The Application of the Rome IV Criteria to Functional Esophagogastroduodenal Disorders in Asia

Suzuki, Hidekazu

doi:10.5056/jnm17018

Cited by 55 publications

(40 citation statements)

References 41 publications

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“…12 This has led to the marketing approval of acotiamide in Japan, and the inclusion of acotiamide as a treatment option in ROME IV. 13 Notably, the same trend for improvement of meal-related symptoms has been shown from the European phase IIb trial post-hoc analysis. 14 As there has been no trial conducted in the western population that assesses the long-term safety of acotiamide, the primary objective of this trial was set to evaluate the safety of acotiamide for 1 year, and secondary objectives set to explore the effect of 1 year acotiamide treatment on FD symptoms, QoL and work productivity.…”

Section: Introductionsupporting

confidence: 57%

Long‐term safety and efficacy of acotiamide in functional dyspepsia (postprandial distress syndrome)—results from the European phase 3 open‐label safety trial

Tack

Pokrotnieks

Urbonas

et al. 2018

Neurogastroenterology Motil

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Backgrounds Acotiamide is a novel acetylcholinesterase inhibitor for treatment of postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). This European phase 3 open‐label safety trial has been conducted to evaluate the long‐term safety of acotiamide and explore the efficacy of acotiamide on PDS symptoms using the validated LPDS, quality of life using SF‐36 and SF‐NDI, and work productivity using WPAI. Methods FD‐PDS patients (defined by ROME III criteria) aged ≥18 years with active PDS symptoms and without predominant overlapping symptoms of epigastric pain syndrome and related disorders were enrolled to receive 100 mg acotiamide three times daily for 1 year. Patients' safety profile and efficacy of acotiamide were monitored. Key Results The majority of patients (81.6%) maintained exposure to acotiamide for >50 weeks, with a mean duration of 320.3 days. No specific clinically significant safety concerns have been shown, with no deaths, treatment‐related severe/serious adverse events, or any clinically significant laboratory test results. Although being an open‐label trial, acotiamide showed a change in severity larger than the minimum clinically important difference at weeks 1 and 2 for postprandial fullness and early satiation (meal‐related symptoms), and showed improvement of quality of life and work productivity from the first measurement (at week 12) up to 1 year. Conclusions & Inferences The long‐term safety of acotiamide treatment was confirmed. A clinically important change for PDS symptoms, QoL, and work productivity was suggested; however a controlled trial is required to confirm this hypothetic efficacy of acotiamide. (NCT01973790).

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Section: Introductionsupporting

confidence: 57%

Long‐term safety and efficacy of acotiamide in functional dyspepsia (postprandial distress syndrome)—results from the European phase 3 open‐label safety trial

Tack

Pokrotnieks

Urbonas

et al. 2018

Neurogastroenterology Motil

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“…An investigation on the effect of meal ingestion on symptom generation indicated that not only postprandial fullness and early satiety but also epigastric pain, an epigastric burning sensation, and nausea (not vomiting) may increase after meals [50]. H. pylori infection is considered a possible cause of dyspepsia if successful eradication leads to a sustained resolution of symptoms for more than 6 months, and such status can be termed HpD [52]. Prompt esophagogastroduodenoscopy and H. pylori testing and treatment would be more beneficial, especially in Asia, which has a high prevalence of gastric cancer.…”

Section: Resultsmentioning

confidence: 99%

New Medical Approach to Functional Dyspepsia, from Core Symposium 3, Japan Gastroenterological Association 2015–2017

Suzuki¹

2018

Digestion

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In the annual meeting of the Japan Gastroenterological Association (JGA), the scientific organizing committee selected the serial topics for the core symposium. One of the core symposia held during 2015-2017 was entitled "New medical approach to functional dyspepsia (FD)." In 2015, the subtitle of this symposium was "Helicobacter pylori gastritis and FD." In 2016, the subtitle of this symposium was "overlap with other functional GI disorders." In 2017, the subtitle was "therapeutic approach to FD." During these 3 years, a total of 24 presentations were included in Core Symposium 3 and deep and intensive discussions were carried out.

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“…All patients were required to have upper gastrointestinal endoscopy and be Helicobacter pylori negative. Helicobacter pylori infection has been suggested as a possible cause of dyspepsia . Eligible patients could not be taking antidepressant drugs, gastrointestinal motility drugs, antacids, or proton pump inhibitor in the two weeks prior to enrollment and had not been treated with acupuncture in the last month.…”

Section: Methodsmentioning

confidence: 99%

Acupuncture of different treatment frequency in postprandial distress syndrome: A pilot randomized clinical trial

Wang

Hou

Yang

et al. 2020

Neurogastroenterology Motil

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Background The evidence for different frequencies of acupuncture treatment in postprandial distress syndrome (PDS) is insufficient. This study determined whether 3 sessions per week of acupuncture treatment are superior to 1 session per week for symptomatic outcomes in PDS. Methods This 16‐week randomized clinical pilot trial was conducted in an outpatient setting in China. Patients with PDS were randomly assigned to receive 3 sessions per week of acupuncture (group H) or 1 session per week of acupuncture (group L) for 4 weeks. The primary outcome was the complete elimination of core symptoms at week 4. Secondary outcomes included overall treatment efficacy, dyspepsia symptoms, quality of life, anxiety, and depression. Key Results Sixty patients were randomized of whom 53 (88.3%) completed this trial. The complete elimination rate of core symptoms was 26.7% (95% CI 12.3%‐45.9%) in group H and 10.0% (95% CI 2.1%‐26.5%) in group L at week 4 (P = .095). There was a significant difference between H and group L at weeks 8, 12, and 16 (P = .038, .02, and .02). All secondary outcomes were better in group H at all time points. No serious adverse events occurred in either groups. Conclusions This trial showed that acupuncture, at 3 sessions per week, tended to improve symptoms and the quality of life among patients with PDS as compared to once a week. Acupuncture treatment for 4 weeks was feasible and safe. A larger sample, multicenter, randomized controlled trial of acupuncture for PDS appears to be justified in the future.

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The Application of the Rome IV Criteria to Functional Esophagogastroduodenal Disorders in Asia

Cited by 55 publications

References 41 publications

Long‐term safety and efficacy of acotiamide in functional dyspepsia (postprandial distress syndrome)—results from the European phase 3 open‐label safety trial

Long‐term safety and efficacy of acotiamide in functional dyspepsia (postprandial distress syndrome)—results from the European phase 3 open‐label safety trial

New Medical Approach to Functional Dyspepsia, from Core Symposium 3, Japan Gastroenterological Association 2015–2017

Acupuncture of different treatment frequency in postprandial distress syndrome: A pilot randomized clinical trial

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