1.Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study
Jie-Hyun KIM ; Hwoon-Yong JUNG ; In Kyung YOO ; Seon-Young PARK ; Jae Gyu KIM ; Jae Kyu SUNG ; Jin Seok JANG ; Gab Jin CHEON ; Kyoung Oh KIM ; Tae Oh KIM ; Soo Teik LEE ; Kwang Bum CHO ; Hoon Jai CHUN ; Jong-Jae PARK ; Moo In PARK ; Jae-Young JANG ; Seong Woo JEON ; Jin Woong CHO ; Dae Hwan KANG ; Gwang Ha KIM ; Jae J. KIM ; Sang Gyun KIM ; Nayoung KIM ; Yong Chan LEE ; Su Jin HONG ; Hyun-Soo KIM ; Sora LEE ; Sang Woo LEE
Gut and Liver 2024;18(1):70-76
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).
2.Evidence-Based Guidelines for the Treatment of Helicobacter pylori Infection in Korea: 2020 Revised Edition
Hye-Kyung JUNG ; Seung Joo KANG ; Yong Chan LEE ; Hyo-Joon YANG ; Seon-Young PARK ; Cheol Min SHIN ; Sung Eun KIM ; Hyun Chul LIM ; Jie-Hyun KIM ; Su Youn NAM ; Woon Geon SHIN ; Jae Myung PARK ; Il Ju CHOI ; Jae Gyu KIM ; Miyoung CHOI ;
Korean Journal of Medicine 2021;96(3):160-189
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.
3.Evidence-Based Guidelines for the Treatment of Helicobacter pylori Infection in Korea: 2020 Revised Edition
Hye-Kyung JUNG ; Seung Joo KANG ; Yong Chan LEE ; Hyo-Joon YANG ; Seon-Young PARK ; Cheol Min SHIN ; Sung Eun KIM ; Hyun Chul LIM ; Jie-Hyun KIM ; Su Youn NAM ; Woon Geon SHIN ; Jae Myung PARK ; Il Ju CHOI ; Jae Gyu KIM ; Miyoung CHOI ;
Korean Journal of Medicine 2021;96(3):160-189
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.
4.Eradication Rates of Clarithromycin Triple Therapy in Korea: A Systematic Review and Meta-analysis
Seung Joo KANG ; Hye-Kyung JUNG ; Yong Chan LEE ; Hyo-Joon YANG ; Seon-Young PARK ; Cheol Min SHIN ; Sung Eun KIM ; Hyun Chul LIM ; Jie-Hyun KIM ; Su Youn NAM ; Woon Geon SHIN ; Jae Myung PARK ; Il Ju CHOI ; Jae Gyu KIM ; Miyoung CHOI ;
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2021;21(1):35-47
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.
5.A 10- or 14-day Bismuth-containing Quadruple Therapy as a First-line Helicobacter pylori Eradication Therapy: A Systematic Review and Meta-analysis
Sung Eun KIM ; Hye-Kyung JUNG ; Seung Joo KANG ; Yong Chan LEE ; Hyo-Joon YANG ; Seon-Young PARK ; Cheol Min SHIN ; Hyun Chul LIM ; Jie-Hyun KIM ; Su Youn NAM ; Woon Geon SHIN ; Jae Myung PARK ; Il Ju CHOI ; Jae Gyu KIM ; Miyoung CHOI ;
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2021;21(1):48-58
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.
6.Salvage Regimens after Failure of Previous Helicobacter pylori Eradication Therapy: A Systematic Review and Meta-analysis
Hyo-Joon YANG ; Hye-Kyung JUNG ; Seung Joo KANG ; Yong Chan LEE ; Seon-Young PARK ; Cheol Min SHIN ; Sung Eun KIM ; Hyun Chul LIM ; Jie-Hyun KIM ; Su Youn NAM ; Woon Geon SHIN ; Jae Myung PARK ; Il Ju CHOI ; Jae Gyu KIM ; Miyoung CHOI ;
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2021;21(1):59-71
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.
7.Evidence-Based Guidelines for the Treatment of Helicobacter pylori Infection in Korea 2020
Hye-Kyung JUNG ; Seung Joo KANG ; Yong Chan LEE ; Hyo-Joon YANG ; Seon-Young PARK ; Cheol Min SHIN ; Sung Eun KIM ; Hyun Chul LIM ; Jie-Hyun KIM ; Su Youn NAM ; Woon Geon SHIN ; Jae Myung PARK ; Il Ju CHOI ; Jae Gyu KIM ; Miyoung CHOI ; Korean College of Helicobacter and Upper Gastrointestinal Research
Gut and Liver 2021;15(2):168-195
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.
8.Evidence based guidelines for the treatment of Helicobacter pylori infection in Korea 2020
Hye-Kyung JUNG ; Seung Joo KANG ; Yong Chan LEE ; Hyo-Joon YANG ; Seon-Young PARK ; Cheol Min SHIN ; Sung Eun KIM ; Hyun Chul LIM ; Jie-Hyun KIM ; Su Youn NAM ; Woon Geon SHIN ; Jae Myung PARK ; Il Ju CHOI ; Jae Gyu KIM ; Miyoung CHOI ;
The Korean Journal of Internal Medicine 2021;36(4):807-838
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.
9.Eradication Rates of Clarithromycin Triple Therapy in Korea: A Systematic Review and Meta-analysis
Seung Joo KANG ; Hye-Kyung JUNG ; Yong Chan LEE ; Hyo-Joon YANG ; Seon-Young PARK ; Cheol Min SHIN ; Sung Eun KIM ; Hyun Chul LIM ; Jie-Hyun KIM ; Su Youn NAM ; Woon Geon SHIN ; Jae Myung PARK ; Il Ju CHOI ; Jae Gyu KIM ; Miyoung CHOI ;
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2021;21(1):35-47
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.
10.A 10- or 14-day Bismuth-containing Quadruple Therapy as a First-line Helicobacter pylori Eradication Therapy: A Systematic Review and Meta-analysis
Sung Eun KIM ; Hye-Kyung JUNG ; Seung Joo KANG ; Yong Chan LEE ; Hyo-Joon YANG ; Seon-Young PARK ; Cheol Min SHIN ; Hyun Chul LIM ; Jie-Hyun KIM ; Su Youn NAM ; Woon Geon SHIN ; Jae Myung PARK ; Il Ju CHOI ; Jae Gyu KIM ; Miyoung CHOI ;
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2021;21(1):48-58
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.

Result Analysis
Print
Save
E-mail