. Vonoprazan showed excellent gastric acid suppression during eradication, with the time percentages of pH > 6 at 75.3% and 97.2% and the median pH levels at 7.4 and 7.8 on the 1st and 7th days, respectively. Furthermore, gastric pH exceeded 6 approximately 4–5 h after the first dose and remained stable at 7–9 thereafter.
Conclusion
The noninferiority of eradication efficacy between 10- and 14-day VA-DT in the first-line treatment was not established, indicating that 10-day therapy cannot be used as a substitute for 14-day therapy. Vonoprazan exerted excellent gastric acid suppression during eradication.
{"title":"Ten-Day Versus 14-Day Vonoprazan and Amoxicillin Dual Therapy for the Firstline Eradication of Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial","authors":"Zhiqiang Song, Xiuli Zuo, Zhenyu Zhang, Xuehong Wang, Ya Lin, Yueyue Li, Xiaojun Xu, Yun Huang, Qiuyan Wang, Yanyan Shi, Liya Zhou","doi":"10.1111/hel.70070","DOIUrl":"https://doi.org/10.1111/hel.70070","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The optimal duration for vonoprazan and amoxicillin dual therapy (VA-DT) remains unclear, and studies on gastric acid suppression of vonoprazan during eradication are still lacking.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>This study conducted a multicenter, randomized controlled trial to compare the eradication efficacy between 10 and 14-day VA-DT, and to identify the dynamic changes of gastric pH during treatment.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This study included 418 naïve adult patients with <i>Helicobacter pylori</i> infection, who were randomly divided into 10 or 14-day VA-DT groups (vonoprazan 20 mg twice daily and amoxicillin 1000 mg thrice daily). <sup>13</sup>C-urea breath tests were conducted at 4–8 weeks after eradication to evaluate the success of treatment. 24-h intragastric pH was monitored in 22 patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Ten and 14-day VA-DT demonstrated eradication rates of 83.3% vs. 88.0% (rate difference: −4.8%, 95% confidence interval: −11.6% to −2.0%) in intention-to-treat analysis, 87.9% vs. 93.9% (−6.0%, −11.9% to −0.3%) in modified intention-to-treat analysis, and 89.1% vs. 95.3% (−6.1%, −11.8% to −0.7%) in per-protocol analysis, respectively. Vonoprazan showed excellent gastric acid suppression during eradication, with the time percentages of pH > 6 at 75.3% and 97.2% and the median pH levels at 7.4 and 7.8 on the 1st and 7th days, respectively. Furthermore, gastric pH exceeded 6 approximately 4–5 h after the first dose and remained stable at 7–9 thereafter.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The noninferiority of eradication efficacy between 10- and 14-day VA-DT in the first-line treatment was not established, indicating that 10-day therapy cannot be used as a substitute for 14-day therapy. Vonoprazan exerted excellent gastric acid suppression during eradication.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>Chinese Clinical Trial Registry: ChiCTR2200057625</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 5","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144998731","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}
Young-Il Kim, Jong Yeul Lee, Chan Gyoo Kim, Il Ju Choi
Background and Aims
Helicobacter pylori (Hp) infection is associated with metachronous gastric cancer (GC) after endoscopic submucosal dissection resection (ESD) in patients with early GC (EGC), but this association has not been well investigated in elderly patients. This study investigated whether Hp infection status was associated with metachronous GC after ESD in patients aged ≥ 75 years.
Methods
This retrospective study involved 298 EGC patients aged ≥ 75 years who underwent ESD. The Hp-negative group (n = 233) included patients with negative or eradicated Hp infection, whereas the Hp-positive group (n = 65) included patients with persistently positive infection or failed eradication. The primary outcome was metachronous GC occurring at ≥ 1 year after ESD.
Results
The median patient age was 78 years (interquartile range [IQR]: 76–80 years). During a median follow-up of 4.4 years (IQR: 2.9–5.9 years), metachronous GC occurred in 16 (6.9% [16/233], 16.3 cases/1000 person-year) and 10 (15.4% [10/65], 37.5 cases/1000 person-year) patients in the Hp-negative and Hp-positive groups, respectively. The incidence of metachronous cancer was higher in the Hp-positive group than in the Hp-negative group (p = 0.035, log-rank test). In a multivariate analysis, persistent Hp infection was an independent risk factor for metachronous GC (age- and sex-adjusted hazard ratio, 2.33; 95% CI: 1.05–5.17).
Conclusions
Persistent H. pylori infection status was associated with a higher risk of metachronous GC, and H. pylori treatment needs to be provided in elderly patients aged ≥ 75 years and older with EGC undergoing ESD.
{"title":"Helicobacter pylori Infection and Metachronous Gastric Cancer in Elderly Patients With Gastric Cancer Aged ≥ 75 Years Who Underwent Endoscopic Submucosal Dissection","authors":"Young-Il Kim, Jong Yeul Lee, Chan Gyoo Kim, Il Ju Choi","doi":"10.1111/hel.70068","DOIUrl":"https://doi.org/10.1111/hel.70068","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background and Aims</h3>\u0000 \u0000 <p><i>Helicobacter pylori</i> (<i>Hp</i>) infection is associated with metachronous gastric cancer (GC) after endoscopic submucosal dissection resection (ESD) in patients with early GC (EGC), but this association has not been well investigated in elderly patients. This study investigated whether <i>Hp</i> infection status was associated with metachronous GC after ESD in patients aged ≥ 75 years.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This retrospective study involved 298 EGC patients aged ≥ 75 years who underwent ESD. The <i>Hp</i>-negative group (<i>n</i> = 233) included patients with negative or eradicated <i>Hp</i> infection, whereas the <i>Hp</i>-positive group (<i>n</i> = 65) included patients with persistently positive infection or failed eradication. The primary outcome was metachronous GC occurring at ≥ 1 year after ESD.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The median patient age was 78 years (interquartile range [IQR]: 76–80 years). During a median follow-up of 4.4 years (IQR: 2.9–5.9 years), metachronous GC occurred in 16 (6.9% [16/233], 16.3 cases/1000 person-year) and 10 (15.4% [10/65], 37.5 cases/1000 person-year) patients in the <i>Hp</i>-negative and <i>Hp</i>-positive groups, respectively. The incidence of metachronous cancer was higher in the <i>Hp</i>-positive group than in the <i>Hp</i>-negative group (<i>p</i> = 0.035, log-rank test). In a multivariate analysis, persistent <i>Hp</i> infection was an independent risk factor for metachronous GC (age- and sex-adjusted hazard ratio, 2.33; 95% CI: 1.05–5.17).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Persistent <i>H. pylori</i> infection status was associated with a higher risk of metachronous GC, and <i>H. pylori</i> treatment needs to be provided in elderly patients aged ≥ 75 years and older with EGC undergoing ESD.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.70068","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144927500","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}
Hack-Lyoung Kim, Dong-Hoon Kim, Kyueng-Whan Min, Byoung Kwan Son, Jaehoon Chung
Helicobacter pylori (HP) infection has been linked to systemic inflammation and vascular dysfunction, potentially contributing to arterial stiffness. Research in younger populations is limited, highlighting the need to explore its early cardiovascular impact. This study investigated the association between histologically confirmed HP infection and arterial stiffness. Data were retrospectively analyzed from a cohort of adults who underwent health check-ups and gastric mucosal biopsies to confirm HP infection. A mong them, young adults aged 19–39 years were included in the analysis. Arterial stiffness was assessed using estimated PWV (ePWV), which was calculated using age and mean arterial pressure according to validated equations. Among 7803 participants, 4289 (53.9%) tested positive for HP. ePWV was significantly higher in HP-positive individuals (6.66 ± 0.60 vs. 6.33 ± 0.58 m/s; p < 0.001), with a linear increase observed across HP severity levels (analysis of variaungnce p < 0.01). A positive correlation was identified between the Updated Sydney System (USS) score and ePWV (p < 0.001). Multiple linear regression analysis demonstrated an independent association between USS score and ePWV after adjusting for confounders. Logistic regression analysis showed that severe HP infection was associated with a markedly higher likelihood of elevated ePWV (odds ratio, 3.87; 95% CI. 3.25–4.60; p < 0.001). HP infection was independently associated with increased arterial stiffness in young adualts, with greater infection severity linked to higher ePWV levels. Early detection may help reduce long-term cardiovascular risk.
幽门螺杆菌（HP）感染与全身炎症和血管功能障碍有关，可能导致动脉僵硬。对年轻人群的研究是有限的，这突出了探索其早期心血管影响的必要性。本研究调查了组织学证实的HP感染与动脉僵硬之间的关系。回顾性分析了一组接受健康检查和胃粘膜活检以确认HP感染的成年人的数据。其中19-39岁的年轻人被纳入分析。通过估算的PWV （ePWV）来评估动脉刚度，ePWV是根据年龄和平均动脉压根据验证方程计算的。在7803名参与者中，4289人（53.9%）检测出HP阳性。HP阳性个体的ePWV显著升高（6.66±0.60 vs. 6.33±0.58 m/s; p < 0.001），且在不同HP严重程度之间呈线性增加（方差分析p <； 0.01）。更新悉尼系统（USS）评分与ePWV呈正相关（p < 0.001）。多元线性回归分析表明，在调整混杂因素后，USS评分与ePWV之间存在独立的关联。Logistic回归分析显示，严重HP感染与ePWV升高的可能性显著增高相关（优势比3.87;95% CI）。3.25 - -4.60;P < 0.001)。HP感染与年轻人动脉僵硬度增加独立相关，感染严重程度越高，ePWV水平越高。早期发现可能有助于降低长期心血管风险。
{"title":"Arterial Stiffness and Histologically Confirmed Helicobacter pylori Infection in Young Adults","authors":"Hack-Lyoung Kim, Dong-Hoon Kim, Kyueng-Whan Min, Byoung Kwan Son, Jaehoon Chung","doi":"10.1111/hel.70067","DOIUrl":"https://doi.org/10.1111/hel.70067","url":null,"abstract":"<div>\u0000 \u0000 <p><i>Helicobacter pylori</i> (HP) infection has been linked to systemic inflammation and vascular dysfunction, potentially contributing to arterial stiffness. Research in younger populations is limited, highlighting the need to explore its early cardiovascular impact. This study investigated the association between histologically confirmed HP infection and arterial stiffness. Data were retrospectively analyzed from a cohort of adults who underwent health check-ups and gastric mucosal biopsies to confirm HP infection. A mong them, young adults aged 19–39 years were included in the analysis. Arterial stiffness was assessed using estimated PWV (ePWV), which was calculated using age and mean arterial pressure according to validated equations. Among 7803 participants, 4289 (53.9%) tested positive for HP. ePWV was significantly higher in HP-positive individuals (6.66 ± 0.60 vs. 6.33 ± 0.58 m/s; <i>p</i> < 0.001), with a linear increase observed across HP severity levels (analysis of variaungnce <i>p</i> < 0.01). A positive correlation was identified between the Updated Sydney System (USS) score and ePWV (<i>p</i> < 0.001). Multiple linear regression analysis demonstrated an independent association between USS score and ePWV after adjusting for confounders. Logistic regression analysis showed that severe HP infection was associated with a markedly higher likelihood of elevated ePWV (odds ratio, 3.87; 95% CI. 3.25–4.60; <i>p</i> < 0.001). HP infection was independently associated with increased arterial stiffness in young adualts, with greater infection severity linked to higher ePWV levels. Early detection may help reduce long-term cardiovascular risk.</p>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144894021","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}
Luochengling Xiang, Ying Zhou, Xiaopei Guo, Michiel C. Mommersteeg, Stella A. V. Nieuwenburg, Maikel P. Peppelenbosch, Manon C. W. Spaander, Gwenny M. Fuhler
Background
A lateral flow assay (LFA) incorporating several biomarkers, including pepsinogen I (PGI), pepsinogen II (PGII), Gastrin-17 (G-17), and Helicobacter pylori IgG, enables the rapid non-invasive detection of atrophic gastritis (AG). However, its diagnostic performance compared to conventional enzyme-linked immunosorbent assay (ELISA) has not been established.
Methods
This head-to-head comparison study included participants from a prospective and multicenter cohort. Patients with gastric premalignant lesions underwent endoscopy, and fasting serum samples were collected for biomarker analysis using both LFA and ELISA.
Results
A total of 204 patients were included in this study. LFA demonstrated diagnostic specificity for AG comparable to ELISA, with specificity rates of 95.74% (95% CI [85.75%–99.24%]) for LFA and 100.00% (95% CI [92.44%–100.00%]) for ELISA (p = 0.49). Both methods showed similar performance in detecting H. pylori infection, with an AUC of 0.754 (95% CI [0.616–0.891]) for LFA and 0.778 (95% CI [0.633–0.922]) for ELISA (p = 0.70). For identifying autoimmune gastritis in corpus AG, a reduced PGI/PGII ratio combined with elevated G-17 levels provided excellent discrimination, achieving an AUC of 0.926 (95% CI [0.870–0.926]) for LFA and 0.924 (95% CI [0.861–0.924]) for ELISA.
Conclusion
The LFA assay is a feasible, rapid, and non-invasive tool for assessing gastric functional mucosa. Its diagnostic performance for detecting AG is comparable to ELISA, making it a supplementary tool in point-of-care settings to improve the early detection of AG.
Trial Registration
This study was not registered as a clinical trial, as it is based on an observational study, Progression and Regression of precancerous Gastric Lesions (PROREGAL) study.
横向流动试验（LFA）包含了多种生物标志物，包括胃蛋白酶原I （PGI）、胃蛋白酶原II （PGII）、胃泌素-17 （G-17）和幽门螺杆菌IgG，能够快速无创检测萎缩性胃炎（AG）。然而，与传统的酶联免疫吸附试验（ELISA）相比，其诊断性能尚未确定。方法本研究纳入了前瞻性多中心队列。胃癌前病变患者行胃镜检查，并收集空腹血清样本，采用LFA和ELISA进行生物标志物分析。结果本研究共纳入204例患者。LFA对AG的诊断特异性与ELISA相当，LFA的特异性为95.74% (95% CI [85.75% ~ 99.24%])， ELISA的特异性为100.00% (95% CI [92.44% ~ 100.00%]) （p = 0.49）。两种方法检测幽门螺杆菌感染的效果相似，LFA的AUC为0.754 (95% CI [0.616-0.891])， ELISA的AUC为0.778 (95% CI [0.633-0.922]) （p = 0.70）。对于鉴别自身免疫性胃炎，PGI/PGII比值降低结合G-17水平升高提供了很好的鉴别，LFA的AUC为0.926 (95% CI [0.870-0.926])， ELISA的AUC为0.924 （95% CI[0.861-0.924]）。结论LFA法是一种可行、快速、无创的胃粘膜功能评价方法。其检测AG的诊断性能与ELISA相当，使其成为护理点环境中提高AG早期检测的补充工具。这项研究没有注册为临床试验，因为它是基于一项观察性研究，癌前胃病变的进展和消退（PROREGAL）研究。
{"title":"Evaluation of Pepsinogen I, II, Gastrin 17 and Helicobacter pylori IgG in Atrophic Gastritis: A Head-To-Head Comparison of Lateral Flow and Enzyme-Linked Immunosorbent Assays","authors":"Luochengling Xiang, Ying Zhou, Xiaopei Guo, Michiel C. Mommersteeg, Stella A. V. Nieuwenburg, Maikel P. Peppelenbosch, Manon C. W. Spaander, Gwenny M. Fuhler","doi":"10.1111/hel.70066","DOIUrl":"https://doi.org/10.1111/hel.70066","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>A lateral flow assay (LFA) incorporating several biomarkers, including pepsinogen I (PGI), pepsinogen II (PGII), Gastrin-17 (G-17), and <i>Helicobacter pylori</i> IgG, enables the rapid non-invasive detection of atrophic gastritis (AG). However, its diagnostic performance compared to conventional enzyme-linked immunosorbent assay (ELISA) has not been established.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This head-to-head comparison study included participants from a prospective and multicenter cohort. Patients with gastric premalignant lesions underwent endoscopy, and fasting serum samples were collected for biomarker analysis using both LFA and ELISA.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 204 patients were included in this study. LFA demonstrated diagnostic specificity for AG comparable to ELISA, with specificity rates of 95.74% (95% CI [85.75%–99.24%]) for LFA and 100.00% (95% CI [92.44%–100.00%]) for ELISA (<i>p</i> = 0.49). Both methods showed similar performance in detecting <i>H. pylori</i> infection, with an AUC of 0.754 (95% CI [0.616–0.891]) for LFA and 0.778 (95% CI [0.633–0.922]) for ELISA (<i>p</i> = 0.70). For identifying autoimmune gastritis in corpus AG, a reduced PGI/PGII ratio combined with elevated G-17 levels provided excellent discrimination, achieving an AUC of 0.926 (95% CI [0.870–0.926]) for LFA and 0.924 (95% CI [0.861–0.924]) for ELISA.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The LFA assay is a feasible, rapid, and non-invasive tool for assessing gastric functional mucosa. Its diagnostic performance for detecting AG is comparable to ELISA, making it a supplementary tool in point-of-care settings to improve the early detection of AG.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>This study was not registered as a clinical trial, as it is based on an observational study, Progression and Regression of precancerous Gastric Lesions (PROREGAL) study.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.70066","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144869831","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}
Autoimmune gastritis (AIG) is a chronic immune-mediated disease characterized by the presence of anti-parietal cell antibody and progressive corpus-predominant atrophy. The global prevalence of AIG and its associated factors remain poorly understood. This study aimed to systematically estimate the prevalence of AIG worldwide and identify demographic and diagnostic factors influencing its variability.
Methods
In this systematic review and meta-analysis, we searched Medline, Scopus, and Embase from database inception until December 7, 2024. Prevalence was pooled using a random-effects model, and potential sources of heterogeneity were explored by subgroup analysis and meta-regression analysis.
Results
A total of 47 studies involving 15,817 individuals were included. The global prevalence of AIG was estimated at 3.85% (95% CI: 2.94–5.04, I2 = 99.3%). Notable geographical variation was observed, with a prevalence of 4.94% in Europe (95% CI: 3.66–6.63), 2.23% in Asia (95% CI: 1.19–4.14), 2.82% in America (95% CI: 1.48–5.31), 8.46% in Africa (95% CI: 5.58–13.14) and 8.08% in Australia (95% CI: 4.69–12.79). The prevalence was highest when diagnosed by serological antibody (5.4%, 95% CI: 3.79–7.65), followed by histology (2.71%, 95% CI: 1.68–4.36) and combined serology and histology (1.81%, 95% CI: 0.80–4.07). Meta-regression analysis revealed a positive correlation between H. pylori infection and AIG prevalence.
Conclusions
This study estimated the global prevalence of AIG and underscored the significant geographical and methodological variability. Future studies of large-scale are still in urgent need to standardize the diagnostic criteria and further investigate risk factors, thus enhancing the understanding and management of AIG.
{"title":"Prevalence of Autoimmune Gastritis Worldwide: A Systematic Review and Meta-Analysis","authors":"Meixuan Li, Yu Huang, Xiao Liang, Hong Lu","doi":"10.1111/hel.70065","DOIUrl":"https://doi.org/10.1111/hel.70065","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Autoimmune gastritis (AIG) is a chronic immune-mediated disease characterized by the presence of anti-parietal cell antibody and progressive corpus-predominant atrophy. The global prevalence of AIG and its associated factors remain poorly understood. This study aimed to systematically estimate the prevalence of AIG worldwide and identify demographic and diagnostic factors influencing its variability.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In this systematic review and meta-analysis, we searched Medline, Scopus, and Embase from database inception until December 7, 2024. Prevalence was pooled using a random-effects model, and potential sources of heterogeneity were explored by subgroup analysis and meta-regression analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 47 studies involving 15,817 individuals were included. The global prevalence of AIG was estimated at 3.85% (95% CI: 2.94–5.04, <i>I</i><sup><i>2</i></sup> = 99.3%). Notable geographical variation was observed, with a prevalence of 4.94% in Europe (95% CI: 3.66–6.63), 2.23% in Asia (95% CI: 1.19–4.14), 2.82% in America (95% CI: 1.48–5.31), 8.46% in Africa (95% CI: 5.58–13.14) and 8.08% in Australia (95% CI: 4.69–12.79). The prevalence was highest when diagnosed by serological antibody (5.4%, 95% CI: 3.79–7.65), followed by histology (2.71%, 95% CI: 1.68–4.36) and combined serology and histology (1.81%, 95% CI: 0.80–4.07). Meta-regression analysis revealed a positive correlation between <i>H. pylori</i> infection and AIG prevalence.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study estimated the global prevalence of AIG and underscored the significant geographical and methodological variability. Future studies of large-scale are still in urgent need to standardize the diagnostic criteria and further investigate risk factors, thus enhancing the understanding and management of AIG.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144869830","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}
A 10 day vonoprazan–amoxicillin (VA) regimen (amoxicillin 750 mg four times daily) achieved > 90% Helicobacter pylori (H. pylori) eradication rates in the initial treatment. Whether less frequent dosing or shorter duration provides comparable efficacy remains unclear. This study aimed to evaluate the efficacy of simplified 7 or 10-day VA regimens to determine the optimal first-line strategy.
Methods
In this multicenter, randomized, open-label, non-inferiority trial, treatment-naive H. pylori-positive patients were randomly assigned (1:1:1:1) to four treatment groups: VA-T7 (amoxicillin 1000 mg three times daily for 7 days), VA-Q7 (amoxicillin 750 mg four times daily for 7 days), VA-T10 (amoxicillin 1000 mg three times daily for 10 days), and VA-Q10 (amoxicillin 750 mg four times daily for 10 days). All the patients received vonoprazan 20 mg twice daily. The primary outcome was the eradication rate. The secondary outcomes included adverse events and adherence.
Results
A total of 500 patients were enrolled. The eradication rates of the VA-T7, VA-Q7, VA-T10, and VA-Q10 groups were 84.0%, 81.6%, 91.2%, and 90.4% by intention-to-treat (ITT) analysis; 86.8%, 83.6%, 92.7%, and 92.6% by modified intention-to-treat (mITT) analysis; 88.2%, 85.7%, 93.4%, and 94.1% by per-protocol (PP) analysis, respectively. The efficacy of VA-T10 was non-inferior to that of VA-Q10 (p = 0.002; p = 0.001; p = 0.002 in the ITT, mITT and PP analyses, respectively). Both 7-day regimens failed to meet the non-inferiority margin of −10%. No significant effect of dosing frequency on eradication rates was observed. Adverse events and adherence were comparable among the groups.
Conclusions
The VA-T10 regimen is effective, well-tolerated, and suitable for first-line H. pylori eradication, whereas 7-day regimens are not recommended due to eradication rates < 90%.
{"title":"Optimizing Duration and Dosing Frequency of Vonoprazan–Amoxicillin Dual Therapy for Helicobacter pylori: A Multicenter Randomized Trial","authors":"Lulong Tao, Haisheng Qian, Leyao Zhang, Peipei Luo, Shijie Ma, Jin Yan, Yajun Liu, Meihong Chen, Yuwen Tao, Jinjin Shi, Guoxin Zhang, Feng Ye","doi":"10.1111/hel.70062","DOIUrl":"https://doi.org/10.1111/hel.70062","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>A 10 day vonoprazan–amoxicillin (VA) regimen (amoxicillin 750 mg four times daily) achieved > 90% <i>Helicobacter pylori (H. pylori)</i> eradication rates in the initial treatment. Whether less frequent dosing or shorter duration provides comparable efficacy remains unclear. This study aimed to evaluate the efficacy of simplified 7 or 10-day VA regimens to determine the optimal first-line strategy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In this multicenter, randomized, open-label, non-inferiority trial, treatment-naive <i>H. pylori</i>-positive patients were randomly assigned (1:1:1:1) to four treatment groups: VA-T7 (amoxicillin 1000 mg three times daily for 7 days), VA-Q7 (amoxicillin 750 mg four times daily for 7 days), VA-T10 (amoxicillin 1000 mg three times daily for 10 days), and VA-Q10 (amoxicillin 750 mg four times daily for 10 days). All the patients received vonoprazan 20 mg twice daily. The primary outcome was the eradication rate. The secondary outcomes included adverse events and adherence.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 500 patients were enrolled. The eradication rates of the VA-T7, VA-Q7, VA-T10, and VA-Q10 groups were 84.0%, 81.6%, 91.2%, and 90.4% by intention-to-treat (ITT) analysis; 86.8%, 83.6%, 92.7%, and 92.6% by modified intention-to-treat (mITT) analysis; 88.2%, 85.7%, 93.4%, and 94.1% by per-protocol (PP) analysis, respectively. The efficacy of VA-T10 was non-inferior to that of VA-Q10 (<i>p</i> = 0.002; <i>p</i> = 0.001; <i>p</i> = 0.002 in the ITT, mITT and PP analyses, respectively). Both 7-day regimens failed to meet the non-inferiority margin of −10%. No significant effect of dosing frequency on eradication rates was observed. Adverse events and adherence were comparable among the groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The VA-T10 regimen is effective, well-tolerated, and suitable for first-line <i>H. pylori</i> eradication, whereas 7-day regimens are not recommended due to eradication rates < 90%.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>ClinicalTrials.gov identifier: ChiCTR2400079754 (www.chictr.org.cn)</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 4","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144832895","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}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号