1.Multicenter, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of a Controlled-release, Once-daily UIC201609/UIC201610 Combination Therapy for Functional Dyspepsia: Preliminary Study
Jung Won LEE ; Young Hoon YOUN ; Suck Chei CHOI ; Kwang Jae LEE ; Nayoung KIM
The Korean Journal of Gastroenterology 2021;77(4):171-178
Background/Aims:
Functional dyspepsia is a disease involving a range of upper gastrointestinal symptoms derived from various pathophysiologies. Tablets containing a combination of rabeprazole and controlled-release (CR) mosapride were recently developed.To investigate a more effective treatment, this trial evaluated the efficacy and safety of UIC201609/UIC201610 as a preliminary study.
Methods:
A multicenter, double-blind, randomized study was performed on 30 subjects. UIC201609/UIC201610 (combination of rabeprazole and CR mosapride) was the case group, and the two control groups were rabeprazole 10 mg once a day and mosapride 15 mg CR tablet once a day. As a primary efficacy endpoint of the study, the changes in the total score of eight items of the Nepean Dyspepsia Index-Korean version were analyzed at 2 weeks and 4 weeks. The outcomes regarding safety were collected.
Results:
The total symptom score of Nepean Dyspepsia Index-Korean decreased in the rabeprazole single group (29.4±17.1), mosapride CR single group (33.4±15.6), and UIC201609/UIC201610 group (33.4±11.8) at 4 weeks without significant differences. On the other hand, the UIC201609/UIC201610 combination group showed more score reduction of pain in the upper abdomen, burning in the upper abdomen compared to each control group, but it did not reach statistical significance. No difference was found in safety analysis.
Conclusions
UIC201609/UIC201610 once daily showed some improvement in epigastric pain and dyspepsia in patients with functional dyspepsia, but there was no significance. Further study based on the advanced clinical trial design will be needed to confirm the efficacy of UIC201609/UIC201610 combination therapy in the future.
2.Multicenter, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of a Controlled-release, Once-daily UIC201609/UIC201610 Combination Therapy for Functional Dyspepsia: Preliminary Study
Jung Won LEE ; Young Hoon YOUN ; Suck Chei CHOI ; Kwang Jae LEE ; Nayoung KIM
The Korean Journal of Gastroenterology 2021;77(4):171-178
Background/Aims:
Functional dyspepsia is a disease involving a range of upper gastrointestinal symptoms derived from various pathophysiologies. Tablets containing a combination of rabeprazole and controlled-release (CR) mosapride were recently developed.To investigate a more effective treatment, this trial evaluated the efficacy and safety of UIC201609/UIC201610 as a preliminary study.
Methods:
A multicenter, double-blind, randomized study was performed on 30 subjects. UIC201609/UIC201610 (combination of rabeprazole and CR mosapride) was the case group, and the two control groups were rabeprazole 10 mg once a day and mosapride 15 mg CR tablet once a day. As a primary efficacy endpoint of the study, the changes in the total score of eight items of the Nepean Dyspepsia Index-Korean version were analyzed at 2 weeks and 4 weeks. The outcomes regarding safety were collected.
Results:
The total symptom score of Nepean Dyspepsia Index-Korean decreased in the rabeprazole single group (29.4±17.1), mosapride CR single group (33.4±15.6), and UIC201609/UIC201610 group (33.4±11.8) at 4 weeks without significant differences. On the other hand, the UIC201609/UIC201610 combination group showed more score reduction of pain in the upper abdomen, burning in the upper abdomen compared to each control group, but it did not reach statistical significance. No difference was found in safety analysis.
Conclusions
UIC201609/UIC201610 once daily showed some improvement in epigastric pain and dyspepsia in patients with functional dyspepsia, but there was no significance. Further study based on the advanced clinical trial design will be needed to confirm the efficacy of UIC201609/UIC201610 combination therapy in the future.
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.Rectal Ulcer Developed in Systemic Lupus Erythematosus without Ischemic Colitis
Ki Chang SOHN ; Won Gak HEO ; Min Su CHU ; Eui Joong KIM ; Jong Hyeok CHUNG ; Suck Chei CHOI ; Ki Jung YUN ; Geom Seog SEO
The Korean Journal of Gastroenterology 2019;73(5):299-302
Rectal involvement by systemic lupus erythematosus (SLE) is quite rare. Approximately 14 cases have been reported worldwide, but only one with ischemic colitis has been reported in Korea. A 17-year-old female patient was hospitalized with abdominal pain and hematochezia. Sigmoidoscopy revealed only a simple rectal ulcer without ischemic colitis. cytomegalovirus and bacterial infections were excluded. A sigmoidoscopic rectal biopsy indicated a rectal invasion by SLE, but the patient showed an acute worsening conditions that did not respond to treatment. This paper reports a case of rectal ulcer that developed in SLE without ischemic colitis with a review of the relevant literature.
Abdominal Pain
;
Adolescent
;
Bacterial Infections
;
Biopsy
;
Colitis, Ischemic
;
Cytomegalovirus
;
Female
;
Gastrointestinal Hemorrhage
;
Humans
;
Korea
;
Lupus Erythematosus, Systemic
;
Sigmoidoscopy
;
Ulcer
5.A Study on the Psychosocial Characteristics and Quality of Life in Functional Gastrointestinal Disorders
So Won KIM ; Seung Ho JANG ; Han Seung RYU ; Suck Chei CHOI ; Seung Ho RHO ; Sang Yeol LEE
Korean Journal of Psychosomatic Medicine 2019;27(1):25-34
OBJECTIVES: This study aimed to compare the psychosocial characteristics among patients with functional gastrointestinal disorder (FGID), adults with functional gastrointestinal symptoms, and normal control group and investigate factors related to quality of life (QoL) of FGID patients. METHODS: 65 patients diagnosed with FGID were selected. 79 adults were selected as normal control group based on the Rome III diagnostic criteria, and 88 adults who showed functional gastrointestinal symptoms were selected as “FGID positive group”. Demographic factors were investigated. Psychosocial factors were evaluated using the Korean-Beck Depression Inventory-II, Korean-Beck Anxiety Inventory, Korean-Childhood Trauma Questionnaire, Multi-dimensional Scale of Perceived Social Support, Connor-Davidson Resilience Scale and WHO Quality of Life Assessment Instrument Brief Form. A one-way ANOVA was used to compare differences among groups. Pearson correlation test was used to analyze correlations between QoL and psychosocial factors in patients with FGID. RESULTS: There were group differences in the education level. Depression (F=29.012, p<0.001), anxiety (F=27.954, p<0.001) and Childhood trauma (F=7.748, p<0.001) were significantly higher in FGID patient group than in both FGID-positive and normal control group. Social support (F=5,123, p<0.001), Resilience (F=9.623, p<0.001) and QoL (F=35.991, p<0.001) were significantly lower in the FGID patient group than in others. QoL of FGID patients showed a positive correlation with resilience (r=0.475, p<0.01), and showed a negative correlation with depression (r=−0.641, p<0.01), anxiety (r=−0.641, p<0.01), and childhood trauma (r=−0.278, p<0.05). CONCLUSIONS: FGID patients have distinctive psychosocial factors compared to the both FGID-positive and normal control group. Therefore, the active interventions for psychosocial factors are required in the treatment of patients with FGID.
Adult
;
Anxiety
;
Demography
;
Depression
;
Education
;
Gastrointestinal Diseases
;
Humans
;
Psychology
;
Quality of Life
6.Rectal Ulcer Developed in Systemic Lupus Erythematosus without Ischemic Colitis
Ki Chang SOHN ; Won Gak HEO ; Min Su CHU ; Eui Joong KIM ; Jong Hyeok CHUNG ; Suck Chei CHOI ; Ki Jung YUN ; Geom Seog SEO
The Korean Journal of Gastroenterology 2019;73(5):299-302
Rectal involvement by systemic lupus erythematosus (SLE) is quite rare. Approximately 14 cases have been reported worldwide, but only one with ischemic colitis has been reported in Korea. A 17-year-old female patient was hospitalized with abdominal pain and hematochezia. Sigmoidoscopy revealed only a simple rectal ulcer without ischemic colitis. cytomegalovirus and bacterial infections were excluded. A sigmoidoscopic rectal biopsy indicated a rectal invasion by SLE, but the patient showed an acute worsening conditions that did not respond to treatment. This paper reports a case of rectal ulcer that developed in SLE without ischemic colitis with a review of the relevant literature.
Abdominal Pain
;
Adolescent
;
Bacterial Infections
;
Biopsy
;
Colitis, Ischemic
;
Cytomegalovirus
;
Female
;
Gastrointestinal Hemorrhage
;
Humans
;
Korea
;
Lupus Erythematosus, Systemic
;
Sigmoidoscopy
;
Ulcer
7.The efficacy and safety of irsogladine maleate in nonsteroidal anti-inflammatory drug or aspirin-induced peptic ulcer and gastritis
Ki Nam SHIM ; Jin Il KIM ; Nayoung KIM ; Sang Gyun KIM ; Yun Ju JO ; Su Jin HONG ; Jeong Eun SHIN ; Gwang Ha KIM ; Kyung Sik PARK ; Suck Chei CHOI ; Joong Goo KWON ; Jie Hyun KIM ; Hyun Jin KIM ; Ji Won KIM
The Korean Journal of Internal Medicine 2019;34(5):1008-1021
BACKGROUND/AIMS:
Irsogladine maleate, an enhancer of gastric mucosal protective factors, has demonstrated its efficacy for various gastric mucosal injuries. The aim of this study was to evaluate the efficacy and safety of irsogladine for prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin-induced peptic ulcer and gastritis.
METHODS:
In this multicenter, randomized, double-blind, exploratory clinical trial, 100 patients over 50 years of age who needed continuous NSAIDs or aspirin for more than 8 weeks were randomly assigned to either test group (irsogladine maleate 2 mg, twice daily, 39 patients for full analysis) or placebo group (37 patients for full analysis). Primary outcomes were incidence of peptic ulcer and ratio of modified Lanza score (MLS) 2 to 4. Secondary outcome was the number of acute erosions confirmed by endoscopy at 8 weeks. Adverse effects were also compared.
RESULTS:
There were no significant differences in gastric protective effects between test and placebo groups. However, two cases of peptic ulcer in the placebo group but none in the test group were observed. These two cases of peptic ulcer were Helicobacter pylori-negative. In addition, H. pylori-negative group showed significant changes in MLS score (p = 0.0247) and edema score (p = 0.0154) after the treatment compared to those before treatment in the test group. There was no significant difference in adverse events between the two groups.
CONCLUSIONS
The efficacy of irsogladine maleate was found in H. pylori-negative group, suggesting its potential as a protective agent against NSAIDs or aspirin-induced peptic ulcer and gastritis.
8.Impact of Socioeconomic Status on Health Behaviors, Metabolic Control, and Chronic Complications in Type 2 Diabetes Mellitus.
So Hun KIM ; Seung Youn LEE ; Chei Won KIM ; Young Ju SUH ; Seongbin HONG ; Seong Hee AHN ; Da Hae SEO ; Moon Suk NAM ; Suk CHON ; Jeong Taek WOO ; Sei Hyun BAIK ; Yongsoo PARK ; Kwan Woo LEE ; Young Seol KIM
Diabetes & Metabolism Journal 2018;42(5):380-393
BACKGROUND: The aim of the study was to assess the impact of socioeconomic status (SES) on health behaviors, metabolic control, and chronic complications in people with type 2 diabetes mellitus (T2DM) from South Korea, a country with universal health insurance coverage and that has experienced rapid economic and social transition. METHODS: A total of 3,294 Korean men and women with T2DM aged 30 to 65 years, participating in the Korean National Diabetes Program (KNDP) cohort who reported their SES and had baseline clinical evaluation were included in the current cross-sectional analysis. SES included the level of education and monthly household income. RESULTS: Lower education level and lower income level were closely related, and both were associated with older age in men and women. Women and men with lower income and education level had higher carbohydrate and lower fat intake. After adjustment for possible confounding factors, higher education in men significantly lowered the odds of having uncontrolled hyperglycemia (glycosylated hemoglobin ≥7.5%) (odds ratio [OR], 0.63; 95% confidence interval [CI], 0.43 to 0.91 for highest education; P(trend)=0.048), while higher household income in men significantly lowered the odds of having diabetic retinopathy (OR, 0.59; 95% CI, 0.37 to 0.95 for highest income level; P(trend)=0.048). In women, lower income was associated with a higher stress level. CONCLUSION: Men with lower SES had higher odds of having diabetic retinopathy and uncontrolled hyperglycemia, showing the need to improve care targeted to this population.
Cohort Studies
;
Cross-Sectional Studies
;
Diabetes Mellitus, Type 2*
;
Diabetic Retinopathy
;
Education
;
Family Characteristics
;
Female
;
Health Behavior*
;
Humans
;
Hyperglycemia
;
Insurance, Health
;
Korea
;
Male
;
Social Class*
9.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
10.Drug-induced liver injury caused by iodine-131.
Chei Won KIM ; Ji Sun PARK ; Se Hwan OH ; Jae Hyung PARK ; Hyun Ik SHIM ; Jae Woong YOON ; Jin Seok PARK ; Seong Bin HONG ; Jun Mi KIM ; Trong Binh LE ; Jin Woo LEE
Clinical and Molecular Hepatology 2016;22(2):272-275
Iodine-131 is a radioisotope that is routinely used for the treatment of differentiated thyroid cancer after total or near-total thyroidectomy. However, there is some evidence that iodine-131 can induce liver injury . Here we report a rare case of drug-induced liver injury (DILI) caused by iodine-131 in a patient with regional lymph node metastasis after total thyroidectomy. A 47-year-old woman was admitted with elevated liver enzymes and symptoms of general weakness and nausea. Ten weeks earlier she had undergone a total thyroidectomy for papillary thyroid carcinoma and had subsequently been prescribed levothyroxine to reduce the level of thyroid-stimulating hormone. Eight weeks after surgery she underwent iodine-131 ablative therapy at a dose of 100 millicuries, and subsequently presented with acute hepatitis after 10 days. To rule out all possible causative factors, abdominal ultrasonography, endoscopic ultrasonography (on the biliary tree and gall bladder), and a liver biopsy were performed. DILI caused by iodine-131 was suspected. Oral prednisolone was started at 30 mg/day, to which the patient responded well.
Abdomen/diagnostic imaging
;
Chemical and Drug Induced Liver Injury/*diagnosis/drug therapy
;
Female
;
Humans
;
Iodine Radioisotopes/chemistry
;
Lymph Nodes/pathology
;
Lymphatic Metastasis
;
Middle Aged
;
Prednisolone/therapeutic use
;
Thyroid Neoplasms/drug therapy/surgery
;
Thyroidectomy
;
Thyroxine/therapeutic use
;
Ultrasonography

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