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M1138 Duration of Proton-Pump Inhibitor-Based Triple Therapy for Helicobacter pylori Eradication: A Meta-Analysis

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Page 1: M1138 Duration of Proton-Pump Inhibitor-Based Triple Therapy for Helicobacter pylori Eradication: A Meta-Analysis

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sand FBMC are significantly associated with high eradication of Helicobacter pylori resistant.KEY WORDS - Helicobacter pylori, eradication, clarithromycin and ceragenin CSA-13

M1138

Duration of Proton-Pump Inhibitor-Based Triple Therapy for Helicobacterpylori Eradication: A Meta-AnalysisHaydee B. Flores, Angela Salvana, Ena Lyn R. Ang, Norberto I. Estanislao, Marie EllaineVelasquez, Janus Ong, Eulenia R. Nolasco, Ma. Lourdes Daez, Virgilio Banez

Introduction Helicobacter pylori (H. pylori) infection has been associated with different diseaseentities such as peptic ulcer disease, non-ulcer dyspepsia and gastric cancer. Differenttreatment strategies have been investigated and triple therapy using proton pump inhibitor,clarithromycin and amoxicillin or an imidazole have been widely accepted. However, optimaltreatment duration remains to be settled. Objectives To determine if a longer duration (10or 14 days) of Proton pump based triple therapy is more effective and safe compared toshorter (7days) treatment duration in terms of H. pylori eradication. Methods A systematicliterature search was carried out in the following databases: Pubmed, The Cochrane Library,the Health Research and Development Network, and EMBASE through January 2009.Abstracts presented from 1995 to 2007 at the United European Gastroenterology Week andDigestive Disease Week was also reviewed. In addition, manual search from the referencesof the papers retrieved was also conducted. Language restrictions were not applied. Aftercritical appraisal of included studies was done, a random effects model using relative riskwas used to synthesize the results (Revman 4.2) Results 26 studies were included, 17compared 7 versus 14 day therapy, 12 studies compared 7versus 10-day therapy. Our reviewshowed a statistically significant improvement with H. pylori eradication with the use of 14days of treatment compared to 7-days (RR 0.79, 95% CI 0.71-0.89, p <0.0001). A similarbenefit was seen with 10 days of treatment compared to 7 days (RR 0.84, 95% CI 0.73-0.96, p 0.01) when all studies are considered. Occurrence of adverse events was not increasedwith a longer treatment duration (14 vs 7days: RR 1.01 95% CI 0.84, 1.22, p 0.92; 10 vs7 days: RR 1.04, 95% CI 0.91-1.20, p 0.53). Conclusion The overall trend shows that longertreatment duration is more favorable in terms of H. pylori eradication and that no significantincrease in adverse events is noted. However, cost-effectiveness studies may need to beperformed and that drug resistance should be considered and tested in areas with highprevalence of drug resistance to the first line H. pylori treatment regimen.

M1139

Sitafloxacin-Based Third-Line Eradication of H. pyloriHidekazu Suzuki, Juntaro Matsuzaki, Toshihiro Nishizawa, Yoshimasa Saito, Kenro Hirata,Hitoshi Tsugawa, Hiroe Muraoka, Toshifumi Hibi

Background and Aim. Increasing prevalence of H. pylori isolates resistant to antimicrobialagents such as clarithromycin and metronidazole has been demonstrated; therefore, othertreatment options are urgently needed especially for 3rd line eradication. While quinolonesmay be possible candidates for 3rd line regimens for H. pylori eradication therapy, wepreviously reported that there is a high prevalence of mutation of the quinolone resistance-determining region (QRDR) of the gyrA gene of H. pylori isolated from patients with multipleeradication failure in Japan (Nishizawa, Suzuki et al. Antimicrob. Agent Chemother.50:1538, 2006); however, we showed that a new-generation quinolone, sitafloxacin (STFX),could overcome the resistance of H. pylori carrying gyrA mutations In Vitro (Suzuki et al.Antimicrob. Agent Chemother. 53:1720, 2009). The present study was designed to investig-ate the efficacy and safety of STFX-based 3rd-line H. pylori eradication therapy. Methods.Twelve patients, in whom eradication treatment with clarithromycin-based 1st line therapyand metronidazole-based 2nd line therapy failed, were enrolled in this study after obtainingtheir written informed consent (UMIN000001558). All patients were treated with rabeprazole10 mg, q.i.d., amoxicillin 500 mg, q.i.d. and STFX 100 mg, b.i.d. for 7 days. Before thetreatment, the minimum inhibitory concentration (MIC) of each antibiotic against H. pyloriwas determined by the agar dilution method. The gyrA mutation status was determined bycomparing the sequences of the PCR products amplified from the QRDR of the gyrA geneof each strain with published sequences of the H. pylori gyrA gene (GenBank accession no.L29481)(J. Med. Microbiol. 53:1019, 2004). Results. The MICs of STFX were less than1.0 μg/ml (range: <0.015 - 0.5 μg/ml; MIC50 0.03 μg/ml; MIC90 0.5 μg/ml). The eradicationrate was 75% (9/12). Even amongst 8 patients with gyrA mutation-positive H. pylori, successfuleradication was achieved in 5 patients (63%). Only minor and transient adverse effects werereported (diarrhea 25%, soft stool 42%, abdominal pain 17%, glossitis, mild bradycardia8%). Conclusion. STFX-based 3rd-line eradication regimen was highly effective and safeeven in patients infected with gyrA-mutation-positive H. pylori strains.

M1140

Helicobacter pylori Eradication Treatment is More Successful When Diagnosisis Made After Urea Breath Test Than After Rapid Urease Testing at Endoscopyin Patients With DyspepsiaAnthony O'Connor, Niall R. O'Moráin, Mark Dobson, Asghar Qasim, Barbara M. Ryan,Niall Breslin, Humphrey J. O'Connor, Colm A. O'Morain

Introduction: Helicobacter pylori infection has major implications for health. It causes themajority of peptic ulcers and many gastric cancers. Eradication rates have fallen over recentyears probably due to rising antibiotic resistance and problems of compliance with treatment.Aims: Regimens for H. pylori eradication are complex. They involve several drugs and aprolonged course. Compliance with therapy is often poor. H. pylori is usually diagnosed inpatients with dyspepsia who have undergone either urea breath test (UBT) or rapid ureasetesting (RUT). We aimed to see if the setting in which treatment was prescribed had anyimpact on eradication rates. Method: 382 patients who initially presented with dyspepsiaand were subsequently diagnosed with H. pylori infection attended for a 13-C UBT for “re-tests” to confirm eradication. 210 were initially diagnosed with H. pylori infection at UBTand 172 had endoscopy with positive RUT (point of care). Baseline and 15-min gas samples

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after ingestion of 100 mg 13C-labeled urea were analyzed for excess 13CO2/12CO2 ratio(ECR). A cut off point of 4.0 was used to diagnose persistent H. pylori infection. Clinicaland demographic Data was gathered from endoscopy reports, patient charts and pathologyreports. Results: Eradication was achieved in 65.7% (n=113) of those treated after a positiveRUT. Eradication was achieved in 72.4% (n=152) of those treated after a positive UBT. Thehigher rate of eradication in the UBT group is statistically significant with a P-value of 0.499based on chi-square analysis. Median age in the RUT group is 51 years compared to 40.5years in the UBT group. Eradication rates in patients under 30 years and over 60 years issignificantly lower in the RUT group than the UBT group (53.6% vs 75% and 58.4% vs72.7% respectively) with no difference in middle life (71.3% vs 71.1%). Of the 172 patientsin the RUT group, 163 had sedation with benzodiazepines, although doses received are notknown. Conclusion: Eradication rates for H. pylori are significantly higher when diagnosisis made after UBT than after RUT in patients with dyspepsia. Worst eradication rates areseen in the under 30 and over 60 age group who had RUT. Benzodiazepines are known tocause most CNS depression in young patients and the elderly. In this group where almostall received benzodiazepines, it is likely that the hypnotic and amnesic effects of sedationnegatively effects compliance lowering eradication rates.We recommend prescriptions shouldnot be given while a patient is still under the influence of a sedative and that discussionemphasising compliance to the patient take place at a later date.

M1141

Diagnostic Accuracy of Serum Pepsinogens and Gastrin to Follow-upHelicobacter pylori Infection: A Pilot StudyLuigi Gatta, Francesco Di Mario, Dino Vaira, Massimo Rugge, Carmelo Scarpignato, PeterMalfertheiner, Marino Venerito, Giulia M. Cavestro, Angelo Franzé

Background: 13C-UBT and stool test are accurate non invasive tools to monitor H. pyloriinfection after treatment, but there is interest in whether changes in blood test would providean equally reliable but simpler determination. Aim: (1) to investigate the effect of H. pylorieradication on serum Pepsinogen I (sPGI), serum Pepsinogen II (sPGII), Ratio and alsoserum gastrin 17 (sG17) 8 weeks after the end of the treatment and (2) to assess their useas tool to diagnose H. pylori eradication Methods: this was a prospective comparison studydesigned to fulfil the STARD (Standards for Reporting of Diagnostic Accuracy) recommenda-tions. In 228 consecutive H. pylori infected patients 13C-UBT and blood samples to measuresPGI, sPGI, and sG17 were taken immediately prior to endoscopy with biopsies. All recruitedpatients were offered a 7-day triple therapy, and were asked to return 8 weeks after theend of treatment to obtain blood sample and perform a 13C-UBT. Results: 175 patientscompleted the study, with an eradication rate of 67%. Percentage change in values beforeand after treatment of sPGII was the best predictor as a decrease in values of sPGII > 22.7%as the cut-off resulted in a sensitivity of 100% (95% CI: 96.8 to 100) and a specificity of96.6% (95% CI: 91.5 to 99.1), with a LR+ve of 29.5 (95% CI: 8.6 to 107), and a LR-ve of0 (95% CI: 0 to 0.03). Spectrum analysis including sex, age, PUD, smoke and alcoholconsumption did not found any difference in in term of sensitivity, specificity, LR+ve andLR-ve. Conclusion: percentage variation of sPGII seems to be accurate and reliable to follow-up H. pylori infection 8 weeks after the end of treatment. However, further studies aredemanded to confirm the results of this preliminary report.

M1142

Hypnotically-Assisted Relaxation Therapy to Treat Globus Sensation: A PilotStudyJennifer L. Kiebles, Monika A. Kwiatek, John E. Pandolfino, Peter J. Kahrilas, LaurieKeefer

Background & Objectives: Globus sensation is a bothersome and difficult to treat symptomthat can occur in isolation or in association with a variety of laryngeal and esophagealpathologies. The aims of this study were to evaluate the acceptability and utility of hypnotic-ally-assisted relaxation (HAR) in decreasing the perception of globus sensation and the effectof HAR on interdeglutitive upper esophageal sphincter (UES) pressure. Methods: 16 subjectswith persistent globus sensation unresponsive to therapy for reflux disease and with normalesophageal/laryngeal imaging studies were invited to participate in a 7-session clinical proto-col including breathing modification, muscle relaxation, and esophagus-directed HAR totreat globus sensation. Before and after HAR, subjects completed standard questionnairesincluding the newly developed esophageal symptoms questionnaire to gauge globus severity.High-resolution manometric assessment of respiratory augmentation and average restingUES pressure were assessed prior to and after HAR. Results: Ten of the 16 subjects agreedto participate in the protocol. All participants were women with median age 51.5 (range30-72 years). None had clinical depression and two had anxiety evident by HADS scoresgreater than 8. Prior to HAR, the length of time with globus sensation ranged from sixweeks to five years, median=11.5 months. The participants found HAR acceptable andcompleted the 7-session trial. Globus symptom severity varied widely pre-treatment (median=52.5, range 16-72), and nine of 10 subjects reported a consistent reduction in globussymptomatology subsequent to treatment (post-treatment median=14.0, range 3-19; p =0.007). Only one subject exhibited abnormal respiratory augmentation of UES pressure(>27 mmHg) prior to treatment and was normal following treatment (9.9 mmHg). RestingUES pressure was normal in all subjects (<118 mmHg). Group respiratory augmentationand average resting UES pressure were unaffected by HAR (p = 0.86). Conclusions: Thiscase series suggests that HAR can provide a substantial improvement in globus sensationirrespective of cause. UES function was unaffected. We suggest that HAR-type treatment isan acceptable and useful intervention for patients with globus sensation.