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Chen CL, Wu IT, Wu DC, Lei WY, Tsay FW, Chuah SK, Chen KY, Yang JC, Liu YH, Kuo CH, Shiu SI, Shie CB, Lin KH, Lee CL, Hsu PI. Independent Risk Factors Predicting Eradication Failure of Hybrid Therapy for the First-Line Treatment of Helicobacter pylori Infection. Microorganisms 2023; 12:6. [PMID: 38276175 PMCID: PMC10820614 DOI: 10.3390/microorganisms12010006] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/01/2023] [Revised: 12/10/2023] [Accepted: 12/12/2023] [Indexed: 01/27/2024] Open
Abstract
Hybrid therapy is a recommended first-line anti-H. pylori treatment option in the American College of Gastroenterology guidelines, the Bangkok Consensus Report on H. pylori management, and the Taiwan H. pylori Consensus Report. However, the cure rates of eradication therapy in some countries are suboptimal, and the factors affecting the treatment efficacy of hybrid therapy remain unclear. The aim of this study is to identify the independent risk factors predicting eradication failure of hybrid therapy in the first-line treatment of H. pylori infection. A retrospective cohort study was conducted on 589 H. pylori-infected patients who received 14-day hybrid therapy between September 2008 and December 2021 in ten hospitals in Taiwan. The patients received a hybrid therapy containing a dual regimen with a proton pump inhibitor (PPI) plus amoxicillin for an initial 7 days and a quadruple regimen with a PPI plus amoxicillin, metronidazole and clarithromycin for a final 7 days. Post-treatment H. pylori status was assessed at least 4 weeks after completion of treatment. The relationships between eradication rate and 13 host and bacterial factors were investigated via univariate and multivariate analyses. In total, 589 patients infected with H. pylori infection were included in the study. The eradication rates of hybrid therapy were determined as 93.0% (95% confidence interval (CI): 90.9-95.1%), 94.4% (95% CI: 93.8-97.2%) and 95.5%% (95% CI: 93.8-97.2%) by intention-to-treat, modified intention-to-treat and per-protocol analyses, respectively. Univariate analysis showed that the eradication rate of clarithromycin-resistant strains was lower than that of clarithromcyin-susceptible strains (83.3% (45/54) vs. 97.6%% (280/287); p < 0.001). Subjects with poor drug adherence had a lower cure rate than those with good adherence (73.3% (11/15) vs. 95.5% (534/559); p = 0.005). Other factors such as smoking, alcohol drinking, coffee consumption, tea consumption and type of PPI were not significantly associated with cure rate. Multivariate analysis revealed that clarithromcyin resistance of H. pylori and poor drug adherence were independent risk factors related to eradication failure of hybrid therapy with odds ratios of 4.8 (95% CI: 1.5 to 16.1; p = 0.009) and 8.2 (95% CI: 1.5 to 43.5; p = 0.013), respectively. A 14-day hybrid therapy has a high eradication rate for H. pylori infection in Taiwan, while clarithromycin resistance of H. pylori and poor drug adherence are independent risk factors predicting eradication failure of hybrid therapy.
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Affiliation(s)
- Chien-Lin Chen
- Department of Medicine, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien 970, Taiwan; (C.-L.C.); (W.-Y.L.)
| | - I-Ting Wu
- Division of Gastroenterology, Department of Medicine, An Nan Hospital, China Medical University, Tainan 709, Taiwan (C.-B.S.)
| | - Deng-Chyang Wu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan; (D.-C.W.); (C.-H.K.)
| | - Wei-Yi Lei
- Department of Medicine, Buddhist Tzu Chi General Hospital, Tzu Chi University, Hualien 970, Taiwan; (C.-L.C.); (W.-Y.L.)
| | - Feng-Woei Tsay
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, National Yang-Ming University, Kaohsiung 813, Taiwan;
| | - Seng-Kee Chuah
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan 333, Taiwan;
| | - Kuan-Yang Chen
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei City Hospital, Renai Branch, Taipei 106, Taiwan
| | - Jyh-Chin Yang
- Division of Gastroenterology, Department of Internal Medicine, National Taiwan University Hospital, Taipei 100, Taiwan;
| | - Yu-Hwa Liu
- Division of Gastroenterology, Department of Internal Medicine, Shin Kong Wu Huo-Shih Memorial Hospital, Taipei 111, Taiwan;
| | - Chao-Hung Kuo
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan; (D.-C.W.); (C.-H.K.)
| | - Sz-Iuan Shiu
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung 407, Taiwan;
| | - Chang-Bih Shie
- Division of Gastroenterology, Department of Medicine, An Nan Hospital, China Medical University, Tainan 709, Taiwan (C.-B.S.)
| | - Kuan-Hua Lin
- Division of Gastroenterology, Department of Medicine, An Nan Hospital, China Medical University, Tainan 709, Taiwan (C.-B.S.)
| | - Chia-Long Lee
- Division of Gastroenterology and Hepatology, Department of Internal Medicine Cathay General Hospital, Taipei 106, Taiwan
| | - Ping-I Hsu
- Division of Gastroenterology, Department of Medicine, An Nan Hospital, China Medical University, Tainan 709, Taiwan (C.-B.S.)
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Lee JY. Triple Therapy. HELICOBACTER PYLORI 2023:541-552. [DOI: 10.1007/978-981-97-0013-4_44] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/05/2025]
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Ozturk MA, Koroglu M, Ayvaz MA. The efficacy of bismuth quadruple therapy, sequential therapy, and hybrid therapy as a first-line regimen for Helicobacter pylori infection compared with standard triple therapy. Niger J Clin Pract 2022; 25:1535-1541. [DOI: 10.4103/njcp.njcp_89_22] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022]
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Hsu PI, Tsay FW, Kao JY, Peng NJ, Chen YH, Tang SY, Kuo CH, Kao SS, Wang HM, Wu IT, Shie CB, Chuah SK, Wu DC. Tetracycline-levofloxacin versus amoxicillin-levofloxacin quadruple therapies in the second-line treatment of Helicobacter pylori infection. Helicobacter 2021; 26:e12840. [PMID: 34390083 DOI: 10.1111/hel.12840] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/30/2021] [Revised: 06/05/2021] [Accepted: 06/27/2021] [Indexed: 12/28/2022]
Abstract
BACKGROUND The Maastricht V/Florence Consensus Report recommends amoxicillin-fluoroquinolone triple or quadruple therapy as a second-line treatment for Helicobacter pylori infection. An important caveat of amoxicillin-fluoroquinolone rescue therapy is poor eradication efficacy in the presence of fluoroquinolone resistance. The study aimed to investigate the efficacies of tetracycline-levofloxacin (TL) quadruple therapy and amoxicillin-levofloxacin (AL) quadruple therapy in the second-line treatment of H. pylori infection. METHODS Consecutive H. pylori-infected subjects after the failure of first-line therapies were randomly allocated to receive either TL quadruple therapy (tetracycline 500 mg QID, levofloxacin 500 mg QD, esomeprazole 40 mg BID, and tripotassium dicitrato bismuthate 300 mg QID) or AL quadruple therapy (amoxicillin 500 mg QID, levofloxacin 500 mg QD, esomeprazole 40 mg BID, and tripotassium dicitrato bismuthate 300 mg QID) for 10 days. Post-treatment H. pylori status was assessed 6 weeks after the end of therapy. RESULTS The study was early terminated after an interim analysis. In the TL quadruple group, 50 out of 56 patients (89.3%) had successful eradication of H. pylori infection. Cure of H. pylori infection was achieved only in 39 of 52 patients (69.6%) receiving AL quadruple therapy. Intention-to-treat analysis showed that TL quadruple therapy achieved a markedly higher eradication rate than AL quadruple therapy (95% confidence interval: 4.8% to 34.6%; p = 0.010). Further analysis revealed that TL quadruple therapy had a high eradication rate for both levofloxacin-susceptible and resistant strains (100% and 88.9%). In contrast, AL quadruple therapy yielded a high eradication for levofloxacin-susceptible strains (90.9%) but a poor eradication efficacy for levofloxacin-resistant strains (50.0%). The two therapies exhibited comparable frequencies of adverse events (37.5% vs 21.4%) and drug adherence (98.2% vs 94.6%). CONCLUSIONS Ten-day TL quadruple therapy is more effective than AL quadruple therapy in the second-line treatment of H. pylori infection in a population with high levofloxacin resistance.
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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
- Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - John Y Kao
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Arbor, Michigan, USA
| | - Nan-Jing Peng
- Department of Nuclear Medicine, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan
| | - Yan-Hua Chen
- Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - Sheng-Yeh Tang
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan
| | - Chao-Hung Kuo
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.,Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Municipal Siaogang Hospital, Kaohsiung, Taiwan
| | - Sung-Shuo Kao
- Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - Huay-Min Wang
- Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
| | - I-Ting Wu
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan
| | - Chang-Bih Shie
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan
| | - Seng-Kee Chuah
- Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan
| | - Deng-Chyang Wu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
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Zhang J, Han C, Lu WQ, Wang N, Wu SR, Wang YX, Ma JP, Wang JH, Hao C, Yuan DH, Liu N, Shi YQ. A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment. J Dig Dis 2020; 21:256-263. [PMID: 32348007 PMCID: PMC7383804 DOI: 10.1111/1751-2980.12870] [Citation(s) in RCA: 17] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/06/2020] [Revised: 04/23/2020] [Accepted: 04/24/2020] [Indexed: 02/06/2023]
Abstract
OBJECTIVE Helicobacter pylori (H. pylori) infection is closely associated with gastric ulcers and gastric adenocarcinomas. We aimed to assess the efficacy and safety of a quadruple regimen with amoxicillin plus berberine vs tetracycline plus furazolidone in rescue therapy for H. pylori eradication. METHODS We conducted a randomized, open-label, multicenter, noninferiority trial. Patients with previous treatment failures recruited from five centers were randomized (1:1) to receive a regimen with esomeprazole and bismuth plus either berberine and amoxicillin (the BA group) or tetracycline and furazolidone (the TF group) for 14 days. Their H. pylori infection status was confirmed 4-8 weeks after treatment. The primary outcome was the eradication rate. The secondary outcomes included the rates of symptom improvement, compliance, and adverse events. This study was registered at ClinicalTrials.gov (NCT03609892). RESULTS Altogether 658 participants were consecutively enrolled. An intention-to-treat analysis demonstrated that the two regimens achieved a similar eradication rate (76.3% vs 77.5%; P = 0.781). The per-protocol analysis reached a similar result (81.5% vs 85.0%; P = 0.278). The eradication rate reached in the BA group was greater than the pre-established margin of noninferiority, at -10% (the lower bounds of the 95% CI were -7.66% and -9.43%, respectively). The rate of adverse events was lower for the BA group than the TF group (18.5% vs 26.1%, P = 0.024). Rates of compliance and symptom improvement were similar for the two therapies. CONCLUSION The efficacy of both regimens in rescue treatment for H. pylori eradication was satisfactory, 14-day BA-based quadruple therapy is noninferior to the TF-based therapy.
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Affiliation(s)
- Jian Zhang
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive DiseasesAir Force Military Medical UniversityXi'anShaanxi ProvinceChina
| | - Chuan Han
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive DiseasesAir Force Military Medical UniversityXi'anShaanxi ProvinceChina,Department of EndocrinologyGeneral Hospital of the Western Theater CommandChengduSichuan ProvinceChina
| | - Wen Quan Lu
- Department of GastroenterologyFirst Affiliated Hospital of Zhengzhou UniversityZhengzhouHenan ProvinceChina
| | - Na Wang
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive DiseasesAir Force Military Medical UniversityXi'anShaanxi ProvinceChina
| | - Si Ran Wu
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive DiseasesAir Force Military Medical UniversityXi'anShaanxi ProvinceChina
| | - Yong Xi Wang
- Department of GastroenterologyXianyang Central HospitalXianyangShaanxi ProvinceChina
| | - Jin Ping Ma
- Department of GastroenterologyXianyang Central HospitalXianyangShaanxi ProvinceChina
| | - Jie Hong Wang
- Department of GastroenterologyAffiliated Hospital of Shaanxi University of Chinese MedicineXianyangShaanxi ProvinceChina
| | - Cheng Hao
- Department of GastroenterologyAffiliated Hospital of Shaanxi University of Chinese MedicineXianyangShaanxi ProvinceChina
| | - Dong Hong Yuan
- Department of GastroenterologyYan'an University Affiliated HospitalYan'anShaanxi ProvinceChina
| | - Na Liu
- Department of GastroenterologySecond Affiliated Hospital of Xi'an Jiaotong UniversityXi'anShaanxi ProvinceChina
| | - Yong Quan Shi
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive DiseasesAir Force Military Medical UniversityXi'anShaanxi ProvinceChina
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Razavizadeh M, Arj A, Madani M, Gilassi H. Comparing the Efficacy of Sequential and Standard Quadruple Therapy for Eradication of H. Pylori Infection. ACTA MEDICA (HRADEC KRALOVE) 2020; 63:183-187. [PMID: 33355079 DOI: 10.14712/18059694.2020.61] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/12/2023]
Abstract
BACKGROUND The aim of this study was comparison the effectiveness of sequential and standard quadruple therapy on eradication of H. pylori infection. METHODS This clinical trial study was conducted on 160 patients with dyspepsia or gastroduodenal ulcer. Patients were randomly divided into two groups. Group A (standard regimen) received omeprazole, amoxicillin, clarithromycin and bismuth subcitrate for 2 weeks. Group B (sequential regimen) received omeprazole and amoxicillin in 5 days and omeprazole, tinidazole and levofloxacin in 5 days. After the end of treatment regimens, 20 mg omeprazole was administered twice daily for 3 weeks. H. pylori eradication was assessed 2 months after antibiotic treatment via fecal antigen. RESULTS Frequency of H. pylori eradication in group A and B was observed in 55 (68.8%) and 63 patients (78.8%), respectively. No significant difference was seen between two groups, regarding H. pylori eradication (p = 0.15). The most common side effects in group A, B were bitterness of mouth (63.8%) and nausea (16.2%), respectively (p H. pylori infection, higher rate of H. pylori eradication was seen in group B than group A. Thus, sequential regimen was a more appropriate regimen with fewer complications.
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Affiliation(s)
- Mohsen Razavizadeh
- Department of Internal Medicine, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran
| | - Abbas Arj
- Department of Internal Medicine, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran.
| | - Maryam Madani
- Department of Internal Medicine, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran
| | - Hamidreza Gilassi
- Department of Internal Medicine, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran
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Tai WC, Liang CM, Bi KW, Kuo CM, Lu LS, Wu CK, Yang SC, Kuo YH, Lee CH, Huang CF, Hsu CN, Hsu PI, Wu DC, Hu TH, Wu KL, Chuah SK. A comparison between dexlansoprazole modified release-based and lansoprazole-based nonbismuth quadruple (concomitant) therapy for first-line Helicobacter pylori eradication: a prospective randomized trial. Infect Drug Resist 2019; 12:2923-2931. [PMID: 31571945 PMCID: PMC6754331 DOI: 10.2147/idr.s213998] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/08/2019] [Accepted: 09/03/2019] [Indexed: 01/10/2023] Open
Abstract
Purpose Steadily maintaining high intra-gastric PH is the major factor for successful Helicobacter pylori (H.pylori) eradication. It is important to search for a stronger PPI. Dexlansoprazole MR is a dual delayed release formulation PPI taken once daily which is capable of maintaining longer duration of high intra-gastric PH. It is very effective in treating gastroesophageal disease but reports on H, pylori eradication is very rare. This study sought to compare dexlansoprazole MR-based concomitant treatment and lansoprazole-based concomitant treatment in H. pylori infection and to investigate the factors that affect the eradication rates. Methods Two hundred two participants with H. pylori infection were included and randomly assigned to seven days of dexlansoprazole MR-based concomitant therapy (dexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily; DACM group) or a seven days of lansoprazole-based concomitant therapy (lansoprazole 30 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily, and metronidazole 500 mg twice daily; LACM group). The participants were asked to perform urea breath tests eight weeks later. Results The eradication rates in the DACM group were 86.1% [95% confidence interval (CI): 77.8%–92.2%] in the ITT analysis and 90.6% (95% CI: 82.9%–95.6%) in the PP analysis, respectively, as compared with 90.1% (95% CI: 82.6%–95.2%) and 92.6% (95% CI: 85.5%–96.9%) (p=0.384 and p=0.572, respectively) in the LACM group for the same analyses. The adverse event rates were 11.5% in the DACM group and 10.2% in the LACM group (p=0.779). Conclusion As a first-line H. pylori treatment regimen, dexlansoprazole MR-based concomitant therapy attained a successful eradication rate of 90%, which was non inferior to that of lansoprazole-based concomitant treatment. ClinicalTrials.gov identifier NCT03829150. ![]()
Point your SmartPhone at the code above. If you have a QR code reader the video abstract will appear. Or use: https://youtu.be/AJ1z88nc4uI
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Affiliation(s)
- Wei-Chen Tai
- Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Chih-Ming Liang
- Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Kuo-Wei Bi
- Division of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Chung-Mou Kuo
- Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Lung-Sheng Lu
- Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Cheng-Kun Wu
- Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Shih-Cheng Yang
- Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Yuan-Hung Kuo
- Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Chen-Hsiang Lee
- Division of Infectious Diseases, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Chih-Fang Huang
- Division of Family Physician, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Chien-Ning Hsu
- Department of Pharmacy, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
| | - Pin-I Hsu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, National Yang-Ming University, Kaohsiung, Taiwan
| | - Deng-Chyang Wu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Tsung-Hui Hu
- Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.,Chang Gung University College of Medicine, Taoyuan City, Taiwan
| | - Keng-Liang Wu
- Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.,Chang Gung University College of Medicine, Taoyuan City, Taiwan
| | - Seng-Kee Chuah
- Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.,Chang Gung University College of Medicine, Taoyuan City, Taiwan
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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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Ten-Day Quadruple Therapy Comprising Proton Pump Inhibitor, Bismuth, Tetracycline, and Levofloxacin is More Effective than Standard Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori Infection: A Randomized Controlled Trial. Am J Gastroenterol 2017; 112:1374-1381. [PMID: 28719592 DOI: 10.1038/ajg.2017.195] [Citation(s) in RCA: 31] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/19/2017] [Accepted: 04/25/2017] [Indexed: 02/07/2023]
Abstract
OBJECTIVES Proton pump inhibitor (PPI)-amoxicillin-fluoroquinolone triple therapy is recommended as a second-line treatment of Helicobacter pylori infection in the Maastricht V/Florence Consensus Report. However, the eradication rate of this standard salvage treatment is suboptimal. The objective of this study is to compare the efficacy of esomeprazole-bismuth-tetracycline-levofloxacin therapy (TL quadruple therapy) and esomeprazole-amoxicillin-levofloxacin triple therapy (AL triple therapy) in rescue treatment for H. pylori infection. METHODS Consecutive H. pylori-infected subjects after failure of first-line therapies were randomly allocated to receive either TL quadruple therapy (esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) or AL triple therapy (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) for 10 days. H. pylori status was assessed 6 weeks after the end of treatment. RESULTS The study was stopped after an interim analysis. Of 50 patients in the TL quadruple therapy, 49 (98.0%) had successful eradication of H. pylori infection. Cure of H. pylori infection was achieved in 36 of 52 patients (69.2%) receiving AL triple therapy. Intention-to-treat analysis demonstrated that TL quadruple therapy achieved a markedly higher eradication rate than AL triple therapy (difference: 28.8%; 95% confidence interval: 15.7% to 41.9%; P<0.001). Per-protocol analysis yielded a similar result (97.8% vs. 68.6%; P<0.001). The two treatment groups exhibited comparable frequencies of overall adverse events (22.0% vs. 11.5%) and drug compliance (90.0% vs. 98.1%). The subgroup analysis showed that TL quadruple therapy was superior to AL triple therapy in patients with failure of either standard triple therapy (100% vs. 75.0%; P=0.010) or non-bismuth quadruple therapy (95.0% vs. 52.6%; P=0.003). CONCLUSIONS Ten-day PPI-bismuth-tetracycline-levofloxacin quadruple therapy is a good option for rescue treatment of H. pylori infection following failure of standard triple or non-bismuth quadruple therapy.
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Sung J, Kim N, Park YH, Hwang YJ, Kwon S, Na G, Choi JY, Kang JB, Kim HR, Kim JW, Lee DH. Rifabutin-based Fourth and Fifth-line Rescue Therapy in Patients with forHelicobacter pyloriEradication Failure. THE KOREAN JOURNAL OF GASTROENTEROLOGY 2017; 69:109-118. [DOI: 10.4166/kjg.2017.69.2.109] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Affiliation(s)
- Jihee Sung
- 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
| | - Yo Han Park
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Young Jae Hwang
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Soohoon Kwon
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Gyeongjae Na
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Joon Young Choi
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Jae Bin Kang
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Hye Rang Kim
- Hospital Health Promotion Center, Seoul St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, Korea
| | - Jin-Wook Kim
- 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
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Lee JY. Triple Therapy. HELICOBACTER PYLORI 2016:427-436. [DOI: 10.1007/978-981-287-706-2_41] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/05/2025]
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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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Harb AH, Chalhoub JM, Abou Mrad R, Sharara AI. Systematic review and meta-analysis: full- vs. half-dose anti-microbials in clarithromycin-based regimens for Helicobacter pylori eradication. Aliment Pharmacol Ther 2015; 42:131-41. [PMID: 26011564 DOI: 10.1111/apt.13259] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/06/2015] [Revised: 03/19/2015] [Accepted: 05/06/2015] [Indexed: 01/30/2023]
Abstract
BACKGROUND Half-dose regimens may be equally effective but associated with diminished adverse events (AE) than standard-dose regimens. AIM To assess efficacy and safety of full- vs. half-dose clarithromycin in the treatment of H. pylori. METHODS Medline, EMBASE and PubMed databases were searched for randomised controlled trials (RCTs) that meet eligibility criteria. Only parallel group RCTs with ≥ 2 arms were eligible. Studies comparing triple, quadruple or sequential therapy for 7-14 days were selected. Regimens had to contain the same drug combination, differing only in dosage; the comparison of full- vs. half-dose clarithromycin was required, regardless if other drugs were dose-reduced or not. Data extraction was performed for primary outcome [eradication by intent-to-treat (ITT) and per-protocol (PP) analyses] and secondary outcome (AE). RESULTS A total of 1622 articles were identified, of which 19 studies were eligible. Overall, eradication was achieved in 82.5% of half-dose (n = 2115) vs. 83.4% of full-dose recipients (n = 2109) on ITT (87.1% vs. 88.4% on PP respectively). Pooled relative risk in the half- vs. full-dose regimen was 0.98 (95% CI: 0.95-1.02) on ITT and 0.99 (95% CI: 0.97-1.01) on PP by the random effects model. Heterogeneity was significant (chi-squared statistic P = 0.05, I(2) = 37%). AE were reported in 29.3% of half- vs. 44.0% of full-dose recipients [pooled RR 0.67 (95% CI: 0.60-0.75)]. Pre-planned subgroup analyses of dose modification, sample size, study origin and treatment duration, as well as sensitivity analysis showed no significant differences between arms. CONCLUSION A half-dose clarithromycin-based regimen is equally effective yet better tolerated than its full-dose counterpart in the treatment of H. pylori.
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Affiliation(s)
- A H Harb
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
| | - J M Chalhoub
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
| | - R Abou Mrad
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
| | - A I Sharara
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
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Tsay FW, Wu DC, Kao SS, Tsai TJ, Lai KH, Cheng JS, Chan HH, Wang HM, Tsai WL, Tseng HH, Peng NJ, Hsu PI. Reverse sequential therapy achieves a similar eradication rate as standard sequential therapy for Helicobacter pylori eradication: a randomized controlled trial. Helicobacter 2015; 20:71-7. [PMID: 25495272 DOI: 10.1111/hel.12176] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
BACKGROUND AND AIMS Sequential therapy is a two-step therapy achieving a promising eradication rate for Helicobacter pylori infection. The rationale of sequential method has been proposed that amoxicillin weakens bacterial cell walls in the initial phase of treatment, preventing the development of drug efflux channels for clarithromycin and metronidazole used in the second phase. The aim of this prospective, randomized, controlled study was to investigate whether the efficacy of reverse sequential therapy was noninferior to sequential therapy in the treatment of H. pylori infection. METHODS From January 2009 to December 2010, consecutive H. pylori-infected patients were randomly assigned to receive either sequential therapy (a 5-day dual therapy with pantoprazole plus amoxicillin, followed by a 5-day triple therapy with pantoprazole plus clarithromycin and metronidazole) or reverse sequential therapy (a 5-day triple therapy with pantoprazole plus clarithromycin and metronidazole, followed by a 5-day dual therapy with pantoprazole plus amoxicillin). H. pylori status was examined 6 weeks after the end of treatment by rapid urease and histology or urea breath test. RESULTS One hundred and twenty-two H. pylori-infected participants were randomized to receive sequential (n = 60) or reverse sequential therapy (n = 62). The eradication rates, by intention-to-treat analysis, were similar: 91.9% (95% confidence interval (CI): 85.1-98.7%) for sequential therapy and 96.7% (95% CI: 92.2-101.2%) for reverse sequential therapy (p = .44). Per-protocol analysis also showed similar results: 91.8% (95% CI: 84.9-98.7%) for sequential group and 96.7% (95% CI: 92.2-101.2%) for reverse sequential therapy (p = .43). The two treatments exhibited comparable frequencies of adverse events (11.3% vs 6.7%, respectively) and drug compliance (98.4% vs 100%, respectively). The overall resistance rates of antibiotics were clarithromycin 10.5%, amoxicillin 0%, and metronidazole 44.2% of patients, respectively. The dual resistance rate of clarithromycin and metronidazole was 4.2%. Both therapies achieved a high eradication rate for clarithromycin-resistant strains (100% vs 100%, respectively) and metronidazole-resistant strains (81.8% vs 95%, respectively) by intention-to-treat analysis. CONCLUSIONS Ten-day reverse sequential therapy and standard sequential therapy are equally effective for H. Pylori eradication. The finding indicates that the sequence of antibiotics administered in sequential therapy does not influence the efficacy of the treatment.
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Affiliation(s)
- Feng-Woei Tsay
- Division of Gastroenterology, Department of internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan; Cheng Shiu University, Kaohsiung, Taiwan
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Lim HC, Lee YJ, An B, Lee SW, Lee YC, Moon BS. Rifabutin-based high-dose proton-pump inhibitor and amoxicillin triple regimen as the rescue treatment for Helicobacter pylori. Helicobacter 2014; 19:455-61. [PMID: 25231089 PMCID: PMC4284035 DOI: 10.1111/hel.12147] [Citation(s) in RCA: 36] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Rifabutin has been known to be effective in multidrug-resistant Helicobacter pylori-harboring patients undergoing treatment failure for H. pylori infection. AIM To evaluate the efficacy of 7-day treatment regimen consisting rifabutin daily but increasing the dose of amoxicillin and lansoprazole in patients who have failed first and second eradication and to assess the side effect profiles in South Korea. METHODS From December 2007 to May 2013, 59 H. pylori-infected patients with two previous eradication failures were enrolled for this study prospectively. The eligible patients were randomly assigned to either group A or B. Group A received lansoprazole 30 mg bid, amoxicillin 1.0 g tid and rifabutin 150 mg bid during 7 days, whereas group B received lansoprazole 60 mg bid, amoxicillin 1.0 g tid and rifabutin 150 mg bid during 7 days. RESULTS In group A, H. pylori eradication was achieved in 25 (78.1%) of the 32 patients in the ITT analysis and in 25 (80.6%) of the 31 patients in the PP analysis. In group B, H. pylori eradication was achieved in 26 (96.3%) of the 27 patients in the ITT analysis and in 27 (100%) of the 26 patients in the PP analysis. There was statistically significant difference between the two groups in terms of the eradication rates in PP analysis (p = .047), whereas a marginally statistical significance was found in terms of the eradication rates in ITT analysis (p = .051). Reported side effects were mild, and treatment was well tolerated. No major changes in physical examination or in standard laboratory parameters were observed after treatment. CONCLUSIONS Rifabutin-based high-dose proton-pump inhibitor (PPI)-combined therapy as empirical rescue treatment is more effective than standard dose PPI-combined rifabutin-based therapy, safe and best tolerable in third-line therapy in the Korean population. The key to successful rescue therapy with rifabutin-amoxicillin-PPI regimen may be to increase doses of PPI.
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Affiliation(s)
- Hyun Chul Lim
- Department of Internal Medicine, Division of Gastroenterology, Yonsei University College of MedicineSeoul, South Korea
| | - Yong Jae Lee
- Department of Family Medicine, Yonsei University College of MedicineSeoul, South Korea
| | - Byoungrak An
- Department of Laboratory Medicine, Yonsei University College of MedicineSeoul, South Korea
| | - Seung Woo Lee
- Department of Internal Medicine, Division of Gastroenterology, Yonsei University College of MedicineSeoul, South Korea
| | - Yong Chan Lee
- Department of Internal Medicine, Division of Gastroenterology, Yonsei University College of MedicineSeoul, South Korea
| | - Byung Soo Moon
- Department of Internal Medicine, Division of Gastroenterology, Yonsei University College of MedicineSeoul, South Korea
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Abstract
The discovery of Helicobacter pylori three decades ago is a modern medical success story. It markedly changed our understanding of the pathophysiology of gastroduodenal diseases and led to an improvement in the treatment of diseases related to H. pylori infection. Many of these diseases (such as ulcer disease and mucosal associated lymphoid tissue lymphoma) have become curable, and others (gastric cancer) might be preventable with the application of H. pylori eradication therapy. Since its discovery, H. pylori has also been identified as a trigger for some extragastric diseases. Promising results in this exciting field might have a clinical effect in the near future. This Timeline gives an overview of the success of clinical research on H. pylori to date and highlights some future trends in this area.
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Lee JY, Kim N. [Future trends of Helicobacter pylori eradication therapy in Korea]. THE KOREAN JOURNAL OF GASTROENTEROLOGY 2014; 63:158-70. [PMID: 24651589 DOI: 10.4166/kjg.2014.63.3.158] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/06/2023]
Abstract
The prevalence of Helicobacter pylori infection in Korea shows a decreasing trend and has changed to that of developed country, especially for those below 30 years old. However, the primary antibiotic resistance rates are higher than those of developed countries. The reason for the decrease in the efficacy of standard triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the standard triple therapy, but the intention-to-treat eradication rate of sequential therapy in Korea, which is mostly under 80.0%, is still not satisfactory. Therefore, a promising regimen is needed. Recently, the Japanese health insurance system admitted 'H. pylori-infected gastritis'as an indication of eradication. Furthermore, the Kyoto Consensus Meeting on H. pylori Gastritis held from January 30th to February 1st, 2014, proposed that 'all H. pylori positive patients should be offered to receive H. pylori eradication'. This suggests that the concept of eradication has been changed from 'treatment' to 'prevention'. Various individualized tailored therapy based on the polymorphism, age and other demographic factors and antibiotic resistance has been attempted to maximize H. pylori eradication therapy. The aim of this article is to review the current epidemiology, H. pylori resistance state, treatment guideline, and to assess the possible future strategy and treatment for H. pylori infection in Korea.
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Affiliation(s)
- Ju Yup Lee
- Department of Internal Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173beon-gil, Bundang-gu, Seongnam 463-707, Korea
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Randomized controlled trial comparing 7-day triple, 10-day sequential, and 7-day concomitant therapies for Helicobacter pylori infection. Antimicrob Agents Chemother 2014; 58:5936-42. [PMID: 25070099 DOI: 10.1128/aac.02922-14] [Citation(s) in RCA: 55] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
With the rising prevalence of antimicrobial resistance, the failure rate of the standard triple therapy for Helicobacter pylori infection is increasing. Sequential therapy and concomitant therapy have been recommended to replace standard triple therapy for H. pylori eradication in regions with high clarithromycin resistance. The aim of this prospective, randomized, and controlled study was to simultaneously assess the efficacies of 10-day sequential and 7-day concomitant therapies versus a 7-day standard triple therapy for treating H. pylori infection. Consecutive H. pylori-infected subjects were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin, and metronidazole for a further 5 days), or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin, and metronidazole for 7 days). H. pylori status was confirmed 6 weeks after therapy. Three hundred seven H. pylori-infected participants were randomized to receive triple (n = 103), sequential (n = 102), or concomitant (n = 102) therapies. The eradication rates by an intention-to-treat analysis in the three treatment groups were 81.6% (95% confidence interval [CI], 74.1% to 89.0%), 89.2% (95% CI, 83.2% to 95.2%), and 94.1% (95% CI, 89.5% to 98.7%). The seven-day concomitant therapy had a higher eradication rate than did the 7-day triple therapy (difference, 12.5%; 95% CI, 3.7% to 21.3%). There were no significant differences in the eradication rates between the sequential and standard triple therapies. All three treatments exhibited similar frequencies of adverse events (8.7%, 8.8%, and 13.7%, respectively) and drug compliance (99.0%, 98.0%, and 100.0%, respectively). In conclusion, the seven-day concomitant therapy is superior to the 7-day standard triple therapy for H. pylori eradication. Additionally, it is less complex than the 10-day sequential therapy because the drugs are not changed halfway through the treatment course. (This study has been registered at ClinicalTrials.gov under registration no. NCT1769365.).
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Hsu PI, Chen WC, Tsay FW, Shih CA, Kao SS, Wang HM, Yu HC, Lai KH, Tseng HH, Peng NJ, Chen A, Kuo CH, Wu DC. Ten-day Quadruple therapy comprising proton-pump inhibitor, bismuth, tetracycline, and levofloxacin achieves a high eradication rate for Helicobacter pylori infection after failure of sequential therapy. Helicobacter 2014; 19:74-9. [PMID: 24033865 DOI: 10.1111/hel.12085] [Citation(s) in RCA: 37] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Sequential therapy has been recommended in the Maastricht IV/Florence Consensus Report as the first-line treatment for Helicobacter pylori eradication in regions with high clarithromycin resistance. However, it fails in 5-24% of infected subjects, and the recommended levofloxacin-containing triple rescue therapy only achieves a 77% eradication rate after failure of sequential therapy. AIM To investigate the efficacy of a novel quadruple therapy comprising proton-pump inhibitor, bismuth, tetracycline, and levofloxacin for rescue treatment of sequential therapy. METHODS This was a multicenter study in which H. pylori-infected patients who had failed sequential therapy received a 10-day quadruple therapy (esomeprazole (40 mg b.d), tripotassium dicitrato bismuthate (120 mg q.d.s.), tetracycline (500 mg q.d.s.), and levofloxacin (500 mg o.d.) for 10 days). H. pylori status was examined 6 weeks after the end of treatment. RESULTS From July 2007 to June 2012, twenty-four subjects received 10-day quadruple therapy. The eradication rates according to intention-to-treat and per-protocol analyses were both 95.8% (23 of 24; 95% confidence interval, 87.8-103.8%). Adverse events were seen in 25.0% (6 of 24) of the patients. Drug compliance was 100.0% (24/24). CONCLUSIONS The 10-day quadruple therapy comprising proton-pump inhibitor, bismuth, tetracycline, and levofloxacin achieves a very high eradication rate for H. pylori infection after failure of sequential therapy. It is well tolerated and has great potential to become a good choice of rescue treatment following non-bismuth-containing quadruple therapy in regions with high clarithromycin resistance.
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Affiliation(s)
- Ping-I Hsu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
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Federico A, Gravina AG, Miranda A, Loguercio C, Romano M. Eradication of Helicobacter pylori infection: Which regimen first? World J Gastroenterol 2014; 20:665-672. [PMID: 24574740 PMCID: PMC3921476 DOI: 10.3748/wjg.v20.i3.665] [Citation(s) in RCA: 31] [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: 09/17/2013] [Revised: 11/07/2013] [Accepted: 12/04/2013] [Indexed: 02/06/2023] Open
Abstract
Helicobacter pylori (H. pylori) is a well-known human pathogen that plays an essential role in the pathogenesis of chronic gastritis, peptic ulcer disease, and gastric malignancies. Although H. pylori is susceptible to several antimicrobials, this infection has proven challenging to cure because of the increasing prevalence of bacterial strains that are resistant to the most commonly used antimicrobials, particularly clarithromycin. An effective (i.e., > 90%) first-line therapy is mandatory for avoiding supplementary treatments and testing, and more importantly for preventing the development of secondary resistance. This study reviews the recent literature on first-line therapies for H. pylori. The eradication rates following standard triple therapy (a proton pump inhibitor plus amoxicillin and clarithromycin) for H. pylori infection are declining worldwide. Several first-line strategies have been proposed to increase the eradication rate, including extending the treatment duration to 14 d, the use of a four-drug regimen (bismuth-containing quadruple, sequential, and concomitant treatments), and the use of novel antibiotics, such as fluoroquinolones. However, the efficacy of these regimens is controversial. A first-line eradication regimen should be based on what works best in a defined geographical area and must take into account the prevalence of antimicrobial resistance in that region.
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Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a prospective randomized study. Eur J Clin Pharmacol 2013; 69:1709-15. [PMID: 23695545 DOI: 10.1007/s00228-013-1524-6] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/31/2012] [Accepted: 04/29/2013] [Indexed: 12/15/2022]
Abstract
PURPOSE Eradication rates following standard triple therapy for Helicobacter pylori infection are declining. Recent studies, conducted in a number of countries, have shown that sequential therapy for H. pylori infection yields high cure rates. AIM To compare the efficacy and tolerability of a sequential regimen as a first-line treatment of H. pylori infection with a standard triple treatment regime in Morocco. METHODS A total of 281 naive H. pylori-infected patients, confirmed by histological examination, were assigned randomly to one of two treatment groups: standard triple therapy [omeprazole (20 mg bid) + amoxicillin (1 g bid) + clarithromycin (500 mg bid) for 7 days] or sequential therapy [omeprazole (20 mg bid) + amoxicillin (1 g bid) for 5 days, followed by omeprazole (20 mg bid) + tinidazole (500 mg bid) + clarithromycin (500 mg bid) for an additional 5 days]. H. pylori eradication was checked 4-6 weeks after treatment initiation by using a ¹³C-urea breath test. Compliance and adverse events were assessed. RESULTS The two groups did not differ significantly in gender, age, previous disease history, endoscopic and histological features and smoking. The intention-to-treat and per-protocol eradication rates were 65.9 and 71 % in the standard triple therapy group, and 82.8 and 89.9 % in the sequential therapy group, respectively. The eradication rate was significantly higher in the sequential therapy group than in the standard triple therapy group (p < 0.001), There was no statistically significant difference in compliance (97.5 vs. 96.3 %) and incidence of side-effects (27.5 vs. 27.9 %) between the two groups. CONCLUSIONS Based on our results, we conclude that for eradication of H. pylori infection, the 10-day sequential therapy is more effective than the standard triple therapy and is equally tolerated. These results confirm those of other studies in other countries.
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Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a prospective randomized study. Eur J Clin Pharmacol 2013. [PMID: 23695545 DOI: 10.1007/s00228] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
PURPOSE Eradication rates following standard triple therapy for Helicobacter pylori infection are declining. Recent studies, conducted in a number of countries, have shown that sequential therapy for H. pylori infection yields high cure rates. AIM To compare the efficacy and tolerability of a sequential regimen as a first-line treatment of H. pylori infection with a standard triple treatment regime in Morocco. METHODS A total of 281 naive H. pylori-infected patients, confirmed by histological examination, were assigned randomly to one of two treatment groups: standard triple therapy [omeprazole (20 mg bid) + amoxicillin (1 g bid) + clarithromycin (500 mg bid) for 7 days] or sequential therapy [omeprazole (20 mg bid) + amoxicillin (1 g bid) for 5 days, followed by omeprazole (20 mg bid) + tinidazole (500 mg bid) + clarithromycin (500 mg bid) for an additional 5 days]. H. pylori eradication was checked 4-6 weeks after treatment initiation by using a ¹³C-urea breath test. Compliance and adverse events were assessed. RESULTS The two groups did not differ significantly in gender, age, previous disease history, endoscopic and histological features and smoking. The intention-to-treat and per-protocol eradication rates were 65.9 and 71 % in the standard triple therapy group, and 82.8 and 89.9 % in the sequential therapy group, respectively. The eradication rate was significantly higher in the sequential therapy group than in the standard triple therapy group (p < 0.001), There was no statistically significant difference in compliance (97.5 vs. 96.3 %) and incidence of side-effects (27.5 vs. 27.9 %) between the two groups. CONCLUSIONS Based on our results, we conclude that for eradication of H. pylori infection, the 10-day sequential therapy is more effective than the standard triple therapy and is equally tolerated. These results confirm those of other studies in other countries.
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Efficacy and safety of sequential therapy versus standard triple therapy in Helicobacter pylori eradication in Kashmir India: a randomized comparative trial. Indian J Gastroenterol 2013; 32:190-4. [PMID: 23515980 DOI: 10.1007/s12664-013-0304-7] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/25/2012] [Accepted: 02/02/2013] [Indexed: 02/04/2023]
Abstract
BACKGROUND Increasing resistance against Helicobacter pylori has resulted in reduced eradication rates. OBJECTIVE This study aims to determine whether eradication rates for H. pylori infection with sequential therapy is better than standard triple therapy. PATIENTS Patients with endoscopy documented peptic ulcer and H. pylori infection confirmed by histology and rapid urease test. INTERVENTION Patients were randomized into two groups; 134 received standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg and amoxicillin 1 g each administered twice daily) for 10 days and 138 received sequential regimen (pantoprazole 40 mg plus amoxicillin 1 g twice daily for 5 days followed by 40 mg pantoprazole, 500 mg clarithromycin, and 500 mg tinidazole each administered twice daily for 5 days). Eradication was confirmed by histology and rapid urease test. Compliance and adverse effects were determined by the recovery of empty medicine strips and questioning. RESULTS The eradication rates with sequential therapy were significantly greater than with standard therapy on both intention-to-treat analysis (76.0 % vs. 61.9 %, p = 0.005; difference, 14.1 % [95 % CI, 6.5-19 %] and per protocol analysis (84.6 % vs. 67.4 %, p = 0.002; difference, 17.2 % [95 % CI, 8.5-23.5 %]). The incidence of side effects did not differ between the two therapy groups. One patient in standard therapy discontinued treatment due to side effects. LIMITATION Cultures were not performed. Loss to follow up was 5.2 % in standard therapy and 6.5 % in sequential therapy. CONCLUSION Sequential therapy was significantly more effective than standard therapy for eradicating H. pylori infection in peptic ulcer disease in Asian patients. Side effects were similar.
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Urgesi R, Cianci R, Riccioni ME. Update on triple therapy for eradication of Helicobacter pylori: current status of the art. Clin Exp Gastroenterol 2012; 5:151-7. [PMID: 23028235 PMCID: PMC3449761 DOI: 10.2147/ceg.s25416] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/15/2012] [Indexed: 12/19/2022] Open
Abstract
With the rising prevalence of antimicrobial resistance, the treatment success of standard triple therapy has recently declined to unacceptable levels (ie, 80% or less). Following the failure of conventional triple therapy, novel eradication regimens have been developed including sequential therapy, concomitant quadruple therapy, hybrid (dual-concomitant) therapy, bismuth-containing quadruple therapy, and a therapy with administration of N-acetylcysteine before a culture-guided antibiotic regimen. This article reviews the literature published on Helicobacter pylori eradication in the last year, focusing on the development of alternative strategies for first-, second-, and third-line rescue therapy for the eradication of H. pylori.
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Giordano A, Cito L. Advances in gastric cancer prevention. World J Clin Oncol 2012; 3:128-36. [PMID: 23061031 PMCID: PMC3468701 DOI: 10.5306/wjco.v3.i9.128] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/20/2012] [Revised: 08/19/2012] [Accepted: 09/06/2012] [Indexed: 02/06/2023] Open
Abstract
Gastric cancer is a multifactorial neoplastic pathology numbering among its causes both environmental and genetic predisposing factors. It is mainly diffused in South America and South-East Asia, where it shows the highest morbility percentages and it is relatively scarcely diffused in Western countries and North America. Although molecular mechanisms leading to gastric cancer development are only partially known, three main causes are well characterized: Helicobacter pylori (H. pylori) infection, diet rich in salted and/or smoked food and red meat, and epithelial cadherin (E-cadherin) mutations. Unhealthy diet and H. pylori infection are able to induce in stomach cancer cells genotypic and phenotypic transformation, but their effects may be crossed by a diet rich in vegetables and fresh fruits. Various authors have recently focused their attention on the importance of a well balanced diet, suggesting a necessary dietary education starting from childhood. A constant surveillance will be necessary in people carrying E-cadherin mutations, since they are highly prone in developing gastric cancer, also within the inner stomach layers. Above all in the United States, several carriers decided to undergo a gastrectomy, preferring changing their lifestyle than living with the awareness of the development of a possible gastric cancer. This kind of choice is strictly personal, hence a decision cannot be suggested within the clinical management. Here we summarize the key points of gastric cancer prevention analyzing possible strategies referred to the different predisposing factors. We will discuss about the effects of diet, H. pylori infection and E-cadherin mutations and how each of them can be handled.
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Affiliation(s)
- Antonio Giordano
- Antonio Giordano, Letizia Cito, INT-CROM, "Pascale Foundation" National Cancer Institute-Cancer Research Center, 83013 Mercogliano, Italy
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7-Day Nonbismuth-Containing Concomitant Therapy Achieves a High Eradication Rate for Helicobacter pylori in Taiwan. Gastroenterol Res Pract 2012; 2012:463985. [PMID: 22888337 PMCID: PMC3408719 DOI: 10.1155/2012/463985] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/31/2012] [Accepted: 06/14/2012] [Indexed: 02/06/2023] Open
Abstract
Background. Ten-day concomitant therapy achieves a high eradication rate in Taiwan. Whether shortening the duration of concomitant therapy can still keep a high eradication rate remains unclear. Aim. To assess the eradication rate of 7-day pantoprazole-containing concomitant therapy in Taiwan and to investigate factors influencing the eradication outcome. Methods. From March 2008 to March 2012, 319 H. pylori-infected patients receiving a 7-day pantoprazole-containing concomitant regimen (pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 7 days) were included. Patients were asked to return at the second week to assess drug compliance and adverse effects. Repeated endoscopy or urea breath test was performed at 8 weeks after the end of eradication therapy. Results. The eradication rates according to intention-to-treat and per-protocol analyses were 93.7% (299/319) and 96.4% (297/308), respectively. Adverse events occurred in 13.2% (42/319) of the patients. The compliance rate was 98.4% (314/319). Multivariate analysis disclosed that poor compliance was the only independent factor influencing the efficacy of anti-H. pylori therapy with an odds ratio of 0.073 (95% confidence interval, 0.011-0.483). Conclusion. 7-day concomitant therapy achieved a very high eradication rate for H. pylori infection in Taiwan. Drug compliance was the only clinical factor influencing treatment efficacy.
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Kuo CH, Kuo FC, Hu HM, Liu CJ, Wang SSW, Chen YH, Hsieh MC, Hou MF, Wu DC. The Optimal First-Line Therapy of Helicobacter pylori Infection in Year 2012. Gastroenterol Res Pract 2012; 2012:168361. [PMID: 22792095 PMCID: PMC3390052 DOI: 10.1155/2012/168361] [Citation(s) in RCA: 28] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/29/2012] [Accepted: 04/17/2012] [Indexed: 02/08/2023] Open
Abstract
This paper reviews the literature about first-line therapies for H. pylori infection in recent years. First-line therapies are facing a challenge because of increasing treatment failure due to elevated antibiotics resistance. Several new treatment strategies that recently emerged to overcome antibiotic resistance have been surveyed. Alternative first-line therapies include bismuth-containing quadruple therapy, sequential therapy, concomitant therapy, and hybrid therapy. Levofloxacin-based therapy shows impressive efficacy but might be employed as rescue treatment due to rapidly raising resistance. Rifabutin-based therapy is also regarded as a rescue therapy. Several factors including antibiotics resistance, patient compliance, and CYP 2C19 genotypes could influence the outcome. Clinicians should use antibiotics according to local reports. It is recommended that triple therapy should not be used in areas with high clarithromycin resistance or dual clarithromycin and metronidazole resistance.
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Affiliation(s)
- Chao-Hung Kuo
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
- Department of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung City 807, Taiwan
- Cancer Center, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
| | - Fu-Chen Kuo
- Department of Health Management, I-Shou University, E-Da Hospital, Kaohsiung County 824, Taiwan
- Department of Public Health, College of Health Sciences, Kaohsiung Medical University, Kaohsiung City 807, Taiwan
| | - Huang-Ming Hu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
- Cancer Center, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
| | - Chung-Jung Liu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
- Cancer Center, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
| | - Sophie S. W. Wang
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
- Cancer Center, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
| | - Yen-Hsu Chen
- Division of Infectious Diseases, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
| | - Ming-Chia Hsieh
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Changhua Christian Hospital, Changhua 500, Taiwan
| | - Ming-Feng Hou
- Cancer Center, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
| | - Deng-Chyang Wu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
- Department of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung City 807, Taiwan
- Cancer Center, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
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Tsay FW, Tseng HH, Hsu PI, Wang KM, Lee CC, Chang SN, Wang HM, Yu HC, Chen WC, Peng NJ, Lai KH, Wu DC. Sequential therapy achieves a higher eradication rate than standard triple therapy in Taiwan. J Gastroenterol Hepatol 2012; 27:498-503. [PMID: 21871025 DOI: 10.1111/j.1440-1746.2011.06885.x] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/05/2023]
Abstract
BACKGROUND AND AIMS Most clinical trials concerning sequential therapy have been conducted in Italy. The efficacy of sequential therapy for Helicobacter pylori (H. pylori) eradication in Asia remains unclear. The aim of this study was to compare the efficacy of sequential therapy with standard triple therapy in Taiwan. METHODS From January 2005 to December 2009, 233 H. pylori-infected patients receiving either a 10-day sequential therapy (40 mg pantoprazole and 1 g amoxicillin, twice daily, for the initial 5 days, followed by 40 mg pantoprazole, 500 mg clarithromycin, and 500 mg metronidazole, twice daily, for the subsequent 5 days, n = 118) or a 7-day standard triple therapy (40 mg pantoprazole, 500 mg clarithromycin, and 1 g amoxicillin twice daily for 7 days, n = 115) were included in the retrospective study. All the patients underwent a follow-up endoscopy with a rapid urease test and histological examination or a urea breath test at 8 weeks after the end of anti-H. pylori therapy to assess H. pylori status. RESULT Intention-to-treat analysis demonstrated a significantly higher eradication rate for the sequential group than for the triple group (93% vs 80%, respectively, P = 0.003). Per-protocol analysis also showed similar results (93% vs 80%, P = 0.005). Both groups had similar frequencies of adverse events (29% vs 22%) and drug compliance (98% vs 97%). CONCLUSION Sequential therapy achieves a higher eradication rate than standard triple therapy in Taiwan. The novel treatment can be used as a first-line therapy for H. pylori infection for Taiwanese.
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Affiliation(s)
- Feng-Woei Tsay
- Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan
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Ghosh P, Kandhare AD, Gauba D, Raygude KS, Bodhankar SL. Determination of efficacy, adverse drug reactions and cost effectiveness of three triple drug regimens for the treatment of Helicobacter pylori infected acid peptic disease patients. ASIAN PACIFIC JOURNAL OF TROPICAL DISEASE 2012. [DOI: 10.1016/s2222-1808(12)60265-5] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
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Park HG, Jung MK, Jung JT, Kwon JG, Kim EY, Seo HE, Lee JH, Yang CH, Kim ES, Cho KB, Park KS, Lee SH, Kim KO, Jeon SW. Randomised clinical trial: a comparative study of 10-day sequential therapy with 7-day standard triple therapy for Helicobacter pylori infection in naïve patients. Aliment Pharmacol Ther 2012; 35:56-65. [PMID: 22066530 DOI: 10.1111/j.1365-2036.2011.04902.x] [Citation(s) in RCA: 69] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND The eradication rates following standard triple therapy for Helicobacter pylori infection are declining worldwide. Recent studies have shown that sequential therapy for H. pylori infection yields high cure rates. AIM To compare the efficacy and tolerability of a sequential regimen as first-line treatment of H. pylori infection with a standard triple regimen. METHODS A total of 348 naïve H. pylori-infected patients from six hospitals in Korea were assigned randomly to standard triple or sequential therapy groups. Standard triple therapy consisted of 20 mg of rabeprazole, 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. Sequential therapy consisted of a 5-day dual therapy (20 mg of rabeprazole and 1 g of amoxicillin, twice daily) followed by a 5-day triple therapy (20 mg of rabeprazole, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily). RESULTS The intention-to-treat (ITT) and per-protocol (PP) eradication rates were 62.2% (95% CI 54.8-69.6%) and 76.0% (95% CI 68.5-83.5%) in the standard triple group, and 77.8% (95% CI 71.4-84.2%) and 87.9% (95% CI 82.3-93.5%) in the sequential group, respectively. The eradication rate was significantly higher in the sequential group compared with the standard triple group in both the ITT and PP populations (P = 0.002 and P = 0.013 respectively), whereas the incidence of adverse events was similar. CONCLUSIONS Ten-day sequential therapy is more effective and equally tolerated for eradication of H. pylori infection compared with standard triple therapy. Sequential therapy may have a role as first-line treatment for H. pylori infection.
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Affiliation(s)
- H G Park
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea
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Modified Sequential Therapy Regimen versus Conventional Triple Therapy for Helicobacter Pylori Eradication in Duodenal Ulcer Patients in China: A Multicenter Clinical Comparative Study. Gastroenterol Res Pract 2011; 2012:405425. [PMID: 22550478 PMCID: PMC3329148 DOI: 10.1155/2012/405425] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2011] [Revised: 10/25/2011] [Accepted: 10/25/2011] [Indexed: 02/08/2023] Open
Abstract
Objective. Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide. To observe the effect of eradicating Helicobacter pylori (H. pylori) and the treatment of duodenal ulcer by 2 kinds of modified sequential therapy through comparing with that of 10-day standard triple therapy. Methods. A total of 210 patients who were confirmed in duodenal ulcer active or heal period by gastroscopy and H. pylori positive confirmed by rapid urease test, serum anti-H. pylori antibody (ELASE), or histological examination enrolled in the study. All the patients were randomly divided into three groups: group A (70 cases) and group B (70 cases) were provided 10-day modified sequential therapy; group C (70 cases) was provided 10-day standard triple therapy. Patients of group A received 20 mg of Esomeprazole, 500 mg of Clarithromycin for the first 5 days, followed by 20 mg of Esomeprazole, 500 mg of Clarithromycin, and 1000 mg of Amoxicillin for the remaining 5 days. Group B received 20 mg of Esomeprazole, 1000 mg of Amoxicillin for the first 5 days, followed by 20 mg of Esomeprazole, 500 mg of Clarithromycin, and 1000 mg of Amoxicillin for the remaining 5 days. Group C received 20 mg of Esomeprazole, 500 mg of Clarithromycin, and 1000 mg of Amoxicillin for standard 10-day therapy. All drugs were given twice daily. H. pylori eradication rate was checked four to eight weeks after taking the medicine by using a 13C urea breath test. In the first, second, third, seventh, twenty-first, thirty-fifth days respectively, the symptoms of patients such as epigastric gnawing, burning pain, and acidity were evaluated simultaneously. Results. Overall, 210 patients accomplished all therapy schemes, 9 case patients were excluded. The examination result indicated that the H. pylori eradication rate of each group was as follows: group A 92.5% (62/67), group B 86.8% (59/68), and group C 78.8% (52/66). The H. pylori eradication rate of group A was slightly higher than group B (P < 0.05) and both of them were obviously higher than group C (P < 0.05). Modified sequential therapy was significantly more effective in patients with clarithromycin-resistant strains (80%/67% versus 31%; P = 0.02). Symptoms improvement: all the three groups could improve the symptoms such as epigastric gnawing, burning pain, and acidity since the first day. There was no significant difference in total score descending of symptoms between each group (P > 0.05). Conclusions. All the three therapy schemes could alleviate symptoms of duodenal ulcer patients in China efficiently. But as far as eradicating H. pylori is concerned, the modified sequential therapy was better than standard triple therapy, especially the therapy scheme used in group A.
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A randomized trial of standard-dose versus half-dose rabeprazole, clarithromycin, and amoxicillin in the treatment of Helicobacter pylori infection. Eur J Gastroenterol Hepatol 2011; 23:865-70. [PMID: 21811161 DOI: 10.1097/meg.0b013e3283496502] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
OBJECTIVES To evaluate the efficacy and safety of a standard-dose versus half-dose 10-day triple regimen for the eradication of Helicobacter pylori infection. METHODS A total of 115 consecutive patients with documented infection were enrolled in this open-label trial. Group A (standard dose) received rabeprazole (20 mg), amoxicillin (1 g), and clarithromycin (500 mg), all twice daily for 10 days. Group B (half dose) received rabeprazole (10 mg), amoxicillin (500 mg), and clarithromycin (250 mg), all twice daily for 10 days. (14)C urea breath tests were performed a minimum of 4 weeks after treatment and a minimum of 2 weeks off any acid-suppressive therapy. Compliance and adverse effects were evaluated throughout the treatment period. RESULTS A total of 115 patients were enrolled (59 women and 56 men; mean age 47.1±14.0 years). Eradication occurred in 45 of 58 patients [77.6%; 95% confidence interval (CI): 66.9-88.3%] in the standard-dose group versus 44 of 57 in the half-dose group (77.2%; 95% CI: 66.3-88.1%) on an intent-to-treat (ITT) analysis (P=1.00). Per protocol eradication rates were 45 of 57 (78.9%; 95% CI: 68.4-85.9%) and 44 of 54 (81.5%; 95% CI: 71.1-91.8%), respectively (P=0.81). The number of patients reporting any adverse effect was significantly higher in the standard-dose group (64.9 vs. 40.4%; P=0.014). The cost of treatment was significantly less in patients receiving the half-dose regimen (ITT analysis; P<0.05). The number needed to harm to suffer one additional failure in the half-dose over the standard-dose arm was 250 (ITT analysis). CONCLUSION A half-dose 10-day regimen of rabeprazole, amoxicillin, and clarithromycin is equally effective but cheaper and better tolerated than its standard-dose regimen in the treatment of Helicobacter pylori. Eradication rates of both regimens are, however, suboptimal compared with accepted standards.
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Chuah SK, Tsay FW, Hsu PI, Wu DC. A new look at anti-Helicobacter pylori therapy. World J Gastroenterol 2011; 17:3971-5. [PMID: 22046084 PMCID: PMC3199554 DOI: 10.3748/wjg.v17.i35.3971] [Citation(s) in RCA: 111] [Impact Index Per Article: 7.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/25/2011] [Revised: 08/11/2011] [Accepted: 08/15/2011] [Indexed: 02/06/2023] Open
Abstract
With the rising prevalence of antimicrobial resistance, the treatment success of standard triple therapy has recently declined to unacceptable levels (i.e., 80% or less) in most countries. Therefore, several treatment regimens have emerged to cure Helicobacter pylori (H. pylori) infection. Novel first-line anti-H. pylori therapies in 2011 include sequential therapy, concomitant quadruple therapy, hybrid (dual-concomitant) therapy and bismuth-containing quadruple therapy. After the failure of standard triple therapy, a bismuth-containing quadruple therapy comprising a proton pump inhibitor (PPI), bismuth, tetracycline and metronidazole can be employed as rescue treatment. Recently, triple therapy combining a PPI, levofloxacin and amoxicillin has been proposed as an alternative to the standard rescue therapy. This salvage regimen can achieve a higher eradication rate than bismuth-containing quadruple therapy in some regions and has less adverse effects. The best second-line therapy for patients who fail to eradicate H. pylori with first-line therapies containing clarithromycin, amoxicillin and metronidazole is unclear. However, a levofloxacin-based triple therapy is an accepted rescue treatment. Most guidelines suggest that patients requiring third-line therapy should be referred to a medical center and treated according to the antibiotic susceptibility test. Nonetheless, an empirical therapy (such as levofloxacin-based or furazolidone-based therapies) can be employed to terminate H. pylori infection if antimicrobial sensitivity data are unavailable.
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Graham DY. Helicobacter pylori eradication therapy research: Ethical issues and description of results. Clin Gastroenterol Hepatol 2010; 8:1032-6. [PMID: 20656062 DOI: 10.1016/j.cgh.2010.07.002] [Citation(s) in RCA: 42] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2010] [Revised: 07/06/2010] [Accepted: 07/07/2010] [Indexed: 01/04/2023]
Abstract
As an infectious disease, the approach to anti-Helicobacter pylori therapy differs from other common gastrointestinal conditions because treatment success of more than 90% to 95% should be expected and the reasons for treatment failure can always be understood. Neither comparisons with another regimen nor randomization are required to identify a highly successful therapy. Treatment success should be judged first in relation to outcome (ie, ≥95% or grade A). Inclusion of a known inferior regimen in a clinical trial is generally unethical. If the use of a known inferior drug is required by a regulatory agency, subjects must be given full and accurate information regarding expectations with each regimen; there can be no deceptions. Comparative trials should be restricted to highly successful treatments (ie, comparisons of different doses, durations, compliance, cost, and so forth). Success should be judged as ordered categories such as <85%, 85%-89%, 90%-94%, or ≥95% and statistically equivalent regimens with the same grade success (ie, 90%-94% [Grade B]) are inferior to those higher category (ie, ≥95% [Grade A]) regimens. Only grade A or B regimens should be prescribed. Here we discuss anti-H pylori eradication studies from the perspective [corrected] of an infectious disease with the goal of providing recommendations regarding changes in approach and in reporting that should help resolve the ethical issues and make the results of clinical trials more useful to clinicians.
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Affiliation(s)
- David Y Graham
- Department of Medicine, Molecular Virology and Microbiology, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas, USA. dgraham@bcm
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Gao XZ, Qiao XL, Song WC, Wang XF, Liu F. Standard triple, bismuth pectin quadruple and sequential therapies for Helicobacter pylori eradication. World J Gastroenterol 2010; 16:4357-62. [PMID: 20818821 PMCID: PMC2937118 DOI: 10.3748/wjg.v16.i34.4357] [Citation(s) in RCA: 52] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: To compare the effectiveness of standard triple, bismuth pectin quadruple and sequential therapies for Helicobacter pylori (H. pylori) eradication in a randomized, double-blinded, comparative clinical trial in China.
METHODS: A total of 215 H. pylori-positive patients were enrolled in the study and randomly allocated into three groups: group A (n = 72) received a 10-d bismuth pectin quadruple therapy (20 mg rabeprazole bid, 1000 mg amoxicillin bid, 100 mg bismuth pectin qid, and 500 mg levofloxacin qd); group B (n = 72) received the sequential therapy (20 mg omeprazole bid, 1000 mg amoxicillin bid, in 5 d, followed by 20 mg omeprazole bid, 500 mg tinidazole bid, 500 mg clarithromycin bid, for another 5 d); group C (n = 71) received a standard 1-wk triple therapy (20 mg omeprazole bid, 1000 mg amoxicillin bid, 500 mg clarithromycin bid). After all these treatments, 20 mg omeprazole bid was administrated for 3 wk. H. pylori status was assessed by histology, 13C-urea breath test and rapid urease test at baseline and 4-6 wk after completion of treatment. Ulcer cicatrization was assessed by gastroscopy. χ2 test (P < 0.05) was used to compare the eradication rates and ulcer cicatrisation rates among the three groups.
RESULTS: The eradication rate was 83.33% (60/72) in group A, 88.89% (64/72) in group B, and 80.56% (58/71) in group C. The ulcer cicatrisation rate was 86.44% (51/59) in group A, 90.16% (55/61) in group B, and 84.91% (45/53) in group C. The sequential therapy yielded a higher eradication rate and ulcer cicatrisation rate than the standard triple and bismuth pectin quadruple therapies. Statistically, the eradication rate of group B was significantly different from groups A and C (P < 0.05), but the difference of ulcer cicatrisation rate and side effects was not statistically significant among the three groups (P > 0.05). The three protocols were generally well tolerated.
CONCLUSION: The sequential therapy has achieved a significantly higher eradication rate, and is a more suitable first-line alternative protocol for anti-H. pylori infection compared with the standard triple and bismuth pectin quadruple therapies.
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Salem EM, Yar T, Bamosa AO, Al-Quorain A, Yasawy MI, Alsulaiman RM, Randhawa MA. Comparative study of Nigella Sativa and triple therapy in eradication of Helicobacter Pylori in patients with non-ulcer dyspepsia. Saudi J Gastroenterol 2010; 16:207-14. [PMID: 20616418 PMCID: PMC3003218 DOI: 10.4103/1319-3767.65201] [Citation(s) in RCA: 62] [Impact Index Per Article: 4.1] [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
BACKGROUND/AIM A large number of diseases are ascribed to Helicobacter pylori (H. pylori), particularly chronic active gastritis, peptic ulcer disease and gastric cancer. Successful treatment of H. pylori infection with antimicrobial agents can lead to regression of H. pylori-associated disorders. Antibiotic resistance against H. pylori is increasing, and it is necessary to find new effective agents. Nigella sativa seed (NS), a commonly used herb, possesses in vitro anti-helicobacter activity. The present study was undertaken to evaluate the efficacy of NS in eradication of H. pylori infection in non-ulcer dyspeptic patients. MATERIALS AND METHODS The study was conducted on 88 adult patients attending King Fahd Hospital of the University, Al-Khobar, Saudi Arabia, from 2007 to 2008, with dyspeptic symptoms and found positive for H. pylori infection by histopathology and urease test. Patients were randomly assigned to four groups, receiving i) triple therapy (TT) comprising of clarithromycin, amoxicillin, omeprazole [n= 23], ii) 1 g NS + 40 mg omeprazole (OM) [n= 21], iii) 2 g NS + OM [n= 21] or iv) 3 g NS + OM [n= 23]. Negative H. pylori stool antigen test four weeks after end of treatment was considered as eradication. RESULTS H. pylori eradication was 82.6, 47.6, 66.7 and 47.8% with TT, 1 g NS, 2 g NS and 3 g NS, respectively. Eradication rates with 2 g NS and TT were statistically not different from each other, whereas H. pylori eradication with other doses was significantly less than that with TT (P < 0.05). Dyspepsia symptoms improved in all groups to a similar extent. CONCLUSIONS N. sativa seeds possess clinically useful anti-H. pylori activity, comparable to triple therapy. Further clinical studies combining N. sativa with antibiotics are suggested.
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Affiliation(s)
- Eyad M. Salem
- Department of Physiology, College of Medicine, King Faisal University, Dammam, Saudi Arabia
| | - Talay Yar
- Department of Physiology, College of Medicine, King Faisal University, Dammam, Saudi Arabia,Address for correspondence: Dr. Talay Yar, Department of Physiology, College of Medicine, King Faisal University, PO Box 2114, Dammam, 31451, Kingdom of Saudi Arabia. E-mail:
| | - Abdullah O. Bamosa
- Department of Physiology, College of Medicine, King Faisal University, Dammam, Saudi Arabia
| | - Abdulaziz Al-Quorain
- Department of Medicine, Division of Gastroenterology, King Fahd Hospital of the University, Al-Khobar, Saudi Arabia
| | - Mohamed I. Yasawy
- Department of Medicine, Division of Gastroenterology, King Fahd Hospital of the University, Al-Khobar, Saudi Arabia
| | - Raed M. Alsulaiman
- Department of Medicine, Division of Gastroenterology, King Fahd Hospital of the University, Al-Khobar, Saudi Arabia
| | - Muhammad A. Randhawa
- Department of Pharmacology, College of Medicine, King Faisal University, Dammam, Saudi Arabia
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Sánchez-Delgado J, Calvet X, Bujanda L, Gisbert JP, Titó L, Castro M. Ten-day sequential treatment for Helicobacter pylori eradication in clinical practice. Am J Gastroenterol 2008; 103:2220-3. [PMID: 18564109 DOI: 10.1111/j.1572-0241.2008.01924.x] [Citation(s) in RCA: 58] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND Cure rates of Helicobacter pylori infection with standard triple therapy are disappointingly low. A very effective, new sequential treatment schedule has recently been described. However, all studies published to date were performed in Italy; it is mandatory to confirm these results in other settings. AIM To assess the cure rate and the acceptability of a new sequential treatment regimen through a pilot study. METHODS A hundred and thirty-nine patients (60% men, mean age 49.6 +/- 15.7 yr) were recruited from six centers. H. pylori status was assessed by histology, urease test or urea breath test. Sequential regime consisted of a 10-day treatment including a proton pump inhibitor (PPI) b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by a PPI b.d. clarithromycin 500 mg b.d. and metronidazole 500 mg b.d for the next 5 days. Eradication was determined 8 wk after the end of treatment by urea breath test or histology. Eradication rates were calculated both per protocol and by intention-to-treat. RESULTS Eradication was achieved in 117 out of 129 patients who returned for a follow-up test. The intention-to-treat eradication rate was thus 84.2% (95%CI: 77%-90%) and the per-protocol cure rate 90.7% (95%CI: 84%-95%). The treatment was well tolerated. Only 14 patients complained of mild side effects. CONCLUSIONS Sequential treatment seems highly effective for eradicating H. pylori.
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Affiliation(s)
- Jordi Sánchez-Delgado
- Hospital de Sabadell, Institut Universitari Parc Taulí, Departament de Medicina, UAB, Barcelona, Spain
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Sezgin O, Altintaş E, Nayir E, Uçbilek E. A pilot study evaluating sequential administration of a PPI-amoxicillin followed by a PPI-metronidazole-tetracycline in Turkey. Helicobacter 2007; 12:629-32. [PMID: 18001405 DOI: 10.1111/j.1523-5378.2007.00547.x] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND There is no effective regimen for the eradication of Helicobacter pylori in our country. It may be due to the increasing prevalence of resistance to antibiotics used for the treatment of H. pylori. Recently, a study from Turkey has revealed that a new treatment scheme consisting of sequential administration of pantoprazole plus amoxicillin for 7 days followed by pantoprazole plus metronidazole, and tetracycline for the remaining 7 days was effective in the first-line treatment of H. pylori. Therefore, we aimed to confirm efficacy of a new therapy scheme in the first-line H. pylori eradication. MATERIAL AND METHODS This is a prospective, open label, single center, pilot study and included 32 patients infected with H. pylori diagnosed by both histologic examinations, rapid urease test and (13)C-urea breath test (UBT). The patients received a 14-day sequential regimen (pantoprazole 40 mg b.d. plus amoxicillin 1000 mg b.d. for 7 days and pantoprazole 40 mg b.d., metronidazole 500 mg b.d. and tetracycline 500 mg q.d. for the remaining 7 days). Eradication was assessed with (13)C-UBT 4 weeks after completion of the therapy. Intention-to-treat and per-protocol eradication rates were determined. RESULTS At intention-to-treat analysis, the eradication rate was 50% (16/32). For the per protocol analysis, the eradication rate was 57% (16/28). There were no significant adverse effects and treatment compliance was good. CONCLUSION A new therapy consisting of sequentially administered drugs for 14 days yielded unacceptably low eradication rates. This scheme was not efficient for H. pylori eradication in our region. Further investigations are needed to determine the effectiveness of this scheme in other regions of Turkey.
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Affiliation(s)
- Orhan Sezgin
- Mersin University, School of Medicine, Department of Gastroenterology, Mersin, Turkey.
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Sezgin O, Altintaş E, Uçbilek E, Tombak A, Tellioğlu B. Low efficacy rate of moxifloxacin-containing Helicobacter pylori eradication treatment: in an observational study in a Turkish population. Helicobacter 2007; 12:518-22. [PMID: 17760720 DOI: 10.1111/j.1523-5378.2007.00535.x] [Citation(s) in RCA: 14] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Abstract
BACKGROUND Standard triple therapy for Helicobacter pylori has an eradication rate of about 50% in Turkey. It may be due to an increased resistance of H. pylori to antibiotics. Therefore, we aimed to investigate the effectiveness of a new second-generation fluoroquinolone, moxifloxacin-containing triple therapy in H. pylori eradication. MATERIAL AND METHODS This is an open-label, prospective, single-center, pilot study. We studied 71 dyspeptic patients infected with H. pylori diagnosed by both histology and rapid urease test. Out of 71 dyspeptic patients, 64 had non-ulcer dyspepsia and seven had peptic ulcer. Patients received pantoprazole (40 mg b.i.d.) plus moxifloxacin (400 mg/day) and amoxicillin (1000 mg b.i.d.) for 14 days. Eradication was assessed 4 weeks after completing the therapy by histology and rapid urease test. Per-protocol and intention-to-treat eradication rates were determined. RESULTS The eradication rate was 42.2% for the intention-to-treat analysis and 47.6% for the per-protocol analysis. Of all patients included in the study, 29.5% had side-effects and only 2.8% of the patients discontinued the treatment because of side-effects. Most of the complications were mild and self-limiting. CONCLUSION Triple therapy with pantoprazole, moxifloxacin, and amoxicillin for 14 days yielded unacceptably low eradication rates. However, using tests of susceptibility to antibiotics, further studies with larger sample sizes are needed to judge these eradication rates of moxifloxacin containing eradication treatment.
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Affiliation(s)
- Orhan Sezgin
- Department of Gastroenterology, School of Medicine, Mersin University, Mersin, Turkey.
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Keshavarz AA, Bashiri H, Rahbar M. Omeprazole-based triple therapy with low-versus high-dose of clarithromycin plus amoxicillin for H pylori eradication in Iranian population. World J Gastroenterol 2007; 13:930-3. [PMID: 17352026 PMCID: PMC4065932 DOI: 10.3748/wjg.v13.i6.930] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: To investigate the efficacy and tolerability of H pylori eradication in an omeprazole-based triple therapy with high- and low-dose of clarithromycin and amoxicillin.
METHODS: One hundred and sixty H pylori positive patients were randomly assigned to two groups based on the following 2 wk investigation; (1) group A or low-dose regimen received omeprazole 20 mg b.i.d, clarithromycin 250 mg b.i.d and amoxicillin 500 mg b.i.d; and (2) group B or high-dose regimen received omeprazole 20 mg b.i.d, clarithromycin 500 mg b.i.d and amoxicillin 1000 mg b.i.d. During the study H pylori status was assessed by histology and rapid urease test prior and by 13C-urea breath test 6 wk after the therapy. Standard questionnaires were administered to determine the compliance to treatment and possible adverse events of therapy. Data were subject to χ2 to compare the eradication rates in the two groups. The significant level of 95% (P≤ 0.05) was considered statistically different.
RESULTS: We found that the per-protocol eradication rate was 88% (68/77) in group A, and 89% (67/75) in group B. The intension-to-treat eradication rate was 85% (68/80) in group A and 83.75% (67/80) in group B. Overall adverse events were 26% in group A and 31% in group B. The adverse events were generally mild in nature and tolerated well in both groups with a compliance of 98% in group A vs 96% in group B.
CONCLUSION: The omeprazole-based low dose regimen of clarithromycin and amoxicillin for two weeks in H pylori eradication is as effective as high dose regimen in Iranian population.
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Affiliation(s)
- Ali-Asghar Keshavarz
- Department of Gastroenterology and Hepatology, Emam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.
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Scaccianoce G, Hassan C, Panarese A, Piglionica D, Morini S, Zullo A. Helicobacter pylori eradication with either 7-day or 10-day triple therapies, and with a 10-day sequential regimen. CANADIAN JOURNAL OF GASTROENTEROLOGY = JOURNAL CANADIEN DE GASTROENTEROLOGIE 2006; 20:113-7. [PMID: 16482238 PMCID: PMC2538976 DOI: 10.1155/2006/258768] [Citation(s) in RCA: 63] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND Helicobacter pylori eradication rates achieved by standard seven-day triple therapies are decreasing in several countries, while a novel 10-day sequential regimen has achieved a very high success rate. A longer 10-day triple therapy, similar to the sequential regimen, was tested to see whether it could achieve a better infection cure rate. METHODS Patients with nonulcer dyspepsia and H pylori infection were randomly assigned to one of the following three therapies: esomeprazole 20 mg, clarithromycin 500 mg and amoxycillin 1 g for seven days or 10 days, or a 10-day sequential regimen including esomeprazole 20 mg plus amoxycillin 1 g for five days and esomeprazole 20 mg, clarithromycin 500 mg and tinidazole 500 mg for the remaining five days. All drugs were given twice daily. H pylori eradication was checked four to six weeks after treatment by using a 13C-urea breath test. RESULTS Overall, 213 patients were enrolled. H pylori eradication was achieved in 75.7% and 77.9%, in 81.7% and 84.1%, and in 94.4% and 97.1% of patients following seven-day or 10-day triple therapy and the 10-day sequential regimen, at intention-to-treat and per protocol analyses, respectively. The eradication rate following the sequential regimen was higher than either seven-day (P=0.002) or 10-day triple therapy (P=0.02), while no significant difference emerged between the latter two regimens (P=0.6). CONCLUSIONS The 10-day sequential regimen was significantly more effective than both triple regimens, while 10-day triple therapy failed to significantly increase the H pylori eradication rate achieved by the standard seven-day regimen.
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Affiliation(s)
| | - Cesare Hassan
- Gastroenterology and Digestive Endoscopy, “Nuovo Regina Margherita” Hospital, Roma, Italy
| | - Alba Panarese
- Digestive Endoscopy, “Umberto I” Hospital, Altamura, Bari, Italy
| | | | - Sergio Morini
- Gastroenterology and Digestive Endoscopy, “Nuovo Regina Margherita” Hospital, Roma, Italy
| | - Angelo Zullo
- Gastroenterology and Digestive Endoscopy, “Nuovo Regina Margherita” Hospital, Roma, Italy
- Correspondence: Dr Angelo Zullo, Ospedale Nuovo Regina Margherita, Gastroenterologia ed Endoscopia Digestiva, Via E Morosini, 30, 00153 Rome, Italy. Telephone 0039-06-5844-6608, fax 0039-06-5844-6533, e-mail
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Borody TJ, Pang G, Wettstein AR, Clancy R, Herdman K, Surace R, Llorente R, Ng C. Efficacy and safety of rifabutin-containing 'rescue therapy' for resistant Helicobacter pylori infection. Aliment Pharmacol Ther 2006; 23:481-8. [PMID: 16441468 DOI: 10.1111/j.1365-2036.2006.02793.x] [Citation(s) in RCA: 57] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND Current 'rescue' therapies provide inadequate Helicobacter pylori eradication rates because of antibiotic resistance. AIM To test the efficacy of a modified triple regimen combining rifabutin, pantoprazole and amoxicillin as rescue therapy for patients in whom eradication of H. pylori had failed standard clarithromycin-based triple therapy. METHODS One hundred and thirty patients (mean age 51.7 +/- 14.8 years) who had failed one or more eradication attempts with omeprazole, clarithromycin and amoxicillin were treated for 12 days with rifabutin 150 mg daily, amoxicillin 1 g or 1.5 g t.d.s, and pantoprazole 80 mg t.d.s. RESULTS The intention-to-treat and per-protocol eradication rates were 90.8/90.8%. Metronidazole or/and clarithromycin resistance had no significant impact on H. pylori eradication rates. A higher overall eradication rate of 96.6% (95% CI: 92.1-101%) was obtained in patients treated with a regimen containing 1.5 g amoxicillin t.d.s compared with 90.7% (95% CI: 82-98.6%) using a regimen with 1 g amoxicillin t.d.s but the difference was not significant. Side-effects reported in 40% of patients were mild. CONCLUSION A 12-day course of low dose of rifabutin with an increased dose of amoxicillin and pantoprazole is well-tolerated and highly effective against dual-resistant H. pylori infection after failure of triple therapy.
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Affiliation(s)
- T J Borody
- Centre for Digestive Disease, NSW, Australia.
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Basset C, Holton J, Gatta L, Ricci C, Bernabucci V, Liuzzi G, Vaira D. Helicobacter pylori infection: anything new should we know? Aliment Pharmacol Ther 2004; 20 Suppl 2:31-41. [PMID: 15335411 DOI: 10.1111/j.1365-2036.2004.02040.x] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
Over the past year, 2003-4, there have been a number of studies consolidating previous work in relation to pathogenesis of disease, diagnosis and management of Helicobacter pylori. Studies into the pathogenesis of disease have identified the main adhesin of H. pylori as an important virulence marker and as a potential target for therapy. Molecular investigations of both the strain and host variations have identified the action of several of the virulence factors, e.g. cagA, vacA, on disrupting host cell signalling and the consequences in respect of the release of chemokines from the damaged gastric epithelium and the effect on apoptosis. Over the past year, there have been further diagnostic kits developed based on modifications of current technology. Two promising areas of research for diagnosis are the use of host/strain genome polymorphisms as a means of identifying high-risk patients who may develop severe disease and the use of proteomics to identify potential antigens of diagnostic (or therapeutic) use. The three main antibiotics that are used in first-line eradication regimens are clarithromycin, metronidazole and amoxycillin. Of these, metronidazole has the highest prevalence of resistance, followed by clarithromycin; amoxycillin resistance is only rarely reported. The decreasing success of current first-line therapy is the driving force for the development of new antibiotic combinations and a search for novel sources for chemotherapeutic agents and novel therapeutic targets.
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Affiliation(s)
- C Basset
- Department of Medical Microbiology, RF and UCL, Medical School, London, UK
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Altintas E, Sezgin O, Ulu O, Aydin O, Camdeviren H. Maastricht II treatment scheme and efficacy of different proton pump inhibitors in eradicating Helicobacter pylori. World J Gastroenterol 2004; 10:1656-8. [PMID: 15162544 PMCID: PMC4572773 DOI: 10.3748/wjg.v10.i11.1656] [Citation(s) in RCA: 44] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
AIM: The Maastricht II criteria suggest the use of amoxicillin and clarithromycin in addition to a proton pump inhibitor over 7-10 d as a first line therapy in the eradication of Helicobacter pylori (H pylori) . For each proton pump inhibitor, various rates of eradication have been reported. The present study was to compare the efficacy of different proton pump inhibitors like omeprazole, lansoprazole and pantoprazole in combination with amoxicillin and clarithromycin in the first line eradication of H pylori and to investigate the success of H pylori eradication in our district.
METHODS: A total of 139 patients were included having a Helicobacter pylori (+) gastroduodenal disorders diagnosed by means of histology and urease test. Besides amoxicillin (1000 mg twice a day) and clarithromycin (500 mg twice a day), they were randomized to take omeprazole (20 mg twice a day), or lansoprazole (30 mg twice a day), or pantoprozole (40 mg twice a day) for 14 d. Four weeks after the therapy, the eradication was assessed by means of histology and urease test. It was evaluated as eradicated if the H pylori was found negative in both. The complaints (pain in epigastrium, nocturnal pain, pyrosis and bloating) were graded in accordance with the Licert scale. The compliance of the patients was recorded.
RESULTS: The eradication was found to be 40.8% in the omeprazole group, 43.5% in the lansoprazole group and 47.4% in the pantoprazole group. Sixty-three out of 139 patients (45%) had eradication. No statistically significant difference was observed between the groups. Significant improvements were seen in terms of the impact on the symptom scores in each group.
CONCLUSION: There was no difference between omeprazole, lansoprazole and pantoprazole in H pylori eradication, and the rate of eradication was as low as 45%. Symptoms were improved independent of the eradication in each treatment group. The low eradication rates suggest that the antibiotic resistance or the genetic differences of the microorganism might be in effect. Further studies are required to verify these suggestions.
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Affiliation(s)
- Engin Altintas
- Department of Gastroenterology, Mersin University, Faculty of Medicine, Turkey.
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De Francesco V, Zullo A, Hassan C, Della Valle N, Pietrini L, Minenna MF, Winn S, Monno R, Stoppino V, Morini S, Panella C, Ierardi E. The prolongation of triple therapy for Helicobacter pylori does not allow reaching therapeutic outcome of sequential scheme: a prospective, randomised study. Dig Liver Dis 2004; 36:322-6. [PMID: 15191200 DOI: 10.1016/j.dld.2003.12.015] [Citation(s) in RCA: 57] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND AIM One-week triple therapy for Helicobacter pylori revealed, during these last few years, a decrease in the eradication rate, so that the prolongation of its duration has been proposed. A sequential scheme recently showed very satisfactory results. We performed a prospective randomised study with the aim of either evaluating whether the triple therapy prolongation may improve its effectiveness and comparing its outcome with that of sequential regimen. PATIENTS AND METHODS Three hundred and forty-two H. pylori positive patients completed the study. They were randomised to receive one of the following treatments: (i) a 7-day triple therapy comprising of rabeprazole (20 mg, b.i.d.) plus clarithromycin (500 mg, b.i.d.) and amoxycillin (1 g, b.i.d.); (ii) a 10-day triple therapy comprising the same scheme; (iii) a 10-day sequential regimen comprising of rabeprazole (20 mg, b.i.d.) plus amoxycillin (1 g, b.i.d.) for 5 days followed by rabeprazole (20 mg, b.i.d.) plus clarithromycin (500 mg, b.i.d.) and tinidazole (500 mg, b.i.d.) for the next 5 days. Therapeutic results were expressed using both intention-to-treat and per protocol analyses with 95% confidence intervals. A model of multivariate logistic regression analysis was performed using therapeutic outcome as a dependent variable and including endoscopic finding, smoking habit, age and sex as candidates for the model. RESULTS Sequential regimen showed a significant gain in the eradication rate as compared to the 7-day (P < 0.0001) and the 10-day (P < 0.01) triple therapies, respectively. Overall eradication was lower in smokers than in non-smokers, but the difference remained significant only in the 7-day triple therapy (P < 0.01). Additionally, the overall eradication was higher in peptic ulcer than dyspepsia (P < 0.01), even if this difference was significant only for both triple therapies. CONCLUSIONS Seven-day triple therapy achieves disappointing eradication rates in dyspeptics and smokers. Prolonging triple therapy to 10 days does not significantly improve the eradication rate. The novel 10-day sequential regimen is more effective and equally tolerated than the 10-day triple therapy.
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Affiliation(s)
- V De Francesco
- Gastroenterology Unit, University of Foggia, Riuniti Hospital, Viale L. Pinto, 71100 Foggia, Italy
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De Francesco V, Della Valle N, Stoppino V, Amoruso A, Muscatiello N, Panella C, Ierardi E. Effectiveness and pharmaceutical cost of sequential treatment for Helicobacter pylori in patients with non-ulcer dyspepsia. Aliment Pharmacol Ther 2004; 19:993-8. [PMID: 15113366 DOI: 10.1111/j.1365-2036.2004.01877.x] [Citation(s) in RCA: 17] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate than standard 7-day therapy in both peptic ulcer disease and non-ulcer dyspepsia. Its higher performance has recently been confirmed using a halved clarithromycin dose in peptic ulcer disease. AIMS To evaluate whether an acceptable eradication rate could also be obtained by halving the clarithromycin dose in dyspeptic patients and to assess the role of possible factors affecting the outcome of therapy. METHODS In a prospective, open-label study, 162 patients with non-ulcer dyspepsia and Helicobacter pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either 10-day sequential therapy, comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (low-dose therapy), or a similar schedule with clarithromycin 500 mg b.d. (high-dose therapy). Four to six weeks after therapy, H. pylori eradication was assessed by endoscopy/histology. RESULTS A similar H. pylori eradication rate was observed following low- and high-dose regimens for both per protocol (94% vs. 95%; P = N.S.) and intention-to-treat (93% vs. 94%; P = N.S.) analyses. No major side-effects were reported. Halving the clarithromycin dose leads to a per patient saving in pharmaceutical costs of 24.6 euros. None of the variables examined affected the effectiveness of eradication of the sequential regimen. CONCLUSION A reduction of the clarithromycin dose does not affect H. pylori eradication with the sequential regimen in non-ulcer dyspepsia and affords lower costs.
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Lamouliatte H, Mégraud F, Delchier JC, Bretagne JF, Courillon-Mallet A, De Korwin JD, Fauchère JL, Labigne A, Fléjou JF, Barthelemy P. Second-line treatment for failure to eradicate Helicobacter pylori: a randomized trial comparing four treatment strategies. Aliment Pharmacol Ther 2003; 18:791-7. [PMID: 14535872 DOI: 10.1046/j.1365-2036.2003.01759.x] [Citation(s) in RCA: 54] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/03/2023]
Abstract
AIM To compare the efficacy of different regimens in patients in whom previous Helicobacter pylori eradication therapy has failed. METHODS In this study named StratHegy patients (n=287) were randomized to receive one of three empirical triple therapy regimens or a strategy based on antibiotic susceptibility. The empirical regimens were omeprazole, 20 mg b.d., plus amoxicillin, 1000 mg b.d., and clarithromycin, 500 mg b.d., for 7 days (OAC7), clarithromycin, 500 mg b.d., for 14 days (OAC14) or metronidazole, 500 mg b.d., for 14 days (OAM14). In the susceptibility-based strategy, patients with clarithromycin-susceptible strains received OAC14, whilst the others received OAM14. The 13C-urea breath test was performed before randomization and 4-5 weeks after eradication therapy. RESULTS In the intention-to-treat analysis, the eradication rates for empirical therapies were as follows: OAC7, 47.4% (27/57); OAC14, 34.5% (20/58); OAM14, 63.2% (36/57); it was 74.3% (84/113) for the susceptibility-based treatment (P<0.01 when compared with OAC7 and OAC14). In patients receiving clarithromycin, the eradication rates were 80% for clarithromycin-susceptible strains and 16% for clarithromycin-resistant strains; in patients receiving OAM14, the eradication rates were 81% for metronidazole-susceptible strains and 59% for metronidazole-resistant strains. CONCLUSIONS Eradication rates of approximately 75% can be achieved with second-line triple therapy based on antibiotic susceptibility testing. If susceptibility testing is not available, OAM14 is an appropriate alternative.
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Affiliation(s)
- H Lamouliatte
- Service des Maladies de l' Appareil Digestif, Hôpital St André, Bordeaux, France
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Perri F, Festa V, Merla A, Barberani F, Pilotto A, Andriulli A. Randomized study of different 'second-line' therapies for Helicobacter pylori infection after failure of the standard 'Maastricht triple therapy'. Aliment Pharmacol Ther 2003; 18:815-20. [PMID: 14535875 DOI: 10.1046/j.1365-2036.2003.01755.x] [Citation(s) in RCA: 33] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
BACKGROUND Triple therapy with proton pump inhibitor, clarithromycin and amoxicillin and, in the event of eradication failure, quadruple therapy with proton pump inhibitor, bismuth, tetracycline and metronidazole have been proposed in Maastricht as the optimal sequential treatment of Helicobacter pylori infection. AIM To compare two second-line regimens with quadruple therapy. METHODS One hundred and eighty patients with a previous failed course of standard therapy were randomly given one of the following 7-day treatments: ranitidine bismuth citrate 400 mg b.d. plus amoxicillin 1 g b.d. and tinidazole 500 mg b.d. (RBCAT), pantoprazole 40 mg b.d. plus amoxicillin 1 g b.d. and levofloxacin 500 mg/day (PAL) and pantoprazole 40 mg b.d., bismuth citrate 240 mg b.d., tetracycline 500 mg q.d.s. and metronidazole 500 mg b.d. (PBTM). The eradication rate was assessed by 13C-urea breath test. Side-effects and compliance were evaluated by a standardized questionnaire and by counting returned medication. RESULTS The RBCAT, PAL and PBTM groups achieved mean intention-to-treat eradication rates of 85%, 63% and 83%, respectively (P<0.05 for PAL vs. either RBCAT or PBTM). Compliance was optimal in all patients, although side-effects were more commonly observed in the PBTM group than in the other two patient groups (P<0.0001). CONCLUSIONS Both RBCAT and PBTM can be used as second-line therapies. Conversely, PAL did not achieve satisfactory eradication rates.
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Affiliation(s)
- F Perri
- Division of Gastroenterology, Hospital, IRCCS, San Giovanni Rotondo, Italy.
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Hassan C, De Francesco V, Zullo A, Scaccianoce G, Piglionica D, Ierardi E, Panella C, Morini S. Sequential treatment for Helicobacter pylori eradication in duodenal ulcer patients: improving the cost of pharmacotherapy. Aliment Pharmacol Ther 2003; 18:641-6. [PMID: 12969091 DOI: 10.1046/j.1365-2036.2003.01694.x] [Citation(s) in RCA: 32] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND Several studies have shown that Helicobacter pylori eradication rates with standard 7-day triple therapy are unsatisfactory. A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate. To improve the pharmacotherapeutic cost, we evaluated whether an acceptable eradication rate could be achieved in peptic ulcer patients by halving the dose of clarithromycin. METHODS In a prospective, open-label study, 152 duodenal ulcer patients with H. pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either a 10-day sequential treatment comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (high-dose therapy), or a similar schedule with the clarithromycin doses halved to 250 mg b.d. (low-dose therapy). No further antisecretory drugs were offered. Four to six weeks after therapy, H. pylori eradication and ulcer healing rates were assessed by endoscopy. RESULTS Similar H. pylori eradication rates were observed following high- and low-dose regimens for both per protocol (97.3% vs. 95.9%; P = N.S.) and intention-to-treat (94.7% vs. 92.2%; P = N.S.) analyses. No major side-effects were reported. At repeat endoscopy, peptic ulcer healing was observed in 93% and 93% of patients following high- and low-dose therapy, respectively. CONCLUSION The cheaper low-dose sequential regimen may be suggested for H. pylori eradication in duodenal ulcer patients, even without continued proton pump inhibitor therapy after eradication treatment.
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Affiliation(s)
- C Hassan
- Gastroenterology and Digestive Endoscopy, 'Nuovo Regina Margherita' Hospital, Rome, Italy.
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Calvet X, Gené E. [Helicobacter pylori eradication. Triple or quadruple therapy?, Long or short treatment?]. GASTROENTEROLOGIA Y HEPATOLOGIA 2003; 26:325-9. [PMID: 12732108 DOI: 10.1016/s0210-5705(03)70366-5] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/06/2023]
Affiliation(s)
- X Calvet
- Unitat de Malalties Digestives. Hospital de Sabadell-Institut Universitari Parc Taulí (UAB). Sabadell. Barcelona. España.
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