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Shih CA, Wu DC, Shie CB, Hsu PI. Dual Therapies Containing an Antibiotic Plus a Proton Pump Inhibitor or Vonoprazan for Helicobacter pylori Infection: A Systematic Review. Microorganisms 2025; 13:715. [PMID: 40284552 PMCID: PMC12029877 DOI: 10.3390/microorganisms13040715] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2025] [Revised: 03/14/2025] [Accepted: 03/19/2025] [Indexed: 04/29/2025] Open
Abstract
Due to the increasing prevalence of antimicrobial resistance, the efficacy of standard triple therapy for Helicobacter pylori (H. pylori) infection has declined, with eradication rates now falling below 80% in most countries. Although bismuth quadruple therapy and concomitant therapy are advised in regions with high clarithromycin resistance, these treatments commonly cause frequent adverse events and require the use of two or three antibiotics. This review article evaluates the effectiveness of 14-day mono-antibiotic therapies for H. pylori infection through randomized controlled trials conducted from 1 October 2014 to 1 October 2024. The pooled eradication rates for 14-day high-dose amoxicillin/proton pump inhibitor (PPI) dual therapies were 86.1% (3335/3875; 95% confidence interval (CI): 85.1-87.2%) by intention-to-treat (ITT) analysis and 87.3% (3232/3702; 95% CI: 86.2-88.4%) by per-protocol (PP) analysis. For 14-day high-dose amoxicillin/vonoprazan dual therapies, the rates were 87.4% (1085/1241; 95% CI: 85.5-89.2%) by ITT and 93.0% (1044/1124; 95% CI: 91.5-94.5%) by PP. In the penicillin-allergic population, 14-day tetracycline/vonoprazan dual therapy showed eradication rates of 92.0% (138/150) by ITT and 95.1% (135/142) by PP. In conclusion, 14-day tetracycline/vonoprazan dual therapy presents an effective option for eradicating H. pylori in patients allergic to penicillin. For those without a penicillin allergy, first-line treatments can include 14-day mono-antibiotic regimens, such as high-dose amoxicillin/PPI dual, high-dose amoxicillin/vonoprazan dual, and tetracycline/vonoprazan dual therapies.
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Affiliation(s)
- Chih-An Shih
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital, Pingtung County 928004, Taiwan;
- Department of Nursing, Meiho University, Pingtung County 912009, Taiwan
| | - Deng-Chyang Wu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 807377, Taiwan;
- Department of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung City 807378, Taiwan
| | - Chang-Bih Shie
- Division of Gastroenterology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan City 709204, Taiwan
| | - Ping-I Hsu
- Division of Gastroenterology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan City 709204, Taiwan
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Yang C, Zhang H, Li S, Zhang Z. Analysis of the status and risk factors for Helicobacter pylori infection and drug resistance in the Lianyungang area, China. BMC Gastroenterol 2025; 25:96. [PMID: 39979852 PMCID: PMC11843961 DOI: 10.1186/s12876-025-03692-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2024] [Accepted: 02/13/2025] [Indexed: 02/22/2025] Open
Abstract
OBJECTIVE Helicobacter pylori (H. pylori) has attracted much attention since its discovery. This bacterium has had a substantial impact on society, the economy, and public health. In recent years, with the continuous increase in drug resistance in H. pylori and the emergence of multidrug resistant strains, the existing diagnostic and treatment options are no longer able to meet clinical needs, so we need to understand the dynamically changing nature of drug resistance of H. pylori in our region. This study collected stool samples from community residents in Lianyungang to analyse the local H. pylori infection status, resistance to commonly used antibacterial agents, and risk factors to provide a reference for local clinical empirical treatment. METHODS Human stool samples from Lianyungang residents were collected, the DNA of H. pylori in the positive samples was extracted, the sites of mutated genes were determined by PCR and nucleic acid mass spectrometry, and genotypes of cytotoxin-associated gene A (CagA) and vacuolating cytotoxin A (VacA) were tested. The resistance rates of local H. pylori strains to five antibacterial agents, levofloxacin, clarithromycin, furazolidone, amoxicillin, and tetracycline, were collected, and the risk factors for drug resistance were analysed statistically based on questionnaire results. RESULTS A total of 221 residents with qualified stool samples were enrolled. The infection rate was 25.3%. DNA was extracted from 56 H. pylori samples. Among them, only 17 H. pylori strains were sensitive to all five antibiotics, and a total of five drug resistance patterns were detected. The main drug resistance patterns were single drug resistance to clarithromycin (30.4%) and double drug resistance to levofloxacin + clarithromycin (21.4%). The levofloxacin resistance mutations were mainly located at N87K and D91Y of the gyrA sequence, and the clarithromycin resistance mutations were mainly located at A2143G in the 23S rRNA sequence. Age, gastrointestinal symptoms, and previous history of H. pylori infection were risk factors for resistant H. pylori. A previous history of H. pylori infection was an independent risk factor for the development of drug resistance in H. pylori. CONCLUSION The H. pylori infection rate in the Lianyungang area is lower than the national rate, but the rates of resistance to levofloxacin and clarithromycin are quite high. Drug sensitivity testing is needed to provide more accurate individualized treatment and improve the eradication rate of H. pylori. Continuous monitoring of local antibiotic resistance patterns remains the first choice for empirical treatment.
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Affiliation(s)
- Chuchu Yang
- Department of Gastroenterology, Lianyungang Clinical College of Nanjing Medical University, Lianyungang, 222000, China
| | - Huahui Zhang
- Department of Gastroenterology, The First People's Hospital of Lianyungang, Lianyungang, Jiangsu, China
| | - Shouying Li
- Department of Gastroenterology, The First People's Hospital of Lianyungang, Lianyungang, Jiangsu, China
| | - Zhimei Zhang
- Department of Gastroenterology, Lianyungang Clinical College of Nanjing Medical University, Lianyungang, 222000, China.
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Guan JL, Xu TT, Lin Y, Mo YS, He BY, Han YY, Li JY, Xia SH, Zhou YN, Liao JZ, Li PY. High-dose dual therapy for Helicobacter pylori eradication inducing less impact on the gut microbiota. Gut Pathog 2025; 17:7. [PMID: 39885529 PMCID: PMC11783801 DOI: 10.1186/s13099-025-00682-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/08/2024] [Accepted: 01/23/2025] [Indexed: 02/01/2025] Open
Abstract
BACKGROUND Helicobacter pylori (H. pylori) eradication regimens may have different effects on the gut microbiota. Few studies have analyzed the safety of high-dose dual therapy (HDDT) from a micro-ecological perspective. This study aimed to compare the impact of H. pylori eradication with HDDT and bismuth quadruple therapy (BQT) on gut microbiota. PATIENTS AND METHODS H. Pylori-infected treatment-naive patients were recruited and screened from September 2023 to April 2024 and randomly assigned to the HDDT group (esomeprazole 20 mg, amoxicillin 750 mg, qid, 14 days) or BQT group (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 600 mg, bid, 14 days). Fresh stool specimens were collected and stored before treatment and at week 2 and week 8 after treatment. The diversity and composition of the gut microbiota were compared and analyzed in both groups using 16 S rRNA gene sequencing. RESULTS Forty-nine H. pylori positive patients were enrolled and randomly assigned to either the HDDT (n = 24) or the BQT group (n = 25) group. Compared with baseline, alpha and beta diversities significantly changed at week 2 after receiving BQT and did not recover fully at week 8. However, in the HDDT group, the diversities at week 2 changed mildly without statistical significance, compared to baseline. Additionally, a greater number of species had alterations in their abundances in the BQT group compared to the HDDT group at week 2. However, the abundances of these species were restored to their previous levels at week 8 in both the HDDT and BQT groups. CONCLUSIONS Compared to BQT, HDDT exerted less impact on the diversity and composition of the gut microbiota. CLINICAL TRIAL REGISTRATION ChiCTR2100053268.
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Affiliation(s)
- Jia-Lun Guan
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China
| | - Ting-Ting Xu
- Department of Gastroenterology, Wenchang People's Hospital, Wenchang, China
| | - Ya Lin
- Department of Gastroenterology, Wenchang People's Hospital, Wenchang, China
| | - Yan-Shuai Mo
- Department of Anesthesiology, Wenchang People's Hospital, Wenchang, China
| | - Bi-Yu He
- Department of Gastroenterology, Wenchang People's Hospital, Wenchang, China
| | - Ying-Ying Han
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China
| | - Ji-Yan Li
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China
| | - Su-Hong Xia
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China
| | - Ya-Ni Zhou
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China
| | - Jia-Zhi Liao
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China.
| | - Pei-Yuan Li
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China.
- Department of Gastroenterology, Wenchang People's Hospital, Wenchang, China.
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Zhou BG, Guo MW, Zhang LJ, Liu ZD, Liu CH, Li XF, Li SS, Xiao P, Bao B, Ai YW, Ding YB. Ten-day vonoprazan-amoxicillin dual therapy versus 14-day esomeprazole-amoxicillin dual therapy for first-line Helicobacter pylori eradication: a prospective multicenter randomized controlled trial. Therap Adv Gastroenterol 2024; 17:17562848241309870. [PMID: 39741655 PMCID: PMC11686653 DOI: 10.1177/17562848241309870] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/12/2024] [Accepted: 12/05/2024] [Indexed: 01/03/2025] Open
Abstract
Background The efficacy of the 14-day esomeprazole-amoxicillin (EA) dual therapy in eradicating Helicobacter pylori (H. pylori) has been widely discussed previously. Vonoprazan, a novel potassium-competitive acid blocker, presents rapid, potent, and long-lasting acid inhibitory effects compared to esomeprazole. However, there is currently a scarcity of direct comparisons between the 10-day vonoprazan-amoxicillin (VA) and the 14-day EA dual therapy for H. pylori eradication. Objectives This study aimed to compare the efficacy and safety of the 10-day VA and the 14-day EA dual therapy for H. pylori first-line eradication. Design This study was a prospective, multicenter, open-label, randomized controlled trial. Methods The study was conducted at 10 hospitals in China. In total, 570 newly diagnosed H. pylori-infected patients were recruited from April 2023 to February 2024. These patients were randomly assigned to either the 10-day VA group (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily) or the 14-day EA group (esomeprazole 20 mg four times daily + amoxicillin 750 mg four times daily). The primary outcome was the eradication rate, with secondary outcomes including adverse events and compliance. Results The 10-day VA regimen outperformed the 14-day EA regimen in terms of eradication rates in intention-to-treat (ITT) analysis (85.4% vs 76.7%, p = 0.008), modified ITT analysis (90.7% vs 84.8%, p = 0.036), and per-protocol (PP) analysis (91.1% versus 85.5%, p = 0.047). The non-inferiority p-values in all three analyses were less than 0.001. No statistically significant difference was observed in the incidence of adverse events between the two groups (9.1% vs 11.7%, p = 0.308). The 10-day VA regimen demonstrated higher compliance compared to the 14-day EA regimen (p = 0.006). Conclusion The 10-day VA dual therapy showed a satisfactory eradication rate of 91.1% (PP analysis), demonstrating good safety and better compliance compared to the 14-day EA dual therapy as the first-line eradication. Trial registration This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2300070475) on April 12, 2023.
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Affiliation(s)
- Ben-Gang Zhou
- Dalian Medical University, Dalian, Liaoning, China
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, Jiangsu, China
| | - Ming-Wen Guo
- Department of Gastroenterology, Qionglai Medical Center Hospital, Chengdu, Sichuan, China
| | - Li-Juan Zhang
- Department of Gastroenterology, Changyang Tujia Autonomous County People’s Hospital, Yichang, Hubei, China
| | - Zhi-Dong Liu
- Department of Gastroenterology, GaoYou Hospital of Traditional Chinese Medicine, Yangzhou, Jiangsu, China
| | - Chun-Hua Liu
- Department of Gastroenterology, Baoying County People’s Hospital, Yangzhou, Jiangsu, China
| | - Xue-Feng Li
- Department of Gastroenterology, Yizheng Traditional Chinese Medicine Hospital, Yangzhou, Jiangsu, China
| | - Shun-Song Li
- Department of Gastroenterology, People’s Hospital of Gaoyou, Yangzhou, Jiangsu, China
| | - Peng Xiao
- Department of Gastroenterology, People’s Hospital of Honghuagang District, Zunyi, Guizhou, China
| | - Bing Bao
- Department of Gastroenterology, People’s Hospital of Yizheng, Yangzhou, Jiangsu, China
| | - Yao-Wei Ai
- Department of Gastroenterology, The First College of Clinical Medical Science, China Three Gorges University, Yichang, Hubei, China
| | - Yan-Bing Ding
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, No.368, Hanjiang Middle Road, Hanjiang District, Yangzhou, Jiangsu, China
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Lin A, Lin Z, Liu Y, Chen S, Shao Y, Qiu F, Xiao Z, Xu Z, Chen L, Chen L, Lin W, Wang Y, Huang Z, Lin Z, Huang X. Ten-day versus 14-day vonoprazan-amoxicillin high-dose dual therapy for Helicobacter pylori eradication in China: A multicenter, open-label, randomized study. J Gastroenterol Hepatol 2024; 39:2645-2653. [PMID: 39582213 DOI: 10.1111/jgh.16761] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/12/2024] [Revised: 09/03/2024] [Accepted: 09/24/2024] [Indexed: 11/26/2024]
Abstract
BACKGROUND AND AIM Only a few studies have investigated the efficacy and safety of different durations of vonoprazan and amoxicillin (VA) high-dose dual therapy for the eradication of Helicobacter pylori. We aimed to compare the efficacy and safety of 10 days versus 14 days of VA high-dose dual therapy for H. pylori eradication. METHODS This study was conducted in 14 centers in China. A total of 250 patients infected with H. pylori were randomly assigned to Group VA-10 or VA-14. Both groups received the VA dual therapy (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily). The primary endpoint was the H. pylori eradication rate. Secondary endpoints included adverse events and patient compliance. RESULTS Group VA-10 achieved eradication rates of 89.60%, 91.06%, and 91.67% as determined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analysis, respectively. The eradication rates were similar to those in Group VA-14: 91.20%, 93.44%, and 93.39%. The difference and 90% confidence interval boundary -1.60% (-7.73% to 4.53%) in the ITT analysis, -2.39% (-8.00% to 3.23%) in the MITT analysis, and -1.72% (-7.29% to 3.85%) in the PP analysis were greater than the predefined noninferiority margin of -10%, establishing a noninferiority of Group VA-10 versus Group VA-14 (noninferiority P = 0.001 in ITT analysis, P < 0.001 in MITT analysis, and P < 0.001 in PP analysis, respectively). No significant differences were observed in adverse events between the two groups. CONCLUSIONS Ten-day VA dual therapy achieves comparable efficacy and safety to the 14-day regimen in Chinese population, providing patients with greater convenience and economic benefits.
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Affiliation(s)
- Aiping Lin
- Department of Gastroenterology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
| | - Zhihui Lin
- Department of Gastroenterology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
| | - Yijuan Liu
- Department of Gastroenterology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
| | - Shuo Chen
- Department of Gastroenterology, Nanping People's Hospital, Nanping, China
| | - Yanfeng Shao
- Department of Gastroenterology, The Third People's Hospital of Fujian Province, Fuzhou, China
| | - Feng Qiu
- Department of Gastroenterology, Fujian Provincial Hospital North Brance Fujian Provincial Geriatric Hospitals, Fuzhou, China
| | - Zhongqin Xiao
- Department of Gastroenterology, Nanping Second Hospital, Nanping, China
| | - Zhangkun Xu
- Department of Gastroenterology, The General Hospital of Fujian Energy Group, Fuzhou, China
| | - Longqun Chen
- Department of Gastroenterology, Jinjiang Second Hospital (Jinjiang Anhai Hospital), Quanzhou, China
| | - Lianghuo Chen
- Department of Gastroenterology, Anxi Country Hospital, Quanzhou, China
| | - Weixing Lin
- Department of Gastroenterology, Fuding City Hospital, Ningde, China
| | - Yongfu Wang
- Department of Gastroenterology, Liancheng Hospital, Longyan, China
| | - Zhonghua Huang
- Department of Gastroenterology, Putian First Hospital, Putian, China
| | - Zhenqun Lin
- Department of Gastroenterology, Zhangzhou Municipal Hospital of TCM, Zhangzhou, China
| | - Xueping Huang
- Department of Gastroenterology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
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Lin X, Huang H, Liu Y, Zeng Y, Lu S, Xu X, Lin Y, Qiu F, Cai F, Pan J, Huang S, Lin S, Lin A, Lin Z, Huang X. Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Prospective, Randomized, Multicenter Study in Fujian, China. Helicobacter 2024; 29:e13151. [PMID: 39523458 DOI: 10.1111/hel.13151] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/22/2024] [Revised: 10/09/2024] [Accepted: 10/20/2024] [Indexed: 11/16/2024]
Abstract
INTRODUCTION Few studies have investigated the efficacy and safety of tegoprazan-amoxicillin (TA) dual therapy for Helicobacter pylori eradication. We aim to evaluate the effectiveness and safety of different dosages of TA dual therapy for H. pylori eradication. METHODS This prospective, randomized, open-label, multicenter study was conducted at four centers in Fujian, China. H. pylori-infective patients were randomized 1:1:1 to receive one of the following treatments: bismuth quadruple therapy (BQT, esomeprazole 20 mg twice daily + potassium bismuth citrate 240 mg twice daily + amoxicillin 1 g twice daily + clarithromycin 500 mg twice daily), tegoprazan-amoxicillin dual therapies (TA-qd, tegoprazan 50 mg once daily + amoxicillin 1 g thrice daily; TA-bid, tegoprazan 50 mg twice daily + amoxicillin 1 g thrice daily) for 14 days. The primary outcome was noninferiority in eradication rates of the different TA groups compared to the BQT group. Secondary outcomes encompassed an assessment of adverse reactions and clinical symptom relief. Additionally, exploratory outcomes were focused on the shifts in gut microbiota and a cost-effectiveness analysis. RESULTS A total of 321 patients were enrolled. The eradication rates in the BQT group, TA-qd group, and TA-bid group were 85.05% (91/107), 85.98% (92/107), and 85.98% (92/107) in the intention-to-treat analysis (ITT) (BQT vs. TA-qd, 95% CI -8.50% to 10.36%, noninferiority p = 0.012; BQT vs. TA-bid, 95% CI -8.50% to 10.36%, noninferiority p = 0.012); 91.00% (91/100), 91.09% (92/101), and 92.93% (92/99) in the modified intention-to-treat analysis (mITT) (BQT vs. TA-qd, 95% CI -7.81% to 7.98%, noninferiority p = 0.006; BQT vs. TA-bid, 95% CI -5.62% to 9.48%, noninferiority p < 0.001); 90.81% (89/98), 91.00% (91/100), and 93.81% (91/97) in the per-protocol analysis (PP) (BQT vs. TA-qd, 95% CI -7.83% to 8.19%, noninferiority p = 0.006; BQT vs. TA-bid, 95% CI 4.46% to 10.46%, noninferiority p < 0.001). The incidence of adverse reactions in the TA-qd and TA-bid groups was significantly lower than in the BQT group (13.33%, 14.56%, and 27.18%, respectively; p = 0.017). The complete remissions of clinical symptoms for BQT, TA-qd, and TA-bid were 36.89%, 65.71%, and 68.93%, respectively, had significant differences (p < 0.001). Two weeks of TA therapy altered gut microbiota diversity and composition, but that recovered 4 weeks after discontinuation. The cost-effectiveness ratios (CERs) for BQT, TA-qd, and TA-bid were 1.85 CNY, 2.08 CNY, and 3.69 CNY, respectively. CONCLUSION Both TA dual therapies provided satisfactory eradication rates of > 90% for eradicating H. pylori, fewer adverse reactions, and greater clinical symptom relief compared to BQT, with a mild, reversible impact on gut microbiota. In addition, the TA dual therapy with low doses of tegoprazan showed better cost-effectiveness. TRIAL REGISTRATION Chinese Clinical Trial Register and registration No.: ChiCTR2300071997.
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Affiliation(s)
- Xueyan Lin
- Department of Gastroenterology, The Shengli Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
- Department of Gastroenterology, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China
| | - Huping Huang
- Department of Gastroenterology, The Shengli Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
- Department of Gastroenterology, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China
| | - Yijuan Liu
- Department of Gastroenterology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
| | - Yanling Zeng
- Department of Gastroenterology, The Shengli Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
- Department of Gastroenterology, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China
| | - Shiyun Lu
- Department of Gastroenterology, The Shengli Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
- Department of Gastroenterology, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China
| | - Xuefeng Xu
- Department of Gastroenterology, The Shengli Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
- Department of Gastroenterology, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China
| | - Yun Lin
- Department of Gastroenterology, The Shengli Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
- Department of Gastroenterology, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China
| | - Feng Qiu
- Department of Gastroenterology, Fujian Provincial Geriatric Hospital, Fuzhou, China
| | - Fangfang Cai
- Department of Gastroenterology, Fujian Provincial Geriatric Hospital, Fuzhou, China
| | - Jie Pan
- Department of Gastroenterology, Pingtan Comprehensive Experimental Area Hospital, Fuzhou, China
| | - Shaozhong Huang
- Department of Gastroenterology, Pingtan Comprehensive Experimental Area Hospital, Fuzhou, China
| | - Shaowei Lin
- School of Public Health, Fujian Medical University, Fuzhou, China
| | - Aiping Lin
- Department of Gastroenterology, The Shengli Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
- Department of Gastroenterology, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China
| | - Zhihui Lin
- Department of Gastroenterology, The Shengli Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
- Department of Gastroenterology, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China
| | - Xueping Huang
- Department of Gastroenterology, The Shengli Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
- Department of Gastroenterology, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China
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Liang JW, Xiong S, Jia YG, Xiao D, Tan SY, Cao JW, Sun J, Tian X, Li SY, Chen RH, Ruan GZ, Xiong JG, Wang XM, Xu SP, Qi LP, Liu YH, Zhao YC, Bai SY, Chen W, Cao MD, Peng W, Li YL, Yang YL, Chen SR, Cui HC, Liu LY, Aruna, Zhou Y, Cheng B. Comparison of vonoprazan bismuth-containing triple therapy with quadruple therapy in Helicobacter pylori-infected treatment-naive patients: a prospective multicenter randomized controlled trial. J Gastroenterol Hepatol 2024; 39:2293-2298. [PMID: 39013587 PMCID: PMC11618220 DOI: 10.1111/jgh.16679] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/19/2024] [Revised: 06/25/2024] [Accepted: 07/04/2024] [Indexed: 07/18/2024]
Abstract
BACKGROUND AND AIM Helicobacter pylori infection is linked to various gastrointestinal conditions, such as chronic active gastritis, peptic ulcers, and gastric cancer. Traditional treatment options encounter difficulties due to antibiotic resistance and adverse effects. Therefore, the aim of this study was to explore the effectiveness of a new treatment plan that combines vonoprazan (VPZ), amoxicillin, and bismuth for the eradication of H. pylori. METHODS A total of 600 patients infected with H. pylori were recruited for this multicenter randomized controlled trial. Patients treated for H. pylori elimination were randomly assigned at a 1:1 ratio to receive 14 days of vonoprazan-based triple therapy (vonoprazan + amoxicillin + bismuth, group A) or standard quadruple therapy (esomeprazole + clarithromycin + amoxicillin + bismuth, group B). Compliance and adverse effects were tracked through daily medication and side effect records. All patients underwent a 13C/14C-urea breath test 4 weeks after treatment completion. RESULTS Intention-to-treat (ITT) and per-protocol (PP) analyses revealed no substantial differences in H. pylori eradication rates between groups A and B (ITT: 83.7% vs 83.2%; PP: 90.9% vs 89.7%). However, significant differences were observed in the assessment of side effects (13.7% vs 28.6%, P < 0.001). Specifically, group A had significantly fewer "bitter mouths" than group B did (3.7% vs 16.2%, P < 0.001). CONCLUSION Triple therapy comprising vonoprazan (20 mg), amoxicillin (750 mg), and bismuth potassium citrate (220 mg) achieved a PP eradication rate ≥90%, paralleling standard quadruple therapy, and had fewer adverse events and lower costs (¥306.8 vs ¥645.8) for treatment-naive patients.
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Affiliation(s)
- Jing Wen Liang
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Si Xiong
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Ye Gui Jia
- Department of GastroenterologyWuhan City Sixth HospitalWuhanChina
| | - Dan Xiao
- Department of GastroenterologyWuhan City Sixth HospitalWuhanChina
| | - Shi Yun Tan
- Department of GastroenterologyHubei General HospitalWuhanChina
| | - Ji Wang Cao
- Department of GastroenterologyHubei General HospitalWuhanChina
| | - Jun Sun
- Department of GastroenterologyHubei General HospitalWuhanChina
| | - Xia Tian
- Department of GastroenterologyWuhan City Third HospitalWuhanChina
| | - Shu Yu Li
- Department of GastroenterologyZhongshan Hospital of Hubei ProvinceWuhanChina
| | - Rui Hong Chen
- Department of GastroenterologyXiantao First People's Hospital Affiliated to Yangtze UniversityXiantaoChina
| | - Gui Zhen Ruan
- Department of GastroenterologyHongan People's HospitalHuanggangChina
| | - Jian Guang Xiong
- Department of GastroenterologyXianning Center HospitalXianningChina
| | - Xiao Ming Wang
- Department of GastroenterologyPanzhihua Municipal Central HospitalPanzhihuaChina
| | - San Ping Xu
- Department of GastroenterologyWuhan Union Hospital of ChinaWuhanChina
| | - Li Ping Qi
- Department of GastroenterologyWuhan Asia Heart HospitalWuhanChina
| | - Yun Hua Liu
- Department of GastroenterologyThe First People's Hospital of Tianmen CityTianmenChina
| | - Yu Chong Zhao
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Shu Ya Bai
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Wei Chen
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Meng Die Cao
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Wang Peng
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Yan Ling Li
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Yi Lei Yang
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Shi Ru Chen
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Hao Chen Cui
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Lu Yao Liu
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Aruna
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
| | - Yi Zhou
- Department of GastroenterologyHubei Provincial Hospital of Traditional Chinese MedicineWuhanChina
| | - Bin Cheng
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
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Zhao YR, Wang XJ, Zhu MJ, Chen AL, Zhang D, Du Q, Kim JJ, Hu WL. Efficacy and safety of low-dose tetracycline, amoxicillin quadruple therapy in Helicobacter pylori infection: A retrospective single center study. World J Gastroenterol 2024; 30:4295-4304. [PMID: 39492823 PMCID: PMC11525849 DOI: 10.3748/wjg.v30.i39.4295] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/14/2024] [Revised: 09/09/2024] [Accepted: 09/24/2024] [Indexed: 10/12/2024] Open
Abstract
BACKGROUND Helicobacter pylori (H. pylori) eradication rates have declined with the rise of antibiotic-resistant strains in recent years. Although highly effective with a low prevalence of resistance, standard dose tetracycline is associated with frequent adverse events. The efficacy and safety of low-dose tetracycline as part of tetracycline and amoxicillin-containing bismuth quadruple therapy are not well described. AIM To compare the efficacy and safety of low-dose compared to standard dose tetracycline with combined amoxicillin-containing bismuth quadruple therapy in patients with H. pylori infection. METHODS Consecutive patients with H. pylori infection receiving tetracycline, amoxicillin, proton pump inhibitor, and bismuth for 14 days at Sir Run Run Shaw Hospital (1/2022-6/2023) were evaluated. The low-dose tetracycline group received tetracycline 500 mg twice daily (bid) while the standard dose group received 750 mg bid or 500 mg three times daily (tid). Primary endpoints were H. pylori eradication rate and treatment-related adverse events. RESULTS The mean age of the 218 patients was 48.7 ± 14.0 years, 120 (55%) were male, and 118 (54.1%) received treatment as primary therapy. Furthermore, 73 (33%) patients received low-dose tetracycline (500 mg bid) and 145 (67%) received standard dose tetracycline including 500 mg tid in 74 (33%) and 750 mg bid in 71 (33%). On intention-to-treat analysis, H. pylori eradication rates were 89% [95% confidence interval (CI): 82%-96%] in the 500 mg bid group, 82% (95%CI: 74%-91%) in the 500 mg tid group, and 79% (95%CI: 69%-89%) in the 750 mg bid group without a statistically significant difference (P = 0.25). The incidence of adverse events was lower in the low-dose compared to the standard dose group (12.3% vs 31.1% or 23.9%; P = 0.02). CONCLUSION Low-dose tetracycline combined with amoxicillin quadruple therapy for 14 days achieved a high eradication rate and fewer adverse events compared to the standard dose tetracycline regimen in patients with H. pylori infection.
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Affiliation(s)
- Yi-Ru Zhao
- Department of Gastroenterology, Sir Run Run Shaw Hospital, Medical School, Zhejiang University, Hangzhou 310016, Zhejiang Province, China
- Department of Gastroenterology, The First Affiliated Hospital, Medical School, Zhejiang University, Hangzhou 310003, Zhejiang Province, China
| | - Xin-Jie Wang
- Department of Gastroenterology, Sir Run Run Shaw Hospital, Medical School, Zhejiang University, Hangzhou 310016, Zhejiang Province, China
| | - Meng-Jia Zhu
- Department of Gastroenterology, Sir Run Run Shaw Hospital, Medical School, Zhejiang University, Hangzhou 310016, Zhejiang Province, China
| | - Ang-Li Chen
- Department of Gastroenterology, Sir Run Run Shaw Hospital, Medical School, Zhejiang University, Hangzhou 310016, Zhejiang Province, China
| | - Dian Zhang
- Department of Gastroenterology, Sir Run Run Shaw Hospital, Medical School, Zhejiang University, Hangzhou 310016, Zhejiang Province, China
| | - Qin Du
- Department of Gastroenterology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou 310000, Zhejiang Province, China
| | - John J Kim
- Keck School of Medicine, University of Southern California, Los Angeles, CA 90089-9021, United States
| | - Wei-Ling Hu
- Department of Gastroenterology, Sir Run Run Shaw Hospital, Medical School, Zhejiang University, Hangzhou 310016, Zhejiang Province, China
- Institute of Gastroenterology, Zhejiang University, Hangzhou 310016, Zhejiang Province, China
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9
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Ye CG, Zhu XJ, Hu N, Wu BH, Fang J, Yang L. Efficacy and safety of high-dose dual therapy in eradicating Helicobacter pylori. Shijie Huaren Xiaohua Zazhi 2024; 32:665-670. [DOI: 10.11569/wcjd.v32.i9.665] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/25/2024] [Revised: 08/21/2024] [Accepted: 09/03/2024] [Indexed: 09/28/2024] Open
Abstract
BACKGROUND The infection rate of Helicobacter pylori (H. pylori) in China remains high, and high-dose dual therapy (HDDT) has been progressively applied in clinical practice and has achieved satisfactory treatment outcomes. This is related to the strong acid inhibition and the full effectiveness of antibiotics. However, there is limited research available on domestically procured drugs.
AIM To evaluate the efficacy and safety of high-dose dual therapy based on domestically procured drugs for eradicating H. pylori.
METHODS A total of 316 patients with newly diagnosed H. pylori infection were consecutively enrolled and randomly divided into two groups: HDDT group (esomeprazole enteric-coated capsules 20 mg qid and amoxicillin 750 mg qid for a total of 14 d) and bismuth-containing quadruple therapy (BQT) (esomeprazole enteric-coated capsules 20 mg bid, potassium citrate bismuth capsules 220 mg bid, amoxicillin 1000 mg bid, and furazolidone 100 mg bid for a total of 14 d). The primary observation index was the H. pylori eradication rate, and the secondary observation indexes were the safety of and patient compliance to the two treatment regimens.
RESULTS Intention-to-treat (ITT) analysis showed that the H. pylori eradication rates in the HDDT and BQT groups were 88.0% and 87.3%, respectively. Modified ITT (MITT) analysis showed H. pylori eradication rates of 91.4% and 92.0% in the two groups, and per-protocol (PP) analysis showed H. pylori eradication rates of 93.3% and 93.9% in the two groups, with no significant difference between the groups (P > 0.05). The incidence of adverse events in the HDDT group was significantly lower than that of the BQT group (P = 0.001). There was no significant difference in treatment compliance between the two groups (P > 0.05).
CONCLUSION HDDT based on domestically procured drugs has a similar eradication rate of H. pylori to BQT, but with a lower incidence of adverse events, making it a good treatment option worth considering in clinical practice.
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Affiliation(s)
- Chang-Gen Ye
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
| | - Xiao-Jia Zhu
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
| | - Na Hu
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
| | - Bai-Hui Wu
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
| | - Jun Fang
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
| | - Li Yang
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
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Kong Q, Mirza IA, Zhang X, Song X, Li X, Zhang Q, Xu L, Guo Y, Yu Y, Zuo X, Li Y, Li Y. Fourteen-Day Tegoprazan-Amoxicillin Dual Therapy as the First-Line Treatment of Helicobacter pylori Infection (SHARE2301): A Multicenter, Noninferiority, Randomized Clinical Trial. Helicobacter 2024; 29:e13098. [PMID: 38853394 DOI: 10.1111/hel.13098] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/03/2024] [Revised: 05/06/2024] [Accepted: 05/19/2024] [Indexed: 06/11/2024]
Abstract
BACKGROUND Potassium-competitive acid blockers have demonstrated enormous potential in the eradication treatment of Helicobacter pylori infection, with tegoprazan being one of the representatives. The available data on the safety and efficacy of tegoprazan in dual therapy are limited. MATERIALS AND METHODS The multicenter, noninferiority, randomized-controlled trial was conducted from May 2023 to March 2024. Treatment-naive subjects were randomly assigned (1:1) to enter either the tegoprazan-amoxicillin (TA) group (tegoprazan 50 mg twice daily and amoxicillin 750 mg four times daily) or the esomeprazole-amoxicillin (EA) group (esomeprazole 20 mg and amoxicillin 750 mg all four times daily), with a duration for 14 days. The primary outcome was eradication rate as determined by 13C-urea breath test, including per-protocol (PP) analysis and intention-to-treat (ITT) analysis. Secondary outcomes were adverse events and compliance. RESULTS A total of 368 individuals were included in the randomization. The eradication rates in the EA group and the TA group were 84.2% and 85.8%, respectively, according to an ITT analysis (p = 0.77), and 88.5% and 88.2%, respectively, according to PP analysis (p = 1.00). The eradication rates for the TA group were not inferior to those of the EA group in both PP (p = 0.0023) and ITT analyses (p = 0.0009). There were no significant statistical differences in the incidence of adverse events and compliance between the two groups. The multivariate logistic regression analysis revealed that poor compliance increased the risk of eradication failure (p < 0.001). CONCLUSIONS Dual therapy containing tegoprazan is safe and effective to be considered as a clinical first-line treatment option, but further optimization involving antimicrobial susceptibility testing and adjustments in dosage and frequency is warranted. TRIAL REGISTRATION ClinicalTrials.gov ID: NCT05870683.
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Affiliation(s)
- Qingzhou Kong
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Iqtida Ahmed Mirza
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Xiaoqian Zhang
- Department of Gastroenterology, Shandong Second Medical University Affiliated Hospital, Weifang, Shandong, China
| | - Xiaohui Song
- Department of Gastroenterology, The People's Hospital of Jimo, Qingdao, Shandong, China
| | - Xiaowei Li
- Department of Gastroenterology, Qilu Hospital of Shandong University Dezhou Hospital, Dezhou, Shandong, China
| | - Qiumei Zhang
- Department of Gastroenterology, Traditional Chinese Medicine Hospital of Yuncheng County, Heze, Shandong, China
| | - Lidong Xu
- Department of Gastroenterology, Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, China
| | - Yuting Guo
- Department of Gastroenterology, The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China
| | - Yanan Yu
- Department of Gastroenterology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
| | - Xiuli Zuo
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Yanqing Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Yueyue Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital of Shandong University, Jinan, Shandong, China
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11
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Wang H, Kong QZ, Li YY, Yang XY, Zuo XL. High-dose dual therapy versus bismuth-containing quadruple therapy for the eradication of Helicobacter pylori: A systematic review and meta-analysis. J Dig Dis 2024; 25:163-175. [PMID: 38577962 DOI: 10.1111/1751-2980.13263] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/23/2023] [Revised: 02/01/2024] [Accepted: 03/06/2024] [Indexed: 04/06/2024]
Abstract
OBJECTIVE To update evidence-based data comparing the efficacy and safety of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) in eradicating Helicobacter pylori infection through meta-analysis. METHODS Multiple databases were systematically searched for randomized controlled trials (RCTs) published up to May 18, 2023. Dichotomous data were evaluated using risk ratio (RR) and 95% confidence interval (CI). Subgroup analysis, sensitivity analysis, risk of bias assessment, and quality of evidence evaluation were performed. RESULTS Twenty RCTs containing 7891 subjects were included in the analysis. There was no statistically significant difference in H. pylori eradication rate between HDDT and BQT in the intention-to-treat (ITT) analysis (86.31% vs 84.88%; RR 1.02, 95% CI 1.00-1.04, P = 0.12). In the per-protocol (PP) analysis, the eradication rates for HDDT and BQT were 90.27% and 89.94%, respectively (RR 1.01, 95% CI 0.99-1.03, P = 0.44). Adverse events were significantly lower with HDDT than with BQT (RR 0.44, 95% CI 0.38-0.51, P < 0.00001). Patient adherence was significantly different between the two groups (RR 1.01, 95% CI 1.00-1.03, P = 0.02). Subgroup analysis based on antibiotic combinations within the BQT group showed a significantly higher eradication rate for HDDT than for BQT only when BQT used amoxicillin combined with clarithromycin (P = 0.0009). CONCLUSIONS HDDT showed comparable efficacy with BQT for H. pylori eradication, with fewer adverse effects and higher compliance. Due to regional differences, antibiotic resistance rates, and combined BQT antibiotics, more studies are needed for further validation and optimization of HDDT.
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Affiliation(s)
- Hui Wang
- Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China
| | - Qing Zhou Kong
- Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China
| | - Yue Yue Li
- Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
| | - Xiao Yun Yang
- Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
| | - Xiu Li Zuo
- Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
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12
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Mi C, Suo B, Tian X, Wang Y, Ma L, Song Z. Application of cefuroxime in the eradication therapy of Helicobacter pylori infection: A review article. Helicobacter 2024; 29:e13073. [PMID: 38601987 DOI: 10.1111/hel.13073] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/07/2024] [Accepted: 03/28/2024] [Indexed: 04/12/2024]
Abstract
BACKGROUND Helicobacter pylori infection and its associated diseases represent a significant global health concern. Patients who cannot use amoxicillin pose a therapeutic challenge and necessitate alternative medications. Preliminary research indicates that cefuroxime demonstrates promising potential for eradicating H. pylori infection, and there is a lack of comprehensive review articles on the use of cefuroxime. MATERIALS AND METHODS This study conducts a thorough systematic literature review and synthesis. A comprehensive systematic search was conducted in PubMed, Web of Science, EMBASE, China National Knowledge Infrastructure, China Biology Medicine disc, and Wanfang Data up to January 13, 2024. The search strategy utilized the following keywords: (Cefuroxime) AND (Helicobacter pylori OR Helicobacter nemestrinae OR Campylobacter pylori OR Campylobacter pylori subsp. pylori OR Campylobacter pyloridis OR H. pylori OR Hp) for both English and Chinese language publications. Sixteen studies from five different countries or regions were included in final literature review. RESULTS Analysis results indicate that H. pylori is sensitive to cefuroxime, with resistance rates similar to amoxicillin being relatively low. Regimens containing cefuroxime have shown favorable eradication rates, which were comparable to those of the regimens containing amoxicillin. Regarding safety, the incidence of adverse reactions in cefuroxime-containing eradication regimens was comparable to that of amoxicillin-containing regimens or other bismuth quadruple regimens, with no significant increase in allergic reactions in penicillin-allergic patients. Regarding compliance, studies consistently report high compliance rates for regimens containing cefuroxime. CONCLUSION Cefuroxime can serve as an alternative to amoxicillin for the patients allergic to penicillin with satisfactory efficacies, safety, and compliance.
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Affiliation(s)
- Changmin Mi
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Baojun Suo
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Xueli Tian
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Yuxin Wang
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Lingling Ma
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Zhiqiang Song
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
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13
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Zhou BG, Jiang X, Ding YB, She Q, Li YY. Vonoprazan-amoxicillin dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: A systematic review and meta-analysis. Helicobacter 2024; 29:e13040. [PMID: 37983865 DOI: 10.1111/hel.13040] [Citation(s) in RCA: 7] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/20/2023] [Revised: 11/08/2023] [Accepted: 11/09/2023] [Indexed: 11/22/2023]
Abstract
BACKGROUND AND OBJECTIVE Recently, vonoprazan-amoxicillin (VA) dual therapy has been reported as a promising approach for Helicobacter pylori (H. pylori) eradication. However, the effects of VA therapy versus bismuth-containing quadruple therapy (BQT) on H. pylori eradication remains unclear. The objective of this meta-analysis was to compare the effects of VA dual therapy with BQT for H. pylori eradication. METHODS A comprehensive search of the literature was conducted from the beginning to September 2023, utilizing PubMed, Embase, the Cochrane Library and Web of Science database. A random-effects model was used to perform a meta-analysis to determine the pooled relative risk (RR) with 95% confidence intervals (CIs). Moreover, trial sequential analysis (TSA) was conducted to evaluate the conclusiveness of the H. pylori eradication rate. RESULTS Six randomized controlled trials (RCTs) with 1233 patients were included. The VA therapy has similar eradication rate (ITT analysis: 87% vs. 85.7%, RR = 1.01, 95% CI: 0.93-1.09, p = 0.84; PP analysis: 92.5% vs. 93.2%, RR = 1.00, 95% CI: 0.94-1.06, p = 0.97) and compliance (RR = 1.01, 95% CI: 0.99-1.03, p = 0.32) compared to BQT. The VA therapy group had a significantly lower incidence of total adverse events than the BQT group (16.3% vs. 40.0%, RR = 0.45, 95% CI: 0.37-0.55, p < 0.00001). The TSA result showed that the effect was conclusive. CONCLUSIONS Current evidence indicated that VA therapy is just as successful as BQT in eliminating H. pylori, yet it has fewer adverse events and similar compliance.
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Affiliation(s)
- Ben-Gang Zhou
- Dalian Medical University, Dalian, China
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China
| | - Xin Jiang
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China
| | - Yan-Bing Ding
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China
| | - Qiang She
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China
| | - Yao-Yao Li
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China
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Li CL, Zhou K, Zhang YX, Suo BJ, Tian XL, Zhang YX, Ren XL, Shi YY, Zhou LY, Song ZQ. Tailored therapy guided by genotypic resistance of clarithromycin and levofloxacin detected by polymerase chain reaction in the first-line treatment of Helicobacter pylori infection. J Dig Dis 2024; 25:36-43. [PMID: 38323705 DOI: 10.1111/1751-2980.13250] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/22/2023] [Revised: 12/28/2023] [Accepted: 01/08/2024] [Indexed: 02/08/2024]
Abstract
OBJECTIVES We aimed to explore the efficacy and safety of tailored therapy guided by genotypic resistance in the first-line treatment of Helicobacter pylori (H. pylori) infection in treatment-naive patients. METHODS Gastric mucosal specimens were taken during gastroscopy, and main mutations of clarithromycin- and levofloxacin-resistant genes were detected by polymerase chain reaction (PCR). Sensitive antibiotics were selected individually for treating H. pylori infection with tailored bismuth-containing quadruple therapy (BQT) consisting of esomeprazole 20 mg twice daily, bismuth potassium citrate 220 mg twice daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily, or levofloxacin 500 mg once daily, or metronidazole 400 mg four times daily. Safety and patient compliance were assessed 1-3 days after eradication. Treatment outcome was evaluated by urea breath test 4-8 weeks after eradication. RESULTS One hundred and thirty-two treatment-naive patients with H. pylori infection were included. PCR results suggested resistance rates of 47.7% and 34.9% for clarithromycin and levofloxacin, respectively, and a dual resistance rate of 18.2%. Eradication rates of tailored BQT were 87.1% and 95.8% by intention-to-treat (ITT) analysis and per-protocol (PP) analysis, respectively. There was no statistically significant difference in the efficacy of 7-day clarithromycin-containing, 7-day levofloxacin-containing, and 14-day full-dose metronidazole-containing BQT (ITT analysis: P = 0.488; PP analysis: P = 0.833). The incidence of adverse events was 19.7%, and patient compliance was 97.7%. CONCLUSION Tailored BQT guided by genotypic resistance can achieve satisfactory efficacy, safety, and patient compliance in the first-line treatment of H. pylori infection.
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Affiliation(s)
- Cai Ling Li
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Kai Zhou
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Yue Xi Zhang
- Department of Gastroenterology, Beijing No. 6 Hospital, Beijing, China
| | - Bao Jun Suo
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Xue Li Tian
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Yu Xin Zhang
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Xin Lu Ren
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Yan Yan Shi
- Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China
| | - Li Ya Zhou
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Zhi Qiang Song
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
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Wu X, Duan M, Kong Q, Zeng S, Xu L, Li Y, Yang X, Zuo X. Clarifying varied Helicobacter pylori eradication therapies: A comprehensive review. Helicobacter 2024; 29:e13048. [PMID: 38716864 DOI: 10.1111/hel.13048] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/25/2023] [Revised: 11/30/2023] [Accepted: 12/12/2023] [Indexed: 05/24/2024]
Abstract
Current global variations exist in Helicobacter pylori (H. pylori) eradication regimens. Triple therapy (TT), bismuth quadruple therapy (BQT), and high-dose dual therapy (HDDT) currently represent the predominant regimens. These regimens diverge in terms of treatment duration, the utilization of susceptibility testing, acid-inhibiting drug administration, and patient education. We conducted a comprehensive systematic literature review on these H. pylori treatment regimens. Our review aims to provide standardized treatment recommendations for H. pylori, reducing the risk of amalgamating findings from diverse eradication regimens. Recent research suggests that the optimal treatment duration for TT and BQT may be 14 and 10 days, respectively. Selecting the appropriate treatment duration for HDDT should rely on regional research evidence, and 14 days may be the optimal duration. The incorporation of susceptibility testing in TT is of paramount importance. In the case of BQT, the absence of susceptibility testing may be considered as an option, contingent upon cost and availability, and should be determined based on local antibiotic resistance patterns and the efficacy of empirical regimens. The type and dosage of acid-inhibiting drug would affect the efficacy of these regimens. Acid-inhibiting drugs should be selected and applied reasonably according to the population and therapies. Adequate patient education plays a pivotal role in the eradication of H. pylori. In regions with accessible local research evidence, the 10-day empirical BQT regimen may be considered a preferred choice for H. pylori eradication.
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Affiliation(s)
- Xiaoqi Wu
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Miao Duan
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Qingzhou Kong
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Shuyan Zeng
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Leiqi Xu
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Yueyue Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Xiaoyun Yang
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Xiuli Zuo
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
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Guan JL, Feng LN, Han YY, Xia SH, Zhao K, Zhang MY, Zhang Y, Dong RN, Huang YJ, Li JY, Liao JZ, Li PY. Global research trends and hotspots of Helicobacter pylori eradication based on clinical trial registration platforms: A cross-sectional analysis. Clin Res Hepatol Gastroenterol 2023; 47:102233. [PMID: 37879535 DOI: 10.1016/j.clinre.2023.102233] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/22/2023] [Revised: 10/15/2023] [Accepted: 10/23/2023] [Indexed: 10/27/2023]
Abstract
BACKGROUND This study aimed to obtain an overview of clinical trials on Helicobacter pylori (H. pylori) eradication and analyze the global trends and hotspots in this field. METHODS We collected the data from clinical trials focused on H. pylori eradication in the primary clinical trial registries from 2000 to 2022 in the world. Then we analyzed the research trends and hotspots in H. pylori eradication regimens in different regions at different periods. RESULTS A total of 780 clinical trials were included, which were mainly conducted in Asia (682), followed by Europe (59), Africa (20), North America (16), South America (7), Oceania (2). The most active countries were China (343), Iran (140), South Korea (63), and Japan (73). "Bismuth-containing quadruple therapy (BQT)" was the most studied regimen (159, 20.38 %). Additionally, clinical trials focused on potassium-competitive acid blockers (P-CABs)-based therapy, probiotics, and high-dose dual therapy (HDDT) were constantly increasing. BQT received the most attention in China (26.53 %) and Iran (22.14 %), while it was tailored therapy in South Korea (23.29 %). P-CABs-based therapy was the main reseach hotspot in Japan (61.90 %). CONCLUSION How to eradicate H. pylori infection has been a heated research topic. BQT, P-CABs-based therapy, probiotics, and HDDT attracted the most attention in recent years.
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Affiliation(s)
- Jia-Lun Guan
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Li-Na Feng
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ying-Ying Han
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Su-Hong Xia
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Kai Zhao
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ming-Yu Zhang
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Yu Zhang
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ruo-Nan Dong
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Yu-Jie Huang
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ji-Yan Li
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Jia-Zhi Liao
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
| | - Pei-Yuan Li
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Department of Gastroenterology, Wenchang People's Hospital, Wenchang, China.
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Han YY, Zhou L, Hu YL, Ding XW, Long H, Liu F, Xu M, Zhang ZY, Li SL, Wang QY, Su CX, Chen Y, Chen J, Lin Y, Li PY. Comparison of vonoprazan-based with rabeprazole-based dual therapy for treatment-naive patients of Helicobacter pylori infection: a prospective, multi-center, randomized controlled study. J Gastroenterol 2023; 58:1167-1177. [PMID: 37777987 DOI: 10.1007/s00535-023-02042-2] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/12/2023] [Accepted: 09/03/2023] [Indexed: 10/03/2023]
Abstract
BACKGROUND The application of vonoprazan significantly improved the eradication rate of Helicobacter pylori (H. pylori). This study aimed to compare efficacy and safety of the 10-day vonoprazan-amoxicillin (VA) and 14-day rabeprazole-amoxicillin (RA) dual therapy, and to provide a more efficient, safer, and convenient dual regimen for H. pylori infection. METHODS This was a prospective, open-label, multi-center, randomized controlled study of treatment-naive patients with H. pylori infection. The participants were randomly assigned to the 10-day VA group with vonoprazan 20 mg Bid plus amoxicillin 1 g Tid or the 14-day RA group with rabeprazole 10 mg Tid plus amoxicillin 1 g Tid. The effectiveness, the adverse events, and the patient compliance of the two groups were compared. RESULTS A total of 690 patients were enrolled. The eradication rates of 10-day VA and 14-day RA dual therapy were 89.3% and 84.9% in intention-to-treat (ITT) analysis (P = 0.088); 90.6% and 85.9% by modified intention-to-treat (mITT) analysis (P = 0.059); 91.4% and 86.6% by per-protocol (PP) analysis (P = 0.047). Non-inferiority was confirmed between the two groups (all P < 0.001). No discernible differences were observed in adverse effects and compliance between groups. Poor compliance reduced the eradication efficacy (P < 0.05). CONCLUSIONS The 10-day VA dual therapy was non-inferior to the 14-day RA dual therapy for H. pylori treatment-naive patients, which should be given priority in the first-line treatment. The application of vonoprazan reduced treatment course and antibiotic use. Patients' adherence was crucial for the success of eradication.
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Affiliation(s)
- Ying-Ying Han
- Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China
| | - Lin Zhou
- Department of Gastroenterology, Suizhou Central Hospital, Suizhou, China
| | - Yun-Lian Hu
- Department of Gastroenterology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China
| | - Xiang-Wu Ding
- Department of Gastroenterology, Wuhan Fourth Hospital, Wuhan, China
| | - Hui Long
- Department of Gastroenterology, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, China
| | - Fei Liu
- Department of Gastroenterology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China
| | - Ming Xu
- Department of Gastroenterology, Shanghai Pudong New Area People's Hospital, Shanghai, China
| | - Zhen-Yu Zhang
- Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Shuang-Ling Li
- Department of Gastroenterology, Suizhou Central Hospital, Suizhou, China
| | - Qiu-Yan Wang
- Department of Gastroenterology, Wenchang People's Hospital, 42 Wenqing Avenue, Wenchang, 571321, China
| | - Cheng-Xia Su
- Department of Gastroenterology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China
| | - Yan Chen
- Department of Gastroenterology, Wuhan Fourth Hospital, Wuhan, China
| | - Jie Chen
- Department of Gastroenterology, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, China
| | - Ya Lin
- Department of Gastroenterology, Wenchang People's Hospital, 42 Wenqing Avenue, Wenchang, 571321, China.
| | - Pei-Yuan Li
- Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China.
- Department of Gastroenterology, Wenchang People's Hospital, 42 Wenqing Avenue, Wenchang, 571321, China.
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Peng X, Chen HW, Wan Y, Su PZ, Yu J, Liu JJ, Lu Y, Zhang M, Yao JY, Zhi M. Combination of vonoprazan and amoxicillin as the first-line Helicobacter pylori eradication therapy: a multicenter, prospective, randomized, parallel-controlled study. Clin Exp Med 2023; 23:4011-4019. [PMID: 37115412 DOI: 10.1007/s10238-023-01074-5] [Citation(s) in RCA: 21] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/03/2023] [Accepted: 04/09/2023] [Indexed: 04/29/2023]
Abstract
The eradication rate of Helicobacter pylori (H. pylori) decreased gradually. This study aimed to analyze the efficacy and safety of a 14-day combination of vonoprazan and amoxicillin as the first-line eradication therapy for H. pylori infection and compared them with those of the bismuth quadruple therapy. A prospective randomized clinical trial (RCT) was designed, involving patients with H. pylori infection in 6 institutions who did not receive any treatment yet. They were randomly assigned into the VA-dual group (vonoprazan 20 mg b.i.d + amoxicillin 750 mg q.i.d) or EACP-quadruple group (esomeprazole 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg + colloidal bismuth subcitrate 220 mg b.i.d) for 14 days in a ratio of 1:1. At least 28 days later, the eradication rate was detected by the 13C-urea breath test (UBT). A total of 562 patients from February 2022 to September 2022 were enrolled and 316 were random. In the ITT analysis, the eradication rates of H. pylori in the VA-dual group and EACP-quadruple group were 89.9% and 81.0%, respectively, p = 0.037. In the PP analysis were 97.9% and 90.8%, p = 0.009. The different eradication rate was 8.9% (95% CI 1.2-16.5%) and 7.2% (95% CI 1.8-12.4%) in ITT and PP analyses, both lower limit of the 95%CI was still higher than the prespecified margin. In addition, the incidence of adverse events in the VA-dual group was significantly lower than that in the EACP-quadruple group (19.0% vs. 43.0%, P < 0.001). The efficacy and safety of a 14-day combination therapy of vonoprazan and amoxicillin in eradicating H. pylori are superior to bismuth quadruple therapy, and this combination significantly reduces the use of antibiotics.
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Affiliation(s)
- Xiang Peng
- Department of Gastroenterology, the Sixth Affiliated Hospital, Sun Yat-sen University, 26 Erheng Road, Yuancun, Tianhe District, Guangzhou, 510655, Guangdong, People's Republic of China
- Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China
| | - Huang-Wei Chen
- Department of Gastroenterology, Nanhai District People's Hospital of Foshan, Foshan, Guangdong, People's Republic of China
| | - Yu Wan
- Department of Gastroenterology, Panyu Central Hospital, Guangzhou, Guangdong, People's Republic of China
| | - Pei-Zhu Su
- Department of Gastroenterology, The First People's Hospital of Foshan, Foshan, Guangdong, People's Republic of China
| | - Jing Yu
- Department of Gastroenterology, The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, People's Republic of China
| | - Jun-Jun Liu
- Department of Gastroenterology, Foshan Fosun Chang Cheng Hospital, Foshan, Guangdong, People's Republic of China
| | - Yi Lu
- Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China
- Department of Gastrointestinal Endoscopy, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China
| | - Min Zhang
- Department of Gastroenterology, the Sixth Affiliated Hospital, Sun Yat-sen University, 26 Erheng Road, Yuancun, Tianhe District, Guangzhou, 510655, Guangdong, People's Republic of China
- Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China
| | - Jia-Yin Yao
- Department of Gastroenterology, the Sixth Affiliated Hospital, Sun Yat-sen University, 26 Erheng Road, Yuancun, Tianhe District, Guangzhou, 510655, Guangdong, People's Republic of China.
- Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.
| | - Min Zhi
- Department of Gastroenterology, the Sixth Affiliated Hospital, Sun Yat-sen University, 26 Erheng Road, Yuancun, Tianhe District, Guangzhou, 510655, Guangdong, People's Republic of China.
- Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.
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Wang X, Teng G, Dong X, Dai Y, Wang W. Efficacy and safety of vonoprazan-amoxicillin dual therapy for Helicobacter pylori first-line treatment: a single-center, randomized, controlled trial. Therap Adv Gastroenterol 2023; 16:17562848231190976. [PMID: 37664169 PMCID: PMC10469240 DOI: 10.1177/17562848231190976] [Citation(s) in RCA: 17] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2023] [Accepted: 07/13/2023] [Indexed: 09/05/2023] Open
Abstract
Background With the increase in antibiotic resistance, the success rate of Helicobacter pylori (H. pylori) eradication therapy has declined in recent years. Vonoprazan-amoxicillin (VA) dual therapy has been reported to be a promising regimen. Objectives To compare the efficacy and safety of VA dual therapy and bismuth quadruple therapy containing amoxicillin and clarithromycin for H. pylori first-line eradication, and to further analyze the effects of clarithromycin resistance on eradication rate. Design This study was a single-center, open-label, randomized controlled trial. Methods Treatment-naïve H. pylori-infected patients were randomly allocated 1:1 to the VA group (vonoprazan 20 mg twice daily and amoxicillin 750 mg four times daily, for 14 days) or the RBAC group (rabeprazole 10 mg, bismuth potassium citrate 220 mg, amoxicillin 1000 mg and clarithromycin 500 mg twice daily, for 14 days). H. pylori clarithromycin resistance and CYP2C19 gene polymorphisms were detected with real-time polymerase chain reaction (PCR) technique. The eradication rates and adverse events were analyzed. Results A total of 151 patients were enrolled. The intention-to-treat (ITT), modified intention-to-treat (mITT), and per-protocol (PP) eradication rates and their 95% confidence intervals (95% CIs) were 94.6% (86.0-98.3%), 98.6% (91.3-99.9%), and 98.5% (90.9-99.9%) for VA group and 87.0% (77.0-93.3%), 91.8% (82.3-96.6%), and 93% (83.7-97.4%) for RBAC group. The eradication rate of the VA group was noninferior to the RBAC group in ITT, mITT, and PP analyses (p < 0.0001). In patients infected with strains of clarithromycin resistance point mutation, the eradication rate of the RBAC group decreased to lower than 90%, but the difference from the VA group did not achieve statistical significance (ITT eradication rate: 81.5% in the RBAC group and 96.2% in the VA group, p = 0.192). The incidence of adverse events in the VA group was 39.2%, which was significantly lower than that in the RBAC group (79.2%, p = 0.000). Conclusion The efficacy of VA dual therapy is noninferior to RBAC in H. pylori first-line eradication, with fewer adverse reactions. Registration This study was registered at the Chinese Clinical Trial Registry (ChiCTR2100052550) on 30 October 2021.
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Affiliation(s)
- Xiaolei Wang
- Department of Gastroenterology, Peking University First Hospital, Beijing, China
| | - Guigen Teng
- Department of Gastroenterology, Peking University First Hospital, Beijing, China
| | - Xinhong Dong
- Department of Gastroenterology, Peking University First Hospital, Beijing, China
| | - Yun Dai
- Department of Gastroenterology, Peking University First Hospital, Beijing, China
| | - Weihong Wang
- Department of Gastroenterology, Peking University First Hospital, No.8 Xishiku Street, Beijing 100034, China
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Zhang XD, Zhang DY, Chen RX, Chen SJ, Chen C, Zeng F, Huang SM, Li D, Bai FH. Ilaprazole-amoxicillin dual therapy at high dose as a first-line treatment for helicobacter pylori infection in Hainan: a single-center, open-label, noninferiority, randomized controlled trial. BMC Gastroenterol 2023; 23:249. [PMID: 37488516 PMCID: PMC10364389 DOI: 10.1186/s12876-023-02890-5] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/26/2023] [Accepted: 07/17/2023] [Indexed: 07/26/2023] Open
Abstract
OBJECTIVES This study aimed to evaluate the efficacy, adverse events, patient compliance, and cost of dual therapy with Ilaprazole-amoxicillin (IA) at high dose versus Ilaprazole-amoxicillin-furazolidone-bismuth (IAFB) quadruple therapy for the Helicobacter pylori (H.pylori) infection among Chinese patients. METHODS 200 patients who had tested positive for H. pylori and undergoing upper gastrointestinal endoscopy after being diagnosed with chronic gastritis participated in this open-label randomized controlled clinical trial. Patients were randomized to Group A and Group B: the 14-day IA dual treatment group (101) and IAFB quadruple treatment group (99). The 13 C urea breath test was conducted to determine whether H. pylori had been eliminated 4-6 weeks after the treatment. Eradication rates, drug-related adverse events, patient compliance, and drug costs were compared between the two treatment groups. RESULTS Eradication rates in group A were 92.1% and 94.9%, depending on the intention-to-treat (ITT), per-protocol (PP), respectively, which was similar to group B (91.9% and 93.6%). There was no significant difference observed in adverse events between the two groups (P = 0.518). Interestingly, compliance was significantly higher in group A compared to the group B (P = 0.031). In addition, drug costs were significantly lower for group A in comparison to the group B. CONCLUSIONS IA dual therapy was found to be equally effective, safer and less costly than IAFB quadruple therapy. Therefore, these therapies can be potentially considered as first-line regimens for empirical treatment.
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Affiliation(s)
| | - Da-Ya Zhang
- Graduate School, Hainan Medical University, Haikou, China
| | - Run-Xiang Chen
- Graduate School, Hainan Medical University, Haikou, China
| | - Shi-Ju Chen
- Graduate School, Hainan Medical University, Haikou, China
| | - Chen Chen
- Graduate School, Hainan Medical University, Haikou, China
| | - Fan Zeng
- Graduate School, Hainan Medical University, Haikou, China
| | - Shi-Mei Huang
- Graduate School, Hainan Medical University, Haikou, China
| | - Da Li
- Graduate School, Hainan Medical University, Haikou, China
| | - Fei-Hu Bai
- Department of Gastroenterology, The Second Affiliated Hospital of Hainan Medical University, Yehai Avenue, #368, Longhua District, Haikou, Hainan Province China
- The Gastroenterology Clinical Medical Center of Hainan Province, Haikou, China
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Suo B, Tian X, Zhang H, Lu H, Li C, Zhang Y, Ren X, Yao X, Zhou L, Song Z. Bismuth, esomeprazole, metronidazole, and minocycline or tetracycline as a first-line regimen for Helicobacter pylori eradication: A randomized controlled trial. Chin Med J (Engl) 2023; 136:933-940. [PMID: 37010246 PMCID: PMC10278689 DOI: 10.1097/cm9.0000000000002629] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/09/2022] [Indexed: 04/04/2023] Open
Abstract
BACKGROUND Given the general unavailability, common adverse effects, and complicated administration of tetracycline, the clinical application of classic bismuth quadruple therapy (BQT) is greatly limited. Whether minocycline can replace tetracycline for Helicobacter pylori ( H . pylori ) eradication is unknown. We aimed to compare the eradication rate, safety, and compliance between minocycline- and tetracycline-containing BQT as first-line regimens. METHODS This randomized controlled trial was conducted on 434 naïve patients with H . pylori infection. The participants were randomly assigned to 14-day minocycline-containing BQT group (bismuth potassium citrate 110 mg q.i.d., esomeprazole 20 mg b.i.d., metronidazole 400 mg q.i.d., and minocycline 100 mg b.i.d.) and tetracycline-containing BQT group (bismuth potassium citrate/esomeprazole/metronidazole with doses same as above and tetracycline 500 mg q.i.d.). Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed at 4-8 weeks after eradication to evaluate outcome. We used a noninferiority test to compare the eradication rates of the two groups. The intergroup differences were evaluated using Pearson chi-squared or Fisher's exact test for categorical variables and Student's t -test for continuous variables. RESULTS As for the eradication rates of minocycline- and tetracycline-containing BQT, the results of both intention-to-treat (ITT) and per-protocol (PP) analyses showed that the difference rate of lower limit of 95% confidence interval (CI) was >-10.0% (ITT analysis: 181/217 [83.4%] vs . 180/217 [82.9%], with a rate difference of 0.5% [-6.9% to 7.9%]; PP analysis: 177/193 [91.7%] vs . 176/191 [92.1%], with a rate difference of -0.4% [-5.6% to 6.4%]). Except for dizziness more common (35/215 [16.3%] vs . 13/214 [6.1%], P = 0.001) in minocycline-containing therapy groups, the incidences of adverse events (75/215 [34.9%] vs . 88/214 [41.1%]) and compliance (195/215 [90.7%] vs . 192/214 [89.7%]) were similar between the two groups. CONCLUSION The eradication efficacy of minocycline-containing BQT was noninferior to tetracycline-containing BQT as first-line regimen for H . pylori eradication with similar safety and compliance. TRIAL REGISTRATION ClinicalTrials.gov, ChiCTR 1900023646.
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Affiliation(s)
- Baojun Suo
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
| | - Xueli Tian
- Digestive Disease Research Center of Peking University, Beijing 100191, China
| | - Hua Zhang
- Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China
| | - Haoping Lu
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
| | - Cailing Li
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
| | - Yuxin Zhang
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
| | - Xinlu Ren
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
| | - Xingyu Yao
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
| | - Liya Zhou
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
| | - Zhiqiang Song
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
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Liu DN, Wang QY, Li PY, Wu DH, Pan J, Chen ZY, Li YQ, Han XY, Lan C, Tang J, Tan Y, Mo CY, Yang WZ, Han JL, Huang XX. Comparing high-dose dual therapy with bismuth-containing quadruple therapy for the initial eradication of Helicobacter pylori infection on Hainan Island: a randomized, multicenter clinical trial. Clin Res Hepatol Gastroenterol 2023; 47:102125. [PMID: 37062356 DOI: 10.1016/j.clinre.2023.102125] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/27/2023] [Revised: 04/06/2023] [Accepted: 04/14/2023] [Indexed: 04/18/2023]
Abstract
BACKGROUND Traditional bismuth-containing quadruple therapy, as a first-line eradication treatment for Helicobacter pylori (H. pylori), has several disadvantages, including drug side effects, low medication adherence, and high costs. Trials of high-dose dual treatment have demonstrated its advantages, which include good safety and adherence profiles. In this study, we investigated the efficacy, safety, and compliance of a high-dose dual therapy when compared with bismuth-based quadruple treatment for the initial eradication of H. pylori infection on Hainan Island, China. METHODS We randomized 846 H. pylori-infected patients into two groups. A bismuth-containing quadruple therapy group was administered the following: esomeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg twice daily, and colloidal bismuth pectin in suspension 150 mg three times/day for 2 weeks. A high-dose dual therapy group was administered the following: esomeprazole 20 mg four times/day and amoxicillin 1000 mg three times/day for 2 weeks. Patients were given a 13C urea breath test at 4 weeks at treatment end. Adverse effects and compliance were evaluated at follow-up visits. RESULTS Eradication rates in the high-dose dual therapy group were: 90.3% (381/422, 95% confidence interval [CI]: 87.1%-92.9%) in intention-to-treat (ITT) and 93.6% (381/407, 95% CI: 90.8%-95.8%) in per-protocol (PP) analyses. Eradication rates were 87.3% in ITT (370/424, 95% CI: 83.7%-90.3%) and 91.8% in PP analyses (370/403, 95% CI: 88.7%-94.3%) for quadruple therapy, with no statistical differences (P = 0.164 in ITT and P = 0.324 in PP analyses). Adverse effects were 13.5% (55/407) in the dual group and 17.4% (70/403) in the quadruple group (P = 0.129). Compliance was 92.4% (376/407) in the dual group and 86.6% (349/403) in the quadruple group (P = 0.007). CONCLUSIONS High-dose dual therapy had high eradication rates comparable with bismuth-based quadruple treatment, with no differences in adverse effects, however higher adherence rates were recorded.
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Affiliation(s)
- Dan-Ni Liu
- Department of Gastroenterology, Central South University Xiangya School of Medicine Affiliated Haikou Hospital, Haikou, China
| | - Qiu-Yan Wang
- Department of Gastroenterology, Tongji Wenchang Hospital of Huazhong University of Science and Technology, Wenchang, China
| | - Pei-Yuan Li
- Department of Gastroenterology, Tongji Wenchang Hospital of Huazhong University of Science and Technology, Wenchang, China
| | - Dong-Han Wu
- Department of Gastroenterology, Sanya Municipal People's Hospital, Sanya, China
| | - Jing Pan
- Department of Gastroenterology, Central South University Xiangya School of Medicine Affiliated Haikou Hospital, Haikou, China
| | - Zheng-Yi Chen
- Department of Gastroenterology, Central South University Xiangya School of Medicine Affiliated Haikou Hospital, Haikou, China
| | - Yan-Qiang Li
- Department of Gastroenterology, Wanning Municipal People's Hospital, Wanning, China
| | - Xiang-Yang Han
- Department of Gastroenterology, Hainan Provincial People's Hospital, Haikou, China
| | - Cheng Lan
- Department of Gastroenterology, Hainan Provincial People's Hospital, Haikou, China
| | - Jing Tang
- Department of Gastroenterology, The First Affiliated Hospital of Hainan Medical College, Haikou, China
| | - Yan Tan
- Department of Gastroenterology, The First Affiliated Hospital of Hainan Medical College, Haikou, China
| | - Cui-Yi Mo
- Department of Gastroenterology, Qionghai Municipal People's Hospital, Qionghai, China
| | - Wei-Zhong Yang
- Department of Gastroenterology, The Second Affiliated Hospital of Hainan Medical College, Haikou, China
| | - Jun-Ling Han
- Department of Gastroenterology, 928th Hospital of Joint service support force of the Chinese People's Liberation Army, Haikou, China
| | - Xiao-Xi Huang
- Department of Gastroenterology, Central South University Xiangya School of Medicine Affiliated Haikou Hospital, Haikou, China.
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23
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Guan JL, Han YY, Wang MR, Xia SH, Li JY, Zhang MY, Zhao K, Feng LN, Zhang Y, Dong RN, Liao JZ, Li PY. Impact of body size on efficacy of high-dose dual therapy for Helicobacter pylori eradication. Helicobacter 2023; 28:e12953. [PMID: 36738099 DOI: 10.1111/hel.12953] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/12/2022] [Revised: 01/11/2023] [Accepted: 01/15/2023] [Indexed: 02/05/2023]
Abstract
BACKGROUND High-dose dual therapy (HDDT) is an emerging and promising therapeutic regime for Helicobacter pylori (H. pylori) eradication. However, the pharmacokinetics of the components of HDDT, amoxicillin and proton pump inhibitor, are likely to be affected by body size. In this study, we aimed to find out the impact of body size on the efficacy of HDDT. METHODS We collected the medical data of 385 treatment-naive patients infected with H. pylori who received HDDT (esomeprazole 20 mg and amoxicillin 750 mg four times daily) for 14 days from July 2020 to December 2021. The associations among the eradication efficacy, adverse events, and variables (sex, age, height, body weight, body mass index (BMI), body surface area (BSA), smoking, drinking, etc.) were analyzed respectively in our study. Among these factors, continuous variables were classified into categorical variables using the cut-off values which were calculated by receiver operating characteristic analysis. RESULTS The eradication rate of HDDT was 89.9%. There were 55 (14.3%) patients who occurred adverse events during the treatment. Patients with height <170.5 cm, body weight <60.5 kg, BMI <20.55 kg/m2 , BSA <1.69 m2 had a higher eradication rate (92.1% vs. 84.0%, 93.1% vs. 86.8%, 96.0% vs. 87.8%, 93.4% vs. 84.8%, all p < .05). The multivariate analysis showed that BSA ≥1.69 m2 (OR 2.53, 95% CI: 1.28-4.99, p = .007) was the only independent predictor of eradication failure. CONCLUSION HDDT could achieve better eradication efficacy in patients with small BSA. Clinicians should be aware of the impact of BSA on the H. pylori eradication rate and pay more attention to patients with large BSA.
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Affiliation(s)
- Jia-Lun Guan
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ying-Ying Han
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Mu-Ru Wang
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Su-Hong Xia
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ji-Yan Li
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ming-Yu Zhang
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Kai Zhao
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Li-Na Feng
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Yu Zhang
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ruo-Nan Dong
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Jia-Zhi Liao
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Pei-Yuan Li
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.,Department of Gastroenterology, Wenchang People's Hospital, Wenchang, China
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24
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Zhang Y, Suo B, Tian X, Zhang H, Lu H, Yao X, Li C, Ren X, Zhou L, Song Z. New regimens as first-line eradication therapy for Helicobacter pylori infection in patients allergic to penicillin: A randomized controlled trial. Helicobacter 2023; 28:e12956. [PMID: 36752304 DOI: 10.1111/hel.12956] [Citation(s) in RCA: 12] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/26/2022] [Revised: 01/25/2023] [Accepted: 01/27/2023] [Indexed: 02/09/2023]
Abstract
BACKGROUND Helicobacter pylori eradication in penicillin-allergic patients is challenging. The effective regimen is lacking in areas with high antibiotic resistance and tetracycline unavailable. Minocycline, cefuroxime, and full-dose metronidazole are promising drugs. AIMS To compare the eradication rate, safety, and compliance among three new bismuth quadruple therapies for first-line H. pylori eradication in penicillin-allergic patients. METHODS This randomized trial was conducted on 450 naive patients with H. pylori infection and penicillin allergy. The 14-day minocycline-metronidazole-containing (minocycline 100 mg twice daily and metronidazole 400 mg four times/day), minocycline-cefuroxime-containing (minocycline 100 mg twice daily and cefuroxime 500 mg twice daily), and cefuroxime-metronidazole-containing (cefuroxime 500 mg twice daily and metronidazole 400 mg four times/day) bismuth quadruple therapies were randomly assigned to the participants. Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed 4-8 weeks after eradication to evaluate outcome. RESULTS The differences of eradication rates in either intention-to-treat (84.0%, 82.7%, and 23 82.0%, p = .896) or per-protocol (91.7%, 90.9%, and 88.2%, p = .599) analysis among minocycline-metronidazole, minocycline-cefuroxime, and cefuroxime-metronidazole-containing bismuth quadruple therapies were statistically insignificant. The incidence of adverse events (35.1%, 22.6%, and 28.9%) and compliance (90.5%, 91.8%, and 91.9%) were similar. Taste distortion, nausea, and anorexia were more common in metronidazole-containing regimens, and dizziness was more common in minocycline-containing regimens. The allergy was rare (~3%). CONCLUSIONS The efficacies of three bismuth quadruple therapies containing minocycline, cefuroxime, and full-dose metronidazole (pairwise) for first-line H. pylori eradication in penicillin-allergic patients were similarly satisfactory with relatively good safety and compliance. The study was registered in the Chinese Clinical Trials Registration (ChiCTR1900023702).
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Affiliation(s)
- Yuxin Zhang
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Baojun Suo
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Xueli Tian
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Hua Zhang
- Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China
| | - Haoping Lu
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Xingyu Yao
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Cailing Li
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Xinlu Ren
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Liya Zhou
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Zhiqiang Song
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
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25
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Tian XL, Suo BJ, Zhang H, Lu HP, Li CL, Zhang YX, Ren XL, Yao XY, Zhou LY, Song ZQ. Bismuth, esomeprazole, metronidazole and amoxicillin or tetracycline as a first-line regimen for Helicobacter pylori eradication: A randomized controlled trial. Helicobacter 2023; 28:e12935. [PMID: 36374159 DOI: 10.1111/hel.12935] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/29/2022] [Revised: 10/14/2022] [Accepted: 10/21/2022] [Indexed: 11/16/2022]
Abstract
BACKGROUND Due to general unavailability and common side effects of tetracycline, the clinical application of bismuth quadruple therapy (BQT) is greatly limited. Whether amoxicillin can replace tetracycline in BQT remains unknown. This study aimed to compare the eradication rate, safety and compliance between amoxicillin-containing and tetracycline-containing BQT as a first-line regimen for Helicobacter pylori eradication. METHODS This randomized trial was conducted on 404 naïve patients for H. pylori eradication. The participants were randomly assigned to 14-day amoxicillin-containing (bismuth potassium citrate 110 mg four times/day, esomeprazole 20 mg twice daily, metronidazole 400 mg four times/day and amoxicillin 500 mg four times/day) and tetracycline-containing (tetracycline 500 mg four times/day and the other three drugs used as above) BQT. Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed 4-8 weeks after eradication to evaluate outcome. RESULTS As for the eradication rates of amoxicillin-containing and tetracycline-containing BQT, the results of both intention-to-treat and per-protocol analyses showed that the difference rate of the lower limit of 95% confidence interval was above -10.0% (intention-to-treat analysis: 81.7% vs. 83.2%, with a rate difference of -1.5% [-6.3% to 9.3%]; per-protocol analysis: 89.0% vs. 91.6%, -2.6% [-4.1% to 9.3%]). The incidence of adverse events in amoxicillin-containing BQT was significantly lower than tetracycline-containing BQT (29.5% vs. 39.7%). Both groups achieved relatively good compliance (92.0% vs. 89.9%). CONCLUSION The eradication efficacy of amoxicillin-containing BQT was non-inferior to tetracycline-containing BQT as a first-line regimen for H. pylori eradication with better safety and similar compliance.
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Affiliation(s)
- Xue-Li Tian
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Bao-Jun Suo
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Hua Zhang
- Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China
| | - Hao-Ping Lu
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Cai-Ling Li
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Yu-Xin Zhang
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Xin-Lu Ren
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Xing-Yu Yao
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Li-Ya Zhou
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Zhi-Qiang Song
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
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26
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Yang Q, He C, Hu Y, Hong J, Zhu Z, Xie Y, Shu X, Lu N, Zhu Y. 14-day pantoprazole- and amoxicillin-containing high-dose dual therapy for Helicobacter pylori eradication in elderly patients: A prospective, randomized controlled trial. Front Pharmacol 2023; 14:1096103. [PMID: 36817141 PMCID: PMC9931190 DOI: 10.3389/fphar.2023.1096103] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2022] [Accepted: 01/23/2023] [Indexed: 02/04/2023] Open
Abstract
Background: Currently, the management of Helicobacter pylori (H. pylori) infection in elderly patients is controversial. We investigated whether high-dose dual therapy would serve as the first-line therapy in elderly patients. Methods: This was a single-center, randomized study of 150 elderly patients with H. pylori infection who were randomly assigned to 14-day therapy with pantoprazole 40 mg 3 times daily and either amoxicillin 1,000 mg 3 times daily or amoxicillin 1,000 mg twice daily, clarithromycin 500 mg twice daily and bismuth 220 mg twice daily. H. pylori eradication was evaluated by a 13C-urea breath test 4 weeks after the completion of treatment. Results: Successful eradication was achieved in 89.3% of the high-dose dual therapy (HT) group in the intention-to-treat (ITT) analysis, 91.7% in the modified intention-to-treat (mITT) analysis, and 93.0% for per-protocol (PP) analysis which was similar to the bismuth-containing quadruple therapy (BQT) group (86.6%, 87.8%, and 90.3%, respectively). There were no significant difference between the HT group and the BQT group in the ITT analysis (p = 0.484), mITT analysis (p = 0.458), or PP analysis (p = 0.403). HT was associated with fewer side effects (10.6% of patients) than BQT (26.6%) (p = 0.026). Conclusion: In this trial, we found that 14-day HT had a similar eradication rate to BQT but fewer side effects, which may be better for elderly patients.
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Affiliation(s)
| | | | | | | | | | | | | | - Nonghua Lu
- Department of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, China
| | - Yin Zhu
- Department of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, China
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Zhang Y, Feng X, Bian L, Zhang Y, Li Q, Xu Y, She Q, Yan C, Lu G, Wu J, Xiao W, Ding Y, Deng B. Antibiotic Resistance of Helicobacter pylori and Related Risk Factors in Yangzhou, China: A Cross-Sectional Study. J Clin Med 2023; 12:816. [PMID: 36769465 PMCID: PMC9917918 DOI: 10.3390/jcm12030816] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2022] [Revised: 01/13/2023] [Accepted: 01/16/2023] [Indexed: 01/22/2023] Open
Abstract
BACKGROUND The antibiotic resistance of Helicobacter pylori (H. pylori) is a common cause of treatment failure. Previous studies showed that H. pylori resistance may be related to some characteristics of patients. This study intended to investigate the resistance of H. pylori to five commonly used antibiotics and risk factors in Yangzhou, China. METHODS We recruited the subjects who joined the endoscopic screening program organized by the Affiliated Hospital of Yangzhou University between April 2018 and September 2019 and endoscopists would take biopsy samples from the antrum and the corpus of the stomach. The antrum biopsy specimens were used to culture H. pylori. Next, we extracted DNA from H. pylori strains and performed the specific DNA amplification. Finally, we use gene chip technology to test the susceptibility to clarithromycin, levofloxacin, metronidazole, amoxicillin and tetracycline. Multivariate logistic analyses were also performed to determine the risk factors for antibiotic resistance of H. pylori. RESULTS A total of 461 H. pylori strains were finally collected. The resistance rate of H. pylori to clarithromycin, levofloxacin, metronidazole, amoxicillin and tetracycline was 41.0%, 44.9%, 38.8%, 6.3% and 1.1%, respectively. In addition, 16 multi-resistance patterns were detected, and strains resistant to all five antibiotics were not found. Multivariate analysis showed that past medical history and clinical outcomes were significantly associated with the resistance to clarithromycin. Drinking, gastrointestinal symptoms and a family history of gastric cancer were significantly associated with the resistance of H. pylori to levofloxacin. Especially gastrointestinal symptoms were significantly associated with the resistance of H. pylori to any antibiotic. CONCLUSION The resistance rates of H. pylori to clarithromycin, levofloxacin and metronidazole were very high in Yangzhou, China, various factors were related to bacterial resistance, and grasping these influencing factors can guide treatment.
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Affiliation(s)
- Yun Zhang
- Department of Gastroenterology, The Affiliated Hospital of Yangzhou University, No. 368 Hanjiang Middle Road, Yangzhou 225001, China
- Department of Emergency, The Affiliated Suqian Hospital of Xuzhou Medical University, Suqian 223800, China
| | - Xinyi Feng
- Department of Gastroenterology, Wuzhong People’s Hospital of Suzhou, Suzhou 215000, China
| | - Lijun Bian
- Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing 211166, China
| | - Yan Zhang
- Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing 211166, China
| | - Qian Li
- Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing 211166, China
| | - Yemin Xu
- Department of Gastroenterology, The Affiliated Hospital of Yangzhou University, No. 368 Hanjiang Middle Road, Yangzhou 225001, China
| | - Qiang She
- Department of Gastroenterology, The Affiliated Hospital of Yangzhou University, No. 368 Hanjiang Middle Road, Yangzhou 225001, China
| | - Caiwang Yan
- Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing 211166, China
| | - Guotao Lu
- Department of Gastroenterology, The Affiliated Hospital of Yangzhou University, No. 368 Hanjiang Middle Road, Yangzhou 225001, China
| | - Jian Wu
- Department of Gastroenterology, The Affiliated Hospital of Yangzhou University, No. 368 Hanjiang Middle Road, Yangzhou 225001, China
| | - Weiming Xiao
- Department of Gastroenterology, The Affiliated Hospital of Yangzhou University, No. 368 Hanjiang Middle Road, Yangzhou 225001, China
| | - Yanbing Ding
- Department of Gastroenterology, The Affiliated Hospital of Yangzhou University, No. 368 Hanjiang Middle Road, Yangzhou 225001, China
| | - Bin Deng
- Department of Gastroenterology, The Affiliated Hospital of Yangzhou University, No. 368 Hanjiang Middle Road, Yangzhou 225001, China
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Song Z, Suo B, Tian X, Ren X, Xue Y, Niu Z, Zhou L. Tailored triple plus bismuth therapy based on previous antibiotic medication history for first-line Helicobacter pylori eradication: A randomized trial. Dig Liver Dis 2023; 55:601-607. [PMID: 36646526 DOI: 10.1016/j.dld.2022.12.019] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/04/2022] [Revised: 12/20/2022] [Accepted: 12/23/2022] [Indexed: 01/18/2023]
Abstract
INTRODUCTION There are no randomized controlled trials that demonstrate the role of tailored therapy based on past medication history in improving efficacy of H. pylori eradication compared to empiric therapies. The objective of this study was to determine whether tailored triple plus bismuth therapy (TBT) can achieve higher eradication rates based on previous antibiotic history than empiric TBTs. METHODS 800 treatment-naïve patients were randomly assigned to four groups receiving clarithromycin-, levofloxacin- or metronidazole-containing empiric TBT and tailored TBT (clarithromycin and levofloxacin chosen based on previous macrolides and quinolones medication history). Correlation analyses were performed between past medication history and resistance or eradication rate. RESULTS The eradication rates of tailored TBT were significantly higher than clarithromycin-, levofloxacin- and metronidazole-containing empiric TBT in both intention-to-treat (89.5%, 80.8%, 81.5% and 81.5%) and per-protocol (95.1%, 86.7%, 86.5% and 87.8%) analyses (P<0.05). In patients with previous macrolides, quinolones or nitroimidazoles medication history, the resistance rates of corresponding clarithromycin, levofloxacin or metronidazole were significantly higher than patients without past medication history, and the eradication rates of corresponding clarithromycin- or levofloxacin-containing empiric TBT were significantly lower. CONCLUSION Tailored TBT based on previous antibiotic history can achieve higher eradication rates than empiric TBT for first-line H. pylori eradication.
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Affiliation(s)
- Zhiqiang Song
- Department of Gastroenterology, Peking University Third Hospital, Beijing, 100191, China
| | - Baojun Suo
- Department of Gastroenterology, Peking University Third Hospital, Beijing, 100191, China
| | - Xueli Tian
- Department of Gastroenterology, Peking University Third Hospital, Beijing, 100191, China
| | - Xinlu Ren
- Department of Gastroenterology, Peking University Third Hospital, Beijing, 100191, China
| | - Yan Xue
- Department of Gastroenterology, Peking University Third Hospital, Beijing, 100191, China
| | - Zhanyue Niu
- Department of Gastroenterology, Peking University Third Hospital, Beijing, 100191, China
| | - Liya Zhou
- Department of Gastroenterology, Peking University Third Hospital, Beijing, 100191, China.
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Zhou BG, Mei YZ, Zhang M, Jiang X, Li YY, Ding YB. High-dose dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a systematic review and meta-analysis with trial sequential analysis. Therap Adv Gastroenterol 2023; 16:17562848221147756. [PMID: 36644129 PMCID: PMC9837272 DOI: 10.1177/17562848221147756] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/05/2022] [Accepted: 12/11/2022] [Indexed: 01/12/2023] Open
Abstract
Background and objective Recently, a large number of trials on proton pump inhibitor-amoxicillin-containing high-dose dual therapy (HDDT) versus bismuth-containing quadruple therapy (BQT) for Helicobacter pylori (H. pylori) eradication have been published with controversial and inconsistent conclusions. The aim of this meta-analysis was to determine the effects of HDDT for H. pylori eradication compared to BQT. Design A systematic review and meta-analysis was conducted. Methods PubMed, Embase, and the Cochrane library database were searched to collect all randomized controlled trials (RCTs) assessing the effects of HDDT versus BQT to H. pylori eradication from inception to September 2022. Meta-analysis was conducted to estimate the pooled relative risk (RR) with 95% confidence intervals (CIs) using a random-effects model. Quality of evidence was appraised using Grading of Recommendations, Assessment, Development and Evaluation system. Trial sequential analysis (TSA) was performed to determine the reliability and conclusiveness. Results A total of 14 RCTs with 5121 patients were included. The results of meta-analysis showed that there was no statistical significance in the eradication rate between HDDT and BQT (intention-to-treat analysis: 86.7% versus 85.1%, RR = 1.01, 95% CI: 0.98-1.04; per-protocol analysis: 89.9% versus 89.4%, RR = 1.01, 95% CI: 0.98-1.03; moderate-quality evidence). The incidence of total adverse effects in HDDT group was significantly lower than in BQT group (5.9% versus 34.1%, RR = 0.42, 95% CI: 0.34-0.50; low-quality evidence). No statistical significance was observed in compliance between HDDT and BQT (RR = 1.01, 95% CI, 1.00-1.03, p = 0.07; low-quality evidence). The TSA result for H. pylori eradication rate indicated that the effect was conclusive. Conclusions Evidence from our updated meta-analysis suggests that HDDT is as effective as BQT in eradicating H. pylori, with fewer adverse effects and similar compliance. Registration Open Science Framework registries (No: osf.io/th4vd).
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Affiliation(s)
- Ben-Gang Zhou
- Dalian Medical University, Dalian, Liaoning Province, China
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou, Jiangsu Province, China
| | - Yu-Zhou Mei
- Department of Gastroenterology, The People’s Hospital of China Three Gorges University, Yichang, Hubei Province, China
| | - Min Zhang
- Public Health Institute of Gusu School, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou, Jiangsu Province, China
| | - Xin Jiang
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou, Jiangsu Province, China
- Yangzhou University, Yangzhou, Jiangsu Province, China
| | - Yao-Yao Li
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, No. 368, Hanjiang Middle Road, Hanjiang District, Yangzhou, Jiangsu Province, China
| | - Yan-Bing Ding
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, No. 368, Hanjiang Middle Road, Hanjiang District, Yangzhou, Jiangsu Province, China
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Duan M, Liu J, Zuo X. Dual therapy for Helicobacter pylori infection. Chin Med J (Engl) 2023; 136:13-23. [PMID: 36805362 PMCID: PMC10106215 DOI: 10.1097/cm9.0000000000002565] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2022] [Indexed: 02/22/2023] Open
Abstract
ABSTRACT Bismuth-containing quadruple therapy (BQT) has long been recommended for Helicobacter pylori ( H. pylori ) eradication in China. Meanwhile, in the latest national consensus in China, dual therapy (DT) comprising an acid suppressor and amoxicillin has also been recommended. In recent years, the eradication rate of H. pylori has reached >90% using DT, which has been used not only as a first-line treatment but also as a rescue treatment. Compared with BQT, DT has great potential for H. pylori eradication; however, it has some limitations. This review summarizes the development of DT and its application in H. pylori eradication. The H. pylori eradication rates of DT were comparable to or even higher than those of BQT or standard triple therapy, especially in the first-line treatment. The incidence of adverse events associated with DT was lower than that with other therapies. Furthermore, there were no significant differences in the effects of dual and quadruple therapies on gastrointestinal microecology. In the short term, H. pylori eradication causes certain fluctuations in the gastrointestinal microbiota; however, in the long term, the gastrointestinal microbiota eventually returns to its normal state. In the penicillin-naïve population, patients receiving DT have a high eradiation rate, better compliance, lower incidence of adverse reactions, and lower primary and secondary resistance to amoxicillin. These findings suggest the safety, efficacy, and potential of DT for H. pylori eradication.
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Affiliation(s)
- Miao Duan
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China
- Robot Engineering Laboratory for Precise Diagnosis and Therapy of Gastrointestinal Tumor, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China
| | - Jing Liu
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China
- Robot Engineering Laboratory for Precise Diagnosis and Therapy of Gastrointestinal Tumor, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China
| | - Xiuli Zuo
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China
- Robot Engineering Laboratory for Precise Diagnosis and Therapy of Gastrointestinal Tumor, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China
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Mei H, Guo Y, Zhao JT, Yang J, Sun WJ, Zhang DK, He P, Shi G, Su NY, Han R, Lan CH. Efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori infection: a multicenter, randomized controlled clinical trial. Therap Adv Gastroenterol 2022; 15:17562848221142925. [PMID: 36600686 PMCID: PMC9806404 DOI: 10.1177/17562848221142925] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/21/2022] [Accepted: 10/25/2022] [Indexed: 12/28/2022] Open
Abstract
BACKGROUND A high-dose proton pump inhibitor (PPI)-amoxicillin dual therapy has been investigated for treatment of patients with Helicobacter pylori (H. pylori) infection. Currently, the efficacy of this dual therapy remains inconclusive, with controversial findings from various single-center clinical trials. OBJECTIVES To assess the efficacy and safety of high-dose dual therapy (HDDT) compared with the bismuth-containing quadruple therapy (BQT) in treatment-naive patients with H. pylori infection. DESIGN A multicenter, open-label, randomized controlled clinical trial. METHODS Three hundred and forty treatment-naïve patients with H. pylori infection were prospectively recruited from seven participating hospitals. The enrolled patients were randomized into one of two treatment groups: the HDDT group (esomeprazole, 20 mg four times daily; amoxicillin, 750 mg four times daily) and the BQT group (esomeprazole, 20 mg, twice daily; bismuth potassium citrate, 600 mg, twice daily; amoxicillin, 1 g, twice daily; metronidazole, 400 mg, four times daily). The primary outcome was eradication rate, and secondary outcomes were safety and patient compliance. RESULTS The eradication rates in the HDDT group versus the BQT group were 86.47% versus 87.06% on intention-to-treat (ITT) analysis, 91.88% versus 92.50% on modified ITT (MITT) analysis, and 91.77% versus 93.04% on per-protocol (PP) analysis, with no significant differences between the two groups. The patient compliance rates in the HDDT group versus the BQT group were 97.02% versus 95.86%, and no significant difference was found between the two groups. Notably, the HDDT group exhibited significantly lower incidence in the drug-induced adverse events (AEs) compared to the BQT group (16.67% versus 47.94%). CONCLUSION HDDT is equally efficacious in eradicating H. pylori infection and resulted in good patient compliance and safety compared with BQT. These findings provide evidence in support of HDDT as a first-line treatment for H. pylori infection. REGISTRATION This clinical trial was registered at The Chinese Clinical Trial Registry (trial registration number: ChiCTR2000039096).
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Affiliation(s)
| | | | | | - Jun Yang
- Department of Gastroenterology, People’s
Hospital of Chongqing Banan District, Chongqing, China
| | - Wen-jing Sun
- Department of Gastroenterology, The 13th
People’s Hospital of Chongqing, Chongqing, China
| | - De-kui Zhang
- Department of Gastroenterology, Lanzhou
University Second Hospital, Lanzhou, China
| | - Ping He
- Department of Gastroenterology, Yongchuan
Hospital of Chongqing Medical University, Chongqing, China
| | - Gang Shi
- Department of Gastroenterology, Chongqing Red
Cross Hospital, Chongqing, China
| | - Na-yun Su
- Department of Gastroenterology, Chongqing Key
Laboratory of Digestive Malignancies, Daping Hospital, Army Medical
University (Third Military Medical University), Chongqing 400042, P. R,
China
| | - Ran Han
- Department of Gastroenterology, Guizhou
Provincial People’s Hospital, Guiyang, China
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Zhou L, Lu H, Song Z, Lyu B, Chen Y, Wang J, Xia J, Zhao Z. 2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment. Chin Med J (Engl) 2022; 135:2899-2910. [PMID: 36579940 PMCID: PMC10106216 DOI: 10.1097/cm9.0000000000002546] [Citation(s) in RCA: 88] [Impact Index Per Article: 29.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/28/2022] [Indexed: 12/30/2022] Open
Abstract
BACKGROUND Helicobacter pylori ( H. pylori ) infection is an infectious disease with a prevalence rate of up to 50% worldwide. It can cause indigestion, gastritis, peptic ulcer, and gastric cancer. H. pylori eradication treatment can effectively control disease progression and reduce the risk of the above conditions. However, the escalating trend of antibiotic resistance presents a global challenge for H. pylori eradication. We aim to provide guidance on pharmacological treatment of H. pylori infection. METHODS This clinical practice guideline is developed following the World Health Organization's recommended process, adopting Grading of Recommendations Assessment, Development and Evaluation in assessing evidence quality, and utilizing Evidence to Decision framework to formulate clinical recommendations, minimizing bias and increasing transparency of the clinical practice guideline development process. We used the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement and The Appraisal of Guidelines for Research and Evaluation II (AGREE II) as reporting and conduct guides to ensure the guideline's completeness and transparency. RESULTS Though decreasing in developed countries, the prevalence of H. pylori remains high in developing countries, causing a major public health burden. This clinical practice guideline contains 12 recommendations concerning pharmacological treatment for H. pylori eradication. Among them, it is worth highlighting that bismuth preparations are inexpensive, safe, and effective, consequently making bismuth quadruple therapy a preferred choice for initial and rescue treatment. In empirical treatment, high-dose dual therapy is equally effective compared with bismuth quadruple therapy. CONCLUSIONS The 12 recommendations in this clinical practice guideline are formed with consideration for stakeholders' values and preferences, resource use, feasibility, and acceptability. Recommendations are generalizable to resource limited settings with similar antibiotic resistance pattern as China, and lower middle-income countries facing comparable sociological and technical challenges. REGISTRATION Guidelines International Network (GIN) website, https://guidelines.ebmportal.com/node/69996 .
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Affiliation(s)
- Liya Zhou
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
| | - Hong Lu
- Department of Gastroenterology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Zhiqiang Song
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
| | - Bin Lyu
- Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang 310018, China
| | - Ye Chen
- Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong 510515, China
| | - Jiyao Wang
- Department of Gastroenterology, Fudan University Affiliated Zhongshan Hospital, Shanghai 200032, China
| | - Jun Xia
- Nottingham Ningbo GRADE Center, Nottingham China Health Institute, University of Nottingham Ningbo China, Ningbo, Zhejiang 315100, China
- Academic Unit of Lifespan and Population Health, School of Medicine, The University of Nottingham, Nottingham, UK
| | - Zhan Zhao
- Systematic Review Solutions Ltd, Shanghai 201403, China
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Zou SP, Cheng Q, Feng CY, Xu C, Sun MH. Comparative effectiveness of first-line therapies for eradication of antibiotic-resistant Helicobacter pylori strains: A network meta-analysis. World J Clin Cases 2022; 10:12959-12970. [PMID: 36569016 PMCID: PMC9782940 DOI: 10.12998/wjcc.v10.i35.12959] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/16/2022] [Revised: 10/08/2022] [Accepted: 11/30/2022] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND As a first-line treatment regimen for Helicobacter pylori (H. pylori) infection, antibiotic therapy is widely used worldwide. However, the question of increasing antibiotic resistance must be considered. Given this issue, we need to find ways to reduce drug resistance. This study examined all currently available first-line regimens and compared them with standard triple treatment through a network meta-analysis of randomized controlled trials (RCTs). AIM To compare first-line treatment regimens for eradication of antibiotic-resistant H. pylori strains. METHODS To compare the effectiveness of the first-line regimens for treating H. pylori infection, a Bayesian network meta-analysis was applied to process data extracted from RCTs. The plausible ranking for each regimen was assessed by the surface under the cumulative ranking curve (SUCRA). In addition, we conducted a relevant search by reference citation analysis. RESULTS Twenty-five RCTs involving 12029 participants [including 1602 infected with clarithromycin (CAM)-resistant strains and 1716 infected with metronidazole (MNZ)-resistant strains] were included, in which a total of seven regimens were used for H. pylori eradication. The results showed that dual therapy containing a high-dose proton pump inhibitor (HDDT) [odds ratio (OR): 4.20, 95% confidence interval (CI): 2.29-8.13] was superior to other therapies for all patients, including those with CAM/MNZ-resistant H. pylori infection. In the comparative effectiveness ranking, for CAM-resistant H. pylori, HDDT (OR: 96.80, 95%CI: 22.46-521.9) had the best results, whereas standard triple therapy ranked last (SUCRA: 98.7% vs 0.3%). In the subgroup of high cure rates (≥ 90%), HDDT was also generally better than other therapies. CONCLUSION For the eradication of CAM- and MNZ-resistant H. pylori strains, HDDT exhibited considerable advantages. The studies of CAM-resistant H. pylori were based on small samples due to a lack of antibiotic sensitivity tests in many RCTs, but the results showed that all patients, including those with CAM-resistant H. pylori infection, had a concordant trend. Overall, HDDT may be a reference for RCTs and other studies of H. pylori eradication.
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Affiliation(s)
- Shu-Peng Zou
- Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, Hubei Province, China
| | - Qian Cheng
- Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, Hubei Province, China
| | - Cheng-Yang Feng
- Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, Hubei Province, China
| | - Chan Xu
- Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, Hubei Province, China
| | - Ming-Hui Sun
- Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, Hubei Province, China
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Shen C, Li C, Lv M, Dai X, Gao C, Li L, Zhang Q, Pan W, Liu C, Han S, Zhang Y, Ding S, Deng H, Yao Y, Xu J, Wei M, Shi H, Yuan P, Yang X, Jian Y, Shan J, Liu Y, Chen Z, Deng X, Liu F, Deng L, Zhong X, Li H, He S, Chen L, Liu G, Xu H, Zhong Y, Shi H, Ren J. The prospective multiple-centre randomized controlled clinical study of high-dose amoxicillin-proton pump inhibitor dual therapy for H. pylori infection in Sichuan areas. Ann Med 2022; 54:426-435. [PMID: 35098820 PMCID: PMC8812792 DOI: 10.1080/07853890.2022.2031269] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023] Open
Abstract
OBJECTIVES To evaluate the safety and efficacy of high-dose amoxicillin-proton pump inhibitor dual therapy, and to provide a new eradication regimen as a first-line option for patients with H. pylori infection. METHODS A total of 971 H. pylori positive patients who received initial treatment were recruited from March to August 2020, and randomly divided into treatment group and control group. The treatment group received of 20 mg esomeprazole four times daily and 750 mg amoxicillin four times daily for 14 days. Control group received of 220 mg bismuth potassium citrate twice daily, 20 mg esomeprazole twice daily, 1000 mg amoxicillin twice daily and 250 mg clarithromycin capsule twice daily for 14 days. Four weeks after the end of treatment, the urea breath test was reviewed to detect whether H. pylori was eradicated. RESULTS There were no statistical differences in age, gender, the total clinical symptom scores before and after initial treatment, the compliance, and the degree of remission of symptoms before and after initial treatment between the two groups. The eradication rates of H. pylori between dual therapy and quadruple therapy were 88.31% and 85.26% (p=.158) by intention-to-treat (ITT) analysis, 88.66% and 85.44% (p=.186) by modified intention-to-treat (mITT) analysis, and 91.63% and 90.60% (p=.116) by PP analysis, respectively. Adverse events in dual therapy group were significantly lower than quadruple therapy group (13.3% vs. 28.2% (p<.01)). CONCLUSIONS For the initial treatment of H. pylori infection, the high-dose dual therapy regimen has the same efficacy as the bismuth-containing quadruple therapy regimen, good compliance, less adverse reactions and high safety, so it can be recommended as the empirical first-line treatment regimen for the eradication of H. pylori (KY2019173).
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Affiliation(s)
- Cheng Shen
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Changping Li
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Muhan Lv
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Xiaosong Dai
- Sichuan Provincial People's Hospital, Chengdu, China
| | - Caiping Gao
- Sichuan Provincial People's Hospital, Chengdu, China
| | - Liangping Li
- Sichuan Provincial People's Hospital, Chengdu, China
| | - Qin Zhang
- First People's Hospital of Liangshan Yi Autonomous Prefecture, Xichang, China
| | - Wen Pan
- Sichuan University West China Hospital Tibet People's Government in Chengdu Office Branch, Chengdu, China
| | - Chao Liu
- Sichuan University West China Hospital Tibet People's Government in Chengdu Office Branch, Chengdu, China
| | - Sijing Han
- Chengdu Medical College Second Affiliated Hospital, Chengdu, China
| | - Yang Zhang
- Chengdu Medical College Second Affiliated Hospital, Chengdu, China
| | | | - Hong Deng
- People's Hospital of Deyang City, Deyang, China
| | - Yong Yao
- Suining Central Hospital, Suining, China
| | - Jianyu Xu
- Suining Central Hospital, Suining, China
| | | | - Haiyan Shi
- Bazhong Central Hospital, Bazhong, China
| | - Peijie Yuan
- The Fourth People's Hospital of GuangYuan, GuangYuan, China
| | - Xiaoyan Yang
- Chengdu Second People's Hospital, Chengdu, China
| | - Yi Jian
- Chengdu Second People's Hospital, Chengdu, China
| | - Jing Shan
- Chengdu Third People's Hospital, Chengdu, China
| | - Yan Liu
- Chengdu Fifth People's Hospital, Chengdu, China
| | - Zonghua Chen
- The Second People's Hospital of Yibin, West China Hospital of Sichuan University, Yibin, China
| | | | - Fei Liu
- Leshan City Geriatric Hospital, Leshan, China
| | - Lijuan Deng
- Leshan Sichuan Armed Police General Hospital, Leshan, China
| | - Xianfei Zhong
- Leshan Sichuan Armed Police General Hospital, Leshan, China
| | - Hong Li
- Pengzhou People's Hospital, Chengdu, China
| | - Shaoya He
- Sichuan Anyue County People's Hospital, Ziyang, China
| | - Li Chen
- Sichuan Anyue County People's Hospital, Ziyang, China
| | - Gang Liu
- Zigong Third People's Hospital, Zigong, China
| | - Hairong Xu
- Zigong Third People's Hospital, Zigong, China
| | - Yuquan Zhong
- First Peoples Hospital of Neijiang, Neijiang, China
| | - Hua Shi
- The First People's Hospital of Ziyang, Ziyang, China
| | - Jiangang Ren
- Wuhou District Third People's Hospital, Chengdu, China
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Hu Y, Zhu Y, Lu NH. The management of Helicobacter pylori infection and prevention and control of gastric cancer in China. Front Cell Infect Microbiol 2022; 12:1049279. [PMID: 36530421 PMCID: PMC9751207 DOI: 10.3389/fcimb.2022.1049279] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2022] [Accepted: 11/14/2022] [Indexed: 12/04/2022] Open
Abstract
Helicobacter pylori (H. pylori) infection, a type-1 carcinogen, was closely associated with gastric cancer (GC). Successfully eradicating H. pylori infection could reduce the incidence of GC. China was a country with high incidence of GC and high prevalence of H. pylori infection. Nearly half of worldwide GC new cases and deaths attributed to H. pylori infection occurred in China. H. pylori prevalence varied over time with the improvement of socioeconomic status and sanitary conditions. The knowledge of antibiotic resistance rate in time was important to guide the clinical choice of antibiotics use in the regimens. With the publication of five Chinese consensus reports on the management of H. pylori infection and the effort of public preach of H. pylori-related knowledge, the standardization of H. pylori diagnosis and treatment by clinicians was improved. Bismuth-containing quadruple therapy was widely applied in clinical practice of H. pylori eradication because of high efficacy and safety. High-dose Proton Pump Inhibitor-amoxicillin dual therapy or vonoprazan-amoxicillin dual therapy showed comparable efficacy and lower side effects than bismuth-containing quadruple therapy, which were the alternative choice. The diagnosis rate of early GC was low and distinguishing Chinese GC risk population for the further endoscopy screening was important. Efforts have been done to establish prediction models to stratify GC risk in the Chinese GC risk population. We reviewed the current situation of the management of H. pylori infection and prevention and control of GC in China here.
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Affiliation(s)
- Yi Hu
- Department Of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China,JiangXi Clinical Research Center for Gastroenterology, Nanchang, Jiangxi, China
| | - Yin Zhu
- Department Of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China,JiangXi Clinical Research Center for Gastroenterology, Nanchang, Jiangxi, China,*Correspondence: Nong-Hua Lu, ; Yin Zhu,
| | - Nong-Hua Lu
- Department Of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China,JiangXi Clinical Research Center for Gastroenterology, Nanchang, Jiangxi, China,*Correspondence: Nong-Hua Lu, ; Yin Zhu,
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Zhao X, Zhang Z, Lu F, Xiong M, Jiang L, Tang K, Fu M, Wu Y, He B. Effects of CYP2C19 genetic polymorphisms on the cure rates of H. pylori in patients treated with the proton pump inhibitors: An updated meta-analysis. Front Pharmacol 2022; 13:938419. [PMID: 36278195 PMCID: PMC9582748 DOI: 10.3389/fphar.2022.938419] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/07/2022] [Accepted: 09/12/2022] [Indexed: 11/28/2022] Open
Abstract
Background: The cure rates of Helicobacter pylori (H. pylori) treatment using a proton pump inhibitor (PPI) are gradually decreasing due to antibiotic resistance, poor compliance, high gastric acidity, and cytochrome P450 2C19 (CYP2C19) polymorphism, and the effects of PPI depend on metabolic enzymes, cytochrome P450 enzymes. The aim of this meta-analysis was to determine whether CYP2C19 polymorphisms affect H. pylori cure rates in patients treated with different proton pump inhibitors (PPIs) according to stratified analysis. Materials and methods: The literature was searched with the key words “H. pylori” and “CYP2C19” in PubMed, CNKI, and Wanfang up to 31 May 2022, and the studies were limited to clinical observational or randomized controlled trials (RCTs). Finally, seven RCTs and 29 clinical observational studies met the inclusion criteria and were used for the meta-analysis via STATA version 16. Results: The cure rates were significantly different between genotypes of homozygous extensive metabolizers (EM) and poor metabolizers (PM) (OR = 0.58, 95% CI: 0.47–0.71) and between EM and heterozygous extensive metabolizers (IM) (OR = 0.71, 95% CI: 0.59–0.86), but not between IM and PM. Moreover, there was a significantly lower H. pylori cure rate in EM subjects than that in IM subjects when treated with omeprazole (66.4% vs. 84.1%), lansoprazole (76.1% vs. 85.6%), but not rabeprazole, esomeprazole, or pantoprazole. In addition, there was a significantly lower H. pylori cure rate in EM subjects than that in IM subjects when treated with a PPIs for 7 days (77.4% vs. 82.1%), but not 14 days (85.4% vs. 90.0%). Conclusion: Carriers of CYP2C19 loss-of-function variant alleles (IM and PM) exhibit a significantly greater cure rate of H. pylori than noncarriers (EM) regardless of other factors (84.7% vs. 79.2%). In addition, pantoprazole- and rabeprazole-based quadruple therapy for H. pylori treatment is less dependent on the CYP2C19 genotype and should be prioritized in Asian populations with H. pylori.
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Affiliation(s)
- Xianghong Zhao
- Department of Clinical Pharmacy, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China
- Division of Clinical Pharmacology, General Clinical Research Center, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Zhongqiu Zhang
- Department of Clinical Pharmacy, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China
- Department of Pharmacy, Nanjing First Hospital, China Pharmaceutical University, Nanjing, China
| | - Fang Lu
- Department of Clinical Pharmacy, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China
- Department of Pharmacy, Nanjing First Hospital, China Pharmaceutical University, Nanjing, China
| | - Mengqiu Xiong
- Division of Clinical Pharmacology, General Clinical Research Center, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Liping Jiang
- Department of Clinical Pharmacy, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China
- Division of Clinical Pharmacology, General Clinical Research Center, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Ke Tang
- Department of Clinical Pharmacy, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China
- Division of Clinical Pharmacology, General Clinical Research Center, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Min Fu
- Department of Clinical Pharmacy, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China
- Division of Clinical Pharmacology, General Clinical Research Center, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Yu Wu
- Division of Clinical Pharmacology, General Clinical Research Center, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
- Department of Laboratory Medicine, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Bangshun He
- Department of Laboratory Medicine, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
- H. pylori Research Key Laboratory, Nanjing Medical University, Nanjing, China
- *Correspondence: Bangshun He,
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Ouyang Y, Wang M, Xu YL, Zhu Y, Lu NH, Hu Y. Amoxicillin-vonoprazan dual therapy for Helicobacter pylori eradication: A systematic review and meta-analysis. J Gastroenterol Hepatol 2022; 37:1666-1672. [PMID: 35716370 DOI: 10.1111/jgh.15917] [Citation(s) in RCA: 34] [Impact Index Per Article: 11.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/07/2022] [Revised: 06/09/2022] [Accepted: 06/14/2022] [Indexed: 12/17/2022]
Abstract
BACKGROUND AND AIM The efficacy and safety of amoxicillin-vonoprazan (VA) dual therapy remained unclear. METHODS This systematic review was conducted in accordance with the PRISMA 2009 guidelines. A systematic search of the Pubmed, Embase, and Cochrane database was conducted using the combination of "Helicobacter pylori or H. pylori or Hp," "amoxicillin or penicillin," and "Vonoprazan or TAK-438 or Takecab or (potassium AND competitive) or potassium-competitive." The initial and secondary outcome of this meta-analysis was to evaluate the efficacy and safety of VA dual therapy. RESULTS Three studies and 668 H. pylori infected patients were included in this meta-analysis. The crude eradication rate of VA dual therapy was 87.5% and 89.6% by ITT and PP analysis, respectively. No significant differences were observed regarding the VA dual therapy and vonoprazan-amoxicillin-clarithromycin (VAC) triple therapy according to ITT (RR = 0.99, 95% CI, 0.93-1.05, P = 0.65) and PP (RR = 0.99, 95% CI, 0.94-1.05, P = 0.82) analysis. The side effect of VA dual therapy was 19.1% (95% CI, 5.9-32.4), which was lower than that of VAC triple therapy but there was no statistical significance (RR = 0.75, 95% CI, 0.59-1.06, P = 0.12). CONCLUSION VA dual therapy shows acceptable efficacy, good safety and avoid unnecessary antibiotic use in the first-line treatment for H. pylori infection. However, its application in other regions need to be further explored.
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Affiliation(s)
- Yaobin Ouyang
- Department Of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
| | - Minghui Wang
- Medical College of Nanchang University, Nanchang, China
| | - Yu-Ling Xu
- Medical College of Nanchang University, Nanchang, China
| | - Yin Zhu
- Department Of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
| | - Nong-Hua Lu
- Department Of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
| | - Yi Hu
- Department Of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
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Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut 2022; 71:gutjnl-2022-327745. [PMID: 35944925 DOI: 10.1136/gutjnl-2022-327745] [Citation(s) in RCA: 594] [Impact Index Per Article: 198.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/29/2022] [Accepted: 06/21/2022] [Indexed: 01/06/2023]
Abstract
Helicobacter pyloriInfection is formally recognised as an infectious disease, an entity that is now included in the International Classification of Diseases 11th Revision. This in principle leads to the recommendation that all infected patients should receive treatment. In the context of the wide clinical spectrum associated with Helicobacter pylori gastritis, specific issues persist and require regular updates for optimised management.The identification of distinct clinical scenarios, proper testing and adoption of effective strategies for prevention of gastric cancer and other complications are addressed. H. pylori treatment is challenged by the continuously rising antibiotic resistance and demands for susceptibility testing with consideration of novel molecular technologies and careful selection of first line and rescue therapies. The role of H. pylori and antibiotic therapies and their impact on the gut microbiota are also considered.Progress made in the management of H. pylori infection is covered in the present sixth edition of the Maastricht/Florence 2021 Consensus Report, key aspects related to the clinical role of H. pylori infection were re-evaluated and updated. Forty-one experts from 29 countries representing a global community, examined the new data related to H. pylori infection in five working groups: (1) indications/associations, (2) diagnosis, (3) treatment, (4) prevention/gastric cancer and (5) H. pylori and the gut microbiota. The results of the individual working groups were presented for a final consensus voting that included all participants. Recommendations are provided on the basis of the best available evidence and relevance to the management of H. pylori infection in various clinical fields.
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Affiliation(s)
- Peter Malfertheiner
- Medical Department 2, LMU, Munchen, Germany
- Department of Radiology, LMU, Munchen, Germany
| | - Francis Megraud
- INSERM U853 UMR BaRITOn, University of Bordeaux, Bordeaux, France
| | - Theodore Rokkas
- Gastroenterology, Henry Dunant Hospital Center, Athens, Greece
- Medical School, European University, Nicosia, Cyprus
| | - Javier P Gisbert
- Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IP), Madrid, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
| | - Jyh-Ming Liou
- Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
| | - Christian Schulz
- Medical Department 2, LMU, Munchen, Germany
- Partner Site Munich, DZIF, Braunschweig, Germany
| | - Antonio Gasbarrini
- Medicina Interna e Gastroenterologia, Fondazione Policlinico Universitario Gemelli IRCCS, Università Cattolica del Sacro Cuore Facoltà di Medicina e Chirurgia, Roma, Italy
| | - Richard H Hunt
- Medicine, McMaster University, Hamilton, Ontario, Canada
- Farncombe Family Digestive Health Research Institute, Hamilton, Ontario, Canada
| | - Marcis Leja
- Faculty of Medicine, University of Latvia, Riga, Latvia
- Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia
| | - Colm O'Morain
- Faculty of Health Sciences, Trinity College Dublin, Dublin, Ireland
| | - Massimo Rugge
- Department of Medicine (DIMED), Surgical Pathology & Cytopathology Unit, University of Padova, Padova, Italy
- Veneto Tumor Registry (RTV), Padova, Italy
| | - Sebastian Suerbaum
- Partner Site Munich, DZIF, Braunschweig, Germany
- Max von Pettenkofer Institute, LMU, Munchen, Germany
| | - Herbert Tilg
- Department of Internal Medicine I, Gastroenterology, Hepatology, Endocrinology & Metabolism, Medizinische Universitat Innsbruck, Innsbruck, Austria
| | - Kentaro Sugano
- Department of Medicine, Jichi Medical School, Tochigi, Japan
| | - Emad M El-Omar
- Department of Medicine, University of New South Wales, Sydney, New South Wales, Australia
- School of Medicine and Dentistry, University of Aberdeen, Aberdeen, UK
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Hu Y, Xu X, Ouyang YB, He C, Li NS, Xie C, Peng C, Zhu ZH, Xie Y, Shu X, Lu NH, Zhu Y. Optimization of vonoprazan-amoxicillin dual therapy for eradicating Helicobacter pyloriinfection in China: A prospective, randomized clinical pilot study. Helicobacter 2022; 27:e12896. [PMID: 35466521 DOI: 10.1111/hel.12896] [Citation(s) in RCA: 36] [Impact Index Per Article: 12.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/17/2022] [Revised: 03/29/2022] [Accepted: 04/07/2022] [Indexed: 12/20/2022]
Abstract
BACKGROUND Vonoprazan-amoxicillin (VA) dual therapy has been shown to achieve acceptable cure rates for treatment of Helicobacter pylori(H. pylori) in Japan. Its effectiveness in other regions is unknown. We aimed to explore the efficacy of VA dual therapy as first-line treatment for H. pyloriinfection in China. METHODS This was a single center, prospective, randomized clinical pilot study conducted in China. Treatment naive H. pyloriinfected patients were randomized to receive either low- or high-dose amoxicillin-vonoprazan consisting of amoxicillin 1 g either b.i.d. or t.i.d plus VPZ 20 mg b.i.d for 7 or 10 days. 13 C-urea breath tests were used to access the cure rate at least 4 weeks after treatment. RESULTS Three hundred and twenty-three patients were assessed, and 119 subjects were randomized. The eradication rates of b.i.d. amoxicillin for 7 and 10 days, t.i.d. amoxicillin for 7 and 10 days were 66.7% (16/24), 89.2% (33/37), 81.0% (17/21), and 81.1% (30/37) (p = .191) by intention-to-treat analysis, respectively, and 72.7% (16/22), 89.2% (33/37), 81.0% (17/21), and 81.1% (30/37) (p = .454) by per-protocol analysis, respectively. CONCLUSION Neither 7- or 10-day VA dual therapy with b.i.d. or t.i.d. amoxicillin provides satisfied efficacy as the first-line treatment for H. pyloriinfection in China. Further optimization is needed.
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Affiliation(s)
- Yi Hu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Xin Xu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Yao-Bin Ouyang
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Cong He
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Nian-Shuang Li
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Chuan Xie
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Chao Peng
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Zhen-Hua Zhu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Yong Xie
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Xu Shu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Nong-Hua Lu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Yin Zhu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
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Zhu G, Lin N, Wu X, Shi J, Tong B, Cai Z, Zhi J, Dong Y. Multicomponent Spiropolymerization of Diisocyanides, Activated Alkynes, and Bis-Anhydrides. Macromolecules 2022. [DOI: 10.1021/acs.macromol.2c00994] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Affiliation(s)
- Guinan Zhu
- Beijing Key Laboratory of Construction Tailorable Advanced Functional Materials and Green Applications, School of Materials Science and Engineering, Beijing Institute of Technology, Beijing 100081, China
| | - Na Lin
- Beijing Key Laboratory of Construction Tailorable Advanced Functional Materials and Green Applications, School of Materials Science and Engineering, Beijing Institute of Technology, Beijing 100081, China
| | - Xinghui Wu
- Beijing Key Laboratory of Construction Tailorable Advanced Functional Materials and Green Applications, School of Materials Science and Engineering, Beijing Institute of Technology, Beijing 100081, China
| | - Jianbing Shi
- Beijing Key Laboratory of Construction Tailorable Advanced Functional Materials and Green Applications, School of Materials Science and Engineering, Beijing Institute of Technology, Beijing 100081, China
| | - Bin Tong
- Beijing Key Laboratory of Construction Tailorable Advanced Functional Materials and Green Applications, School of Materials Science and Engineering, Beijing Institute of Technology, Beijing 100081, China
| | - Zhengxu Cai
- Beijing Key Laboratory of Construction Tailorable Advanced Functional Materials and Green Applications, School of Materials Science and Engineering, Beijing Institute of Technology, Beijing 100081, China
| | - Junge Zhi
- Key Laboratory of Cluster Science of Ministry of Education, School of Chemistry and Chemical Engineering, Beijing Institute of Technology, Beijing 100081, China
| | - Yuping Dong
- Beijing Key Laboratory of Construction Tailorable Advanced Functional Materials and Green Applications, School of Materials Science and Engineering, Beijing Institute of Technology, Beijing 100081, China
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Bi H, Chen X, Chen Y, Zhao X, Wang S, Wang J, Lyu T, Han S, Lin T, Li M, Yuan D, Liu J, Shi Y. Efficacy and safety of high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial. Chin Med J (Engl) 2022; 135:1707-1715. [PMID: 36193978 PMCID: PMC9509165 DOI: 10.1097/cm9.0000000000002289] [Citation(s) in RCA: 23] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023] Open
Abstract
BACKGROUND High-dose dual therapy (HDDT) with proton pump inhibitors (PPIs) and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of high-dose PPI-amoxicillin dual therapy and bismuth-containing quadruple therapy for H. pylori rescue treatment. METHODS This was a prospective, randomized, multicenter, non-inferiority trial. Patients recruited from eight centers who had failed previous treatment were randomly (1:1) allocated to two eradication groups: HDDT (esomeprazole 40 mg and amoxicillin 1000 mg three times daily; the HDDT group) and bismuth-containing quadruple therapy (esomeprazole 40 mg, bismuth potassium citrate 220 mg, and furazolidone 100 mg twice daily, combined with tetracycline 500 mg three times daily; the tetracycline, furazolidone, esomeprazole, and bismuth [TFEB] group) for 14 days. The primary endpoint was the H. pylori eradication rate. The secondary endpoints were adverse effects, symptom improvement rates, and patient compliance. RESULTS A total of 658 patients who met the criteria were enrolled in this study. The HDDT group achieved eradication rates of 75.4% (248/329), 81.0% (248/306), and 81.3% (248/305) asdetermined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analyses, respectively. The eradication rates were similar to those in the TFEB group: 78.1% (257/329), 84.2% (257/305), and 85.1% (257/302). The lower 95% confidence interval boundary (-9.19% in the ITT analysis, - 9.21% in the MITT analysis, and -9.73% in the PP analysis) was greater than the predefined non-inferiority margin of -10%, establishing a non-inferiority of the HDDT group vs. the TFEB group. The incidence of adverse events in the HDDT group was significantly lower than that in the TFEB group (11.1% vs. 26.8%, P < 0.001). Symptom improvement rates and patients' compliance were similar between the two groups. CONCLUSIONS Fourteen-day HDDT is non-inferior to bismuth-containing quadruple therapy, with fewer adverse effects and good treatment compliance, suggesting HDDT as an alternative for H. pylori rescue treatment in the local region. TRIAL REGISTRATION Clinicaltrials.gov, NCT04678492.
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Affiliation(s)
- Hanxin Bi
- Xi’an Medical University, Xi’an, Shaanxi 710021, China,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China
| | - Xingxing Chen
- Xi’an Medical University, Xi’an, Shaanxi 710021, China,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China
| | - Yuxin Chen
- Xi’an Medical University, Xi’an, Shaanxi 710021, China,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China
| | - Xin Zhao
- Xi’an Medical University, Xi’an, Shaanxi 710021, China,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China
| | - Shasha Wang
- Department of Gastroenterology, Xianyang Central Hospital, Xianyang, Shaanxi 712000, China
| | - Jiehong Wang
- Department of Gastroenterology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi 712000, China
| | - Ting Lyu
- Department of Gastroenterology, Shaanxi Nuclear Industry 215 Hospital, Xianyang, Shaanxi 712000, China
| | - Shuang Han
- Department of Gastroenterology, Xi’an Red Cross Hospital, Xi’an, Shaanxi 710054, China
| | - Tao Lin
- Department of Gastroenterology, Xi’an Daxing Hospital, Xi’an, Shaanxi 710082, China
| | - Mingquan Li
- Department of Gastroenterology, Yan’an People's Hospital, Yan’an, Shaanxi 716000, China
| | - Donghong Yuan
- Department of Gastroenterology, Yan’an University Affiliated Hospital, Yan’an, Shaanxi 716000, China
| | - Junye Liu
- Department of Radiation Protective Medicine, Air Force Medical University, Xi’an, Shaanxi 710032, China
| | - Yongquan Shi
- Xi’an Medical University, Xi’an, Shaanxi 710021, China,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China
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Chen J, Li P, Huang Y, Guo Y, Ding Z, Lu H. Primary Antibiotic Resistance of Helicobacter pylori in Different Regions of China: A Systematic Review and Meta-Analysis. Pathogens 2022; 11:pathogens11070786. [PMID: 35890031 PMCID: PMC9316315 DOI: 10.3390/pathogens11070786] [Citation(s) in RCA: 31] [Impact Index Per Article: 10.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/12/2022] [Revised: 06/29/2022] [Accepted: 07/04/2022] [Indexed: 01/30/2023] Open
Abstract
Aim: Understanding the prevalence of antibiotic resistance can provide reliable information for selecting treatment options. The goal of this meta-analysis was to observe the primary antibiotic resistance of Helicobacter pylori (H. pylori) in different regions and time periods of China. Method: We searched PubMed, EMBASE, Chinese Biomedical databases and the China National Knowledge Infrastructure from inception to 20 February 2022. Data on the prevalence of H. pylori primary resistance at various time points were included. A random-effect model was established to calculate the pooled antibiotic resistance. Results: In total, 2150 articles were searched, with 70 meeting the inclusion criteria. The resistance to clarithromycin, metronidazole, levofloxacin amoxicillin, tetracycline and furazolidone in 2016–2020 were 34% (95% CI: 30–39%), 78% (95% CI: 73–84%), 35% (95% CI: 30–40%), 3% (95% CI: 1–5%), 2% (95%CI: 1–4%) and 1% (95% CI: 0–4%), respectively. Clarithromycin showed regional difference, as the resistance was higher in northern (37%, 95% CI: 32–41%) and western China (35%, 95% CI: 17–54%) than that in southern (24%, 95% CI: 17–32%) and eastern China (24%, 95% CI: 20–28%). Conclusion: The resistance of H. pylori to clarithromycin and metronidazole was high and increased over time, whereas resistance to levofloxacin, amoxicillin, tetracycline and furazolidone remained stable.
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Affiliation(s)
- Jinnan Chen
- Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology &Hepatology NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200120, China; (J.C.); (Y.H.); (Y.G.); (Z.D.)
| | - Puheng Li
- School of Mathematical Sciences, Peking University, Beijing 100091, China;
| | - Yu Huang
- Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology &Hepatology NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200120, China; (J.C.); (Y.H.); (Y.G.); (Z.D.)
| | - Yixian Guo
- Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology &Hepatology NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200120, China; (J.C.); (Y.H.); (Y.G.); (Z.D.)
| | - Zhaohui Ding
- Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology &Hepatology NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200120, China; (J.C.); (Y.H.); (Y.G.); (Z.D.)
| | - Hong Lu
- Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology &Hepatology NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200120, China; (J.C.); (Y.H.); (Y.G.); (Z.D.)
- Correspondence: ; Tel.: +8621-58752345
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Shao QQ, Yu XC, Yu M, Ma J, Zhao JB, Yuan L, Qi YB, Hu RB, Wei PR, Xiao W, Lan L, Jia BL, Zhang LZ, Ding SZ. Rabeprazole plus amoxicillin dual therapy is equally effective to bismuth-containing quadruple therapy for Helicobacter pylori eradication in central China: A single-center, prospective, open-label, randomized-controlled trial. Helicobacter 2022; 27:e12876. [PMID: 35150597 DOI: 10.1111/hel.12876] [Citation(s) in RCA: 14] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/30/2021] [Revised: 01/10/2022] [Accepted: 01/16/2022] [Indexed: 12/11/2022]
Abstract
BACKGROUND Antibiotic resistance emerges as a major issue for Helicobacter pylori (H. pylori) treatment. High-dose dual therapy has recently shown encouraging results in H. pylori eradication, but it has yet to be validated in this H. pylori highly infected area; it is also not known if this concept can be extended to antibiotics other than amoxicillin, and factors that affect the eradication. We investigate if rabeprazole plus amoxicillin or furazolidone regimens could be a first-line therapy for H. pylori eradication, and factors that affect the curing rate. METHODS This is a single-center, prospective, open-label, randomized-controlled trial. Naive patients (n=292) were randomly treated with bismuth-containing quadruple therapy (BQT), rabeprazole plus amoxicillin (RADT), or furazolidone (RFDT) groups. RADT and FADT use three times daily regimens. H. pylori diagnosis and eradication were determined and confirmed by 13 C-urea breath test. RESULTS In per-protocol (PP) analysis, H. pylori eradication rate was 91.2% in BQT group, 89.6% in RADT, and 51.0% in RFDT group. In intention-to-treat (ITT) analysis, infection was eradicated in 86.7% of patients in BQT group, 85.8% in RADT, and 48.1% in RFDT groups, respectively. Noninferiority was confirmed between BQT and RADT groups. The incidence of side effects in BQT group was significantly higher than that in RADT group. Successful eradication was associated with lower body surface area (BSA) and low body mass index (BMI) in BQT group. Smoking and high BSA index reduced H. pylori eradication rate in RADT group. CONCLUSIONS Rabeprazole-amoxicillin dual therapy is equally effective to the bismuth-containing quadruple therapy for H. pylori eradication with fewer side effects and saves use of one antibiotic per each treatment. Successful eradication is also associated with low BSA and non-smoking condition, which deserves future stratified analysis for refinement and optimization.
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Affiliation(s)
- Qiao-Qiao Shao
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Xue-Chun Yu
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Miao Yu
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Jing Ma
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Jun-Bo Zhao
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Lin Yuan
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Ya-Bin Qi
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Ruo-Bing Hu
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Pei-Ru Wei
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Wei Xiao
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Ling Lan
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Bai-Ling Jia
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Lian-Zhong Zhang
- Department of Ultrasound Imaging, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, China
| | - Song-Ze Ding
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
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Guan JL, Hu YL, An P, He Q, Long H, Zhou L, Chen ZF, Xiong JG, Wu SS, Ding XW, Luo HS, Li PY. Comparison of high-dose dual therapy with bismuth-containing quadruple therapy in Helicobacter pylori-infected treatment-naive patients: An open-label, multicenter, randomized controlled trial. Pharmacotherapy 2022; 42:224-232. [PMID: 35075679 DOI: 10.1002/phar.2662] [Citation(s) in RCA: 29] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/12/2021] [Revised: 10/21/2021] [Accepted: 11/23/2021] [Indexed: 12/13/2022]
Abstract
OBJECTIVE Bismuth-containing quadruple therapy for Helicobacter pylori (H. pylori) eradication has a relatively high rate of side effects and high cost, thus the option of a high-dose dual therapy with a high eradication rate and fewer adverse events is a consideration. However, studies of dual therapy are still scarce and are mostly single-center studies with limited generalizability. Large-scale, multicenter studies are required. Our study investigated and compared the effectiveness, adverse events, patient compliance, and costs of high-dose dual therapy with those of bismuth-containing quadruple therapy in H. pylori-infected treatment-naive patients in a prospective, multicenter, open-label, randomized controlled trial. METHOD Treatment-naive patients infected with H. pylori were randomly assigned to receive high-dose dual therapy (esomeprazole 20 mg 4 times daily and amoxicillin 1000 mg 3 times daily, for 14 days) or bismuth-containing quadruple therapy (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all twice daily for 14 days). The effectiveness, adverse events, patient compliance, and costs of both groups were compared. RESULTS A total of 700 patients were enrolled. The high-dose dual therapy group (N = 350) achieved eradication rates of 89.4% (intention-to-treat), 90.4% (modified intention-to-treat), and 90.6% (per-protocol), which were similar to rates in the bismuth-containing quadruple therapy group (N = 350), 84.6%, 88.0%, and 88.2%, respectively (p > 0.05). The high-dose dual therapy group had a lower rate of adverse events (12.9% vs. 28.1%, p < 0.001) and lower costs (¥590.2 vs. ¥723.22) compared with the quadruple therapy group, respectively. The compliance of both groups was satisfactory (97.7% high-dose dual vs. 96.8% quadruple, p > 0.05). CONCLUSION High-dose dual therapy for H. pylori eradication had similar efficacy and compliance, fewer adverse events, and lower costs than bismuth-containing quadruple therapy for treatment-naive patients.
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Affiliation(s)
- Jia-Lun Guan
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Yun-Lian Hu
- Department of Gastroenterology, Hubei University of Chinese Medicine, Wuhan, China
| | - Ping An
- Department of Gastroenterology, Wuhan University People's Hospital, Wuhan, China
| | - Qiong He
- Department of Gastroenterology, Wuhan Red Cross Hospital, Wuhan, China
| | - Hui Long
- Department of Gastroenterology, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, China
| | - Lin Zhou
- Department of Gastroenterology, Suizhou Central Hospital, Wuhan, China
| | - Zhi-Fen Chen
- Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, China
| | - Jian-Guang Xiong
- Department of Gastroenterology, Xianning Central Hospital, Wuhan, China
| | - Shi-Sheng Wu
- Department of Gastroenterology, The Second Hospital of Huangshi, Wuhan, China
| | - Xiang-Wu Ding
- Department of Gastroenterology, Wuhan Puai Hospital, Wuhan, China
| | - He-Sheng Luo
- Department of Gastroenterology, Wuhan University People's Hospital, Wuhan, China
| | - Pei-Yuan Li
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.,Department of Gastroenterology, Wenchang People's Hospital, Hainan, China
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Shiotani A, Roy P, Lu H, Graham DY. Helicobacter pylori diagnosis and therapy in the era of antimicrobial stewardship. Therap Adv Gastroenterol 2021; 14:17562848211064080. [PMID: 34987609 PMCID: PMC8721397 DOI: 10.1177/17562848211064080] [Citation(s) in RCA: 33] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/18/2021] [Accepted: 11/15/2021] [Indexed: 02/04/2023] Open
Abstract
The diagnosis and therapy of Helicobacter pylori infection have undergone major changes based on the use the principles of antimicrobial stewardship and increased availability of susceptibility profiling. H. pylori gastritis now recognized as an infectious disease, as such there is no placebo response allowing outcome to be assessed in relation to the theoretically obtainable cure rate of 100%. The recent recognition of H. pylori as an infectious disease has changed the focus to therapies optimized to reliably achieve high cure rates. Increasing antimicrobial resistance has also led to restriction of clarithromycin, levofloxacin, or metronidazole to susceptibility-based therapies. Covid-19 resulted in the almost universal availability of polymerase chain reaction testing in hospitals which can be repurposed to utilize readily available kits to provide rapid and inexpensive detection of clarithromycin resistance. In the United States, major diagnostic laboratories now offer H. pylori culture and susceptibility testing and American Molecular Laboratories offers next-generation sequencing susceptibility profiling of gastric biopsies or stools for the six commonly used antibiotics without need for endoscopy. Current treatment recommendations include (a) only use therapies that are reliably highly effective locally, (b) always perform a test-of-cure, and (c) use that data to confirm local effectiveness and share the results to inform the community regarding which therapies are effective and which are not. Empiric therapy should be restricted to those proven highly effective locally. The most common choices are 14-day bismuth quadruple therapy and rifabutin triple therapy. Prior guidelines and treatment recommendations should only be used if proven locally highly effective.
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Affiliation(s)
- Akiko Shiotani
- Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan
| | - Priya Roy
- Department of Medicine, Baylor College of Medicine, Houston, TX, USA
| | - Hong Lu
- GI Division, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - David Y. Graham
- Department of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX 77030, USA
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Suzuki S, Kusano C, Horii T, Ichijima R, Ikehara H. The Ideal Helicobacter pylori Treatment for the Present and the Future. Digestion 2021; 103:62-68. [PMID: 34662879 DOI: 10.1159/000519413] [Citation(s) in RCA: 35] [Impact Index Per Article: 8.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/29/2021] [Accepted: 08/31/2021] [Indexed: 02/04/2023]
Abstract
BACKGROUND Helicobacter pylori eradication treatments are widely performed to improve gastric mucosal inflammation, promote ulcer healing, and reduce the incidence of gastric cancer. However, there are several issues associated with H. pylori eradication treatment. First, various treatment regimens are currently used worldwide, and the standard treatment varies with region and country. Second, the antimicrobial resistance of H. pylori is increasing due to indiscriminate antibiotic use. Finally, gut microbiota dysbiosis is potentially induced by H. pylori treatment. SUMMARY Based on current international guidelines and a network meta-analysis comparing the effects of various treatment regimens, nonbismuth quadruple therapies for 10-14 days and vonoprazan-based triple therapy for 7 days are the currently recommended H. pylori treatment regimens. These regimens show good eradication rates of approximately 90%, even in areas where antimicrobial-resistant strains are highly prevalent. However, these regimens still have inherent drawbacks that may promote further increases in antimicrobial resistance and induce gut microbiota dysbiosis because of the empiric use of multiple antibiotics. Key Message: The ideal concept for the present and future H. pylori eradication treatment involves "a simple, cost-effective strategy that fosters compliance without having a negative impact on the gut microbiota or contributing to future antimicrobial resistance." One interesting possibility that may fulfill this concept is a dual therapy involving vonoprazan and amoxicillin. This is the simplest treatment regimen that provides acceptable eradication rates, improves safety and tolerability, and minimizes the potential for increasing antimicrobial resistance or causing gut microbiota dysbiosis.
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Affiliation(s)
- Sho Suzuki
- Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Itabashi City, Japan,
| | - Chika Kusano
- Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Sagamihara, Japan
| | - Toshiki Horii
- Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Itabashi City, Japan
| | - Ryoji Ichijima
- Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Itabashi City, Japan
| | - Hisatomo Ikehara
- Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Itabashi City, Japan
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Li C, Shi Y, Suo B, Tian X, Zhou L, Song Z. PPI-amoxicillin dual therapy four times daily is superior to guidelines recommended regimens in the Helicobacter pylori eradication therapy within Asia: A systematic review and meta-analysis. Helicobacter 2021; 26:e12816. [PMID: 34002433 DOI: 10.1111/hel.12816] [Citation(s) in RCA: 30] [Impact Index Per Article: 7.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/12/2021] [Revised: 04/17/2021] [Accepted: 04/19/2021] [Indexed: 12/20/2022]
Abstract
BACKGROUND Systematic reviews suggested that the eradication efficacy of PPI-amoxicillin dual therapy is similar to that of other commonly used regimens. However, it might be affected by the medication frequency. Basic and clinical studies have shown that dual therapy administered four-times daily has a reliable pathophysiological basis and could achieve satisfactory efficacy. Therefore, a systematic review of RCTs of dual therapy and other regimens was conducted to clarify whether dual therapy is superior to guidelines recommended regimens. MATERIALS AND METHODS The RCTs comparing dual therapy with other regimens were subjected to meta-analysis to evaluate the eradication rate, adverse reactions, and compliance using a random-effects model. RESULTS Dual therapy administered four-times daily had a higher eradication rate than other regimens (intention-to-treat analysis: 89.7% vs 84.6%, OR: 1.52, 95%CI 1.08-2.14, p = 0.02; per-protocol analysis: 92.6% vs 88.2%, OR: 1.54, 95%CI 1.01-2.34, p = 0.04). In first-line therapy, according to intention-to-treat analysis, the eradication rate of dual therapy was higher than other regimens (89.8% vs 84.2%, OR: 1.63, 95%CI 1.02-2.61, p = 0.04). In per-protocol analysis, dual therapy showed better efficacy than others (92.9% vs 88.3%, OR: 1.68, 95% CI 0.98-2.89, p = 0.06), but not significantly. In salvage treatment, no significant difference was detected. The safety of dual therapy was significantly better than other regimens (19.6% vs 36.7%, p < 0.01), but no difference was observed in compliance (p = 0.58). CONCLUSION PPI-amoxicillin dual therapy administered four-times daily has better efficacy and safety in H. pylori eradication than current guidelines recommended regimens, especially in first-line therapy, and mainly in Asia.
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Affiliation(s)
- Cailing Li
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Yanyan Shi
- Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China
| | - Baojun Suo
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Xueli Tian
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Liya Zhou
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Zhiqiang Song
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
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