Functional Dyspepsia Symptoms Research Articles

Modern Possibilities of Using Acotiamide in the Treatment of Functional Dyspepsia

Aim: to evaluate the efficacy and safety of the new prokinetic drug acotiamide in the treatment of functional dyspepsia.Key findings. Acotiamide is an antagonist of inhibitory muscarinic receptors of type 1 and 2 and a reversible inhibitor of acetylcholinesterase activity. In patients with functional dyspepsia acotiamide normalizes the accommodation of the fundal part of the stomach and accelerates delayed gastric emptying. The conducted studies have confirmed the higher efficacy of acotiamide compared to placebo in reducing the severity of such symptoms of functional dyspepsia as a feeling of epigastric postprandial fullness and bloating, early satiation. The advantage of acotiamide in comparison to other prokinetics (in particular, metoclopramide and domperidone) is the high safety of use and the absence of influence on the duration of the Q-T interval.Conclusion. The high efficacy and safety of the application makes it advisable to use acotiamide in the treatment of patients with functional dyspepsia.

The Role of Ultrasonography in the Diagnosis of Functional Dyspepsia

Abstract Functional dyspepsia (FD) is a syndrome mostly diagnosed by subjective patients’ symptoms after excluding organic, systemic and metabolic diseases. Aim: The goal of this study is to evaluate gastric emptying in patients with functional dyspepsia, by measuring the antral area (cm2) after the intake of a test meal using ultrasonography as an objective and widely applicable method. Material and Methods: This study included 30 patients (mean age of 46.53 ±9.73 years) with symptoms of FD according to the ROMA IV criteria and 30 healthy individuals (mean age of 42.87 ±4.42 years). A 5 MHz ultrasound probe was used to measure the stomach antral area at 6 different time points: in the fasting state, following the meal intake at 5, 30, 60, 90 and 120 min postprandially. Results: The antral area was statistically significantly larger after a 30-minute postprandial period in patients with FD comparing to healthy controls (p<0.05). There was a statistically significant difference in the rate of gastric emptying at 120 minutes in patients with functional dyspepsia, compared to healthy subjects (p <0.01). Patients with postprandial distress syndrome had the average value of gastric emptying 48.25 compared to 56.09 in patients with epigastric pain syndrome (p <0.05). The slowest emptying was observed in patients with nausea and postprandial fullness (p <0.05). Conclusion: Functional dyspepsia is associated with delayed gastric emptying. Using ultrasonography to measure the antral area helps us to assess gastric emptying and therefore to assess patients with functional dyspepsia. The antral area was significantly larger in patients with functional dyspepsia compared to healthy subjects after the test meal, suggesting slower gastric emptying in the dyspeptic patients. Since the diagnosis of functional dyspepsia is based mostly on diverse patients’ symptoms, using ultrasonography to measure the antral area helps us to objectively assess this problem.

Chuna therapy include Space Spinal Conduction Exercise and Manipulation Treatment for Functional dyspepsia patients: A case report

Objectives: The purpose of this case study was to report the effect of Chuna therapy include Space Spinal Conduction Exercise and Manipulation Treatment for Functional dyspepsia patients.Methods: A 32-years-old male patients with functional dyspepsia visited the clinic ten times from March 17th 2023 to April 22th 2023. To assess the treatment outcomes, we used the Standard tool for pattern identification of Functional dyspepsia and Nepean Dyspepsia Index-Korean version (NDI-K) symptom score.Result: After treatment, Standard tool for pattern identification of Functional dyspepsia and Nepean Dyspepsia Index-Korean version (NDI-K) score decreased.Conclusion: Chuna therapy include Space Spinal Conduction Exercise and Manipulation Treatment was effective in the treatment of patient with Functional dyspepsia.

Targeted metabolomics revealed the mechanisms underlying the role of Liansu capsule in ameliorating functional dyspepsia

Ethnopharmacological relevanceLiansu capsule could alleviate dyspeptic symptoms; however, the mechanisms underlying its role in treating functional dyspepsia (FD) remain unclear. Aim of the studyTo elucidate the mechanism underlying the efficacy of Liansu capsule in alleviating FD symptoms. Materials and methodsThirty-six male mice were randomly divided into the following six groups: control, model, low-strength Liansu, moderate-strength Liansu, high-strength Liansu, and domperidone groups. Small intestine propulsion rate, gastric residual rate and histopathological analysis were performed to evaluate efficacy of Liansu capsule. Levels of interleukin-1β, interleukin-6, tumor necrosis factor α, phosphorylation of p65, ghrelin and gastrin were verified by real-time quantitative polymerase chain reaction and immunofluorescence assays. Targeted metabolomic analyses, western blotting and immunofluorescence assays were used to explore the mechanism of Liansu capsule in ameliorating FD. ResultsThe Liansu capsule significantly ameliorated the symptoms of FD, and markedly increased the levels of ghrelin and gastrin. Moreover, Liansu capsule significantly downregulated the levels of the proinflammatory cytokine interleukin-1β, interleukin-6, tumor necrosis factor α, and inhibited the phosphorylation of p65. Targeted metabolomic analyses showed that Liansu capsule significantly reduced the levels of deoxycholic acid and hyodeoxycholic acid, which were significantly elevated in the model group. Furthermore, these results showed that deoxycholic acid and hyodeoxycholic acid markedly promoted the levels of Takeda G-protein-coupled receptor 5 (TGR5), phosphorylated signal transducer and activator of transcription 3 (STAT3), and Kruppel-like factor 5 (KLF5) in vitro. whereas, Liansu capsule significantly reduced the levels of TGR5, phosphorylated STAT3, and KLF5. ConclusionOur findings indicated that Liansu capsule improved FD by regulating the deoxycholic acid/hyodeoxycholic acid-TGR5-STAT3-KLF5 axis. The findings reveal a novel mechanism underlying the role of Liansu capsule, which may be a promising therapeutic strategy for FD.

P346 Assessing Brain Morphology in Functional Gastrointestinal and Inflammatory Bowel Disorders Using Functional Magnetic Resonance Imaging (fMRI)

Abstract Background Functional gastrointestinal disorders (FGIDs) and non-specific inflammatory bowel diseases (IBD) are increasingly common in young adults. Studies have shown abnormal interhemispheric interactions in FGIDs and altered Default Mode Network (DMN) connectivity in brain regions linked to gastric sensations and emotional regulation. This study explores these neural mechanisms in FGIDs and IBDs, focusing on chronic visceral pain and its association with DMN reorganization. Methods The study included patients with functional dyspepsia (FD), N=18; irritable bowel syndrome (IBS), N=20 and IBD, N=18 alongside a control group of 18 healthy volunteers. Selection criteria included the Rome III Criteria for FGIDs and various diagnostic tests for IBDs. MRI scans were conducted using a 3T Achieva TX Scanner, applying standard T1 and T2 sequences without contrast agents. Functional imaging utilized T2 Gradient Echo-Planar Imaging. Results DMN analysis showed no anterior-posterior split. Significant differences were observed in the IBD group compared to controls, particularly in the left superior frontal gyrus. When comparing all patient groups with controls, increased DMN connectivity was noted in the left cingulum and supplementary motor area. These areas were also significant when comparing only FGIDs patients with controls, indicating altered DMN connectivity in these disorders. Please see: Figure 1 and Table 1. Conclusion The study highlights differences in DMNs between patient and control groups, especially in the left superior frontal gyrus, left cingulum, and left supplementary motor area. All disease groups showed variations from controls in the DMN pattern within the left cingulum. Significant differences in the DMN of the supplementary motor area were observed in functional gastric disease groups compared to controls. These findings suggest a link between brain areas involved in sensorimotor processes and symptoms of FD and IBS, providing insights into the neural basis of these conditions. Despite varied changes, common features differentiating the entire study group from healthy controls were identified. This condensed version focuses on the key aspects of your original text, ensuring that the main findings and methodology are clearly presented within the character limit.

Efficacy and Safety of STW 5-II for Functional Dyspepsia Treatment: A Patient Data-Based Meta-Analysis

Introduction: Functional dyspepsia (FD) is a chronic relapsing gastroduodenal disorder with limited treatment options. Herbal products, like the six-herb combination STW 5-II, can target multiple FD gastrointestinal symptoms. In this meta-analysis, we evaluated the efficacy and safety of STW 5-II for overall FD, and key symptoms, based on Rome IV criteria. Methods: We systematically screened the literature for randomized controlled clinical studies testing STW 5-II in FD. Meta-analysis was performed using data from individual patients with at least one key FD symptom (fullness, early satiety, or epigastric pain) of at least moderate severity at baseline. ANCOVA-based meta-analyses were performed on improvements in the total symptom sum score, and single symptoms, after 4 and 8 weeks. Safety data were analyzed by calculating odds ratios for all adverse events. Results: Four randomized controlled trials, including 613 patients, were identified, and two were eligible for efficacy analysis. STW 5-II significantly improved the FD symptom sum score (mean difference of 1.74 after 4 weeks and 2.07 after 8 weeks) and key FD symptoms of fullness (0.28 and 0.29), early satiety (0.25 and 0.26), and epigastric/upper abdominal pain (0.26 and 0.3). Treatment-related or severe adverse events did not differ between STW 5-II and placebo. Conclusion: The results support that STW 5-II significantly improves FD symptoms after 4 and 8 weeks of treatment with no difference in relation to safety signals compared to placebo. Thus, STW 5-II can be considered an effective and safe treatment option for FD.

Comparing the efficacy of duloxetine and nortriptyline in alleviating the symptoms of functional dyspepsia - a randomized clinical trial.

To compare the efficacy of Duloxetine and Nortriptyline in alleviating the symptoms of severity, anxiety, depression and quality of life in patients with functional dyspepsia (FD). We conducted a single-blinded 3-month trial of Duloxetine 20-30 mg daily in 20 patients and Nortriptyline 25 mg daily in 25 FD patients. The primary outcome measure was the severity of FD symptoms by Gastrointestinal symptoms rating scale. Secondary measures included Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, and Nepean Dyspepsia Index. the patients were measured in 3 stages. 45 patients with FD with a mean age of 37.18 ± 10.62 years participated in the study. The severity of symptoms was significantly lower in the Nortriptyline group than in the Duloxetine group after three months (p = 0.031). The level of anxiety (p = 0.049), depression (p = 0.045) and quality of life (p = 0.046) improved significantly after three months in the Duloxetine group compared to Nortriptyline. Mediation analysis using linear regression revealed a significant mediator role for anxiety. This mediation analysis revealed a 21.13% reduction in anxiety in the Duloxetine group. While both medications demonstrated efficacy, Nortriptyline appeared to be superior in symptom reduction. Duloxetine exhibited more advantages compared to Nortriptyline in addressing anxiety and depression and enhancing the overall quality of life. Also, Duloxetine may have a noteworthy impact, contributing to a 20% reduction in FD symptoms by lowering anxiety levels. https://en.irct.ir/trial/65512.

Efficacy and safety of alpha-pinene capsule in the management of functional dyspepsia and eradication of helicobacter pylori: a randomized clinical trial.

Our objective was to assess the efficacy and safety of adding alpha-pinene (a herbal terpenoid) to quadruple therapy compared to a placebo in improving symptoms and Helicobacter pylori (H. pylori) eradication rates in Functional dyspepsia (FD) patients. FD is a prevalent upper gastrointestinal condition, and no definitive pharmacological treatment is available for its management. We conducted a randomized, double-blinded, placebo-controlled trial on FD patients diagnosed with H. pylori infection. We collected baseline demographic data and assessed FD symptoms in the participants. Patients were randomly allocated to receive either standard quadruple therapy with α-pinene capsules (0.25 mg/day) or quadruple therapy with a placebo for two weeks. We employed a validated questionnaire, the Short Form Leeds Dyspepsia Questionnaire (SF-LDQ), to evaluate FD symptoms. The eradication rate of H. pylori was compared between the two groups one month after completing the treatment regimens. Any reported adverse drug reactions (ADRs) were documented throughout the trial. Over four months, a total of 66 patients completed the trial. Notably, there were no significant differences in baseline SF-LDQ scores between the two groups (p=0.83); however, a significant divergence emerged at the trial's conclusion (p=0.03). The H. pylori eradication rates did not show notable differences between the two treatment arms (p=0.43). Importantly, there were no dropouts from the trial due to ADRs. Among reported ADRs, participants experienced abdominal pain, headache, diarrhea, and a metallic taste, with no significant variance in incidence rates observed between the two groups (p=0.62). These findings suggest that α-pinene could be an effective and safe agent for reducing FD symptoms.

Relative Frequency of Gastrointestinal Functional Disorders in Patients with Inflammatory Bowel Disease Based on Rome IV: A Case-Control Study.

Inflammatory bowel disease (IBD) is a digestive system ailment that causes significant bodily disruption. This problem may coexist with other digestive system illnesses. One of the diseases that reduces the quality of life and other disorders is functional dyspepsia (FD), the diagnosis of which is associated with unique limitations. In this study, we aim to investigate the relative frequency of FD in IBD patients and compare it with a healthy control group. In a case-control study, we selected a group of IBD patients and healthy controls, and all participants were prepared for a diagnosis of FD symptoms using ROME IV criteria. Data were analyzed and compared using Chi-square and t-test, and P ≤ 0.05 was considered significant. There were 100 IBD patients, including 91 with ulcerative colitis and 9 with Crohn's disease (mean age, 41.37 ± 13; 39 males, 61 females). Furthermore, 100 healthy control subjects (mean age, 44.23 ± 14; 38 males, 62 females) were analyzed. 10% of IBD patients met the criteria of FD, which was comparable with the controls (5, 5%) (P > 0.05). Some of the symptoms of irritable bowel syndrome (IBS) including abdominal pain (P = 0.01) and bowel movement (P = 0.02) were significantly higher in IBD patients than in non-IBD subjects. The symptoms of FD were not significantly greater in IBD patients compared to the control group, while IBS symptoms were significantly higher in IBD individuals, indicating a possible overlap of Rome IV IBS and FD.

Hyperprolactinemia in Functional Dyspepsia: The Entangled Domperidone Link.

The commonest medications prescribed in functional dyspepsia are prokinetic agents, specifically domperidone. However, its administration at times elevates serum prolactin levels, which can lead to pathological hyperprolactinemia. The present study investigated the effect of 28 days of 30 mg domperidone therapy on prolactinemia in functional dyspepsia patients. We recruited 97 patients (60 men and 37 women, aged18-80 years) who had functional dyspepsia diagnosed as per the Rome IV criteria. After taking a preliminary clinical history, we measured and compared serum prolactin levels at day 'zero' and day 'twenty-eight'. We found increased prolactin levels from day '0' to day '28' after treatment with domperidone in functional dyspepsia patients, specifically in male participants aged less than 40 years, who are married and belong to middle socioeconomic status. The most common functional dyspepsia symptom found was pain in the epigastric region. To conclude, our pragmatic domperidone-induced-hyperprolactinemia link warrants this side effect to be robustly taken into account while treating functional dyspepsia patients with domperidone.

The Effect of STW5 (Iberogast) on Reflux Symptoms in Patients With Concurrent Dyspeptic Symptoms: A Double-blind Randomized Placebo-controlled Crossover Trial.

It has been suggested that STW5 (Iberogast) reduces heartburn symptoms in patients with functional dyspepsia, but underlying mechanisms of action are unclear. The aim of this study is to investigate whether STW5 affects esophageal sensitivity or esophageal motility, thereby reducing occurrence and perception of reflux events. We performed a double-blind, randomized, placebo-controlled, crossover trial in patients with functional dyspepsia (Rome IV) and reflux symptoms. After 4 weeks of treatment with either placebo or STW5, patients were studied with an esophageal acid perfusion test and ambulatory 24-hour pH-impedance monitoring. A total of 18 patients (7 men, median age 54, range [19-76]), were included in the study. Although we found no statistical difference in our primary outcome the total Reflux Disease Questionnaire score 2.33 (0.25-4.33) vs 2.67 (1.17-4.00), P = 0.347, "gastroesophageal reflux disease" and "regurgitation" subscale scores were lower after STW5 treatment compared to placebo (P = 0.049 and P = 0.007). There was no statistical difference in number of reflux events, acid exposure time and acid sensitivity scores between STW5 and placebo. In a subgroup analysis of patients with pH-metry confirmed gastroesophageal reflux disease, treatment with STW5 significantly reduced the total number of acidic reflux events (P = 0.028). Moreover, in patients with reflux esophagitis, the median lag time to acid perception increased after STW5 treatment (P = 0.042). We found some indications pointing towards a beneficial effect of STW5 on reflux symptoms in dyspeptic patients, with reduction of esophageal hypersensitivity as a potential underlying mechanism. Our findings will have to be confirmed in larger studies.

Associations among the Duodenal Ecosystem, Gut Microbiota, and Nutrient Intake in Functional Dyspepsia.

: Functional dyspepsia (FD) has long been regarded as a syndrome because its pathophysiology is multifactorial. However, recent reports have provided evidence that changes in the duodenal ecosystem may be the key. This study aimed to identify several gastrointestinal factors and biomarkers associated with FD, specifically changes in the duodenal ecosystem that may be key to understanding its pathophysiology. : In this case-control study, 28 participants (12 with FD and 16 healthy control individuals) were assessed for dietary nutrients, gastrointestinal symptom severity, immunological status of the duodenal mucosa, and microbiome composition from oral, duodenal, and fecal samples. Integrated data were analyzed using immunohistochemistry, real-time polymerase chain reaction, 16S rRNA sequencing, and network analysis. : Duodenal mucosal inflammation and impaired expression of tight junction proteins were confirmed in patients with FD. The relative abundance of duodenal Streptococcus (p=0.014) and reductions in stool Butyricicoccus (p=0.047) were confirmed. These changes in the gut microbiota were both correlated with symptom severity. Changes in dietary micronutrients, such as higher intake of valine, were associated with improved intestinal barrier function and microbiota. : This study emphasizes the relationships among dietary nutrition, oral and gut microbiota, symptoms of FD, impaired function of the duodenal barrier, and inflammation. Assessing low-grade inflammation or increased permeability in the duodenal mucosa, along with changes in the abundance of stool Butyricicoccus, is anticipated to serve as effective biomarkers for enhancing the objectivity of FD diagnosis and monitoring.

Electrogastrography in patients with gastric motility disorders.

Electrogastrography (EGG) is a novel diagnostic modality for assessing the gastrointestinal tract (GI) that generates spontaneous electrical activity and monitors gastric motility. The aim of this study was to compare patients with functional dyspepsia (FD) and diabetic gastroparesis (D-GP) with healthy controls (CT) to use established findings on abnormalities of gastric motility based on EGG characteristics. In this study, 50 patients with FD, 50 D-GP patients, and 50 CT subjects were studied to compare EGG with discrete wavelet transform models (DWT) to extract signal characteristics using a variety of different qualitative and quantitative metrics from pre-prandial and postprandial states. As a result, higher statistically significant (p < 0.05*) were found in the DWT models based on power spectral density (PSD) analysis in both states. We also present that the correlations between EGG metrics and the presence of FD, D-GP, and CT symptoms were inconsistent. This paper represents that EGG assessments of FD and D-GP patients differ from healthy controls in terms of abnormalities of gastric motility. Additionally, we demonstrate that diverse datasets showed adequate gastric motility responses to a meal. We anticipate that our method will provide a comprehensive understanding of gastric motility disorders for better treatment and monitoring in both clinical and research settings. In conclusion, we present potential future opportunities for precise gastrointestinal electrophysiological disorders.

OGBN P44 Does laparoscopic fundoplication have a role in non-erosive reflux disease?

Abstract Background Non-erosive reflux disease (NERD) is a sub-group of gastro-oesophageal reflux disease (GORD) characterised by reflux related symptoms without endoscopic evidence of oesophageal mucosal erosion. Management can be challenging as the prevalence of functional dyspepsia and IBS-related symptoms is often high. This study was undertaken to examine symptom control after laparoscopic fundoplication in patients with NERD compared to those with oesophagitis associated GORD. Methods Patients who underwent laparoscopic fundoplication for NERD or GORD with oesophagitis between January 2017 and January 2022 were included in this study. Patients were asked to score their current symptoms using the modified DeMeester Clinical Symptom Score (CSS) and Gastrointestinal Symptom Rating Scale (GSRS), and then rate their satisfaction with the procedure. Results 14 patients who underwent surgery for NERD and 31 with oesophagitis associated GORD were included in this study, with a mean follow up of 3.4 years and 2.7 years respectively after surgery. 86% of NERD patients and 94% of oesophagitis patients reported an improvement in symptoms after surgery. There was a trend for higher symptom scores in NERD patients (NERD patients CSS 4.57±1.95, oesophagitis patients CSS 3.45±1.79, p=0.065; NERD patients GSRS 1.99±0.37, oesophagitis patients GSRS 1.72±0.49, p=0.069). NERD patients with higher pre-operative DeMeester scores from pH testing had lower GSRS scores (r=-0.616, p=0.043). Conclusions With careful patient selection and detailed pre-operative counselling, surgery can play a role in the management of NERD patients. Whilst post-operative symptom control may not be as good as that achieved with classical oesophagitis associated GORD, these findings suggest that NERD patients do achieve symptom improvement after laparoscopic fundoplication. Further research is needed to help identify other factors that predict response to surgery in NERD to optimise patient selection and improve shared decision making.

Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trial

Functional dyspepsia is a form of dyspepsia lacking in clear causes following clinical assessment. Dyspepsia is characterized by episodic or persistent abdominal pain or discomfort of the upper gastrointestinal (GI) tract. Its onset has been linked with a deficiency or dysfunction of digestive enzymes. Thus, consumption of digestive multi-enzymatic preparations may be effectively used for the reduction of symptoms. The aim of this study is to assess the effectiveness and tolerability of the supplementation of a normal diet with a multi-enzyme blend obtained from fungal fermentation, in a randomized, placebo-controlled, double-blind, clinical trial. Enrolled subjects (n = 120, male: 63, female: 57), aged 18–59 years, were randomized (allocation ratio 1:1) to receive either 2 capsules per day of the food supplement (containing 200 mg of the multi-enzyme blend/capsule) or placebo, for 2 months. The primary outcome of the study (i.e., improvements in quality of life) was evaluated by the Nepean Dyspepsia Index-SF (NDI-SF) questionnaire, while the secondary outcomes (i.e., severity of pain and the quality of sleep) were assessed through the Visual Analogue Scale (VAS) and Pittsburgh Sleep Quality Index (PSQI) questionnaire. The results showed an improvement in NDI-SF1, NDI-SF2–5, VAS, and PSQI scores in subjects treated with the multi-enzyme blend, indicating an improvement in quality of life and of sleep, and a decreased severity of pain, following the supplementation with digestive enzymes, without side effects. In conclusion, treatment with digestive enzymes was found to be effective in the reduction of functional dyspepsia symptoms and in the improvement of sleep quality, and is well-tolerated.

Understanding functional dyspepsia and its subtypes and the role of prokinetics in its management: a cross-sectional clinician-based survey

Background: This survey evaluated opinions of consulting physicians or gastroenterologists on functional dyspepsia (FD) in the Indian population and the management of FD with prokinetics, especially itopride. Methods: A total of 243 clinicians involved in the clinical practice of FD were invited to complete an internet-based, structured survey questionnaire. Questionnaire comprised 29 questions on the diagnosis and treatment options for FD. Results: Majority of the clinicians opined that females were more affected by FD than males in both hospital-based (53.4%) and community-based (56.6%) practices. As per 33.3% of clinicians each, the age group of 21-40 years and 41-60 years were the two most commonly affected groups. FD symptoms were present for &gt;6 months before patients seek consultation as reported by 62.6% of the clinicians. The participating clinicians preferred using detailed patient history (77.7%) and ROME IV criteria (71.1%) for diagnosing FD. Prokinetics were regarded as the therapy of choice primarily because of their efficacy in reducing FD symptoms. Among all prokinetics used, itopride was most preferred for postprandial distress syndrome (64.2% clinicians) and for epigastric pain syndrome in combination with PPIs (66.7% clinicians). Itopride was reported by 93.6% clinicians to be well tolerated, with the leading advantage being absence of extrapyramidal or cardiac side effects according to 40% of clinicians. Conclusions: The clinicians considered itopride to be most preferred to reduce FD symptoms and to be well-tolerated when taken alone or in combination with PPIs.

Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study.

Vagal nerve stimulation (VNS) can be used to modulate gastrointestinal motility, inflammation, and nociception. However, it remains unclear whether VNS is effective in adult patients with functional dyspepsia (FD). We investigated the effectiveness of transcutaneous auricular VNS (taVNS) in patients with FD. Consecutive patients with FD meeting Rome IV criteria with modified FD Symptom Diary score ≥10 were enrolled. Patients were randomly allocated to 10-Hz taVNS (V10 group), 25-Hz taVNS (V25 group), or sham group, with 30 minutes of treatment twice a day for 4 weeks. The primary outcome was the response rate at week 4, defined as the proportion of patients whose modified FD Symptom Diary score was reduced ≥5 when compared with the baseline. Secondary outcomes included adequate relief rate and adverse events. A total of 300 patients were randomized to V10 (n = 101), V25 (n = 99), and sham groups (n = 100). After 4 weeks of treatment, V10 and V25 groups had a higher response rate (81.2% vs 75.9% vs 47%, both P < 0.001) and adequate relief rate (85.1% vs 80.8% vs 67%, both P < 0.05) compared with the sham group. There was no significant difference between V10 and V25 in response rate and adequate relief rate (both P > 0.05). The efficacy of taVNS (both 10 and 25 Hz) lasted at week 8 and week 12 during follow-up period. Adverse events were all mild and comparable among the 3 groups (1%-3%). Our study firstly showed that 4-week taVNS (both 10 and 25 Hz) was effective and safe for the treatment of adult FD ( clinicaltrials.gov number: NCT04668534).

The Effect of Ginger Supplementation on the Improvement of Dyspeptic Symptoms in Patients With Functional Dyspepsia.

Background Functional dyspepsia (FD) is a common gastrointestinal disorder with a higher occurrence in the Western world. Conventional medications are not effective for FD with patients turning to alternative herbal medicines such as ginger. This study aimed to evaluate the effect of ginger supplementation on the improvement of FD symptoms. Methodology A before-and-after clinical study was conducted at the University of Debrecen, Internal Medicine outpatient department over a period of four weeks. Two Swanson ginger supplements each at a dose of 540 mg/day before lunch and dinner were given to 51 FD patients. Wilcoxon signed-rank test was used to estimate the differences in FD symptoms after ginger supplementation and at the baseline. The p-value was determined to test the association between variables, with p-values <0.05 considered the cutoff for statistically significant association. Results In this study, after four weeks of ginger supplementation, we observed a significant change in most dyspepsia symptoms as follows: postprandial fullness (p = 0.033, 95% CI = 0.01-0.26), early satiety (p = 0.001, 95% CI = 0.10-0.37), epigastric pain (p = 0.000, 95% CI = 0.16-0.42), epigastric burning (p = 0.003, 95% CI = 0.10-0.45), and heartburn (p = 0.209, 95% CI = -0.04-0.20). Conclusions Based on our findings ginger can be considered as a promising alternative supplementary medicine for FD.

Psychometric Comparison of EQ-5D-Y, CHU-9D, and PedsQL 4.0 in Chinese Children and Adolescents With Functional Dyspepsia: A Multicenter Study

ObjectivesThis study aimed to assess and compare psychometric properties of the 3 health-related quality of life (HRQOL) instruments EQ-5D Youth version (EQ-5D-Y), Child Health Utility 9D (CHU-9D), and Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) in children and adolescents with functional dyspepsia (FD) in China. MethodsA consecutive sample of FD outpatients were recruited from 6 tertiary medical centers in Hangzhou. The patients self-completed the 3 instruments in random order. Their feasibility, acceptability, construct validity (convergent, divergent, and known-group validity), and sensitivity were assessed. Multiple linear regression was used for identifying HRQOL-associated factors. ResultsA total of 1100 patients (mean age, 9.2 years; girl, 56.8%) completed the survey with no missing responses. Ceiling effect was quite higher in EQ-5D-Y (60.9%) than CHU-9D (33.8%) and PedsQL 4.0 (1.0%). The EQ-5D-Y and CHU-9D utility scores and PedsQL 4.0 total score were highly correlated (|r| = 0.593-0.661), except for the EuroQol visual analog scale score (EQ-VAS). The intraclass correlation coefficient between the 2 utility scores was fair (0.542). Most conceptually similar dimensions among the 3 instruments showed moderate to high correlations (|r| > 0.3) as hypothesized. The difference was statistically significant for the 2 utility scores and PedsQL 4.0 total score in varied severity groups (P < .001), and PedsQL 4.0 total score had higher relative efficiency and effect size values. The child’s age, severity of FD symptoms, and their guardian’s education had significant impact on HRQOL (P < .001). ConclusionsEQ-5D-Y, CHU-9D, and PedsQL 4.0 demonstrated acceptable psychometric properties in Chinese children with FD. PedsQL 4.0 showed superior sensitivity and is recommended. EQ-5D-Y and CHU-9D utility scores were not interchangeable. The measurement properties of EQ-VAS need to be further explored.

Brief cognitive-behavioral treatment for avoidant/restrictive food intake disorder in the context of functional dyspepsia: Study protocol for a feasibility randomized controlled trial

BackgroundAvoidant/restrictive food intake disorder (ARFID) symptoms are common (up to 40%) among adults with functional dyspepsia (FD), a disorder of gut-brain interaction characterized by early satiation, post-prandial fullness, epigastric pain, and/or epigastric burning. Using an 8-session exposure-based cognitive-behavioral treatment (CBT) for adults with FD + ARFID compared to usual care (UC) alone, we aim to: (1) determine feasibility, (2) evaluate change in clinical outcomes in, and (3) explore possible mechanisms of action. MethodsWe will randomize adults with FD who meet criteria for ARFID with ≥5% weight loss (N = 50) in a 1:1 ratio to CBT (with continued UC) or to UC alone. A priori primary benchmarks will be: ≥75% eligible participants enroll; ≥75% participants complete assessments; ≥70% participants attend 6/8 sessions; ≥70% of sessions have all content delivered; ≥70% participants rate Client Satisfaction Questionnaire scores above scale midpoint. We will also examine the size of changes in FD symptom severity and related quality of life within and between groups, and explore possible mechanisms of action. ConclusionsFindings from this trial will inform next steps with treatment development or evaluation—either for further refinement or for next-step efficacy testing with a fully-powered clinical trial.