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Su1158 Comparative Study of Helicobacter pylori Eradication Rates With 10-Day Quadruple “Concomitant” Therapy and 10-Day “Sequential” Therapy
Su1155
treatment efficacy and distinctly decreases the adverse effects of therapy and the symptoms of the underlying disease.
AGA Abstracts
Benefit of Helicobacter pylori Eradication Therapy to Symptomatology Is Greater in Patients Without Metaplastic Gastritis Sun-Young Lee, Jeong Hwan Kim, In Kyung Sung, Hyung Seok Park, Chan Sup Shim, Choon Jo Jin Background: Improvements to dyspeptic symptoms after medication is often incomplete, and thus controversy exists over the use of Helicobacter pylori eradication therapy in nonulcer dyspepsia. This study analyzed the factors predictive of the benefits to symptomatology after H. pylori eradication. Methods: Consecutive patients presenting with dyspeptic symptoms were included in a prospective setting. Metaplastic gastritis was diagnosed by endoscopic findings with a gastric biopsy. The urea breath test (UBT) was performed 4 weeks after H. pylori eradication by a 7-day course of pantoprazole, amoxicillin and clarithromycin. A positive UBT resulted in a subsequent 7-day course of pantoprazole, bismuth, tetracycline, and metronidazole. The patients were asked to score five major symptoms (epigastric pain, early satiety, postprandial fullness, bloating, and nausea) as 0 (none), 1 (rare), 2 (intermittent), 3 (frequent) to 4 (always) before and after the successful eradication. Results: Of 153 H. pylori-infected subjects, 120 patients were successfully eradicated after first-line therapy, with second-line therapy being successful in the remaining 31 patients and third-line therapy using fluoroquinolone in 2 patients. The symptoms persisted after the eradication in 28 (54.9%) of 51 metaplastic gastritis patients and in 24 (23.5%) of 102 non-metaplastic gastritis patients (p<0.001). Early satiation (p<0001), postprandial fullness (p=0.004), and bloating (p=0.002) showed less improvement in metaplastic gastritis patients than in nonmetaplastic gastritis patients after H. pylori eradication. Conclusions: The benefit to symptomatology is more pronounced in dyspeptic patients without metaplastic gastritis than in those with metaplastic gastritis. This represents further evidence that H. pylori eradication should be considered in patients before metaplastic gastritis develops. Su1156
Subject distribution by arm
The Trend in Helicobacter pylori Eradication Rates by First-Line Triple Therapy and Related Factors in Eradication Therapy Sung Eun Kim, Moo In Park, Seun Ja Park, Won Moon, Youn Jung Choi, Hye Jung Kwon, Jae Hyun Kim
Su1158 Comparative Study of Helicobacter pylori Eradication Rates With 10-Day Quadruple "Concomitant" Therapy and 10-Day "Sequential" Therapy Seung Young Kim, Jang Soo Han, Jong Jin Hyun, Sung Woo Jung, Ja Seol Koo, Jong-Jae Park, Hoon Jai Chun, Sang Woo Lee
Background: Trends in successful eradication of Helicobacter pylori by first-line triple therapy, comprised of a proton pump inhibitor, amoxicillin, and clarithromycin, have been understudied. We will evaluate H. pylori eradication rates in a single center during the last ten years and identify risk factors related to eradication failure. Methods: This study included 1,413 patients who were diagnosed with H. pylori infection and received 7 days of triple therapy between January 2003 and December 2012. We retrospectively investigated H. pylori eradication rates with respect to the year of therapy as well as demographic and clinical factors. H. pylori eradication was confirmed by a 13C-urea breath test or a rapid urease test at least 4 weeks after the completion of triple therapy. Results: The overall H. pylori eradication rate was 84.9%. Annual eradication rates from 2003 to 2012 were 93.5%, 80.0%, 87.2%, 88.5%, 92.0%, 88.3%, 85.7%, 84.1%, 83.7%, and 78.8% respectively, by per-protocol analysis. The eradication rate in first-line triple therapy decreased during the last ten years (p = .015). Multivariate analysis showed that female sex (OR 1.69; 95% CI 1.12-2.55) and smoking (OR 1.61; 95% CI 1.05-2.47) were associated with the failure of H. pylori eradication therapy. Conclusions: The efficacy of first-line triple therapy for H. pylori infection has decreased during the last ten years, which suggests an increase in antibiotic resistant H. pylori strains. Therefore, other first-line therapies may be necessary for H. pylori eradication in the near future.
Background: Since the efficacy of the standard triple therapies for Helicobacter pylori (H. pylori) eradication has decreased, novel antibiotic regimens have been introduced. The aim of this study was to compare concomitant quadruple therapy with sequential therapy for the first-line H. pylori eradication. Methods: A total of 137 patients (mean age 53 year, male 63.5%) with proven H. pylori infection were randomly assigned to one of 2 regimens: amoxicillin 1000mg with clarithromycin 500 mg, metronidazole 500 mg, and pantoprazole 40mg twice daily for 10 days (concomitant therapy) or amoxicillin 1000mg with pantoprazole 40mg twice daily for 5 days followed by clarithromycin 500mg with metronidazole 500mg, and pantoprazole 40mg twice daily for 5 days (sequential therapy). The success of eradication was evaluated 4 to 5 weeks after completion of treatment by using a 13C-urea breath test, biopsy or rapid urease test. Results: Eradication rates were 93.8% in the concomitant therapy and 86.8% in the sequential therapy (per protocol), but the difference was not statistically significant (P = 0.27). Respective compliances were 96.4% in concomitant therapy and 95.8% in sequential therapy. Mild adverse events were more frequently reported in the sequential-therapy group (41.7%) than in the concomitant-therapy group (38.2%) (P = 0.72). Conclusions: Concomitant therapy led to a non-statistically advantage (7%) over sequential therapy, coming closer to 90% eradication rates for H. pylori in Korea.
Su1157 The Efficacy of Probiotics As Adjuvant Treatment in Eradicating H. pylori by Standard Triple Therapy: A Prospective, Randomized, Double Blind and Placebo Controlled Trial Goran Hauser, Nermin N. Salkic, Karina Vukelic, Vedrana Kuzmic, Davor Stimac
Su1159 High Efficacy of 14-Day Standard Triple Therapy Plus Bismuth With Probiotic Supplement for H. pylori Eradication in Low Clarithromycin Resistance Areas Chanagune Srinarong, Varocha Mahachai, Ratha-korn Vilaichone
Objectives: The current report of the European Helicobacter Study Group considers probiotics as an adjuvant treatment in reducing side effects during the standard Helicobacter pylori eradication therapy. The primary objective in the study is determination of efficacy of probiotic preparation as a supportive therapy in eradication of H. Pylori Methods: The trial was prospective, randomized, placebo controlled, double-blind, multicenter trial. The enrolment of subjects into the trial was conducted in 121 general practitioners' offices, from September 2009 until June 2012, uniformly distributed throughout Croatia. A total of 804 persons meeting the inclusion/exclusion criteria were enrolled in the trial. The initial diagnosis of H. pylori infection was established using one of three commonly accepted methods- rapid urease test, stool antigen, or urea breath test. Probiotic preparation contains of Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12® in the concentration of 108to 1010 living bacteria. Selection of proton pump inhibitors and antibiotics are under discretion of attending physician.The primary endpoint of the trial was defined as the share of subjects with successfully administered treatment, i.e. negative result for H. pylori at 6 weeks (42 days +/- 2 days). An additional objective was to monitor the intensity of the 10 symptoms: epigastric pain, bloating, flatulence, taste disturbance, loss of appetite, nausea, vomiting, heartburn, skin rash, and diarrhea. We used a verbal rating scale consisting of 4 categories (from 0 - no symptoms to 3 -severe symptoms) at baseline and at two weeks after enrolment. Results: The results show a significantly larger share of cured subjects in the probiotic arm versus the placebo arm 87.92% vs. 72.70%; OR 2.73 (95% CI 1.77-4.22). Overall, at baseline the average value of intensity for all 10 symptoms was similar in booth groups mean=1.17 (SD=0.49) for subjects on probiotic and for subjects on placebo mean=1.07 (SD =0.51) (p<0.01). At follow-up visit 15 days after the start of the trial, the intensity of the same symptoms that were monitored at enrolment was again evaluated. Overall, the average intensity value for all 10 symptoms was lower in subjects on probiotic, mean=0.55 (SD= 0.64), versus those on placebo, mean=0.76 (SD=0.77) (p<0.001). Conclusions: Adding probiotics to the standard triple therapy for H. pylori infection significantly contributes to
Objective: Standard triple therapy for H. pylori eradication is no longer effective in many countries. This study was designed to evaluate efficacy of adding bismuth and probiotic to standard triple therapy for H. pylori eradication in low clarithromycin resistance areas. Method: A prospective study was done in Thailand. H pylori infected gastritis patients were randomized to 7- or 14-day standard triple therapy plus bismuth with or without probiotic supplement (Dutch Mill Co., Ltd, Thailand) consisting of bismuth subsalicylate (524) 2 tab twice daily, lansoprazole (30 mg) twice daily, amoxicillin 1 g twice daily and clarithromycin MR 1 g once daily. H. pylori was defined as positive culture or two positive tests (CLO test and histology). CYP2C19 genotyping and antibiotic susceptibility tests were done. H pylori eradication was evaluated by 13C-UBT 2 weeks after treatment. Results: 100 subjects were enrolled (50 each to 7- and 14-day regimens). Antibiotic susceptibility testing (50 strains) showed 42% metronidazole resistance and 5% of clarithromycin resistance. CYP2C19 genotyping (50 subjects) revealed 52% RM, 34% IM and 14% PM. The eradication rate of 14day regimen was significantly higher than 7-day regimen (98%vs 84%, P-value <0.05). The difference was related to improved eradication at 14 days in rapid metabolizers (i.e., 98% vs. 82%). Side effects were less in probiotic supplement group especially in 14-day regimen (ie. bitter taste 44% vs 16%). Conclusion: 14-day standard triple therapy plus bismuth provided excellent cure rate (98%) regardless of CYP2C19 genotype and metronidazole resistance. Adding probiotic could be minimizing side effects and help patients completed treatment regimens.
S-391
AGA Abstracts
treatment efficacy and distinctly decreases the adverse effects of therapy and the symptoms of the underlying disease.
AGA Abstracts
Benefit of Helicobacter pylori Eradication Therapy to Symptomatology Is Greater in Patients Without Metaplastic Gastritis Sun-Young Lee, Jeong Hwan Kim, In Kyung Sung, Hyung Seok Park, Chan Sup Shim, Choon Jo Jin Background: Improvements to dyspeptic symptoms after medication is often incomplete, and thus controversy exists over the use of Helicobacter pylori eradication therapy in nonulcer dyspepsia. This study analyzed the factors predictive of the benefits to symptomatology after H. pylori eradication. Methods: Consecutive patients presenting with dyspeptic symptoms were included in a prospective setting. Metaplastic gastritis was diagnosed by endoscopic findings with a gastric biopsy. The urea breath test (UBT) was performed 4 weeks after H. pylori eradication by a 7-day course of pantoprazole, amoxicillin and clarithromycin. A positive UBT resulted in a subsequent 7-day course of pantoprazole, bismuth, tetracycline, and metronidazole. The patients were asked to score five major symptoms (epigastric pain, early satiety, postprandial fullness, bloating, and nausea) as 0 (none), 1 (rare), 2 (intermittent), 3 (frequent) to 4 (always) before and after the successful eradication. Results: Of 153 H. pylori-infected subjects, 120 patients were successfully eradicated after first-line therapy, with second-line therapy being successful in the remaining 31 patients and third-line therapy using fluoroquinolone in 2 patients. The symptoms persisted after the eradication in 28 (54.9%) of 51 metaplastic gastritis patients and in 24 (23.5%) of 102 non-metaplastic gastritis patients (p<0.001). Early satiation (p<0001), postprandial fullness (p=0.004), and bloating (p=0.002) showed less improvement in metaplastic gastritis patients than in nonmetaplastic gastritis patients after H. pylori eradication. Conclusions: The benefit to symptomatology is more pronounced in dyspeptic patients without metaplastic gastritis than in those with metaplastic gastritis. This represents further evidence that H. pylori eradication should be considered in patients before metaplastic gastritis develops. Su1156
Subject distribution by arm
The Trend in Helicobacter pylori Eradication Rates by First-Line Triple Therapy and Related Factors in Eradication Therapy Sung Eun Kim, Moo In Park, Seun Ja Park, Won Moon, Youn Jung Choi, Hye Jung Kwon, Jae Hyun Kim
Su1158 Comparative Study of Helicobacter pylori Eradication Rates With 10-Day Quadruple "Concomitant" Therapy and 10-Day "Sequential" Therapy Seung Young Kim, Jang Soo Han, Jong Jin Hyun, Sung Woo Jung, Ja Seol Koo, Jong-Jae Park, Hoon Jai Chun, Sang Woo Lee
Background: Trends in successful eradication of Helicobacter pylori by first-line triple therapy, comprised of a proton pump inhibitor, amoxicillin, and clarithromycin, have been understudied. We will evaluate H. pylori eradication rates in a single center during the last ten years and identify risk factors related to eradication failure. Methods: This study included 1,413 patients who were diagnosed with H. pylori infection and received 7 days of triple therapy between January 2003 and December 2012. We retrospectively investigated H. pylori eradication rates with respect to the year of therapy as well as demographic and clinical factors. H. pylori eradication was confirmed by a 13C-urea breath test or a rapid urease test at least 4 weeks after the completion of triple therapy. Results: The overall H. pylori eradication rate was 84.9%. Annual eradication rates from 2003 to 2012 were 93.5%, 80.0%, 87.2%, 88.5%, 92.0%, 88.3%, 85.7%, 84.1%, 83.7%, and 78.8% respectively, by per-protocol analysis. The eradication rate in first-line triple therapy decreased during the last ten years (p = .015). Multivariate analysis showed that female sex (OR 1.69; 95% CI 1.12-2.55) and smoking (OR 1.61; 95% CI 1.05-2.47) were associated with the failure of H. pylori eradication therapy. Conclusions: The efficacy of first-line triple therapy for H. pylori infection has decreased during the last ten years, which suggests an increase in antibiotic resistant H. pylori strains. Therefore, other first-line therapies may be necessary for H. pylori eradication in the near future.
Background: Since the efficacy of the standard triple therapies for Helicobacter pylori (H. pylori) eradication has decreased, novel antibiotic regimens have been introduced. The aim of this study was to compare concomitant quadruple therapy with sequential therapy for the first-line H. pylori eradication. Methods: A total of 137 patients (mean age 53 year, male 63.5%) with proven H. pylori infection were randomly assigned to one of 2 regimens: amoxicillin 1000mg with clarithromycin 500 mg, metronidazole 500 mg, and pantoprazole 40mg twice daily for 10 days (concomitant therapy) or amoxicillin 1000mg with pantoprazole 40mg twice daily for 5 days followed by clarithromycin 500mg with metronidazole 500mg, and pantoprazole 40mg twice daily for 5 days (sequential therapy). The success of eradication was evaluated 4 to 5 weeks after completion of treatment by using a 13C-urea breath test, biopsy or rapid urease test. Results: Eradication rates were 93.8% in the concomitant therapy and 86.8% in the sequential therapy (per protocol), but the difference was not statistically significant (P = 0.27). Respective compliances were 96.4% in concomitant therapy and 95.8% in sequential therapy. Mild adverse events were more frequently reported in the sequential-therapy group (41.7%) than in the concomitant-therapy group (38.2%) (P = 0.72). Conclusions: Concomitant therapy led to a non-statistically advantage (7%) over sequential therapy, coming closer to 90% eradication rates for H. pylori in Korea.
Su1157 The Efficacy of Probiotics As Adjuvant Treatment in Eradicating H. pylori by Standard Triple Therapy: A Prospective, Randomized, Double Blind and Placebo Controlled Trial Goran Hauser, Nermin N. Salkic, Karina Vukelic, Vedrana Kuzmic, Davor Stimac
Su1159 High Efficacy of 14-Day Standard Triple Therapy Plus Bismuth With Probiotic Supplement for H. pylori Eradication in Low Clarithromycin Resistance Areas Chanagune Srinarong, Varocha Mahachai, Ratha-korn Vilaichone
Objectives: The current report of the European Helicobacter Study Group considers probiotics as an adjuvant treatment in reducing side effects during the standard Helicobacter pylori eradication therapy. The primary objective in the study is determination of efficacy of probiotic preparation as a supportive therapy in eradication of H. Pylori Methods: The trial was prospective, randomized, placebo controlled, double-blind, multicenter trial. The enrolment of subjects into the trial was conducted in 121 general practitioners' offices, from September 2009 until June 2012, uniformly distributed throughout Croatia. A total of 804 persons meeting the inclusion/exclusion criteria were enrolled in the trial. The initial diagnosis of H. pylori infection was established using one of three commonly accepted methods- rapid urease test, stool antigen, or urea breath test. Probiotic preparation contains of Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12® in the concentration of 108to 1010 living bacteria. Selection of proton pump inhibitors and antibiotics are under discretion of attending physician.The primary endpoint of the trial was defined as the share of subjects with successfully administered treatment, i.e. negative result for H. pylori at 6 weeks (42 days +/- 2 days). An additional objective was to monitor the intensity of the 10 symptoms: epigastric pain, bloating, flatulence, taste disturbance, loss of appetite, nausea, vomiting, heartburn, skin rash, and diarrhea. We used a verbal rating scale consisting of 4 categories (from 0 - no symptoms to 3 -severe symptoms) at baseline and at two weeks after enrolment. Results: The results show a significantly larger share of cured subjects in the probiotic arm versus the placebo arm 87.92% vs. 72.70%; OR 2.73 (95% CI 1.77-4.22). Overall, at baseline the average value of intensity for all 10 symptoms was similar in booth groups mean=1.17 (SD=0.49) for subjects on probiotic and for subjects on placebo mean=1.07 (SD =0.51) (p<0.01). At follow-up visit 15 days after the start of the trial, the intensity of the same symptoms that were monitored at enrolment was again evaluated. Overall, the average intensity value for all 10 symptoms was lower in subjects on probiotic, mean=0.55 (SD= 0.64), versus those on placebo, mean=0.76 (SD=0.77) (p<0.001). Conclusions: Adding probiotics to the standard triple therapy for H. pylori infection significantly contributes to
Objective: Standard triple therapy for H. pylori eradication is no longer effective in many countries. This study was designed to evaluate efficacy of adding bismuth and probiotic to standard triple therapy for H. pylori eradication in low clarithromycin resistance areas. Method: A prospective study was done in Thailand. H pylori infected gastritis patients were randomized to 7- or 14-day standard triple therapy plus bismuth with or without probiotic supplement (Dutch Mill Co., Ltd, Thailand) consisting of bismuth subsalicylate (524) 2 tab twice daily, lansoprazole (30 mg) twice daily, amoxicillin 1 g twice daily and clarithromycin MR 1 g once daily. H. pylori was defined as positive culture or two positive tests (CLO test and histology). CYP2C19 genotyping and antibiotic susceptibility tests were done. H pylori eradication was evaluated by 13C-UBT 2 weeks after treatment. Results: 100 subjects were enrolled (50 each to 7- and 14-day regimens). Antibiotic susceptibility testing (50 strains) showed 42% metronidazole resistance and 5% of clarithromycin resistance. CYP2C19 genotyping (50 subjects) revealed 52% RM, 34% IM and 14% PM. The eradication rate of 14day regimen was significantly higher than 7-day regimen (98%vs 84%, P-value <0.05). The difference was related to improved eradication at 14 days in rapid metabolizers (i.e., 98% vs. 82%). Side effects were less in probiotic supplement group especially in 14-day regimen (ie. bitter taste 44% vs 16%). Conclusion: 14-day standard triple therapy plus bismuth provided excellent cure rate (98%) regardless of CYP2C19 genotype and metronidazole resistance. Adding probiotic could be minimizing side effects and help patients completed treatment regimens.
S-391
AGA Abstracts