3.Phase 4 Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole
Justin C Y WU ; Bor-Shyang SHEU ; Ming-Shiang WU ; Yong Chan LEE ; Myung-Gyu CHOI
Journal of Neurogastroenterology and Motility 2020;26(1):85-95
Background/Aims:
Since the use of dexlansoprazole in Asian subjects with gastroesophageal reflux disease (GERD) has not been adequately characterized, this study was conducted to evaluate the efficacy and safety of dexlansoprazole modified-release in Asian subjects with non-erosive reflux disease (NERD) and erosive esophagitis (EE).
Methods:
In this phase 4, open-label, non-randomized, uncontrolled, multicenter, multi-country study sponsored by Takeda, subjects aged ≥ 20 years with persistent typical GERD symptoms for at least 6 months underwent endoscopy. Based on endoscopic findings, they were assigned to either dexlansoprazole modified-release 30 mg once-daily for 4 weeks (NERD group) or dexlansoprazole modified-release 60 mg once-daily for 8 weeks (EE group). The primary endpoint was the percentage of days that subjects did not experience any 24- hour heartburn or acid regurgitation.
Results:
Of the 445 subjects screened from Hong Kong, South Korea, and Taiwan, 208 were enrolled in the NERD group (mean age: 53.6 years, male: 34.6%) and 88 in the EE group (mean age: 51.7 years, male: 55.7%). Over the treatment period, the median percentage of days that subjects did not experience any 24-hour heartburn or acid regurgitation was 26.9% and 65.5% in the NERD and EE groups, respectively; for nighttime heartburn or acid regurgitation the proportions were 59.3% and 83.3%, respectively. The treatment was well tolerated with low incidence of treatment-related adverse events in NERD and EE groups (6.7% and 5.7%, respectively).
Conclusion
In Asian patients with GERD, treatment with dexlansoprazole modified-release indicates a favorable efficacy and safety profile in relieving heartburn and acid regurgitation symptoms.
4.Development and Psychometric Assessment of a Self-evaluation Questionnaire for Gastroesophageal Reflux Disease
Hye Kyung JUNG ; Myung Gyu CHOI ; Myung Ki BAEK ; Justin C Y WU
Journal of Neurogastroenterology and Motility 2018;24(4):584-592
BACKGROUND/AIMS: There is uncertainty about how to measure outcomes reported by patients in gastroesophageal reflux disease (GERD). This study was conducted to develop an instrument and to determine of the definition of respondent for a patient reported outcomes to assess the efficacy of a treatment used for GERD treatment. METHODS: A structural process has developed a self-evaluation questionnaire for GERD (SEQ-GERD); health-related quality of life questionnaire for GERD (GERD-QOL) was translated through cross-cultural validation. Two-week reproducibility was evaluated and construct validity was assessed by correlating the SEQ-GERD with the Patient Assessment of Gastrointestinal Disorders (PAGI-SYM), the reflux disease questionnaire (RDQ), and GERD-QOL. Changes in SEQ-GERD scores were compared to assess the discriminative validity following 4 weeks of proton pump inhibitor administration. RESULTS: A total of 83 Korean patients were included (mean age 46 ± 14 years, females 61.4%). The internal consistency of the 19-item SEQ-GERD was good (alpha = 0.60–0.94) and the test–retest reliability was high (intra-class correlation coefficient = 0.67–0.95). The SEQ-GERD highly correlated with the GERD domain of the PAGI-SYM (correlation coefficient r = 0.894, P < 0.001), the RDQ-GERD (r = 0.877, P < 0.001), and GERD-QOL (r =−0.536, P < 0.05). SEQ-GERD scores significantly varied according to the overall treatment effectiveness scale of drug responsiveness and significantly decreased after drug treatment (mean differences according to the overall treatment effectiveness scale, P = 0.020). CONCLUSION: This study supports that SEQ-GERD is reliable and valid, and can be used to evaluate the treatment response in patients with GERD.
Diagnostic Self Evaluation
;
Female
;
Gastroesophageal Reflux
;
Humans
;
Proton Pumps
;
Psychometrics
;
Quality of Life
;
Surveys and Questionnaires
;
Treatment Outcome
;
Uncertainty
5.Does Acupuncture Therapy Alter Activation of Neural Pathway for Pain Perception in Irritable Bowel Syndrome?: A Comparative Study of True and Sham Acupuncture Using Functional Magnetic Resonance Imaging.
Winnie C W CHU ; Justin C Y WU ; David T W YEW ; Liang ZHANG ; Lin SHI ; David K W YEUNG ; Defeng WANG ; Raymond K Y TONG ; Yawen CHAN ; Lixing LAO ; Ping C LEUNG ; Brian M BERMAN ; Joseph J Y SUNG
Journal of Neurogastroenterology and Motility 2012;18(3):305-316
BACKGROUND/AIMS: Patients with irritable bowel syndrome (IBS) are characterized by abnormal central processing with altered brain activation in response to visceral nociceptive signals. The effect of electroacupuncture (EA) on IBS patients is unclear. The study is set to study the effect of EA on brain activation during noxious rectal distension in IBS patients using a randomized sham-controlled model. METHODS: Thirty IBS-diarrhea patients were randomized to true electroacupuncture or sham acupuncture. Functional MRI was performed to evaluate cerebral activation at the following time points: (1) baseline when there was rectal distension only, (2) rectal distension during application of EA, (3) rectal distension after cessation of EA and (4) EA alone with no rectal distension. Group comparison was made under each condition using SPM5 program. RESULTS: Rectal distension induced significant activation of the anterior cingulated cortex, prefrontal cortex, thalamus, temporal regions and cerebellum at baseline. During and immediately after EA, increased cerebral activation from baseline was observed in the anterior cingulated cortex, bilateral prefrontal cortex, thalamus, temporal regions and right insula in both groups. However, true electroacupuncture led to significantly higher activation at right insula, as well as pulvinar and medial nucleus of the thalamus when compared to sham acupuncture. CONCLUSIONS: We postulate that acupuncture might have the potential effect of pain modulation in IBS by 2 actions: (1) modulation of serotonin pathway at insula and (2) modulation of mood and affection in higher cortical center via ascending pathway at the pulvinar and medial nucleus of the thalamus.
Acupuncture
;
Acupuncture Therapy
;
Brain
;
Cerebellum
;
Electroacupuncture
;
Humans
;
Irritable Bowel Syndrome
;
Magnetic Resonance Imaging
;
Magnetic Resonance Spectroscopy
;
Magnetics
;
Magnets
;
Neural Pathways
;
Pain Perception
;
Prefrontal Cortex
;
Pulvinar
;
Salicylamides
;
Serotonin
;
Thalamus
6.Validation of Self-administrated Questionnaire for Psychiatric Disorders in Patients with Functional Dyspepsia.
Ada W Y TSE ; Larry H LAI ; C C LEE ; Kelvin K F TSOI ; Vincent W S WONG ; Yawen CHAN ; Joseph J Y SUNG ; Francis K L CHAN ; Justin C Y WU
Journal of Neurogastroenterology and Motility 2010;16(1):52-60
INTRODUCTION: Psychiatric comorbidity is common in patients with functional dyspepsia (FD) but a good screening tool for psychiatric disorders in gastrointestinal clinical practice is lacking. Aims: 1) Evaluate the performance and optimal cut-off of 12-item General Health Questionnaire (GHQ-12) as a screening tool for psychiatric disorders in FD patients; 2) Compare health-related quality of life (HRQoL) in FD patients with and without psychiatric comorbidities. METHODS: Consecutive patients fulfilling Rome III criteria for FD without medical co-morbidities and gastroesophageal reflux disease were recruited in a gastroenterology clinic. The followings were conducted at 4 weeks after index oesophagogastroduodenoscopy: self-administrated questionnaires on socio-demographics, dyspeptic symptom severity (4-point Likert scale), GHQ-12, and 36-item short-form health survey (SF-36). Psychiatric disorders were diagnosed with Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) by a trained psychiatrist, which served as reference standard. RESULTS: 55 patients underwent psychiatrist-conducted interview and questionnaire assessment. 27 (49.1%) had current psychiatric disorders as determined by SCID (anxiety disorders: 38.2%, depressive disorders: 16.4%). Receiver operating characteristic curve analysis of GHQ-12 revealed an area under curve of 0.825 (95%CI: 0.698-0.914). Cut-off of GHQ-12 at > or =3 gave a sensitivity of 63.0% (95%CI = 42.4-80.6%) and specificity of 92.9% (95%CI = 76.5%-98.9%). Subjects with co-existing psychiatric disorders scored significantly lower in multiple domains of SF-36 (mental component summary, general health, vitality and mental health). By multivariate linear regression analysis, current psychiatric morbidities (Beta = -0.396, p = 0.002) and family history of psychiatric illness (Beta = -0.299, p = 0.015) were independent risk factors for poorer mental component summary in SF-36, while dyspepsia severity was the only independent risk factor for poorer physical component summary (Beta = -0.332, p = 0.027). CONCLUSIONS: Concomitant psychiatric disorders adversely affect HRQoL in FD patients. The use of GHQ-12 as a reliable screening tool for psychiatric disorders allows early intervention and may improve clinical outcomes of these patients.
Area Under Curve
;
Axis, Cervical Vertebra
;
Comorbidity
;
Diagnostic and Statistical Manual of Mental Disorders
;
Dyspepsia
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Early Intervention (Education)
;
Gastroenterology
;
Gastroesophageal Reflux
;
Health Surveys
;
Humans
;
Linear Models
;
Mass Screening
;
Mental Disorders
;
Psychiatry
;
Quality of Life
;
Surveys and Questionnaires
;
Risk Factors
;
ROC Curve
;
Rome
;
Sensitivity and Specificity
7.The Practice of Gastrointestinal Motility Laboratory During COVID-19 Pandemic: Position Statements of the Asian Neurogastroenterology and Motility Association (ANMA-GML-COVID-19 Position Statements)
Kewin T H SIAH ; M Masudur RAHMAN ; Andrew M L ONG ; Alex Y S SOH ; Yeong Yeh LEE ; Yinglian XIAO ; Sanjeev SACHDEVA ; Kee Wook JUNG ; Yen-Po WANG ; Tadayuki OSHIMA ; Tanisa PATCHARATRAKUL ; Ping-Huei TSENG ; Omesh GOYAL ; Junxiong PANG ; Christopher K C LAI ; Jung Ho PARK ; Sanjiv MAHADEVA ; Yu Kyung CHO ; Justin C Y WU ; Uday C GHOSHAL ; Hiroto MIWA
Journal of Neurogastroenterology and Motility 2020;26(3):299-310
During the Coronavirus Disease 2019 (COVID-19) pandemic, practices of gastrointestinal procedures within the digestive tract require special precautions due to the risk of contraction of severe acute respiratoy syndrome coronavirus-2 (SARS-CoV-2) infection. Many procedures in the gastrointestinal motility laboratory may be considered moderate to high-risk for viral transmission. Healthcare staff working in gastrointestinal motility laboratories are frequently exposed to splashes, air droplets, mucus, or saliva during the procedures. Moreover, some are aerosol-generating and thus have a high risk of viral transmission. There are multiple guidelines on the practices of gastrointestinal endoscopy during this pandemic. However, such guidelines are still lacking and urgently needed for the practice of gastrointestinal motility laboratories. Hence, the Asian Neurogastroenterology and Motility Association had organized a group of gastrointestinal motility experts and infectious disease specialists to produce a position statement paper based-on current available evidence and consensus opinion with aims to provide a clear guidance on the practices of gastrointestinal motility laboratories during the COVID-19 pandemic. This guideline covers a wide range of topics on gastrointestinal motility activities from scheduling a motility test, the precautions at different steps of the procedure to disinfection for the safety and well-being of the patients and the healthcare workers. These practices may vary in different countries depending on the stages of the pandemic, local or institutional policy, and the availability of healthcare resources. This guideline is useful when the transmission rate of SARS-CoV-2 is high. It may change rapidly depending on the situation of the epidemic and when new evidence becomes available.
8.Pharmacological and Safety Profile of Dexlansoprazole: A New Proton Pump Inhibitor - Implications for Treatment of Gastroesophageal Reflux Disease in the Asia Pacific Region.
Khean Lee GOH ; Myung Gyu CHOI ; Ping I HSU ; Hoon Jai CHUN ; Varocha MAHACHAI ; Udom KACHINTORN ; Somchai LEELAKUSOLVONG ; Nayoung KIM ; Abdul Aziz RANI ; Benjamin C Y WONG ; Justin WU ; Cheng Tang CHIU ; Vikram SHETTY ; Joseph C BOCOBO ; Melchor M CHAN ; Jaw Town LIN
Journal of Neurogastroenterology and Motility 2016;22(3):355-366
Although gastroesophageal reflux disease is not as common in Asia as in western countries, the prevalence has increased substantially during the past decade. Gastroesophageal reflux disease is associated with considerable reductions in subjective well-being and work productivity, as well as increased healthcare use. Proton pump inhibitors (PPIs) are currently the most effective treatment for gastroesophageal reflux disease. However, there are limitations associated with these drugs in terms of partial and non-response. Dexlansoprazole is the first PPI with a dual delayed release formulation designed to provide 2 separate releases of medication to extend the duration of effective plasma drug concentration. Dexlansoprazole has been shown to be effective for healing of erosive esophagitis, and to improve subjective well-being by controlling 24-hour symptoms. Dexlansoprazole has also been shown to achieve good plasma concentration regardless of administration with food, providing flexible dosing. Studies in healthy volunteers showed no clinically important effects on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition, with no dose adjustment of clopidogrel necessary when coprescribed. This review discusses the role of the new generation PPI, dexlansoprazole, in the treatment of gastroesophageal reflux disease in Asia.
Asia*
;
Blood Platelets
;
Delayed-Action Preparations
;
Delivery of Health Care
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Dexlansoprazole*
;
Efficiency
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Esophagitis
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Gastroesophageal Reflux*
;
Healthy Volunteers
;
Plasma
;
Prevalence
;
Proton Pump Inhibitors
;
Proton Pumps*
;
Protons*
9.Primary Care Management of Chronic Constipation in Asia: The ANMA Chronic Constipation Tool.
Kok Ann GWEE ; Uday C GHOSHAL ; Sutep GONLACHANVIT ; Andrew Seng Boon CHUA ; Seung Jae MYUNG ; Shaman RAJINDRAJITH ; Tanisa PATCHARATRAKUL ; Myung Gyu CHOI ; Justin C Y WU ; Min Hu CHEN ; Xiao Rong GONG ; Ching Liang LU ; Chien Lin CHEN ; Nitesh PRATAP ; Philip ABRAHAM ; Xiao Hua HOU ; Meiyun KE ; Jane D RICAFORTE-CAMPOS ; Ari Fahrial SYAM ; Murdani ABDULLAH
Journal of Neurogastroenterology and Motility 2013;19(2):149-160
Chronic constipation (CC) may impact on quality of life. There is substantial patient dissatisfaction; possible reasons are failure to recognize underlying constipation, inappropriate dietary advice and inadequate treatment. The aim of these practical guidelines intended for primary care physicians, and which are based on Asian perspectives, is to provide an approach to CC that is relevant to the existing health-care infrastructure. Physicians should not rely on infrequent bowel movements to diagnose CC as many patients have one or more bowel movement a day. More commonly, patients present with hard stool, straining, incomplete feeling, bloating and other dyspeptic symptoms. Physicians should consider CC in these situations and when patients are found to use laxative containing supplements. In the absence of alarm features physicians may start with a 2-4 week therapeutic trial of available pharmacological agents including osmotic, stimulant and enterokinetic agents. Where safe to do so, physicians should consider regular (as opposed to on demand dosing), combination treatment and continuous treatment for at least 4 weeks. If patients do not achieve satisfactory response, they should be referred to tertiary centers for physiological evaluation of colonic transit and pelvic floor function. Surgical referral is a last resort, which should be considered only after a thorough physiological and psychological evaluation.
Asia
;
Asian Continental Ancestry Group
;
Colon
;
Constipation
;
Health Resorts
;
Humans
;
Pelvic Floor
;
Physicians, Primary Care
;
Primary Health Care
;
Quality of Life
;
Referral and Consultation
;
Sprains and Strains
10.2019 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.