Psychological Characteristics and Quality of Life of Patients With Functional Dyspepsia.

OBJECTIVE: The objective of this study is to compare the psychosocial characteristics of functional dyspepsia (FD) with its subgroups, epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS), against a healthy control group, and to investigate the quality of life (QoL). METHODS: All of the subjects were 210 adults, 131 patients with FD were diagnosed by gastroenterologist and 79 adults with no observable symptoms of FD were selected as the normal control group. Demographic factors were investigated. The Korean-Beck Depression Inventory-II, Korean-Beck Anxiety Inventory, Korean-Childhood Trauma Questionnaire, Multidimensional Scale of Perceived Social Support, Connor-Davidson Resilience Scale, and WHO Quality of Life Assessment Instrument Brief Form were used to assess psychological factors. A one-way analysis of variance was used to compare differences among the groups. Further, a stepwise regression analysis was conducted to determine factors affecting the QoL of the FD group. RESULTS: Between-group differences in demographic characteristics were not significant. Depression (F=37.166, p<0.001), anxiety (F=30.261, p<0.001), and childhood trauma (F=6.591, p<0.01) were all significantly higher in FD group compared to the normal control. Among FD subgroups, EPS exhibited higher levels of both depression and anxiety than PDS. Social support (F=17.673, p<0.001) and resilience (F=8.425, p<0.001) were significantly lower in FD group than in other groups, and the values were higher in PDS than in EPS. Resilience (ß=0.328, p<0.001) was the most important explanatory variable. The explained variance was 46.6%. CONCLUSION: Significantly more symptoms of depression, anxiety, childhood trauma was observed for both FD sub-group. These groups also had less social support, resilience, and QoL than the control groups.

Food, Dietary Patterns, or Is Eating Behavior to Blame? Analyzing the Nutritional Aspects of Functional Dyspepsia.

Functional dyspepsia is a gastrointestinal disorder characterized by postprandial fullness, early satiation, epigastric pain, and epigastric burning. The pathophysiology of the disease is not fully elucidated and there is no permanent cure, although some therapies (drugs or herbal remedies) try to reduce the symptoms. Diet plays a critical role in either the reduction or the exacerbation of functional dyspepsia symptoms; therefore dietary management is considered to be of high importance. Several foods have been suggested to be associated with worsening functional dyspepsia, such as fatty and spicy foods, soft drinks, and others, and other foods are thought to alleviate symptoms, such as apples, rice, bread, olive oil, yogurt, and others. Although an association between functional dyspepsia and irregular eating habits (abnormal meal frequency, skipping meals, late-night snacking, dining out, etc.) has been established, not many dietary patterns have been reported as potential factors that influence the severity of functional dyspepsia. A higher adherence to Western diets and a lower adherence to FODMAPs diets and healthy patterns, such as the Mediterranean diet, can contribute to the worsening of symptoms. More research is needed on the role of specific foods, dietary patterns, or specific eating habits in the management of functional dyspepsia.

Lactobacillus rhamnosus GG supplementation on eradication rate and dyspepsia in Helicobacter pylori infection treated with three-in-one bismuth quadruple therapy.

Introduction: Helicobacter pylori (Hp)-related dyspepsia has been related to gastroduodenal dysbiosis. The role of probiotic supplementation in the clinical management of Hp infection has been the object of several studies in terms of improvement of efficacy and tolerability of eradication treatments but data on their effects on the outcomes of post-eradication dyspepsia are lacking. The aim of the present study was to evaluate the influence of Lactobacillus rhamnosus GG (LGG) supplementation on bismuth quadruple therapy (BQT) in the clinical management of Hp-related infection both in terms of efficacy and tolerability and persistence of post-treatment dyspepsia. Methods: A total of 164 (121 women) Hp-positive adult patients were enrolled in this pilot study and assigned to two different treatment regimens: group A received BQT for 10 days (three capsules qid, IPP bid) and group B received BQT for 10 days in combination with 6 × 109CFU LGG (ATCC53103) taken for 24 days (7 days before, 10 days during, and 7 days after therapy). Eradication was assessed after 45 days using the 13C-urea breath test (13C-UBT). Dyspepsia, distinguished into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), was assessed at the time of enrollment and 6 months after eradication. Results: Approximately 98 patients were enrolled in group A and 66 patients in group B. At the enrollment, dyspepsia was present in 76.5% of group A and 86.5% of group B. No significant differences were observed in eradication rate between the 2 groups, both in intention-to-treat (ITT) analysis (82.3 vs. 75.0%) and per-protocol (PP) analysis (95 vs. 96%), and in the presence of side effects during the treatment (70.6 vs. 65.4%). At 6 months after eradication of Hp infection, the persistence of dyspepsia was statistically higher in patients of group A than in group B (38.8 vs. 16.1%; p = 0.032). The positive influence of LGG supplementation in improving post-eradication dyspepsia resulted in statistically more effectiveness in PDS dyspepsia, whose remission was 41.7% in group A and 84% in group B patients (p = 0.011). Conclusion: In conclusion, LGG supplementation during Hp eradication therapy, even if not affecting eradication rates and therapy-related side effects, significantly impacts the remission of dyspepsia.

The Impact of Duodenal Mucosal Vulnerability in the Development of Epigastric Pain Syndrome in Functional Dyspepsia.

An unidentified cause of functional dyspepsia (FD) is closely associated with medication resistance. Acid suppression is a traditional and preferential method for the treatment of FD, but the efficacy of this treatment varies between epigastric pain syndrome (EPS) and postprandial syndrome (PDS): it is efficient in the former but not much in the latter. Transepithelial electrical resistance (TEER), a surrogate of mucosal barrier function, was measured under pH 3 and pH 5 acidic conditions using duodenal biopsy specimens obtained from the patients with EPS and PDS and asymptomatic healthy controls. The infiltration of inflammatory cells to the duodenal mucosa was accessed by immunohistochemical analysis. The duodenal mucosal TEER in EPS patients was decreased by exposure to the acidic solution compared to that of the controls and the PDS patients. The decrease in TEER of the EPS patients was observed even under pH 5 weak acidic condition and was correlated to degree of the epigastric pain. Moreover, the duodenal mucosa of EPS patients presented an increase in mast cells and plasma cells that expressed Ig-E. Duodenal mucosal vulnerability to acid is likely to develop EPS.

[Characteristic of eating behavior in functional dispepsy].

Functional dyspepsia is the actual problem of modern gastroenterology, its manifestations contribute to the lifting of lifestyle and nutrition. However, a comprehensive assessment of the effect of violations of food behavior, the distribution of adipose tissue and the level of gosters regulating appetite on the severity of gastroenterological symptoms in individuals with various types of functional dyspepsia hasn't been carried out yet. Aim - to clarify the effect of food behavior, ghrelin and leptin blood concentrations on clinical symptoms in patients with different types of functional dyspepsia. Material and methods. A prospective study with the participation of 90 people aged 22.3±0.2, divided into 3 groups was carried out: patients with postprandial distress syndrome (PDS), patients with epigastric pain syndrome (EPS), and practically healthy. All respondents were interviewed using the GSRS, DEBQ questionnaires, their anthropometric data have been defined, body composition indicators were calculated based on the measurement of body circumference measurements, leptin and ghrelin concentration in blood serum was measured by the enzyme immunoassay method. Results and discussion. EPS was characterized by more pronounced symptoms (10.10±0.32 points on the GSRS questionnaire) due to abdominal pain syndrome (4.33±0.51 points) compared with patients with PDS and healthy individuals. In both variants of the functional dyspepsia, all three types of food behavior disorders were revealed, however, the external type was more characteristic for PDS. Patients with PDS had a larger volume of visceral adipose tissue (42.84% of the total fat tissue in the body) than those with EPS (34.02%) and healthy ones (35.55%). Blood leptin concentration in patients with both variants of the functional dyspepsia was lower (especially in patients with EPS - 0.17±0.03 ng/ml, p=0.039) than in healthy (0.32±0.08 ng/ml). Ghrelin level in patients with EPS (14.91±0.17 ng/ml) was significantly higher than in healthy (11.55±0.44 ng/ml, p=0.022). Factor analysis made it possible to identify the stress factor showing the connection of emotional disorders of food behavior with increasing gastrointestinal symptoms and blood leptin concentration and decreasing blood ghrelin level. Conclusion. Different variants of functional dyspepsia are characterized by their own peculiarities of eating behavior, the distribution of fat in the body, the degree of changes in leptin and ghrelin levels, which determine their clinical symptoms. The identification and accounting of these factors will make it possible to individualize the approach to the curation of patients with functional dyspepsia.

Prevalencia de dispepsia funcional en adolescentes cubanos / Prevalence of Functional Dyspepsia in Cuban Adolescents

Resumen Introducción: los trastornos digestivos funcionales son frecuentes en niños; sin embargo, hay escasos datos sobre la dispepsia funcional (DF) en adolescentes cubanos. Objetivo: determinar la prevalencia de DF en adolescentes cubanos y sus posibles asociaciones. Metodología: se usó el cuestionario para síntomas digestivos pediátricos de Roma IV en español para identificar la presencia de DF en adolescentes de 3 centros escolares de La Habana, Cuba. Se tuvieron en cuenta variables sociodemográficas, personales, familiares, clínicas y epidemiológicas. Resultados: de los 318 adolescentes que participaron en el estudio, 11 adolescentes (3,5 %) de 11,4 ± 1,2 años de edad, 81,8 % de sexo femenino, presentaron DF. La DF fue más frecuente en el sexo femenino (odds ratio [OR]: 5,33; intervalo de confianza [IC] 95 %: 1,06-51,45; p = 0,019). El síndrome de dificultad posprandial (SDP) fue mayor que el síndrome de dolor epigástrico (SDE) en una proporción 1,8:1. En el 63,6 % se presentó superposición entre DF y estreñimiento funcional. Hubo predominio de DF en los niños con padres separados/divorciados (OR: 4,74; IC 95 %: 1,09-28,31; p = 0,014). Conclusión: la DF es más común en adolescentes femeninas, el SDP es el subtipo más frecuente y su presencia está asociada con padres separados/divorciados.

Abstract Introduction: functional gastrointestinal disorders (FGID) are common in children. However, data on functional dyspepsia (FD) in Cuban adolescents is scarce. Objective: to determine the prevalence of FD in Cuban adolescents and their possible associations. Methodology: the questionnaire for pediatric digestive symptoms of Rome IV was used in Spanish to identify the presence of DF in adolescents from 3 schools in La Havana, Cuba. Sociodemographic, personal, family, clinical, and epidemiological variables were considered. Results: of the 318 adolescents who participated in the study, 11 (3.5%) aged 11.4 ± 1.2 years, 81.8% female, presented FD. Functional dyspepsia was more frequent in females (odds ratio [OR]: 5.33; 95% confidence interval [CI]: 1.06-51.45; p = 0.019). The postprandial distress syndrome (PDS) was higher than the epigastric pain syndrome (SDE) by a 1.8:1 ratio. There was an overlap between DF and functional constipation in 63.6% of the patients. There was an FD predominance in children with separated or divorced parents (OR: 4.74; 95% CI: 1.09-28.31; p = 0.014). Conclusion: functional dyspepsia is most common in female adolescents, PSD is the most frequent subtype, and its presence is associated with separated or divorced parents.

Quality of life in Indian patients with functional dyspepsia: Translation and validation of the Hindi version of Short-Form Nepean Dyspepsia Index.

BACKGROUND/PURPOSE: Patients with functional dyspepsia (FD) have poor health-related quality of life (HRQOL), but Indian data are  lacking. Also, there is non-availability of validated disease-specific questionnaire to assess HRQOL in Hindi-speaking patients with dyspepsia. We aimed to develop and validate a reliable translation of Short-Form Nepean Dyspepsia Index (SF-NDI) in Hindi, and assess the impact of FD on HRQOL in Indian patients. METHODS: Cross-cultural adaptation of English version of SF-NDI, translation to Hindi, and adaptation of Hindi version were performed using standard procedures. English and Hindi versions were assessed against Short Form-36 (SF-36), examining for internal consistency, test-retest reliability, and validity. RESULTS: Total 211 FD patients (144 Hindi speaking, 67 English speaking) were enrolled (mean age 40.8 ± 11.7 years; male:female = 115:96). Median total SF-NDI scores for both languages were 38.75 and 40.0, respectively. Test-retest reliability intraclass correlation coefficients were 0.85 (Hindi) and 0.89 (English). Internal consistency evaluation revealed Cronbach's α coefficient of 0.79-0.86 (Hindi) and 0.78-0.89 (English). SF-NDI sub-scales showed moderate to good correlation with various domains of SF-36 (content validity). There was significant (p < 0.001) decline of HRQOL in patients with severe dyspepsia relative to those with mild dyspepsia (construct validity). On multivariate analysis, factors independently associated with HRQOL were duration of symptoms and dyspepsia severity. CONCLUSION: Both English and Hindi versions of SF-NDI are reliable and valid for HRQOL assessment in Indian FD patients, and will be useful in future epidemiological and clinical studies. Indian FD patients have poor HRQOL, being worse in those with severe dyspepsia and longer duration of symptoms.

Efficacy of acotiamide on postprandial distress syndrome and epigastric pain syndrome depending on the estimated gastric acid secretion level.

BACKGROUND/AIMS: Gastric acid secretion is suspected to be a pivotal contributor to the pathogenesis of functional dyspepsia. The present study investigates the potential association of the gastric acid secretion estimated by measuring serum pepsinogen with therapeutic responsiveness to the prokinetic drug acotiamide. METHODS: Dyspeptic patients consulting participating clinics from October 2017 to March 2019 were prospectively enrolled in the study. The dyspeptic symptoms were classified into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS). Gastric acid secretion levels were estimated by the Helicobacter pylori infection status and serum pepsinogen using established criteria and classified into hypo-, normo-, and hyper-secretion. Each patient was then administered 100 mg acotiamide thrice daily for 4 weeks, and the response rate to the treatment was evaluated using the overall treatment efficacy scale. RESULTS: Of the 86 enrolled patients, 56 (65.1%) and 26 (30.2%) were classified into PDS and EPS, respectively. The estimated gastric acid secretion was not significantly different between PDS and EPS. The response rates were 66.0% for PDS and 73.1% for EPS, showing no significant difference. While the response rates were stable, ranging from 61.0% to 75.0% regardless of the estimated gastric acid secretion level among subjects with PDF, the rates were significantly lower in hyper-secretors than in non-hyper-secretors among subjects with EPS (42.0% vs 83.0%, P = 0.046). CONCLUSION: Although acotiamide is effective for treating EPS as well as PDS overall, the efficacy is somewhat limited in EPS with gastric acid hypersecretion, with gastric acid suppressants, such as proton pump inhibitors, being more suitable.

Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet versus traditional dietary advice for functional dyspepsia: a randomized controlled trial.

BACKGROUND AND AIM: Prospective trials evaluating efficacy of specific diet restriction in functional dyspepsia (FD) are scarce. We aimed to assess efficacy of low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet in FD, compared with traditional dietary advice (TDA). METHODS: In this prospective, single-blind trial, patients with FD (Rome IV) were randomized into low FODMAP diet (LFD) and TDA groups, for 4 weeks (phase I). In phase II (4-12 weeks), LFD group was advised systematic re-introduction of FODMAPs. Symptom severity and quality of life were assessed using "Short-Form Nepean Dyspepsia Index (SF-NDI)." Primary outcome was symptomatic response (symptom score reduction of ≥ 50%), at 4 weeks. Study was registered with CTRI (2019/06/019852). RESULTS: Of 184 patients screened, 105 were randomized to LFD (n = 54) and TDA (n = 51) groups. At 4 weeks, both groups showed significant reduction in SF-NDI symptom scores compared with baseline, with no significant difference in inter-group response rates [LFD: 66.7% (36/54); TDA: 56.9% (29/51); P = 0.32]. On sub-group analysis, patients with postprandial distress syndrome or bloating had significantly better symptomatic response with LFD (P = 0.04). SF-NDI quality of life scores improved significantly in both groups. On multivariate analysis, factors predicting response to LFD were bloating and male gender. Incidences of adverse events (minor) were similar in both groups. CONCLUSIONS: In patients with FD, LFD and TDA lead to significant symptomatic and quality of life improvement. Patients with postprandial distress syndrome or bloating respond significantly better to LFD. Therefore, dietary advice for FD should be individualized according to FD subtype.

Clinical and Psychological Factors Predict Outcome in Patients With Functional Dyspepsia: A Prospective Study.

BACKGROUND & AIMS: Symptoms of functional dyspepsia (FD) fluctuate over time but there are limited data on the impact of factors on change in dyspepsia symptom severity over time. We aimed to evaluate the demographic, clinical, and psychological factors associated with change in dyspepsia symptom severity. METHODS: Consecutive patients with FD presenting to a tertiary care center completed questionnaires assessing clinical and psychological symptoms at the time of the initial visit (baseline) and 3- to 6-month follow-up evaluations. FD and irritable bowel syndrome (IBS) were diagnosed using Rome IV criteria. FD severity was measured using patient assessment of gastrointestinal symptom severity. Patient-reported outcome measures information scales were used to assess the severity of anxiety, depression, and sleep disturbance. RESULTS: Of 128 FD patients, 64 (50%) also met Rome IV criteria for IBS. In the final multivariable model, lower baseline sleep disturbance, improvement in anxiety scores, absence of IBS, and a lower number of medications taken for gastrointestinal symptoms were associated with improvement in dyspepsia scores (P < .05 for all). Conversely, higher baseline dyspepsia severity was associated with greater improvement in dyspepsia severity at follow-up evaluation (P < .001). CONCLUSIONS: Improvement in FD symptom severity over 3 to 6 months was associated with improvement of anxiety, lower sleep disturbance at baseline, absence of IBS, and higher baseline dyspepsia severity.

Role of Neuromodulators for the Management of Post-Gastric-Fundoplication Dyspepsia: A Retrospective Series.

Post-fundoplication dyspepsia is a common complication of gastric fundoplication surgeries. This can be attributable to the loss of fundal relaxation, decreased gastric accommodation, and/or alterations in gastric motility and sensitivity following fundoplication. The role of neuromodulators in the management of such symptoms is unknown. We retrospectively assessed the efficacy of neuromodulators such as tricyclic antidepressants, buspirone, and mirtazapine for the management of post-fundoplication dyspepsia.

Role of Helicobacter pylori eradication in patients with functional dyspepsia.

BACKGROUND: Helicobacter pylori (H. pylori) is implicated in the pathogenesis of functional dyspepsia (FD). There is conflicting data regarding the benefit of H. pylori eradication for symptom relief in FD. AIMS: To study the benefit of eradicating H. pylori in patients with FD as compared to standard medical treatment (SMT). Secondary aims were to find efficacy of H. pylori eradication therapy, recurrence of H. pylori after eradication, and predictors of efficacy. METHODS: Consecutive adult patients of FD (ROME IV) with H. pylori infection presenting in the outpatient department of our hospital were enrolled. Patients with Global Overall Symptom (GOS) scale > 2 and H. pylori infection were included. Patients were randomized into two groups: group 1 received H. pylori eradication therapy and group 2 received SMT. Treatment success was defined as symptom relief (GOS score < 2 and reduction by at least 2 points at 6 months) and H. pylori eradication was defined as stool antigen negative at 4 weeks. RESULTS: Of 329 participants with FD, 253 were H. pylori positive (rapid urease test and stool antigen test) (76.89%). After exclusions, 202 were randomized into two groups of 101 each. Thirty-two patients in group 1 and 31 in group 2 had treatment success (31.7% vs. 30.7%, p=1.000). The efficacy of H. pylori eradication therapy was 74.46% (70/94). H. pylori reinfection rate was 26.02% (19/73). CONCLUSIONS: H. pylori eradication therapy does not provide additional benefit in symptom relief in patients with FD as compared with SMT. TRIAL REGISTRATION: NCT04697641 (retrospectively registered on www.clinicaltrials.gov in January 2021).

Efficacy and Safety of Acotiamide Versus Mosapride in Patients With Functional Dyspepsia Associated With Meal-Induced Postprandial Distress Syndrome: A Phase III Randomized Clinical Trial.

BACKGROUND:  Acotiamide is a novel prokinetic drug that acts by enhancing the release of acetylcholine and is used in the treatment of functional dyspepsia-postprandial distress syndrome (FD-PDS). Mosapride is indicated to FD-PDS as per the Rome III treatment guidelines. Mosapride 5 mg three times daily (TID) is approved by the Drugs Controller General of India (DCGI) for the treatment of FD-PDS. The objective of this study was to determine the efficacy and safety of Acotiamide in comparison with Mosapride on FD-PDS. METHODS: The 220 patients of either gender (aged 18-64 years) with active PDS included in the study were centrally randomized 1:1 to receive either 100 mg Acotiamide (test product) or 5 mg Mosapride (reference product) TID for four weeks. Responder rates for the overall treatment effect (OTE) at the end of four weeks were the primary efficacy endpoint. Secondary efficacy endpoints included the elimination rate of postprandial fullness, upper abdominal bloating, and early satiation. The study also evaluated the OTE at each week, individual symptom scores, and quality of life (QoL) assessed by the Short Form-Nepean Dyspepsia Index questionnaire (SF-NDI). The safety endpoints included assessments of treatment-emergent adverse events (TEAEs). RESULTS:  At the end of four weeks, the responders in the Acotiamide versus Mosapride group for OTE was 98% versus 93.27% in the per-protocol (PP) population. Among the intent to treat (ITT) population, the comparison of Acotiamide versus Mosapride stood at 95.15% versus 89.81%. Secondary efficacy endpoints were significantly improved with 100 mg TID Acotiamide, which was evident from the improvement in postprandial fullness (14.56%), upper abdominal bloating (15.53%), early satiation (10.68%), and QoL (13.7 ± 4.67). CONCLUSIONS:  Our study results demonstrated that Acotiamide is effective, safe, and well-tolerated and had significantly improved the QoL over a four-week treatment period in FD-PDS patients. The efficacy and safety profiles of Acotiamide were similar to Mosapride.

Functional dyspepsia: A critical appraisal of the European consensus from a global perspective.

The European Society for Neurogastroenterology and Motility's (ESNM) consensus document on functional dyspepsia (FD) has provided a critical review of the evidence for 36 statements highly relevant to the diagnosis and treatment of FD. We provide here our expert opinion on the North American, Australian and Asian assessments of the same topics discussed, and provide evidence where the ESNM consensus may deviate from those in the other continents. New and exciting data about the pathogenesis of FD are emerging including the possible central role of duodenal micro-inflammation (most notably eosinophilic duodenitis and intestinal mast cell disease), but this is a very dynamic field with several gaps remaining in our understanding that are summarized in this review. Identification of non-invasive biomarkers and testing of targeted therapies, including assessing the benefits of multidisciplinary teams in the management of FD, should be future priorities.

Efficacy and Safety of Orally Administered Acotiamide Extended-Release Tablets Among Functional Dyspepsia-Postprandial Distress Syndrome Patients: A Randomized, Double-Blind, Multicenter Study.

BACKGROUND: Acotiamide, is the world's first-in-class, prokinetic drug and world's first approved treatment for postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). An extended-release (ER) formulation of this drug product, developed first-time in the world has been evaluated in phase 3, a comparative trial to explore the efficacy and safety in patients with FD-PDS. METHODS: In this study, 219 patients with FD-PDS aged 18-65 years were randomized (1:1) to receive either acotiamide ER 300 mg once daily or acotiamide 100 mg three times daily for four weeks. The primary efficacy endpoint was responder rates for the overall treatment effect (OTE) at end of week 4. Secondary efficacy endpoints included OTE at each week, elimination rate of postprandial fullness, upper abdominal bloating and early satiation, improvement of individual symptom scores, and quality of life (QoL). The safety endpoints included assessments of treatment-emergent adverse events (TEAEs). RESULTS: The responder rate for OTE at the end of the four week period, in acotiamide ER 300 mg OD versus acotiamide 100 mg TID group was 92.66% and 94.39% (97.5% CI -8.3,4.8), respectively, in per-protocol (PP) population and 92.66% and 92.73% (97.5% CI -7.0,6.8), respectively, in intent to treat (ITT) population. All other secondary efficacy endpoints, including QoL, were significantly improved with acotiamide ER 300 mg. Both the formulations of acotiamide significantly improved symptom severity and eliminated meal-related symptoms in patients with FD. Adverse events were reported by 7.9% of patients in acotiamide ER 300 mg and 9.2% in acotiamide 100 mg patients; the most common adverse event reported was a headache. CONCLUSIONS: The efficacy and safety of acotiamide ER 300 mg once daily were observed to be comparable to acotiamide immediate release 100 mg thrice daily. A significant improvement in QoL over a four-week treatment period in FD-PDS patients was observed.

Update on Indigestion.

Dyspepsia affects a large percentage of the general population and can lead to lost work productivity and reduced quality of life. Patients with dyspepsia younger than 60 should not routinely undergo endoscopy but instead should pursue Helicobacter pylori test-and-treat approach. For patients 60 and older, endoscopy should be performed. Patients without any identifiable cause for their symptoms are diagnosed with functional dyspepsia. Guideline-based treatment includes H pylori eradication and proton pump inhibitor use. If acid suppression is not adequate, treatment with a tricyclic antidepressant followed by a prokinetic agent and psychological therapy are considered. Complementary therapies are not recommended due to limited evidence.

Effects of Low-Dose Amitriptyline on Epigastric Pain Syndrome in Functional Dyspepsia Patients.

AIM: To observe the therapeutic effect of low-dose amitriptyline (AMT) on epigastric pain syndrome (EPS) in patients with functional dyspepsia. METHODS: Sixty patients with EPS were randomly divided into the following two groups for a four-week clinical trial: routine treatment with pantoprazole (RT group) and the AMT group. The RT group was treated with 40 mg of pantoprazole once daily. The AMT group received 25 mg of AMT once daily before bedtime. The Nepean Dyspepsia Index (NDI) checklist, Hamilton Rating Scale of Anxiety/Depression (HAMA/HAMD), and Pittsburgh Sleep Quality Index (PSQI) were employed to evaluate dyspepsia symptoms, psychological distress, and sleep, respectively. RESULTS: All items were similar between the two groups before treatment (0 week). After 4 weeks of treatment, the NDI-symptom checklist score as well as the severity and bothersomeness of EPS in the AMT group was significantly decreased compared with those in the RT group (p < 0.05). However, no differences were found in the frequency of NDI checklist, psychological status (HAMD/HAMA scores) of EPS, or sleep quality (PSQI score) between the two groups after treatment. In addition, the time to fall asleep was shorter in the AMT group compared with the RT group after 4 weeks of treatment (p < 0.05). CONCLUSION: Low-dose AMT effectively improved the dyspepsia symptoms and the time to fall asleep in the EPS patients, compared with pantoprazole, although it did not reduce the psychological distress. Therefore, AMT could be considered as a good candidate for EPS treatment in the clinic.

Epigastric pain syndrome: What can traditional Chinese medicine do? A randomized controlled trial of Biling Weitong Granules.

BACKGROUND: Recent research suggests that although prokinetic agents, acid suppressors, and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia (FD), a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions. Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases. The present study was designed to verify the efficacy of Biling Weitong Granules (BLWTG), a traditional Chinese medicinal herbal compound formula, in alleviating epigastric pain syndrome (EPS) in FD patients, in an attempt to provide an effective prescription for the clinical treatment of this disease. AIM: To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD. METHODS: In this multicenter, stratified, randomized, double-blind, placebo-controlled, parallel group clinical trial, eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk. Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared. RESULTS: The baseline demographic data and clinical characteristics, such as epigastric pain symptoms, pain intensity, and frequency of attacks, were matched between the two groups before randomization. After 6 wk of treatment and after the center effect was eliminated, the epigastric pain was significantly improved in 28.33% and 85.59% of the patients in the placebo and BLWTG groups, respectively (P < 0.05). At 6 wk, the resolution rate of epigastric pain was 15% and 69.49% in the placebo and BLWTG groups, respectively (P < 0.05). The differences of total FD clinical score between these two groups were significant (P < 0.05) at 2, 4, and 6 wk (P < 0.05). The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation. CONCLUSION: Compared with placebo, BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.

Anhedonia and functional dyspepsia in obese patients: Relationship with binge eating behaviour.

BACKGROUND: Obese patients (Ob) with a binge eating disorders (BED) behavior pattern have a higher prevalence of postprandial distress syndrome (PDS) compared to Ob without a BED behavior pattern, while an increase of PDS has been described in Ob after sleeve gastrectomy (SG). Hedonic response to a meal is dissociable from satiation in healthy subjects. Anhedonia is the lowered ability to experience pleasure. There are no studies investigating the presence of anhedonia in Ob with and without SG and its relationship to PDS symptoms. AIM: To assess the relationship among anhedonia, BED and upper gastrointestinal symptoms in two group of morbidly Ob with and without SG. METHODS: Eighty-one Ob without SG, 45 Ob with SG and 55 healthy controls (HC) were studied. All subjects fulfilled the binge eating scale (BES) to investigate BED, the validated 14 items Snaith-Hamilton pleasure scale (SHAPS) to assess Anhedonia as well as the Beck Depression Inventory-II (BDI II) and State Trait Anxiety Inventory (STAI) questionnaires to screen for depression and anxiety. All patients underwent a standardized questionnaire investigating the intensity-frequency scores (0-6) of upper gastrointestinal symptoms and were diagnosed for the presence of functional dyspepsia (FD) and its subtypes according to ROME IV criteria. RESULTS: Ob without SG who were positive for BED had a 4.7 higher risk of FD compared to Ob without SG who were negative for BED (OR: 4.7; 95.0%CI 1.23-18.24; P = 0.02). STAI-Y2 scores were significantly higher in Ob without SG positive for BED (42.2 ± 1.5 vs Ob negative for BED: 39.6 ± 1 .0, P = 0.04), while SHAPS scores and BDI II did not differ in the two groups (1.16 ± 1.30 vs 0.89 ± 1.02, P = 0.49). A lower prevalence of BED (BES > 17: 11.4% vs 40.7%, P = 0.001) and BDI-II (6.8 ± 1.2 vs 13.8 ± 1.9, P = 0.005) was reported in Ob with SG than Ob without SG, on the contrary total mean scores of STAI-Y1 and STAI-Y2 were significantly higher in Ob with SG than Ob without SG. Thirty-five percent of Ob with SG fulfilled the diagnosis of FD. SHAPS mean scores and the prevalence of anhedonia did not differ among the two groups (18.2 vs 8.1%, P = 0.2). Fifty-four percent of Ob with SG achieved surgical success excess weight loss > 50%. Excess weight loss was negatively related to SHAPS total mean scores [adjusted B: -7. 099 (95%CI: -13.91 to -0.29), P = 0.04]. CONCLUSION: Ob without SG showed a higher prevalence of PDS, mood disorders and anxiety when positive for BE behavior compared to those negative for BE behavior, whereas no differences were found in SHAPS score. Ob with SG showed a higher prevalence of PDS compared to Ob without SG. Concerning psychological aspect, BED and depression are less frequent in the Ob with SG, while both state and trait anxiety are significantly higher. Moreover, the more an Ob with SG is anhedonic, less surgical success was achieved.

Agreement of gastroenterologists in traditional Chinese medical differential diagnosis of functional dyspepsia compared with traditional Chinese medical practitioners: A prospective, multicenter study.

OBJECTIVE: To compare the performance of gastroenterologists major in western medicine in diagnosing traditional Chinese medicine (TCM) syndrome types of functional dyspepsia (FD), postprandial distress (PDS) and epigastric pain syndromes (EPS) based on the main symptoms, with that of traditional TCM practitioners in outpatient services. METHODS: Patients with PDS or EPS were enrolled in the study from six tertiary referral centers between January 2016 and December 2017. Their symptoms were first diagnosed by medical doctors, and then by the TCM practitioners. The diagnostic agreement between the gastroenterologists and the TCM practitioners was calculated. The patients' data and their types of FD syndrome were collected and analyzed. RESULTS: In total 160 patients, including 81 with PDS and 79 with EPS were enrolled. The total diagnostic consistency rate between the gastroenterologists and TCM practitioners was 86.3%, while that of PDS and EPS was 85.2% and 87.3%, respectively. The most common type of PDS diagnosed by TCM practitioners was liver-stomach disharmony syndrome (33.3%), spleen deficiency and qi-stagnation syndrome (33.3%), while that for EPS was liver-stomach disharmony syndrome (36.7%). CONCLUSIONS: Gastroenterologists had a high diagnostic agreement about the types of FD syndromes based on differential diagnosis of the main symptoms, compared with TCM practitioners. This may aid gastroenterologists in selecting Chinese medicine for FD-based on syndrome differentiation.