Proton Pump Inhibitor-based Triple Therapy Research Articles

Improvement of Platelet Count after Helicobacter Pylori Screening and Eradication in Immune Thrombocytopenia Patients: A Randomized Open-Label Study

Background:Helicobacter pylori (HP) has been known as a secondary cause of immune thrombocytopenia (ITP). Previous studies have demonstrated platelet count improvement after HP eradication in ITP. However, the impact of HP screening in adults with ITP remains unclear. Methods: We conducted a randomized open-label study to evaluate the benefit of HP screening to improve platelet count in ITP patients. Persistent or chronic ITP patients with ≥ 18 years of age who had platelet count below 150 x109/L were eligible. Patients were excluded if there were HIV or hepatitis C virus infection, active cancer, history of HP eradication within 1 year, or antibiotics/bismuth use within one month before enrollment. Patients were allocated in a 3:1 ratio to the HP screening arm or non-screening arm. Patients in the HP screening arm underwent 2 methods of HP screening: urea breath test (UBT) and HP serology test (Assure® H. pylori Rapid Test). Patients who had positive HP results by either test were received HP eradication with a 14-day course of proton pump inhibitor-based triple therapy. Treated patients were subsequently confirmed HP eradication by stool antigen test at 1 month. Dose modifications of treatments for ITP were allowed according to the treating physician's decision. Platelet count and 3-month cumulative dose of prednisolone were measured at baseline, 3 months, and 6 months. Quality of life using the Thai version of EQ-5D-5L was assessed at baseline and 6 months. The primary outcome was the mean difference in platelet count at 6 months. Key secondary outcomes were the prevalence of HP infection in adult ITP patients and improvement of EQ-5D-5L score at 6 months. Other outcome was the diagnostic accuracy of the HP serology test. Results: A total of 64 patients were enrolled. Forty-nine patients were assigned to the HP screening arm and 15 patients to the non-screening arm. Mean age was 47.2 years (SD 15.7). Fifty patients (78%) were female. Forty patients (62.5%) were using prednisolone with a mean dose of 8.5 mg/day. Mean platelet count at baseline was 73.8 x109/L (SD 29.5). Baseline characteristics were balanced (Table 1). All of the patients, except one, in the HP screening arm completed 2 methods of screening. Twenty-three of 48 patients had HP positive results by UBT, as a result, the prevalence of HP was 47.9%. All HP-positive patients completed an HP eradication course. One patient had a positive result of stool antigen test after HP eradication, which was successfully eradicated with levofloxacin-based treatment. At 6 months follow-up, patients in the HP screening arm had a significant improvement in platelet count as compared to baseline with a mean difference of 21.8 x109/L (95% CI 22.2 - 41.3, p=0.030) (Table 2). In addition, the EQ-5D-5L score revealed a significant improvement at 6 months as compared to baseline in the HP screening arm with a mean difference of 4.2 points (95% CI 0.8 - 7.6, p=0.016) (Table 2). Patients in the non-screening arm had no significant changes in platelet count or EQ-5D-5L score. A 3-month cumulative dose of prednisolone and dose adjustments of concomitant ITP treatments at 6 months in both arms were not significantly changed. Of 23 UBT-positive patients, only 11 patients had positive results with HP serology. All 25 UBT-negative patients also had negative results with HP serology. The sensitivity and specificity of the HP serology test were 47.8% and 100%, respectively. Conclusion: The prevalence of HP infection in adult Thai ITP patients was 47.9%. HP screening is effective in the improvement of platelet count and quality of life at 6 months in adult ITP patients with platelet count below 150 x 109/L. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Rates of Antimicrobial Resistance in Helicobacter pylori Isolates From Clinical Trial Patients Across the US and Europe.

Guidelines recommend that proton pump inhibitor-based triple regimens with clarithromycin not be used for Helicobacter pylori infection in areas where clarithromycin resistance is ≥15%, or in patients with prior macrolide use. Up-to-date information on local resistance patterns is limited, especially in the US. Here, we report resistance rates to antibiotics commonly used to treat H. pylori from a large study conducted in the US and Europe (pHalcon-HP). Gastric mucosal biopsies were collected from adult participants with H. pylori infection during screening. Minimum inhibitory concentrations were determined via agar dilution for clarithromycin, amoxicillin, and metronidazole, with breakpoints ≥1 μg/mL, >0.125 μg/mL, and >8 μg/mL, respectively. Resistance rates were obtained for the US and Europe, and also for US subregions and participating European countries. Resistance rates were established in isolates from 907 participants. Overall, 22.2% were resistant to clarithromycin, 1.2% to amoxicillin, and 69.2% to metronidazole. Resistance in the US and Europe was similar; metronidazole resistance was the most prevalent (50%-79%) and amoxicillin the least (≤5%). In all subregions, ≥15% of isolates were resistant to clarithromycin, except the UK (0/8 isolates). Among clarithromycin-resistant isolates, 75% were also metronidazole-resistant. Two US isolates were resistant to clarithromycin and amoxicillin; one of these was also metronidazole-resistant. The resistance rates observed in this study argue against the continued empiric use of proton pump inhibitor-based triple therapy containing clarithromycin, per treatment guidelines, and highlight the need for antibiotic resistance surveillance and novel treatment strategies for H. pylori infection in the US and Europe.

Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial

Background/AimsWe examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication.MethodsA randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)-based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases.ResultsIn total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences.ConclusionsTPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea (ClinicalTrials.gov identifier NCT03317223).

Therapeutic efficiency of adipose-derived mesenchymal stem cells in healing of experimentally induced gastric ulcers in rats.

Gastric (peptic) ulcer is a major gastrointestinal disorder with high morbidity and mortality. While several drugs have been used to treat gastric ulcers, such as proton pump inhibitor-based triple therapy for Helicobacter pylori eradication, but hey result in adverse side effects. Therefore, development of new alternative therapies is desirable. Many recent studies have shown that mesenchymal stem cells (MSCs) might have an enhancing effect on the ulcerated gastric mucosa. The aim of this study is to evaluate the efficacy of MSCs in the treatment of indomethacin-induced gastric ulcer, and to compare it with the normal ulcer autohealing. This work was performed on 36 adult male albino rats, divided into four groups: Group I (control group), Group II (ulcer group), Group III (autohealing group), and Group IV (stem cells-treated group). The histological changes of gastric mucosa were examined in sections stained with H&E using light microscope for expression of vascular endothelial growth factors (VEGF) and proliferating cell nuclear antigen (PCNA) in immunohistochemical stained sections using image analyzer. The results from MSCs-treated group revealed restoration of the normal architecture of the gastric mucosa with comparison to the autohealing group which showed excessive granulation tissue and heavy cellular infiltration with disorganized architecture of the fundic mucosa. Immunohistochemical examination showed strong expression of both VEGF and PCNA in the MSCs-treated group. So it was concluded that MSCs accelerate gastric ulcer healing when injected intraperitoneally, compared to autohealing process which showed delayed healing.

Vonoprazan-based triple therapy is non-inferior to susceptibility-guided proton pump inhibitor-based triple therapy for Helicobacter pylori eradication

BackgroundAll Helicobacter pylori-infected patients are recommended for eradication with an appropriate regimen in each geographic area. The choice of the therapy is somewhat dependent on the antimicrobial susceptibility. The rate of clarithromycin resistance has been increasing and is associated with failure; thus, susceptibility testing is recommended before triple therapy with clarithromycin. However, antimicrobial susceptibility testing is not yet clinically available and an alternative newly developed acid inhibitor vonoprazan is used for triple therapy in Japan. The aim of this study was to determine whether vonoprazan-based triple therapy is plausible treatment in H. pylori eradication.MethodsA retrospective observational study of H. pylori eradication was conducted in a single institute. The patients who requested antimicrobial susceptibility testing were treated with susceptibility-guided proton pump inhibitor-based triple therapy in International University of Health and Welfare Hospital from 2013 to 2016. Other patients were treated with empirical treatment with a proton pump inhibitor. From 2015 to 2016, vonoprazan-based triple treatment (vonoprazan, 20 mg; amoxicillin, 750 mg; and clarithromycin, 200 or 400 mg, b.i.d.) was conducted, and its effectiveness was compared with susceptibility-guided proton pump inhibitor-based triple therapy. We also investigated the improvement in eradication rate when antimicrobial susceptibility testing was performed, and compared the outcomes of vonoprazan-based and proton pump inhibitor-based empirical therapy.ResultsA total of 1355 patients who received first-line eradication treatment were enrolled in the present study. The eradication rates of the empirical proton pump inhibitor-based therapy and the vonoprazan-based therapy group in a per-protocol analysis were 86.3% (95% CI 83.8–88.8) and 97.4% (95% CI 95.7–99.1), respectively. In 212 patients who received antimicrobial susceptibility testing, the rate of clarithromycin resistant was 23.5% and the eradication rate in susceptibility-guided treatment was 95.7% (95% CI 92.9–98.4). The difference between susceptibility-guided and vonoprazan-based therapy was − 1.7% (95% CI − 4.9 to 1.5%), and the non-inferiority of vonoprazan-based triple therapy was confirmed.ConclusionsVonoprazan-based triple therapy was effective as susceptibility-guided triple therapy for H. pylori eradication. An empirical triple therapy with vonoprazan is preferable even in area with high rates of clarithromycin-resistance.Trial registration The study was retrospectively registered in University Hospital Medical Information Network (UMIN000032351)

Ten-day high-dose proton pump inhibitor triple therapy versus sequential therapy for Helicobacter pylori eradication.

Eradication rates of Helicobacter pylori following standard triple therapy are declining worldwide, but high-dose proton pump inhibitor-based triple therapy (HD-PPI-TT) and sequential therapy (ST) have demonstrated higher cure rates. We aimed to compare the efficacy and tolerability of HD-PPI-TT and ST in H.pylori-associated functional dyspepsia (FD). One hundred and twenty H.pylori-associated functional dyspepsia patients were randomized to receive 10-day HD-PPI-TT (60mg lansoprazole/500mg clarithromycin/1g amoxicillin, each administered twice daily for 10days) or 10-day ST (30mg lansoprazole/1g amoxicillin, each administered twice daily for 5days followed by 30mg lansoprazole/500mg clarithromycin/400mg metronidazole, each administered twice daily for 5days). H.pylori status was determined in post-treatment week 4 by 14 C-urea breath test. Eradication and antibiotic resistance rates, dyspeptic symptoms, drug compliance, and adverse effects were compared. Intention-to-treat eradication rates were similar in the ST and HD-PPI-TT groups (85% vs. 80%; P=0.47). However, the eradication rate was significantly higher following ST compared with HD-PPI-TT in per protocol analysis (94.4% vs. 81.4%; P=0.035). ST achieved higher cure rates than HD-PPI-TT in clarithromycin-resistant H.pylori strains (100% vs. 33.3%; P=0.02). Treatment compliance was similar in the HD-PPI-TT and ST groups, although nausea and dizziness were more common in the ST group. Sequential therapy achieved better H.pylori eradication than HD-PPI-TT in patients with FD. However, the eradication rate for ST fell from 94.4% in per protocol to 85% in intention-to-treat analysis. Adverse effects might result in poorer compliance and compromise actual ST efficacy (ClinicalTrials.gov: NCT01888237).

Tu1302 - Vonoprazan- Versus Proton-Pump Inhibitor-Based Third-Line 7-Day Sitafloxacin-Containing Triple Therapy for Helicobacter Pylori: A Prospective, Randomized Trial

Tu1302 - Vonoprazan- Versus Proton-Pump Inhibitor-Based Third-Line 7-Day Sitafloxacin-Containing Triple Therapy for Helicobacter Pylori: A Prospective, Randomized Trial

Addition of cranberry to proton pump inhibitor-based triple therapy for Helicobacter pylori eradication.

Objective:Proton pump inhibitor-based triple therapy with two antibiotics for Helicobacter pylori eradication is widely accepted, but this combination fails in a considerable number of cases. Some studies have shown that cranberry inhibits the adhesion of a wide range of microbial pathogens, including H. pylori. The aim of this study was to assess the effect of cranberry on H. pylori eradication with a standard therapy including lansoprazole, clarithromycin, and amoxicillin (LCA) in patients with peptic ulcer disease (PUD).Methods:In this study, H. pylori-positive patients with PUD were randomized into two groups: Group A: A 14-day LCA triple therapy with 30 mg lansoprazole bid, 1000 mg amoxicillin bid, and 500 mg clarithromycin bid; Group B: A 14-day 500 mg cranberry capsules bid plus LCA triple therapy. A 13C-urea breath test was performed for eradication assessment 6 weeks after the completion of the treatment.Findings:Two hundred patients (53.5% males, between 23 and 77 years, mean age ± standard deviation: 50.29 ± 17.79 years) continued treatment protocols and underwent 13C-urea breath testing. H. pylori eradication was achieved in 74% in Group A (LCA without cranberry) and 89% in Group B (LCA with cranberry) (P = 0.042).Conclusion:The addition of cranberry to LCA triple therapy for H. pylori has a higher rate of eradication than the standard regimen alone (up to 89% and significant).

Online Registry for Nationwide Database of Current Trend of Helicobacter pylori Eradication in Korea: Interim Analysis.

Eradication of Helicobacter pylori using first-line therapy is becoming less effective. Subjects who had been treated for H. pylori infection were prospectively enrolled through an on-line database registry from October 2010 to December 2012. Demographic data, detection methods, treatment indication, regimens, durations, compliance, adverse events, and eradication results for H. pylori infection were collected. Data of 3,700 patients from 34 hospitals were analyzed. The overall eradication rate of the first-line therapy was 73.0%. Eradication failure was significantly associated with old age, concomitant medication, and comorbidity. Regional differences in eradication rates were observed. The most common first-line therapy was proton pump inhibitor-based triple therapy (standard triple therapy, STT) for 7 days (86.8%). The eradication rates varied with regimens, being 73% in STT, 81.8% in bismuth-based quadruple therapy, 100% in sequential therapy, and 90.3% in concomitant therapy. The eradication rate in treatment-naïve patients was higher than that in patients previously treated for H. pylori infection (73.8% vs. 58.5%, P < 0.001). The overall eradication rate for second-line therapy was 84.3%. There was no statistical difference in eradication rates among various regimens. H. pylori eradication rate using STT is decreasing in Korea and has become sub-optimal, suggesting the need for alternative regimens to improve the efficacy of first-line therapy for H. pylori infection.

Influence of CYP2C19 on Helicobacter pylori eradication in Brazilian patients with functional dyspepsia.

The aim of this study was to examine the effect of polymorphisms in the cytochrome P450 (CYP) 2C19 gene (CYP2C19) on the Helicobacter pylori eradication rate in Brazilian patients with functional dyspepsia. Adults diagnosed with functional dyspepsia based on the ROME III criteria and infected with H. pylori were recruited to this study. The patients were subjected to gastrointestinal endoscopy and the H. pylori status was defined when both urease test and histopathology results were negative or positive. The patients were treated with proton pump inhibitor-based triple therapy (omeprazole, amoxicillin, and clarithromycin). CYP2C19*2 and CYP2C19*3 were genotyped by polymerase chain reaction-restriction fragment length polymorphism. One hundred and forty-eight patients (81.8% women) with a mean (± SD) age of 46.1 (12.2) years were included in this study. Based on the CYP2C19 genotypes, the patients were classified as homozygous extensive metabolizer (HomEM; 67.6%), heterozygous extensive metabolizer (HetEM; 26.3%), or poor metabolizer (PM; 6.1%). The H. pylori eradication rates in patients with HomEM, HetEM, and PM were 85.0, 89.7, and 100.0% (P = 0.376), respectively. The included study population comprised a high frequency of patients carrying the HomEM genotype. Although the genotypes of CYP2C19 variants were not statistically significant, the results of this study suggest a possible effect of the PM genotype on the efficacy of H. pylori eradication.

A comparison between 15-day sequential, 10-day sequential and proton pump inhibitor-based triple therapy for Helicobacter pylori infection in Korea

Objective. The eradication rate of 10-day sequential therapy for Helicobacter pylori (H. pylori) infection was not satisfactory in Korea, probably due to antibiotic resistance. To compare the treatment efficacy of 15-day and 10-day sequential therapy of conventional 7-day proton pump inhibitor (PPI) triple therapy for the treatment of H. pylori infection. Methods. A total of 332 patients with H. pylori infection were randomly assigned to receive either 7-day PPI triple therapy, 10-day sequential therapy or 15-day sequential therapy. Eradication rate, drug compliance, and adverse events were compared among the three regimens. Results. The eradication rates by intention-to-treat analysis were 64.3% (95% CI: 55.5–73.2; 74 of 115 patients), 72.1% (95% CI: 63.6–80.5; 80 of 111 patients), and 80.2% (95% CI: 72.5–87.9; 85 of 106 patients) in the 7-day PPI triple, 10-day and 15-day sequential therapy groups, respectively (p = 0.032). The eradication rates by per-protocol analysis were 68.5% (95% CI: 59.6–77.4; 74 of 108 patients), 78.4% (95% CI: 70.3–86.5; 80 of 102 patients), and 89.5% (95% CI: 83.2–95.8; 85 of 95 patients) in the 7-day PPI triple, 10-day and 15-day sequential therapy groups, respectively (p = 0.001). There were no statistically significant differences between the three eradication therapy groups in regard to drug compliance and adverse events. Conclusion. The 15-day sequential therapy demonstrated improved eradication efficacy compared with 7-day PPI triple and 10-day sequential therapy in Korea.

Levofloxacin and proton pump inhibitor‐based triple therapy versus standard triple first‐line therapy for Helicobacter pylori eradication

Standard triple therapy for Helicobacter pylori infection fails in up to one quarter of patients. Levofloxacin-based triple therapy may be more efficacious. The aim of this paper was to compare levofloxacin and proton pump inhibitor-based triple therapy with standard triple therapy for H. pylori infection. PubMed, Embase, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, Google Scholar, and Ovid were systematically searched to identify randomized controlled trials comparing levofloxacin and proton pump inhibitor-based therapy with standard triple therapy in treatment-naive patients with H. pylori infection until August 2013. Ten randomized controlled trials involving 2676 patients (1357 in the levofloxacin group and 1319 in the control group) met the inclusion criteria. The pooled odds ratio by intention-to-treat analysis and by per protocol analysis in the levofloxacin regimen versus standard regimen was 1.28 [95% confidence interval (CI): 0.88-1.85] and 1.23 (95% CI: 0.82-1.84) by the random effects model, respectively. There was no statistical significance of the incidence of total side effects between the groups, but levofloxacin-based therapy was associated with a significant reduction in the incidence of taste disturbance compared with standard third therapy. Levofloxacin-based therapy was as safe and effective as triple therapy for H. pylori infection and could be considered as an additional treatment option. However, more rigorous research is required to accurately assess the role of levofloxacin in eradicating H. pylori infection.

Proton pump inhibitor-based triple therapies versus dual therapies for Helicobacter pylori eradication

Proton pump inhibitor-based triple therapies versus dual therapies for Helicobacter pylori eradication

Randomised clinical trial: the effects ofHelicobacter pylorieradication on glandular atrophy and intestinal metaplasia after subtotal gastrectomy for gastric cancer

Helicobacter pylori eradication is recommended for early gastric cancer (GC) patients after resection. To evaluate whether H. pylori eradication improves glandular atrophy and intestinal metaplasia (IM) in GC patients undergoing subtotal gastrectomy. This randomised, double-blind trial was performed in tertiary care setting. Distal GC patients with H. pylori infection were randomised to receive proton pump inhibitor-based triple therapy or placebo. The histology was evaluated using the updated Sydney system before and at 36months after surgery. The endpoints were the comparison of atrophy and IM score changes between the allocated groups and according to final H. pylori status. Overall, 190 patients were randomised to the treatment and placebo groups. For lesser curvature of the corpus, mean atrophy and IM scores did not differ between the treatment and placebo groups. However, the H. pylori-eradicated patients had significantly lower mean scores than the H. pylori-persistent patients regarding atrophy (0.55±0.95 vs. 1.05±1.10 respectively; P=0.0046) and IM (0.66±0.99 vs. 1.05±1.16 respectively; P=0.0284). The percentage change from baseline was more marked in the H. pylori-negative than in the H. pylori-positive groups (-58.6% vs. -11.0% for atrophy and -60.5% vs. -35.6% for IM respectively). For greater curvature, mean atrophy score was lower in the H. pylori-negative group than in the H. pylori-positive group (0.14±0.50 vs. 0.41±0.75 respectively; P=0.0281). The percentage change was -36.4% vs. 86.3%. Helicobacter pylori eradication in GC patients is beneficial, as reflected by lower scores of atrophy and IM at 36months after subtotal gastrectomy. (ClinicalTrials.gov number, NCT01002443).

Effects of CYP2C19 Loss-of-Function Variants on the Eradication of H. pylori Infection in Patients Treated with Proton Pump Inhibitor-Based Triple Therapy Regimens: A Meta-Analysis of Randomized Clinical Trials

BackgroundThere are inconsistent conclusions about whether CYP2C19 variants could affect H. pylori eradication rate in patients treated with the proton pump inhibitor (PPI)-based therapy. We therefore performed a meta-analysis of randomized clinical trials (RCTs) to re-evaluate the impact of CYP2C19 variants on PPI-based triple therapy for the above indication.MethodsAll relevant RCTs in the PubMed, Cochrane Library, EMBASE, Web of Science and two Chinese databases (up to February 2013) were systematically searched, and a pooled analysis was performed with the odds ratio (OR) and 95% confidence interval (CI) by the STATA software.ResultsSixteen RCT datasets derived from 3680 patients were included. There was no significant heterogeneity across the data available in this meta-analysis. There were significant differences in that rate between homozygous (HomEMs) and heterozygous (HetEMs) extensive metabolizers (OR 0.724; 95% CI 0.594–0.881), between HomEMs and poor metabolizers (PM) (OR 0.507; 95%CI 0.379–0.679), or between HetEMs and PMs (OR 0.688; 95%CI 0.515–0.920), regardless of the PPI being taken. Furthermore, sub-analysis of individual PPIs was carried out to explore the difference across all the PPIs used. A significantly low rate was seen in HomEMs vs. HetEMs taking either omeprazole (OR 0.329; 95%CI 0.195–0.553) or lansoprazole (OR 0.692; 95%CI 0.485–0.988), and also in HomEMs vs. PMs for omeprazole (OR 0.232; 95%CI 0.105–0.515) or lansoprazole (OR 0.441; 95%CI 0.252–0.771). However, there was no significant difference between HetEMs and PMs taking either one. No significant differences were observed for rabeprazole or esomeprazole across the CYP2C19 genotypes of interest.ConclusionsCarriage of CYP2C19 loss-of-function variants is associated with increased H. pylori eradication rate in patients taking PPI-based triple therapies when omeprazole or lansoprazole is chosen. However, there is no a class effect after use of rabeprazole or esomeprazole.

Helicobacter pylori eradication: A randomised comparative trial of 7-day versus 14-day triple therapy

Background. Helicobacter pylori is associated with several upper gastrointestinal conditions including chronic gastritis, peptic ulcer disease, and gastric malignancy. Proton pump inhibitor-based triple therapies are considered the standard regimens for H. pylori eradication, but the optimal duration of therapy is controversial. To prevent infection and complications, local studies should be undertaken to evaluate H. pylori eradication rates in a country. Objectives. We compared 7-day and 14-day regimens to determine the optimum duration of triple therapy for H. pylori eradication. Methods. We undertook a prospective randomised comparative trial of 7-day and 14-day triple therapy regimen for H. pylori eradication at the Aga Khan University Hospital, Nairobi; 120 patients with dyspepsia and H. pylori infection were randomised to receive esomeprazole, amoxicillin and clarithromycin for either 7 days (EAC 7) or 14 days (EAC 14). Compliance and side-effects were assessed 2 weeks after the start of therapy and H. pylori eradication was assessed by stool antigen tests 4 weeks after treatment. Results. Both the intention-to-treat (ITT; N=120) and per protocol (PP; N=97) analyses showed no significant differences between the eradication rates of EAC 7 (ITT 76.7%; PP 92%) and EAC 14 (ITT 73.3%; PP 93.6%) (ITT p=0.67; PP p=0.76). Poor compliance was reported in one patient in the EAC 14 group. The incidence of adverse events was comparable in the two groups. Conclusion. One-week and 2-week triple treatments for H. pylori eradication are similar in terms of efficacy, safety and patient compliance.

Su1698 Comparison of Ten-Day, Fifteen-Day Sequential Therapy and Proton-Pump Inhibitor-Based Triple Therapy in Korea: A Prospective Randomized Study

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 forH. 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.

Management of Helicobacter pylori-related disorders

The discovery of Helicobacter pylori has opened new opportunities in the management of gastrointestinal disorders, with the cure of chronic ulcer disease now being possible for the first time. The 1994 United States National Institutes of Health Consensus Conference recommended that patients with duodenal or gastric ulcers unrelated to the use of non-steroidal anti-inflammatory drugs (NSAID) should be given eradication therapy. These guidelines were refined at a conference held recently in Maastricht. The updated guidelines strongly recommend treatment in patients with duodenal or gastric ulcer disease, low-grade mucosa-associated lymphoid tissue (MALT) gastric lymphoma, gastritis with severe macro-or microscopic changes and after resection of early gastric cancer. Despite a lack of hard scientific evidence, the guidelines also suggest that eradication treatment is advisable in patients with unequivocally diagnosed functional dyspepsia, a family history of gastric cancer, long-term treatment with proton-pump inhibitors for gastro-oesophageal reflux disease (GORD), planned or existing NSAID treatment, after gastric surgery for ulcer or cancer, or if the patient wants to be treated. Many different therapeutic regimens have been used previously, but at present the best treatment is proton-pump inhibitor-based triple therapy, comprising a proton-pump inhibitor plus two drugs out of clarithromycin, a nitroimidazole and amoxycillin. One-week low-dose triple therapy cures 85-95% of infected patients.

Efficacy of Proton Pump Inhibitor-based Triple Therapy and Bismuth-based Quadruple Therapy forHelicobacter pyloriEradication in Korean Children

PurposeThe aim of this study was to assess and compare the efficacies of proton pump inhibitor-based triple therapy and bismuth-based quadruple therapy as first-line treatments for Helicobacter pylori eradication in Korean children.MethodsWe retrospectively reviewed the data of children who had been diagnosed with H. pylori infection at the Seoul National University Bundang Hospital from March 2004 to August 2012. The patients were randomly assigned to receive either triple therapy consisting of omeprazole, amoxicillin, and clarithromycin for 2 weeks (OAC group) or quadruple therapy comprising omeprazole, amoxicillin, metronidazole, and bismuth salts for 1 week (OAMB group). The patients were evaluated for eradication of H. pylori infection at 4 weeks after the completion of the treatment.ResultsOf the 129 children enrolled in this study, 118 (91.5%) were included in the final analysis. The eradication rates in OAC and OAMB groups were 67.7% (42/62) and 83.9% (47/56), respectively, which were significantly different between the 2 treatment groups (p=0.041). The eradication rates in the OAMB group during the periods 2004-2006, 2007-2009, and 2010-2012 were superior to those in the OAC group.ConclusionThis study indicated that the 1-week bismuth-based quadruple therapy, compared with the standard 2-week triple therapy, was significantly more successful in eradicating H. pylori infection in Korean children.

Randomised clinical trial: the efficacy of a 10-day sequential therapy vs. a 14-day standard proton pump inhibitor-based triple therapy for Helicobacter pylori in Korea

The eradication rates of Helicobacter pylori (H. pylori) using a proton pump inhibitor (PPI)-based triple therapy have declined due to antibiotic resistance worldwide. To compare the eradication rate of the 10-day sequential therapy for H. pylori infection with that of the 14-day standard PPI-based triple therapy. This was a prospective, randomised, controlled study. A total of 409 patients with H. pylori infection were randomly assigned to receive either the 10-day sequential therapy regimen, which consisted of pantoprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then pantoprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for another five consecutive days or the 14-day PPI-based triple therapy regimen, which consisted of pantoprazole (40 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice a day for 14 days. The pre- and post-treatment H. pylori status were assessed by rapid urease test, urea breath test, or histology. Successful eradication was confirmed at least 4 weeks after finishing the treatment. In the intention-to-treat analysis, the eradication rates of the 10-day sequential therapy and of the 14-day PPI-based triple therapy were 85.9% (176/205) and 75.0% (153/205), respectively (P = 0.006). In the per-protocol analysis, the eradication rates were 92.6% (175/205) and 85% (153/204), respectively (P = 0.019). There was no statistically significant difference between the two investigated groups regarding the occurrence of adverse event rates (18.9% vs. 13.3%, P = 0.143). The 10-day sequential therapy achieved significantly higher eradication rates than the 14-day standard PPI-based triple therapy in Korea.