BACKGROUND/AIMS: This nationwide, multicenter prospective randomized controlled trial aimed to compare the efficacy and safety of 10-day concomitant therapy (CT) and 10-day sequential therapy (ST) with 7-day clarithromycin-containing triple therapy (TT) as first-line treatment for Helicobacter pylori infection in the Korean population. METHODS: Patients with H. pylori infection were assigned randomly to 7d-TT (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 7 days), 10d-ST (lansoprazole 30 mg and amoxicillin 1 g twice daily for the first 5 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg twice daily for the remaining 5 days), or 10d-CT (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 10 days). The primary endpoint was eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. RESULTS: A total of 1,141 patients were included. The 10d-CT protocol achieved a markedly higher eradication rate than the 7d-TT protocol in both the ITT (81.2% vs 63.9%) and PP analyses (90.6% vs 71.4%). The eradication rate of the 10d-ST protocol was superior to that of the 7d-TT protocol (76.3% vs 63.9%, ITT analysis; 85.0% vs 71.4%, PP analysis). No significant differences in adherence or serious side effects were found among the three treatment arms. CONCLUSIONS: The 10d-CT and 10d-ST regimens were superior to the 7d-TT regimen as standard first-line treatment in Korea.
Amoxicillin ; Arm ; Clarithromycin ; Disease Eradication ; Helicobacter pylori ; Helicobacter ; Humans ; Korea ; Lansoprazole ; Metronidazole ; Prospective Studies

BACKGROUND/AIMS: Although some previous studies reported that a treatment combined with mucoprotective agent could improve the eradication rate in dual or triple therapy, there are other reports that question the efficacy of combining these drugs in concomitant therapy (CoCTx). The aim of this study was to investigate the effects of rebamipide or ecabet on the Helicobacter pylori (H. pylori) eradication combined with CoCTx. METHODS: We retrospectively reviewed the medical records of 277 patients with proven H. pylori infection. They were assigned to one of 3 regimens for 10 days, twice daily: (a) CoCTx (n=118): lansoprazole 30 mg, amoxicillin 1 g, metronidazole 500 mg, and clarithromycin 500 mg; (b) CoCTx+rebamipide (100 mg) (n=85); (c) CoCTx+ecabet (1 g) (n=74). RESULTS: The baseline characteristics were not significantly different. H. pylori eradication rates were 82.2% (97/118) in CoCTx, 90.6% (77/85) in CoCTx+rebamipide, and 89.2% (66/74) in CoCTx+ecabet (p=0.17), which were statistically insignificant. Overall adverse events were more frequently reported in the CoCTx+rebamipide (50.6%. 43/85) and CoCTx+ecabet (44.6%, 33/74) groups than in the CoCTx (32.2%, 38/118) (p = 0.03) group. Drug compliances were not different between three groups (CoCTx: 95.8%, 113/118; CoCT+rebamipide: 92.9%, 79/85; CoCTx+ecabet 98.6%,73/74) (p=0.209). Multivariate analysis showed that the risk of eradication failure was significantly increased with decreased drug compliance (odds ratio 3.52, 95% confidence interval 1.00–12.32; p=0.05). CONCLUSIONS: Addition of these mucoprotective agent was not superior to CoCTx alone for eradicating H. pylori infection with frequent adverse events. Rather, drug compliance is the most related factor affecting the eradication rate. Our data suggest the importance of drug compliance over the drugs used.
Amoxicillin ; Clarithromycin ; Compliance ; Helicobacter pylori* ; Helicobacter* ; Humans ; Lansoprazole ; Medical Records ; Metronidazole ; Multivariate Analysis ; Retrospective Studies ; Sodium*

PURPOSE: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. MATERIALS AND METHODS: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). RESULTS: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. CONCLUSIONS: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).
Drug Therapy ; Follow-Up Studies ; Hemorrhage* ; Humans ; Incidence ; Lansoprazole ; Primary Prevention ; Prospective Studies ; Proton Pump Inhibitors ; Proton Pumps* ; Protons* ; Stomach Neoplasms*

BACKGROUND/AIMS: Although intravenous proton pump inhibitor (PPI) has been used for the prevention of post endoscopic submucosal dissection (ESD) bleeding, the route of administration has not been confirmed. The aim of the present study was to compare the efficacy of intravenous and oral PPI administration for the prevention of delayed post ESD bleeding. METHODS: Total 166 consecutive patients were randomly assigned to 30 mg lansoprazol twice a day (PO group) and 120 mg pantoprazole intravenous injection (IV group) for 48 hours. Finally, 65 patients in PO group and 87 patients in IV group were analyzed. After ESD, all patients underwent follow up endoscopy after 24 hours and were observed the symptoms of bleeding up to 60 days after ESD. RESULTS: Age, sex and use of anticoagulants were not different between groups. At follow up endoscopy after 24 hours, oozing and exposed vessel was noted in 4.6% of PO group and 8.0% of IV group and there was no significant difference. Delayed bleeding occurred in 4 of 65 patients (6.2%) in the PO group and 8 of 87 patients (9.2%) in the IV group (p>0.999). By multivariate analysis, oozing or exposed vessels at follow up endoscopy were risk factors for delayed bleeding (OR=17.5, p=0.022). CONCLUSIONS: There was no significant difference in the delayed bleeding, length of hospital stay according to the administration route. Bleeding stigmata at follow up endoscopy was risk factor of delayed bleeding. Oral PPI administration can cost-effectively replace IV PPI for prevention of post ESD bleeding.
2-Pyridinylmethylsulfinylbenzimidazoles/therapeutic use ; *Administration, Oral ; Aged ; Anticoagulants/therapeutic use ; Endoscopic Mucosal Resection/*adverse effects ; Female ; Gastroscopy ; Humans ; *Injections, Intravenous ; Lansoprazole/therapeutic use ; Male ; Middle Aged ; Odds Ratio ; Postoperative Hemorrhage/etiology/*prevention & control ; Prospective Studies ; Proton Pump Inhibitors/*therapeutic use ; Risk Factors ; Stomach Neoplasms/surgery

BACKGROUND/AIMS: The aim of this study was to evaluate the effect of the synthetic S-allyl-l-cysteine (SAC) PMK-S005 on gastric acid secretion, inflammation, and antioxidant enzymes in aging rats. METHODS: The rats were divided into four groups at 31 weeks of age and were continuously fed a diet containing a vehicle control, PMK-S005 (5 or 10 mg/kg), or lansoprazole (5 mg/kg). Gastric acid secretion and connective tissue thickness of the lamina propria were evaluated at 74 weeks and 2 years of age. Tumor necrosis factor (TNF)-α, interleukin (IL)-1β, and COX-2 levels were measured by using enzyme-linked immunosorbent assays (ELISAs) or Western blot assays. Levels of antioxidant enzymes, including heme oxyganase 1 (HO-1) and NAD(P)H:quinone oxidoreductase 1 (NQO-1), were also measured. RESULTS: As the rats aged, gastric acid secretion significantly decreased, and the connective tissue of the lamina propria increased. However, 74-week-old rats in the PMK-S005 group exhibited greater levels of gastric acid secretion than those of the control and lansoprazole groups. The increase of TNF-α, IL-1β, and COX-2 expression in 74-week and 2-year-old control rats were inhibited by PMK-S005. In addition, the decrease in HO-1 and NQO-1 protein expression that occurred with aging was inhibited by PMK-S005 in the 74-week-old rats. CONCLUSIONS: These results suggest that PMK-S005 has therapeutic potential as an antiaging agent to ameliorate age-related gastric acid secretion, inflammation, and oxidative stress in the stomach.
Aging ; Animals ; Antioxidants ; Blotting, Western ; Child, Preschool ; Connective Tissue ; Diet ; Enzyme-Linked Immunosorbent Assay ; Gastric Acid* ; Heme ; Humans ; Inflammation* ; Interleukins ; Lansoprazole ; Mucous Membrane ; Oxidative Stress ; Rats* ; Stomach* ; Tumor Necrosis Factor-alpha

BACKGROUND/AIMS: To evaluate changes in gut microbiota composition following long-term proton pump inhibitor (PPI) treatment. METHODS: Twenty-four-week-old F344 rats were fed diets with (n=6) or without (n=5) lansoprazole for 50 weeks. Profiles of luminal microbiota in the terminal ileum were then analyzed. Pyrosequencing of the 16S rRNA gene was performed using an FLX genome sequencer (454 Life Sciences/Roche). RESULTS: Rats treated with lansoprazole showed significantly reduced body weights compared to controls (lansoprazole-treated rats and controls, 322.3±15.3 g vs 403.2±5.2 g, respectively, p<0.001). However, stool frequencies and consistencies did not differ between the two groups. The composition of the gut microbiota in lansoprazole-treated rats was quite different from that of the controls. In the controls, the microbiota profiles obtained from the terminal ileum showed a predominance of Proteobacteria (93.9%) due to the abundance of Escherichia and Pasteurella genera. Conversely, lansoprazole-treated rats showed an elevated population of Firmicutes (66.9%), which was attributed to an increased ratio of Clostridium g4 to Lactobacillus genera. CONCLUSIONS: This preliminary study suggests that long-term administration of PPI may cause weight loss and changes to the microbiota in the terminal ileum.
Animals ; Body Weight ; Clostridium ; Diet ; Escherichia ; Firmicutes ; Gastrointestinal Microbiome* ; Genes, rRNA ; Genome ; Ileum ; Lactobacillus ; Lansoprazole ; Microbiota ; Pasteurella ; Phenobarbital ; Pilot Projects* ; Proteobacteria ; Proton Pump Inhibitors ; Proton Pumps* ; Protons* ; Rats ; Rats, Inbred F344* ; Weight Loss

BACKGROUND/AIMS: To evaluate changes in gut microbiota composition following long-term proton pump inhibitor (PPI) treatment. METHODS: Twenty-four-week-old F344 rats were fed diets with (n=6) or without (n=5) lansoprazole for 50 weeks. Profiles of luminal microbiota in the terminal ileum were then analyzed. Pyrosequencing of the 16S rRNA gene was performed using an FLX genome sequencer (454 Life Sciences/Roche). RESULTS: Rats treated with lansoprazole showed significantly reduced body weights compared to controls (lansoprazole-treated rats and controls, 322.3±15.3 g vs 403.2±5.2 g, respectively, p<0.001). However, stool frequencies and consistencies did not differ between the two groups. The composition of the gut microbiota in lansoprazole-treated rats was quite different from that of the controls. In the controls, the microbiota profiles obtained from the terminal ileum showed a predominance of Proteobacteria (93.9%) due to the abundance of Escherichia and Pasteurella genera. Conversely, lansoprazole-treated rats showed an elevated population of Firmicutes (66.9%), which was attributed to an increased ratio of Clostridium g4 to Lactobacillus genera. CONCLUSIONS: This preliminary study suggests that long-term administration of PPI may cause weight loss and changes to the microbiota in the terminal ileum.
Animals ; Body Weight ; Clostridium ; Diet ; Escherichia ; Firmicutes ; Gastrointestinal Microbiome* ; Genes, rRNA ; Genome ; Ileum ; Lactobacillus ; Lansoprazole ; Microbiota ; Pasteurella ; Phenobarbital ; Pilot Projects* ; Proteobacteria ; Proton Pump Inhibitors ; Proton Pumps* ; Protons* ; Rats ; Rats, Inbred F344* ; Weight Loss

BACKGROUND/AIMS: Because the efficacy of standard triple therapy for Helicobacter pylori eradication has declined, new regimens such as sequential therapy (ST) and concomitant therapy (CoCTx) have been introduced. The aim of this study was to compare the efficacy of 10-day ST and 10-day CoCTx for H. pylori eradication. METHODS: We retrospectively reviewed the medical records of 316 patients with proven H. pylori infection. They were assigned to one of 2 regimens; ST (n=191) consisted of, lansoprazole 30 mg and amoxicillin 1 g for 5 days followed by lansoprazole 30 mg, metronidazole 500 mg, and clarithromycin 500 mg for 5 days, and CoCTx (n=125) consisted of lansoprazole 30 mg, amoxicillin 1 g, metronidazole 500 mg, and clarithromycin 500 mg for 10 days. All drugs were administered twice a day. Bacterial eradication was checked by using a 13C-urea breath test at least 4 weeks after completion of treatment. RESULTS: The mean age and male to female ratio was 51.74 and 1.03, respectively. Baseline characteristics were not different in both groups. Ten day CoCTx group (94.4%, 118/125) showed better eradication rate than ST group (82.2%, 157/191) (p=0.002). Drug compliances were not statistically different between the two groups (p=0.19). Side effects were more frequently reported in the CoCTx group than in the ST group (p=0.03). CONCLUSIONS: Ten-day CoCTx was superior to ST in terms of eradicating H. pylori infection. Although the CoCTx producing more side effects than ST, CoCTx can be thought to be a promising alternative to ST as a treatment regimen for H. pylori eradication.
Adult ; Aged ; Amoxicillin/therapeutic use ; Anti-Bacterial Agents/*therapeutic use ; Breath Tests ; Clarithromycin/therapeutic use ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Helicobacter Infections/diagnosis/*drug therapy ; *Helicobacter pylori ; Humans ; Lansoprazole/therapeutic use ; Logistic Models ; Male ; Metronidazole/therapeutic use ; Middle Aged ; Proton Pump Inhibitors/*therapeutic use ; Retrospective Studies ; Risk Factors ; Treatment Outcome

BACKGROUND/AIMS: Proton pump inhibitor (PPI) is generally prescribed to prevent post endoscopic submucosal dissection (ESD) bleeding. However, there was no consensus about the effectiveness of intravenous (IV) or oral PPI. We conducted this investigation to evaluate whether oral PPI can be also safely and effectively used to prevent post-ESD bleeding by measurement of intragastric pH. MATERIALS AND METHODS: Patients were assigned in the fixed order to IV pantoprazole by 40 mg every 12 hours and oral lansoprazole fast disintegrating tablet (LFDT) by 30 mg every 8 hours. We checked intragastric pH and hemoglobin (Hb) levels at pre and post-ESD procedure. RESULTS: A total of 10 patients (LFDT group: 6 patients, IV pantoprazole group: 4 patients) were included. There was no difference of baseline Hb level between two groups (LFDT, 14.38+/-0.46 mg/dL; IV pantoprazole, 13.85+/-0.83 mg/dL; P=0.18). After 24 hours, change of Hb level was not different between LFDT (0.95+/-0.30 mg/dL) and IV pantoprazole group (0.98+/-0.45 mg/dL; P=0.96). Baseline intragastric pH was 3.72+/-0.19 with LFDT and 4.31+/-0.41 with IV pantoprazole group (P=0.18). After 24 hours, there was no significant difference of the extent of pH increase between LFDT (2.38+/-0.28) and IV pantoprazole group (2.17+/-0.21; P=0.60). CONCLUSIONS: There was no difference in both the increase of post-24 hour intragastric pH and decrease of post-24 hour Hb between LFDT and IV pantoprazole group. Oral PPI regimen may be able to replace IV PPI therapy for the prevention of post-ESD bleeding and LFDT might be superior to IV PPIs in the aspect of cost-effectiveness.
Consensus ; Hemorrhage* ; Humans ; Hydrogen-Ion Concentration ; Lansoprazole* ; Proton Pump Inhibitors ; Proton Pumps

BACKGROUND/AIMS: Proton pump inhibitor (PPI) is generally prescribed to prevent post endoscopic submucosal dissection (ESD) bleeding. However, there was no consensus about the effectiveness of intravenous (IV) or oral PPI. We conducted this investigation to evaluate whether oral PPI can be also safely and effectively used to prevent post-ESD bleeding by measurement of intragastric pH. MATERIALS AND METHODS: Patients were assigned in the fixed order to IV pantoprazole by 40 mg every 12 hours and oral lansoprazole fast disintegrating tablet (LFDT) by 30 mg every 8 hours. We checked intragastric pH and hemoglobin (Hb) levels at pre and post-ESD procedure. RESULTS: A total of 10 patients (LFDT group: 6 patients, IV pantoprazole group: 4 patients) were included. There was no difference of baseline Hb level between two groups (LFDT, 14.38+/-0.46 mg/dL; IV pantoprazole, 13.85+/-0.83 mg/dL; P=0.18). After 24 hours, change of Hb level was not different between LFDT (0.95+/-0.30 mg/dL) and IV pantoprazole group (0.98+/-0.45 mg/dL; P=0.96). Baseline intragastric pH was 3.72+/-0.19 with LFDT and 4.31+/-0.41 with IV pantoprazole group (P=0.18). After 24 hours, there was no significant difference of the extent of pH increase between LFDT (2.38+/-0.28) and IV pantoprazole group (2.17+/-0.21; P=0.60). CONCLUSIONS: There was no difference in both the increase of post-24 hour intragastric pH and decrease of post-24 hour Hb between LFDT and IV pantoprazole group. Oral PPI regimen may be able to replace IV PPI therapy for the prevention of post-ESD bleeding and LFDT might be superior to IV PPIs in the aspect of cost-effectiveness.
Consensus ; Hemorrhage* ; Humans ; Hydrogen-Ion Concentration ; Lansoprazole* ; Proton Pump Inhibitors ; Proton Pumps