1
|
Jung YD, Kim YJ, Chung WC. A Pilot Study of Helicobacter pylori Eradication Using a Polymerase Chain Reaction-based Test for Clarithromycin Resistance. THE KOREAN JOURNAL OF HELICOBACTER AND UPPER GASTROINTESTINAL RESEARCH 2017. [DOI: 10.7704/kjhugr.2017.17.4.200] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Affiliation(s)
- Yun Duk Jung
- Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Yeon-Ji Kim
- Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Woo Chul Chung
- Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
| |
Collapse
|
2
|
Choi KD. Current Trends ofHelicobacter pyloriEradication in Korea. THE KOREAN JOURNAL OF HELICOBACTER AND UPPER GASTROINTESTINAL RESEARCH 2015. [DOI: 10.7704/kjhugr.2015.15.3.147] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Affiliation(s)
- Kee Don Choi
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| |
Collapse
|
3
|
Makhlough A, Fakheri H, Farkhani AR, Seddighi O, Hossieni SV, Khademloo M, Bari Z. A comparison between standard triple therapy and sequential therapy on eradication of Helicobacter pylori in uremic patients: A randomized clinical trial. Adv Biomed Res 2014; 3:248. [PMID: 25590026 PMCID: PMC4283243 DOI: 10.4103/2277-9175.146372] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/26/2012] [Accepted: 05/14/2013] [Indexed: 02/06/2023] Open
Abstract
Background: The prevalence of peptic ulcer disease in hemodialysis dependent patients is higher than the general population. These patients are also more prone to upper gastrointestinal bleeding. The aim of this study was to compare the effects of a standard triple therapy with a sequential therapy on Helicobacter pylori eradication in azotemic and hemodialysis patients. Materials and Methods: Forty nine hemodialysis and azotemic patients, naïve to H. pylori treatment, were randomized into two groups to receive either standard triple therapy (pantoprazole 40 mg, amoxicillin 500 mg and clarithromycin 250 mg twice a day for 14 days) or a sequential therapy (pantoprazole 40 mg for 10 days, amoxicillin 500 mg twice a day for the first 5 days and clarithromycin 250 mg + tinidazole 500 mg twice a day just during the second 5 days). H. pylori eradication was evaluated by fecal H. pylori antigen assessment 8 weeks after the treatment. Results: Of 49 patients, 45 patients (21 in triple therapy group and 24 in the sequential group) completed the study. Based on intention to treat analysis, H. pylori eradication rates were 66.7% (95% confidence interval [CI]: 47.8-85.5%) in standard triple therapy group and 84% (95% CI: 69.6-98.3%) in sequential therapy group (P = 0.34). Per-protocol (PP) eradication rates were (95% CI: 76.2%. 6-89.3%) 54 and 87.5% (95% CI: 68.8-95.5%), respectively (P = 0.32). Conclusion: According to Maastricht III consensus report, the results of our study showed that sequential therapy might be a better choice compared with the standard triple therapy in azotemic and hemodialysis patients Iran. We propose to assess the effects of shorter-duration sequential therapy (less than 10 days) for H. pylori eradication.
Collapse
Affiliation(s)
- Atieh Makhlough
- Department of Nephrology, Imam Khomeini Hospital, Biology Molecular and Cellular Research Center, Sari, Iran ; Department of Immunology, Biology Molecular and Cellular Research Center, Sari, Iran
| | - Hafez Fakheri
- Department of Gastroenterology, Mazandaran University of Medical Sciences, Sari, Iran
| | | | - Omid Seddighi
- Department of Nephrology, Imam Khomeini Hospital, Sari, Iran
| | | | - Mohammad Khademloo
- Department of Community Medicine, Mazandaran University of Medical Sciences, Sari, Iran
| | - Zohreh Bari
- Department of Internal Medicine, Mazandaran University of Medical Sciences, Sari, Iran
| |
Collapse
|
4
|
Masjedizadeh AR, Hajiani E, Jalal Hashemi S, Alavinejad P, Dalvand H. Sequential Therapy vs Quadruple Therapy for Helicobacter pylori Eradication in South West of Iran. Euroasian J Hepatogastroenterol 2014; 4:63-66. [PMID: 29699349 PMCID: PMC5913897 DOI: 10.5005/jp-journals-10018-1103] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/03/2014] [Accepted: 06/17/2014] [Indexed: 02/06/2023] Open
Abstract
Aim To compare the efficacy of quadruple and sequential therapy in eradication of Helicobocter pylori (H. pylori) in a randomized study. Method Three hundred H. pylori positive patients were enrolled into the study. These patients were randomly divided into two groups: group I (n = 150) received quadruple therapy (20 mg omeprazole bid, 240 mg bismuth subcitrate bid, 1,000 mg tetracycline bid and 500 mg metronidazole bid) for 14 days, group II (n = 150) received sequential therapy (20 mg omeprazole bid, 1,000 mg amoxicillin bid for 5 days, followed by 20 mg omeprazole bid, 500 mg metronidazole bid, 500 mg clarithromycin for the other 5 days). H. pylori status was assessed by histology and rapid urease test at baseline. Follow-up breath test by 14C urea breath test (UBT) was performed 4 weeks after completion of treatment. Eradication was defined as negative results on UBT. Results Successful eradication was achieved in 245 patients. In each group, five patients did not tolerate the regimen and were excluded from analysis. About 29 (20%) patients who received sequential therapy and 21 (14.5%) of the quadruple group tolerated mild side effects (p = 0.21). Per-protocol analysis demonstrated eradication rates of 86.9% for sequential therapy and 82.7% for quadruple therapy (p = 0.26). Results according to the intention to treat analysis were 84 and 79.5% in the sequential and quadruple group respectively. Eradication rate differences were not significant. Conclusion The success rate of sequential therapy is comparable with quadruple therapy. Sequential therapy due to the short duration and lesser drug usage is a good alternative for eradication of H. pylori in the country. How to cite this article: Masjedizadeh AR, Hajiani E, Hashemi SJ, Alavinejad P, Dalvand H. Sequential Therapy vi Quadruple Therapy for Helicobocter pylori Eradication in South West of Iran. Euroasian J Hepato-Gastroenterol 2014;4(2):63-66.
Collapse
Affiliation(s)
- Abdol Rahim Masjedizadeh
- Division of Gastroenterology and Hepatology, Department of Internal Medicine; Research Center for Infectious Diseases of Digestive System, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
| | - Eskandar Hajiani
- Division of Gastroenterology and Hepatology, Department of Internal Medicine; Research Center for Infectious Diseases of Digestive System, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
| | - Seyed Jalal Hashemi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine; Research Center for Infectious Diseases of Digestive System, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
| | - Pezhman Alavinejad
- Division of Gastroenterology and Hepatology, Department of Internal Medicine; Research Center for Infectious Diseases of Digestive System, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
| | - Hasan Dalvand
- Research Center for Infectious Diseases of Digestive System, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
| |
Collapse
|
5
|
Giorgio F, Principi M, De Francesco V, Zullo A, Losurdo G, Di Leo A, Ierardi E. Primary clarithromycin resistance to Helicobacter pylori: Is this the main reason for triple therapy failure? World J Gastrointest Pathophysiol 2013; 4:43-46. [PMID: 23946886 PMCID: PMC3740258 DOI: 10.4291/wjgp.v4.i3.43] [Citation(s) in RCA: 31] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/16/2013] [Revised: 06/20/2013] [Accepted: 07/05/2013] [Indexed: 02/06/2023] Open
Abstract
Conventional triple therapies for Helicobacter pylori (H. pylori) eradication have recently shown a disappointing reduction in effectiveness in many countries. The main reason for failure was found to be bacterial resistance to one of the most commonly used antibiotics, clarithromycin. An additional problem for conventional triple therapy is the high rate of resistance to metronidazole found in Europe, America and Asia. In Italy, in the last 15 years a 2-fold increase in resistance has occurred. A recent study of the whole of Italy included about 20 patients from each region at the first endoscopic diagnosis of H. pylori infection. The most surprising result was the patchy distribution of resistance, which was almost absent in two regions (one northern and one southern), although the highest prevalence was found in some regions of the South. In the paediatric population we found a 25% prevalence of resistance in a sample of H. pylori positive children observed between 2002 and 2007, mirroring data obtained in southern European countries. Clarithromycin resistance assessment is currently based on phenotypic detection performed after culture the agar dilution method or E-test, and genotypic methods based on polymerase chain reaction (PCR). In a recent comparative study we found a 71.2% agreement between the two methods. Culture-free techniques are highly accurate in finding even minimal traces of genotypically resistant strains. Moreover, PCR-based tools are accurate in detecting a heteroresistant status, defined as the co-existence of some strains that are susceptible and some resistant to the same antibiotic in an individual patient. Three point mutations, namely A2143G, A2142G and A2142C, are responsible for 90% of cases of primary clarithromycin resistance in H. pylori strains isolated in Western countries, although we previously demonstrated that the presence of the A2143G mutation, but not A2142G or A2142C, significantly lowered the H. pylori eradication rate. Treatment failure has considerable cost/benefit implications because of “waste” of National Health System and patient resources, in terms of drugs, further diagnostic tests and medical examination expenses. Therefore, in future it would be very useful to be able to test for clarithromycin resistance before starting conventional triple therapy. Hopefully, fast, effective non-invasive tests may soon be devised to determine this condition.
Collapse
|
6
|
Modified sequential therapy regimens for Helicobacter pylori eradication: a systematic review. Dig Liver Dis 2013; 45:18-22. [PMID: 23022424 DOI: 10.1016/j.dld.2012.08.025] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/28/2012] [Revised: 08/23/2012] [Accepted: 08/29/2012] [Indexed: 02/08/2023]
Abstract
BACKGROUND Different modified sequential therapies have been proposed for Helicobacter pylori eradication. However, the efficacy of these regimens is controversial. METHODS We performed a systematic review of the literature and pooled-data analysis to assess: (a) the efficacy of different modified sequential therapies for H. pylori eradication, (b) the eradication rates achieved by these regimens as compared to either standard triple therapies or standard sequential regimen when available. RESULTS Overall 21 trials met inclusion criteria. The most used modified sequential therapy was the seven plus seven tetracycline-based regimen which achieved an overall 73.3% eradication rate (6 trials). Such therapy was more effective than the 14-day triple therapy (77.2% vs. 63.6%; 3 trials). The most used five plus five levofloxacin-based sequential therapy achieved a 95.8% and 90% cure rates when 250 mg and 500 mg levofloxacin twice daily were used, respectively. These success rates were higher as compared to that of either standard sequential or triple therapies. Other modified sequential therapies did not achieved acceptably high cure rates. Contradictory results emerged from 2 studies assessing the efficacy of a levofloxacin-based sequential regimen as a second-line therapy. CONCLUSIONS Both levofloxacin- and tetracycline-based sequential therapies have been proved to be more effective than standard triple therapies, confirming that the 'sequential' administration of drugs is a successful therapeutic procedure for H. pylori infection.
Collapse
|
7
|
Abstract
BACKGROUND Alternative treatment regimens for standard triple therapy are urgently needed. AIM To critically review the evidence on the role of "sequential" regimen for the treatment of Helicobacter pylori infection. METHODS Bibliographical searches were performed in MEDLINE and international congresses. RESULTS Several pooled-data analyses and meta-analyses have demonstrated that sequential regimen is more effective than standard triple therapy. Sequential therapy is not affected by bacterial (CagA status, infection density) and host factors (underlying disease, smoking). Clarithromycin resistance seems to be the only factor reducing their efficacy. However, even in these patients, an acceptable >75% eradication rate can be achieved. Unfortunately, almost all the studies have been performed in Italy. Whether it is necessary to provide the drugs sequentially or if the 4 components of sequential therapy can be given concurrently is unclear. Nonbismuth quadruple therapy seems to be an effective and safe alternative to triple therapy and is less complex than sequential therapy. CONCLUSIONS Sequential therapy is a novel promising treatment approach that deserves consideration as a treatment strategy for H. pylori infection. However, further robust assessment across a much broader range of patients is required before sequential therapy could supplant existing treatment regimens and be generally recommended in clinical practice.
Collapse
|
8
|
Ten and eight-day sequential therapy in comparison to standard triple therapy for eradicating Helicobacter pylori infection: a randomized controlled study on efficacy and tolerability. J Clin Gastroenterol 2010; 44:261-6. [PMID: 20195162 DOI: 10.1097/mcg.0b013e3181acebef] [Citation(s) in RCA: 49] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND Sequential therapy (SQT) is effective in the eradication of Helicobacter pylori and could become an alternative to standard triple therapy (STT). AIM To compare the efficacy and tolerability of SQT, for either 8 or 10 days, with a 7-day STT. METHODS A total of 270 naive H. pylori-positive patients were randomized to receive: SQT for 8 days (SQT-8, n=90) or 10 days (SQT-10, n=90) including esomeprazole 20 mg twice daily (bid) associated with amoxicillin 1000 mg bid (early 4 and 5 d, respectively), followed by esomeprazole 20 mg bid associated with clarithromycin 500 mg bid plus tinidazole 500 mg bid (last 4 and 5 d, respectively); STT (n=90) including esomeprazole 20 mg bid plus amoxicillin 1000 mg bid and clarithromycin 500 mg bid for 7 days. Tolerability was assessed by scoring the severity of symptoms. RESULTS Eradication rates after SQT-8 and SQT-10 were higher than that of after STT at both intention-to-treat (83% and 86% vs. 66%, P<0.02) and per-protocol analysis (90% and 88% vs. 75%, P<0.05), whereas no difference was found between the 2 SQTs. CONCLUSIONS This study shows that SQT, for 8 or 10 days, is well tolerated and highly effective in H. pylori eradication and could represent a valid alternative to STT. Further studies, with more power, on larger populations and from other countries are necessary to validate the present findings.
Collapse
|
9
|
Gisbert JP, Calvet X, O'Connor JPA, Mégraud F, O'Morain CA. The sequential therapy regimen forHelicobacter pylorieradication. Expert Opin Pharmacother 2010; 11:905-18. [PMID: 20205606 DOI: 10.1517/14656561003657152] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022]
|
10
|
Vaira D, Zullo A, Hassan C, Fiorini G, Vakil N. Sequential Therapy for Helicobacter Pylori Eradication: The Time is Now! Therap Adv Gastroenterol 2009; 2:317-22. [PMID: 21180579 PMCID: PMC3002562 DOI: 10.1177/1756283x09343326] [Citation(s) in RCA: 42] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Affiliation(s)
- Dino Vaira
- Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy
| | | | | | | | | |
Collapse
|
11
|
Graham DY, Lu H, Yamaoka Y. Therapy for Helicobacter pylori infection can be improved: sequential therapy and beyond. Drugs 2008; 68:725-36. [PMID: 18416582 DOI: 10.2165/00003495-200868060-00001] [Citation(s) in RCA: 68] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
As with other bacterial infections, successful treatment of Helicobacter pylori infections depends on the use of antibacterial agents to which the organism is susceptible. In this article, we use the proposed report card grading scheme (i.e. grade A, B, C, D, F) for the outcome of clinical trials, where intention-to-treat cure rates >95% = A, 90-95% = B, 85-89% = C, 81-84% = D and <81% = F. The goal of therapy is to consistently cure >95% of patients (e.g. provide grade A results). Like tuberculosis, H. pylori infections are difficult to cure and successful treatment generally requires the administration of several antibacterial agents simultaneously. Duration of therapy is also important and depends upon whether resistance is present; 14 days is often best. With few exceptions, worldwide increasing macrolide resistance now undermines the effectiveness of the legacy triple therapy (e.g. a proton pump inhibitor [PPI], clarithromycin and amoxicillin) and, in most areas, cure rates have declined to unacceptable levels (e.g. grade F). The development of sequential therapy was one response to this problem. Sequential therapy has repeatedly been shown in head-to-head studies to be superior to legacy triple therapy. Sequential therapy, as originally described, is the sequential administration of a dual therapy (a PPI plus amoxicillin) followed by a Bazzoli-type triple therapy (a PPI plus clarithromycin and tinidazole) and has been shown to be especially useful where there is clarithromycin resistance. However, the cure rates of the original sequential treatment are grade B and can probably be further improved by changes in dose, duration or administration, such as by continuing the amoxicillin into the triple therapy arm. The sequential approach may also be more complicated than necessary, based on the fact that the same four drugs have also been given concomitantly (at least nine publications with >700 patients) as a quadruple therapy with excellent success. This article discusses the approach to therapy in the modern era where antimicrobial resistance is an increasing problem and legacy triple therapy is no longer an acceptable initial choice. Methods to achieve acceptable eradication rates (e.g. grade A or B results) are discussed and, specifically, sequential therapy is considered both conceptually and practically. Suggestions are provided regarding how sequential therapy might be improved to become a grade A therapy as well as how to identify situations where it can be expected to yield unacceptable results. New uses for current drugs are discussed and suggestions for subsequent randomized comparisons to overcome phenotypic and genotypic resistance are given. We propose a change in focus from comparative studies (designed to prove that a new therapy is superior to a known inferior therapy) to demanding that efficacious therapies meet or exceed a pre-specified level of success (i.e. grade A or B result). To do so, coupled with less concern about the effect of recommendations on the pharmaceutical industry, should provide clinicians with much higher quality information, and improve the quality of medical care and recommendations regarding treatment. Ultimately, there is little or no justification for comparative testing that includes an arm with known unacceptably low results. H. pylori gastritis is an infectious disease and should be approached and treated as such.
Collapse
Affiliation(s)
- David Y Graham
- Department of Medicine, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas 77030, USA.
| | | | | |
Collapse
|
12
|
Shehada S, Srugo I, Shaoul R. Failure of sequential therapy to eradicate Helicobacter pylori in previously treated subjects. Helicobacter 2007; 12:645-7. [PMID: 18001409 DOI: 10.1111/j.1523-5378.2007.00558.x] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
BACKGROUND Recently, studies in adults and subsequently in children have demonstrated a very high success rate for sequential therapy as a primary therapy when compared to traditional therapy regimens. METHODS We report our experience with a sequential therapy regimen for the eradication of Helicobacter pylori in five infected children and a young adult, whose conventional therapy regimens had been unsuccessful. RESULTS Five patients failed the sequential therapy. All of them experienced between two and four failures of traditional therapy prior to the sequential treatment protocol. The only patient who succeeded on the sequential therapy had just one previous failure. All of our patients who had failed sequential therapy achieved eradication of the bacteria with quadruple therapy. CONCLUSIONS In view of our disappointing results, sequential therapy is unsuccessful as a therapy for children and young adults who have failed previous treatment regimens. At the present time, quadruple therapy is indicated for this group. Well-designed placebo-controlled trials are indicated to further characterize this group of patients.
Collapse
|
13
|
Abstract
Eradication therapy for Helicobacter pylori is recommended in a number of clinical conditions. In this article, we discuss the epidemiology and cellular mechanisms that result in antimicrobial resistance, the results of current eradication therapies, and new approaches to the management of Helicobacter pylori infection.
Collapse
Affiliation(s)
- Nimish Vakil
- Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
| | | |
Collapse
|
14
|
Abstract
Helicobacter pylori causes a serious bacterial infectious disease, and the expectations of therapy should reflect this fact. Increasing antibiotic resistance, especially to clarithromycin, has significantly undermined the effectiveness of legacy triple therapy consisting of a proton pump inhibitor, clarithromycin, and amoxicillin. Current cure rates are consistently below 80% intention-to-treat, the accepted threshold separating acceptable from unacceptable treatment results. Grading clinical studies into effectiveness categories using prespecified criteria would allow clinicians to objectively identify and compare regimens. We offer a therapy report card similar to that used to grade the performance of school children. The intention-to-treat cure rate categories are: F or unacceptable ( 80%), D or poor (81-84%), C or fair (85-89%), B or good (90-95%), and A or excellent (95-100%). The category of "excellent" is based on the cure rates expected with other prevalent bacterial infectious diseases. We propose that only therapies that score "excellent" (grade = A) should be prescribed. Regimens scoring as B or "good" can be used if "excellent" results are not obtainable. In most regions legacy triple therapy should be abandoned as unacceptable. Quadruple therapy and sequential therapy are reasonable alternatives for initial therapy.
Collapse
|
15
|
Lee YC, Wu HM, Chen THH, Liu TY, Chiu HM, Chang CC, Wang HP, Wu MS, Chiang H, Wu MC, Lin JT. A community-based study of Helicobacter pylori therapy using the strategy of test, treat, retest, and re-treat initial treatment failures. Helicobacter 2006; 11:418-24. [PMID: 16961802 DOI: 10.1111/j.1523-5378.2006.00432.x] [Citation(s) in RCA: 34] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/05/2023]
Abstract
BACKGROUND Although eradication of Helicobacter pylori infection can decrease the risk of gastric cancer, the optimal regimen for treating the general population remains unclear. We report the eradication rate (intention-to-treat and per protocol) of a community-based H. pylori therapy using the strategy of test, treat, retest, and re-treat initial treatment failures. MATERIALS AND METHODS In 2004, a total of 2658 residents were recruited for 13C-urea breath testing. Participants with positive results for infection received a standard 7-day triple therapy (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily), and a 10-day re-treatment (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and levofloxacin 500 mg once daily) if the follow-up tests remained positive. Both H. pylori status and side-effects were assessed 6 weeks after treatment. RESULTS Among 886 valid reporters, eradication rates with initial therapy were 86.9% (95% confidence interval [CI]: 84.7-89.1%) and 88.7% (95%CI: 86.5-90.9%) by intention-to-treat and per protocol analysis, respectively. Re-treatment eradicated infection in 91.4% (95%CI: 86-96.8%) of 105 nonresponders. Adequate compliance was achieved in 798 (90.1%) of 886 subjects receiving the initial treatment and in all 105 re-treated subjects. Mild side-effects occurred in 24% of subjects. Overall intention-to-treat and per protocol eradication rates were 97.7% (95%CI: 96.7-98.7%) and 98.8% (95%CI: 98.5-99.3%), respectively, which were only affected by poor compliance (odds ratio, 3.3; 95%CI, 1.99-5.48; p < .0001). CONCLUSIONS A comprehensive plan using drugs in which the resistance rate is low in a population combined with the strategy of test, treat, retest, and re-treat of needed can result in virtual eradication of H. pylori from a population. This provides a model for planning country- or region-wide eradication programs.
Collapse
Affiliation(s)
- Yi-Chia Lee
- Institute of Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan
| | | | | | | | | | | | | | | | | | | | | |
Collapse
|
16
|
Kawakami E, Machado RS, Ogata SK, Langner M, Fukushima E, Carelli AP, Bonucci VCG, Patricio FRS. Furazolidone-based triple therapy for H pylori gastritis in children. World J Gastroenterol 2006; 12:5544-9. [PMID: 17006997 PMCID: PMC4088242 DOI: 10.3748/wjg.v12.i34.5544] [Citation(s) in RCA: 17] [Impact Index Per Article: 0.9] [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 evaluate the furazolidone-based triple therapy in children with symptomatic H pylori gastritis.
METHODS: A prospective and consecutive open trial was carried out. The study included 38 patients with upper digestive symptoms sufficiently severe to warrant endoscopic investigation. H pylori status was defined based both on histology and on positive 13C-urea breath test. Drug regimen was a seven-day course of omeprazole, clarithromycin and furazolidone (100 mg, 200 mg if over 30 kg) twice daily. Eradication of H pylori was assessed two months after treatment by histology and 13C-urea breath test. Further clinical evaluation was performed 7 d, 2 and 6 mo after the treatment.
RESULTS: Thirty-eight patients (24 females, 14 males) were included. Their age ranged from 4 to 17.8 (mean 10.9 ± 3.7) years. On intent-to-treat analysis (n = 38), the eradication rate of H pylori was 73.7% (95% CI, 65.2%-82%) whereas in per-protocol analysis (n = 33) it was 84.8% (95% CI, 78.5%-91%). All the patients with duodenal ulcer (n = 7) were successfully treated (100% vs 56.2% with antral nodularity). Side effects were reported in 26 patients (68.4%), mainly vomiting (14/26) and abdominal pain (n = 13). Successfully treated dyspeptic patients showed improvement in 78.9% of H pylori-negative patients after six months and in 50% of H pylori-positive patients after six months of treatment.
CONCLUSION: Triple therapy with furazolidone achieves moderate efficacy in H pylori treatment. The eradication rate seems to be higher in patients with duodenal ulcer.
Collapse
Affiliation(s)
- Elisabete Kawakami
- Peptic Diseases Outpatient Clinic, Pediatric Gastroenterology Division, Universidade Federal do São Paulo/Escola Paulista de Medicina, São Paulo SP, Brazil
| | | | | | | | | | | | | | | |
Collapse
|
17
|
Graham DY, Abudayyeh S, El-Zimaity HMT, Hoffman J, Reddy R, Opekun AR. Sequential therapy using high-dose esomeprazole-amoxicillin followed by gatifloxacin for Helicobacter pylori infection. Aliment Pharmacol Ther 2006; 24:845-50. [PMID: 16918889 DOI: 10.1111/j.1365-2036.2006.03072.x] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
BACKGROUND The success rate of current anti-Helicobacter pylori triple therapies in now generally 80% or less. Sequential therapy has proved superior. AIM To test a new sequential therapy for H. pylori eradication. METHODS This was a pilot study of a sequential therapy consisting of 40 mg of esomeprazole and 1 g amoxicillin t.d.s., for 12 days. On days 6 through 12 gatifloxacin (400 mg in the morning) was added. Outcome was accessed 4 or more weeks after ending antibiotic therapy. Both naive and treatment failures were eligible. RESULTS Thirty patients were entered in the study. One was lost to follow-up and one stopped early because of side effects. The success rate intention-to-treat was 80% (95% CI: 61-92%). The per-protocol eradication rate was 85.7% (95% CI: 67-95%); two of the four failures had pre-treatment gatifloxacin-resistant H. pylori. Side effects were reported by 13 patients (46%) and were generally mild with diarrhoea being most common (n = 6). Only one patient stopped medicine because of side effects of dizziness (severe) and diarrhoea (mild). CONCLUSIONS Sequential therapy using the combination of a high dose of proton-pump inhibitor and amoxicillin followed gatifloxacin was effective, but pre-treatment susceptibility testing may become necessary as fluoroquinolone resistance increases.
Collapse
Affiliation(s)
- D Y Graham
- VAMC and Baylor College of Medicine, Houston, TX 77030, usa.
| | | | | | | | | | | |
Collapse
|
18
|
|
19
|
Francavilla R, Lionetti E, Castellaneta SP, Magistà AM, Boscarelli G, Piscitelli D, Amoruso A, Di Leo A, Miniello VL, Francavilla A, Cavallo L, Ierardi E. Improved efficacy of 10-Day sequential treatment for Helicobacter pylori eradication in children: a randomized trial. Gastroenterology 2005; 129:1414-9. [PMID: 16285942 DOI: 10.1053/j.gastro.2005.09.007] [Citation(s) in RCA: 86] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2005] [Accepted: 07/27/2005] [Indexed: 02/08/2023]
Abstract
BACKGROUND & AIMS The currently recommended first-line eradication treatment of Helicobacter pylori in children is usually successful in about 75%. Recently, in adults, a novel 10-day sequential treatment has achieved an eradication rate of 95%. The aim of the study was to assess the H pylori eradication rate of the sequential treatment regimen compared with conventional triple therapy in children. METHODS Seventy-eight consecutive children with H pylori infection were randomized to receive either sequential treatment (omeprazole plus amoxicillin for 5 days, followed by omeprazole plus clarithromycin plus tinidazole for another 5 days) (n = 38; 15 boys [39.5%]; median age, 11.0 years [range, 3.3-16 years]) or triple therapy (omeprazole, amoxicillin, and metronidazole) for 1 week (n = 37; 15 boys [40.5%]; median age, 9.9 years [range, 4.3-16 years]). H pylori infection was based on 2 out of 3 positive tests results: 13C-urea breath test, rapid urease test, and histologic analysis. Eradication was assessed by 13C-urea breath test 8 weeks after therapy. RESULTS Seventy-four patients completed the study. H pylori eradication was achieved in 36 children receiving sequential treatment (97.3%; 95% confidence interval, 86.2-99.5) and 28 children receiving triple therapy (75.7%; 95% confidence interval, 59.8-86.7) (P < .02). Compliance with therapy was good (>95%) in all. CONCLUSIONS Our study shows, for the first time in children, that 10-day sequential treatment achieves a higher eradication rate than standard triple therapy, which is consistent with the results of adult studies.
Collapse
Affiliation(s)
- Ruggiero Francavilla
- Department of Biomedicina dell'Età Evolutiva, Università degli Studi di Bari, Bari, Italy.
| | | | | | | | | | | | | | | | | | | | | | | |
Collapse
|
20
|
Abstract
The efficacy of established Helicobacter pylori regimes needs to be reviewed. In view of drug resistance, side effects, and compliance and expense of therapy, treatment failure is increasing and second-line treatment strategies need to be developed. A simulation model suggested by the Cochrane review group showed that H. pylori eradication is cost-effective for duodenal and gastric ulcer long-term. The duration of eradication therapy continues to be controversial. In Europe and other parts of the world, 7-day triple regimes are used, whereas guidelines from the United States recommend 10-14 days of therapy. Antibiotic resistance is a major factor affecting the outcome of eradication therapy. New modified eradication regimes involve substitution of antibiotics used in conjunction with other drugs. The newer generation fluoroquinolones have shown some promise as part of an eradication regimen. Quadruple therapy (bismuth, proton pump inhibitor [PPI] and two antibiotics and sequential treatment [PPI with three antibiotics]) are promising first-line treatments. Novel agents have been tried, but with disappointing results. New drugs and administration forms have been reported but their efficacy needs confirmation.
Collapse
Affiliation(s)
- Peter Bytzer
- Department of Medical Gastroenterology, Glostrup University Hospital, DK-2600 Glostrup, Denmark.
| | | |
Collapse
|
21
|
Calvet X, Ducons J, Bujanda L, Bory F, Montserrat A, Gisbert JP. Seven versus ten days of rabeprazole triple therapy for Helicobacter pylori eradication: a multicenter randomized trial. Am J Gastroenterol 2005; 100:1696-701. [PMID: 16086704 DOI: 10.1111/j.1572-0241.2005.50019.x] [Citation(s) in RCA: 39] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
BACKGROUND Ten-day triple therapy is somewhat more effective than 7-day treatment for curing Helicobacter pylori infection. Recent studies have suggested that rabeprazole-a proton pump inhibitor with fast onset of acid inhibition-could raise the efficacy of 7-day therapies to the levels obtained with 10-day treatment. OBJECTIVE To compare the efficacy of 7- and 10-day rabeprazole-based triple therapy for H. pylori eradication. PATIENTS AND METHODS Four hundred and fifty-eight patients were randomized to 7 or 10 days of triple therapy, including rabeprazole 20 mg, clarithromycin 500 mg, and amoxicillin 1 g, all twice a day. Cure rates were evaluated by urea breath test. RESULTS Two hundred and thirty-seven patients received 7-day and 221 received 10-day therapy. Groups were comparable in terms of demographic variables. Intention to treat cure rates were 73.8% (95% CI: 67-79%) for 7-day and 79.6% (95%: CI:74-85%) for 10-day therapy (p= 0.09). Per-protocol cure rates were 81.8% (95% CI:76-86%) and 89.3% (95% CI: 84-93%), p= 0.02, respectively. Cure rates were similar in peptic ulcer patients but in subjects without ulcer they were clearly lower for 7-day therapy: 66%versus 77% by intention to treat (p= 0.08) and 73%versus 91% in the per-protocol analysis (p= 0.004). Side effects and compliance in the two groups were comparable. CONCLUSIONS Seven- and 10-day triple therapies seem equally efficient in peptic ulcer patients. In contrast, 7-day therapy is significantly less effective in nonulcer dyspepsia patients. Ten-day therapy, therefore, seems preferable when treating nonulcer patients.
Collapse
Affiliation(s)
- X Calvet
- Digestive Diseases Unit, Hospital de Sabadell, Barcelona, Spain
| | | | | | | | | | | |
Collapse
|
22
|
McLoughlin RM, O'Morain CA, O'Connor HJ. Eradication of Helicobacter pylori: recent advances in treatment. Fundam Clin Pharmacol 2005; 19:421-7. [PMID: 16011728 DOI: 10.1111/j.1472-8206.2005.00340.x] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
Helicobacter pylori plays a key role in dyspepsia, peptic ulcer disease, and gastric neoplasia and eradication of the infection has become an important treatment goal in clinical practice. Seven-day proton-pump inhibitor-amoxicillin-clarithromycin triple therapy is the current first-line therapy for H. pylori but eradication rates are compromised by poor compliance and antibiotic resistance. Ten-day sequential treatment may emerge as an alternative first-line therapy. Bismuth-based quadruple therapy is the second-line regimen of choice. Antimicrobial sensitivity testing is not recommended in the routine management of H. pylori infection. Novel triple-therapy regimens containing rifabutin, levofloxacin, or furazolidone may be useful alternatives as second- or third-line therapy.
Collapse
Affiliation(s)
- Ramona M McLoughlin
- Department of Gastroenterology, Adelaide and Meath Hospital, Tallaght, Dublin 24 and Faculty of Health Sciences, Trinity College, Dublin, Ireland
| | | | | |
Collapse
|
23
|
Zullo A, Gatta L, De Francesco V, Hassan C, Ricci C, Bernabucci V, Cavina M, Ierardi E, Morini S, Vaira D. High rate of Helicobacter pylori eradication with sequential therapy in elderly patients with peptic ulcer: a prospective controlled study. Aliment Pharmacol Ther 2005; 21:1419-24. [PMID: 15948808 DOI: 10.1111/j.1365-2036.2005.02519.x] [Citation(s) in RCA: 68] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Abstract
BACKGROUND Helicobacter pylori eradication rates with triple therapies are decreasing, and few data in elderly patients are available. A 10-day sequential regimen succeeded in curing such H. pylori infection in unselected patients. AIM To compare this sequential regimen and the standard triple therapy for H. pylori eradication in geriatric patients with peptic ulcer. METHODS Overall, 179 H. pylori-infected patients with peptic ulcer were enrolled (mean age: 69.5 years; range: 65-83). Patients were randomized to 10-day sequential therapy (rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg, clarithromycin 500 mg and tinidazole 500 mg, all b.d., for the remaining 5 days) or standard 7-day triple regimen (rabeprazole 20 mg, clarithromycin 500 mg and amoxicillin 1 g, all b.d.). Helicobacter pylori status was assessed by histology and rapid urease test at baseline and 4-6 weeks after completion of treatment. RESULTS The sequential regimen achieved eradication rates significantly higher in comparison with the standard regimen at both intention-to-treat (94% vs. 80%; P = 0.008) and per-protocol (97% vs. 83%; P = 0.006) analyses. In both treatment groups, compliance to the therapy was high (> 95%), and the rate of mild side-effects was similarly low (< 12%). At repeated upper endoscopy, peptic ulcer lesions were healed in 97% patients, without a statistically significant difference between the sequential regimen and the standard triple therapy. CONCLUSIONS In elderly patients with peptic ulcer disease, the 10-day sequential treatment regimen achieved significantly higher eradication rates in comparison with standard triple therapy.
Collapse
Affiliation(s)
- A Zullo
- Gastroenterology and Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.
| | | | | | | | | | | | | | | | | | | |
Collapse
|