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Datta S, Khyriem AB, Lynrah KG, Marbaniang E, Topno N. Antimicrobial resistance pattern of Helicobacter pylori in patients evaluated for dyspeptic symptoms in North-Eastern India with focus on detection of clarithromycin resistance conferring point mutations A2143G and A2142G within bacterial 23S rRNA gene. Indian J Med Microbiol 2024; 50:100652. [PMID: 38906329 DOI: 10.1016/j.ijmmb.2024.100652] [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: 02/16/2024] [Revised: 05/12/2024] [Accepted: 06/19/2024] [Indexed: 06/23/2024]
Abstract
PURPOSE In India there is evidence of antimicrobial resistance in Helicobacter pylori, a definitive pathobiont whose only known niche is human gastric mucosa. This in turn can lead to failure of treatment, persistence or chronicity of infection. This hospital based, prospective, observational study investigates the presence of antimicrobial resistance in the organism with focus on detection of A2143G and A2142G major point mutations in domain V of H. pylori 23S rRNA gene as a molecular mechanism of conferring resistance. METHODS Endoscopic gastric biopsy samples from 52 patients presenting with dyspeptic symptoms from January 2016 to December 2016 were subjected to culture in a microaerophilic environment using Campylobacter agar with for 2-5 days. Isolates were identified using gram-staining, motility test and biochemical reactions. Modified Kirby-Bauer Disc diffusion method was used to determine antimicrobial susceptibility against Clarithromycin, Metronidazole, Amoxycillin, Levofloxacin, Tetracycline, Cotrimoxazole and Erythromycin. Additionally, detection of A2143G and A2142G point mutations conferring Clarithromycin resistance was carried out using real time PCR following extraction and quantification of bacterial DNA. Histopathological examination was carried out on all biopsy samples. Descriptive and inferential statistical analytical methods were used. Differences were considered significant for p < 0.05. RESULTS Culture positivity for H. pylori by phenotypic method was found to be 36.54%. Histopathologic Examination detected H. pylori in 55.7% and PCR detected 48.08% for either the wild type or one of two mutant strains A2143G and A2142G. No sample was found positive for both mutations. Metronidazole showed the highest resistance among antibiotics (78.9%) followed by Clarithromycin (47.3%). CONCLUSION Prevalence of antimicrobial resistance in H. pylori in North-Eastern India is substantially high with A2143G mutation being clinically most important in conferring Clarithromycin resistance. This resistance might be associated with low eradication rates despite initiation of therapy. ROC analysis of PCR proved it to be a good diagnostic tool.
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Affiliation(s)
- Saranya Datta
- Department of Microbiology, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Mawdiangdiang, Shillong, 793018, India.
| | - Annie B Khyriem
- Department of Microbiology, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Mawdiangdiang, Shillong, 793018, India.
| | - Kyrshanlang G Lynrah
- Department of Medicine, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Mawdiangdiang, Shillong, 793018, India.
| | - Evarisalin Marbaniang
- Department of Pathology, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Mawdiangdiang, Shillong, 793018, India.
| | - Noor Topno
- Department of General Surgery, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Mawdiangdiang, Shillong, 793018, India.
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Valizadeh Toosi SM, Feyzi S, Kazemi A. Comparison of the Efficacy of 12-day Concomitant Quadruple Therapy versus 14-day High dose Dual Therapy as a First-line H. pylori Eradication Regimen. THE KOREAN JOURNAL OF GASTROENTEROLOGY = TAEHAN SOHWAGI HAKHOE CHI 2024; 83:150-156. [PMID: 38659251 DOI: 10.4166/kjg.2024.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/29/2024] [Revised: 04/01/2024] [Accepted: 04/12/2024] [Indexed: 04/26/2024]
Abstract
Background/Aims Helicobacter pylori (H. pylori) is the most prevalent infection in the world and is strongly associated with gastric adenocarcinoma, lymphoma and gastric or duodenal ulcers. Different regimens have been used for H. pylori eradication. We aimed to compare the efficacy of two different regimens as first-line H. pylori eradication regimens, in an area with high antibiotic resistance. Methods In this RCT, we assigned 223 patients with H. pylori infection, who were naïve to treatment. They were randomly divided into two groups to receive either 12-day concomitant quadruple therapy (consisting of pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg every 12 hours) or 14-day high dose dual therapy (consisting of esomeprazole 40 mg and amoxicillin 1 g TDS). H. pylori eradication was assessed eight weeks after the end of treatment. Results H. pylori eradication rate by PP analysis for 12-day concomitant quadruple therapy and 14-day high dose dual therapy were 90.4% and 79.1%, respectively (p=0.02). According to ITT analysis, the eradication rates were 86.2% and 76.3%, respectively (p=0.06). Adverse drug reactions were 12.3% in high dose dual therapy and 36.8% in concomitant quadruple therapy (p<0.001). Conclusions Twelve-day concomitant therapy seems to be an acceptable regimen for first-line H. pylori eradication in Iran, a country with a high rate of antibiotic resistance. Although, high dose dual therapy did not result in an ideal eradication rate, but it had fewer drug side effects than the 12-day concomitant regimen.
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Affiliation(s)
- Seyed Mohammad Valizadeh Toosi
- Gut and Liver Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran
| | - Sahar Feyzi
- Medicine faculty, Mazandaran University of Medical Sciences, Sari, Iran
| | - Arash Kazemi
- Gut and Liver Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran
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Georgopoulos SD, Xirouchakis E, Liatsos C, Apostolopoulos P, Kasapidis P, Martinez-Gonzalez B, Laoudi F, Stoupaki M, Axiaris G, Sgouras D, Mentis A, Michopoulos S. Equivalence Trial of the Non-Bismuth 10-Day Concomitant and 14-Day Hybrid Therapies for Helicobacter pylori Eradication in High Clarithromycin Resistance Areas. Antibiotics (Basel) 2024; 13:280. [PMID: 38534715 DOI: 10.3390/antibiotics13030280] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/03/2024] [Revised: 03/12/2024] [Accepted: 03/15/2024] [Indexed: 03/28/2024] Open
Abstract
Background and aim: We conducted an equivalence trial of quadruple non-bismuth "concomitant" and "hybrid" regimens for H. pylori eradication in a high clarithromycin resistance area. Methods: There were 321 treatment-naïve H. pylori-positive individuals in this multicenter clinical trial randomized to either the hybrid (esomeprazole 40 mg/bid, amoxicillin 1 g/bid for 7 days, then 7 days esomeprazole 40 mg/bid, amoxicillin 1 g/bid, clarithromycin 500 mg/bid, and metronidazole 500 mg/bid) or the concomitant regimen (all medications given concurrently bid for 10 days). Eradication was tested using histology and/or a 13C-urea breath test. Results: The concomitant regimen had 161 patients (90F/71M, mean 54.5 years, 26.7% smokers, 30.4% ulcer) and the hybrid regimen had 160 (80F/80M, mean 52.8 years, 35.6% smokers, 31.2% ulcer). The regimens were equivalent, by intention to treat 85% and 81.8%, (p = 0.5), and per protocol analysis 91.8% and 87.8%, (p = 0.3), respectively. The eradication rate by resistance, between concomitant and hybrid regimens, was in susceptible strains (97% and 97%, p = 0.6), clarithromycin single-resistant strains (86% and 90%, p = 0.9), metronidazole single-resistant strains (96% and 81%, p = 0.1), and dual-resistant strains (70% and 53%, p = 0.5). The side effects were comparable, except for diarrhea being more frequent in the concomitant regimen. Conclusions: A 14-day hybrid regimen is equivalent to a 10-day concomitant regimen currently used in high clarithromycin and metronidazole resistance areas. Both regimens are well tolerated and safe.
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Affiliation(s)
| | - Elias Xirouchakis
- GI and Hepatology Department, Athens Medical, Paleo Faliron Hospital, 17562 Athens, Greece
| | - Christos Liatsos
- Gastroenterology Department, 401 General Military Hospital of Athens, 17562 Athens, Greece
| | | | | | | | - Fotini Laoudi
- GI and Hepatology Department, Athens Medical, Paleo Faliron Hospital, 17562 Athens, Greece
| | - Maria Stoupaki
- Gastroenterology Department, Alexandra General Hospital, 11528 Athens, Greece
| | - Georgios Axiaris
- Gastroenterology Department, Alexandra General Hospital, 11528 Athens, Greece
| | - Dionysios Sgouras
- Laboratory of Medical Microbiology, Hellenic Pasteur Institute, 11521 Athens, Greece
| | - Andreas Mentis
- Laboratory of Medical Microbiology, Hellenic Pasteur Institute, 11521 Athens, Greece
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Temido MJ, Mbanze D, Almeida N, Oliveiros B, Gravito-Soares E, Figueiredo P. Is hybrid therapy more efficient in the eradication of Helicobacter pylori infection? A systematic review and meta-analysis. Ann Clin Microbiol Antimicrob 2023; 22:54. [PMID: 37403171 DOI: 10.1186/s12941-023-00582-2] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/27/2022] [Accepted: 04/11/2023] [Indexed: 07/06/2023] Open
Abstract
INTRODUCTION Hybrid therapy (HT) is a non-bismuth quadruple therapy created to surpass Helicobacter pylori's (H. pylori) resistance rates to antibiotics. HT has excellent eradication rates, as well as a very good compliance and safety profile. We aim to compare HT with sequential therapy (ST) and concomitant therapy (CT) for the eradication of H. pylori. METHODS This systematic review was conducted following the principles of the PRISMA guidelines. Literature was electronically searched on the CENTRAL library, PubMed, Embase, Scopus, LILACS, and ClinicalTrials.gov. Only randomized controlled trials were included. The primary outcome evaluated was eradication rate of H. pylori. The secondary outcomes evaluated were adverse events and compliance rates. Meta-analyses were performed with Cochrane Review Manager 5.4. The Mantel-Haenszel method was used to estimate the pooled relative risk and 95% confidence interval of the eradication rates between HT and other regimens, as well as the secondary outcomes. RESULTS 10 studies were included, comprising 2993 patients. The mean eradication rates achieved by HT with intention-to-treat (ITT) and per-protocol (PP) analyses were, respectively, 86% (range: 79.2-90.8%) and 91.7% (range: 82.6-96.1%). No statistically significant difference was found in ITT eradication rate between HT and CT (relative risk: 1; 95% CI: 0.96- 1.03) and between HT and ST (relative risk: 1.02; 95% CI: 0.92-1.14). PP analysis revealed similar results. HT was associated with higher compliance rates than CT and slightly lower than ST. As far as adverse events are concerned, this meta-analysis demonstrated a higher occurrence of adverse events on the group of patients treated with CT when compared with HT. HT and ST showed similar results. CONCLUSION HT has similar eradication, compliance and adverse event rates when compared to ST, but a better safety profile than the CT.
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Affiliation(s)
- Maria José Temido
- Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Prof. Mota Pinto, 3004-561, Coimbra, Portugal
| | - Dara Mbanze
- Faculty of Medicine, University of Coimbra, Coimbra, Portugal
- Centro Hospitalar e Universitário de Coimbra, Praceta Prof. Mota Pinto, 3004-561, Coimbra, Portugal
| | - Nuno Almeida
- Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Prof. Mota Pinto, 3004-561, Coimbra, Portugal.
- Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
| | | | - Elisa Gravito-Soares
- Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Prof. Mota Pinto, 3004-561, Coimbra, Portugal
- Faculty of Medicine, University of Coimbra, Coimbra, Portugal
| | - Pedro Figueiredo
- Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Prof. Mota Pinto, 3004-561, Coimbra, Portugal
- Faculty of Medicine, University of Coimbra, Coimbra, Portugal
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Ten-day concomitant and sequential therapy for Helicobacter pylori effective in region with high antibiotic resistance rates. Indian J Gastroenterol 2022; 41:627-633. [PMID: 36573961 DOI: 10.1007/s12664-022-01272-1] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/20/2022] [Accepted: 06/07/2022] [Indexed: 02/03/2023]
Abstract
BACKGROUND Increasing antibiotic-resistant Helicobacter pylori (H. pylori) strains complicate efforts to eradicate infection. In regions with high dual resistance to both clarithromycin and metronidazole, bismuth quadruple therapy is recommended. But, with lack of easy availability of bismuth, the (non-bismuth) concomitant and sequential regimens are used commonly as first-line therapy. Recent reports indicate suboptimal results with sequential therapy in such regions. We aimed to compare the efficacy of concomitant therapy vs. sequential therapy in the eradication of H. pylori in a region with high antibiotic resistance rates, and to compare adherence rates and adverse events with the regimens. METHODS One hundred and twenty-four consecutive H. pylori-infected patients (diagnosed using rapid urease test or urea breath test) were randomized to receive sequential or concomitant therapy for 10 days each. Four weeks after treatment completion, urea breath test was done to confirm eradication of the infection. Cure rates were compared between the two regimens and note was made of adherence rates and adverse events. RESULTS Concomitant therapy showed a statistically non-significant higher cure rate compared to sequential therapy in intention-to-treat (87.1% vs. 81.4%%, p = 0.46) and per-protocol (94.7% vs. 83.9%, p = 0.07) analyses. Both the regimens were well tolerated and showed similar adherence rates (p = 1.00) and incidence of adverse events (p = 0.44). CONCLUSION In a region with high dual resistance, both concomitant and sequential therapy for H. pylori infection achieved eradication rates >80%, but concomitant therapy showed a statistically non-significant higher cure rate, with similar adherence and adverse event profiles.
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Wang F, Liu Y, Yan H, Wang D, Chu Z, Li K, Tong L, Chen M, Gong J. Revealing dissolution behavior and thermodynamic properties of Tinidazole in 12 mono-solvents based on experiments and molecular simulation. J Mol Liq 2022. [DOI: 10.1016/j.molliq.2022.120081] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
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First-line therapies for H. pylori infection in Italy: a pooled-data analysis. Acta Gastroenterol Belg 2022; 85:295-299. [PMID: 35709773 DOI: 10.51821/85.2.9680] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/10/2022]
Abstract
Background: Curing H. pylori infection remains challenging, and the use of most effective first-line therapy represents a therapeutic cornerstone. To monitor the efficacy of first-line therapies in Italy, we designed a systematic review with pooled- data analysis of data published in the last 15 years.
Methods: The search was focused on standard regimens and adult patients. Studies that included modified therapy regimens, pediatric patients, case series with less than 5 patients, and those in language other than English were excluded.
Results: A total of 40 studies, with 74 therapeutic arms and 13,539 patients were evaluated. Among the 14-day triple therapies, the combination with proton pump inhibitor (PPI), clarithromycin and amoxicillin achieved the highest (77.9%) success rate, whilst the lowest success rate (62.7%) was observed following the 14-day PPI, clarithromycin and tinidazole regimen. The overall efficacy of triple therapies significantly decreased from 75.7% to 72.1% in the last decade. Sequential (88.3% on 3431 patients), concomitant (88.8% on 376 patients), and the bismuth-based quadruple therapy with three-in-one capsule, containing bismuth subcitrate potassium (140 mg), metronidazole (125 mg), tetracycline (125 mg) (90.4% on 999 patients) achieved similarly high eradication rates, but data on concomitant are still limited. The bismuth-based was associated with the higher (38.7%) incidence of side-effects.
Conclusions: Data found that all triple therapies, irrespective of drug combination and therapy duration, should be abandoned in Italy due to their unacceptable low success rates. Monitoring the efficacy of standard first-line therapies in other countries could be clinically useful for both patients and clinicians.
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Gisbert JP, Alcedo J, Amador J, Bujanda L, Calvet X, Castro-Fernández M, Fernández-Salazar L, Gené E, Lanas Á, Lucendo AJ, Molina-Infante J, Nyssen OP, Pérez-Aisa A, Puig I. V Spanish Consensus Conference on Helicobacter pylori infection treatment. GASTROENTEROLOGIA Y HEPATOLOGIA 2022; 45:392-417. [PMID: 34629204 DOI: 10.1016/j.gastrohep.2021.07.011] [Citation(s) in RCA: 25] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/01/2021] [Revised: 06/30/2021] [Accepted: 07/16/2021] [Indexed: 02/07/2023]
Abstract
Helicobacter pylori infection is very common in the Spanish population and represents the main cause of chronic gastritis, peptic ulcer, and gastric cancer. The last iteration of Spanish consensus guidelines on H. pylori infection was conducted in 2016. Recent changes in therapeutic schemes along with increasing supporting evidence were key for developing the V Spanish Consensus Conference (May 2021). Fourteen experts performed a systematic review of the scientific evidence and developed a series of recommendations that were subjected to an anonymous Delphi process of iterative voting. Scientific evidence and the strength of the recommendation were classified using GRADE guidelines. An eradication therapy, when prescribed empirically, is considered acceptable when it reliably achieves, or preferably surpass, 90% cure rates. Currently, only quadruple therapies (with or without bismuth) and generally lasting 14 days, accomplish this goal in first- and second-line therapies. A non-bismuth quadruple concomitant regimen (proton pump inhibitor, clarithromycin, amoxicillin, and metronidazole) or a quadruple bismuth-based combination (proton pump inhibitor, bismuth, tetracycline, and metronidazole), are recommended as first-line regimens. Rescue therapies after eradication failure and management of H. pylori infection in peptic ulcer disease were also reviewed.
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Affiliation(s)
- Javier P Gisbert
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, España.
| | - Javier Alcedo
- Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Zaragoza, España
| | - Javier Amador
- Medicina de Familia, Centro de Salud Los Ángeles, Dirección Asistencial Centro, SERMAS, Madrid, España
| | - Luis Bujanda
- Servicio de Aparato Digestivo, Hospital Donostia/Instituto Biodonostia, Universidad del País Vasco UPV/EHU, CIBEREHD, San Sebastián, España
| | - Xavier Calvet
- Servicio de Aparato Digestivo, Hospital Parc Taulí, Universitat Autónoma de Barcelona, CIBEREHD, Sabadell, Barcelona, España
| | | | - Luis Fernández-Salazar
- Servicio de Aparato Digestivo, Hospital Clínico Universitario de Valladolid, Gerencia Regional de Salud (SACYL), Universidad de Valladolid, Valladolid, España
| | - Emili Gené
- Servicio de Urgencias, Hospital Parc Taulí Sabadell, CIBEREHD, Universitat Internacional de Catalunya, Barcelona, España
| | - Ángel Lanas
- Servicio de Aparato Digestivo, Hospital Clínico Universitario de Zaragoza, Instituto de Investigación Sanitaria de Aragón (IIS Aragón), CIBEREHD, Zaragoza
| | - Alfredo J Lucendo
- Servicio de Aparato Digestivo, Hospital General de Tomelloso, CIBEREHD, Ciudad Real, España
| | - Javier Molina-Infante
- Servicio de Aparato Digestivo, Hospital Universitario de Cáceres, CIBEREHD, Cáceres, España
| | - Olga P Nyssen
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, España
| | - A Pérez-Aisa
- Servicio de Aparato Digestivo, Agencia Sanitaria Costa del Sol, Marbella, Málaga, España
| | - Ignasi Puig
- Servicio de Aparato Digestivo, Althaia Xarxa Assistencial Universitària de Manresa, Universitat de Vic-Universitat Central de Catalunya (UVicUCC), Manresa, Barcelona, España
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Wang K, Lou D, Dai W, Fu R, Ma Z. Comparison of sequential therapy with concomitant therapy in first-line treatment of Helicobacter pylori: an updated meta-analysis. J Med Microbiol 2022; 71. [PMID: 35041577 DOI: 10.1099/jmm.0.001490] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022] Open
Abstract
Sequential therapy (ST) and concomitant therapy (CT) are common first-line treatments for Helicobacter pylori (HP). This study aimed to assess the efficiency and safety of ST and CT in the first-line treatment of HP by comparing their clinical outcomes. Two authors independently searched PubMed, EBSCO, Web of Science and the Cochrane Library for all the relevant articles published before March 2021 to compare the clinical outcomes of HP patients undergoing ST or CT. The primary outcome measures were HP eradication rates and adverse events (AEs). This meta-analysis included 24 articles with 7531 HP patients. CT was better than ST in eradicating HP from per-protocol analysis (PP) (RR=0.96, P<0.001) and modified intent-to-treat analysis (MITT) (RR=0.94, P=0.005). Compared with non-Asia, CT demonstrated more apparent advantages than ST in Asia. CT treated with lansoprazole, pantoprazole and esomeprazole outperformed ST treated with the same PPIs. CT for 10 days and ST for 14 days were the better choices of course of treatment. The incidence rates of AEs were significantly higher in CT than in ST for diarrhoea (RR=0.65, P<0.001), vomiting (RR=0.68, P=0.03), dysgeusia (RR=0.83, P=0.03) and dizziness (RR=0.77, P=0.05). Both ST and CT are safe and effective first-line treatments for HP. Although the AEs were more frequent with CT than ST, CT was superior to ST, especially in Asia. The effect of various PPIs varied in various therapies. The best course of treatment was 10 days for CT and 14 days for ST.
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Affiliation(s)
- Keliang Wang
- Department of Gastroenterology, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, PR China.,Ningbo Institute of Life and Health Industry, University of Chinese Academy of Sciences, Ningbo, PR China
| | - Dandi Lou
- The First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, PR China
| | - Wei Dai
- The Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, PR China
| | - Rongrong Fu
- The First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, PR China
| | - Zhenhua Ma
- Department of Gastroenterology, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, PR China
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Jung HK, Kang SJ, Lee YC, Yang HJ, Park SY, Shin CM, Kim SE, Lim HC, Kim JH, Nam SY, Shin WG, Park JM, Choi IJ, Kim JG, Choi M. Evidence based guidelines for the treatment of Helicobacter pylori infection in Korea 2020. Korean J Intern Med 2021; 36:807-838. [PMID: 34092054 PMCID: PMC8273819 DOI: 10.3904/kjim.2020.701] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/31/2020] [Accepted: 05/06/2021] [Indexed: 01/10/2023] Open
Abstract
Helicobacter pylori infection is one of the most common infectious diseases worldwide. H. pylori is responsible for substantial gastrointestinal morbidity with a high disease burden. Since the revision of the H. pylori Clinical Practice Guidelines in 2013 in Korea, the eradication rate of H. pylori has gradually decreased with the use of a clarithromycin based triple therapy. According to a nationwide randomized controlled study by the Korean College of Helicobacter and Upper Gastrointestinal Research released in 2018, the intention-to-treat eradication rate was only 63.9%, which was mostly due to increased antimicrobial resistance to clarithromycin. The clinical practice guidelines for treatment of H. pylori were updated based on evidence-based medicine from a meta-analysis conducted on a target group receiving the latest level of eradication therapy. The draft recommendations developed based on the meta-analysis were finalized after expert consensus on three recommendations regarding the indication for treatment and eight recommendations on the treatment itself. These guidelines were designed to provide clinical evidence for the treatment of H. pylori to patients, nurses, medical school students, policymakers, and clinicians. These may differ from current medical insurance standards, and will be revised if more evidence emerges in the future.
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Affiliation(s)
- Hye-Kyung Jung
- Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul,
Korea
| | - Seung Joo Kang
- Department of Internal Medicine, Seoul National University Hospital Healthcare System Gangnam Center, Seoul,
Korea
| | - Yong Chan Lee
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul,
Korea
| | - Hyo-Joon Yang
- Division of Gastroenterology, Department of Internal Medicine and Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul,
Korea
| | - Seon-Young Park
- Department of Internal Medicine, Chonnam National University Medical School, Gwangju,
Korea
| | - Cheol Min Shin
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam,
Korea
| | - Sung Eun Kim
- Department of Internal Medicine, Kosin University College of Medicine, Busan,
Korea
| | - Hyun Chul Lim
- Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin,
Korea
| | - Jie-Hyun Kim
- Department of Internal Medicine and Institute of Gastroenterology, Yonsei University College of Medicine, Seoul,
Korea
| | - Su Youn Nam
- Center for Gastric Cancer, Kyungpook National University Chilgok Hospital, Daegu,
Korea
| | - Woon Geon Shin
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon,
Korea
| | - Jae Myung Park
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul,
Korea
| | - Il Ju Choi
- Center for Gastric Cancer, National Cancer Center, Goyang,
Korea
| | - Jae Gyu Kim
- Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul,
Korea
| | - Miyoung Choi
- Division of Healthcare Technology Assessment Research, National Evidence-based Healthcare Collaborating Agency, Seoul,
Korea
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Xu H, Wang W, Ma X, Feng R, Su Y, Cheng L, Yang Y, Zhang D. Comparative efficacy and safety of high-dose dual therapy, bismuth-based quadruple therapy and non-bismuth quadruple therapies for Helicobacter pylori infection: a network meta-analysis. Eur J Gastroenterol Hepatol 2021; 33:775-786. [PMID: 32639419 DOI: 10.1097/meg.0000000000001835] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
Helicobacter pylori (H. pylori) infection is associated with the development of multiple diseases. The eradication rate of H. pylori has gradually decreased, suggesting the need to discover more effective therapies. This study aimed to compare the effectiveness of first-line treatments including high-dose dual therapy (HDDT), bismuth-based quadruple therapy (BQT), sequential therapy (ST), concomitant therapy (CT) and hybrid therapy (HT) by network meta-analysis (NMA). A comprehensive search on PubMed, Embase, Cochrane Library and Web of Science, was performed from their inception to 1 September 2019. A network analysis of randomized controlled trials (RCTs) comparing first-line therapies were carried out using Stata 14.0 and Revman 5.2. Moreover, a sensitivity analysis was conducted by omitting non-Asian studies. Finally, 41 RCTs with 14 119 patients were included. The NMA showed that, in terms of eradication rate, ST for 10 days (ST-10) was significantly lower than CT for 10 or 14 days (CT ≥ 10). Sensitivity analysis among the Asian population showed that ST-10 denoted the lowest effectiveness among the interventions. The ranking results based on probability showed that HDDT ranked first for the eradication rate. As for adverse events, HDDT was significantly less than BQT and CT regardless of duration, while BQT for 14 days represented higher adverse events than ST, HT and CT ≥ 10. HDDT ranked first among the therapies. In conclusion, HDDT for 14 days appeared to be the most optimal first-line therapy for H. pylori among the Asian population with comparable efficacy and compliance but causing fewer adverse events.
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Affiliation(s)
- Huimei Xu
- Department of Gastroenterology, Lanzhou University Second Hospital, Lanzhou, Gansu Province
| | - Wancong Wang
- Department of Gastroenterology, the Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Xueni Ma
- Department of Gastroenterology, Lanzhou University Second Hospital, Lanzhou, Gansu Province
| | - Rukun Feng
- Department of Gastroenterology, Lanzhou University Second Hospital, Lanzhou, Gansu Province
| | - Yujing Su
- Department of Gastroenterology, Lanzhou University Second Hospital, Lanzhou, Gansu Province
| | - Long Cheng
- Department of Gastroenterology, Lanzhou University Second Hospital, Lanzhou, Gansu Province
| | - Yifan Yang
- Department of Gastroenterology, Lanzhou University Second Hospital, Lanzhou, Gansu Province
| | - Dekui Zhang
- Department of Gastroenterology, Lanzhou University Second Hospital, Lanzhou, Gansu Province
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Jung HK, Kang SJ, Lee YC, Yang HJ, Park SY, Shin CM, Kim SE, Lim HC, Kim JH, Nam SY, Shin WG, Park JM, Choi IJ, Kim JG, Choi M. Evidence-Based Guidelines for the Treatment of Helicobacter pylori Infection in Korea 2020. Gut Liver 2021; 15:168-195. [PMID: 33468712 PMCID: PMC7960974 DOI: 10.5009/gnl20288] [Citation(s) in RCA: 82] [Impact Index Per Article: 20.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2020] [Revised: 10/14/2020] [Accepted: 10/20/2020] [Indexed: 01/10/2023] Open
Abstract
Helicobacter pylori infection is one of the most common infectious diseases worldwide. Although the prevalence of H. pylori is gradually decreasing, approximately half of the world's population still becomes infected with this disease. H. pylori is responsible for substantial gastrointestinal morbidity worldwide, with a high disease burden. It is the most common cause of gastric and duodenal ulcers and gastric cancer. Since the revision of the H. pylori clinical practice guidelines in 2013 in Korea, the eradication rate of H. pylori has gradually decreased with the use of a clarithromycin-based triple therapy for 7 days. According to a nationwide randomized controlled study conducted by the Korean College of Helicobacter and Upper Gastrointestinal Research released in 2018, the intention-to-treat eradication rate was only 63.9%, which was mostly due to increased antimicrobial resistance, especially from clarithromycin. The clinical practice guidelines for the treatment of H. pylori were updated according to evidence-based medicine from a meta-analysis conducted on a target group receiving the latest level of eradication therapy. The draft recommendations developed based on the meta-analysis were finalized after an expert consensus on three recommendations regarding the indication for treatment and eight recommendations for the treatment itself. These guidelines were designed to provide clinical evidence for the treatment (including primary care treatment) of H. pylori infection to patients, nurses, medical school students, policymakers, and clinicians. These may differ from current medical insurance standards and will be revised if more evidence emerges in the future.
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Affiliation(s)
- Hye-Kyung Jung
- Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea
| | - Seung Joo Kang
- Department of Internal Medicine, Seoul National University Hospital Gangnam Center, Seoul, Korea
| | - Yong Chan Lee
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - Hyo-Joon Yang
- Division of Gastroenterology, Department of Internal Medicine and Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Seon-Young Park
- Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
| | - Cheol Min Shin
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Sung Eun Kim
- Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea
| | - Hyun Chul Lim
- Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Korea
| | - Jie-Hyun Kim
- Department of Internal Medicine and Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
| | - Su Youn Nam
- Center for Gastric Cancer, Kyungpook National University Hospital Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, Korea
| | - Woon Geon Shin
- Department of Internal Medicine, Hallym University College of Medicine, Seoul, Korea
| | - Jae Myung Park
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Il Ju Choi
- Center for Gastric Cancer, National Cancer Center, Goyang, Korea
| | - Jae Gyu Kim
- Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
| | - Miyoung Choi
- Division of Healthcare Technology Assessment Research, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea
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Mestrovic A, Perkovic N, Bozic J, Pavicic Ivelja M, Vukovic J, Kardum G, Puljiz Z, Tonkic A. Randomised clinical trial comparing concomitant and hybrid therapy for eradication of Helicobacter pylori infection. PLoS One 2020; 15:e0244500. [PMID: 33378403 PMCID: PMC7773256 DOI: 10.1371/journal.pone.0244500] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2020] [Accepted: 12/09/2020] [Indexed: 02/07/2023] Open
Abstract
BACKGROUND The primary objective of this study was to compare concomitant and hybrid therapy in the first line eradication treatment of Helicobacter pylori infection in Split-Dalmatia County, Croatia, in which clarithromycin resistance is above 20%. The secondary objective of the study was to determine and compare compliance and adverse events rate between these therapeutic protocols. MATERIALS AND METHODS In an open-label, randomised clinical trial 140 patients total with H. pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 g, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or hybrid (esomeprazole 40 mg and amoxicillin 1 g twice daily during 14 days with adding metronidazole 500 mg and clarithromycin 500 mg twice daily, in the last 7 days,) treatment group. RESULTS Eradication rates for concomitant group and hybrid therapy group were 84.1% (58/69) and 83.1% (59/71) respectively in the intention-to-treat analysis and 96.7% (58/60) and 95.2% (59/62) in per-protocol analysis. There was no significant difference between the groups (ITT analysis: P = 0.878; PP analysis: P = 0.675). Adverse events were more frequent in the concomitant group (33.3% vs 18.3%, P = 0.043). There was no difference among groups regarding compliance rate. CONCLUSION Hybrid therapy has similar eradication rate as concomitant therapy, with lower adverse events rate. In the era of increasing antibiotic resistance, eradication regime with less antibiotic's usage, as hybrid therapy, should be reasonable first line treatment choice for H. pylori infection. Clinical Trials, gov: NCT03572777.
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Affiliation(s)
- Antonio Mestrovic
- Department of Gastroenterology, University Hospital of Split, Split, Croatia
- * E-mail:
| | - Nikola Perkovic
- Department of Gastroenterology, University Hospital of Split, Split, Croatia
| | - Josko Bozic
- Department of Pathophysiology, University of Split School of Medicine, Split, Croatia
| | | | - Jonatan Vukovic
- Department of Gastroenterology, University Hospital of Split, Split, Croatia
| | - Goran Kardum
- Department of Psychology, Faculty of Humanities and Social Sciences, University of Split, Split, Croatia
| | - Zeljko Puljiz
- Department of Gastroenterology, University Hospital of Split, Split, Croatia
- Department of Internal Medicine, University of Split School of Medicine, Split, Croatia
| | - Ante Tonkic
- Department of Gastroenterology, University Hospital of Split, Split, Croatia
- Department of Internal Medicine, University of Split School of Medicine, Split, Croatia
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14
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Jung HK, Kang SJ, Lee YC, Yang HJ, Park SY, Shin CM, Kim SE, Lim HC, Kim JH, Nam SY, Shin WG, Park JM, Choi IJ, Kim JG, Choi M. Evidence-based Guidelines for the Treatment of Helicobacter pylori Infection in Korea: 2020 Revised Edition. THE KOREAN JOURNAL OF HELICOBACTER AND UPPER GASTROINTESTINAL RESEARCH 2020. [DOI: 10.7704/kjhugr.2020.0045] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases worldwide. Although its incidence is gradually decreasing, about half of the world's population still get infected. H. pylori infection is responsible for substantial gastrointestinal morbidity worldwide. It is the most common cause of gastric and duodenal ulcers as well as gastric cancer. Since the revision of the H. pylori Clinical Practice Guidelines in 2013, the eradication rate of H. pylori has gradually decreased with the use of classical triple therapy, wherein amoxicillin, clarithromycin, and proton pump inhibitors are administered, for 7 days. According to a nationwide randomized controlled study conducted by the Korean College of Helicobacter and Upper Gastrointestinal Research released in 2018, the intention-to-treat eradication rate was only 63.9%, which was due to increased antimicrobial resistance induced by the use of antibiotics, especially clarithromycin. The update of clinical practice guideline for treatment of H. pylori was developed based on evidence-based medicine by conducting a meta-analysis. The draft recommendations were finalized after expert consensus on three recommendations regarding the indication for treatment and eight recommendations on the treatment itself. These guidelines are designed to provide patients, nurses, medical school students, policymakers, and clinicians with clinical evidence to guide primary care and treatment of H. pylori infection. These may differ from current medical insurance standards and will be revised further, if necessary, based on research-based evidence.
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15
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Hsu PI, Tsay FW, Kao JY, Peng NJ, Tsai KW, Tsai TJ, Kuo CH, Kao SS, Wang HM, Chen YH, Shie CB, Wu DC. Equivalent efficacies of reverse hybrid and concomitant therapies in first-line treatment of Helicobacter pylori infection. J Gastroenterol Hepatol 2020; 35:1731-1737. [PMID: 32167605 DOI: 10.1111/jgh.15034] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/10/2020] [Revised: 03/09/2020] [Accepted: 03/10/2020] [Indexed: 12/13/2022]
Abstract
BACKGROUND AND AIM Concomitant therapy is a recommended first-line treatment for Helicobacter pylori infection in most national or international consensuses. Reverse hybrid therapy is a modified 14-day concomitant therapy without clarithromycin and metronidazole in the final 7 days. This study aims to test whether 14-day reverse hybrid therapy is non-inferior to 14-day concomitant therapy in the first-line treatment of H. pylori infection. METHODS Helicobacter pylori-infected adult patients were randomly assigned to receive either reverse hybrid therapy (dexlansoprazole 60 mg o.d. plus amoxicillin 1 g b.d. for 14 days, and clarithromycin 500 mg plus metronidazole 500 mg b.d. for initial 7 days) or concomitant therapy (dexlansoprazole 60 mg once o.d. plus amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg b.d. for 14 days). H. pylori status was assessed 6 weeks after the end of treatment. RESULTS Helicobacter pylori-infected participants (n = 248) were randomized to receive either 14-day reverse hybrid therapy (n = 124) or 14-day concomitant therapy (n = 124). Intention-to-treat analysis demonstrated that the two therapies had comparable eradication rate (95.2% vs 93.5%; 95% confidence interval, -4.0% to 7.4%; P = 0.582). However, reverse hybrid therapy had a much lower frequency of adverse events than concomitant therapy (20.2% vs 38.7%, P = 0.001). The two therapies exhibited comparable drug adherence (93.5% vs 87.9%, P = 0.125). CONCLUSIONS Fourteen-day reverse hybrid therapy and 14-day concomitant therapy are equivalent in efficacy for the first-line treatment of H. pylori infection. However, reverse hybrid therapy has fewer adverse events compared with concomitant therapy.
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Affiliation(s)
- Ping-I Hsu
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan
| | - Feng-Woei Tsay
- Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - John Y Kao
- Department of Internal Medicine, Division of Gastroenterology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan, USA
| | - Nan-Jing Peng
- Department of Nuclear Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - Kuo-Wang Tsai
- Department of Medical Education and Research, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
| | - Tzung-Jiun Tsai
- Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - Chao-Hung Kuo
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Municipal Siaogang Hospital, Kaohsiung, Taiwan
| | - Sung-Shuo Kao
- Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - Huay-Min Wang
- Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - Yan-Hua Chen
- Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - Chang-Bih Shie
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan
| | - Deng-Chyang Wu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Municipal Siaogang Hospital, Kaohsiung, Taiwan
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Bari Z, Fakheri H, Taghvaei T, Yaghoobi M. A Comparison between 10-day and 12-day Concomitant Regimens for Helicobacter Pylori Eradication: A Randomized Clinical Trial. Middle East J Dig Dis 2020; 12:106-110. [PMID: 32626563 PMCID: PMC7320987 DOI: 10.34172/mejdd.2020.169] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/26/2022] Open
Abstract
BACKGROUND Helicobacter pylori (H. pylori) infection is one of the most common bacterial infections worldwide, which is associated with peptic ulcer disease and gastric cancer. In this study, we compared the efficacy of 10-day versus 12-day concomitant therapy as the first-line treatment for H. pylori eradication in Iran. METHODS 218 patients with peptic ulcer disease and naïve H. pylori infection, were randomly divided into two groups to receive either 10-day or 12-day concomitant regimens, composed of pantoprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg, all given twice daily. Eight weeks after treatment, H. pylori eradication was assessed by 14C- urea breath test. The trial was registered in the Iranian Registry of Clinical Trials (code: IRCT20170521034070N2). RESULTS 212 patients completed the study. According to the intention to treat analysis, the eradication rates were 83.6% (95% CI: 76.6-90.5) and 88.8% (95% CI: 82.8-94.7) in 10-day and 12-day concomitant therapy groups, respectively (p = 0.24). Per-protocol eradication rates were 85.9% (95% CI: 79.3–92.4) and 92.6% (95% CI: 87.6–97.5), respectively (p = 0.19). The rates of severe side effects were not statistically different between the two groups (3.6% vs. 8.1%; p = 0.428). CONCLUSION 12-day concomitant therapy could achieve ideal eradication rates by both intention to treat and perprotocol analyses. In order to reduce the cost of drugs and the rate of adverse effects of therapy, among 10-day and 12day regimens, 12-day concomitant therapy seems to be a good alternative to 14-day concomitant therapy that has been suggested by international guidelines.
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Affiliation(s)
- Zohreh Bari
- Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Hafez Fakheri
- Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Tarang Taghvaei
- Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Mohammad Yaghoobi
- Associate Professor of Gastroenterology, Division of Gastroenterology, Deartment of Medicine, McMaster University Medical Center, Hamiton, Ontarion, Canada
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Lin TF, Wu DC, Tsay FW, Tsai KW, Tsai TJ, Peng NJ, Kao SS, Chen WC, Chen YH, Hsu PI. Reverse hybrid therapy achieves a similar eradication rate as standard hybrid therapy for Helicobacter pylori infection. J Chin Med Assoc 2020; 83:233-237. [PMID: 31934941 DOI: 10.1097/jcma.0000000000000256] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND Reverse hybrid therapy is a simplified hybrid treatment for Helicobacter pylori infection. It achieves a higher eradication rate than standard triple therapy. This study aimed to compare the efficacies of reverse hybrid and hybrid therapies in the treatment of H. pylori infection. METHODS From September 2008 to September 2017, 490 H. pylori-infected patients who received 14 days of reverse hybrid therapy (proton pump inhibitor plus amoxicillin for 14 days and clarithromycin plus metronidazole for the initial 7 days; n = 252) or hybrid therapy (proton pump inhibitor plus amoxicillin for 14 days and clarithromycin plus metronidazole for the final 7 days; n = 238) were included in this retrospective cohort study. Helicobacter pylori status was examined 6-8 weeks after therapy. RESULTS The eradication rates of the reverse hybrid and hybrid therapies by modified intention-to-treat analysis were comparable (96.4% vs 96.6%; p = 0.899). There were no differences in the efficacy of eradication between therapies for clarithromycin-resistant strains (87.0% vs 90.0%) or metronidazole-resistant strains (97.7% vs 100.0%). In addition, there were comparable frequencies of adverse events for both treatments (18.7% vs 13.0%) and treatment adherence (94.4% vs 97.1%). CONCLUSION Reverse hybrid therapy can achieve a similar eradication rate to hybrid therapy for H. pylori infection.
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Affiliation(s)
- Te-Fu Lin
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Da Chien General Hospital, Miaoli, Taiwan, ROC
| | - Deng-Chyang Wu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan, ROC
| | - Feng-Woei Tsay
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC
| | - Kuo-Wang Tsai
- Department of Medical Education and Research, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC
| | - Tzung-Jiun Tsai
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC
| | - Nan-Jing Peng
- Department of Nuclear Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan, ROC
| | - Sung-Shuo Kao
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC
| | - Wen-Chi Chen
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC
| | - Yan-Hua Chen
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC
| | - Ping-I Hsu
- Division of Gastroenterology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan, ROC
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Jaka H, Mueller A, Kasang C, Mshana SE. Predictors of triple therapy treatment failure among H. pylori infected patients attending at a tertiary hospital in Northwest Tanzania: a prospective study. BMC Infect Dis 2019; 19:447. [PMID: 31113384 PMCID: PMC6528280 DOI: 10.1186/s12879-019-4085-1] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/03/2019] [Accepted: 05/14/2019] [Indexed: 12/12/2022] Open
Abstract
BACKGROUND Helicobacter pylori (H.pylori) infection is a common medical problem in resource limited areas. The treatment outcome after triple therapy has not been well studied in developing countries and preliminary data suggests a high rate of treatment failure. This study investigated the triple therapy treatment failure rate and associated factors among dyspeptic patients receiving H. pylori first line therapy at a tertiary hospital, Tanzania. METHODS A prospective study in the Gastroenterology unit of the Bugando Medical Centre (BMC) was conducted between October 2015 and May 2017. All dyspeptic patients with stool antigen tests positive for H.pylori were given first line therapy, and stool antigen testing was repeated within 7 days and 5 weeks after completion of the treatment. Biopsies were taken before initiation of therapy and analysed for clarithromycin and quinolone resistance mutations using polymerise chain reaction (PCR) and sequencing. Adherence and other social-demographic characteristics were documented. RESULTS A total of 210 patients were enrolled; the median age was 35 years (interquartile range, 27-48). First line treatment failure as defined by positive stool antigen 5 weeks post treatment was observed in 65/210 (31%) of patients. Independent predictors of first line treatment failure were presence of clarithromycin resistance mutations (OR: 23.12, 95% CI (9.38-56.98), P < 0.001) and poor adherence (OR: 7.39, 95% CI (3.25-16.77), P < 0.001). The sensitivity and specificity of stool antigen testing within 7 days after completion therapy in detecting treatment failure was 100 and 93.2%, respectively. CONCLUSION Nearly one-third of patients with clarithromycin resistance mutations and poor adherence develop first line treatment failure. Routine stool antigen testing within seven days after completion of therapy can be considered in order to initiate second line treatment early to prevent associated morbidities.
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Affiliation(s)
- Hyasinta Jaka
- Department of Internal medicine-Gastroenterology and Hepatology unit, Catholic University of Health and Allied Sciences, P.O.Box 1464, Bugando, Mwanza, Tanzania.
| | - Andreas Mueller
- Tropenmedizin, Missionsärztliche Klinik, Salvatorstr. 7, 97074, Würzburg, Germany
| | - Christa Kasang
- Medical Mission Institute, Hermann Schell Str. 7, 97074, Würzburg, Germany
| | - Stephen E Mshana
- Department of Microbiology and Immunology, Catholic University of Health and Allied Sciences, P.O.Box 1464, Bugando, Mwanza, Tanzania
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Macías-García F, Bastón-Rey I, de la Iglesia-García D, Calviño-Suárez C, Nieto-García L, Domínguez-Muñoz JE. Bismuth-containing quadruple therapy versus concomitant quadruple therapy as first-line treatment for Helicobacter Pylori infection in an area of high resistance to clarithromycin: A prospective, cross-sectional, comparative, open trial. Helicobacter 2019; 24:e12546. [PMID: 30346636 DOI: 10.1111/hel.12546] [Citation(s) in RCA: 20] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/12/2018] [Revised: 09/14/2018] [Accepted: 09/18/2018] [Indexed: 12/11/2022]
Abstract
BACKGROUND Concomitant quadruple (CQT) or bismuth-containing quadruple therapy (BQT) is recommended as first-line treatment for Helicobacter pylori infection depending on antibiotic resistance. AIM To compare the efficacy, safety, and compliance of CQT and BQT as first-line therapy for H. pylori eradication in real clinical practice in an area of high resistance to clarithromycin. METHODS A prospective, open, comparative cross-sectional study including dyspeptic patients >18 years with H. pylori infection and with no previous eradication treatment was performed. CQT (omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1 g + metronidazole 500 mg, all given twice daily, for 14 days) or BQT (omeprazole 20 mg twice daily + 3 capsules of Pylera® 4 times a day, for 10 days) was prescribed at the discretion of the prescribing physician. Eradication was tested by 13 C-urea breath test. Efficacy was assessed by intention-to-treat (ITT) and per-protocol (PP) analyses. RESULTS One hundred and four consecutive patients were included (64.4% female, age 52.9 years). Fifty patients received CQT and 54 BQT. Eradication rate was similar with both therapies at the PP (CQT 97.9%, 95% CI: 93.9-100 vs BQT 96.2%, 95% CI: 90.9-100, P = 0.605) and ITT analyses (CQT 98.0%, 95% CI: 94-100 vs BQT 94.4%, 95% CI: 88.1-100, P = 0.346). The rate of adverse events was also similar with CQT (56%) and BQT (46.3%). One patient in each group discontinued the treatment due to significant adverse events. CONCLUSION The use of CQT and BQT as first-line treatment against H. pylori is similarly effective and safe strategy in an area of high clarithromycin resistance.
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Affiliation(s)
- Fernando Macías-García
- Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain.,Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain
| | - Iria Bastón-Rey
- Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain.,Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain
| | - Daniel de la Iglesia-García
- Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain.,Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain
| | - Cristina Calviño-Suárez
- Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain.,Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain
| | - Laura Nieto-García
- Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain
| | - Juan Enrique Domínguez-Muñoz
- Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain.,Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain
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Talebi Bezmin Abadi A, Yamaoka Y. Helicobacter pylori therapy and clinical perspective. J Glob Antimicrob Resist 2018; 14:111-117. [PMID: 29581076 DOI: 10.1016/j.jgar.2018.03.005] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2017] [Revised: 03/06/2018] [Accepted: 03/16/2018] [Indexed: 02/06/2023] Open
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COELHO LGV, MARINHO JR, GENTA R, RIBEIRO LT, PASSOS MDCF, ZATERKA S, ASSUMPÇÃO PP, BARBOSA AJA, BARBUTI R, BRAGA LL, BREYER H, CARVALHAES A, CHINZON D, CURY M, DOMINGUES G, JORGE JL, MAGUILNIK I, MARINHO FP, MORAES-FILHO JPD, PARENTE JML, PAULA-E-SILVA CMD, PEDRAZZOLI-JÚNIOR J, RAMOS AFP, SEIDLER H, SPINELLI JN, ZIR JV. IVTH BRAZILIAN CONSENSUS CONFERENCE ON HELICOBACTER PYLORI INFECTION. ARQUIVOS DE GASTROENTEROLOGIA 2018; 55:97-121. [PMID: 30043876 DOI: 10.1590/s0004-2803.201800000-20] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/19/2018] [Accepted: 02/22/2018] [Indexed: 02/06/2023]
Abstract
ABSTRACT Significant progress has been obtained since the III Brazilian Consensus Conference on H. pylori infection held in 2012, in Bento Gonçalves, Brazil, and justify a fourth meeting to establish updated guidelines on the current management of H. pylori infection. Therefore, the Núcleo Brasileiro para Estudo do Helicobacter pylori e Microbiota (NBEHPM), association linked to Brazilian Federation of Gastroenterology (FBG) held its fourth meeting again in Bento Gonçalves, RS, Brazil, on August 25-27, 2017. Twenty-six delegates, including gastroenterologists, endoscopists, and pathologists from the five regions of Brazil as well as one international guest from the United States, participated in the meeting. The participants were invited based on their knowledge and contribution to the study of H. pylori infection. The meeting sought to review different aspects of treatment for infection; establish a correlation between infection, dyspepsia, intestinal microbiota changes, and other disorders with a special emphasis on gastric cancer; and reassess the epidemiological and diagnostic aspects of H. pylori infection. Participants were allocated into four groups as follows: 1) Epidemiology and Diagnosis, 2) Dyspepsia, intestinal microbiota and other afections, 3) Gastric Cancer, and, 4) Treatment. Before the consensus meeting, participants received a topic to be discussed and prepared a document containing a recent literature review and statements that should be discussed and eventually modified during the face-to-face meeting. All statements were evaluated in two rounds of voting. Initially, each participant discussed the document and statements with his group for possible modifications and voting. Subsequently, during a second voting in a plenary session in the presence of all participants, the statements were voted upon and eventually modified. The participants could vote using five alternatives: 1) strongly agree; 2) partially agree; 3) undecided; 4) disagree; and 5) strongly disagree. The adopted consensus index was that 80% of the participants responded that they strongly or partially agreed with each statement. The recommendations reported are intended to provide the most current and relevant evidences to management of H. pylori infection in adult population in Brazil.
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Kefeli A, Başyigit S, Yeniova AO, Ozkan S, Nazligul Y. Comparison of the efficacy and safety of hybrid and sequential therapies as a first-line regimen for Helicobacter pylori infection in Turkey. Arch Med Sci 2018; 14:276-280. [PMID: 29593799 PMCID: PMC5868654 DOI: 10.5114/aoms.2016.58595] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2015] [Accepted: 12/07/2015] [Indexed: 12/14/2022] Open
Abstract
INTRODUCTION Helicobacter pylori infection is a common infection worldwide. The most frequently recommended treatment for eradication of H. pylori remains triple therapy. In this study, we compared sequential and hybrid regimens for H. pylori eradication in a region of Turkey with high resistance to clarithromycin. MATERIAL AND METHODS Three hundred and forty H. pylori-positive patients were enrolled in the study. The subjects were randomly divided into two groups. The first group (170 patients) received rabeprazole (40 mg/b.i.d.) and amoxicillin (1000 mg/b.i.d.) for 2 weeks and metronidazole and clarithromycin (500 mg/b.i.d.) during the second week in the hybrid therapy group. The second group (170 patients) received rabeprazole (40 mg/b.i.d.) for 14 days, amoxicillin (1000 mg/b.i.d.) for the first 7 days, and metronidazole plus clarithromycin (each 500 mg/b.i.d.) during the next 7 days in the sequential therapy group. RESULTS In the per-protocol analysis, the eradication rate in the hybrid therapy group was 96.1% (147/153), and in the sequential therapy group it was 90.9% (140/154). There was no significant difference between the two groups (p = 0.06). Ninety-seven of those 340 patients reported minor adverse drug reactions. The percentages of patients with adverse reactions were 30.6% in the hybrid therapy group and 26.5% in the sequential therapy group (p = 0.74). CONCLUSIONS Both therapies are highly effective for eradication of H. pylori, and could be recommended as a first-line therapy in regions with high antibiotic resistance.
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Affiliation(s)
- Ayşe Kefeli
- Gastroenterology Department, Siirt State Hospital, Siirt, Turkey
| | - Sebahat Başyigit
- Gastroenterology Department, Kecioren Training Hospital, Ankara, Turkey
| | | | - Serdar Ozkan
- Thoracic Surgery, Siirt State Hospital, Siirt, Turkey
| | - Yasar Nazligul
- Gastroenterology Department, Kecioren Training Hospital, Ankara, Turkey
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Georgopoulos SD, Papastergiou V, Martinez-Gonzalez B, Xirouchakis E, Familias I, Sgouras D, Mentis A, Karatapanis S. Hybrid therapy as first-line regimen for Helicobacter pylori eradication in a high clarithromycin resistance area: a prospective open-label trial. Ann Gastroenterol 2018; 31:205-210. [PMID: 29507467 PMCID: PMC5825950 DOI: 10.20524/aog.2017.0221] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/24/2017] [Accepted: 10/26/2017] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Hybrid therapy is a promising first-line regimen for Helicobacter pylori (H. pylori) eradication. We evaluated a hybrid therapy, assessing the impact of antibiotic resistance on eradication outcome. METHODS This was a prospective study that included 155 treatment-naïve patients diagnosed with H. pylori infection by positive CLO-test, confirmed with histology and/or culture. The hybrid therapy consisted of 40 mg esomeprazole and 1 g amoxicillin for 14 days, with the addition of 500 mg clarithromycin and 500 mg metronidazole for the final 7 days (all b.i.d.). Eradication was defined by negative 13C-urea breath test or histology. RESULTS The eradication rates were 85.8% (133/155; 95% confidence interval [CI] 79.4-90.5%) by intention-to-treat and 90.2% (129/143; 95%CI 84.1-94.2%) by per-protocol analysis in a setting of high antibiotic resistance (clarithromycin 25.9%, metronidazole 31.1%, dual resistance 8.9%). Adverse events occurred in 29.7% and 1.3% discontinued treatment because of adverse events. Adherence >90% was achieved in 96.6%. The eradication rate in patients with dual clarithromycin/metronidazole resistance (50%) was markedly lower compared to those with single clarithromycin resistance (91.4%), single metronidazole resistance (90.5%) or dual susceptibility (97.8%). Dual resistance was the only factor to correlate with the failure of hybrid therapy (odds ratio 14.4, 95%CI 3.8-54.9, P=0.0003). CONCLUSIONS Hybrid therapy is an effective and safe first-line regimen in populations with relatively high rates of antibiotic resistance. However, dual clarithromycin/metronidazole resistance may significantly compromise its efficacy.
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Affiliation(s)
- Sotirios D. Georgopoulos
- Gastroenterology Department, Athens Medical, Paleo Faliron Hospital, Athens (Sotirios D. Georgopoulos, Elias Xirouchakis), Greece
| | - Vasilios Papastergiou
- First Department of Internal Medicine, General Hospital of Rhodes, Rhodes (Vasilios Papastergiou, Ioannis Familias, Stylianos Karatapanis), Greece
| | - Beatriz Martinez-Gonzalez
- Laboratory of Medical Microbiology, Hellenic Pasteur Institute, Athens (Beatriz Martinez-Gonzalez, Dionysis Sgouras, Andreas Mentis), Greece
| | - Elias Xirouchakis
- Gastroenterology Department, Athens Medical, Paleo Faliron Hospital, Athens (Sotirios D. Georgopoulos, Elias Xirouchakis), Greece
| | - Ioannis Familias
- First Department of Internal Medicine, General Hospital of Rhodes, Rhodes (Vasilios Papastergiou, Ioannis Familias, Stylianos Karatapanis), Greece
| | - Dionysis Sgouras
- Laboratory of Medical Microbiology, Hellenic Pasteur Institute, Athens (Beatriz Martinez-Gonzalez, Dionysis Sgouras, Andreas Mentis), Greece
| | - Andreas Mentis
- Laboratory of Medical Microbiology, Hellenic Pasteur Institute, Athens (Beatriz Martinez-Gonzalez, Dionysis Sgouras, Andreas Mentis), Greece
| | - Stylianos Karatapanis
- First Department of Internal Medicine, General Hospital of Rhodes, Rhodes (Vasilios Papastergiou, Ioannis Familias, Stylianos Karatapanis), Greece
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De Francesco V, Pontone S, Bellesia A, Serviddio G, Panetta C, Palma R, Zullo A. Quadruple, sequential, and concomitant first-line therapies for H. pylori eradication: a prospective, randomized study. Dig Liver Dis 2018; 50:139-141. [PMID: 29089267 DOI: 10.1016/j.dld.2017.10.009] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/16/2017] [Revised: 09/06/2017] [Accepted: 10/10/2017] [Indexed: 12/11/2022]
Abstract
BACKGROUND Current Italian guidelines recommend 10-day bismuth-based or bismuth-free (sequential and concomitant) regimens for first-line H. pylori eradication. However, comparison among these regimens is lacking in our country. AIM To perform a 'head-to-head' comparison among these three therapies as first-line treatment for H. pylori eradication in clinical practice. METHODS This was a prospective, open-label randomized study enrolling consecutive patients diagnosed with H. pylori infection never previously treated. Patients were randomized to receive one of the following 10-day therapies: (a) Bismuth-based therapy: esomeprazole 20mg b.i.d and Pylera 3 tablets q.i.d; (b) Concomitant therapy: esomeprazole 20mg plus amoxicyllin 1,000mg, clarithromycin 500mg and tinidazole 500mg (all b.i.d.), and (c) Sequential therapy: esomeprazole 20mg plus amoxicyllin 1,000mg for 5days followed by esomeprazole 20mg plus clarithromycin 500mg and tinidazole 500mg for 5days (all b.i.d). H. pylori eradication was assessed by using UBT 4-6 weeks after the end of therapy. RESULTS Overall, 187 patients were enrolled. The eradication rates achieved with Pylera, concomitant and sequential were 85.2%, 95.2%, and 93.6%, respectively, at intention to treat, and 94.5%, 96.7%, and 95.1% at per protocol analyses, without a statistically significant difference. The incidence of severe side-effects was higher with the bismuth-based therapy than with the two bismuth-free regimens (9.8% vs 1.6%; p=0.046). CONCLUSIONS Bismuth-based and bismuth-free therapies are equally effective for first-line H. pylori eradication. However, bismuth therapy was more frequently interrupted for side-effects than bismuth-free therapies.
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Affiliation(s)
- Vincenzo De Francesco
- Section of Gastroenterology and Department of Medical Sciences, University of Foggia, Foggia, Italy.
| | - Stefano Pontone
- Department of Surgical Sciences, "Sapienza" University of Rome, Italy
| | - Annamaria Bellesia
- Section of Gastroenterology and Department of Medical Sciences, University of Foggia, Foggia, Italy
| | - Gaetano Serviddio
- Cure University Centre for Liver Disease Research and Treatment, Institute of Internal Medicine, Department of Medical and Surgical Sciences, University of Foggia, Italy
| | - Cristina Panetta
- Department of Surgical Sciences, "Sapienza" University of Rome, Italy
| | - Rossella Palma
- Department of Surgical Sciences, "Sapienza" University of Rome, Italy
| | - Angelo Zullo
- Gastroenterology,'Nuovo Regina Margherita' Hospital, Rome, Italy
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25
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Wang H, Qian D, Xiao X, Deng C, Liao L, Deng J, Lin YW. Preparation and application of a carbon paste electrode modified with multi-walled carbon nanotubes and boron-embedded molecularly imprinted composite membranes. Bioelectrochemistry 2018; 121:115-124. [PMID: 29413861 DOI: 10.1016/j.bioelechem.2018.01.006] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/25/2017] [Revised: 01/14/2018] [Accepted: 01/14/2018] [Indexed: 12/29/2022]
Abstract
An innovative electrochemical sensor was fabricated for the sensitive and selective determination of tinidazole (TNZ), based on a carbon paste electrode (CPE) modified with multi-walled carbon nanotubes (MWCNTs) and boron-embedded molecularly imprinted composite membranes (B-MICMs). Density functional theory (DFT) calculations were carried out to investigate the utility of template-monomer interactions to screen appropriate monomers for the rational design of B-MICMs. The distinct synergic effect of MWCNTs and B-MICMs was evidenced by the positive shift of the reduction peak potential of TNZ at B-MICMs/MWCNTs modified CPE (B-MICMs/MWCNTs/CPE) by about 200 mV, and the 12-fold amplification of the peak current, compared with a bare carbon paste electrode (CPE). Moreover, the coordinate interactions between trisubstituted boron atoms embedded in B-MICMs matrix and nitrogen atoms of TNZ endow the sensor with advanced affinity and specific directionality. Thereafter, a highly sensitive electrochemical analytical method for TNZ was established by different pulse voltammetry (DPV) at B-MICMs/MWCNTs/CPE with a lower detection limit (1.25 × 10-12 mol L-1) (S/N = 3). The practical application of the sensor was demonstrated by determining TNZ in pharmaceutical and biological samples with good precision (RSD 1.36% to 3.85%) and acceptable recoveries (82.40%-104.0%).
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Affiliation(s)
- Hongjuan Wang
- School of Chemistry and Chemical Engineering, Key Discipline Laboratory for National Defense for Biotechnology in Uranium Mining and Hydrometallurgy, University of South China, Hengyang, Hunan 421001, PR China
| | - Duo Qian
- School of Chemistry and Chemical Engineering, Key Discipline Laboratory for National Defense for Biotechnology in Uranium Mining and Hydrometallurgy, University of South China, Hengyang, Hunan 421001, PR China
| | - Xilin Xiao
- School of Chemistry and Chemical Engineering, Key Discipline Laboratory for National Defense for Biotechnology in Uranium Mining and Hydrometallurgy, University of South China, Hengyang, Hunan 421001, PR China.
| | - Chunyan Deng
- College of Chemistry and Chemical Engineering, Key Laboratory of Resources Chemistry of Nonferrous Metals, Central South University, Changsha, Hunan 410083, PR China
| | - Lifu Liao
- School of Chemistry and Chemical Engineering, Key Discipline Laboratory for National Defense for Biotechnology in Uranium Mining and Hydrometallurgy, University of South China, Hengyang, Hunan 421001, PR China
| | - Jian Deng
- School of Chemistry and Chemical Engineering, Key Discipline Laboratory for National Defense for Biotechnology in Uranium Mining and Hydrometallurgy, University of South China, Hengyang, Hunan 421001, PR China.
| | - Ying-Wu Lin
- School of Chemistry and Chemical Engineering, Key Discipline Laboratory for National Defense for Biotechnology in Uranium Mining and Hydrometallurgy, University of South China, Hengyang, Hunan 421001, PR China
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So S, Ahn JY, Na HK, Jung KW, Lee JH, Kim DH, Choi KD, Song HJ, Lee GH, Jung HY. Efficacy of Ecabet Sodium for Helicobacter pylori Eradication with Sequential Therapy. THE KOREAN JOURNAL OF HELICOBACTER AND UPPER GASTROINTESTINAL RESEARCH 2018. [DOI: 10.7704/kjhugr.2018.18.3.180] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Affiliation(s)
- Seol So
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Ji Yong Ahn
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Hee Kyong Na
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Kee Wook Jung
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Jeong Hoon Lee
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Do Hoon Kim
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Kee Don Choi
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Ho June Song
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Gin Hyug Lee
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Hwoon-Yong Jung
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
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A Randomized Controlled Trial Shows that both 14-Day Hybrid and Bismuth Quadruple Therapies Cure Most Patients with Helicobacter pylori Infection in Populations with Moderate Antibiotic Resistance. Antimicrob Agents Chemother 2017; 61:AAC.00140-17. [PMID: 28807915 DOI: 10.1128/aac.00140-17] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2017] [Accepted: 08/01/2017] [Indexed: 12/14/2022] Open
Abstract
Hybrid therapy is a novel two-step treatment achieving a high eradication rate for Helicobacter pylori infection. Currently, whether this new therapy achieves a higher eradication rate than bismuth quadruple therapy remains an unanswered question. The aim of this prospective, randomized comparative study was to investigate the efficacies of 14-day hybrid therapy and bismuth quadruple therapy in the treatment of H. pylori infection. From July 2013 to June 2015, eligible H. pylori-infected subjects were randomly assigned to receive either 14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole for 14 days) or 14-day hybrid therapy (a 7-day dual therapy with pantoprazole plus amoxicillin, followed by a 7-day quadruple therapy with pantoprazole plus amoxicillin, clarithromycin, and metronidazole). H. pylori status was examined 6 weeks after the end of treatment. Three hundred thirty H. pylori-infected participants were randomized to receive 14-day bismuth quadruple therapy (n = 164) or 14-day hybrid therapy (n = 166). The eradication rates by intention-to-treat analysis were similar: 93.9% versus 92.8%, respectively (95% confidence interval [CI], -4.3% to 5.4%; P = 0.68). Per-protocol analysis yielded similar results (96.7% versus 94.9%, respectively; P = 0.44). However, bismuth quadruple therapy had a higher frequency of adverse events than hybrid therapy (55.5% versus 15.7%, respectively; 95% CI, 30.4% to 49.2%; P < 0.001). The two treatments exhibited comparable drug adherence (93.9% versus 97%, respectively). The resistance rates of antibiotics were: clarithromycin, 16.7% of patients; amoxicillin, 1.3%; metronidazole, 25%; and tetracycline, 0%. In the bismuth quadruple therapy group, the eradication rate of metronidazole-resistant strains was lower than that of metronidazole-susceptible strains (70.0% versus 96.4%, respectively; P = 0.04). In the hybrid therapy group, no significant impact of clarithromycin or metronidazole resistance on eradication rates was identified. Both 14-day hybrid and bismuth quadruple therapies cure most patients with H. pylori infection in populations with moderate antibiotic resistance. However, the 14-day hybrid therapy has fewer adverse effects than the bismuth quadruple therapy. (This study has been registered at ClinicalTrials.gov under identifier NCT02541864.).
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Sequential versus concomitant therapy for treatment of Helicobacter pylori infection: an updated systematic review and meta-analysis. Eur J Clin Pharmacol 2017; 74:1-13. [DOI: 10.1007/s00228-017-2347-7] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/20/2017] [Accepted: 09/29/2017] [Indexed: 02/06/2023]
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Kwon S, Lee DH, Kang JB, Kim N, Park YS, Shin CM, Yoon H, Choi YJ. [The Efficacy of Moxifloxacin-containing Triple Therapy after Hybrid Therapy Failure in Helicobacter pylori Eradication]. THE KOREAN JOURNAL OF GASTROENTEROLOGY 2017; 70:72-80. [PMID: 28830132 DOI: 10.4166/kjg.2017.70.2.72] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
Abstract
Background/Aims Hybrid therapy was successful in eradicating Helicobacter pylori (H. pylori) according to previous reports. However, to the best of our knowledge, there have only been a few studies evaluating the optimal choice after hybrid failure. Hence, we aimed to evaluate the efficacy of moxifloxacin-containing triple therapy after hybrid therapy failure in H. pylori eradication. Methods Between January 2013 and March 2016, we retrospectively reviewed patients who underwent failed hybrid therapy, as first line treatment, in eradicating H. pylori (rabeprazole and amoxicillin b.i.d for 14 days, in addition to clarithromycin and metronidazole b.i.d for final 7 days). Then, we investigated the eradication rates of moxifloxacin-containing triple therapy (rabeprazole, amoxicillin b.i.d and moxifloxacin qd) as the second line of treatment. Intention-to-treat (ITT) and per-protocol (PP) analyses were used to determine the eradication rate. We evaluated the status of H. pylori by using 13C-urea breath test 6 weeks after the final treatment. Moreover, compliance and adverse effects of each patient were analyzed. Results Among those who failed the initial hybrid therapy, 11 patients received moxifloxacin-containing triple therapy. The overall eradication rates, as determined by ITT and PP, were 72.7% (n=8/11) and 80% (n=8/10), respectively. The compliance rate was 100%, and there were no serious adverse effects. Conclusions Moxifloxacin-containing triple therapy can be used as a second line therapy in case of hybrid therapy failure. A large scale study is necessary to confirm the findings of this study and establish clinical evidence.
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Affiliation(s)
- Soohoon Kwon
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Dong Ho Lee
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.,Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Jae Bin Kang
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Nayoung Kim
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.,Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Young Soo Park
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.,Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Cheol Min Shin
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Hyuk Yoon
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Yoon Jin Choi
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
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Gisbert JP, McNicholl AG. Optimization strategies aimed to increase the efficacy of H. pylori eradication therapies. Helicobacter 2017; 22. [PMID: 28464347 DOI: 10.1111/hel.12392] [Citation(s) in RCA: 57] [Impact Index Per Article: 7.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
Abstract
BACKGROUND As with any other infectious disease, we should aim for treatments offering ≥90% Helicobacter pylori eradication rates in clinical practice. AIM To summarize optimization strategies aimed to increase the efficacy of H. pylori eradication therapies. METHODS A systematic bibliographic search (in PubMed up to August 2016) was designed to identify studies investigating optimization strategies aimed to increase the efficacy of H. pylori eradication therapies. RESULTS The most direct way to optimize a treatment is using higher doses of drugs unless it has been shown that lower doses are equally effective. Similarly, prescriptions should use 14-day duration unless a shorter scheme has been shown locally to be equally effective. Double-dose proton-pump inhibitor therapy is recommended for triple therapy and may probably increase the efficacy of nonbismuth concomitant regimen as well. The efficacy of triple therapies in the presence of resistance can be significantly improved by the addition of bismuth salts, which offer an additive effect in combination with antibiotics. Overall, probiotics seem to reduce antibiotic side effects, but the increase in eradication rates is not so evident; therefore, they cannot be generally recommended for clinical practice yet. CONCLUSIONS Using potent acid inhibition and/or higher antibiotic doses-especially by increasing the number of daily intakes-and lengthening treatments up to 14 days improves efficacy in most regimens and should be generally recommended. Triple therapies can be efficiently improved by the addition of bismuth salts, turning them into quadruple therapies. Finally, some treatments will require a combination of optimization strategies to significantly improve results.
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Affiliation(s)
- Javier P Gisbert
- Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
| | - Adrian G McNicholl
- Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
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31
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Huang CC, Tsai KW, Tsai TJ, Hsu PI. Update on the first-line treatment for Helicobacter pylori infection - a continuing challenge from an old enemy. Biomark Res 2017; 5:23. [PMID: 28702193 PMCID: PMC5505131 DOI: 10.1186/s40364-017-0103-x] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/15/2017] [Accepted: 06/29/2017] [Indexed: 02/07/2023] Open
Abstract
Because the prevalence of antibiotic resistance markedly increases with time worldwide, anti-H. pylori treatment is continuing to be a great challenge forsphysicians in clinical practice. The Real-world Practice & Expectation of Asia-Pacific Physicians and Patients in Helicobacter Pylori Eradication (REAP-HP) Survey demonstrated that the accepted minimal eradication rate of anti-H. pylori regimen in H. pylori-infected patients was 91%. The Kyoto Consensus Report on Helicobacter Pylori Gastritis also recommended that, within any region, only regimens which reliably produce eradication rates of ≥90% in that population should be used for empirical treatment. This article is aimed to review current first-line eradication regimens with a per-protocol eradication rate exceeding 90% in most geographic areas. In regions with low (≦15%) clarithromycin resistance, 14-day hybrid (or reverse hybrid), 10 ~ 14-day sequential, 7 ~ 14-day concomitant, 10 ~ 14-day bismuth quadruple or 14-day triple therapy can achieve a high eradication rate in the first-line treatment of H. pylori infection. However, in areas with high (>15%) clarithromycin resistance, standard triple therapy should be abandoned because of low eradication efficacy, and 14-day hybrid (or reverse hybrid), 10 ~ 14-day concomitant or 10 ~ 14-day bismuth quadruple therapy are the recommended regimens. If no recent data of local antibiotic resistances of H. pylori strains are available, universal high efficacy regimens such as 14-day hybrid (or reverse hybrid), concomitant or bismuth quadruple therapy can be adopted to meet the recommendation of consensus report and patients’ expectation.
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Affiliation(s)
- Chih-Chieh Huang
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - Kuo-Wang Tsai
- Department of Medical Education and Research, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
| | - Tzung-Jiun Tsai
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.,Taiwan Acid-related Disease (TARD) Study Group, Kaohsiung, Taiwan
| | - Ping-I Hsu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.,Taiwan Acid-related Disease (TARD) Study Group, Kaohsiung, Taiwan.,Division of Gastroenterology, Department of Internal Medicine, Kaoshiung Veterans General Hospital, 386 Ta Chung 1st Road, Kaohsiung, 813 Taiwan, ROC
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De Francesco V, Bellesia A, Ridola L, Manta R, Zullo A. First-line therapies for Helicobacter pylori eradication: a critical reappraisal of updated guidelines. Ann Gastroenterol 2017; 30:373-379. [PMID: 28655973 PMCID: PMC5479989 DOI: 10.20524/aog.2017.0166] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/24/2017] [Accepted: 05/18/2017] [Indexed: 01/06/2023] Open
Abstract
Helicobacter pylori (H. pylori) treatment remains a challenge for the clinician, as no available therapy is able to cure the infection in all treated patients. In the last two decades, several antibiotic combinations have been proposed, including triple therapies, bismuth-free therapies (sequential, concomitant, hybrid regimens), and bismuth-based quadruple therapy. Some national and international guidelines on H. pylori management have recently been updated, recommending or discouraging the use of each of these therapeutic approaches, based mainly on the presumed pattern of primary antibiotic resistance in different geographic areas. We examined the recommendations on first-line therapies in the most recently updated guidelines worldwide, taking into account other data affecting the efficacy of a therapy regimen beyond the primary resistance pattern. Although several guidelines highlighted that the results achieved by an eradication therapy are population-specific and not directly transferable, it emerged that some therapy regimens are recommended or discouraged with no mention of the vital need for national data.
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Affiliation(s)
- Vincenzo De Francesco
- Section of Gastroenterology, "Riuniti" Hospitals, Foggia (Vincenzo De Francesco, Annamaria Bellesia)
| | - Annamaria Bellesia
- Section of Gastroenterology, "Riuniti" Hospitals, Foggia (Vincenzo De Francesco, Annamaria Bellesia)
| | - Lorenzo Ridola
- Gastroenterology Unit, "Sapienza" University of Rome, Polo Pontino, Latina (Lorenzo Ridola)
| | - Raffaele Manta
- Gastroenterology Unit, Nuovo Ospedale Civile Sant'Agostino-Estense, Baggiovara-Modena (Raffaele Manta)
| | - Angelo Zullo
- Gastroenterology and Digestive Endoscopy, "Nuovo Regina Margherita" Hospital, Rome (Angelo Zullo), Italy
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Abstract
Objective: Helicobacter pylori (H. pylori) eradication remains a challenge with increasing antibiotic resistance. Hybrid therapy has attracted widespread attention because of initial report with good efficacy and safety. However, many issues on hybrid therapy are still unclear such as the eradication efficacy, safety, compliance, influencing factors, correlation with antibiotic resistance, and comparison with other regimens. Therefore, a comprehensive review on the evidence of hybrid therapy for H. pylori infection was conducted. Data Sources: The data used in this review were mainly from PubMed articles published in English up to September 30, 2015, searching by the terms of “Helicobacter pylori” or “H. pylori”, and “hybrid”. Study Selection: Clinical research articles were selected mainly according to their level of relevance to this topic. Results: Totally, 1871 patients of 12 studies received hybrid therapy. The eradication rates were 77.6–97.4% in intention-to-treat and 82.6–99.1% in per-protocol analyses. Compliance was 93.3–100.0%, overall adverse effects rate was 14.5–67.5%, and discontinued medication rate due to adverse effects was 0–6.7%. H. pylori culture and sensitivity test were performed only in 13.3% patients. Pooled analysis showed that the eradication rates with dual clarithromycin and metronidazole susceptible, isolated metronidazole or clarithromycin resistance, and dual clarithromycin and metronidazole resistance were 98.5%, 97.6%, 92.9%, and 80.0%, respectively. Overall, the efficacy, compliance, and safety of hybrid therapy were similar with sequential or concomitant therapy. However, hybrid therapy might be superior to sequential therapy in Asians. Conclusions: Hybrid therapy showed wide differences in the efficacy but consistently good compliance and safety across different regions. Dual clarithromycin and metronidazole resistance were the key factor to efficacy. Hybrid therapy was similar to sequential or concomitant therapy in the efficacy, safety, and compliance.
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Affiliation(s)
| | | | - Li-Ya Zhou
- Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
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Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut 2017; 66:6-30. [PMID: 27707777 DOI: 10.1136/gutjnl-2016-312288] [Citation(s) in RCA: 1906] [Impact Index Per Article: 238.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/19/2016] [Accepted: 08/09/2016] [Indexed: 02/06/2023]
Abstract
Important progress has been made in the management of Helicobacter pylori infection and in this fifth edition of the Maastricht Consensus Report, key aspects related to the clinical role of H. pylori were re-evaluated in 2015. In the Maastricht V/Florence Consensus Conference, 43 experts from 24 countries examined new data related to H. pylori in five subdivided workshops: (1) Indications/Associations, (2) Diagnosis, (3) Treatment, (4) Prevention/Public Health, (5) H. pylori and the Gastric Microbiota. The results of the individual workshops were presented to 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 the various clinical scenarios.
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Affiliation(s)
- P Malfertheiner
- Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University Magdeburg, Magdeburg, Germany
| | - F Megraud
- Laboratoire de Bactériologie, Inserm U853, Université de Bordeaux, Bordeaux, France
| | - C A O'Morain
- Faculty of Health Sciences, Trinity College, Dublin, Ireland
| | - J P Gisbert
- Department of 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
| | - E J Kuipers
- Erasmus University Medical Center, Rotterdam, The Netherlands
| | | | - F Bazzoli
- Internal Medicine and Gastroenterology, University of Bologna Italy, Bologna, Italy
| | - A Gasbarrini
- Gastroenterology, and Liver Unit, Internal Medicine, Roma, Italy
| | | | - D Y Graham
- Department of Medicine (111D), Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA
| | - R Hunt
- Department of Medicine, McMaster University, Hamilton, Canada.,Hillcroft, Beaconsfield, Buckinghamshire, UK
| | - P Moayyedi
- Department of Gastroenterology, McMaster University, Hamilton, Canada
| | - T Rokkas
- Department of Gastroenterology, Henry Dunant Hospital, Athens, Greece
| | - M Rugge
- Department of Diagnostic Sciences, University of Padova, Padova, Italy
| | | | - S Suerbaum
- Medizinische Hochschule Hannover, Institut für Medizinische Mikrobiologie, Hannover, Germany
| | - K Sugano
- Department of Medicine, Jichi Medical School, Tochigi, Japan
| | - E M El-Omar
- St George and Sutherland Clinical School, University of New South Wales, Sydney, Australia
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Ashokkumar S, Agrawal S, Mandal J, Sureshkumar S, Sreenath GS, Kate V. Hybrid Therapy versus Sequential Therapy for Eradication of Helicobacter pylori: A Randomized Controlled Trial. J Pharmacol Pharmacother 2017; 8:62-67. [PMID: 28706400 PMCID: PMC5497401 DOI: 10.4103/jpp.jpp_24_17] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022] Open
Abstract
Objective: To compare the sequential therapy (ST) with the hybrid therapy (HT) for the eradication of Helicobacter pylori. Materials and Methods: Patients with peptic ulcer disease and gastritis found to be H. pylori positive were randomized to HT group who received omeprazole (20 mg bid) and amoxicillin (1 g bid) for 7 days followed by omeprazole (20 mg bid), amoxicillin (1 g bid), clarithromycin (500 mg bid), and metronidazole (400 mg tid) for the next 7 days and ST group who received omeprazole and amoxicillin for 5 days followed by omeprazole, clarithromycin, and metronidazole for the next 5 days. Eradication rate, compliance, and complications were compared. Results: A total of 120 patients were included, sixty in each group. H. pylori eradication rate was significantly higher in HT group on intention-to-treat analysis (88.3% [confidence interval (CI) 78.3%–94.8%] vs. 73.3% [CI 61.1%–83.3%]; P = 0.037). Per-protocol analysis showed higher eradication rate with HT (93% [CI 83.9%–93.7%] vs. 81.5% [CI 69.5%–90.2%]; P = 0.068); however, the difference was insignificant. Compliance and side effects were similar. A complete course of HT costs $10.77, while ST costs only $6.347. Conclusions: HT achieves significantly higher H. pylori eradication rate than ST with comparable patient compliance and side effects but at an higher price. However, it can be used in places where ST is ineffective.
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Affiliation(s)
- Sahoo Ashokkumar
- Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| | - Sonia Agrawal
- Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| | - Jharna Mandal
- Department of Microbiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| | - Sathasivam Sureshkumar
- Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| | - Gubbi Shamanna Sreenath
- Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| | - Vikram Kate
- Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
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Losurdo G, Giorgio F, Iannone A, Principi M, Barone M, Di Leo A, Ierardi E. Role of concomitant therapy for Helicobacter pylori eradication: A technical note. World J Gastroenterol 2016; 22:8638-8640. [PMID: 27784977 PMCID: PMC5064046 DOI: 10.3748/wjg.v22.i38.8638] [Citation(s) in RCA: 2] [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: 07/11/2016] [Revised: 08/27/2016] [Accepted: 09/12/2016] [Indexed: 02/06/2023] Open
Abstract
We read with interest the recent meta-analysis by Lin et al who evaluated the effectiveness of concomitant regimen for Helicobacter pylori (H. pylori) in Chinese regions. They found that 7-d concomitant regimen is undoubtedly superior to 7-d triple therapy (91.2% vs 77.9%, P < 0.0001). However, it is a common belief that a triple therapy lasting 7 d should be definitively removed from the clinical practice for its ineffectiveness. Only its prolongation to 14 d may give satisfactory success rate. Thus, the assessment of an old and outdated treatment versus a more recent and successful one does not seem to bring novel and useful information. Moreover, a 7-d duration has not been ascertained for concomitant regimen, as main guidelines recommend a 10-d schedule for this scheme. Therefore, only studies comparing 10-d concomitant versus 14-d triple seem to be appropriate according to current Guidelines and would clarify which regimen is the most suitable worldwide. Additionally, in this meta-analysis concomitant and sequential therapy showed similar performances, despite it is common opinion that sequential is more prone than concomitant therapy to fail when metronidazole resistance occurs, and China is characterized by high rate of resistance to this antibiotic. None of the included studies evaluated a priori antibiotic resistances, and the lack of this detail hampers the unveiling of this apparent contradiction. In conclusion, the lack of the evaluation of the quality of included trials as well as their high heterogeneity constitute a burdensome limit to draw solid conclusions in this meta-analysis. On the bases of these considerations and the low number of examined trials, we believe that further studies and the knowledge of antibiotic resistances will support with high quality evidence which is the best regimen and its optimal duration.
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Song Z, Zhou L, Zhang J, He L, Bai P, Xue Y. Hybrid Therapy as First-Line Regimen for Helicobacter pylori Eradication in Populations with High Antibiotic Resistance Rates. Helicobacter 2016; 21:382-8. [PMID: 26809022 DOI: 10.1111/hel.12294] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND Hybrid therapy has recently attracted widespread attention. However, many issues require further exploration. For example, research in regions with high antibiotic resistance rates is limited, and the correlation between eradication efficacy and antibiotic resistance remains unclear. The aim of this study was to determine the efficacy, compliance, safety, and risk factors of hybrid therapy as first-line regimen in a region with high antibiotic resistance rates. MATERIALS AND METHODS This prospective study was conducted in a tertiary hospital between January 2014 and June 2015. A total of 196 patients with dyspepsia but without prior eradication therapy received hybrid regimen (esomeprazole 20 mg and amoxicillin 1000 mg twice daily for 14 days with the addition of clarithromycin 500 mg and tinidazole 500 mg twice daily for the final 7 days). All patients underwent Helicobacter pylori culture, antibiotic susceptibility testing and cytochrome P450 isoenzyme 2C19 polymorphism testing. RESULTS Hybrid therapy achieved eradication rates of 77.0% (95% confidence interval (CI), 70.9-83.7%) in intention-to-treat (ITT), 83.9% (78.9-88.9%) in modified ITT and 86.0% (80.2-91.3%) in per-protocol analyses in a setting with high antibiotic resistance rates (amoxicillin 2.0%, clarithromycin 44.9%, metronidazole 67.3% and dual clarithromycin and metronidazole 33.3%). Adverse reactions occurred in 31.9% patients and 2.7% discontinued medications due to adverse reactions. Good compliance was achieved by 92.0%. Multivariate analyses identified clarithromycin resistance (odds ratio, 3.494; 95% CI, 1.237-9.869), metronidazole resistance (3.012; 1.013-12.054) and poor compliance (5.840; 1.126-30.296) as independent predictors of treatment failure. The eradication rate with dual clarithromycin and metronidazole resistance (70.2%) was markedly decreased compared to isolated clarithromycin resistance (87.5%), isolated metronidazole resistance (88.6%), or dual susceptibility (96.4%) (p = .014). CONCLUSIONS Despite good compliance and safety, hybrid therapy as first-line regimen in populations with high antibiotic resistance rates had unsatisfactory efficacy, primarily due to dual clarithromycin and metronidazole resistance.
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Affiliation(s)
- Zhiqiang Song
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Liya Zhou
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
| | - Jianzhong Zhang
- State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Lihua He
- State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Peng Bai
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Yan Xue
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
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38
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Apostolopoulos P, Koumoutsos I, Ekmektzoglou K, Dogantzis P, Vlachou E, Kalantzis C, Tsibouris P, Alexandrakis G. Concomitant versus sequential therapy for the treatment of Helicobacter pylori infection: a Greek randomized prospective study. Scand J Gastroenterol 2016; 51:145-51. [PMID: 26435055 DOI: 10.3109/00365521.2015.1079646] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
OBJECTIVE The objective of this study is to compare, in Greece, a region with >20% local resistance to clarithromycin, the efficacy rates of the concomitant versus the sequential H. pylori eradication therapy. MATERIALS AND METHODS Our prospective randomized study included 364 patients with newly diagnosed H. pylori infection, randomized to receive a 10-day concomitant or 10-day sequential therapy. Treatment outcome was assessed by C(13)-urea breath test at least 4 weeks after therapy. Intention to treat (ITT) and per protocol (PP) analysis of the eradication rates were performed. Secondary end points included patient compliance and safety. RESULTS The concomitant therapy group achieved statistically significant higher eradication rates when compared with the sequential treatment group, both in the ITT and in the PP analysis (84.6% versus 70.9%, p = 0.002, and 90.6% versus 78.1%, p = 0.001, respectively), after adjusting for age, gender, smoking status, and the presence or not of ulcer and/or non-ulcer dyspepsia. Both groups displayed excellent compliance rates (99.5% for the concomitant therapy group and 96.2% for the sequential therapy group, p = 0.067). Regarding treatment safety, major adverse events that led to the discontinuation of both regimens were few, with no statistical difference between the two groups (7.0% for the concomitant therapy group and 2.9% for the sequential therapy group). CONCLUSIONS Concomitant therapy led to statistically significant higher eradication rates over sequential therapy. Both therapies showed excellent compliance and an acceptable safety profile. The 10-day quadruple concomitant scheme should be the adopted for first-line H. pylori eradication in Greece.
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Affiliation(s)
| | - Ioannis Koumoutsos
- a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece
| | | | - Panagiotis Dogantzis
- a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece
| | - Erasmia Vlachou
- a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece
| | | | - Panagiotis Tsibouris
- a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece
| | - Georgios Alexandrakis
- a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece
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Chung JW, Han JP, Kim KO, Kim SY, Hong SJ, Kim TH, Kim CW, Kim JS, Kim BW, Bang BW, Kim HG, Yun SC. Ten-day empirical sequential or concomitant therapy is more effective than triple therapy for Helicobacter pylori eradication: A multicenter, prospective study. Dig Liver Dis 2016; 48:888-92. [PMID: 27257049 DOI: 10.1016/j.dld.2016.05.005] [Citation(s) in RCA: 28] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/23/2016] [Revised: 04/11/2016] [Accepted: 05/04/2016] [Indexed: 02/06/2023]
Abstract
BACKGROUND The resistance of Helicobacter pylori to antibiotics has increased the need for new empirical, first-line treatments. However, the efficacy of sequential therapy (ST) and concomitant therapy (CT) compared with triple therapy (TT) has not been adequately evaluated. AIM In this study, we evaluated the efficacy of these empirical three regimens. METHODS The 517 patients enrolled in the study were prospectively randomized to receive 10 days of TT (n=171), ST (n=170), and CT (n=176) at 5 university-affiliated hospitals from May 2013 to March 2015. The post-treatment H. pylori status was determined using the (13)C-urea breath test. RESULTS The baseline characteristics were similar among the three groups. The intention-to-treat eradication rates were 62.6%, 70.6%, and 77.8% in the TT, ST, and CT groups, respectively (p<0.01). The corresponding per-protocol eradication rates were 82.8%, 89.5%, and 94.4%, respectively (p<0.01). There were no significant differences in the compliance, side effects, and follow-up loss rates. CONCLUSION A higher eradication rate was achieved with empirical 10-day ST, and CT than with the TT regimen, with similar rates of compliance and treatment side effects.
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Affiliation(s)
- Jun-Won Chung
- Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
| | - Jae Pil Han
- Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea
| | - Kyoung Oh Kim
- Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
| | - Su Young Kim
- Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea
| | - Su Jin Hong
- Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea
| | - Tae Ho Kim
- Division of Gastroenterology, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea
| | - Chang Whan Kim
- Division of Gastroenterology, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea
| | - Joon Sung Kim
- Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea
| | - Byung-Wook Kim
- Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea.
| | - Byoung Wook Bang
- Division of Gastroenterology, Department of Internal Medicine, Inha University College of Medicine, Incheon, Republic of Korea
| | - Hyung Gil Kim
- Division of Gastroenterology, Department of Internal Medicine, Inha University College of Medicine, Incheon, Republic of Korea.
| | - Sung-Cheol Yun
- Clinical Epidemiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea
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Georgopoulos SD, Xirouchakis E, Martinez-Gonzales B, Zampeli E, Grivas E, Spiliadi C, Sotiropoulou M, Petraki K, Zografos K, Laoudi F, Sgouras D, Mentis A, Kasapidis P, Michopoulos S. Randomized clinical trial comparing ten day concomitant and sequential therapies for Helicobacter pylori eradication in a high clarithromycin resistance area. Eur J Intern Med 2016; 32:84-90. [PMID: 27134145 DOI: 10.1016/j.ejim.2016.04.011] [Citation(s) in RCA: 37] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/02/2016] [Revised: 04/09/2016] [Accepted: 04/11/2016] [Indexed: 02/07/2023]
Abstract
BACKGROUND Currently only a few studies compare sequential and concomitant non-bismuth Helicobacter pylori therapies referring to high antibiotic resistance populations. MATERIALS AND METHODS This multicenter prospective randomized clinical trial included 353 H. pylori positive, treatment naïve, patients. All patients had positive CLO-test and/or histology and culture. They received sequential (esomeprazole 40mg, amoxicillin 1g/bid for 5days, followed by 5days of esomeprazole 40mg, clarithromycin 500mg and metronidazole 500mg bid), or concomitant treatment (all drugs taken concomitantly bid for 10days). Eradication was confirmed by (13)C-urea breath test or histology 4-6weeks after treatment. Adverse events and adherence were evaluated. RESULTS Allocated to concomitant were 175 (72F/103M, mean 52.3years, 38.3% smokers, 25.7% ulcer disease) and 178 (87F/91M, mean 52years, 31% smokers, 19.1% ulcer disease) patients to sequential treatment. There were 303/353 (85.8%) positive cultures, with the following resistances: 34% metronidazole, 27.7% clarithromycin, and 7.9% dual. Eradication rates were, respectively, 89.1% (156/175) vs. 78.7% (140/178) by intention to treat (p=0.01, 95% CI=2.7-18) and 93.4%(156/167) vs. 82.8% (140/169) per protocol (p=0.004, 95% CI=3.6-17.6). Overall, adherence was (98.9%, 95% CI=97-100). Eradication rates according to resistance were the following: dual susceptible strains 67/69 (97.1%), 62/67 (92%) (p=0.4), metronidazole single resistant 38/39 (97.4%), 31/39 (79.5%) (p=0.03, 95% CI=3.5-33), clarithromycin single resistant 25/28 (89.3%), 26/31 (83.9%) (p=0.8), and dual resistant 9/12 (75%), 4/11 (36.4%) (p=0.1) for concomitant and sequential regimens, respectively. Side effects were comparable among regimens, except from diarrhea being more frequent among patients treated with concomitant treatment. CONCLUSIONS Concomitant treatment eradication rate overcomes 90% per protocol and has a significant advantage over sequential therapy. This is probably due to its better efficacy on metronidazole resistant strains. Both regimens were well tolerated and safe.
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Affiliation(s)
- Sotirios D Georgopoulos
- GI and Hepatology Department, Athens Medical, Paleo Faliron Hospital, 36 Areos str., 175 62 Athens, Greece.
| | - Elias Xirouchakis
- GI and Hepatology Department, Athens Medical, Paleo Faliron Hospital, 36 Areos str., 175 62 Athens, Greece
| | | | - Evanthia Zampeli
- Gastroenterology Department, Alexandra General Hospital, Athens, Greece
| | - Elias Grivas
- Gastrenterology Department, Central Clinic of Athens, Athens, Greece
| | - Charikleia Spiliadi
- Department of Histopathology, Athens Medical, Amaroussion Hospital, Athens, Greece
| | - Maria Sotiropoulou
- Department of Histopathology, Alexandra General Hospital, Athens, Greece
| | - Kalliopi Petraki
- Department of Histopathology, Metropolitan Hospital, Athens, Greece
| | - Kostantinos Zografos
- GI and Hepatology Department, Athens Medical, Paleo Faliron Hospital, 36 Areos str., 175 62 Athens, Greece
| | - Fotini Laoudi
- GI and Hepatology Department, Athens Medical, Paleo Faliron Hospital, 36 Areos str., 175 62 Athens, Greece
| | - Dionysios Sgouras
- Laboratory of Medical Microbiology, Hellenic Pasteur Institute, Athens, Greece
| | - Andreas Mentis
- Laboratory of Medical Microbiology, Hellenic Pasteur Institute, Athens, Greece
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41
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Gisbert JP, Molina-Infante J, Amador J, Bermejo F, Bujanda L, Calvet X, Castro-Fernández M, Cuadrado-Lavín A, Elizalde JI, Gene E, Gomollón F, Lanas Á, Martín de Argila C, Mearin F, Montoro M, Pérez-Aisa Á, Pérez-Trallero E, McNicholl AG. IV Spanish Consensus Conference on Helicobacter pylori infection treatment. GASTROENTEROLOGIA Y HEPATOLOGIA 2016; 39:697-721. [PMID: 27342080 DOI: 10.1016/j.gastrohep.2016.05.003] [Citation(s) in RCA: 73] [Impact Index Per Article: 8.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/25/2016] [Revised: 05/18/2016] [Accepted: 05/19/2016] [Indexed: 02/06/2023]
Abstract
Helicobacter pylori approximately infect 50% of Spanish population and causes chronic gastritis, peptic ulcer and gastric cancer. Until now, three consensus meetings on H.pylori infection had been performed in Spain (the last in 2012). The changes in the treatment schemes, and the increasing available evidence, have justified organizing the IVSpanish Consensus Conference (March 2016), focused on the treatment of this infection. Nineteen experts participated, who performed a systematic review of the scientific evidence and developed a series of recommendation that were subjected to an anonymous Delphi process of iterative voting. Scientific evidence and the strength of the recommendation were classified using GRADE guidelines. As starting point, this consensus increased the minimum acceptable efficacy of recommended treatments that should reach, or preferably surpass, the 90% cure rate when prescribed empirically. Therefore, only quadruple therapies (with or without bismuth), and generally lasting 14 days, are recommended both for first and second line treatments. Non-bismuth quadruple concomitant regimen, including a proton pump inhibitor, clarithromycin, amoxicillin and metronidazole, is recommended as first line. In the present consensus, other first line alternatives and rescue treatments are also reviewed and recommended.
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Affiliation(s)
- Javier P Gisbert
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, España.
| | | | - Javier Amador
- Medicina de Familia, Centro de Salud Los Ángeles, Madrid, España
| | - Fernando Bermejo
- Servicio de Aparato Digestivo, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, España
| | - Luis Bujanda
- Servicio de Digestivo, Hospital Donostia/Instituto Biodonostia, Universidad del País Vasco UPV/EHU, CIBEREHD, San Sebastián, España
| | - Xavier Calvet
- Servicio de Aparato Digestivo, Hospital Parc Taulí, Universitat Autónoma de Barcelona, CIBEREHD, Sabadell, Barcelona, España
| | | | | | - J Ignasi Elizalde
- Servicio de Aparato Digestivo, Hospital Clínic, CIBEREHD, Barcelona, España
| | - Emili Gene
- Servicio de Urgencias, Hospital Parc Taulí Sabadell, CIBEREHD, Universitat Internacional de Catalunya, Sabadell, Barcelona, España
| | - Fernando Gomollón
- Servicio de Aparato Digestivo, Hospital Clínico Universitario de Zaragoza, IIS Aragón, CIBEREHD, Zaragoza, España
| | - Ángel Lanas
- Servicio de Aparato Digestivo, Hospital Clínico Universitario de Zaragoza, IIS Aragón, CIBEREHD, Zaragoza, España
| | - Carlos Martín de Argila
- Servicio de Aparato Digestivo, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, España
| | - Fermín Mearin
- Servicio de Aparato Digestivo, Centro Médico Teknon, Barcelona, España
| | - Miguel Montoro
- Servicio de Aparato Digestivo, Hospital San Jorge, Huesca, España
| | - Ángeles Pérez-Aisa
- Servicio de Aparato Digestivo, Agencia Sanitaria Costa del Sol, Marbella, Málaga, España
| | - Emilio Pérez-Trallero
- Servicio de Microbiología, Hospital Donostia/Instituto Biodonostia, Universidad del País Vasco UPV/EHU, CIBEREHD, San Sebastián, España
| | - Adrián G McNicholl
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, España
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Laird-Fick HS, Saini S, Hillard JR. Gastric adenocarcinoma: the role of Helicobacter pylori in pathogenesis and prevention efforts. Postgrad Med J 2016; 92:471-7. [PMID: 27222587 DOI: 10.1136/postgradmedj-2016-133997] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2016] [Accepted: 04/24/2016] [Indexed: 12/20/2022]
Abstract
Gastric cancer is the third most common cause of cancer deaths in the world, prompting high-risk countries like South Korea and Japan to establish nationwide screening programmes. Helicobacter pylori is linked to the majority of gastric adenocarcinoma cases and to the vast majority of non-cardia gastric adenocarcinomas. Several studies have demonstrated the effectiveness of 'test-and-treat' programmes for H. pylori infection to prevent gastric cancer in high-risk populations. While this strategy has gained momentum, providers in low-risk developed countries may be unaware of the risk individual patients face, particularly those who have emigrated from high-risk regions and members of economically disadvantaged minority groups. Rapidly evolving science in recent years has made it difficult for clinicians to keep up with the current best practices. This article reviews the epidemiology of H. pylori and gastric cancer, screening and diagnostic tests and the current treatment regimens for clinicians.
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Affiliation(s)
- Heather S Laird-Fick
- Department of Medicine, Michigan State University, East Lansing, Michigan, USA Department of Medicine, EW Sparrow Hospital, Lansing, Michigan, USA
| | - Shivani Saini
- Department of Medicine, Michigan State University, East Lansing, Michigan, USA
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Song ZQ, Zhou LY. Hybrid, sequential and concomitant therapies for Helicobacter pylori eradication: A systematic review and meta-analysis. World J Gastroenterol 2016; 22:4766-4775. [PMID: 27217708 PMCID: PMC4870083 DOI: 10.3748/wjg.v22.i19.4766] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/09/2015] [Revised: 01/14/2016] [Accepted: 01/30/2016] [Indexed: 02/06/2023] Open
Abstract
AIM: To compare hybrid therapy (HT) with traditional sequential therapy (ST) and concomitant therapy (CT) for Helicobacter pylori (H. pylori) eradication.
METHODS: We performed an electronic search of PubMed, Embase, and the CENTRAL database. Randomized controlled trials (RCTs) of HT were included in the meta-analysis. The primary outcome was the eradication rate of H. pylori. The secondary outcomes included the compliance rate and adverse event rate. Effect estimates were pooled using the random-effects model.
RESULTS: Twelve studies were included. Pooled results showed no significant differences in eradication rate between HT and ST in per-protocol (PP) analysis (RR = 1.03, 95%CI: 0.94-1.12, P = 0.59) or in intention-to-treat (ITT) analysis (RR = 1.00, 95%CI: 0.89-1.12, P = 0.94). HT and ST showed similarly high compliance rate (96% vs 98%, P = 0.55) and acceptable adverse event rate (30.3% vs 28.2%, P = 0.63). No significant results were seen in the eradication rate between HT and CT in PP analysis (RR = 1.01, 95%CI: 0.96-1.05, P = 0.76) or in ITT analysis (RR = 0.99, 95%CI: 0.95-1.03, P = 0.47). HT displayed a slightly higher compliance rate than CT (95.8% vs 93.2%, P < 0.05). The adverse event rates of HT and CT were similar (39.5% vs 44.2%, P = 0.24).
CONCLUSION: Compared with ST or CT, HT yields a similar eradication rate, high compliance rate, and acceptable safety profiles.
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Alhooei S, Tirgar Fakheri H, Hosseini V, Maleki I, Taghvaei T, Valizadeh SM, Bari Z. A Comparison between Hybrid and Concomitant Regimens for Helicobacter Pylori Eradication: A Randomized Clinical Trial. Middle East J Dig Dis 2016; 8:219-225. [PMID: 27698972 PMCID: PMC5045675 DOI: 10.15171/mejdd.2016.24] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Helicobacter pylori (H. pylori) is one of the most common bacterial infections worldwide. We designed a study to compare the efficacy of 14-day hybrid regimen with 10-day concomitant therapy for H. pylori eradication in Iran. METHODS 252 patients with naïve H. pylori infection were randomly divided to receive either hybrid regimen (pantoprazole 40 mg, and amoxicillin 1 gr twice daily for 14 days, accompanied by clarithromycin 500 mg, and metronidazole 500 mg, twice daily just during the last 7 days) or concomitant regimen (pantoprazole 40 mg, amoxicillin 1 gr, clarithromycin 500 mg, and metronidazole 500 mg, all twice daily for 10 days). 8 weeks after therapy, 14C- urease breath test was performed to confirm eradication. RESULTS According to intention to treat analysis, the eradication rates were 87.3% (95% CI: 81.4-93.1) and 80.9% (95% CI: 74-87.8) in hybrid and concomitant groups, respectively (p=0.38). Per-protocol eradication rates were 89.3% (95% CI: 83.8-94.7) and 83.1% (95% CI: 76.3-89.8), respectively (p=0.19). The rates of severe side effects were not statistically different between the two groups (4% vs. 8.7%). CONCLUSION 14-day hybrid therapy can be considered as a nearly acceptable regimen with few severe side effects in Iran. However, it seems that the efficacy of this therapy is decreasing as the resistance rates to antibiotics are increasing. We suggest further studies to assess the efficacy of a more prolonged concomitant therapy for H. pylori eradication in Iran.
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Affiliation(s)
- Saman Alhooei
- Assistant Professor, Department of Gastroenterology, Golestan University of Medical Sciences, Gorgan, Iran
| | - Hafez Tirgar Fakheri
- Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Vahid Hosseini
- Associate Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Iradj Maleki
- Associate Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Tarang Taghvaei
- Associate Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Seyed Mohammad Valizadeh
- Assistant Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Zohreh Bari
- Fellow of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
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Dolapcioglu C, Sayiner M, Akkus EE, Kural A, Dolapcioglu H, Dabak R, Ahishali E. First-line Bismuth-containing Five-day Concomitant Quintuple Therapy for Helicobacter Pylori Eradication. Helicobacter 2016; 21:100-5. [PMID: 26103789 DOI: 10.1111/hel.12241] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Widespread use of antibiotics has resulted in increased rates of antibiotic resistance and decreased rates of Helicobacter pylori (H. pylori) eradication, leading to a search for newer therapeutic options. This study aimed to examine the efficacy, tolerability, and patient compliance of a first-line bismuth-containing 5-day concomitant quintuple therapy. MATERIALS AND METHODS This prospective study included 144 eradication treatment naïve H. pylori positive patients with dyspeptic complaints. Patients received the following concomitant quintuple therapy for 5 days: bismuth subcitrate 300 mg q.i.d, omeprazole 20 mg b.i.d, clarithromycin 500 mg b.i.d., amoxicillin 1 g b.i.d., and metronidazole 500 mg t.i.d. Eradication was assessed with H. pylori stool antigen test or urea-breath test 6 weeks after the completion of therapy. RESULTS Treatment compliance rate in this study was 97.2%. Intention to treat and per-protocol eradication rates were 134/144 (93.1%, 95% CI, 88.9-97.2) and 134/140 (95.7%, 95% CI, 92.2-98.6), respectively. Side effect was reported by 8.5% of the patients that attended follow-up visits, including epigastric pain (2.8%), nausea/vomiting (2.1%), diarrhea (1.4%), taste disturbance (1.4%), and fatigue (0.7%). CONCLUSIONS Bismuth-containing, short course, quintuple concomitant therapy appears to be an effective and safe therapeutic option for the first-line H. pylori eradication, particularly in populations with high resistance.
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Affiliation(s)
- Can Dolapcioglu
- Department of Gastroenterology, Dr. Lutfi Kirdar Kartal Research and Training Hospital, Istanbul, Turkey
| | - Mehmet Sayiner
- Department of Family Medicine, Dr. Lutfi Kirdar Kartal Research and Training Hospital, Istanbul, Turkey
| | - Esra Elif Akkus
- Department of Family Medicine, Dr. Lutfi Kirdar Kartal Research and Training Hospital, Istanbul, Turkey
| | - Abdulaziz Kural
- Department of Gastroenterology, Dr. Lutfi Kirdar Kartal Research and Training Hospital, Istanbul, Turkey
| | - Hatice Dolapcioglu
- Department of Pathology, Fatih Sultan Mehmet Research and Training Hospital, Istanbul, Turkey
| | - Resat Dabak
- Department of Family Medicine, Dr. Lutfi Kirdar Kartal Research and Training Hospital, Istanbul, Turkey
| | - Emel Ahishali
- Department of Gastroenterology, Dr. Lutfi Kirdar Kartal Research and Training Hospital, Istanbul, Turkey
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Makhlough A, Fakheri H, Hojati S, Hosseini V, Bari Z. A Comparison between Hybrid Therapy and Standard Triple Therapy for Helicobacter pylori Eradication in Patients with Uremia: A Randomized Clinical Trial. Middle East J Dig Dis 2016; 8:39-43. [PMID: 26933480 PMCID: PMC4773081 DOI: 10.15171/mejdd.2016.05] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/31/2022] Open
Abstract
BACKGROUND
The prevalence of peptic ulcer disease in hemodialysis patients is more than the general population. They are also more prone to complications including upper gastrointestinal bleeding. The aim of this study was to compare the efficacy of 14 days hybrid regimen with 14 days triple therapy for Helicobacter pylori (H. pylori ) eradication in hemodialysis patients.
METHODS
Forty hemodialysis patients with naïve H.pylori infection were randomized to receive either hybrid regimen (pantoprazole 40 mg + amoxicillin 500 mg, both twice a day during the first 7 days, followed by pantoprazole 40 mg + amoxicillin 500 mg + clarithromycin 500 mg + tinidazole 500 mg, all twice a day, for the second 7 days, or standard triple therapy including pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 500 mg, all twice a day for 14 days. H.pylori eradication was assessed by fecal H.pylori antigen test 8 weeks after the treatment.
RESULTS
All the patients completed the study. According to both intention to treat and per-protocol analyses, H.pylori eradication rates were 100% (95% confidence interval (CI): 100) in those who received hybrid therapy and 70% (95% CI: 69.4 – 70.8) in those who were treated by standard triple therapy (p=0.02). Severe adverse effects were not reported by any patient; however, mild adverse effects were more frequent in those who received standard triple therapy (p<0.05).
CONCLUSION
Hybrid regimen could achieve ideal H.pylori eradication rates with low rates of adverse effects.
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Affiliation(s)
- Atieh Makhlough
- Associate Professor, Department of Nephrology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Hafez Fakheri
- Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Samaneh Hojati
- Resident of Internal Medicine, Mazandaran University of Medical Sciences, Sari, Iran
| | - Vahid Hosseini
- Associate Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
| | - Zohreh Bari
- Fellow of Gastroenterology, Mazandaran University of Medical Sciences, Sari, Iran
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Das R, Sureshkumar S, Sreenath GS, Kate V. Sequential versus concomitant therapy for eradication of Helicobacter Pylori in patients with perforated duodenal ulcer: A randomized trial. Saudi J Gastroenterol 2016; 22:309-15. [PMID: 27488326 PMCID: PMC4991202 DOI: 10.4103/1319-3767.187605] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
OBJECTIVES Comparison of Helicobacter pylori eradication rates, side effects, compliance, cost, and ulcer recurrence of sequential therapy (ST) with that of concomitant therapy (CT) in patients with perforated duodenal ulcer following simple omental patch closure. METHODS Sixty-eight patients with perforated duodenal ulcer treated with simple closure and found to be H. pylori positive on three months follow-up were randomized to receive either ST or CT for H. pylori eradication. Urease test and Giemsa stain were used to assess for H. pylori eradication status. Follow-up endoscopies were done after 3 months, 6 months, and 1 year to evaluate the ulcer recurrence. RESULTS H. pylori eradication rates were similar in ST and CT groups on intention-to-treat (ITT) analysis (71.43% vs 81.80%,P = 0.40). Similar eradication rates were also found in per-protocol (PP) analysis (86.20% vs 90%,P = 0.71). Ulcer recurrence rate in ST groups and CT groups at 3 months (17.14% vs 6.06%,P = 0.26), 6 months (22.86% vs 9.09%,P = 0.19), and at 1 year (25.71% vs 15.15%,P = 0.37) of follow-up was also similar by ITT analysis. Compliance and side effects to therapies were comparable between the groups. The most common side effects were diarrhoea and metallic taste in ST and CT groups, respectively. A complete course of ST costs Indian Rupees (INR) 570.00, whereas CT costs INR 1080.00. CONCLUSION H. pylori eradication rates, side effects, compliance, cost, and ulcer recurrences were similar between the two groups. The ST was more economical compared with CT.
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Affiliation(s)
- Roby Das
- Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| | - Sathasivam Sureshkumar
- Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| | - Gubbi S. Sreenath
- Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| | - Vikram Kate
- Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India,Address for correspondence: Dr. Vikram Kate, Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry - 605 006, India. E-mail:
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Hsu PI, Lin PC, Graham DY. Hybrid therapy for Helicobacter pylori infection: A systemic review and meta-analysis. World J Gastroenterol 2015; 21:12954-62. [PMID: 26668516 PMCID: PMC4671047 DOI: 10.3748/wjg.v21.i45.12954] [Citation(s) in RCA: 35] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/29/2015] [Revised: 08/07/2015] [Accepted: 09/30/2015] [Indexed: 02/06/2023] Open
Abstract
AIM To compare the effectiveness of hybrid therapy with other recommended regimens using meta-analysis. METHODS Bibliographical searches for randomized trials comparing hybrid and other therapies were performed in PubMed, the Cochrane Library and relevant congresses up to February 2015 using the following keywords (all fields and/or MeSH): ("Helicobacter pylori" or "H. pylori") and ("hybrid therapy" or "sequential-concomitant therapy"). Meta-analyses were performed with Cochrane Review Manager 5.1. The random effect model proposed by DerSimonian and Laird and the Mantel-Haenszel method were used to estimate the pooled relative risk and 95%CI of the efficacy outcomes between hybrid therapy and other eradication therapies. RESULTS Eight studies (2516 subjects) met entry criteria. The antimicrobial resistance in the study groups ranged from 6.9% to 23.5%. The mean cure rates of hybrid therapy by intention-to-treat (ITT) and per-protocol analyses were 88.5% (n = 1207; range: 80.0% to 97.4%) and 93.3% (n = 1109; range: 85.7% to 99.1%), respectively. Meta-analysis showed there was no significant difference in ITT eradication rate between hybrid and sequential therapy (relative risk: 1.01; 95%CI: 0.92-1.11). Subgroup analysis revealed hybrid therapy was more effective than sequential therapy in the non-Italian populations (95%CI: 1.01-1.18) and was only less effective in one, Italian population (95%CI: 0.83-0.98). There was no significant difference in eradication rate between hybrid therapy and concomitant therapy (95%CI: 0.93-1.02). No head-to-head comparisons of hybrid therapy and standard triple therapy or bismuth quadruple therapy were found. However, a multicenter, randomized trial showed that reverse hybrid therapy was superior to standard triple therapy (95.5% vs 88.6% ITT; P = 0.011). CONCLUSION Hybrid therapy appears to be an effective, safe, and well-tolerated treatment for H. pylori infection in the era of increasing antibiotic resistance.
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Hsu PI, Kao SS, Wu DC, Chen WC, Peng NJ, Yu HC, Wang HM, Lai KH, Cheng JS, Chen A, Chuah SK, Tsay FW. A Randomized Controlled Study Comparing Reverse Hybrid Therapy and Standard Triple Therapy for Helicobacter pylori Infection. Medicine (Baltimore) 2015; 94:e2104. [PMID: 26632893 PMCID: PMC4674196 DOI: 10.1097/md.0000000000002104] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
Reverse hybrid therapy is an 1-step 2-phase treatment for Helicobacter pylori (H. pylori) infection with less cost than standard triple therapy. We conducted a randomized, controlled study to compare the efficacies of standard triple therapy and reverse hybrid therapy in the treatment of H. pylori infection. From October 2012 to March 2015, consecutive H. pylori-infected subjects were randomly allocated to receive either a reverse hybrid therapy (pantoprazole plus amoxicillin for 12 days and clarithromycin plus metronidazole for the initial 7 days) or a standard triple therapy (pantoprazole plus amoxicillin and clarithromycin for 12 days). H. pylori status was assessed 6 weeks after treatment. Additionally, antibiotic resistances and host CYP2C19 genotypes were examined and analyzed. A total of 440 H. pylori-infected patients were randomly assigned to receive either a reverse hybrid (n = 220) or a standard triple therapy (n = 220). The reverse hybrid group had a higher eradication rate than standard triple group either by intention-to-treat (93.6% vs. 86.8%; P = 0.016) or per-protocol analysis (95.7% vs. 88.3%; P = 0.005). The 2 patient groups exhibited similar frequencies of overall adverse events (14.1% vs. 9.5%) and drug compliance (96.8% vs. 98.6%). Clarithromycin resistance was an independent risk factor predicting eradication failure in standard triple group (P < 0.001), but not in reverse hybrid group. CYP2C19 genotypes did not affect the eradication rates in both groups. Reverse hybrid therapy can be considered for first-line treatment of H. pylori infection since the new therapy achieves a higher eradication rate than standard triple therapy with similar tolerability and less pharmaceutical cost.
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Affiliation(s)
- Ping-I Hsu
- From the Division of Gastroenterology, Kaohsiung, Taiwan (P-IH, S-SK, W-CC, H-CY, H-MW, K-HL, J-S C, F-WT); Department of Internal Medicine, Kaohsiung, Taiwan; Department of Nuclear Medicine, Kaohsiung, Taiwan (N-JP); Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan; Division of Gastroenterology, Kaohsiung, Taiwan (D-CW); Department of Internal Medicine and Cancer Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Department of Medicine, Kaohsiung, Taiwan (D-CW); Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Institute of Biomedical Sciences, Kaohsiung, Taiwan (AC), National Sun Yat-Sen University, Kaohsiung, Taiwan; Division of Hepato-Gastroenterology, Kaohsiung, Taiwan (S-KC); and Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; Chang Gung University College of Medicine, Kaohsiung, Taiwan
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Sokic-Milutinovic A, Alempijevic T, Milosavljevic T. Role of Helicobacter pylori infection in gastric carcinogenesis: Current knowledge and future directions. World J Gastroenterol 2015; 21:11654-11672. [PMID: 26556993 PMCID: PMC4631967 DOI: 10.3748/wjg.v21.i41.11654] [Citation(s) in RCA: 38] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/21/2015] [Revised: 07/16/2015] [Accepted: 09/22/2015] [Indexed: 02/06/2023] Open
Abstract
Helicobacter pylori (H. pylori) plays a role in the pathogenesis of gastric cancer. The outcome of the infection depends on environmental factors and bacterial and host characteristics. Gastric carcinogenesis is a multistep process that is reversible in the early phase of mucosal damage, but the exact point of no return has not been identified. Therefore, two main therapeutic strategies could reduce gastric cancer incidence: (1) eradication of the already present infection; and (2) immunization (prior to or during the course of the infection). The success of a gastric cancer prevention strategy depends on timing because the prevention strategy must be introduced before the point of no return in gastric carcinogenesis. Although the exact point of no return has not been identified, infection should be eradicated before severe atrophy of the gastric mucosa develops. Eradication therapy rates remain suboptimal due to increasing H. pylori resistance to antibiotics and patient noncompliance. Vaccination against H. pylori would reduce the cost of eradication therapies and lower gastric cancer incidence. A vaccine against H. pylori is still a research challenge. An effective vaccine should have an adequate route of delivery, appropriate bacterial antigens and effective and safe adjuvants. Future research should focus on the development of rescue eradication therapy protocols until an efficacious vaccine against the bacterium becomes available.
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