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Su1696 Efficacy of Second-Line Treatment for Helicobacter pylori Infection: Moxifloxacin-Containing Triple Therapy vs. Bismuth-Containing Quadruple Therapy
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Metaanalysis: Moxifloxacin Triple Therapy for First-Line and Rescue Treatment of Helicobacter pylori Infection Stephan Miehlke, Gerta Rücker, Susanne Krasz, Andrea Morgner, Joachim Labenz
Levofloxacin, Metronidazole and Lansoprazole Triple Therapy Compared to Quadruple Therapy as a Second Line Treatment of Helicobacter pylori Infection Ji Yoon Moon, Gwang Ha Kim, Mun Ki Choi, Bong Eun Lee, Chul Soo Song, Geun Am Song
Background: Moxifloxacin triple therapy (MTT) has shown promising results in first-line and rescue therapy of H. pylori infection. Aims: To systematically review the efficacy and tolerability of MTT for first-line and rescue treatment of H. pylori infection, and to compare MTT with standard triple therapy (STT) and with bismuth quadruple therapy (BQT), respectively. Methods: By searching PubMed and the Cochrane Central Registry of Controlled Trials, randomized controlled trials (RCT) and other studies reporting eradication rates of MTT were identified. Metaanalyses of RCT comparing first-line MTT with STT and RCT comparing rescue MTT with BQT were performed and pooled intention-to-treat eradication rates and risk ratios (RR) with 95% confidence intervals were calculated. Results: We identified 16 studies (2481 patients) including three RCT comparing MTT with STT and five RCT comparing MTT with BQT. Pooled estimates revealed similar efficacy (RR 1.06; 0.91-1.23) and similar tolerability (RR 0.61; 0.25-1.48) of first-line MTT and STT. Rescue MTT was superior over BQT in terms of efficacy (RR 1.20; 1.07-1.36) and tolerability (RR 0.41; 0.25-0.67). Considering all MTT arms, the ITT eradication rate was 79% (72-86%) in first-line therapy and 77% (72-82%) in rescue therapy. The adverse event rate of MTT was 18.5% in first-line therapy and 18.7% in rescue therapy. Conclusions: Moxifloxacin triple therapy is superior to bismuth quadruple therapy for rescue treatment of H. pylori infection, but does not appear to offer an advantage over standard triple therapy in firstline treatment.
Background Several rescue therapies have been recommended to eradicate Helicobacter pylori (H. pylori) infection in patients with first eradication failure, but they still fail in more than 20% of the cases. Aim To evaluate the efficacy and safety of levofloxacin, metronidazole and lansoprazole triple therapy compared to quadruple therapy as a second line treatment of H. pylori infection. Methods A total of 123 patients who failed first line triple therapy for H. pylori infection were randomly assigned to 2 groups; (i) levofloxacin, metronidzole and lansoprazole (LML) for 7 days, (ii) tetracycline, bismuth subcitrate, metronidazole and lansoprazole (quadruple) for 7 days. Successful eradication was defined as a negative 13Curea breath test 6-8 wk after completion of treatment. Results Of 123 patients, 56 patients were enrolled to LML group and 57 patients to quadruple group. According to intentionto-treat analysis, the infection was eradicated in 38/56 (67.9%) patients in the LML group and 48/57 (84.2%) in the quadruple group (P = 0.042). Per-protocol analysis showed successful eradication in 38/52 (73.1%) patients from the LML group and 48/52 (92.3%) from the quadruple group (P = 0.010). There were no significant differences in the side effects experienced by the patients in the two treatment groups. Conclusion LML triple therapy is considered as a second line treatment of H. pylori infection. However, it would be less effective than quadruple therapy.
Su1693 Lactobacillus Reuteri Improves the Eradication Rate of Helicobacter pylori Cesare Efrati, Giorgia Nicolini, Claudio Cannaviello Several studies report an inhibitory effect of probiotics on Helicobacter pylori. In particular, Lactobacillus Reuteri (LR) exerts a competition of binding to glycolipid receptor of and suppresses H. pylori urease activity. The aim of this study is to evaluate whether adding LR to antibiotic therapy may improve the H. pylori eradication rate. The H. pylori infection was diagnosed in 90 adult dyspeptic patients. Patients were excluded if previously treated for H. pylori infection and if they were taking PPI, H2-receptor antagonist or antibiotics in the four weeks preceding the study. Patients were assigned to receive one of the following therapies: (a) 7- day triple (PPI plus clarithromycin and amoxicillin or metronidazole) plus LR supplementation during the antibiotic treatment; (b) 7-day triple plus LR supplementation after the antibiotic treatment; (c) sequential regimen (5-day PPI plus amoxicillin therapy followed by a 5-day PPI, clarithromicin and tinidazole) plus LR supplementation during the antibiotic treatment; (d) sequential regimen plus LR supplementation after the antibiotic treatment. Successful eradication therapy was defined as a negative UBT performed at least 4 weeks following the eradication treatment. Eighty-three patients (30 males and 53 females; mean age 57 ± 13 years) completed the study. Nineteen patients were administrated a 7day triple treatment: 11 with LR supplementation during and 8 after therapy. Sixty-four patients were administered sequential regimen: 32 with LR supplementation during and 32 after therapy. At the end of the study, the whole eradication rate with the LR supplementation was 82% versus 74-76 % reported in literature without probiotics. Furthermore, in our population the eradication rate was significantly higher in the sequential group compared with the 7-day triple (88 % vs 63 %; p = 0.01). The results of our study confirmed that as the first-line, the sequential therapy seems more efficiency than standard 7-day, in the H. pylori eradication. The LR supplementation appears improve the H. pylori eradication rate, although large, double-bind, controlled studies are needed to confirm these results.
Su1696 Efficacy of Second-Line Treatment for Helicobacter pylori Infection: Moxifloxacin-Containing Triple Therapy vs. Bismuth-Containing Quadruple Therapy Kwang Hyun Chung, Dong Ho Lee, Nayoung Kim, Cheol Min Shin, Jin Hyeok Hwang, Sang Hyub Lee, Donghyeon Lee, Hong Sang Oh, Eun Hyo Jin
Su1694 Meta-Analysis of Levofloxacin-Containing Triple Therapy vs. BismuthContaining Quadruple Therapy as Second-Line Treatment in the Eradication of Helicobacter pylori Alicia C Marin, Adrian G. McNicholl, Javier P. Gisbert
BACKGROUNDS: Although there are various retreatment strategies for treatment failure of Helicobacter pylori infection, optimal retreatment regimen is not established and eradication rate varies depending on regions and populations. The purpose of this study is to compare the efficacy of moxifloxacin-containing triple therapy with bismuth-containing quadruple therapy. METHODS: Between January 1st, 2010 and September 30th, 2011, a total of 101 patients were confirmed to initial treatment failure by urea breath test performed 4 weeks or longer after completion of therapy. Initial treatment regimens were triple therapy (rabeprazole 20 mg bid, clarithromycin 500 mg bid and amoxicillin 1000 mg bid for 7 days; n = 48), sequential therapy (rabeprazole 20 mg bid plus amoxicillin 1000 mg bid for 5 days followed by rabeprazole 20 mg bid plus clarithromycin 500 mg bid and metronidazole 500 mg bid for 5 more days; n = 21) and concomitant therapy (Rabeprazole 20 mg bid, clarithromycin 500 mg bid, amoxicillin 1000 mg bid and metronidazole 500 mg bid for 14 days; n = 30). The efficacies of second-line treatment regimens were compared which were moxifloxacin-containing triple therapy (rabeprazole 20 mg bid plus amoxicillin 1000 mg bid and moxifloxacin 400 mg qd for 7 days) and bismuth-containing quadruple therapy (rabeprazole 20 mg bid, tetracycline 500 mg qid, metronidazole 500 mg tid, and tripotassium dicitrato bismuthate 300 mg qid for 7 days). Eradication was confirmed by urea breath test performed 4 weeks or longer after completion of therapy. RESULTS: In the 48 patients who failed initially with triple therapy, 9 patients were treated with moxifloxacin-containing triple therapy and 37 patients were treated with bismuth-containing quadruple therapy. Eradication rates were 4/9 (44.4%) and 29/37 (78.4%). All the patients who initially failed with sequential therapy were treated with moxifloxacin-containing triple therapy and eradication rate was 12/21 (57.1%). 28 of 30 patients who initially failed with concomitant therapy were treated with moxifloxacin-containing triple therapy and eradication rate was 17/28 (60.7%). Overall eradication rate of second-line treatment with moxifloxacin-containing triple therapy and bismuth-containing quadruple therapy were 34/59 (57.6%) and 29/37 (78.4%), respectively (P = 0.037). There were no differences in frequency of non-compliance and adverse effects. CONCLUSIONS: Moxifloxacin-containing triple therapy, which is widely used in patients who were initially failed with concomitant or sequential regimen, produced unacceptably low eradication rate. The eradication rate of bismuth-containing quadruple therapy (78.4%)
BACKGROUND: After one Helicobacter pylori eradication failure, the most recommended rescue option has been the bismuth-containing quadruple therapy (BQT). Levofloxacincontaining triple therapy (LTT) has been presented as an alternative option. AIM: To conduct a meta-analysis of studies comparing the efficacy and safety of LTT versus BQT in the eradication of H. pylori after one treatment failure. METHODS Selection of studies: randomized controlled trials comparing LTT and BQT after one H. pylori eradication failure. Search strategy: electronic and manual bibliographical searches. Data synthesis: intention-to-treat eradication rate and adverse events rate. RESULTS: 13 studies were included, with a total of 1709 patients (1011 in the LTT and 698 in the BQT). The overall analysis showed a tendency towards better eradication results for LTT (79% vs. 70%;OR=1.43;95%C.I.=0.882.31;p=0.15;I2=72%) with a significantly lower rate of adverse effects (14% vs. 32%;OR= 0.30;95%C.I.=0.19-0.50;p<0.001;I2=46%) and serious adverse effects (0.7% vs. 7.8%;OR= 0.15; 95%C.I.=0.04-0.59;p=0.007;I2=0%). There were 2 outlying studies showing better results for BQT, what may be explained because both studies used a 7 (instead of 10) day LTT. Excluding these studies, heterogeneity was reduced and results improved for LTT (81% vs. 68%;OR=1.88;95%C.I.=1.27-2.79;p=0.002;I2=52%). As LTT showed better efficacy in ten days courses than in seven days (89% vs. 70%), a subanalysis including only 10 day LTT with levofloxacin, amoxicillin and PPI studies showed an even better efficacy for LTT compared with BQT (89% vs. 66%;OR=4.22; 95%C.I.=2.84-6.26;p<0.001;I2=0%;NNT=4). CONCLUSION: The meta-analysis performed demonstrates that ten day LTT is more effective and better tolerated than BQT, as a second-line rescue option for H. pylori eradication.
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AGA Abstracts
AGA Abstracts
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is superior to moxifloxacin-containing triple therapy (57.6%), but both results are unsatisfactory. Further studies are needed to find more effective alternative regimens.
analysis, 10-day hybrid therapy achieved 94.6% eradication rate, while 12-day hybrid therapy can maintain grade A (>95%) eradication rate as 14-day hybrid therapy (97.1% vs. 97.1%). Conclusion: For hybrid therapy, shorter treatment period to 12 days (esomeprazole and amoxicillin for 5 days followed by esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can maintain greater than 95% eradication rate, either by intention-to-treat or by per-protocol analysis.
AGA Abstracts
Su1697 Final Data of a New Electrochemical Device That Enables Rapid and Accurate Detection of Helicobacter pylori Infection Helmut Neumann, Stefan Foertsch, Bianca Ritter, Michael Vieth, Rainer Kuth, Markus F. Neurath
Su1700 Tailored Therapy Based on Dpo Multiplex PCR Improves Helicobacter pylori Eradication Rate Chang-Il Kwon, Han Gyung Seon, Sang Pil Yun, Harry Yoon, Jeong Guil Lee, Kwang Hyun Ko, Sung-Pyo Hong, Pil Won Park
Introduction: Helicobacter pylori (H. pylori) infection affects about 30-50% of adults in developed countries and causes persistent gastric infection and chronic inflammation. H. pylori infection is a major cause of gastric ulcer disease and gastric cancer. Diagnostic tests include histology, rapid urease test (RUT), breath tests and stool antigen tests. Previously, we have introduced a new electrochemical device for rapid H. pylori detection. Aims: To prospectively evaluate the newly developed electrochemical device for H. pylori detection in the clinical setting. Material & Methods: Seventy consecutive patients (43 female, 27 male; mean age 65 years, range 26-85 years) were included. The electrochemical device for H. pylori detection consists of a working and reference electrode between which a biopsy sample was administered. Acquired voltage-values between both electrodes were analysed for characteristics typical for H. pylori infection (ammonia). According to Sydney classification, biopsies were taken from gastric antrum and corpus for electrochemical H. pylori detection, RUT and immunohistochemistry (IHC). RUT results were evaluated after 24 hours. Every patient received 13C-urea breath test. Detection rates for H. pylori were analysed blinded to IHC results, which was designated as the gold standard of H. pylori diagnosis. Results: IHC had a sensitivity, specificity and accuracy of 100%. RUT analysis and 13C-urea breath test received both a sensitivity of 100% and a specificity of 92% and 95%, respectively. Accuracy of RUT was 93% and 96% for 13C-urea breath test. The new electrochemical H. pylori detection method showed a sensitivity of 100%, specificity of 94% and accuracy of 94%, respectively. Definitive results for H. pylori detection with the new device were available within 10 seconds. Conclusion: The new developed electrochemical H. pylori detection method allows rapid and accurate detection of the infection and has therefore the potential to improve H. pylori diagnosis and treatment.
Background and Aims: The eradication rate of Helicobacter pylori (H. pylori) has gradually decreased. One of the major risk factors for treatment failure was thought to be clarithromycinresistant H. pylori groups. The present study aimed to assess the outcome of tailored eradiaction therapy according to clarithromycin susceptibility identified by dual-priming oligonucleotide (DPO)-based multiplex PCR. Methods: A retrospective cohort study was conducted in an academic referral medical center in a region where H. pylori clarithromycin resistance is highly prevalent. 87 H. pylori infected patients (mean age 58.4 years) were enrolled in the tailored group and 482 H. pylori infected patients (mean age 53.1 years) were enrolled in the control group. They were naïve to H. pylori eradication treatment, and had undergone endoscopy and has been diagnosed with peptic ulcer disease or early gastric cancer. To examine clarithromycin resistance, two biopsy samples were obtained from the gastric antrum and DPO multiplex PCR was performed to detect point mutations in 23S rRNA gene of H. pylori within hours. In the tailored group, patients with clarithromycin-sensitive strains (wild type) were given PPI + amoxicillin + clarithromycin therapy, and those with clarithromycinresistant strains (mutant type) were given PPI + tetracycline + bismuth + metronidazole therapy. In the control group, all patients were given PPI + amoxicillin + clarithromycin therapy. Urea breath test (UBT) was performed to assess eradication therapy at 1 month after eradication. Results: In the tailored group, wild type was diagnosed in 69 patients (79.3%) and mutant type was diagnosed in 18 patients (20.7%). Point mutation at A2143G was present in 18 patients, whereas, point mutations at A2142G or A2142C were not found. The overall eradication rate was 73.5% (64 of 87) - 68.1% (47 of 69) in the clarithromycinsensive H. pylori, 95% (17 of 18) in the clarithromycin-resistant H. pylori group, respectively. The eradication rate in the tailored group was significantly higher than the control group (73.5% vs 58%). Conclusion: The infection rate of genotypically clarithromycin resistant H. pylori was 20.7% in our result. Tailored eradication therapy with DPO multiplex PCR exam can be highly effective and benefitial in clarithromycin-resistant H. pylori prevalent areas.
Su1698 Comparison of Ten-Day, Fifteen-Day Sequential Therapy and Proton-Pump Inhibitor-Based Triple Therapy in Korea: A Prospective Randomized Study Nayoung Kim, Ryoung Hee Nam, Jae Yeon Kim, Mi Kyoung Lee, Jung Won Lee Background and Aims: The eradication rate of proton-pump inhibitor (PPI)-based triple therapy for H. pylori infection has decreased mainly due to increase of clarithromycin resistance. The aim of this study was to compare the efficacy of 10-, 15-day sequential therapy and PPI triple therapy as the first-line treatment for eradication of H. pylori in Korea. Methods: A total of 111 patients with H. pylori infection randomized to receive one of three kinds of eradication therapy prospectively: 10-day (n=34) and 15-day sequential therapy (n=33) (40mg of esomeprazole and 1g of amoxicillin, twice daily for the first 5 days, followed by 40mg of esomeprazole, 500mg of clarithromycin, and 500mg of metronidazole, twice daily for the remaining 5 days or 10 days); 7-day triple therapy (n=34) (40mg of esomeprazole, 500mg of clarithromycin, and 1g of amoxicillin, twice daily for 7 days). Eradication was evaluated by the (13) C-urea breath test 4 weeks after completion of treatment. Compliance and adverse events were assessed. H. pylori culture with MIC test was performed in part of enrolled patients for clarithromycin and metronidazole with agar dilution method before treatment. Results: The eradication rates of 10-, 15-day sequential therapy and PPI-based triple therapy were 64.7% (22/34), 63.6% (21/33) and 67.6% (23/34) by intention to treat analysis, respectively (P=0.732), and 78.6% (22/28), 84.0% (21/25) and 79.3% (23/29) by per protocol analysis, respectively (P=0.874). Compliance (>85%) of these three therapies were 93.1%, 88.0% and 96.6%, respectively, and adverse events occurred in 44.8%, 46.4% and 20.7%, respectively (P=0.077). Two patients having H. pylori with resistance to metronidazole and/or clarithromycin were not eradicated by 10 and 15-day sequential therapy, respectively. However, two patients having H. pylori with sensitive to both antibiotics were eradicated by 10 and 15-day sequential therapy, respectively. Conclusion: There was no significant advantage of 10- or 15-day sequential therapy against PPI triple therapy as a first-line treatment for H. pylori infection in Korea, so far. Further enrollment is going on.
Su1701 Influence of Helicobacter pylori Eradication on the Management of Type 2 Diabetes Masao Akanuma, Ayako Yanai, Kei Sakamoto, Yoshihiro Hirata, Yutaka Yamaji, Shin Maeda Objective: Helicobacter pylori eradication therapy has been widely performed. In addition, the number of patients with type 2 diabetes is increasing worldwide. The aim of this study was to understand the influence of H. pylori eradication therapy on the management of type 2 diabetes. Methods: A total of 174 patients with type 2 diabetes who did not have an active peptic ulcer or serious complications and were cured successfully of their H. pylori infection at our institute were included in this study. The time course of mean glycosylated hemoglobin (HbA1c) values and body mass index (BMI) during the year before and after H. pylori eradication were assessed by a paired Student's t-test. The cumulative incidence of intensified diabetes treatments during the 6 months before and after H. pylori eradication was compared using the log-rank test. Results: No significant changes in mean HbA1c values were observed during the year before or after eradication. However, the mean BMI, which did not change during the year before eradication, increased significantly at 6 months (23.1 ± 2.6 kg/m2, P < 0.05) and 12 months (23.1 ± 2.7 kg/m2, P < 0.05) after eradication as compared with the time point of eradication (22.9 ± 2.6 kg/m2). Although the result did not reach statistical significance, diabetes treatments after H. pylori eradication had a stronger tendency to be intensified than those before eradication (P = 0.0709). Conclusion: H. pylori eradication significantly increased BMI but not HbA1c in patients with type 2 diabetes, despite diabetes treatment.
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Optimal Duration to Maintain Greater Than 95% Eradication Rate in Hybrid Therapy for H. pylori Jeng-Yih Wu, Ping-I Hsu, Deng-Chyang Wu, David Graham
A Systematic Review and Meta-Analysis of Performance of Sequential Therapy in Clinical Trial on NaïVE Adult and Children Infected With H. pylori Luigi Gatta, Chiara Ricci, Valentina Castelli, Angelo Zullo, Dino Vaira
Background: Although 10-day sequential therapy is effective therapy in several studies, most of the studies did not reach grade A (>95%) eradication rate. Higher eradication rate (99.1% by per-protocol analysis and 97.4% by intention-to-treat analysis) was reported by a 14day sequential-concomitant hybrid therapy (esomeprazole and amoxicillin for 7 days followed by esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days). However, it is not very clear whether >95% eradication rate (Grade A) is maintained with therapy shorter than 14 days in hybrid therapy. Aim: The goal of this study is to evaluate the eradication rate in different treatment duration of hybrid therapy. Materials and methods: This multicenter, pilot study was designed into 3 groups, 10-day, 12-day, and 14-day hybrid therapy (esomeprazole and amoxicillin for 3 days, 5 days, 7 days respectively, then followed by esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days). Patients infected with H. pylori randomly received a 10-day, 12-day, or 14-day hybrid therapy. H. pylori status was assessed 8 weeks after therapy. Success was defined as achieving 95% or greater eradication by per-protocol (PP) analysis. Results: Totally, 115 patients were enrolled in this study. Forty-one, thirty-six, thirty-eight patients were randomized to 10-day, 12-day, and 14-day hybrid therapy, respectively. For intention-to-treat analysis, the eradication rate was 92.7%, 97.2%, and 92.1% in 10-day, 12-day, and 14-day hybrid therapy. By per-protocol
AGA Abstracts
Aim: to perform a systematic review and meta-analysis of the eradication rate of sequential therapy in naïve adult and children with HP. Data sources: MEDLINE, EMBASE, and the Cochrane central register of controlled trials were searched (up to November 2011), as well as abstracts from the major US, European and Asian gastroenterology conferences. Eligibility criteria for selecting studies: superiority RCTs or CCTs with a parallel group design comparing sequential therapy in adult and children never treated before for HP. No language restriction was used. Study appraisal and synthesis methods: Eradication data according to ITT analysis were pooled using a random effects model and reported as RR of eradicating HP with 95% CIs. Planned subgroup analysis included performance in patient with PUD and NUD, sideeffect, quality of the study according to the Jadad scale, type of study and country of origin. Assessment of risk of bias was performed by recording method used to generate the randomization schedule and conceal allocation, whether blinding was implemented, what proportion of patients completed follow-up, whether an intention-to-treat analysis was extractable, and whether there was evidence of selective reporting of outcomes. Funnel plots was assessed for evidence of asymmetry, publication bias or other small study effects were
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Metaanalysis: Moxifloxacin Triple Therapy for First-Line and Rescue Treatment of Helicobacter pylori Infection Stephan Miehlke, Gerta Rücker, Susanne Krasz, Andrea Morgner, Joachim Labenz
Levofloxacin, Metronidazole and Lansoprazole Triple Therapy Compared to Quadruple Therapy as a Second Line Treatment of Helicobacter pylori Infection Ji Yoon Moon, Gwang Ha Kim, Mun Ki Choi, Bong Eun Lee, Chul Soo Song, Geun Am Song
Background: Moxifloxacin triple therapy (MTT) has shown promising results in first-line and rescue therapy of H. pylori infection. Aims: To systematically review the efficacy and tolerability of MTT for first-line and rescue treatment of H. pylori infection, and to compare MTT with standard triple therapy (STT) and with bismuth quadruple therapy (BQT), respectively. Methods: By searching PubMed and the Cochrane Central Registry of Controlled Trials, randomized controlled trials (RCT) and other studies reporting eradication rates of MTT were identified. Metaanalyses of RCT comparing first-line MTT with STT and RCT comparing rescue MTT with BQT were performed and pooled intention-to-treat eradication rates and risk ratios (RR) with 95% confidence intervals were calculated. Results: We identified 16 studies (2481 patients) including three RCT comparing MTT with STT and five RCT comparing MTT with BQT. Pooled estimates revealed similar efficacy (RR 1.06; 0.91-1.23) and similar tolerability (RR 0.61; 0.25-1.48) of first-line MTT and STT. Rescue MTT was superior over BQT in terms of efficacy (RR 1.20; 1.07-1.36) and tolerability (RR 0.41; 0.25-0.67). Considering all MTT arms, the ITT eradication rate was 79% (72-86%) in first-line therapy and 77% (72-82%) in rescue therapy. The adverse event rate of MTT was 18.5% in first-line therapy and 18.7% in rescue therapy. Conclusions: Moxifloxacin triple therapy is superior to bismuth quadruple therapy for rescue treatment of H. pylori infection, but does not appear to offer an advantage over standard triple therapy in firstline treatment.
Background Several rescue therapies have been recommended to eradicate Helicobacter pylori (H. pylori) infection in patients with first eradication failure, but they still fail in more than 20% of the cases. Aim To evaluate the efficacy and safety of levofloxacin, metronidazole and lansoprazole triple therapy compared to quadruple therapy as a second line treatment of H. pylori infection. Methods A total of 123 patients who failed first line triple therapy for H. pylori infection were randomly assigned to 2 groups; (i) levofloxacin, metronidzole and lansoprazole (LML) for 7 days, (ii) tetracycline, bismuth subcitrate, metronidazole and lansoprazole (quadruple) for 7 days. Successful eradication was defined as a negative 13Curea breath test 6-8 wk after completion of treatment. Results Of 123 patients, 56 patients were enrolled to LML group and 57 patients to quadruple group. According to intentionto-treat analysis, the infection was eradicated in 38/56 (67.9%) patients in the LML group and 48/57 (84.2%) in the quadruple group (P = 0.042). Per-protocol analysis showed successful eradication in 38/52 (73.1%) patients from the LML group and 48/52 (92.3%) from the quadruple group (P = 0.010). There were no significant differences in the side effects experienced by the patients in the two treatment groups. Conclusion LML triple therapy is considered as a second line treatment of H. pylori infection. However, it would be less effective than quadruple therapy.
Su1693 Lactobacillus Reuteri Improves the Eradication Rate of Helicobacter pylori Cesare Efrati, Giorgia Nicolini, Claudio Cannaviello Several studies report an inhibitory effect of probiotics on Helicobacter pylori. In particular, Lactobacillus Reuteri (LR) exerts a competition of binding to glycolipid receptor of and suppresses H. pylori urease activity. The aim of this study is to evaluate whether adding LR to antibiotic therapy may improve the H. pylori eradication rate. The H. pylori infection was diagnosed in 90 adult dyspeptic patients. Patients were excluded if previously treated for H. pylori infection and if they were taking PPI, H2-receptor antagonist or antibiotics in the four weeks preceding the study. Patients were assigned to receive one of the following therapies: (a) 7- day triple (PPI plus clarithromycin and amoxicillin or metronidazole) plus LR supplementation during the antibiotic treatment; (b) 7-day triple plus LR supplementation after the antibiotic treatment; (c) sequential regimen (5-day PPI plus amoxicillin therapy followed by a 5-day PPI, clarithromicin and tinidazole) plus LR supplementation during the antibiotic treatment; (d) sequential regimen plus LR supplementation after the antibiotic treatment. Successful eradication therapy was defined as a negative UBT performed at least 4 weeks following the eradication treatment. Eighty-three patients (30 males and 53 females; mean age 57 ± 13 years) completed the study. Nineteen patients were administrated a 7day triple treatment: 11 with LR supplementation during and 8 after therapy. Sixty-four patients were administered sequential regimen: 32 with LR supplementation during and 32 after therapy. At the end of the study, the whole eradication rate with the LR supplementation was 82% versus 74-76 % reported in literature without probiotics. Furthermore, in our population the eradication rate was significantly higher in the sequential group compared with the 7-day triple (88 % vs 63 %; p = 0.01). The results of our study confirmed that as the first-line, the sequential therapy seems more efficiency than standard 7-day, in the H. pylori eradication. The LR supplementation appears improve the H. pylori eradication rate, although large, double-bind, controlled studies are needed to confirm these results.
Su1696 Efficacy of Second-Line Treatment for Helicobacter pylori Infection: Moxifloxacin-Containing Triple Therapy vs. Bismuth-Containing Quadruple Therapy Kwang Hyun Chung, Dong Ho Lee, Nayoung Kim, Cheol Min Shin, Jin Hyeok Hwang, Sang Hyub Lee, Donghyeon Lee, Hong Sang Oh, Eun Hyo Jin
Su1694 Meta-Analysis of Levofloxacin-Containing Triple Therapy vs. BismuthContaining Quadruple Therapy as Second-Line Treatment in the Eradication of Helicobacter pylori Alicia C Marin, Adrian G. McNicholl, Javier P. Gisbert
BACKGROUNDS: Although there are various retreatment strategies for treatment failure of Helicobacter pylori infection, optimal retreatment regimen is not established and eradication rate varies depending on regions and populations. The purpose of this study is to compare the efficacy of moxifloxacin-containing triple therapy with bismuth-containing quadruple therapy. METHODS: Between January 1st, 2010 and September 30th, 2011, a total of 101 patients were confirmed to initial treatment failure by urea breath test performed 4 weeks or longer after completion of therapy. Initial treatment regimens were triple therapy (rabeprazole 20 mg bid, clarithromycin 500 mg bid and amoxicillin 1000 mg bid for 7 days; n = 48), sequential therapy (rabeprazole 20 mg bid plus amoxicillin 1000 mg bid for 5 days followed by rabeprazole 20 mg bid plus clarithromycin 500 mg bid and metronidazole 500 mg bid for 5 more days; n = 21) and concomitant therapy (Rabeprazole 20 mg bid, clarithromycin 500 mg bid, amoxicillin 1000 mg bid and metronidazole 500 mg bid for 14 days; n = 30). The efficacies of second-line treatment regimens were compared which were moxifloxacin-containing triple therapy (rabeprazole 20 mg bid plus amoxicillin 1000 mg bid and moxifloxacin 400 mg qd for 7 days) and bismuth-containing quadruple therapy (rabeprazole 20 mg bid, tetracycline 500 mg qid, metronidazole 500 mg tid, and tripotassium dicitrato bismuthate 300 mg qid for 7 days). Eradication was confirmed by urea breath test performed 4 weeks or longer after completion of therapy. RESULTS: In the 48 patients who failed initially with triple therapy, 9 patients were treated with moxifloxacin-containing triple therapy and 37 patients were treated with bismuth-containing quadruple therapy. Eradication rates were 4/9 (44.4%) and 29/37 (78.4%). All the patients who initially failed with sequential therapy were treated with moxifloxacin-containing triple therapy and eradication rate was 12/21 (57.1%). 28 of 30 patients who initially failed with concomitant therapy were treated with moxifloxacin-containing triple therapy and eradication rate was 17/28 (60.7%). Overall eradication rate of second-line treatment with moxifloxacin-containing triple therapy and bismuth-containing quadruple therapy were 34/59 (57.6%) and 29/37 (78.4%), respectively (P = 0.037). There were no differences in frequency of non-compliance and adverse effects. CONCLUSIONS: Moxifloxacin-containing triple therapy, which is widely used in patients who were initially failed with concomitant or sequential regimen, produced unacceptably low eradication rate. The eradication rate of bismuth-containing quadruple therapy (78.4%)
BACKGROUND: After one Helicobacter pylori eradication failure, the most recommended rescue option has been the bismuth-containing quadruple therapy (BQT). Levofloxacincontaining triple therapy (LTT) has been presented as an alternative option. AIM: To conduct a meta-analysis of studies comparing the efficacy and safety of LTT versus BQT in the eradication of H. pylori after one treatment failure. METHODS Selection of studies: randomized controlled trials comparing LTT and BQT after one H. pylori eradication failure. Search strategy: electronic and manual bibliographical searches. Data synthesis: intention-to-treat eradication rate and adverse events rate. RESULTS: 13 studies were included, with a total of 1709 patients (1011 in the LTT and 698 in the BQT). The overall analysis showed a tendency towards better eradication results for LTT (79% vs. 70%;OR=1.43;95%C.I.=0.882.31;p=0.15;I2=72%) with a significantly lower rate of adverse effects (14% vs. 32%;OR= 0.30;95%C.I.=0.19-0.50;p<0.001;I2=46%) and serious adverse effects (0.7% vs. 7.8%;OR= 0.15; 95%C.I.=0.04-0.59;p=0.007;I2=0%). There were 2 outlying studies showing better results for BQT, what may be explained because both studies used a 7 (instead of 10) day LTT. Excluding these studies, heterogeneity was reduced and results improved for LTT (81% vs. 68%;OR=1.88;95%C.I.=1.27-2.79;p=0.002;I2=52%). As LTT showed better efficacy in ten days courses than in seven days (89% vs. 70%), a subanalysis including only 10 day LTT with levofloxacin, amoxicillin and PPI studies showed an even better efficacy for LTT compared with BQT (89% vs. 66%;OR=4.22; 95%C.I.=2.84-6.26;p<0.001;I2=0%;NNT=4). CONCLUSION: The meta-analysis performed demonstrates that ten day LTT is more effective and better tolerated than BQT, as a second-line rescue option for H. pylori eradication.
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AGA Abstracts
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is superior to moxifloxacin-containing triple therapy (57.6%), but both results are unsatisfactory. Further studies are needed to find more effective alternative regimens.
analysis, 10-day hybrid therapy achieved 94.6% eradication rate, while 12-day hybrid therapy can maintain grade A (>95%) eradication rate as 14-day hybrid therapy (97.1% vs. 97.1%). Conclusion: For hybrid therapy, shorter treatment period to 12 days (esomeprazole and amoxicillin for 5 days followed by esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can maintain greater than 95% eradication rate, either by intention-to-treat or by per-protocol analysis.
AGA Abstracts
Su1697 Final Data of a New Electrochemical Device That Enables Rapid and Accurate Detection of Helicobacter pylori Infection Helmut Neumann, Stefan Foertsch, Bianca Ritter, Michael Vieth, Rainer Kuth, Markus F. Neurath
Su1700 Tailored Therapy Based on Dpo Multiplex PCR Improves Helicobacter pylori Eradication Rate Chang-Il Kwon, Han Gyung Seon, Sang Pil Yun, Harry Yoon, Jeong Guil Lee, Kwang Hyun Ko, Sung-Pyo Hong, Pil Won Park
Introduction: Helicobacter pylori (H. pylori) infection affects about 30-50% of adults in developed countries and causes persistent gastric infection and chronic inflammation. H. pylori infection is a major cause of gastric ulcer disease and gastric cancer. Diagnostic tests include histology, rapid urease test (RUT), breath tests and stool antigen tests. Previously, we have introduced a new electrochemical device for rapid H. pylori detection. Aims: To prospectively evaluate the newly developed electrochemical device for H. pylori detection in the clinical setting. Material & Methods: Seventy consecutive patients (43 female, 27 male; mean age 65 years, range 26-85 years) were included. The electrochemical device for H. pylori detection consists of a working and reference electrode between which a biopsy sample was administered. Acquired voltage-values between both electrodes were analysed for characteristics typical for H. pylori infection (ammonia). According to Sydney classification, biopsies were taken from gastric antrum and corpus for electrochemical H. pylori detection, RUT and immunohistochemistry (IHC). RUT results were evaluated after 24 hours. Every patient received 13C-urea breath test. Detection rates for H. pylori were analysed blinded to IHC results, which was designated as the gold standard of H. pylori diagnosis. Results: IHC had a sensitivity, specificity and accuracy of 100%. RUT analysis and 13C-urea breath test received both a sensitivity of 100% and a specificity of 92% and 95%, respectively. Accuracy of RUT was 93% and 96% for 13C-urea breath test. The new electrochemical H. pylori detection method showed a sensitivity of 100%, specificity of 94% and accuracy of 94%, respectively. Definitive results for H. pylori detection with the new device were available within 10 seconds. Conclusion: The new developed electrochemical H. pylori detection method allows rapid and accurate detection of the infection and has therefore the potential to improve H. pylori diagnosis and treatment.
Background and Aims: The eradication rate of Helicobacter pylori (H. pylori) has gradually decreased. One of the major risk factors for treatment failure was thought to be clarithromycinresistant H. pylori groups. The present study aimed to assess the outcome of tailored eradiaction therapy according to clarithromycin susceptibility identified by dual-priming oligonucleotide (DPO)-based multiplex PCR. Methods: A retrospective cohort study was conducted in an academic referral medical center in a region where H. pylori clarithromycin resistance is highly prevalent. 87 H. pylori infected patients (mean age 58.4 years) were enrolled in the tailored group and 482 H. pylori infected patients (mean age 53.1 years) were enrolled in the control group. They were naïve to H. pylori eradication treatment, and had undergone endoscopy and has been diagnosed with peptic ulcer disease or early gastric cancer. To examine clarithromycin resistance, two biopsy samples were obtained from the gastric antrum and DPO multiplex PCR was performed to detect point mutations in 23S rRNA gene of H. pylori within hours. In the tailored group, patients with clarithromycin-sensitive strains (wild type) were given PPI + amoxicillin + clarithromycin therapy, and those with clarithromycinresistant strains (mutant type) were given PPI + tetracycline + bismuth + metronidazole therapy. In the control group, all patients were given PPI + amoxicillin + clarithromycin therapy. Urea breath test (UBT) was performed to assess eradication therapy at 1 month after eradication. Results: In the tailored group, wild type was diagnosed in 69 patients (79.3%) and mutant type was diagnosed in 18 patients (20.7%). Point mutation at A2143G was present in 18 patients, whereas, point mutations at A2142G or A2142C were not found. The overall eradication rate was 73.5% (64 of 87) - 68.1% (47 of 69) in the clarithromycinsensive H. pylori, 95% (17 of 18) in the clarithromycin-resistant H. pylori group, respectively. The eradication rate in the tailored group was significantly higher than the control group (73.5% vs 58%). Conclusion: The infection rate of genotypically clarithromycin resistant H. pylori was 20.7% in our result. Tailored eradication therapy with DPO multiplex PCR exam can be highly effective and benefitial in clarithromycin-resistant H. pylori prevalent areas.
Su1698 Comparison of Ten-Day, Fifteen-Day Sequential Therapy and Proton-Pump Inhibitor-Based Triple Therapy in Korea: A Prospective Randomized Study Nayoung Kim, Ryoung Hee Nam, Jae Yeon Kim, Mi Kyoung Lee, Jung Won Lee Background and Aims: The eradication rate of proton-pump inhibitor (PPI)-based triple therapy for H. pylori infection has decreased mainly due to increase of clarithromycin resistance. The aim of this study was to compare the efficacy of 10-, 15-day sequential therapy and PPI triple therapy as the first-line treatment for eradication of H. pylori in Korea. Methods: A total of 111 patients with H. pylori infection randomized to receive one of three kinds of eradication therapy prospectively: 10-day (n=34) and 15-day sequential therapy (n=33) (40mg of esomeprazole and 1g of amoxicillin, twice daily for the first 5 days, followed by 40mg of esomeprazole, 500mg of clarithromycin, and 500mg of metronidazole, twice daily for the remaining 5 days or 10 days); 7-day triple therapy (n=34) (40mg of esomeprazole, 500mg of clarithromycin, and 1g of amoxicillin, twice daily for 7 days). Eradication was evaluated by the (13) C-urea breath test 4 weeks after completion of treatment. Compliance and adverse events were assessed. H. pylori culture with MIC test was performed in part of enrolled patients for clarithromycin and metronidazole with agar dilution method before treatment. Results: The eradication rates of 10-, 15-day sequential therapy and PPI-based triple therapy were 64.7% (22/34), 63.6% (21/33) and 67.6% (23/34) by intention to treat analysis, respectively (P=0.732), and 78.6% (22/28), 84.0% (21/25) and 79.3% (23/29) by per protocol analysis, respectively (P=0.874). Compliance (>85%) of these three therapies were 93.1%, 88.0% and 96.6%, respectively, and adverse events occurred in 44.8%, 46.4% and 20.7%, respectively (P=0.077). Two patients having H. pylori with resistance to metronidazole and/or clarithromycin were not eradicated by 10 and 15-day sequential therapy, respectively. However, two patients having H. pylori with sensitive to both antibiotics were eradicated by 10 and 15-day sequential therapy, respectively. Conclusion: There was no significant advantage of 10- or 15-day sequential therapy against PPI triple therapy as a first-line treatment for H. pylori infection in Korea, so far. Further enrollment is going on.
Su1701 Influence of Helicobacter pylori Eradication on the Management of Type 2 Diabetes Masao Akanuma, Ayako Yanai, Kei Sakamoto, Yoshihiro Hirata, Yutaka Yamaji, Shin Maeda Objective: Helicobacter pylori eradication therapy has been widely performed. In addition, the number of patients with type 2 diabetes is increasing worldwide. The aim of this study was to understand the influence of H. pylori eradication therapy on the management of type 2 diabetes. Methods: A total of 174 patients with type 2 diabetes who did not have an active peptic ulcer or serious complications and were cured successfully of their H. pylori infection at our institute were included in this study. The time course of mean glycosylated hemoglobin (HbA1c) values and body mass index (BMI) during the year before and after H. pylori eradication were assessed by a paired Student's t-test. The cumulative incidence of intensified diabetes treatments during the 6 months before and after H. pylori eradication was compared using the log-rank test. Results: No significant changes in mean HbA1c values were observed during the year before or after eradication. However, the mean BMI, which did not change during the year before eradication, increased significantly at 6 months (23.1 ± 2.6 kg/m2, P < 0.05) and 12 months (23.1 ± 2.7 kg/m2, P < 0.05) after eradication as compared with the time point of eradication (22.9 ± 2.6 kg/m2). Although the result did not reach statistical significance, diabetes treatments after H. pylori eradication had a stronger tendency to be intensified than those before eradication (P = 0.0709). Conclusion: H. pylori eradication significantly increased BMI but not HbA1c in patients with type 2 diabetes, despite diabetes treatment.
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Optimal Duration to Maintain Greater Than 95% Eradication Rate in Hybrid Therapy for H. pylori Jeng-Yih Wu, Ping-I Hsu, Deng-Chyang Wu, David Graham
A Systematic Review and Meta-Analysis of Performance of Sequential Therapy in Clinical Trial on NaïVE Adult and Children Infected With H. pylori Luigi Gatta, Chiara Ricci, Valentina Castelli, Angelo Zullo, Dino Vaira
Background: Although 10-day sequential therapy is effective therapy in several studies, most of the studies did not reach grade A (>95%) eradication rate. Higher eradication rate (99.1% by per-protocol analysis and 97.4% by intention-to-treat analysis) was reported by a 14day sequential-concomitant hybrid therapy (esomeprazole and amoxicillin for 7 days followed by esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days). However, it is not very clear whether >95% eradication rate (Grade A) is maintained with therapy shorter than 14 days in hybrid therapy. Aim: The goal of this study is to evaluate the eradication rate in different treatment duration of hybrid therapy. Materials and methods: This multicenter, pilot study was designed into 3 groups, 10-day, 12-day, and 14-day hybrid therapy (esomeprazole and amoxicillin for 3 days, 5 days, 7 days respectively, then followed by esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days). Patients infected with H. pylori randomly received a 10-day, 12-day, or 14-day hybrid therapy. H. pylori status was assessed 8 weeks after therapy. Success was defined as achieving 95% or greater eradication by per-protocol (PP) analysis. Results: Totally, 115 patients were enrolled in this study. Forty-one, thirty-six, thirty-eight patients were randomized to 10-day, 12-day, and 14-day hybrid therapy, respectively. For intention-to-treat analysis, the eradication rate was 92.7%, 97.2%, and 92.1% in 10-day, 12-day, and 14-day hybrid therapy. By per-protocol
AGA Abstracts
Aim: to perform a systematic review and meta-analysis of the eradication rate of sequential therapy in naïve adult and children with HP. Data sources: MEDLINE, EMBASE, and the Cochrane central register of controlled trials were searched (up to November 2011), as well as abstracts from the major US, European and Asian gastroenterology conferences. Eligibility criteria for selecting studies: superiority RCTs or CCTs with a parallel group design comparing sequential therapy in adult and children never treated before for HP. No language restriction was used. Study appraisal and synthesis methods: Eradication data according to ITT analysis were pooled using a random effects model and reported as RR of eradicating HP with 95% CIs. Planned subgroup analysis included performance in patient with PUD and NUD, sideeffect, quality of the study according to the Jadad scale, type of study and country of origin. Assessment of risk of bias was performed by recording method used to generate the randomization schedule and conceal allocation, whether blinding was implemented, what proportion of patients completed follow-up, whether an intention-to-treat analysis was extractable, and whether there was evidence of selective reporting of outcomes. Funnel plots was assessed for evidence of asymmetry, publication bias or other small study effects were
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