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Background/Aims@#H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA.However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis. @*Methods@#A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared. @*Results@#According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different. @*Conclusions@#DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
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Background/Aims@#Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone. @*Methods@#This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either EsoduoⓇ/sup> (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ/sup> (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4. @*Results@#A total of 355 patients completed the study (180 in the EsoduoⓇ/sup> group and 175 in the NexiumⓇ/sup> group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the EsoduoⓇ/sup> group and 35% in the NexiumⓇ/sup> group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles. @*Conclusions@#EsoduoⓇ/sup> is as effective and safe as NexiumⓇ/sup> for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).
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Purpose@#Endoscopic procedures can cause anxiety, which can lead to more uncomfortable, difficult, and incomplete procedures, in addition to greater use of sedative medication. Here, we investigate whether exposing patients to virtual reality (VR) prior to endoscopic procedures can reduce their anxiety levels. @*Materials and Methods@#Forty patients at Gangnam Severance Hospital were enrolled and divided into the VR group and the control group. Patients in the VR group were exposed to VR prior to their procedure to alleviate anxiety. The primary data outcomes were State-Trait Anxiety Inventory (STAI), pain score, satisfaction with sedation, and satisfaction with the procedure. @*Results@#The mean STAI-state and STAI-trait did not differ significantly between the control group and the VR group. While defining a high anxiety STAI score as ≥45 in an STAI-state, the proportion of patients with high anxiety at baseline was 35% and increased to 50% prior to the procedure in the control group. However, in the VR group, the proportion of patients with high anxiety at baseline was 60% and decreased to 50% prior to the procedure. The proportion changes of patients with high anxiety in the STAI-state exhibited a significant difference between the control and VR groups (p=0.007). Furthermore, patients’ satisfaction with sedation was significantly greater in the VR group compared to the control group (p=0.017). @*Conclusion@#VR exposure may relieve patients’ anxiety levels prior to endoscopic procedures, but further well-designed placebocontrolled studies are needed. VR, an inexpensive, easily available, and non-invasive method, also improved the satisfaction with sedation of endoscopic procedures.
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Background/Aims@#The eCura system, a scoring model for stratifying the lymph node metastasis risk after noncurative endoscopic resection for early gastric cancer (EGC), has been internally validated, primarily for differentiated-type EGC. We aimed to externally validate this model for undifferentiated-type EGC. @*Methods@#This multicenter, retrospective cohort study included 634 patients who underwent additional surgery (radical surgery group, n=270) or were followed up without additional treatment (no additional treatment group, n=364) after noncurative endoscopic resection for undifferentiated-type EGC between 2005 and 2015. The lymph node metastasis and survival rates were compared according to the risk categories. @*Results@#For the radical surgery group, the lymph node metastasis rates were 2.6%, 10.9%, and 14.8% for the low-, intermediate-, and high-risk eCura categories, respectively (p for trend=0.003). For the low-, intermediate-, and high-risk categories in the no additional treatment group, the overall survival (92.7%, 68.9%, and 80.0% at 5 years, respectively, p<0.001) and cancer-specific survival rates (99.7%, 94.7%, and 80.0% at 5 years, respectively, p<0.001) differed significantly. In the multivariate analysis, the hazard ratios (95% confidence interval) in the no additional treatment group relative to the radical surgery group were 3.18 (1.41 to 7.17; p=0.005) for overall mortality and 2.60 (0.46 to 14.66; p=0.280) for cancer-specific mortality in the intermediate-tohigh risk category. No such differences were noted in the low-risk category. @*Conclusions@#The eCura system can be applied to undifferentiated-type EGC. Close follow-up without additional treatment might be considered for low-risk patients, while additional surgery is recommended for intermediate- and high-risk patients.
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Background/Aims@#To investigate the risk of metabolic syndrome and fatty liver diseases in gastric cancer survivors compared to non-cancer subjects. @*Methods@#The data from the health screening registry of the Gangnam Severance Hospital from 2014–2019 was used. Ninety-one gastric cancer survivors and a propensity-score-matching 445 non-cancer subjects were analyzed. Gastric cancer survivors were divided into those with surgical treatment (OpGC, n=66) and non-surgical treatment (non-OpGC, n=25). Metabolic syndrome, fatty liver by ultrasonography, and metabolic dysfunction-associated fatty liver disease (MAFLD) were assessed. @*Results@#Metabolic syndrome was in 15.4% of gastric cancer survivors (OpGC; 13.6%, non-OpGC; 20.0%). Fatty liver by ultrasonography was in 35.2% in gastric cancer survivors (OpGC; 30.3%, non-OpGC: 48.0%). MAFLD was in 27.5% of gastric cancer survivor (OpGC; 21.2%, non-OpGC; 44.0%). After adjusting for age, sex, smoking, and alcohol, the risk of metabolic syndrome was lower in OpGC than in non-cancer subjects (OR, 0.372; 95% CI, 0.176-0.786, p=0.010). After adjusting, OpGC showed lower risks of fatty liver by ultrasonography (OR, 0.545; 95% CI, 0.306-0.970, p=0.039) and MAFLD (OR, 0.375; 95% CI, 0.197-0.711, p=0.003) than did non-cancer subjects. There were no significant differences in the risks of metabolic syndrome and fatty liver diseases between non-OpGC and non-cancer subjects. @*Conclusions@#OpGC showed lower risks of metabolic syndrome, fatty liver by ultrasonography, and MAFLD than non-cancer subjects, but there were no significant differences in the risks between non-OpGC and non-cancer subjects. Further studies on metabolic syndrome and fatty liver diseases in gastric cancer survivors are warranted.
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Background/Aims@#We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication. @*Methods@#A 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. @*Results@#In 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. @*Conclusions@#TPZ 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
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Background/Aims@#Papillary gastric cancer (GC) is classified as differentiated adenocarcinoma, together with well-differentiated (WD) and moderately differentiated (MD) adenocarcinoma. This study evaluated the risk of lymph node metastasis (LNM) in submucosal (SM) invasive papillary GC compared with other differentiated early GC types. @*Methods@#This retrospective study involved three tertiary hospitals and enrolled 1,798 lesions with differentiated SM invasive GC treated with curative gastrectomy between March 2001 and December 2012. All pathology slides were reviewed, and clinicopathologic findings associated with LNM, including tumor size, location, gross type, ulceration, depth and width of SM invasion, and lymphovascular invasion (LVI), were analyzed. @*Results@#The proportion of SM papillary GC was 2.8% (n=51). SM papillary GC was associated with larger tumor size and deeper and wider SM invasion than other differentiated GC types.LNM was significantly higher in the papillary type than in the MD and WD types. LNM was found in 27.5% of SM papillary GC patients (WD: 9.0%, MD: 21.2%). LVI was the only significant risk factor for LNM in SM papillary GC. The depth or width of SM invasion was not associated with LNM in papillary GC. Lower third location or elevated gross appearance was significantly associated with LVI. @*Conclusions@#SM papillary GC had the highest LNM rate, with features different from those of other differentiated SM invasive GCs. The treatment strategy for SM papillary GC should be carefully approached, especially for lesions located in the lower third or of the elevated gross type.
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Helicobacter pylori infection is one of the most common infectious diseases worldwide. Although the prevalence of H. pylori is gradually decreasing, approximately half of the world's population still becomes infected with this disease. H. pylori is responsible for substantial gastrointestinal morbidity worldwide, with a high disease burden. It is the most common cause of gastric and duodenal ulcers and gastric cancer. Since the revision of the H. pylori clinical practice guidelines in 2013 in Korea, the eradication rate of H. pylori has gradually decreased with the use of a clarithromycin-based triple therapy for 7 days. According to a nationwide randomized controlled study conducted by the Korean College of Helicobacter and Upper Gastrointestinal Research released in 2018, the intention-to-treat eradication rate was only 63.9%, which was mostly due to increased antimicrobial resistance, especially from clarithromycin. The clinical practice guidelines for the treatment of H. pylori were updated according to evidence-based medicine from a meta-analysis conducted on a target group receiving the latest level of eradication therapy. The draft recommendations developed based on the meta-analysis were finalized after an expert consensus on three recommendations regarding the indication for treatment and eight recommendations for the treatment itself. These guidelines were designed to provide clinical evidence for the treatment (including primary care treatment) of H. pylori infection to patients, nurses, medical school students, policymakers, and clinicians. These may differ from current medical insurance standards and will be revised if more evidence emerges in the future.
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Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases worldwide. Although its incidence is gradually decreasing, about half of the world's population still get infected. H. pylori infection is responsible for substantial gastrointestinal morbidity worldwide. It is the most common cause of gastric and duodenal ulcers as well as gastric cancer. Since the revision of the H. pylori Clinical Practice Guidelines in 2013, the eradication rate of H. pylori has gradually decreased with the use of classical triple therapy, wherein amoxicillin, clarithromycin, and proton pump inhibitors are administered, for 7 days. According to a nationwide randomized controlled study conducted by the Korean College of Helicobacter and Upper Gastrointestinal Research released in 2018, the intention-to-treat eradication rate was only 63.9%, which was due to increased antimicrobial resistance induced by the use of antibiotics, especially clarithromycin. The update of clinical practice guideline for treatment of H. pylori was developed based on evidence-based medicine by conducting a meta-analysis. The draft recommendations were finalized after expert consensus on three recommendations regarding the indication for treatment and eight recommendations on the treatment itself. These guidelines are designed to provide patients, nurses, medical school students, policymakers, and clinicians with clinical evidence to guide primary care and treatment of H. pylori infection. These may differ from current medical insurance standards and will be revised further, if necessary, based on research-based evidence.
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Background/Aims@#Standard triple therapy, including a proton pump inhibitor, clarithromycin, and amoxicillin, has been recommended as the first-line for Helicobacter pylori infection. However, the eradication rate of standard triple therapy has declined over the past years because of the increasing resistance to clarithromycin in Korea. We analyzed the eradication rates and the 10-year change in the eradication rates in Korea. @*Methods@#PubMed, EMBASE, the Cochrane Library, and KoreaMed were searched for studies published between January 2007 and June 2018. The pooled eradication rates and their 95% CIs were estimated using a random-effect logistic regression model. @*Results@#Twenty-six randomized controlled studies on standard triple therapy conducted in Korea were selected. The intention-to-treat (ITT) and per protocol analyses showed pooled eradication rates of standard triple therapy of 71.6% (95% CI, 69.9~73.3%) and 79.6% (95% CI, 76.6~82.2%), respectively. The eradication rate decreased with time. The ITT analysis showed that the 14-day therapy (78.1% [95% CI, 75.2~80.7%]) had significantly higher eradication rates than the 7-day therapy (70.0% [95% CI, 68.5~71.4%]) (P<0.01). @*Conclusions@#These results suggest that the eradication rate of standard triple therapy, as the first-line therapy, has shown an unacceptable decrease. The eradication rate increased when the duration of therapy was increased to 14 days, but it was not satisfactory. Therefore, other treatment regimens or therapies based on susceptibility tests should be considered for the first-line therapy.
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Background/Aims@#The eradication rate of the first-line standard triple therapy (STT) for Helicobacter pylori (H. pylori) infection has decreased since 2000; therefore, other first-line therapies are required. This study was aimed at investigating the efficacy of bismuth-containing quadruple therapy (PBMT) for first-line H. pylori eradication compared to STT, sequential therapy (SQT), and concomitant therapy (CT). @*Materials and Methods@#The Ovid-MEDLINE, Koreamed, EMBASE, KMBASE, and Cochrane Library databases were searched from January 2008 to July 2018. All identified randomized controlled trials (RCTs) comparing PBMT and non-PBMT for first-line H. pylori eradication therapy were included in the final analysis. @*Results@#A total of 3,653 patients from seven RCTs were enrolled. The pooled eradication rates of PBMT by intention-to-treat (ITT) and per-protocol (PP) analyses were 82.1% (95% CI, 68.2~90.8%) and 88.8% (95% CI, 77.1~94.9%), respectively. However, no statistically significant difference was observed in eradication rates of the 10- or 14-day PBMT as compared to 14-day STT, 10-day SQT, and 10-day CT in ITT and PP analyses. PBMT was significantly higher in adverse events than in the other eradication regimens (RR, 1.64; 95% CI, 1.11~2.44). Considerable heterogeneity in adverse events was observed among studies (χ2=88.7; P<0.001, I2=93%). @*Conclusions@#PBMT can be the first-line treatment for H. pylori eradication in Korea when other first-line options, including STT, SQT, or CT, are unavailable due to their high adverse event rates.
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Background/Aims@#As antibiotic resistance increases and new first-line therapies emerge, salvage therapies for Helicobacter pylori (H. pylori) eradication failures are becoming more common and complicated. This study aimed to systematically review overall salvage regimens after previous failure of H. pylori eradication. @*Materials and Methods@#A systematic review of randomized clinical trials evaluating salvage therapies after previous H. pylori eradication failure was performed. A meta-analysis was conducted when an adequate number of studies suitable for grouping was found. @*Results@#Overall, 36 studies with 77 treatment arms were identified, and they were highly heterogeneous regarding previously failed regimens and salvage regimens under comparison. Bismuth quadruple therapy after failure of standard triple therapy showed a pooled intention-to-treat (ITT) eradication rate of 75.5% (95% CI, 71.6~79.1%), and the rates were significantly higher with 14-day therapy than 7-day therapy by 9% (95% CI, 2~15%). Levofloxacin triple therapy after failure of standard triple therapy demonstrated a pooled ITT eradication rate of 73.3% (95% CI, 68.4~77.3%). In direct comparison, the two regimens were not significantly different in eradication rates. No study evaluated salvage regimens after the failure of bismuth or non-bismuth quadruple therapy. @*Conclusions@#The current studies regarding salvage regimens are highly heterogeneous. Bismuth quadruple therapy and levofloxacin triple therapy may be a reliable option after failure of standard triple therapy, but the regional profile of antibiotic resistance should be considered. Further studies are needed for salvage regimens after failure of non-bismuth or bismuth quadruple therapy.
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Helicobacter pylori infection is one of the most common infectious diseases worldwide. H. pylori is responsible for substantial gastrointestinal morbidity with a high disease burden. Since the revision of the H. pylori Clinical Practice Guidelines in 2013 in Korea, the eradication rate of H. pylori has gradually decreased with the use of a clarithromycin based triple therapy. According to a nationwide randomized controlled study by the Korean College of Helicobacter and Upper Gastrointestinal Research released in 2018, the intention-to-treat eradication rate was only 63.9%, which was mostly due to increased antimicrobial resistance to clarithromycin. The clinical practice guidelines for treatment of H. pylori were updated based on evidence-based medicine from a meta-analysis conducted on a target group receiving the latest level of eradication therapy. The draft recommendations developed based on the meta-analysis were finalized after expert consensus on three recommendations regarding the indication for treatment and eight recommendations on the treatment itself. These guidelines were designed to provide clinical evidence for the treatment of H. pylori to patients, nurses, medical school students, policymakers, and clinicians. These may differ from current medical insurance standards, and will be revised if more evidence emerges in the future.
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Background/Aims@#This study examined the long-term outcomes of undifferentiated-type early gastric cancer (UD EGC) with positive horizontal margins (HMs) after endoscopic resection (ER) and compared them between additional surgery and nonsurgical management. @*Methods@#From 2005 to 2015, a total of 1,124 patients with UD EGC underwent ER at 18 tertiary hospitals in Korea. Of them, 92 patients with positive HMs as the only noncurative factor (n=25) or with both positive HMs and tumor size >2 cm (n=67) were included. These patients underwent additional surgery (n=40), underwent additional endoscopic treatment (n=6), or were followed up without further treatment (n=46). @*Results@#No lymph node (LN) metastasis was found in patients who underwent additional surgery. During a median follow-up of 57.7 months (interquartile range, 27.6 to 68.8 months), no LN or distant metastases or gastric cancer-related deaths occurred in the overall cohort. At baseline, the residual cancer rate was 57.8% (26/45) after additional surgery or ER. The 5-year local recurrence rate was 33.6% among patients who were followed up without additional treatment. The 5-year overall survival rates were 95.0% and 87.8% after additional surgery and nonsurgical management (endoscopic treatment or close follow-up), respectively (log-rank p=0.224). In the multivariate Cox regression analysis, nonsurgical management was not associated with an increased risk of mortality. @*Conclusions@#UD EGC with positive HMs after ER may have favorable long-term outcomes and a very low risk of LN metastasis. Nonsurgical management may be suggested as an alternative, particularly for patients with old age or chronic illness.
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Although surgery was the standard treatment for early gastrointestinal cancers, endoscopic resection is now a standard treatment for early gastrointestinal cancers without regional lymph node metastasis. High-definition white light endoscopy, chromoendoscopy, and image-enhanced endoscopy such as narrow band imaging are performed to assess the edge and depth of early gastrointestinal cancers for delineation of resection boundaries and prediction of the possibility of lymph node metastasis before the decision of endoscopic resection. Endoscopic mucosal resection and/or endoscopic submucosal dissection can be performed to remove early gastrointestinal cancers completely by en bloc fashion. Histopathological evaluation should be carefully made to investigate the presence of risk factors for lymph node metastasis such as depth of cancer invasion and lymphovascular invasion. Additional treatment such as radical surgery with regional lymphadenectomy should be considered if the endoscopically resected specimen shows risk factors for lymph node metastasis. This is the first Korean clinical practice guideline for endoscopic resection of early gastrointestinal cancer. This guideline was developed by using mainly de novo methods and encompasses endoscopic management of superficial esophageal squamous cell carcinoma, early gastric cancer, and early colorectal cancer. This guideline will be revised as new data on early gastrointestinal cancer are collected.
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Background/Aims@#Although prolonged post-operative ileus (PPOI) is an important factor for the prolonged length of post-operative hospital stay, there is still a lack of effective predictive and therapeutic methods for PPOI. Previous studies reported that increased inflammatory markers, such as C-reactive protein (CRP) level and neutrophil to lymphocyte ratio (NLR), are associated with malignancies. The aim of our study is to elucidate the association between peri-operative inflammatory markers and PPOI after gastrectomy for gastric cancer. @*Methods@#We enrolled patients who received gastrectomy for gastric cancer from June 2013 to January 2016 at a single tertiary referral center in Seoul, Korea. We evaluated peri-operative inflammatory markers, including CRP level, NLR, and platelet to lymphocyte ratio (PLR) of enrolled patients. We compared these data between control group and PPOI group. @*Results@#A total of 390 subjects were enrolled in this study, and 132 patients (33.8%) showed PPOI. In univariate analysis, preoperative CRP level and NLR, post-operative day (POD) 1 CRP level, NLR, and PLR, and POD3 CRP level, NLR, and PLR were significantly associated with PPOI. In multivariate analysis, preoperative NLR (P = 0.014), POD1 NLR (P = 0.019), POD3 CRP (P = 0.004), and POD3 NLR (P = 0.008) were independent risk factors for PPOI. @*Conclusions@#Peri-operative inflammatory markers, such as CRP level and NLR, are useful predictive factors for PPOI who received gastrectomy for gastric cancer. Moreover, prophylactic antibiotics and anti-inflammatory drugs can be preventive and therapeutic agents for PPOI.
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Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases worldwide. Although its incidence is gradually decreasing, about half of the world's population still get infected. H. pylori infection is responsible for substantial gastrointestinal morbidity worldwide. It is the most common cause of gastric and duodenal ulcers as well as gastric cancer. Since the revision of the H. pylori Clinical Practice Guidelines in 2013, the eradication rate of H. pylori has gradually decreased with the use of classical triple therapy, wherein amoxicillin, clarithromycin, and proton pump inhibitors are administered, for 7 days. According to a nationwide randomized controlled study conducted by the Korean College of Helicobacter and Upper Gastrointestinal Research released in 2018, the intention-to-treat eradication rate was only 63.9%, which was due to increased antimicrobial resistance induced by the use of antibiotics, especially clarithromycin. The update of clinical practice guideline for treatment of H. pylori was developed based on evidence-based medicine by conducting a meta-analysis. The draft recommendations were finalized after expert consensus on three recommendations regarding the indication for treatment and eight recommendations on the treatment itself. These guidelines are designed to provide patients, nurses, medical school students, policymakers, and clinicians with clinical evidence to guide primary care and treatment of H. pylori infection. These may differ from current medical insurance standards and will be revised further, if necessary, based on research-based evidence.
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Background/Aims@#Standard triple therapy, including a proton pump inhibitor, clarithromycin, and amoxicillin, has been recommended as the first-line for Helicobacter pylori infection. However, the eradication rate of standard triple therapy has declined over the past years because of the increasing resistance to clarithromycin in Korea. We analyzed the eradication rates and the 10-year change in the eradication rates in Korea. @*Methods@#PubMed, EMBASE, the Cochrane Library, and KoreaMed were searched for studies published between January 2007 and June 2018. The pooled eradication rates and their 95% CIs were estimated using a random-effect logistic regression model. @*Results@#Twenty-six randomized controlled studies on standard triple therapy conducted in Korea were selected. The intention-to-treat (ITT) and per protocol analyses showed pooled eradication rates of standard triple therapy of 71.6% (95% CI, 69.9~73.3%) and 79.6% (95% CI, 76.6~82.2%), respectively. The eradication rate decreased with time. The ITT analysis showed that the 14-day therapy (78.1% [95% CI, 75.2~80.7%]) had significantly higher eradication rates than the 7-day therapy (70.0% [95% CI, 68.5~71.4%]) (P<0.01). @*Conclusions@#These results suggest that the eradication rate of standard triple therapy, as the first-line therapy, has shown an unacceptable decrease. The eradication rate increased when the duration of therapy was increased to 14 days, but it was not satisfactory. Therefore, other treatment regimens or therapies based on susceptibility tests should be considered for the first-line therapy.
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Background/Aims@#The eradication rate of the first-line standard triple therapy (STT) for Helicobacter pylori (H. pylori) infection has decreased since 2000; therefore, other first-line therapies are required. This study was aimed at investigating the efficacy of bismuth-containing quadruple therapy (PBMT) for first-line H. pylori eradication compared to STT, sequential therapy (SQT), and concomitant therapy (CT). @*Materials and Methods@#The Ovid-MEDLINE, Koreamed, EMBASE, KMBASE, and Cochrane Library databases were searched from January 2008 to July 2018. All identified randomized controlled trials (RCTs) comparing PBMT and non-PBMT for first-line H. pylori eradication therapy were included in the final analysis. @*Results@#A total of 3,653 patients from seven RCTs were enrolled. The pooled eradication rates of PBMT by intention-to-treat (ITT) and per-protocol (PP) analyses were 82.1% (95% CI, 68.2~90.8%) and 88.8% (95% CI, 77.1~94.9%), respectively. However, no statistically significant difference was observed in eradication rates of the 10- or 14-day PBMT as compared to 14-day STT, 10-day SQT, and 10-day CT in ITT and PP analyses. PBMT was significantly higher in adverse events than in the other eradication regimens (RR, 1.64; 95% CI, 1.11~2.44). Considerable heterogeneity in adverse events was observed among studies (χ2=88.7; P<0.001, I2=93%). @*Conclusions@#PBMT can be the first-line treatment for H. pylori eradication in Korea when other first-line options, including STT, SQT, or CT, are unavailable due to their high adverse event rates.
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Background/Aims@#As antibiotic resistance increases and new first-line therapies emerge, salvage therapies for Helicobacter pylori (H. pylori) eradication failures are becoming more common and complicated. This study aimed to systematically review overall salvage regimens after previous failure of H. pylori eradication. @*Materials and Methods@#A systematic review of randomized clinical trials evaluating salvage therapies after previous H. pylori eradication failure was performed. A meta-analysis was conducted when an adequate number of studies suitable for grouping was found. @*Results@#Overall, 36 studies with 77 treatment arms were identified, and they were highly heterogeneous regarding previously failed regimens and salvage regimens under comparison. Bismuth quadruple therapy after failure of standard triple therapy showed a pooled intention-to-treat (ITT) eradication rate of 75.5% (95% CI, 71.6~79.1%), and the rates were significantly higher with 14-day therapy than 7-day therapy by 9% (95% CI, 2~15%). Levofloxacin triple therapy after failure of standard triple therapy demonstrated a pooled ITT eradication rate of 73.3% (95% CI, 68.4~77.3%). In direct comparison, the two regimens were not significantly different in eradication rates. No study evaluated salvage regimens after the failure of bismuth or non-bismuth quadruple therapy. @*Conclusions@#The current studies regarding salvage regimens are highly heterogeneous. Bismuth quadruple therapy and levofloxacin triple therapy may be a reliable option after failure of standard triple therapy, but the regional profile of antibiotic resistance should be considered. Further studies are needed for salvage regimens after failure of non-bismuth or bismuth quadruple therapy.