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Hsu JY, Wu UI, Wang JT, Sheng WH, Chen YC, Chang SC. Managing Helicobacter pylori as an Infectious Disease: Implementation of Antimicrobial Stewardship. Helicobacter 2025; 30:e70013. [PMID: 39895365 DOI: 10.1111/hel.70013] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2024] [Revised: 01/11/2025] [Accepted: 01/23/2025] [Indexed: 02/04/2025]
Abstract
Helicobacter pylori is prevalent globally and implicated in various gastric diseases and malignancies. Rising antibiotic resistance has increasingly compromised the effectiveness of standard H. pylori eradication therapies. This review explores the role of antimicrobial stewardship (AMS) as a structured approach to optimizing H. pylori management through the "5D" strategy: Diagnosis-utilizing advanced diagnostic tools to accurately detect bacterial resistance; Drug-selecting antibiotics tailored to resistance profiles and patient-specific factors; Dosage-optimizing dosing and frequency based on pharmacokinetic properties to maximize efficacy; Duration-employing shorter treatment courses where supported by evidence; and Discontinuation-balancing the benefits and risks of repeated antibiotic treatments. We discuss recent advances in diagnostic technologies, such as polymerase chain reaction and next-generation sequencing, and their impact on therapeutic decision-making. Additionally, we evaluate treatment regimens, with a particular focus on emerging alternatives such as regimens containing potassium-competitive acid blockers. Given the growing global resistance and limited pipeline for new antibiotics, we advocate for a more strategic and resource-conscious approach to H. pylori management, integrating AMS principles within the "One Health" framework to address the pathogen's transmission across humans, animals, and the environment. With advancements in resistance testing and diagnostics, H. pylori therapies are likely to become increasingly personalized and precise. To achieve this, effective AMS implementation necessitates interdisciplinary collaboration to maximize therapeutic outcomes, minimize adverse effects, combat resistance, and reduce healthcare costs.
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Affiliation(s)
- Jen-Yu Hsu
- Division of Infectious Diseases, Department of Internal Medicine & Department of Occupational Medicine and Clinical Toxicology, Taipei Veterans General Hospital, Taipei, Taiwan
- Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan
- School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan
| | - Un-In Wu
- Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
- Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan
- Center for Quality Management and Infection Control & Department of Medicine, National Taiwan University Cancer Center, Taipei, Taiwan
| | - Jann-Tay Wang
- Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
- Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan
| | - Wang-Huei Sheng
- Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
- Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan
- Department of Internal Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan
| | - Yee-Chun Chen
- Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
- Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan
| | - Shan-Chwen Chang
- Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
- Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan
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Han S, Deng Z, Cheung K, Lyu T, Chan P, Li Y, Ni L, Luo X, Li K. Vonoprazan-based triple and dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori infection in China: a three-arm, randomised clinical trial protocol. BMC Gastroenterol 2023; 23:231. [PMID: 37420205 DOI: 10.1186/s12876-023-02872-7] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/10/2023] [Accepted: 07/04/2023] [Indexed: 07/09/2023] Open
Abstract
BACKGROUND Helicobacter pylori infection and associated diseases are a growing global public health issue. H. pylori infection is the major cause of gastric cancer, over 90% of duodenal ulcers, and over 70% of gastric ulcers. The infection rate of H. pylori is approximately 50%, and approximately 50% of new cases of gastric cancer worldwide occur in China. Bismuth (BI)-based quadruple therapy is recommended as the first-line treatment for H. pylori in China. Vonoprazan (VPZ), a new potassium-competitive acid blocker that can inhibit gastric acid secretion more effectively than proton pump inhibitors (PPIs), has been combined with antibiotics to effectively eradicate H. pylori. In this study, we compared the efficacy and safety of two VPZ-based therapies with that of BI-based therapy for H. pylori treatment. METHODS A three-armed randomised controlled trial (RCT) is being conducted in Shenzhen, with 327 participants recruited from the Gastroenterology Clinic of the University of Hong Kong-Shenzhen Hospital. Patients were diagnosed with H. pylori infection based on a positive 13C-urea breath test (UBT). Patients are kept naïve to their treatment and are randomly assigned in a 1:1:1 ratio to either VPZ-based triple, VPZ-based dual, or BI-based quadruple therapy for 14 days. All groups are subjected to follow-up evaluations of safety, adverse drug reactions, and clinical variables in the first, second, and fourth weeks after treatment. Successful eradication is confirmed by a negative 13C-UBT six weeks after treatment. If initial treatment fails, (1) those patients are turned to another regimen, or (2) a drug resistance test is conducted, after which an individualised treatment regimen shall be prescribed according to antimicrobial susceptibility testing. The resulting data will be evaluated using intention-treat and a per-protocol analysis. DISCUSSION This study is the a RCT aims to evaluate the efficacy and safety of 14-day VPZ-based triple and dual therapies in comparison with BI-based quadruple therapy. The outcomes of this study may allow treatment recommendations and update drug instructions in China. TRIAL REGISTRATION Chinese Clinical Trial Registry (No. ChiCTR2200056375). Registered on February 4, 2022, https://www.chictr.org.cn/showproj.aspx?proj=141314.
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Affiliation(s)
- ShaoWei Han
- Shantou University Medical College, Shantou, China
- Department of Pharmacy, University of Hong Kong-Shenzhen Hospital, Shenzhen, China
| | - ZiJie Deng
- Department of Medicine, University of Hong Kong-Shenzhen Hospital, Shenzhen, China
| | - KaShing Cheung
- Department of Medicine, University of Hong Kong-Shenzhen Hospital, Shenzhen, China
- Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China
| | - Tao Lyu
- Department of Medicine, University of Hong Kong-Shenzhen Hospital, Shenzhen, China
| | - PuiLing Chan
- Department of Pharmacy, University of Hong Kong-Shenzhen Hospital, Shenzhen, China
| | - Ying Li
- Department of Pharmacy, University of Hong Kong-Shenzhen Hospital, Shenzhen, China
| | - Li Ni
- Department of Medicine, University of Hong Kong-Shenzhen Hospital, Shenzhen, China
| | - XiaPeng Luo
- Department of Medicine, University of Hong Kong-Shenzhen Hospital, Shenzhen, China
| | - Kuan Li
- Department of Pharmacy, Shenzhen People's Hospital, Second Clinical Medical College, Jinan University, First Affiliated Hospital, Southern University of Science and Technology, Shenzhen, China.
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Losurdo G, Pricci M, De Bellis M, Celiberto F, Russo F, Riezzo G, D'attoma B, Iannone A, Rendina M, Ierardi E, Di Leo A. Effect of metronidazole resistance on Helicobacter pylori eradication regimens. J Dig Dis 2022; 23:561-567. [PMID: 36321440 DOI: 10.1111/1751-2980.13142] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/12/2022] [Revised: 10/14/2022] [Accepted: 10/30/2022] [Indexed: 11/06/2022]
Abstract
OBJECTIVES Guidelines suggest bismuth-containing quadruple therapy (BQT) or concomitant therapy (CT) as first-line therapy in our geographic area. Both schedules contain metronidazole. We aimed to evaluate the effect of metronidazole resistance to Helicobacter pylori (H. pylori) eradication therapy. METHODS We recruited treatment-naïve subjects with H. pylori infection who received either CT or BQT during January 2020 and December 2021. Before therapy, a fecal sample was collected using the THD fecal test device from each patient. H. pylori DNA was extracted and mutations of rdxA and frxA genes and A2143G for metronidazole and clarithromycin resistance were investigated using real-time polymerase chain reaction with a high-resolution melting curve. RESULTS Ninety-six patients were enrolled, including 29 received BQT and 67 received CT. The overall eradication rate was 94.8% (100% for BQT and 92.5% for CT). Metronidazole resistance was found in 18 (18.8%) subjects, while clarithromycin resistance was found in 19 (19.8%). All 18 patients with metronidazole resistance achieved successful eradication (five treated with BQT and 13 with CT). The eradication rate in metronidazole-sensitive strains was 93.6%. Of these, 24 received BQT with 100% success, and 54 had CT with five failures (successful eradication in 90.7%). Two patients with treatment failure were resistant to clarithromycin, and the remaining three were susceptible to both clarithromycin and metronidazole. No statistical significance was observed in the eradication rate between metronidazole-resistant and -sensitive strains (100% vs 93.6%, P = 0.58). CONCLUSION Metronidazole resistance does not influence the eradication rate of BQT and CT regimens in our geographical area, even if such results need to confirmed in a larger sample.
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Affiliation(s)
- Giuseppe Losurdo
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, Bari, Italy
- PhD Course in Organs and Tissues Transplantation and Cellular Therapies, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, Bari, Italy
| | | | - Margherita De Bellis
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, Bari, Italy
| | - Francesca Celiberto
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, Bari, Italy
- PhD Course in Organs and Tissues Transplantation and Cellular Therapies, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, Bari, Italy
| | - Francesco Russo
- Laboratory of Nutritional Pathophysiology, National Institute of Gastroenterology "S. de Bellis" Research Hospital, Castellana Grotte, Italy
| | - Giuseppe Riezzo
- Laboratory of Nutritional Pathophysiology, National Institute of Gastroenterology "S. de Bellis" Research Hospital, Castellana Grotte, Italy
| | - Benedetta D'attoma
- Laboratory of Nutritional Pathophysiology, National Institute of Gastroenterology "S. de Bellis" Research Hospital, Castellana Grotte, Italy
| | - Andrea Iannone
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, Bari, Italy
| | - Maria Rendina
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, Bari, Italy
| | - Enzo Ierardi
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, Bari, Italy
| | - Alfredo Di Leo
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, Bari, Italy
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Primer for Development of Guidelines for Helicobacter pylori Therapy Using Antimicrobial Stewardship. Clin Gastroenterol Hepatol 2022; 20:973-983.e1. [PMID: 33775895 PMCID: PMC8464630 DOI: 10.1016/j.cgh.2021.03.026] [Citation(s) in RCA: 63] [Impact Index Per Article: 21.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/09/2021] [Revised: 03/11/2021] [Accepted: 03/22/2021] [Indexed: 02/06/2023]
Abstract
We provide a primer to assist in the difficult transition of Helicobacter pylori therapy guidelines to those that adhere to the principles of antimicrobial stewardship. This transition will entail abandonment of many of the principles that heretofore formed the basis of treatment guidelines and recommendations. The goals of antimicrobial stewardship include optimization of the use of antibiotics while reducing antimicrobial resistance. The critical outcome measure is absolute cure rate which largely restricts comparative trials to those which reliably produce high cure rates (eg, ∼95%). Therapies that fail to achieve at least a 90% cure rate should be abandoned as unacceptable. Because only optimized therapies should be prescribed, guidance on the principles and practices of optimization will we required. Therapies that contain antibiotics which do not contribute to outcome should be eliminated. Surveillance, one of the fundamental elements of antimicrobial stewardship, must be done to provide ongoing assurance that the recommended therapies remain effective. It is yet not widely recognized when utilizing otherwise highly successful therapies, the routine test of cure data is an indirect, surrogate method for susceptibility testing. To systematically guide therapy, test of cure data should be collected, shared and integrated into local antimicrobial stewardship programs to provide guidance regarding best practices to both prescribers and public health individuals. Treatment recommendations should be compatible with those of the American Society of Infectious Disease white paper on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens which include criteria for ethical active-controlled superiority studies of antibacterial agents.
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Antimicrobial Susceptibility Testing for Helicobacter pylori Is Now Widely Available: When, How, Why. Am J Gastroenterol 2022; 117:524-528. [PMID: 35081545 PMCID: PMC8976707 DOI: 10.14309/ajg.0000000000001659] [Citation(s) in RCA: 33] [Impact Index Per Article: 11.0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/15/2021] [Accepted: 01/21/2022] [Indexed: 12/11/2022]
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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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Hosseini RS, Rahimian G, Shafigh MH, Validi M, Khaledi M, Gholipour A. Correlation between clarithromycin resistance, virulence factors and clinical characteristics of the disease in Helicobacter pylori infected patients in Shahrekord, Southwest Iran. AMB Express 2021; 11:147. [PMID: 34731345 PMCID: PMC8566624 DOI: 10.1186/s13568-021-01310-9] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/02/2021] [Accepted: 10/28/2021] [Indexed: 12/12/2022] Open
Abstract
The purpose of this study was to determine the mutations associated with clarithromycin resistance in Helicobacter pylori strains isolated from biopsy samples that were collected from the endoscopic ward of Shahrekord Hajar teaching Hospital and also to study the frequency of virulence factor and their correlation and pathological findings with clarithromycin resistance during the years 2019-2020. In this cross-sectional descriptive study, 152 patients with Helicobacter pylori infection were considered, and then, two common A2142G and A2143G mutations in the 23SrRNA gene associated with resistance were analyzed by Real-time PCR (Taq man). The presence of vacA, iceA1, iceA2, cagA, babA2, and oipA virulence genes was investigated by PCR and electrophoresis in 8% polyacrylamide gel. Then, data were analyzed using the relevant statistical tests. In this study, the frequency of Helicobacter pylori was 76% and the frequency of mutant isolates was 57.2%. The frequencies of A2142G and A2143G point mutations were 42.1% and 28.3%. There was a significant correlation among oipA, vacA, and iceA1 virulence factors, type of disease, chronic inflammatory score, and glandular atrophy with the antibiotic resistance to clarithromycin. There was no significant correlation between the age and sex of the patients with antibiotic resistance. According to the results of this study, it seems that the use of clarithromycin to combat this bacterium should be limited.
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Sholeh M, Maleki F, Krutova M, Bavari S, Golmoradi R, Sadeghifard N, Amiriani T, Kouhsari E. The increasing antimicrobial resistance of Helicobacter pylori in Iran: A systematic review and meta-analysis. Helicobacter 2020; 25:e12730. [PMID: 32705749 DOI: 10.1111/hel.12730] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/08/2020] [Revised: 06/12/2020] [Accepted: 06/28/2020] [Indexed: 12/23/2022]
Abstract
BACKGROUND Antimicrobial resistance of Helicobacter pylori can result in eradication failure. Metadata on the antimicrobial resistance of H pylori in Iran could help to formulate H pylori eradication strategies in Iran. METHODS A systematic review was performed after searching in MEDLINE, Scopus, Embase, Web of Science, and the Cochrane Library. A meta-analysis was performed, and a comparison of the rates between children and adults; time periods (1999-2010, 2011-2016, 2017-2019); and the methods used was carried out. RESULTS A total of 66 studies investigating 5936 H pylori isolates were analyzed. The weighted pooled resistance (WPR) rates were as follows: clarithromycin 21% (95% CI 16-26), metronidazole 62% (95% 57-67), clarithromycin in combination with metronidazole 16% (95% CI 10-23), ciprofloxacin 24% (95% CI 15-33), levofloxacin 18% (95% CI 9-30), erythromycin 29% (95% CI 12-50), furazolidone 13% (95% CI 4-27), tetracycline 8% (95% CI 5-13), and amoxicillin 15% (95% CI 9-22). During the three time periods, there was an increased resistance to amoxicillin, clarithromycin, ciprofloxacin, furazolidone, and tetracycline (P ˂ .05). Furazolidone and a clarithromycin/metronidazole combination had the higher resistance rates in children (P ˂ .05). CONCLUSION An increasing rate of resistance to amoxicillin, clarithromycin, ciprofloxacin, furazolidone, and tetracycline in Iranian H pylori isolates was identified. In children, the resistance to furazolidone and a combination of clarithromycin and metronidazole is higher compared to adults. As a stable, high resistance to metronidazole was found in children and adults in all Iranian provinces, we suggest that metronidazole should not be included in the Iranian H pylori eradication scheme.
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Affiliation(s)
- Mohammad Sholeh
- Department of Microbiology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran
| | - Farajolah Maleki
- Department of Laboratory Sciences, School of Allied Medical Sciences, Ilam University of Medical sciences, Ilam, Iran
| | - Marcela Krutova
- Department of Medical Microbiology, Charles University, 2nd Faculty of Medicine and Motol University Hospital, Prague, Czech Republic
| | - Shirin Bavari
- Department of Microbiology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran
| | - Rezvan Golmoradi
- Department of Microbiology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran
| | - Nourkhoda Sadeghifard
- Clinical Microbiology Research Center, Ilam University of Medical Sciences, Ilam, Iran
| | - Taghi Amiriani
- Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran
| | - Ebrahim Kouhsari
- Clinical Microbiology Research Center, Ilam University of Medical Sciences, Ilam, Iran.,Laboratory Sciences Research Center, Golestan University of Medical Sciences, Gorgan, Iran
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Zou Y, Qian X, Liu X, Song Y, Song C, Wu S, An Y, Yuan R, Wang Y, Xie Y. The effect of antibiotic resistance on Helicobacter pylori eradication efficacy: A systematic review and meta-analysis. Helicobacter 2020; 25:e12714. [PMID: 32533599 DOI: 10.1111/hel.12714] [Citation(s) in RCA: 68] [Impact Index Per Article: 13.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/15/2020] [Revised: 05/22/2020] [Accepted: 05/25/2020] [Indexed: 12/11/2022]
Abstract
BACKGROUND The occurrence of antibiotic-resistant strains has been rapidly increasing due to the wide use of antibiotics. To evaluate the current effects of antibiotic resistance on Helicobacter pylori eradication efficacy, we conducted this systematic review and meta-analysis. METHODS Literature searches were conducted in the following databases: PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. Statistical analysis was performed using STATA version 12.0 (StataCorp LP, College Station, TX, USA). RESULTS A total of 120 studies, including 28 707 patients, were assessed. Only first-line therapy was considered. The pooled RR of eradication rate in patients with Helicobacter pylori strains sensitive versus resistant to clarithromycin was 0.682 (95% CI: 0.636-0.731). The pooled RR of eradication rate in patients with Helicobacter pylori strains sensitive versus resistant to metronidazole was 0.843 (95% CI: 0.810-0.877). The pooled RR of eradication rate in patients with Helicobacter pylori strains sensitive versus resistant to levofloxacin was 0.794 (95% CI: 0.669-0.941). The pooled RR of eradication rate in patients with Helicobacter pylori strains sensitive versus resistant to dual clarithromycin and metronidazole was 0.674 (95% CI: 0.590-0.770). CONCLUSION Antibiotic resistance causes a decrease in the eradication rate of H pylori today. Quadruple concomitant therapy may overcome the declining H pylori eradication rate caused by metronidazole-only resistance.
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Affiliation(s)
- Yunzhi Zou
- Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China
- Medical College of Nanchang University, Nanchang, China
| | - Xing Qian
- Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China
- Department of Gastroenterology, First People's Hospital of Fuzhou, Fuzhou, China
| | - Xiaoqun Liu
- Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China
- Affiliated Hospital of Jiujiang University, Jiujiang, China
| | - YanPing Song
- Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China
| | - Conghua Song
- Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China
| | - Shuang Wu
- Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China
| | - Ying An
- Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China
| | - Rui Yuan
- Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China
- Fuzhou Medical College of Nanchang University, Fuzhou, China
| | - Youhua Wang
- Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China
| | - Yong Xie
- Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China
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Salmanroghani H, Mirvakili M, Baghbanian M, Salmanroghani R, Sanati G, Yazdian P. Efficacy and Tolerability of Two Quadruple Regimens: Bismuth, Omeprazole, Metronidazole with Amoxicillin or Tetracycline as First-Line Treatment for Eradication of Helicobacter Pylori in Patients with Duodenal Ulcer: A Randomized Clinical Trial. PLoS One 2018; 13:e0197096. [PMID: 29889843 PMCID: PMC5995362 DOI: 10.1371/journal.pone.0197096] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/12/2017] [Accepted: 04/26/2018] [Indexed: 12/22/2022] Open
Abstract
AIM To evaluate the efficacy and tolerability of tetracycline vs. high-dose amoxicillin in bismuth-based quadruple therapy for Helicobacter pylori(H. pylori) eradication. METHODS This randomized, open-label clinical trial included 228 patients with H.pylori infection and duodenal ulcer without a history of H.pylori treatment. Patients were randomly divided into two groups. The amoxicillin group received metronidazole 500mg, bismuth subcitrate 240mg, and amoxicillin 1000mg, all three times a day, plus omeprazole 20 mg twice a day, for 14 days. The tetracycline group received metronidazole 500mg three times a day; bismuth subcitrate240mg and tetracycline HCl 500mg, both four times a day; and omeprazole 20 mg twice a day, for 14 days. Evaluation for compliance and drug-relatedadverse effects were evaluated at the end of two weeks. Eight weeks after the end of treatment, the rate of H.pylori eradication was assessed by the C13urease breath test. RESULTS There were no significant demographic differences between the two groups. Eradication rate was higher with the amoxicillin-containing regimen than the tetracycline-containing regimen: 105/110 (95.51%; 95% confidence interval, 91.5%-99.3%) vs. 88/105 (83.8%; 95%CI, 76.7%-90.8%) by per-protocol analysis (p = 0.005) and 92.9% (95%CI, 88.1%-97.6%) vs. 76.5% (95%CI, 68.7%-84.2%) by intention-to-treat analysis (ITT, p = 0.001). Adverse effects were significant higher in the tetracycline groupthan in the amoxicillin group (65.2% vs. 43.4%; p = 0.001). CONCLUSION Bismuth-based quadruple therapy including high-dose amoxicillin and metronidazole achieved an acceptable rate of H.pylori infection eradication with good tolerance in patients with duodenal ulcer. This regimen can overcome treatment resistance in areas with high prevalence of metronidazole and clarithromycin resistance. TRIAL REGISTRATION The Thai Clinical Trial Registry (TCTR) 20170623004.
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Affiliation(s)
- Hassan Salmanroghani
- Department of Internal Medicine, ShahidSadoughi University of Medical Sciences, Yazd, Iran
- * E-mail:
| | - Massoud Mirvakili
- Department of Internal Medicine, ShahidSadoughi University of Medical Sciences, Yazd, Iran
| | - Mahmud Baghbanian
- Department of Internal Medicine, ShahidSadoughi University of Medical Sciences, Yazd, Iran
| | - Roham Salmanroghani
- Department of Internal Medicine, ShahidSadoughi University of Medical Sciences, Yazd, Iran
| | - Golshid Sanati
- Immunology Research Center, Tehran University of Medical Sciences, Tehran, Iran
| | - Pouria Yazdian
- Department of Internal Medicine, ShahidSadoughi University of Medical Sciences, Yazd, Iran
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Ji Y, Lu H. Meta-analysis: High-dose vs. low-dose metronidazole-containing therapies for Helicobacter pylori eradication treatment. PLoS One 2018; 13:e0189888. [PMID: 29370199 PMCID: PMC5784897 DOI: 10.1371/journal.pone.0189888] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2017] [Accepted: 12/04/2017] [Indexed: 01/06/2023] Open
Abstract
Objective The purpose of this study was to evaluate the efficacy of high dose of metronidazole in the treatment of Helicobacter pylori (H. pylori) infection. Methods Studies were identified from databases (Pubmed, Embase, Cochrane Library, ClinicalTrials.gov) searched from January 1990 to September 2017 using a battery of keywords. We included randomized controlled trials (RCTs) of H. pylori treatment comparing the high-dose and low-dose metronidazole-containing therapies (high-dose and low-dose therapies). Two reviewers independently selected studies, extracted relevant data and assessed study quality. A meta-analysis was performed by using Review Manager 5.3. Dichotomous data were pooled to obtain the relative risk (RR) of the eradication rate, with 95% confidence intervals (CIs). Results Four randomized controlled trials, a total of 612 patients with a diagnosis of H. pylori infection were included. Overall the meta-analysis showed that both high-dose and low-dose therapies achieved similar efficacy of intention-to-treat (ITT) eradication rate 82% vs. 76%, RR 1.12 (95%CI: 0.96 to 1.30), P = 0.15, and adherence 94% vs. 94%, RR 1.00 (95%CI: 0.97 to 1.04), P = 0.81, but side effects were more likely in high-dose therapies [32% vs. 17%, RR 1.84 (95%CI: 1.17 to 2.88), P = 0.008]. In subgroup analysis, increasing the dose of metronidazole enhanced eradication rates in areas with high metronidazole resistance [74% vs 52%, RR 1.40 (95%CI: 1.08 to 1.82), P = 0.01] and in individuals with metronidazole-resistant strains [71% vs. 46%, RR 1.50 (95%CI: 1.02 to 2.19), P = 0.04]. Conclusions Both high-dose and low-dose therapies can achieve similar eradication rates and adherence and generally low-dose therapies cause fewer side effects. In populations with high metronidazole resistance, high dose of metronidazole can increase the eradication rates of H. pylori infection.
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Affiliation(s)
- Yingjie Ji
- Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Hong Lu
- Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
- * E-mail:
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Fallone CA, Chiba N, van Zanten SV, Fischbach L, Gisbert JP, Hunt RH, Jones NL, Render C, Leontiadis GI, Moayyedi P, Marshall JK. The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology 2016; 151:51-69.e14. [PMID: 27102658 DOI: 10.1053/j.gastro.2016.04.006] [Citation(s) in RCA: 621] [Impact Index Per Article: 69.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
Abstract
BACKGROUND & AIMS Helicobacter pylori infection is increasingly difficult to treat. The purpose of these consensus statements is to provide a review of the literature and specific, updated recommendations for eradication therapy in adults. METHODS A systematic literature search identified studies on H pylori treatment. The quality of evidence and strength of recommendations were rated according to the Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach. Statements were developed through an online platform, finalized, and voted on by an international working group of specialists chosen by the Canadian Association of Gastroenterology. RESULTS Because of increasing failure of therapy, the consensus group strongly recommends that all H pylori eradication regimens now be given for 14 days. Recommended first-line strategies include concomitant nonbismuth quadruple therapy (proton pump inhibitor [PPI] + amoxicillin + metronidazole + clarithromycin [PAMC]) and traditional bismuth quadruple therapy (PPI + bismuth + metronidazole + tetracycline [PBMT]). PPI triple therapy (PPI + clarithromycin + either amoxicillin or metronidazole) is restricted to areas with known low clarithromycin resistance or high eradication success with these regimens. Recommended rescue therapies include PBMT and levofloxacin-containing therapy (PPI + amoxicillin + levofloxacin). Rifabutin regimens should be restricted to patients who have failed to respond to at least 3 prior options. CONCLUSIONS Optimal treatment of H pylori infection requires careful attention to local antibiotic resistance and eradication patterns. The quadruple therapies PAMC or PBMT should play a more prominent role in eradication of H pylori infection, and all treatments should be given for 14 days.
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Affiliation(s)
- Carlo A Fallone
- Division of Gastroenterology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada.
| | - Naoki Chiba
- Guelph GI and Surgery Clinic, Guelph, Ontario, Canada; Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada
| | | | - Lori Fischbach
- Department of Epidemiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas
| | - Javier P Gisbert
- Gastroenterology Service, Hospital Universitario de la Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
| | - Richard H Hunt
- Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada; Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada
| | - Nicola L Jones
- Division of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, Departments of Paediatrics and Physiology, University of Toronto, Toronto, Ontario, Canada
| | - Craig Render
- Kelowna General Hospital, Kelowna, British Columbia, Canada
| | - Grigorios I Leontiadis
- Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada; Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada
| | - Paul Moayyedi
- Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada; Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada
| | - John K Marshall
- Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada; Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada
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Majlesi A, Sayedin Khorasani M, khalilian AR, Aslani MM, jaefari M, Alikhani MY. Antibiotic Susceptibility of Helicobacter pylori Clinical Isolates in Hamadan, West of Iran. INTERNATIONAL JOURNAL OF ENTERIC PATHOGENS 2013. [DOI: 10.17795/ijep9344] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
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Shevchenko KV, Trufanova AV, Nagaev IY. Stability of the antiulcer peptides PGP, DHA-PGP, and GPGPGP in horse gastric juice. Pharm Chem J 2011. [DOI: 10.1007/s11094-011-0530-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
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15
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Riahizadeh S, Malekzadeh R, Agah S, Zendehdel N, Sotoudehmanesh R, Ebrahimi-Dariani N, Pourshams A, Vahedi H, Mikaeli J, Khatibian M, Massarrat S. Sequential metronidazole-furazolidone or clarithromycin-furazolidone compared to clarithromycin-based quadruple regimens for the eradication of Helicobacter pylori in peptic ulcer disease: a double-blind randomized controlled trial. Helicobacter 2010; 15:497-504. [PMID: 21073605 DOI: 10.1111/j.1523-5378.2010.00798.x] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND Furazolidone is a much cheaper drug with a very low resistance against Helicobacter pylori compared to clarithromycin. We aim to evaluate safety and efficacy of a sequential furazolidone-based regimen versus clarithromycin-based therapy in H. pylori eradication for ulcer disease. MATERIALS Patients with proven peptic ulcer or duodenitis were randomized into three groups: OAB-M-F; metronidazole (M) (500 mg bid) for the first 5 days, followed by furazolidone (F) (200 mg bid) for the second 5 days; OAC-P; clarithromycin (C) (500 mg bid) for 10 days; and OAB-C-F; clarithromycin (500 mg bid) for the first 5 days and furazolidone (200 mg bid) for the second 5 days. All groups received omeprazole (O) (20 mg bid) and amoxicillin (A) (1 g bid). Groups OAB-M-F and OAB-C-F were also given bismuth subcitrate (B) (240 mg bid), whereas a placebo (P) was given to group OAC-P. Adverse events were scored and recorded. Two months after treatment, a C(13) -urea breath test was performed. RESULTS Three hundred and ten patients were enrolled and 92 (OAB-M-F), 95 (OAC-P), and 98 (OAB-C-F) completed the study. The intention-to-treat eradication rates were 78.5% (95% CI = 69-85), 81.1% (95% CI = 73-88), and 82% (95% CI = 74-89), and per-protocol eradication rates were 91.3% (95% CI = 83-96), 90.4% (95% CI = 82-95), and 88.7% (95% CI = 81-94), for group OAB-M-F, OAC-P, and OAB-C-F, respectively. Eradication rate differences did not reach statistical significance. The most common adverse event, bad taste, occurred in all groups, but more frequently in groups OAC-P (34%) and OAB-C-F (32%), than OAB-M-F (14%) (p < .05). Adverse symptoms score were 0.88 ± 2.05 in group OAB-M-F, 1.15 ± 1.40 in group OAC-P, and 1.87 ± 1.62 in group OAB-C-F. CONCLUSION Furazolidone can replace clarithromycin in H. pylori eradication regimens because of lack of development of resistance and very low cost.
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Affiliation(s)
- Saghi Riahizadeh
- Digestive Disease Research Center, Iran University of Medical Sciences, Tehran, Iran
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Hasan SR, Vahid V, Reza PM, Roham SR. Short-duration furazolidone therapy in combination with amoxicillin, bismuth subcitrate, and omeprazole for eradication of Helicobacter pylori. Saudi J Gastroenterol 2010; 16:14-8. [PMID: 20065568 PMCID: PMC3023095 DOI: 10.4103/1319-3767.58762] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/17/2023] Open
Abstract
BACKGROUND/AIM Resistance to metronidazole is one of the most common reasons for Helicobacter pylori treatment failure with the classic triple therapy. The clarithromycin-based regimen is not cost-effective for use in developing countries. Though furazolidone is a great substitute it has many side effects. Decreasing the duration of treatment with furazolidone to 1 week may help decrease the drug's side effects. AIM To study the efficacy and side effects of furazolidone when given for 1 week in combination with bismuth subcitrate, amoxicillin, and omeprazole. MATERIALS AND METHODS One hundred and seventy-seven patients with duodenal ulcer were randomly divided into two groups. Group I received omeprazole 2 Chi 20 mg + amoxicillin 2 Chi 1 g + bismuth subcitrate 4 Chi 120 mg for 2 weeks, with furazolidone 2 Chi 200 mg in the first week only. Group II received the same regimen, except that 1 week of furazolidone was followed by 1 week of metronidazole in the second week. Control endoscopy was performed after 6 weeks. Three biopsies from the antrum and three from the corpus were taken for urease testing and histology. Eradication was concluded if all tests were negative for H pylori. RESULTS One hundred and fifty-seven patients completed the study. Two subjects from group I and three from group II did not tolerate the regimen and were excluded from the analysis. No serious complication was detected in any patient. The eradication rates by per-protocol (PP) analysis and intention-to-treat (ITT) analysis were 89% and 79.3% in group I and 86.6% and 74.4% in group II, respectively. CONCLUSION One week of furazolidone in combination with 2 weeks of amoxicillin, omeprazole, and bismuth subcitrate is a safe and cost-effective regimen for the eradication of H pylori. Adding metronidazole to the above regimen does not increase the eradication rate.
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Affiliation(s)
- Salman R. Hasan
- Depatment of Internal Medicine, Yazd University of Medical Science and Health Services, Yazd, Iran
| | | | - Pahlvanzadah M. Reza
- Depatment of Microbiology and Pathology, Yazd University of Medical Science and Health Services, Yazd, Iran
| | - Salman R. Roham
- Tehran University of Medical Science Research Center, Tehran, Iran,Address for correspondence: Dr. Salman Roghani Hasan, Shahid Sadoghi University of Medical Sciences, Safaiyeh Ebne Sina Avenue, Shahid Sadoghi Hospital, Yazd, Iran
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Fischbach L, Evans EL. Meta-analysis: the effect of antibiotic resistance status on the efficacy of triple and quadruple first-line therapies for Helicobacter pylori. Aliment Pharmacol Ther 2007; 26:343-57. [PMID: 17635369 DOI: 10.1111/j.1365-2036.2007.03386.x] [Citation(s) in RCA: 281] [Impact Index Per Article: 15.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND Information regarding the effects of drug resistance on therapies for Helicobacter pylori is limited. AIMS To determine the effect of drug resistance on the efficacy of first-line treatment regimens for H. pylori and identify the most efficacious treatments in the presence of drug resistance. METHODS We searched for studies using the keywords: 'Helicobacter pylori','resistance' and 'treatment' or 'therapy'. Multilevel meta-regression models were used to determine the effect of drug resistance on treatment efficacy. RESULTS We analysed data from 93 studies with 10,178 participants. For triple therapies, clarithromycin resistance had a greater effect on treatment efficacy than nitroimidazole resistance. Metronidazole resistance reduced efficacy by 26% in triple therapies containing a nitroimidazole, tetracycline and bismuth, while efficacy was reduced by only 14% when a gastric acid inhibitor was added to the regimen. Quadruple therapies containing both clarithromycin and metronidazole were the most efficacious; >80% of H. pylori infections were consistently eradicated with these regimens. CONCLUSIONS Drug resistance was a strong predictor of efficacy across triple therapies for the eradication of H. pylori in adults. Resistance to either clarithromycin or metronidazole, but not both simultaneously, may be overcome by using quadruple therapies, especially those containing both clarithromycin and metronidazole.
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Affiliation(s)
- L Fischbach
- University of North Texas Health Science Center, School of Public Health, Fort Worth, TX 76107, USA.
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Keshavarz AA, Bashiri H, Rahbar M. Omeprazole-based triple therapy with low-versus high-dose of clarithromycin plus amoxicillin for H pylori eradication in Iranian population. World J Gastroenterol 2007; 13:930-3. [PMID: 17352026 PMCID: PMC4065932 DOI: 10.3748/wjg.v13.i6.930] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: To investigate the efficacy and tolerability of H pylori eradication in an omeprazole-based triple therapy with high- and low-dose of clarithromycin and amoxicillin.
METHODS: One hundred and sixty H pylori positive patients were randomly assigned to two groups based on the following 2 wk investigation; (1) group A or low-dose regimen received omeprazole 20 mg b.i.d, clarithromycin 250 mg b.i.d and amoxicillin 500 mg b.i.d; and (2) group B or high-dose regimen received omeprazole 20 mg b.i.d, clarithromycin 500 mg b.i.d and amoxicillin 1000 mg b.i.d. During the study H pylori status was assessed by histology and rapid urease test prior and by 13C-urea breath test 6 wk after the therapy. Standard questionnaires were administered to determine the compliance to treatment and possible adverse events of therapy. Data were subject to χ2 to compare the eradication rates in the two groups. The significant level of 95% (P≤ 0.05) was considered statistically different.
RESULTS: We found that the per-protocol eradication rate was 88% (68/77) in group A, and 89% (67/75) in group B. The intension-to-treat eradication rate was 85% (68/80) in group A and 83.75% (67/80) in group B. Overall adverse events were 26% in group A and 31% in group B. The adverse events were generally mild in nature and tolerated well in both groups with a compliance of 98% in group A vs 96% in group B.
CONCLUSION: The omeprazole-based low dose regimen of clarithromycin and amoxicillin for two weeks in H pylori eradication is as effective as high dose regimen in Iranian population.
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Affiliation(s)
- Ali-Asghar Keshavarz
- Department of Gastroenterology and Hepatology, Emam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.
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Emami MH, Saberfiroozi MM, Arj A, Taghavi AR, Bagheri-Lankarani K, Dehbashi N, Fattahi MR, Alizadeh M, Kaviani MJ, Bahri-Najafi R, Geramizadeh B, Esmaeili A. Does delayed gastric emptying shorten the H pylori eradication period? A double blind clinical trial. World J Gastroenterol 2006; 12:6310-6315. [PMID: 17072954 PMCID: PMC4088139 DOI: 10.3748/wjg.v12.i39.6310] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/16/2006] [Revised: 01/28/2006] [Accepted: 02/24/2006] [Indexed: 02/07/2023] Open
Abstract
AIM To evaluate the gastric emptying inhibitory effects of sugar and levodopa on H pylori eradication period. METHODS A total of 139 consecutive patients were randomized into 6 groups. The participants with peptic ulcer disease or non-ulcer dyspepsia non-responding to other medications who were also H pylori-positive patients either with positive rapid urease test (RUT) or positive histology were included. All groups were pretreated with omeprazole for 2 d and then treated with quadruple therapy regimen (omeprazole, bismuth, tetracycline and metronidazole); all drugs were given twice daily. Groups 1 and 2 were treated for 3 d, groups 3, 4 and 5 for 7 d, and group 6 for 14 d. Groups 1 to 4 received sugar in the form of 10% sucrose syrup. Levodopa was prescribed for groups 1 and 3. Patients in groups 2 and 4 were given placebo for levodopa and groups 5 and 6 received placebos for both sugar and levodopa. Upper endoscopy and biopsies were carried out before treatment and two months after treatment. Eradication of H pylori was assessed by RUT and histology 8 wk later. RESULTS Thirty patients were excluded. Per-protocol analysis showed successful eradication in 53% in group 1, 56% in group 2, 58% in group 3, 33.3% in group 4, 28% in group 5, and 53% in group 6. Eradication rate, patient compliance and satisfaction were not significantly different between the groups. CONCLUSION It seems that adding sugar or levodopa or both to anti H pylori eradication regimens may lead to shorter duration of treatment.
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Affiliation(s)
- Mohammad Hassan Emami
- Isfahan University of Medical Sciences, Poursina Hakim Research Institute, Mail box: 81465-1798, Isfahan, Iran.
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Mirbagheri SA, Hasibi M, Abouzari M, Rashidi A. Triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication: A comparative three-armed randomized clinical trial. World J Gastroenterol 2006; 12:4888-91. [PMID: 16937475 PMCID: PMC4087627 DOI: 10.3748/wjg.v12.i30.4888] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: To compare the effectiveness of triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication in a comparative three-armed randomized clinical trial.
METHODS: A total of 360 H pylori-positive patients suffering from dyspepsia and aging 24-79 years with a median age of 42 years were enrolled in the study and randomly allocated into the following three groups: group A (n = 120) received a standard 1-wk triple therapy (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 500 mg clarithromycin b.i.d.); group B (n = 120) received a 10-d standard quadruple therapy (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 240 mg colloidal bismuth subcitrate b.i.d., and 500 mg metronidazole b.i.d.); group C (n = 120) received the new protocol, i.e. 375 mg sultamicillin (225 mg ampicillin plus 150 mg sulbactam) b.i.d. (before breakfast and dinner), instead of amoxicillin in the standard quadruple therapy for the same duration. Chi-square test with the consideration of P < 0.05 as significant was used to compare the eradication rates by intention-to-treat and per-protocol analyses in the three groups.
RESULTS: The per-protocol eradication rate was 91.81% (101 patients from a total of 110) in group A, 85.84% (97 patients from a total of 113) in group B, and 92.85% (104 patients from a total of 112) in group C. The intention-to-treat eradication rate was 84.17% in group A, 80.83% in group B, and 86.67% in group C. The new protocol yielded the highest eradication rates by both per-protocol and intention-to-treat analyses followed by the standard triple and quadruple regimens, respectively. However, the differences were not statistically significant between the three groups.
CONCLUSION: The results of this study provide further support for the equivalence of triple and quadruple therapies in terms of effectiveness, compliance and side-effect profile when administered as first-line treatment for H pylori infection. Moreover, the new protocol using ampicillin-sulbactam instead of amoxicillin in the quadruple regimen is a suitable first-line alternative to be used in regions with amoxicillin-resistant H pylori strains.
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Mousavi S, Toussy J, Yaghmaie S, Zahmatkesh M. Azithromycin in one week quadruple therapy for H pylori eradication in Iran. World J Gastroenterol 2006; 12:4553-6. [PMID: 16874871 PMCID: PMC4125646 DOI: 10.3748/wjg.v12.i28.4553] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: To investigate eradication rates, patient compliance and tolerability of a 1-wk Azithromycin-based quadruple therapy versus the 2-wk conventional therapy.
METHODS: A total of 129 H pylori-positive patients were randomized to either omeprazole 20 mg, bismuth subcitrate 240 mg, azithromycin 250 mg, and metronidazole 500 mg, all twice daily for 1-wk (B-OAzM) or omeprazole 20 mg, bismuth subcitrate 240 mg, amoxicillin 1g, and metronidazole 500 mg all twice daily for 2-wk (B-OAM). H pylori infection was defined at entry by histology and rapid urease test and cure of infection was determined by negative urea breath test.
RESULTS: H pylori eradication rates produced by B-OAzM and B-OAM were 74.1% and 70.4% respectively based on an intention to treat analysis, and 78.1% versus 75.7% respectively based on a per-protocol analysis. The incidence of poor compliance was lower, although not significantly so, in patients randomized to B-OAzM than for B-OAM (3.5% versus 4.3%) but intolerability was similar in the two groups ( 35% versus 33.3%).
CONCLUSION: 1-wk azithromycin based quadruple regimen achieves an H pylori eradication rate comparable to that of standard 2-wk quadruple therapy, and is associated with comparable patient compliance and complications.
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Affiliation(s)
- Shahrokh Mousavi
- Semnan Gastrointestinal and Liver diseases Research Center, Department of gastroenterology, Fatemieh Hospital, Semnan University of Medical Sciences, Semnan, Iran.
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Abstract
AIM: To examine the frequency of antibiotic resistance in Iranian Helicobacter pylori (H pylori) strains isolated from two major hospitals in Tehran.
METHODS: Examination of antibiotic resistance was performed on 120 strains by modified disc diffusion test and PCR-RFLP methods. In addition, in order to identify the possible causes of the therapeutic failure in Iran, we also determined the resistance of these strains to the most commonly used antibiotics (metronidazole, amoxicillin, and tetracycline) by modified disc diffusion test.
RESULTS: According to modified disc diffusion test, 1.6% of the studied strains were resistant to amoxicillin, 16.7% to clarithromycin, 57.5% to metronidazole, and there was no resistance to tetracycline. Of the clarithromycin resistant strains, 73.68% had the A2143G mutation in the 23S rRNA gene, 21.05% A2142C, and 5.26% A2142G. None of the sensitive strains were positive for any of the three point mutations. Of the metronidazole resistant strains, deletion in rdxA gene was studied and detected in only 6 (5%) of the antibiogram-based resistant strains. None of the metronidazole sensitive strains possessed rdxAgene deletion.
CONCLUSION: These data show that despite the fact that clarithromycin has not yet been introduced to the Iranian drug market as a generic drug, nearly 20% rate of resistance alerts toward the frequency of macrolide resistance strains, which may be due to the widespread prescription of erythromycin in Iran. rdxA gene inactivation, if present in Iranian H pylori strains, may be due to other genetic defects rather than gene deletion.
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Affiliation(s)
- Marjan Mohammadi
- Biotechnology Research Center, Pasteur Institute of Iran, Tehran, Iran.
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Roghani HS, Massarrat S, Shirekhoda M, Butorab Z. Effect of different doses of furazolidone with amoxicillin and omeprazole on eradication of Helicobacter pylori. J Gastroenterol Hepatol 2003; 18:778-82. [PMID: 12795748 DOI: 10.1046/j.1440-1746.2003.03058.x] [Citation(s) in RCA: 35] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND Resistance to metronidazole is one of the most common reasons for Helicobacter pylori treatment failure with classic triple therapy. In contrast, the clarithromycin-based regimen is not cost-effective for developing countries. Furazolidone is a very good substitute for metronidazole and clarithromycin, but its many side-effects limit widespread use. The aim of the present study was to assess the efficacy of two different doses of furazolidone in combination with amoxycillin and omeprazole. METHODS A total of 123 patients with duodenal ulcer were randomized and received the following medications for two weeks. Group A: furazolidone 2 x 200 mg + amoxycillin 2 x 1 g + omeprazole 2 x 20 mg/day. Group B: furazolidone 2 x 50 mg + amoxycillin 2 x 1 g + omeprazole 2 x 20 mg/day. Control endoscopy was performed after 6 weeks and two biopsy specimens from the antrum and two from the corpus were taken for a urease test and histology. Eradication was concluded if all tests were negative for H. pylori. RESULTS In total, 110 patients completed the study. Four patients in group A did not tolerate the regimen on day 8 of therapy and were excluded from the study. Serious complications such as fever, and fatigue and dizziness, which occurred in the beginning of the second week of treatment (days 8-10), were more common in group A than in group B (19%, 15.9% and 14.3%, respectively, in group A vs 0% in group B). The eradication rate by per protocol analysis was significantly higher in group A than in group B (88.9%vs 67.9%, respectively, P = 0.008). However, this difference was low and not statistically significant by intention-to-treat analysis (76.2% in group A and 62.3% in group B, P = 0.09). CONCLUSION The regimen with a non-reduced dose of furazolidone in combination with amoxycillin and omeprazole was effective when the patients tolerated the drugs and completed the study.
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Abstract
Helicobacter pylori in the developing world is associated with many unique challenges not encountered in an industrialized setting. The 20% prevalence of infection with H. pylori among adolescents in the United States pales in comparison to infection rates exceeding 90% by 5 years of age in parts of the developing world. While H. pylori within the developed world is associated with gastritis, which may lead to peptic ulcer and gastric carcinoma, the infection in the developing world appears to also be linked with chronic diarrhea, malnutrition and growth faltering as well as predisposition to other enteric infections, including typhoid fever and cholera. Once identified, treatment of H. pylori within the developing world presents increased difficulties due to the frequency of antibiotic resistance as well as the frequency of recurrence after successful treatment. Control, and possibly eradication, of H. pylori could likely be achieved through increased standards of living and improved public health, as it has in the industrialized world. However, these measures are distant objectives for most developing countries, making long-term control of the organism dependent on the development and administration of an effective vaccine.
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Affiliation(s)
- Robert W Frenck
- Enteric Disease Research Program, US Naval Medical Research Unit #3, Cairo, Egypt.
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Malekzadeh R, Merat S, Derakhshan MH, Siavoshi F, Yazdanbod A, Mikaeli J, Sotoudemanesh R, Sotoudeh M, Farahvash MJ, Nasseri-Moghaddam S, Pourshams A, Dolatshahi S, Abedi B, Babaei M, Arshi S, Majidpour A. Low Helicobacter pylori eradication rates with 4- and 7-day regimens in an Iranian population. J Gastroenterol Hepatol 2003; 18:13-7. [PMID: 12519218 DOI: 10.1046/j.1440-1746.2003.02897.x] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND In Iran, there is insufficient information on the efficacy of Helicobacter pylori eradication regimens shorter than 10 days. This study aims at assessing the efficacy of 4- and 7-day H. pylori eradication regimens in a high-incidence area of gastric cancer in Iran. METHODS Subjects with an endoscopic diagnosis of gastritis, positive urease test, and a histological diagnosis of chronic gastritis were enrolled. Patients were randomly assigned to one of three groups: AOC7 (1000 mg amoxicillin, 20 mg omeprazole, and 500 mg clarithromycin twice daily for 7 days), FOT4 (200 mg furazolidone, 20 mg omeprazole, and 500 mg tetracycline twice daily for 4 days) and FOT7 (the same treatment as the FOT4 group but for 7 days). Sensitivity to these antibiotics was determined in all isolates recovered from culture. The efficacy of eradication was assessed 8 weeks after the end-of-treatment by the 14C-urea breath test. RESULTS One hundred and twenty-eight patients were enrolled in the study. Culture was positive for 84 patients and none of these were resistant to amoxicillin, tetracycline or furazolidone, 1.2% were resistant to clarithromycin and 32.1% to metronidazole. Forty-five, 41 and 42 patients were randomly allocated to the AOC7, FOT4, and FOT7 groups, respectively. The intention-to-treat eradication rates were 35.5, 17.1, and 23.8% for the AOC7, FOT4, and FOT7 groups, respectively. CONCLUSION Treatment regimens of 4 or 7 days are unacceptable for H. pylori infection in Iran, even in the presence of a favorable sensitivity profile.
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Affiliation(s)
- Reza Malekzadeh
- Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran and Ardabil University of Medical Sciences, Ardabil, Iran
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Sharara AI, Chedid M, Araj GF, Barada KA, Mourad FH. Prevalence of Helicobacter pylori resistance to metronidazole, clarithromycin, amoxycillin and tetracycline in Lebanon. Int J Antimicrob Agents 2002; 19:155-158. [PMID: 11850169 DOI: 10.1016/s0924-8579(01)00482-4] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
The aim of this study was to determine the prevalence of antimicrobial resistance amongst Helicobacter pylori isolates cultured from gastric biopsies taken during routine endoscopies at the American University of Beirut Medical Center in Lebanon. Fifty-four consecutively recovered H. pylori isolates were tested against metronidazole, clarithromycin, tetracycline and amoxycillin using the epsilometer test. Resistance to metronidazole (MIC > 8 mg/l) was found in 29.5% of the isolates while resistance to clarithromycin (MIC > or =0.25 mg/l) and tetracycline (MIC > or =4 mg/l) was low (4 and 2%, respectively). All isolates were susceptible to amoxycillin (MIC < or =8 mg/l). These findings are comparable with those reported from Europe and the United States. The prevalence of metronidazole resistance in our study was lower than that from other parts of the Middle East and the developing world.
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Affiliation(s)
- Ala I Sharara
- Department of Internal Medicine, Box 11-0236/16B, American University of Beirut Medical Center, Beirut, Lebanon.
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Kaviani MJ, Malekzadeh R, Vahedi H, Sotoudeh M, Kamalian N, Amini M, Massarrat S. Various durations of a standard regimen (amoxycillin, metronidazole, colloidal bismuth sub-citrate for 2 weeks or with additional ranitidine for 1 or 2 weeks) on eradication of Helicobacter pylori in Iranian peptic ulcer patients. A randomized controlled trial. Eur J Gastroenterol Hepatol 2001; 13:915-9. [PMID: 11507355 DOI: 10.1097/00042737-200108000-00007] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
INTRODUCTION One of the most economical and effective therapeutic regimens for eradication of Helicobacter pylori is the classic triple therapy with amoxycillin or tetracycline, metronidazole and a bismuth derivative. Addition of H2-receptor antagonists to these drugs may heighten the rate of eradication and shorten the duration. We therefore performed a randomized controlled trial comparing twice daily metronidazole, bismuth derivative and amoxycillin for 2 weeks with additional ranitidine for 1 or 2 weeks. PATIENTS AND METHODS In total, 240 adult patients with duodenal ulcer and H. pylori infection were randomly assigned to one of the following regimens: (1) amoxycillin 1 g bid, metronidazole 500 mg bid, bismuth sub-citrate 240 mg bid and ranitidine 300 mg bid for 1 week; (2) triple therapy without ranitidine for 2 weeks; or (3) triple therapy plus ranitidine 300 mg bid for 2 weeks. Side-effects of the drugs were evaluated two weeks after starting the treatment. The rapid urease test and histology from antrum and corpus, and/or 14C- urea breath test were used to determine H. pylori eradication six weeks after starting the treatment. RESULTS In total, 195 patients were followed up for 6 weeks. The most frequent drug side-effects were unpleasant taste (46%), dry mouth (41%) and fatigue (26%), which had an equal distribution in all treatment groups. Endoscopy and 14C- urea breath test were performed for 178 and 123 patients, respectively. Eradication of H. pylori was documented in 19/64 (29.7%), 29/63 (46%) and 50/68 (73.5%) of patients in groups 1, 2 and 3, respectively (P < 0.000001 for group 1 versus group 3; P < 0.0014 for group 2 versus group 3; difference not significant for group 1 versus group 2). An intention-to-treat analysis showed eradication rates of 19/80 (23.75%), 29/80 (36.25%) and 50/80 (62.5%) for groups 1, 2 and 3, respectively. At four weeks post-treatment, the most sensitive test for evaluation of eradication of H. pylori was histology. CONCLUSION Although combined use of an H2-receptor antagonist and twice daily triple therapy in a two-week regimen is more effective than two-week triple or one-week quadruple therapy in Iranian patients, none of these regimens is ideal in countries with a probable high rate of resistant and strongly toxic strains of H. pylori.
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Affiliation(s)
- M J Kaviani
- Gastroenterology Division, Internal Medicine Ward, Shiraz University of Medical Sciences, Shiraz, Iran.
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Al-Qurashi AR, El-Morsy F, Al-Quorain AA. Evolution of metronidazole and tetracycline susceptibility pattern in Helicobacter pylori at a hospital in Saudi Arabia. Int J Antimicrob Agents 2001; 17:233-6. [PMID: 11282271 DOI: 10.1016/s0924-8579(00)00336-8] [Citation(s) in RCA: 18] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
The association of Helicobacter pylori with chronic gastritis and peptic ulcer disease led to new therapeutic approaches including the use of antibiotics. Recently, resistance of H. pylori to antibiotics has emerged as the major cause of treatment failure. This retrospective analysis was aimed at investigating the development of antimicrobial susceptibility patterns amongst H. pylori strains isolated at King Fahd Hospital of the University, Al-Khobar. Susceptibility patterns obtained using isolates from a pilot study (1987-1988) were compared with those subsequently isolated (1990-1996). Metronidazole resistance was estimated to be 35.2% in the first period but more than doubled (78.5%) during the second period. Isolates from females showed a higher resistance rate to metronidazole than those from males. Only one strain was tetracycline resistant. The extremely high resistance rate to metronidazole indicates that it may not be very effective for eradication of H. pylori. Tetracycline should prove a useful component of treatment regimens in this geographical region.
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Affiliation(s)
- A R Al-Qurashi
- Department of Microbiology, College of Medicine, King Faisal University, P.O. Box 2114, Dammam 31451, Saudi Arabia.
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Baena Díez JM, López Mompó C, Rams Rams F, García Lareo M, Rosario Hernández Ibáñez M, Teruel Gila J. [Efficacy of a multistep strategy for Helicobacter pylori eradication: quadruple therapy with omeprazole, metronidazole, tetracycline and bismuth after failure of a combination of omeprazole, clarithromycin and amoxycillin]. Med Clin (Barc) 2000; 115:617-9. [PMID: 11141403 DOI: 10.1016/s0025-7753(00)71640-x] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
BACKGROUND To evaluate the efficacy of a multistep strategy for Helicobacter pylori (HP) eradication. PATIENTS AND METHOD 151 patients, with peptic ulcer or chronic gastritis, infected by HP, treated (first-step) with omeprazole (20 mg/12 h), clarithromycin (500 mg/12 h) and amoxycillin (1 g/12 h) for a week (OCA) and second-step (first-step failures) with omeprazole (20 mg/12 h), metronidazole (500 mg/12 h), tetracyclin (500 mg/6 h) and bismuth (120 mg/6 h) for two weeks. RESULTS Intention-to-treat analysis, eradication was achieved with OCA in 78.1% (CI 95%: 71.6-84.7) and OMTB in 90.3% (CI 95%: 74.2-98), with an cumulative eradication rate of 96.7% (CI 95%: 92.4-98.9). CONCLUSIONS The efficacy of multistep strategy is high. Therapy with OMTB its a good option after failure with OCA.
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De Boer WA, Van Etten RJ, Van De Wouw BA, Schneeberger PM, Van Oijen AH, Jansen JB. Bismuth-based quadruple therapy for Helicobacter pylori - a single triple capsule plus lansoprazole. Aliment Pharmacol Ther 2000; 14:85-9. [PMID: 10632650 DOI: 10.1046/j.1365-2036.2000.00686.x] [Citation(s) in RCA: 22] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/08/2022]
Abstract
BACKGROUND Recently a new 'all in one' single capsule with the three components of bismuth-based triple therapy became available in trials for treating Helicobacter pylori. AIM To investigate the efficacy and tolerability of this new capsule when combined with lansoprazole. METHODS A total of 66 consecutive infected patients from a single centre received two single triple capsules four times daily and lansoprazole 30 mg b.d. for 7 days. Each capsule contained 60 mg of bismuth subcitrate, 125 mg of tetracycline and 125 mg of metronidazole. Endoscopy with biopsies for CLO-test, histology and culture from antrum and corpus was performed before and at least 5 weeks after treatment. RESULTS The per protocol cure rate was 56/64 (88%, 95% CI: 79-95%); by intention-to-treat 56/65 (86%, 95% CI: 78-95%). The per protocol cure rate in metronidazole sensitive strains was 40/43 (93%, 95% CI: 85-100%); in resistant strains 5/9 (56%, 95% CI: 23-88%). There was one drop-out due to adverse events. CONCLUSIONS It is possible to combine the components of bismuth-based triple therapy into a single capsule. Based on the results it can be assumed that the capsule releases its content in the stomach. When combined with lansoprazole it reaches high cure rates, especially in metronidazole sensitive strains. This new approach simplifies bismuth-based anti-Helicobacter therapy.
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Affiliation(s)
- W A De Boer
- Department of Internal Medicine, Sint Anna Hospital, Oss, the Netherlands; Department of Gastroenterology, University of Nijmegen Radboud Hospital, Nijmegen, the Netherlands
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