Real-world study on efficacy and safety of pancreatin enteric-coated capsules in treatment of postprandial distress syndrome in older patients
Background:Functional dyspepsia is common among older adults, with postprandial distress syndrome (PDS) as the main subtype. Clinical guidelines recommend prokinetic agents as first-line treatment for symptom relief of PDS. However, concerns over side effects limit their application with older patients. We investigated the efficacy and safety of pancreatin in treating older PDS patients.Methods:In this multicenter, real-world study, 175 older patients (age ≥ 60 years) diagnosed with PDS were divided into three groups: itopride monotherapy (56 patients), pancreatin enteric-coated capsule (PECC) monotherapy (62 patients), and combination therapy with PECC and itopride (57 patients). We compared the efficacy and safety of the treatments over a 2-week period, with follow-up 2 weeks post-treatment. The primary outcome was symptom improvement, change in Leuven postprandial distress scale (LPDS) score. Secondary outcomes were percentage changes in patient anxiety (generalized anxiety disorder-7 [GAD-7]) and depression (patient health questionnaire-9 [PHQ-9]) scores and adverse event incidence.Results:Baseline characteristics were similar among groups (P > 0.05). All groups experienced symptom relief from day 1 of treatment, with significant improvement through weeks 1 and 2 (P < 0.05). Changes in LPDS scores were not significantly different between the treatment groups at any time point. Average PHQ-9 scores for all groups decreased during treatment and stabilized after discontinuation. GAD-7 scores also significantly decreased then remained stable, with no significant difference among groups. No treatment-related adverse events were observed.Conclusion:PECC monotherapy effectively and safely treats PDS, with efficacy comparable to itopride monotherapy and combination therapy with pancreatin and itopride.
- Research Article
5
- 10.5056/jnm.2013.19.3.409
- Jul 8, 2013
- Journal of Neurogastroenterology and Motility
The Rome criteria have been the most widely used criteria for defining dyspepsia.The Rome III criteria have divided functional dyspepsia into postprandial distress syndrome (PDS), characterized by postprandial fullness and early satiation, and epigastric pain syndrome (EPS), characterized by epigastric pain or burning.1 PDS and EPS are thought to have different patho-
- Research Article
2
- 10.3760/cma.j.issn.1674-4756.2013.05.017
- Mar 10, 2013
Objective To analyze the realationship of anxiety and depression states in the patients with functional dyspepsia.Methods The patients with functional dyspepsia(FD) were divided into two groups which included postprandial distress syndrome (PDS) and epigastria pain syndrome(EPS).Set control group.All the candidates had finished the self rating scale in anxiety and depression.The relationship between the FD patients' state of depression and anxiety and Roma Ⅲ subtypes,overlapping irritable bowel syndrome(IBS) was analyzed by SPSS 16.0.Results ①The ratios of anxiety and depression state in the FD patients (63.3%,70%) were higher than that of control group (19.2%,7.5%).②The ratios of anxiety and depression state in the PDS were 69.8% and 73.6%,and those in the EPS were 58.2% and 67.2%.There was no significantly different between the two groups.③In the FD group no overlapping IBS,the ratios of no accompanied by anxiety and depression were 51.9% and 37.0%,and the ratios of accompanied by anxiety and depression were 48.1% and 63.0%.In the group of FD overlapping IBS,the ratios of no accompanied by anxiety and depression were 5.1% and 15.4%,and the ratios of accompanied by anxiety and depression were 94.9% and 84.6%.There were significant differences in the ratios of anxiety and depression state between FD overlapping IBS and its counterpart no overlapping IBS.④The ratios of IBS-constipation,IBS-diarrhea,IBS-mix,non IBS in the PDS were 33.9%,1.9%,0,64.2%and those in the EPS were 7.5%,20.9%,1.5%,70.1%.It was significantly different between the PDS and the EPS.Conclusions The ratios of anxiety and depression state in the FD patients were higher than that of control group.The patients with FD overlapping IBS were accompanied by anxiety and depression state more commonly than the counterpart not overlapping IBS.The ratio of IBS-constipation in the PDS was higher than that in the EPS and the ratio of IBS-diarrhea in the EPS was higher than that in the PDS Key words: Functional dyspepsia; Anxiety; Depression; Irritable bowel syndrome
- Research Article
74
- 10.1038/ajg.2013.89
- Apr 9, 2013
- American Journal of Gastroenterology
The Rome III criteria for functional dyspepsia recognize two distinct subgroups: postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS). The aim of this exploratory analysis was to evaluate the Rome III criteria and the validity of the PDS/EPS subgrouping in primary care patients with upper gastrointestinal symptoms. Primary care patients with frequent upper gastrointestinal symptoms included in the Diamond study (NCT00291746) underwent esophageal endoscopy and 24-h pH-metry. Gastroesophageal reflux disease (GERD) was defined as the presence of at least one of the following: reflux esophagitis, pathological esophageal acid exposure, positive symptom association probability (SAP ≥95%) for association of symptoms with acid reflux. Functional dyspepsia was defined by the absence of GERD and peptic ulcer disease on investigation. PDS and/or EPS were diagnosed according to Rome III criteria. In total, 138 patients (41%) had upper gastrointestinal symptoms with normal endoscopy, pH-metry, and SAP results, consistent with the presence of functional dyspepsia. Of these patients, 130 (94%) met criteria for PDS and/or EPS: 13 (10%) had PDS alone, 31 (24%) had EPS alone, and 86 (66%) met criteria for both PDS and EPS. PDS and EPS overlap in the majority of patients with functional dyspepsia. The value of dividing functional dyspepsia into the subgroups of PDS and EPS is thus questionable. A new approach to classifying functional dyspepsia is needed.
- Research Article
1754
- 10.1053/j.gastro.2016.03.035
- May 1, 2016
- Gastroenterology
Rome IV—Functional GI Disorders: Disorders of Gut-Brain Interaction
- Research Article
61
- 10.1111/apt.15308
- May 20, 2019
- Alimentary Pharmacology & Therapeutics
It is unexplained why functional dyspepsia and gastro-oesophageal reflux disease (GERD) overlap more often than expected by chance. Post-prandial distress syndrome has been linked to impaired gastric fundic accommodation which may induce increased transient lower oesophageal sphincter relaxations and consequent GERD. Duodenal eosinophilia has been linked to functional dyspepsia and post-prandial distress syndrome. To identify if there is an association between duodenal eosinophilia in functional dyspepsia and symptoms of GERD and whether post-prandial distress syndrome or epigastric pain syndrome are associated with new onset GERD. Participants (n=1000) were randomly selected from the national Swedish population register and surveyed by questionnaires and oesophagogastroduodenoscopy in 1999-2001. All eligible subjects (n=887) were invited to a follow-up study in 2010 (response rate 79%). In a case-control study of 213 subjects (functional dyspepsia vs healthy controls), histology from the duodenum was evaluated at baseline and the possible association of eosinophilia to new onset GERD symptoms was analysed. Functional dyspepsia (OR 7.6; 95% CI 2.93-19.4, P<0.001) and post-prandial distress syndrome at baseline (OR 9.0, 95% CI 3.36-24.0, P<0.001) were associated with an increased risk of GERD at follow-up. Eosinophilia in the second part of duodenum only was independently associated with an increased risk of GERD amongst those with functional dyspepsia (OR 4.2; 95% CI 1.2-4.77, P=0.024) and post-prandial distress syndrome at baseline (OR 6.0; 95% CI 1.50-23.6, P=0.011), respectively. Duodenal eosinophilia is associated with increased risk of GERD at 10-year follow-up in those with functional dyspepsia and post-prandial distress syndrome at baseline. Duodenal eosinophilia may explain the link between GERD and functional dyspepsia, suggesting subsets of functional dyspepsia and GERD may be part of the same disease spectrum.
- Research Article
256
- 10.1053/j.gastro.2009.03.039
- Mar 26, 2009
- Gastroenterology
Anxiety Is Associated With Uninvestigated and Functional Dyspepsia (Rome III Criteria) in a Swedish Population-Based Study
- Research Article
1
- 10.14309/ctg.0000000000000900
- Aug 4, 2025
- Clinical and Translational Gastroenterology
INTRODUCTION:Functional dyspepsia (FD) is subdivided into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), each with a different pathophysiological mechanisms driving the symptoms of these syndromes. Cine MRI aids observation in any continuous cross-section and measures gastrointestinal peristalsis without radiation exposure. In this study, we aimed to evaluate gastric peristalsis in FD using cine MRI.METHODS:This study was a prospective interventional study. Patients diagnosed with FD according to ROME IV diagnostic criteria were included. Cine MRI was performed before and after the test meal. Gastric maximum short axis diameter, amplitude, contraction frequency, peristaltic wave height, peristaltic wave velocity, and gastric motility index were evaluated and compared between healthy control (HC) and patients with FD (PDS/EPS).RESULTS:This study consisted of 18 HC and 31 patients with FD (including 22 with PDS and 9 with EPS). Preprandial comparison of the HC, PDS, and EPS groups showed no significant difference. Postprandial comparison of the 3 groups showed significant differences in maximum short axis diameter of fornix (HC: 51.5 ± 9.1/PDS: 47.1 ± 10.3/EPS: 59.0 ± 13.6 mm, P = 0.045), amplitude of fornix (HC: 7.3 ± 5.1/PDS: 12.1 ± 4.3/EPS: 11.3 ± 8.7 mm, P = 0.009), contraction frequency (HC: 2.9 ± 0.3/PDS: 2.7 ± 0.5/EPS: 2.6 ± 0.2 times/min, P = 0.007), peristaltic wave height (HC: 14.9 ± 4.0/PDS: 9.2 ± 2.5/EPS: 9.5 ± 3.2 mm, P < 0.001), and gastric motility index (HC: 24.5 ± 7.1/PDS: 16.8 ± 6.1/EPS: 15.9 ± 6.3 mm2/s, P = 0.002).DISCUSSION:Cine MRI can be used to visually evaluate gastric peristalsis dysfunction and impaired gastric accommodation in FD.
- Abstract
- 10.1136/gutjnl-2023-bsg.341
- Jun 1, 2023
- Gut
IntroductionFunctional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health burden. Almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as...
- Research Article
8
- 10.1111/nmo.14324
- Jan 19, 2022
- Neurogastroenterology & Motility
Functional dyspepsia (FD) is a very common disease worldwide. Dysmenorrhea impairs quality of life among females of reproductive age. Although dysmenorrhea is associated with irritable bowel syndrome (IBS), no study has yet evaluated the association between dysmenorrhea and FD. This study's subjects consisted of 4693 female Japanese university students. We defined FD according to the Rome III criteria. Subjects completed a self-reported questionnaire regarding menstrual irregularity, menstrual pain, and medication for menstrual pain. Age, body mass index, drinking, smoking, exercise habit, anemia, and first-year student status were selected as potential confounding factors. The prevalence of FD, epigastric pain syndrome (EPS), and postprandial distress syndrome (PDS) was 2.5%, 0.6%, and 2.1%, respectively. Heavy menstrual pain was independently positively associated with FD and PDS but not EPS (adjusted ORs: FD, 3.18 [95% CI: 1.60-6.89] and PDS, 2.93 [95% CI: 1.56-7.93] for heavy menstrual pain, p for trend=0.001 and 0.004, respectively). Using medication for menstrual pain often was independently positively associated with FD, EPS, and PDS, respectively, (adjusted ORs: FD, 2.41 [95% CI: 1.50-3.83], EPS, 2.93 [95% CI: 1.04-7.93], PDS, 2.44 [95% CI: 1.46-4.01]). Irregular menstrual cycle was not associated with FD or with subtype of FD. Among the young female Japanese population, menstrual pain might be independently positively associated with FD and PDS but not EPS. The use of medication for menstrual pain might be independently positively associated with FD including subtype of FD.
- Research Article
- 10.3760/cma.j.issn.1674-4756.2017.18.016
- Sep 25, 2017
Objective To investigate the quality of life and influencing factors of functional dyspepsia(FD) in different subtypes. Methods Two hundred and ten patients with FD were divided into postprandial distress syndrome(PDS) , epigastric pain syndrome (EPS) and overlapping(PDS+ EPS). SF-36 quality of life questionnaire(SF-36), Hamilton depression scale(HAMD), Hamilton anxiety scale(HAMA), the Eysenck’s Personality Questionnaire(EPQ) and the life event scale (LES) were used in the three groups. Results ①There was no significant difference in physiological function(PF)or role physical (RP)among the three groups; the body pain(BP), general health(GH), vitality(VT), social function(SF), role Emotional(RE), mental health(MH), physical component summary(PCS)and mental component summary(MCS) in patients with PDS+ EPS were lower than those of patients with PDS or EPS. The VT and MH, PDS were higher than those of EPS. There was no significant difference among the rest of the dimension between PDS and EPS. ②PCS and MCS in three subtypes, the influencing factors were Somatic anxiety factor. In the PCS, the influencing factor was PDS with sleep disturbance factor. In the MCS, the influencing factors were PDS with Sleep disturbance factor and L, EPS with sleep disturbance factor and E, PDS + EPS with N. Conclusions There are significant differences in the quality of life among the three subtypes of FD patients. Different psychological intervention and treatment should be taken according to different subtypes of patients, in order to cure disease and improve their quality of lives. Key words: Functional dyspepsia; Subtypes; Quality of life; Influencing factors
- Research Article
62
- 10.1111/nmo.12585
- Jul 28, 2015
- Neurogastroenterology & Motility
The Rome III consensus proposed to subdivide functional dyspepsia (FD) into two groups: meal-related dyspepsia or postprandial distress syndrome (PDS), and meal-unrelated dyspepsia or epigastric pain syndrome (EPS). However, in clinical practice, overlap between both has been reported to be as high as 50%, thereby hampering clinical applicability. Although EPS is referred to as meal-unrelated dyspepsia, relationship of symptoms to meal ingestion in this category is not formally addressed in the Rome III criteria. The aim of our study was to investigate whether taking into account the relationship of epigastric pain and nausea to meal ingestion may help to improve separation between EPS and PDS. Consecutive ambulatory tertiary-care patients with epigastric symptoms filled out Rome III gastro-duodenal questionnaires with supplementary questions. Those fulfilling Rome III FD criteria and a negative endoscopy were identified and subdivided into 'pure' PDS patients (i.e., meeting criteria for PDS without EPS symptoms), 'pure' EPS (i.e., meeting criteria for EPS without PDS symptoms), and overlapping PDS-EPS (i.e., symptoms of both PDS and EPS). Out of 1029 patients coming to endoscopy, 199 patients (73% females, 45.9 ± 1.0 years, BMI: 23.7 ± 0.35) fulfilled Rome III FD diagnostic criteria, and could be subdivided into pure PDS (69% females, 49 ± 2 years, BMI: 24.2 ± 0.61), pure EPS (59% females, 47.4 ± 2 years, BMI: 23.2 ± 0.97) and overlapping PDS-EPS (64% females, age 43 ± 5 years, BMI: 26 ± 0.46). Compared with pure EPS patients, the overlap PDS-EPS patients were characterized by a higher occurrence of postprandial epigastric pain (70% vs 31%, p < 0.0001), while the occurrence of epigastric pain in between meals was borderline (48% vs 38%, p = 0.05). In addition, the overlap PDS-EPS patients reported a higher occurrence of postprandial nausea (23% vs 0%, p < 0.0001), and bloating (79% vs 28%, p = 0.0001). When postprandial epigastric pain and postprandial nausea were considered as PDS symptoms, the 'adapted' subdivision identified 48% pure PDS, 16% pure EPS, and 36% overlapping PDS-EPS patients. EPS and PDS symptoms frequently coexist in FD patients, with postprandial symptoms substantially contributing to the overlap. A more rigorous linking of postprandially occurring symptoms to PDS, regardless of their qualitative nature, may improve the separation between PDS and EPS.
- Research Article
- 10.3760/cma.j.issn.0254-1432.2015.07.008
- Jul 15, 2015
- Chinese Journal of Digestion
Objective To explore the distribution of the liquid food in the stomach of patients with postprandial distress syndrome (PDS)-predominated functional dyspepsia (FD) and the mechanism of its gastric dynamic dysfunction. Methods Fifty-two patients with PDS and 18 healthy volunteers underwent gastric emptying examination with ultrasound scanner provided. The proximal and distal gastric area and volume, area and volume ratio of proximal and distal gastric as well as emptying rate of proximal and distal gastric were calculated at fasting, maximum satiety, 30 min, 60 min, 90 min and 120 min after meal. Student's t test and χ2 test were performed for statistical analysis. Results Proximal gastric volume of PDS group at the time of fasting and 120 min after meal were (9.06±7.88) and (24.72±24.02) cm3, which were larger than those of healthy control group ((5.96±2.13) cm3, (19.48±12.32) cm3), and the differences were statistically significant (t=-1.637 and -0.875, both P 0.05). Conclusions The volume of distal stomach was larger than that of proximal stomach in PDS patients at maximum satiety in liquid food distribution, which may be the cause of decreasing emptying rate of proximal stomach. And proximal stomach dominated gastric motility in PDS patients. Key words: Functional dyspepsia; Postprandial distress syndrome; Gastric motility; Liquid food; Abnormal distribution
- Research Article
54
- 10.1016/j.cgh.2019.07.053
- Aug 5, 2019
- Clinical Gastroenterology and Hepatology
Analysis of Postprandial Symptom Patterns in Subgroups of Patients With Rome III or Rome IV Functional Dyspepsia
- Research Article
3
- 10.1111/nmo.14733
- Jan 4, 2024
- Neurogastroenterology & Motility
Almost 80% of individuals with functional dyspepsia experience meal-related symptoms and are diagnosed with postprandial distress syndrome (PDS). However, studies evaluating dietary modifications in PDS are sparse. We performed a single-center randomized trial comparing reassurance and diagnostic explanation (RADE) with or without traditional dietary advice (TDA) in PDS. Following a normal upper gastrointestinal endoscopy, individuals with PDS were randomized to a leaflet providing RADE ± TDA; the latter recommending small, regular meals and reducing the intake of caffeine/alcohol/fizzy drinks and high-fat/processed/spicy foods. Questionnaires were completed over 4 weeks, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Nepean Dyspepsia Index for quality of life. The primary endpoint(s) to define clinical response were (i) ≥50% adequate relief of dyspeptic symptoms and (ii) >0.5-point reduction in the PDS subscale of the LPDS (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating). Of the 53 patients with PDS, 27 were assigned RADE-alone and 26 to additional TDA. Baseline characteristics were similar between groups, with a mean age of 39 years, 70% female, 83% white British, and coexistent irritable bowel syndrome in 66%. The primary endpoints of (i) adequate relief of dyspeptic symptoms were met by 33% (n = 9) assigned RADE-alone versus 39% (n = 10) with TDA; p-value = 0.70, while (ii) a reduction of >0.5 points in the PDS subscale was met by 37% (n = 10) assigned RADE-alone versus 27% (n = 7) with TDA; p-value = 0.43. Response rates did not differ according to irritable bowel syndrome status. There were no significant between-group changes in the gastrointestinal symptom rating scale and dyspepsia quality of life. This study of predominantly white British patients with PDS found the addition of TDA did not lead to significantly greater symptom reduction compared with RADE alone. Alternate dietary strategies should be explored in this cohort.
- Research Article
- 10.36740/wlek201910103
- Oct 1, 2019
- Wiadomości Lekarskie
Among all causes of epigastric pain or burning, early satiety, bothersome fullness, the most common one is functional dyspepsia (FD). Analysis of psychological peculiarities of patients with FD becomes one of the key problems. The aim: To compare the level of anxiety, depression, and social functioning of patients with postprandial distress syndrome (PDS), patients with epigastric pain syndrome (EBS), and healthy volunteers. This cross-sectional study was conducted in adult patients with FD (58 patients with PDS and 37 patients with EPS) and healthy volunteers (30 persons). Patients’ social functioning was assessed with the 36-Item Short Form Health Survey (SF-36). Anxiety and depression levels were measured with the Hospital Anxiety and Depression Scale (HADS). Patients with PDS showed significantly lower rates of physical functioning (p=0.0002), role physical (p=0.003), bodily pain (p=0.0001), general health (p=0.0001), vitality (p=0.0001), and social functioning (p=0.0003), in comparison with healthy volunteers. This group also showed significantly lower rates of general health (p=0.041), and social functioning (p=0.048), as compared to patients with EPS. FD led to an increase in anxiety levels regardless of the type of disease as compared with healthy volunteers (p=0.024). Patients with PDS had elevated depression levels compared to patients with EPS (p=0.023) and healthy volunteers (p=0.001). Each type of FD has a certain impact on the social functioning, anxiety and depression levels. Patients with PDS manifested significant differences in the psychological state as compared to patients with EPS, and healthy volunteers.