1.On-demand Versus Continuous Maintenance Treatment With a Proton Pump Inhibitor for Mild Gastroesophageal Reflux Disease: A Prospective Randomized Multicenter Study
Da Hyun JUNG ; Young Hoon YOUN ; Hye-Kyung JUNG ; Seung Young KIM ; Cheal Wung HUH ; Cheol Min SHIN ; Jung-Hwan OH ; Kyu Chan HUH ; Moo In PARK ; Suck Chei CHOI ; Ki Bae KIM ; Seon-Young PARK ; Joong Goo KWON ; Yu Kyung CHO ; Jung Ho PARK ; Jeong Eun SHIN ; Eun Jeong GONG ; Jae Hak KIM ; Su Jin HONG ; Hyun Jin KIM ; Sam Ryong JEE ; Ju Yup LEE ; Kee Wook JUNG ; Hee Man KIM ; Kwang Jae LEE
Journal of Neurogastroenterology and Motility 2023;29(4):460-469
Background/Aims:
It remains unclear which maintenance treatment modality is most appropriate for mild gastroesophageal reflux disease (GERD).We aimed to compare on-demand treatment with continuous treatment using a proton pump inhibitor (PPI) in the maintenance treatment for patients with non-erosive GERD or mild erosive esophagitis.
Methods:
Patients whose GERD symptoms improved after 4 weeks of standard dose PPI treatment were prospectively enrolled at 25 hospitals.Subsequently, the enrolled patients were randomly assigned to either an on-demand or a continuous maintenance treatment group, and followed in an 8-week interval for up to 24 weeks.
Results:
A total of 304 patients were randomized to maintenance treatment (continuous, n = 151 vs on-demand, n = 153). The primary outcome, the overall proportion of unwillingness to continue the assigned maintenance treatment modality, failed to confirm the noninferiority of on-demand treatment (45.9%) compared to continuous treatment (36.1%). Compared with the on-demand group, the GERD symptom and health-related quality of life scores significantly more improved and the overall satisfaction score was significantly higher in the continuous treatment group, particularly at week 8 and week 16 of maintenance treatment. Work impairment scores were not different in the 2 groups, but the prescription cost was less in the on-demand group. Serum gastrin levels significantly elevated in the continuous treatment group, but not in the on-demand group.
Conclusions
Continuous treatment seems to be more appropriate for the initial maintenance treatment of non-erosive GERD or mild erosive esophagitis than on-demand treatment. Stepping down to on-demand treatment needs to be considered after a sufficient period of continuous treatment.
2.A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease
Su Hyun PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung Gyu CHOI ; Jie-Hyun KIM ; In-Kyung SUNG ; Jae Young JANG ; Kyung Sik PARK ; Hoon Jai CHUN ; Eun Young KIM ; Jun Kyu LEE ; Jin Seok JANG ; Gwang Ha KIM ; Su Jin HONG ; Yong Chan LEE ; Suck-Chei CHOI ; Hyun Soo KIM ; Tae Oh KIM ; Gwang Ho BAIK ; Yong Cheol JEON
Gut and Liver 2023;17(2):226-233
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).
3.2019 Seoul Consensus on Esophageal Achalasia Guidelines
Hye-Kyung JUNG ; Su Jin HONG ; Oh Young LEE ; John PANDOLFINO ; Hyojin PARK ; Hiroto MIWA ; Uday C GHOSHAL ; Sanjiv MAHADEVA ; Tadayuki OSHIMA ; Minhu CHEN ; Andrew S B CHUA ; Yu Kyung CHO ; Tae Hee LEE ; Yang Won MIN ; Chan Hyuk PARK ; Joong Goo KWON ; Moo In PARK ; Kyoungwon JUNG ; Jong Kyu PARK ; Kee Wook JUNG ; Hyun Chul LIM ; Da Hyun JUNG ; Do Hoon KIM ; Chul-Hyun LIM ; Hee Seok MOON ; Jung Ho PARK ; Suck Chei CHOI ; Hidekazu SUZUKI ; Tanisa PATCHARATRAKUL ; Justin C Y WU ; Kwang Jae LEE ; Shinwa TANAKA ; Kewin T H SIAH ; Kyung Sik PARK ; Sung Eun KIM ;
Journal of Neurogastroenterology and Motility 2020;26(2):180-203
Esophageal achalasia is a primary motility disorder characterized by insufficient lower esophageal sphincter relaxation and loss of esophageal peristalsis. Achalasia is a chronic disease that causes progressive irreversible loss of esophageal motor function. The recent development of high-resolution manometry has facilitated the diagnosis of achalasia, and determining the achalasia subtypes based on high-resolution manometry can be important when deciding on treatment methods. Peroral endoscopic myotomy is less invasive than surgery with comparable efficacy. The present guidelines (the “2019 Seoul Consensus on Esophageal Achalasia Guidelines”) were developed based on evidence-based medicine; the Asian Neurogastroenterology and Motility Association and Korean Society of Neurogastroenterology and Motility served as the operating and development committees, respectively. The development of the guidelines began in June 2018, and a draft consensus based on the Delphi process was achieved in April 2019. The guidelines consist of 18 recommendations: 2 pertaining to the definition and epidemiology of achalasia, 6 pertaining to diagnoses, and 10 pertaining to treatments. The endoscopic treatment section is based on the latest evidence from meta-analyses. Clinicians (including gastroenterologists, upper gastrointestinal tract surgeons, general physicians, nurses, and other hospital workers) and patients could use these guidelines to make an informed decision on the management of achalasia.
4.Female Gender is a Poor Predictive Factor of Functional Dyspepsia Resolution after Helicobacter pylori Eradication: A Prospective, Multi-center Korean Trial.
Sung Eun KIM ; Nayoung KIM ; Seon Mee PARK ; Won Hee KIM ; Gwang Ho BAIK ; Yunju JO ; Kyung Sik PARK ; Ju Yup LEE ; Ki Nam SHIM ; Gwang Ha KIM ; Bong Eun LEE ; Su Jin HONG ; Seon Young PARK ; Suck Chei CHOI ; Jung Hwan OH ; Hyun Jin KIM
The Korean Journal of Gastroenterology 2018;72(6):286-294
BACKGROUND/AIMS: The predictive factors of functional dyspepsia (FD) remain controversial. Therefore, we sought to investigate symptom responses in FD patients after Helicobacter pylori (H. pylori) eradication and used predictive factor analysis to identify significant factors of FD resolution at one-year after commencing eradication therapy. METHODS: This prospective, multi-center clinical trial was performed on 65 FD patients that met Rome III criteria and had H. pylori infection. Symptom responses and factors that predicted poor response were determined by analysis one year after commencing H. pylori eradication therapy. RESULTS: A total of 63 patients completed the one-year follow-up. When an eradication success group (n=60) and an eradication failure group (n=3) were compared with respect to FD response rate at one year, results were as follows; complete response 73.3% and 0.0%, satisfactory response 1.7% and 0.0%, partial response 10.0% and 33.3%, and refractory response 15.0% and 66.7%, respectively (p=0.013). Univariate analysis showed persistent H. pylori infection (p=0.021), female gender (p=0.025), and medication for FD during the study period (p=0.013) were associated with poor FD response at one year. However, age, smoking, alcohol consumption, and underlying disease were not found to affect response. Finally, multivariate analysis showed that female gender (OR, 4.70; 95% CI, 1.17-18.88) was the sole independent risk factor of poor FD response at one year after commencing H. pylori eradication therapy. CONCLUSIONS: Female gender was found to predict poor response in FD patients despite H. pylori eradication. Furthermore, successful H. pylori eradication appears to be associated with FD improvement, but the number of non-eradicated patients was too small to conclude.
Alcohol Drinking
;
Dyspepsia*
;
Female*
;
Follow-Up Studies
;
Helicobacter pylori*
;
Helicobacter*
;
Humans
;
Multivariate Analysis
;
Prospective Studies*
;
Risk Factors
;
Smoke
;
Smoking
;
Symptom Assessment
5.Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study.
Yoon Jin CHOI ; Dong Ho LEE ; Myung Gyu CHOI ; Sung Joon LEE ; Sung Kook KIM ; Geun Am SONG ; Poong Lyul RHEE ; Hwoon Yong JUNG ; Dae Hwan KANG ; Yong Chan LEE ; Si Hyung LEE ; Suck Chei CHOI ; Ki Nam SHIM ; Sang Yong SEOL ; Jeong Seop MOON ; Yong Woon SHIN ; Hyun Soo KIM ; Soo Teik LEE ; Jin Woong CHO ; Eun Kwang CHOI ; Oh Young LEE ; Jin Seok JANG
Journal of Korean Medical Science 2017;32(11):1807-1813
This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was −0.4% (95% confidence interval, −9.8% to 9.1%), which was above the non-inferiority margin of −14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670)
Artemisia
;
Double-Blind Method
;
Drug-Related Side Effects and Adverse Reactions
;
Endoscopy
;
Gastritis*
;
Humans
;
Seoul
6.A novel transurethral resection technique for superficial flat bladder tumor: Grasp and bite technique.
Kyung Jin OH ; Yoo Duk CHOI ; Ho Suck CHUNG ; Eu Chang HWANG ; Seung Il JUNG ; Dong Deuk KWON ; Kwangsung PARK ; Taek Won KANG
Korean Journal of Urology 2015;56(3):227-232
PURPOSE: Transurethral resection of bladder tumor (TURBT) can be a challenging procedure for an inexperienced surgeon. We suggest an easy technique for TURBT, which we have named the "grasp and bite" technique. We describe this technique and compare its effectiveness and safety with that of conventional TURBT. MATERIALS AND METHODS: Monopolar TURBT (24-Fr Karl Storz) was performed in 35 patients who had superficial bladder tumors. After defining the tumor margin, the tumor and surrounding mucosa were grasped by use of a loop electrode and resectoscope sheath. With tight grasping, linear moving resection was performed. The patients' demographic, intraoperative, and postoperative data were analyzed between the conventional and grasp and bite TURBT groups. RESULTS: Of 35 patients, 16 patients underwent conventional TURBT (group 1), and the other 19 patients underwent grasp and bite TURBT (group 2). Both groups were similar in age, tumor multiplicity, size, anesthesia method, and location. Grasp and bite TURBT could be performed as safely and effectively as conventional TURBT. There were no significant differences in irrigation duration, urethral catheterization, postoperative hemoglobin drop, or length of hospital stay. No significant side effects such as bladder perforation, severe obturator reflex, or persistent bleeding occurred. There were no significant pathological differences between specimens according to the type of resection technique. CONCLUSIONS: The grasp and bite TURBT technique was feasible for superficial bladder tumors. It may be a good tool for inexperienced surgeons owing to its convenient and easy manner.
Aged
;
Cystoscopy
;
Electrodes
;
Female
;
Humans
;
Male
;
Middle Aged
;
Postoperative Complications
;
Urinary Bladder/pathology/*surgery
;
Urinary Bladder Neoplasms/pathology/*surgery
;
Urologic Surgical Procedures/instrumentation/*methods
7.Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia.
Myung Gyu CHOI ; Poong Lyul RHEE ; Hyojin PARK ; Oh Young LEE ; Kwang Jae LEE ; Suck Chei CHOI ; Sang Young SEOL ; Hoon Jai CHUN ; Jong Sun REW ; Dong Ho LEE ; Geun Am SONG ; Hwoon Yong JUNG ; Hyung Yong JEONG ; In Kyung SUNG ; Joon Seong LEE ; Soo Teik LEE ; Sung Kook KIM ; Yong Woon SHIN
Journal of Neurogastroenterology and Motility 2015;21(3):414-422
BACKGROUND/AIMS: Therapies of functional dyspepsia (FD) are limited. DA-9701 is a novel prokinetic agent formulated with Pharbitis semen and Corydalis Tuber. We aimed to assess the efficacy of DA-9701 compared with itopride in FD patients. METHODS: Patients with FD randomly received either itopride 50 mg or DA-9701 30 mg t.i.d after a 2-week baseline period. After 4 weeks of treatment, 2 primary efficacy endpoints were analyzed: the change from baseline in composite score of the 8 dyspeptic symptoms and the overall treatment effect. Impact on patients' quality of life was assessed using the Nepean Dyspepsia Index (NDI) questionnaire. RESULTS: We randomly assigned 464 patients with 455 having outcome data. The difference of the composite score change of the 8 symptoms between the 2 groups was 0.62, indicating that DA-9701 was not inferior to itopride. The overall treatment effect response rate was not different between the groups. When responder was defined as > or = 5 of the 7 Likert scale, responder rates were 37% of DA-9701 and 36% of itopride group. Patients receiving DA-9701 experienced similar mean percentage of days with adequate relief during the 4-week treatment period compared with those receiving itopride (56.8% vs 59.1%). Both drugs increased the NDI score of 5 domains without any difference in change of the NDI score between the groups. The safety profile of both drugs was comparable. CONCLUSIONS: DA-9701 significantly improves symptoms in patients with FD. DA-9701 showed non-inferior efficacy to itopride with comparable safety.
Corydalis
;
Dyspepsia*
;
Humans
;
Quality of Life
;
Surveys and Questionnaires
;
Semen
8.Sodium Picosulfate with Magnesium Citrate (SPMC) Plus Laxative Is a Good Alternative to Conventional Large Volume Polyethylene Glycol in Bowel Preparation: A Multicenter Randomized Single-Blinded Trial.
Hyun Gun KIM ; Kyu Chan HUH ; Hoon Sup KOO ; Seong Eun KIM ; Jin Oh KIM ; Tae Il KIM ; Hyun Soo KIM ; Seung Jae MYUNG ; Dong Il PARK ; Jeong Eun SHIN ; Dong Hoon YANG ; Suck Ho LEE ; Ji Sung LEE ; Chang Kyun LEE ; Dong Kyung CHANG ; Young Eun JOO ; Jae Myung CHA ; Sung Pil HONG ; Hyo Jong KIM
Gut and Liver 2015;9(4):494-501
BACKGROUND/AIMS: We investigated whether sodium picosulfate with magnesium citrate (SPMC) plus bisacodyl compares favorably with conventional polyethylene glycol (PEG) with respect to bowel cleansing adequacy, compliance, and safety. METHODS: We performed a multicenter, prospective, single-blinded study in outpatients undergoing daytime colonoscopies. Patients were randomized into a split preparation SPMC/bisacodyl group and a conventional split PEG group. We compared preparation adequacy using the Boston bowel preparation scale (BBPS), ease of use using a modified Likert scale (LS), compliance/satisfaction level using a visual analogue scale (VAS), and safety by monitoring adverse events during the colonoscopy between the two groups. RESULTS: A total of 365 patients were evaluated by intention to treat (ITT) analysis, and 319 were evaluated by per protocol (PP) population analysis (153 for SPMC/bisacodyl, 166 for PEG). The mean total BBPS score was not different between the two groups in both the ITT and PP analyses (p>0.05). The mean VAS score for satisfaction and LS score for the ease of use were higher in the SPMC/bisacodyl group (p<0.001). The adverse event rate was lower in the SPMC/bisacodyl group than in the PEG group (p<0.05). CONCLUSIONS: The SPMC/bisacodyl treatment was comparable to conventional PEG with respect to bowel preparation adequacy and superior with respect to compliance, satisfaction, and safety.
Adult
;
Aged
;
Cathartics/*administration & dosage
;
Citrates/*administration & dosage
;
Citric Acid/*administration & dosage
;
Colon/*drug effects/surgery
;
*Colonoscopy
;
Drug Combinations
;
Drug Therapy, Combination/methods
;
Female
;
Humans
;
Intention to Treat Analysis
;
Laxatives/*administration & dosage
;
Male
;
Middle Aged
;
Organometallic Compounds/*administration & dosage
;
Patient Compliance
;
Patient Satisfaction
;
Picolines/*administration & dosage
;
Polyethylene Glycols/*administration & dosage
;
Preoperative Care/methods/psychology
;
Single-Blind Method
;
Young Adult
9.Lindera obtusiloba Extends Lifespan of Caenorhabditis elegans.
Ha Na KIM ; Hyun Won SEO ; Bong Seok KIM ; Hyun Ju LIM ; Ha Na LEE ; Jin Suck PARK ; Young Jin YOON ; Jong Woo OH ; Mi Jin OH ; Jin KWON ; Chan Ho OH ; Dong Seok CHA ; Hoon JEON
Natural Product Sciences 2015;21(2):128-133
Lindera obtusiloba has been widely used as a traditional medicine for the treatment of lots of diseases, including abdominal pain, bruise, and hepatocirrhosis. Here in this study, we elucidated the lifespan-extending effect of methanolic extract of Lindera obtusiloba (MLO) using Caenorhabditis elegans model system. We found that MLO has potent lifespan extension activities under normal culture condition. Then, we determined the protective effects of MLO on the stress conditions such as osmotic, thermal and oxidative stress. To reveal possible mechanism of MLO-mediated lifespan, we further investigated the effect of MLO on the antioxidant enzyme activities and intracellular ROS levels. Our results demonstrated that superoxide dismutase and catalase activities were significantly up-regulated by MLO treatment, resulted in reduced intracellular ROS levels. In this work, we also tested whether MLO-mediated longevity activity was associated with aging-related factors such as food intake and growth. Our data revealed that both of pharyngeal pumping rate and body length were significantly shifted by MLO treatment, indicating these factors were involved in MLO's lifespan-extension effects. Although MLO induces reduction in food intake, the body movement of MLO-fed aged worms was not decreased, compared to untreated control worms, indicating MLO might extend lifespan without affecting healthspan.
Abdominal Pain
;
Caenorhabditis elegans*
;
Caenorhabditis*
;
Catalase
;
Contusions
;
Eating
;
Lindera*
;
Longevity
;
Medicine, Traditional
;
Methanol
;
Oxidative Stress
;
Superoxide Dismutase
10.The Effect of Infliximab on Patients with Ulcerative Colitis in Korea.
Hyun Il SEO ; Dong Il PARK ; Tae Oh KIM ; You Sun KIM ; Suck Ho LEE ; Ji Won KIM ; Jae Hak KIM ; Jeong Eun SHIN
Intestinal Research 2014;12(3):214-220
BACKGROUND/AIMS: Infliximab was introduced recently as a rescue therapy for ulcerative colitis (UC) patients refractory to conventional treatments such as therapy with 5-amiono salicylic acids (5-ASA), immune modulators, and corticosteroids. However, there is insufficient data about its efficacy and safety in Korea. METHODS: From 7 tertiary referral hospitals, 33 patients who were treated with infliximab for moderate to severe (Mayo score 6-12) UC refractory to conventional treatment were recruited to this study. Clinical remission was defined as a total Mayo score of 2 or lower and every subscore less than 2. Partial response was defined as a decrease of Mayo score at least 3 points from baseline. RESULTS: Twenty-three patients (69.7%) showed clinical remission and 29 patients (87.8%) showed partial response in the observation period. When the remission and non-remission groups were compared in univariate analysis, only a higher total Mayo score at base line (11.0+/-0.9 vs. 9.9+/-1.5; P=0.04) was related to remission. The remission maintenance rate decreased with time in the Kaplan-Meier analysis. Two patients experienced re-remission after the first remission followed by aggravation during infliximab treatment. Three patients stopped infliximab treatment owing to adverse events including rhabdomyolysis, pneumonia, and fever of unknown origin. CONCLUSIONS: If there is no choice except surgery for UC patients refractory to conventional treatment, infliximab is an effective and relatively safe treatment option for these patients in Korea.
Adrenal Cortex Hormones
;
Colitis, Ulcerative*
;
Fever of Unknown Origin
;
Humans
;
Infliximab
;
Kaplan-Meier Estimate
;
Korea
;
Pneumonia
;
Rhabdomyolysis
;
Salicylates
;
Salicylic Acid
;
Tertiary Care Centers

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