Article

Symptom Overlap Between Postprandial Distress and Epigastric Pain Syndromes of the Rome III Dyspepsia Classification

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Abstract

Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.

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... PDS patients usually complaint of postprandial fullness and early satiation, while those with EPS mainly report epigastric pain and burning 3 . It is acknowledged that PDS are more common amongst Asian FD patients 4 , but it is uncertain that whether separate treatment for PDS and EPS patients are needed 5 . ...
... 3 It is acknowledged that PDS are more common amongst Asian FD patients, 4 but it is uncertain that whether separate treatment for PDS and EPS patients are needed. 5 FD is one of the most common gastrointestinal disorders encountered in clinical practice, with a prevalence of 8% in the Hong Kong population. 6 About 50% of patients remain to be symptomatic over 5 years since consultation, 7 hence incurring significant treatment cost and loss of productivity. ...
... 33 Other studies found a higher prevalence of altered gastric accommodation and increased duodenal eosinophils in epigastric pain syndrome. 34 Epidemiologic studies confirmed the defined presence of both groups, but the separation was not always clear, due to the great overlapping between them, in the Mexican population, as well. 26,35 More recent studies have shown that the subgroups can be reclassified and the overlap between them reduced, when symptom induction through food consumption is recognized. ...
... In clinical practice, it may not only be artificial, but also impossible, to exclude symptoms such as heartburn, acid regurgitation, vomiting, or the complaints that disappear upon evaluating the clinical criteria of functional dyspepsia. 34 One out of every 4 patients with functional dyspepsia shows gastric emptying delay and 86% of the patients with gastroparesis meet the clinical criteria for functional dyspepsia. 12 The line that separates functional dyspepsia from gastroparesis is not clearly defined, due to the poor correlation between gastric emptying delay and the pattern and severity of symptoms, as well as to the lack of emptying delay stability over time. ...
Article
Full-text available
Since the publication of the 2007 dyspepsia guidelines of the Asociación Mexicana de Gastroenterología, there have been significant advances in the knowledge of this disease. A systematic search of the literature in PubMed (01/2007 to 06/2016) was carried out to review and update the 2007 guidelines and to provide new evidence-based recommendations. All high-quality articles in Spanish and English were included. Statements were formulated and voted upon using the Delphi method. The level of evidence and strength of recommendation of each statement were established according to the GRADE system. Thirty-one statements were formulated, voted upon, and graded. New definition, classification, epidemiology, and pathophysiology data were provided and include the following information: Endoscopy should be carried out in cases of uninvestigated dyspepsia when there are alarm symptoms or no response to treatment. Gastric and duodenal biopsies can confirm Helicobacter pylori infection and rule out celiac disease, respectively. Establishing a strong doctor-patient relationship, as well as dietary and lifestyle changes, are useful initial measures. H2-blockers, proton-pump inhibitors, prokinetics, and antidepressants are effective pharmacologic therapies. H. pylori eradication may be effective in a subgroup of patients. There is no evidence that complementary and alternative therapies are beneficial, with the exception of Iberogast and rikkunshito, nor is there evidence on the usefulness of prebiotics, probiotics, or psychologic therapies. The new consensus statements on dyspepsia provide guidelines based on up-to-date evidence. A discussion, level of evidence, and strength of recommendation are presented for each statement.
... FD was categorized as postprandial distress syndrome, epigastric pain syndrome, or mixed subtype based on the Rome III criteria. 32,33 Postprandial distress syndrome was defined as the presence of meal-induced dyspeptic symptoms such as postprandial fullness and early satiation. Epigastric pain syndrome was diagnosed based on the presence of epigastric pain or burning sensations. ...
... Epigastric pain syndrome was diagnosed based on the presence of epigastric pain or burning sensations. 32,33 IBS was defined by recurrent abdominal pain or discomfort with at least 2 of the following characteristics: relief with defecation, onset associated with a change in frequency of stool, and onset associated with a change in form (appearance) of stool. 34 IBS was subclassified into IBS with constipation, IBS with diarrhea, mixed IBS, or unsubtyped IBS, as described previously. ...
Article
Background/aims: Overlap functional gastrointestinal disorder (FGID) is associated with more severe gastrointestinal symptoms and lower quality of life. The aim of this study is to evaluate clinical features of non-erosive reflux disease (NERD), functional dyspepsia, irritable bowel syndrome, their overlap in terms of sex and gender, and to assess the risk factors, including genetic polymorphisms. Methods: A total of 494 FGIDs and 239 controls were prospectively enrolled between 2004 and 2020. FGIDs were diagnosed based on the Rome III criteria and symptoms were evaluated using a questionnaire. Follow-up questionnaires were conducted to determine the change of symptoms during the 75.8-month mean observation period. Risk factors including genetic polymorphisms in neurotransmitter receptor (SLC6A4 5-HTTLPR, GNB3, ADRA2A, CCKAR, and TRPV1) and cytokine (TNFA and IL10) genes. Results: NERD was more prevalent in men, and functional dyspepsia in women. Overlap FGIDs (n = 239) were more prevalent than nonoverlap FGIDs (n = 255) in women (P = 0.019). Anxiety and depression scores were higher in the overlaps (P = 0.012 and P < 0.001, respectively). Symptoms were more frequent and severe in the overlap FGIDs than in the non-overlaps (P < 0.001). During followup, symptoms progressed more frequently in the overlap FGIDs, especially in patients with the L/S genotype of SLC6A4 5-HTTLPR and anxiety/depression. Conclusions: Overlap FGID patients need attention given their association with anxiety/depression and more severe symptoms, especially in women. Genetic polymorphisms also may be associated with certain symptoms of overlap FGIDs.
... In particular, many individuals with functional dyspepsia also report being troubled by heartburn and regurgitation. 9 Sleep disturbances have been described in patients with functional dyspepsia, 10 but the relationship between sleep disturbances and the presence of reflux symptoms remains to be explored in this population. ...
... 23 We have recently shown that, in a primary care population of patients who have functional dyspepsia with no evidence of GERD on endoscopy and pH monitoring, heartburn and regurgitation are frequent complaints. 9 In the current analysis, we show that heartburn and regurgitation in the functional dyspepsia population are related to adverse effects on sleep, with increased symptom frequency and severity paralleling an increased frequency of sleep disturbances. There is little information in the literature about the impact of heartburn and regurgitation on sleep in patients with functional dyspepsia; however, indirect evidence from a recent study supports our findings, showing that sleep disturbances were more common in Japanese patients with functional dyspepsia than in healthy controls. ...
Article
Background: Reflux symptoms (heartburn and regurgitation) are common in patients with functional dyspepsia who do not have gastroesophageal reflux disease (GERD). Objective: The purpose of this study was to assess the relationship of reflux symptoms with sleep disturbances in patients with functional dyspepsia without GERD and in those with GERD. Methods: This post-hoc analysis of data from the Diamond study (NCT00291746) included patients with frequent upper gastrointestinal symptoms, of whom 137 had functional dyspepsia and 193 had GERD (diagnosed by endoscopy and pH monitoring). Patients completed symptom questionnaires and were interviewed by physicians. Results: During the seven nights before study entry, 46.0% of patients with functional dyspepsia and 64.8% of those with GERD reported sleep disturbances (any frequency) related to reflux symptoms. Frequent (often/every night) sleep disturbances were experienced by 12.4% of patients with functional dyspepsia and 24.9% of those with GERD (p = 0.005). Among patients with functional dyspepsia, the prevalence of sleep disturbances was highest in those whose heartburn and/or regurgitation were moderate to severe (vs mild/very mild) and frequent (4-7 vs 1-3 days/week). Conclusions: Sleep disturbances due to reflux symptoms are common in patients with functional dyspepsia who do not have GERD, and become more frequent with increasing reflux symptom severity and frequency.
... In future studies, a less in- tensive treatment frequency in acupuncture will be considered, to make the acupuncture protocol easier to generalize. Fourthly, PDS and EPS overlap in most of clinical symptoms of FD, 35 so we may include patients with both PDS and EPS. We recruited pa- tients with symptoms of early satiety, postprandial fullness, and bloating, which are the clinical manifestations that mainly affects patients with PDS. ...
... We recruited pa- tients with symptoms of early satiety, postprandial fullness, and bloating, which are the clinical manifestations that mainly affects patients with PDS. 35 A recent study indicates that biomarkers may be useful for differentiating PDS and EPS in addition to the clinical manifestations, 36 showing a solution to this problem in future trial design. ...
Article
Background: To test the efficacy of electroacupuncture for patients with refractory functional dyspepsia (FD). Methods: A 24-week, 2-arm, single-blind, randomized controlled trial was conducted at three hospitals in China. Patients with refractory FD were randomly assigned to receive 20 sessions of authentic or sham electroacupuncture in a treatment duration of 4 weeks. The primary outcome was complete absence of dyspeptic symptoms at 16 weeks after initiation of acupuncture (week 16). The secondary outcomes included adequate relief of dyspeptic symptoms, Leeds Dyspepsia Questionnaire (LDQ), Nepean Dyspepsia Index (NDI), and adverse events. Intention-to-treat analysis was performed. Key results: Two hundred patients were included, of which 196 (98%) completed follow-up data at week 24. At week 16, 17 (17%) patients in the authentic electroacupuncture group vs 6 (6%) patients in the sham group achieved the primary outcome (P = .014). Sixty-two (62%) patients had adequate relief in the authentic electroacupuncture group, as compared to 22 (22%) in the sham group (P = .001). The scores of LDQ and NDI were significantly improved in both groups at week 16, and patients in the authentic electroacupuncture group have more improvements (LDQ, mean difference, -2.2, 95% confidence interval, -2.3 to -2.1, P < .001; NDI, -7.3, -10.5 to -4.2, P < .001). Results were similar for all the outcomes assessed at week 24. No serious adverse events were reported in both groups. Conclusion: Acupuncture efficaciously improves dyspeptic symptoms in patients with refractory FD.
... 3,5 Although current Rome III criteria classify FD into EPS and PDS, most patients with FD in our study had EPS-PDS overlap rather than any pure sub-type. This is in accordance with several earlier studies such as those from Italy, Sweden, and Japan, [19][20][21] but in contrast to studies from China, Taiwan, Nigeria, Europe, and Canada. [21][22][23] In population surveys from different countries, overlap between PDS and EPS varied between 5.6% and 62.3%. ...
... This is in accordance with several earlier studies such as those from Italy, Sweden, and Japan, [19][20][21] but in contrast to studies from China, Taiwan, Nigeria, Europe, and Canada. [21][22][23] In population surveys from different countries, overlap between PDS and EPS varied between 5.6% and 62.3%. 24 Such high frequency of overlap has clinical implication in respect to diagnosis and treatment of this disorder. ...
Article
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Background: Background and Aim: As best estimates on functional gastrointestinal disorders (FGIDs) prevalence are expected from community studies, which are scanty from Asia, we evaluated the prevalence and risk factors of FGIDs in a rural Indian community. Methods: House-to-house survey was undertaken by trained interviewers using translated- validated Rome III and hospital anxiety and depression questionnaires. Result: Among 3426 subjects ≥ 18 years old from 3 villages in Uttar Pradesh, 84% participated, of whom 80% were finally analyzed. Of these 2774 subjects (age 38.4 ± 16.5 years, 1573 [56.7%] male), 2654 [95.7%] were vegetarian and 120 [4.3%] non-vegetarian. Socio- economic classes were upper (16.7%), upper middle (15.1%), lower middle (22%), upper lower (22.2%), and lower (24%) using Prasad’s Classification; 603 (21.7%) had FGIDs (413 [14.9%] dyspepsia, 75 [2.7%] irritable bowel syndrome (IBS) and 115 [4.1%] dyspepsia-IBS overlap), by Rome III criteria. In subjects with dyspepsia, 49/528 (9%) had epigastric pain, 141 (27%) postprandial distress syndromes (EPS, PDS) and 338 (64%) EPS-PDS overlap. IBS was more often diarrhea than constipation-predominant sub- type. On univariate analysis, chewing tobacco, aerated drink, tea/coffee, disturbed sleep, vegetarianism, and anxiety parameters and presence of dyspepsia predicting occurrence of IBS were associated with FGIDs. On multivariate analysis, chewing tobacco, aerated soft drink, tea/coffee, vegetarianism, anxiety parameters, and presence of dyspepsia predicting IBS were significant. Conclusion: Functional gastrointestinal disorders, particularly dyspepsia-IBS overlap, are common in rural Indian population; the risk factors included chewing tobacco, aerated soft drink, tea/coffee, vegetarian diet, disturbed sleep, anxiety, and dyspepsia predicting occur- rence of IBS.
... The Rome definitions have been developed to better differentiate between patients with gastro-esophageal reflux disease or with functional dyspepsia for inclusion in studies. There is however considerable overlap in symptom presentation in these patients, making the Rome definitions less suitable for everyday clinical practice [11,12]. Another, more suitable definition for clinical practice, is that of the American College of Gastroenterology (ACG) and the Canadian Association of Gastroenterology (CAG) defining dyspepsia as the presence of predominant epigastric pain lasting one month, which can be associated with upper GI symptoms such as epigastric fullness, nausea, vomiting or heartburn [1]. ...
... They were developed to better differentiate gastro-esophageal reflux disease from functional dyspepsia in order to perform prospective studies with well-defined populations. The Rome criteria can however not always be used in clinical practice as there is substantial overlap in symptom presentation [11,12]. We believe that by including patients meeting a clinical definition of dyspepsia the results of this study are better applicable to clinical practice and could potentially help reduce overuse of upper GI endoscopy. ...
Article
Full-text available
Background and aims Upper gastrointestinal (GI) endoscopy is frequently performed in patients with upper abdominal symptoms. Although guidelines recommend withholding an endoscopy in the absence of alarm symptoms, dyspeptic symptoms remain a predominant indication for endoscopy. We aimed to investigate the yield of upper GI endoscopy in patients with low-risk dyspeptic symptoms. Methods We conducted an analysis in a prospectively maintained endoscopy reporting database. We collected the results of all upper GI endoscopy procedures between 2015 and 2019 that was performed in adult patients aged <60 years with dyspeptic symptoms. Patients with documented alarm symptoms were excluded. We categorized endoscopic findings into major and minor endoscopic findings. Results We identified 26,440 patients with dyspeptic symptoms who underwent upper GI endoscopy. A total of 13,978 patients were considered low-risk and included for analysis (median age 46 years, interquartile range (IQR) [36–53], 62% female). In 11,353 patients (81.2%), no endoscopic abnormalities were detected. Major endoscopic findings were seen in 513 patients (3.7%) and minor endoscopic findings in 2178 patients (15.6%). Endoscopic findings indicative of upper GI cancer were reported in 47 patients (0.3%), including 16 (0.1%) oesophageal, 28 (0.2%) gastric and 5 (0.04%) duodenal lesions. Despite an initial unremarkable endoscopy result, 1015 of 11,353 patients (8.9%) underwent a follow-up endoscopy after a median of 428 days [IQR 158–819]. This did not lead to the additional identification of malignancy. Conclusions The yield of upper GI endoscopy in low-risk (<60 years, no alarm symptoms) patients with dyspepsia is very limited. This study further supports a restrictive use of upper GI endoscopy in these patients.
... Por ejemplo, la infección por Helicobacter pylori, la soltería, los trastornos del sueño y la depresión se asociaron al síndrome de malestar (distress) posprandial 33 . Otros estudios encontraron una mayor prevalencia de acomodación gástrica alterada e incremento de eosinófilos duodenales en el síndrome de dolor epigástrico 34 . Los estudios epidemiológicos confirmaron la presencia definida de ambos grupos, pero la separación no siempre fue clara debido a la gran sobreposición entre ellos, inclusive en población mexicana 26,35 . ...
... La sobreposición de la dispepsia con estos padecimientos es evidente no solo por la frecuente coexistencia de síntomas en un mismo enfermo, sino por fenómenos fisiopatológicos compartidos (v.gr., estados postinfecciosos, inflamación de bajo grado o trastornos motores). En la práctica clínica, excluir síntomas como las pirosis, las regurgitaciones ácidas, el vómito o los malestares que desaparecen al evaluar los criterios clínicos de dispepsia funcional puede no solo ser artificial sino imposible 34 . Uno de cada 4 pacientes con dispepsia funcional muestra retraso en el vaciamiento gástrico y el 86% de los pacientes con gastroparesia cumplen con criterios clínicos de dispepsia funcional 12 . ...
Article
Full-text available
Since the publication of the 2007 dyspepsia guidelines of the Asociación Mexicana de Gastroenterología, there have been significant advances in the knowledge of this disease. A systematic search of the literature in PubMed (01/2007 to 06/2016) was carried out to review and update the 2007 guidelines and to provide new evidence-based recommendations. All high-quality articles in Spanish and English were included. Statements were formulated and voted upon using the Delphi method. The level of evidence and strength of recommendation of each statement were established according to the GRADE system. Thirty-one statements were formulated, voted upon, and graded. New definition, classification, epidemiology, and pathophysiology data were provided and include the following information: Endoscopy should be carried out in cases of uninvestigated dyspepsia when there are alarm symptoms or no response to treatment. Gastric and duodenal biopsies can confirm Helicobacter pylori infection and rule out celiac disease, respectively. Establishing a strong doctor-patient relationship, as well as dietary and lifestyle changes, are useful initial measures. H2-blockers, proton-pump inhibitors, prokinetics, and antidepressants are effective pharmacologic therapies. H.pylori eradication may be effective in a subgroup of patients. There is no evidence that complementary and alternative therapies are beneficial, with the exception of Iberogast and rikkunshito, nor is there evidence on the usefulness of prebiotics, probiotics, or psychologic therapies. The new consensus statements on dyspepsia provide guidelines based on up-to-date evidence. A discussion, level of evidence, and strength of recommendation are presented for each statement. Copyright © 2017 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved.
... 3 While different risk factors have been identified for each FD subtype, 14,15 overlap is seen in approximately 30-60% of cases. [16][17][18] Individuals' symptoms may also change over time. 19 Moreover, many patients with FD have concomitant IBS 20,21 or gastroesophageal reflux disease (GERD). ...
Article
Background: Functional dyspepsia (FD) is a common and debilitating gastrointestinal disorder attributed to altered gut-brain interactions. While the etiology of FD remains unknown, emerging research suggests the mechanisms are likely multifactorial and heterogenous among patient subgroups. Small bowel motor disturbances, visceral hypersensitivity, chronic microinflammation, and increased intestinal tract permeability have all been linked to the pathogenesis of FD. Recently, alterations to the gut microbiome have also been implicated to play an important role in the disease. Changes to the duodenal microbiota may either trigger or be a consequence of immune and neuronal disturbances observed in the disease, but the mechanisms of influence of small intestinal flora on gastrointestinal function and symptomatology are unknown. Purpose: This review summarizes and synthesizes the literature on the link between the microbiota, low-grade inflammatory changes in the duodenum and FD. This review is not intended to provide a complete overview of FD or the small intestinal microbiota, but instead outline some of the key conceptual advances in understanding the interactions between altered gastrointestinal bacterial communities; dietary factors; host immune activation; and stimulation of the gut-brain axes in patients with FD versus controls. Current and emerging treatment approaches such as dietary interventions and antibiotic or probiotic use that have demonstrated symptom benefits for patients are reviewed, and their role in modulating the host-microbiota is discussed. Finally, suggested opportunities for diagnostic and therapeutic improvements for patients with this condition are presented.
... FD was defined to the according to the Rome Ⅲ criteria [15,16] . FD patients were categorized into PDS, EPS and mixed subgroups on the basis of the Rome Ⅲ criteria [18] . Individuals without GI symptoms and any endoscopic lesion were assigned to the controls. ...
Article
Full-text available
AIM to evaluate gender differences in the aspect of ghrelin, nociception-related genes and psychological aspects and the quality of life (QoL) in Korean functional dyspepsia (FD) patients. METHODS Total of 191 persons were prospectively enrolled between March 2013 and May 2016 in Seoul National Bundang Hospital, and classified into control and FD group based on ROME III criteria. Questionnaire included assessment for dyspepsia symptoms, QoL and anxiety or depression. Preproghrelin and nociception genes in the gastric mucosa and plasma acyl/des-acyl ghrelin were measured. RESULTS Lower level of plasma acyl ghrelin in FD patients compared to control was significant only in male (15.9 fmol/mL vs 10.4 fmol/mL, P = 0.017). Significantly higher mRNA expressions of nerve growth factor and transient receptor potential vanilloid receptor 1 were observed in male (P = 0.002 and P = 0.014, respectively) than in female. In contrast, female FD patients had a higher anxiety and depression score than male FD (P = 0.029), and anxiety score was correlated with epigastric pain only in female FD patients (female: Spearman rho = 0.420, P = 0.037). The impairment of overall QoL was more prominent in female FD patients than male patients (5.4 ± 0.3 vs 6.5 ± 0.3, P = 0.020). CONCLUSION Gender differences of ghrelin and nociception-related genes in male and psychological factors in female underlie FD symptoms. More careful assessment of psychological or emotional status is required particularly for the female FD patients.
... Th ese defi nitions have attempted to minimize the inclusion of gastro-esophageal refl ux disease in those with dyspepsia by excluding patients with heartburn and acid regurgitation ( 15 ). Rome defi nitions have been helpful in better-standardizing patients that are included in studies of dyspepsia but are less relevant to clinical practice as there is considerable overlap in symptom presentation ( 16 ) making classifi cation diffi cult in many patients presenting in primary and secondary care. For this reason, we have used a clinically relevant defi nition of dyspepsia as predominant epigastric pain ...
Article
Full-text available
We have updated both the American College of Gastroenterology (ACG) and the Canadian Association of Gastroenterology (CAG) guidelines on dyspepsia in a joint ACG/CAG dyspepsia guideline. We suggest that patients ≥60 years of age presenting with dyspepsia are investigated with upper gastrointestinal endoscopy to exclude organic pathology. This is a conditional recommendation and patients at higher risk of malignancy (such as spending their childhood in a high risk gastric cancer country or having a positive family history) could be offered an endoscopy at a younger age. Alarm features should not automatically precipitate endoscopy in younger patients but this should be considered on a case-by-case basis. We recommend patients <60 years of age have a non-invasive test Helicobacter pylori and treatment if positive. Those that are negative or do not respond to this approach should be given a trial of proton pump inhibitor (PPI) therapy. If these are ineffective tricyclic antidepressants (TCA) or prokinetic therapies can be tried. Patients that have an endoscopy where no pathology is found are defined as having functional dyspepsia (FD). H. pylori eradication should be offered in these patients if they are infected. We recommend PPI, TCA and prokinetic therapy (in that order) in those that fail therapy or are H. pylori negative. We do not recommend routine upper gastrointestinal (GI) motility testing but it may be useful in selected patients.Am J Gastroenterol advance online publication, 20 June 2017; doi:10.1038/ajg.2017.154.
... p < 0.05) (16). Another study in the United States reported a similar distribution of FD subtypes between the groups of patients with FD-only and GERD-FD overlap groups (17). Other risk factors and pathological mechanisms contribute to this difference. ...
Article
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AimTo assess (1) the overlap rate of gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) and (2) the yield of esophagogastroduodenoscopy in patients clinically presenting with FD.Materials and Methods Outpatients aged ≥18 years with typical reflux symptoms ≥2 times a week or clinically fulfilling the Rome IV criteria for FD were recruited and underwent esophagogastroduodenoscopy. GERD was classified into non-erosive reflux disease (NERD) and erosive reflux disease (ERD), and FD was classified into epigastric pain syndrome and postprandial distress syndrome. The endoscopic findings that could explain patients’ symptoms were considered clinically significant endoscopic findings. After esophagogastroduodenoscopy, patients were categorized into three groups: GERD-only, FD-only, and GERD-FD overlap.ResultsThere were 439 patients with a mean age of 42.3 ± 11.6 years. Ninety-one (20.7%) patients had clinically significant endoscopic findings: 73 (16.6%) reflux esophagitis, 6 (1.4%) Barrett’s esophagus and 14 (3.2%) gastroduodenal ulcers. After excluding gastroduodenal ulcers, the numbers of patients with GERD-only, FD-only, and GERD-FD overlap were 69 (16.2%), 138 (32.5%), and 218 (51.3%), respectively. Postprandial distress syndrome was more prevalent in GERD-FD overlap than in FD-only (72.9 vs. 44.2%, p < 0.001). The rates of gastroduodenal ulcers in patients clinically fulfilling the criteria for FD with and without reflux symptoms were 0.6 and 4.7%, respectively (p = 0.027).Conclusion The GERD-FD overlap was more common than each disorder alone, of which postprandial distress syndrome was significantly prominent. Organic dyspepsia was uncommon in patients clinically fulfilling the Rome IV criteria for FD.
... 8 Many patients with FD present with overlapping symptoms of PDS and EPS although in population-based studies PDS and EPS separate out more clearly. 18,19 1. Meal testing Meal induced symptoms are an important and increasingly recognized feature of FD. In a landmark study, a solid test meal was ingested by patients with FD who either self-reported they had meal induced symptoms such as fullness or bloating, or reported their symptoms were not meal induced. ...
Article
Full-text available
Functional dyspepsia (FD) is a common but under-recognized syndrome comprising bothersome recurrent postprandial fullness, early satiety, or epigastric pain/burning. Epidemiologically, there are two clinically distinct FD syndromes (although these often overlap clinically): postprandial distress syndrome (PDS; comprising early satiety or meal-related fullness) and epigastric pain syndrome. Symptoms of gastroesophageal reflux disease overlap with FD more than expected by chance; a subset has pathological acid reflux. The pre-test probability of FD in a patient who presents with classical FD symptoms and no alarm features is high, approximately 0.7. Coexistent heartburn should not lead to the exclusion of FD as a diagnosis. One of the most exciting observations in FD has been the consistent finding of increased duodenal eosinophilia, notably in PDS. Small bowel homing T cells, signaling intestinal inflammation, and increased cytokines have been detected in the circulation, and elevated tumor necrosis factor-α levels have been significantly correlated with increased anxiety. Postinfectious gastroenteritis is a risk factor for FD. Therapeutic options remain limited and provide only symptomatic benefit in most cases. Only one therapy is known to change the natural history of FD–Helicobacter pylori eradication. Treatment of duodenal eosinophilia is under investigation.
... Це, напевно, є найчастішою коморбідністю при даному захворюванні. Порушення моторики верхніх відділів травної системи і процесів акомодації шлунка, вісцеральна гіперчутливість створюють патофізіологічну основу для формування як синдрому шлункової диспепсії, так і ГЕРХ [24,25]. За даними дослідження, яке ми проводили на базі закладів ПМСД м. ...
Article
Ключовим фактором ризику ГЕРХ на сьогодні вважають ожиріння. Його визнано фактором ризику і есенціальної артеріальної гіпертензії (АГ), і цукрового діабету (ЦД), і первинного остеоартрозу, і ХОЗЛ.Матеріал і методи. У клініко-діагностичній гастроентерологічній лабораторії ВНМУ імені М. І. Пирогова проводили обстеження хворих на ожиріння та ГЕРХ з гіперлептинемією. За допомогою методики експрес-гастро-рН-індикації вивчали показники рН у двох групах: у хворих на ожиріння та ГЕРХ та у хворих на ГЕРХ з нормальною масою тіла. Спостерігали сталу тенденцію до більшої секреції HCl у хворих на ожиріння та ГЕРХ.У дослідженні, проведеному у хворих на ГЕРХ в поєднанні з АГ, ми намагались з’ясувати особливості порушень моторики нижнього стравохідного сфінктера при цих двох захворюваннях. Для цього проводили 3-годинний 3-канальний езофаго-гастро-рН-моніторинг. У хворих на ГЕРХ з АГ та без неї була однакова кількість кислотних та усіх рефлюксів, проте у хворих з супутньою АГ спостерігали більш тривалі найдовші рефлюкси, та загалом кислотна експозиція мала тенденцію до подовження (p>0,05).За даними дослідження, яке ми проводили на базі закладів ПМСД м. Вінниці і області у вигляді опортуністичного скринінгу анкет на першому етапі (1431 доросла особа) з подальшим інструментально-лабораторним дообстеженням, було з’ясовано, що 69,72 % хворих на ГЕРХ (343 особи) мали симптоми шлункової диспепсії. Проведення нелінійного регресійного аналізу впливу факторів ризику показало, що потужним чинником, який налаштовує на патологічний гастроезофагеальний рефлюкс, є ожиріння.Висновки. Поєднання ГЕРХ з шлунковими диспепсіями (в т.ч. ФД), гіпертензією, надлишковою масою тіла є поширеним і виявляється у 47,3 %, 45,45 % і 63,86 % обстежених відповідно. У випадку поєднання цих недуг мова йде про очевидну коморбідність. Надмірна маса тіла є основним фактором коморбідності ГЕРХ з артеріальною гіпертензією, спричиняючи більш інтенсивний рефлюкс, що відображається на збільшенні кислотної експозиції та схильності до тривалих рефлюксів. Додатковий вплив може мати схильність хворих на артеріальну гіпертензію до шлункової гіперацидності.
... Patients were divided into 3 FD subtypes based on their symptoms: PDS, EPS, and mixed. 31 Patients with peptic ulcer, reflux esophagitis, or typical IBS; concomitant systemic diseases such as diabetes mellitus or any malignancy; major depression, psychosis, or eating disorders; and daily users of NSAID or anticoagulants were excluded. Symptomatic subjects whose symptoms did not fulfill the Rome III criteria were also excluded. ...
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The etiological basis of functional dyspepsia (FD) is incompletely understood. The aim of this study was to evaluate the involvement of nociceptor-related genes and Helicobacter pylori (HP) in the pathogenesis of FD. The expression of nociceptor-related genes was measured in gastric cell lines that were co-cultured with HP. FD patients (n = 117) and controls (n = 55) were enrolled from a tertiary hospital gastroenterology clinic. Expression of the genes nerve growth factor (NGF), glial cell line-derived neurotrophic factor (GDNF), and transient receptor potential cation channel subfamily V member 1 (TRPV1) in the gastric mucosa were detected by reverse transcription polymerase chain reaction (RT-PCR), and immunohistochemical staining of TRPV1 was analyzed. These measurements were repeated after 1 year. TRPV1, GDNF, and NGF expression was elevated in gastric cell lines co-cultured with HP. TRPV1 immunostaining was stronger in HP-positive than HP-negative subjects. The FD group showed higher expression levels of TRPV1, GDNF, and NGF and increased TRPV1 immunostaining compared with those of the control group (all P < 0.05). Among 61 subjects who were followed up at 1 year, controls with successful HP eradication and patients whose symptoms had improved both showed significant reductions in the expression of TRPV1 and NGF (all P < 0.05) compared with controls without HP eradication and patients whose symptoms had not improved, respectively. The expression of NGF, GDNF, and TRPV1 may be associated with the pathogenesis of FD. Since HP infection may induce the increased expression of these genes, anti-HP therapy could be beneficial for HP-positive patients with FD.
... Acknowledging this, the Rome III classification of functional dyspepsia refined earlier definitions by introducing a distinction between postprandial distress and epigastric pain syndromes. A form of enquiry to identify the former has been proposed [15], but these two variants of functional dyspepsia often occur concurrently, prompting some to suggest that this classification is inherently unsatisfactory [16]. However, better identification of symptoms gained from more detailed enquiry may be helpful [17,18]. ...
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Objective The objective of this study was to develop a self-administered questionnaire for upper gastrointestinal (GI) symptoms using lay vocabulary uninfluenced by established medical terminology or concepts and to conduct a survey of symptom occurrence among sufferers in four countries. Methods The questionnaire was designed by integrating information gained from the vocabulary used by 38 upper GI symptom sufferers. There was no medical input to its development. The questionnaire was then used, after appropriate translation, in Brazil, Russia, the UK and the USA. Details of 10 659 symptom episodes were obtained from 2665 individuals. Results Nine symptoms described in lay vocabulary were identified during questionnaire development. Of these, one corresponded to regurgitation, whereas two that were distinguished by survey participants might both be interpreted as heartburn. One chest symptom for which a corresponding medical term was uncertain occurred in ∼30% of the respondents. Five different ‘stomach’ or abdominal symptoms were identified. The predominant symptom and the pattern of concurrent symptoms often varied from one symptom episode to another. Use of the terms ‘heartburn’, ‘reflux’, ‘indigestion’ and ‘burning stomach’ to describe symptoms varied between countries. Conclusion Some common upper GI symptoms described by those who suffer them have no clear counterpart in conventional medical terminology. Inadequacy of the conventional terminology in this respect deserves attention, first, to characterize it fully, and thereafter to construct enquiry that delivers more precise symptom identification. Our results suggest that improvement may require the use of vocabulary of individuals suffering the symptoms without imposing conformity with established symptom concepts.
... Identifier: NCT00291746). 1 The Diamond study was a single-blind, single-arm study conducted in north-western Europe and Canada. 1 The study enrolled 507 patients, of whom 308 were suitable for the full primary analysis 1 and 336 were evaluable for exploratory analyses. [5][6][7] Our post hoc histology analyses were based on 231 (69%) of the 336 patients included in exploratory analyses who had biopsies that were assessed by a single pathologist (MV) and that were deemed evaluable for total epithelial thickness with regard to orientation and depth of biopsy. ...
Article
Background: The diagnosis of gastro-oesophageal reflux disease (GERD) in clinical practice is limited by the sensitivity and specificity of symptoms and diagnostic testing. Aim: To determine if adding histology as a criterion and excluding patients with epigastric pain enhances the diagnosis for GERD. Methods: Patients with frequent upper gastrointestinal symptoms who had not taken a proton pump inhibitor in the previous 2 months and who had evaluable distal oesophageal biopsies were included (Diamond study: NCT00291746). Epithelial hyperplasia was identified when total epithelial thickness was at least 430 μm. Investigation-based GERD criteria were: presence of erosive oesophagitis, pathological oesophageal acid exposure and/or positive symptom-acid association probability. Symptoms were assessed using the Reflux Disease Questionnaire and a pre-specified checklist. Results: Overall, 127 (55%) of the 231 included patients met investigation-based GERD criteria and 195 (84%) met symptom-based criteria. Epithelial hyperplasia was present in 89 individuals, of whom 61 (69%) met investigation-based criteria and 83 (93%) met symptom-based criteria. Adding epithelial hyperplasia as a criterion increased the number of patients diagnosed with GERD on investigation by 28 [12%; number needed to diagnose (NND): 8], to 155 (67%). The proportion of patients with a symptom-based GERD diagnosis who met investigation-based criteria including epithelial hyperplasia was significantly greater when concomitant epigastric pain was absent than when it was present (P < 0.05; NND: 8). Conclusions: Histology increases diagnosis of GERD and should be performed when clinical suspicion is high and endoscopy is negative. Excluding patients with epigastric pain enhances sensitivity for the diagnosis of GERD.
... 3 It is acknowledged that PDS is more common among Asian patients with FD, 4 but it is uncertain whether a separate treatment for patients with PDS and EPS is needed. 5 FD is one of the most common gastrointestinal (GI) disorders encountered in clinical practice, with a prevalence of 8% in the Hong Kong population. 6 About 50% of patients remain to be symptomatic over 5 years since consultation, 7 hence incurring significant treatment cost and loss of productivity. ...
Article
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Introduction This trial proposes to compare the effectiveness and cost-effectiveness of electroacupuncture (EA) plus on-demand gastrocaine with waiting list for EA plus on-demand gastrocaine in providing symptom relief and quality-of-life improvement among patients with functional dyspepsia (FD). Methods and analysis This is a single-centre, pragmatic, randomised parallel-group, superiority trial comparing the outcomes of (1) EA plus on-demand gastrocaine group and (2) waiting list to EA plus on-demand gastrocaine group. 132 (66/arm) endoscopically confirmed, Helicobacter pylori-negative patients with FD will be recruited. Enrolled patients will respectively be receiving (1) 20 sessions of EA over 10 weeks plus on-demand gastrocaine; or (2) on-demand gastrocaine and being nominated on to a waiting list for EA, which entitles them 20 sessions of EA over 10 weeks after 12 weeks of waiting. The primary outcome will be the between-group difference in proportion of patients achieving adequate relief of symptoms over 12 weeks. The secondary outcomes will include patient-reported change in global symptoms and individual symptoms, Nepean Dyspepsia Index, Nutrient Drink Test, 9-item Patient Health Questionnaire (PHQ9), and 7-item Generalised Anxiety Disorder Scale (GAD7). Adverse events will be assessed formally. Results on direct medical costs and on the EuroQol (EQ-5D) questionnaire will also be used to assess cost-effectiveness. Analysis will follow the intention-to-treat principle using appropriate univariate and multivariate methods. A mixed model analysis taking into account missing data of these outcomes will be performed. Cost-effectiveness analysis will be performed using established approach. Ethics and dissemination The study is supported by the Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region of China. It has been approved by the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee. Results will be published in peer-reviewed journals and be disseminated in international conference. Trial registration number ChiCTR-IPC-15007109; Pre-result.
... Majority of the patients with functional dyspepsia landed in to abnormal HADS in accordance to studies from Sweden, Australia and Finland 19 . Patients with EPS-PDS overlap were in abundance and scored higher on HADS in accordance to several studies from Italy, Sweden and Japan 20,21 but in contrast to studies from China, Nigeria, Taiwan, Europe and Canada 21,14 . Unemployed patients with a median age of 55 years presented with abundance and with higher scores on HADS in contrast to other studies where employed patients had a greater percentage 18 . ...
Article
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Objectives: To determine the frequency of functional dyspepsia, relation between functional dyspepsia andanxio-depressive disorders and to determine its impact on quality-of-life. Study Design: Cross-sectional study. Place and Duration of Study: Department of Gastroenterology, Pak Emirates Military Hospital Rawalpindi from May 2017 to October 2017. Material and Methods: Four hundred patients were enrolled and organic causes for dyspepsia were ruled out after extensive assessment. They were segregated into three categories according to their performance on Hospital-Anxiety-and-Depression-Scale (HADS) and the impact on health related quality of life was observed through Short-Form-36 (SF-36) General Health Survey questionnaire. Results: Males were in slight predominance (53%), unemployed individuals were in abundance (82.9%), the median age of presentation was 31-40 years, symptoms duration was less than 2 years for majority of the patients (42.5%) and the most commonly presenting symptom was Epigastric-Pain-Syndrome/Postprandial-Distress- Syndrome overlap (EPS-PDS) (80.5%). Forty nine and half percent of the patients had abnormal HADS and had worse quality of life and had more frequent Out-Patient-Department visits. Conclusion: Functional dyspepsia considerably affects emotional, physical and psychological health and impairs quality of life.
... FD affects the upper GI tract and is characterized by PDS and EPS, the 2 currently recognized subtypes. Although the Rome III and IV criteria describe these subtypes as having distinct symptom profiles, the literature suggests the overlap of these profiles to be as high as 66% in clinical practice, 16 limiting the utility of such subtyping in predicting response to therapy and management. A study by Carbone and colleagues 17 reported an EPS/PDS overlap of 51%, but proposed that this overlap could be mitigated by reclassifying postprandial epigastric pain as a symptom of PDS, suggesting that with further investigation, the onset of symptoms following ingestion of a meal may be important in the clinical distinction of patients with FD. ...
Article
There is growing appreciation that functional gastrointestinal disorders (FGIDs) such as functional dyspepsia and irritable bowel syndrome are heterogeneous conditions linked by subtle inflammation within the gastrointestinal (GI) tract. The literature suggests that while the symptoms of these diseases may manifest with similar clinical presentations, there are significant differences in triggers and disease severity among patients classified into the same subtype. It is hypothesized that the subtle inflammation observed in these patients is related to an imbalance in GI homeostasis. Disruption of the delicate homeostatic balance within the GI tract can result from any number or combination of factors, including dysbiosis, loss of barrier integrity, genetic predisposition, or immune responses to dietary or luminal antigens. This article discusses the interplay between the immune system, microbiota, and luminal environment in FGIDs. In addition, the article proposes emerging immune pathways, including those involving T-helper type 17 response and innate lymphoid cells, as potential regulators of the subtle inflammation characteristic of FGIDs that warrant investigation in future studies.
... Кишечно-мозговая ось рассматривается как одна из основных составляющих возникновения и прогрессирования функциональных заболеваний ЖКТ, непосредственно ассоциированная с психическим состоя-нием и соматизацией, что определило возможность использования антидепрессантов в качестве возможной терапии ФД [33]. В ряде работ подчеркивается, что эффективность антидепрессантов связана с антиангинальным [39] эффектом и расслаблением фундального отдела желудка при ФД [40], при этом только ТЦА достоверно улучшают течение ФД [41]. В рекомендациях ACG/CAG предлагается использовать ТЦА для лечения больных ФД, которые не реагируют на ИПП и эрадикационную терапию H. pylori. ...
Article
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The article presents the views on dyspepsia in world practice, data on the difficulties of diagnosis and the problem of the effectiveness of various therapy regimens. Particular attention is paid to the use of fixed forms of drugs for functional dyspepsia, in particular Omez DSR.
... Boala de reflux asociată unei DF este susţinută de prezenţa arsurii retrosternale şi a regurgitaţiilor acide, precum şi de examenul endoscopic. Circa 50% din DF prezintă pirozis şi regurgitaţii acide, simptome care sunt preponderente la 30% din bolnavi (2). ...
Article
The present pathophysiological features and therapeutic methods are presented. A treatment and diagnostic algorithm is offered. New therapies in refractory functional dyspepsia are presented.
... One study demonstrated that more than 50% of patients with functional dyspepsia with a normal pH study reported heartburn and regurgitation. 4 In a study published by the National Institutes of Health Gastroparesis Clinical Research Consortium, patients with functional dyspepsia and idiopathic gastroparesis were essentially clinically indistinguishable. Other studies have demonstrated that more than 25% of patients who postprandial distress syndrome and epigastric pain syndrome ( Figure 1). 1 Of patients with functional dyspepsia, approximately 38% are classified with postprandial distress syndrome, 27% are classified with epigastric pain syndrome, and 35% meet criteria for both. 2 Dyspepsia patients often report a range of upper gastrointestinal symptoms, 3 and this complex presentation is further complicated by the fact that patients use terms such as heartburn or indigestion to describe epigastric pain or burning. ...
Article
The community prevalence of dyspepsia ranges from 20% to 40%, and dyspepsia accounts for 3% to 5% of primary care visits. Dyspepsia symptoms include epigastric pain, epigastric burning, postprandial fullness, early satiety, epigastric bloating, nausea, and belching. Functional dyspepsia is diagnosed when an organic etiology for the symptoms is not identified. Diagnostic symptom-based criteria are defined by Rome IV. Functional dyspepsia is further subclassified into postprandial distress syndrome and epigastric pain syndrome based on the predominance of post-prandial bloating and fullness vs epigastric pain. Evaluation of functional dyspepsia is driven by patient age and the presence of red-flag symptoms, such as patients over age 60 years or those with anemia undergoing evaluation with esophagogastroduodenoscopy. Helicobacter pylori infection should be excluded in all patients. Treatment options include proton pump inhibitors, neuromodulators, and prokinetics; however, the evidence supporting these therapies is weak, and the response rate is less than robust.
... Furthermore, other studies showed that GER symptoms were present in up to 24% and 23% of patients with FD with predominant epigastric pain and discomfort, respectively (72,73). Focusing on one of the main symptoms of GERD, heartburn, and higher prevalence rates ranging 50%-74% was observed in patients with FD with this typical symptom (72,(74)(75)(76). Evidently, when different criteria for dyspepsia were used, the overlap rates between FD and GERD varied accordingly (Tables 4-6). ...
Article
Introduction: Gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) are 2 of the most prevalent upper gastrointestinal (GI) disorders in the Western world. Previous Rome definitions excluded patients with predominant heartburn from the definition of FD because they were considered to have GERD. However, more recent studies showed that heartburn and acid regurgitation are also common symptoms in patients with FD. The aim of this study is to provide an overview of the prevalence of overlap between GERD and FD, the underlying pathophysiology and implications for treatment. Methods: A review of the literature was performed using the PubMed database, and a meta-analysis with random effects model was completed. Results: This review showed considerable overlap between GERD and FD. A meta-analysis on the data included in this review showed 7.41% (confidence interval [CI]: 4.55%-11.84%) GERD/FD overlap in the general population, 41.15% (CI: 29.46%-53.93%) GERD with FD symptoms, and 31.32% (CI: 19.43%-46.29%) FD with GERD symptoms. Although numerous committees and consensus groups attempted to develop uniform definitions for the diagnosis of GERD and FD, various diagnostic criteria are used across studies and clinical trials (frequency, severity, and location of symptoms). Several studies showed that the overlap between GERD and FD can be explained by a shared pathophysiology, including delayed gastric emptying and disturbed gastric accommodation. Discussion: For diagnoses of GERD and FD, uniform definitions that are easy to implement in population studies, easy to interpret for physicians, and that need to be well explained to patients to avoid overestimation or underestimation of true prevalence are needed. Both GERD and FD coexist more frequently than expected, based on coincidence, suggesting a potential pathophysiological link. More research is needed to explore the common GERD/FD overlap population to identify the underlying pathophysiological mechanisms, which may lead to a more effective therapeutic approach.
... FD group were classified into the PDS, EPS, and mixed subtype based on the Rome III criteria. 19 The control group was defined as individuals who had no GI symptoms and showed normal endoscopic findings. This study was approved by the Institutional Review Board (B-1101/119-010). ...
Article
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Background/aims: To determine whether the expression of tight junction proteins (TJPs) differs depending on the subtype of functional dyspepsia (FD) and sex. Methods: Control (n = 95) and FD (n = 165) groups based on Rome III criteria were prospectively enrolled. Gastric mucosal mRNA expression levels of various TJPs (claudins [CLDN] 1, 2, and 4; zonula occludens-1; occludin [OCLN]) were assessed by reverse transcription polymerase chain reaction. Western blot was performed to determine the levels of various TJPs. Helicobacter pylori infection status was evaluated by histology, rapid urease test, and culture. Questionnaires were analyzed. Results: In all groups irrespective of H. pylori , FD group showed significantly higher CLDN2 mRNA levels than control group (P = 0.048). The level of CLDN4 mRNA expression was significantly lower in female FD group than in male FD group (P = 0.018). In H. pylori uninfected subjects, the level of CLDN1 mRNA expression in female FD group was significantly lower than that of male FD group (P = 0.014). The level of CLDN2 mRNA expression was significantly higher in the male postprandial distress syndrome (P = 0.001) and male epigastric pain syndrome (P = 0.023) groups than in the male control group. In Western blot analysis, the expression of OCLN was significantly elevated 48 hour after the culture with H. pylori strain 43504. Conclusions: H. pylori can affect a variety of TJPs, particularly claudin-4 and occludin. Claudin-2 is thought to be involved in FD irrespective of H. pylori status, especially in the pathophysiology of male FD.
... It is a chronic clinical syndrome associated with postprandial fullness, early satiation, epigastric burning, or epigastric pain. The Rome III criteria subdivided FD into two distinct clinical entities: the postprandial distress syndrome (PDS) and the epigastric pain syndrome (EPS) with significant overlap between two groups [3,4]. Because of lacking structural lesions and undetermined underlying cause, satisfactory treatment of FD is limited and is mainly targeted towards symptom relief. ...
Article
Full-text available
Background and study aims The pathogenesis of functional dyspepsia (FD) is complex and still remains to be established. Recent studies support duodenal inflammation with increased infiltration of eosinophils and a higher level of systemic cytokines among patients with FD. These findings may help to understand the underlying pathophysiology of FD. The aim of this study was to evaluate the association between duodenal eosinophilia and FD. Patients and methods A total of 84 patients (42 cases of FD and 42 subjects without dyspepsia as control, mean age 31 years, 56% female) were recruited for this prospective observational study. FD was diagnosed by validated Bangla version of the ROME III criteria. Patients with no symptoms of FD who were referred for upper gastrointestinal endoscopy for other reasons were included as control. Biopsy specimens were taken from the second part (D2) of the duodenum of all participants. The eosinophil count was quantitatively evaluated by hematoxylin and eosin staining and expressed in numbers per 5 HPF. The association between duodenal eosinophilia (defined as ≥22/5HPF a priori) and FD was assessed. Result Significantly increased duodenal eosinophil count was found in patients with FD than patients without dyspepsia (p = 0.001). 57.1% of patients with FD had duodenal eosinophilia. A significant positive association was found between duodenal eosinophilia and FD (OR = 5.67, 95% CI 1.92–17.2, p = 0.001). A positive association was also observed between duodenal eosinophilia and postprandial distress syndrome (OR = 5.54, 95% CI 0.86–45.24, p = 0.036). A higher odds ratio was noticed among those who complain of early satiety. Conclusion A significant positive association was found between duodenal eosinophilia and FD especially among those with postprandial distress syndrome. It requires further large scale multicenter studies to establish duodenal eosinophilia as a biomarker of FD.
... In our study, the prevalence of PDS alone was 62.8% and EPS alone was 14.1%, while PDS-EPS overlap was present in 23.1% of subjects. In previous studies, PDS prevalence of up to 83% [22], EPS prevalence of up to 86% [23], and PDS-EPS overlap ranging from 5.6% to 64% have been reported [3,11,24]. Recognition of the subtypes of FD and their overlap in a particular population is important as it will help in understanding the pathophysiology, identifying possible risk factors, and guiding appropriate management of patients. ...
Article
Background/PurposeThere is scarcity of data on prevalence, overlap, and risk factors for functional gastrointestinal disorders (FGID) by Rome IV criteria. We evaluated these factors among medical, nursing, and humanities students.Methods Rome IV Diagnostic Questionnaire (for all FGIDs), Rome III questionnaire (for irritable bowel syndrome [IBS], functional diarrhea [FDr], and functional constipation [FC]), and questionnaires assessing demography, physical activity, anxiety, and depression were used.ResultsA total of 1309 college students were included (medical 425, nursing 390, humanities 494; mean age 20.5 ± 2.1 years; 36.5% males). Prevalence of Rome IV FGIDs was 26.9% (n = 352), significantly higher among females compared with males (32.3% vs. 17.6%; p < 0.001) and significantly higher among medical (34.4%) and nursing students (29.2%) compared with humanities students (18.6%) (p < 0.05). Most common FGIDs were functional dyspepsia (FD) (15.2%), IBS (6.2%), reflux hypersensitivity (3.5%), FDr (2.9%), FC (2.1%), and unspecified functional bowel disorder (2.1%). FGID overlap was present in 9.3%, most common being FD-IBS overlap (4.4%). With Rome III criteria, prevalence of IBS was higher (9.5%), while that of FDr (0.92%) and of FC (1.3%) were lower. On multivariate analysis, independent predictors for FGIDs were female gender, medical student, non-vegetarian diet, junk food, tea/coffee, poor physical activity, anxiety, and insomnia.Conclusion Rome IV FGIDs were present among one-fourth of college students with preponderance among females and medical students. FD, IBS, and reflux hypersensitivity were the most common FGIDs. Rome IV criteria led to a reduction in IBS prevalence and increase in FDr and FC prevalence. Dietary factors, physical activity, anxiety, and insomnia affected FGID prevalence.
... For this reason, a clinically relevant definition of dyspepsia as predominant epigastric pain lasting at least 1 month is preferred. This can be associated with any other upper gastro intestinal symptom such as epigastric fullness, nausea, vomiting, or heartburn, provided epigastric pain is the patient's primary concern [9]. The rapid introduction of new diagnostic criteria for dyspepsia has made very difficult or virtually impossible to compare prevalence rates from different periods or geographic regions [10]. ...
Article
Background: Dyspepsia is a common clinical problem and has a great impact on the patient's quality of life. More than half of patients presenting with dyspepsia have no detectable lesion for their symptoms. The common organic causes of dyspepsia include peptic ulcer, esophagitis and cancer. The diagnostic test of choice is endoscopy. Age specific thresholds to trigger endoscopic evaluation may differ by gender, availability of resources and regional disease specific risks. Aim: The aim of the study was to determine the prevalence of significant endoscopic lesions in patients presenting with dyspepsia. Materials and methods: This was a retrospective study. Data on patients presenting with dyspepsia and scheduled for upper gastrointestinal (UGI) endoscopy between January 2011 and December 2016 was collected. Results: Nine thousand five hundred and twenty five patients with persistent dyspepsia were assessed by Upper GastroIntestinal (UGI) endoscopy. 58.8% were male. The mean age was 41 years. Endoscopy revealed normal findings or miscellaneous irrelevant findings in 6967 patients (73.1%). Significant endoscopic findings were diagnosed in 2558 (26.9%). These included peptic ulcers in 493 patients (5.1%), esophagitis in 560 (5.9%), erosive Gastroduodenitis in 1069 (11.2%), Varices in 40 patients (0.4%) and UGI malignancy in 279 (2.9%). Conclusion: The endoscopic diagnosis of persistent dyspepsia in our setting showed a predominance of functional disease. Every 4th person (26.7%) with persistent dyspepsia had organic lesions whereas UGI malignancy was an uncommon finding. The most frequent significant pathologies included erosive gastroduodenitis, esophagitis and peptic ulcer disease. Patients with recent onset of dyspepsia who are in the age group at risk of gastric malignancy should undergo early endoscopy. UGI endoscopy is simple procedure that can be undertaken for early diagnosis of benign as well as malignant lesions in patient presenting with dyspepsia.
... It is a chronic clinical syndrome associated with postprandial fullness, early satiation, epigastric burning, or epigastric pain. The Rome III criteria subdivided FD into two distinct clinical entities: the postprandial distress syndrome (PDS) and the epigastric pain syndrome (EPS) with significant overlap between two groups [3,4]. Because of lacking structural lesions and undetermined underlying cause, satisfactory treatment of FD is limited and is mainly targeted towards symptom relief. ...
Article
Several mechanisms have been proposed to explain the symptoms of functional dyspepsia but actual pathogenesis is still poorly understood. Recent studies support duodenal abnormality to be the most important causal link to explain symptoms and to understand abnormal pathophysiology of functional dyspepsia. The aim of this prospective observational study is to compare eosinophil count in duodenal mucosa between patients with functional dyspepsia and control subjects without dyspepsia and was done at the department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from December 2015 to December 2016. Total 42 patients of functional dyspepsia based on Bangla validated version of ROME III criteria and 42 controls who were referred for upper gastrointestinal endoscopy for reasons other than dyspepsia were included. Biopsy specimens were collected from the second part (D2) of the duodenum of all participants. Eosinophil count was quantitatively evaluated by hematoxylin and eosin staining and expressed in numbers per 5 HPF. Significantly increased duodenal eosinophil count was found in functional dyspepsia group than non dyspeptic patients (22.78±08.78 vs. 14.90±10.70, p=0.001). Higher duodenal eosinophil count was found in patients with postprandial distress syndrome. Increased duodenal eosinophil count was found in patient of functional dyspepsia. It requires further large scale multicenter studies to establish duodenal eosinophilia as a biomarker of functional dyspepsia.
Article
Background: Functional dyspepsia (FD) is a common functional gastrointestinal disorder with incompletely understood pathophysiology and heterogeneous symptom presentation. Assessment of treatment efficacy in FD is a methodological challenge as response to treatment must be assessed primarily by measuring subjective symptoms. Therefore, the use of patient-reported outcome measures (PROMs) is recommended by regulatory authorities to assess gastrointestinal symptoms in clinical trials for FD. In the last decades, a multitude of outcome measures has been developed. However, currently no PROM has been approved by the regulatory authorities, and no consensus has been reached with regard to the most relevant outcome measure in FD. Purpose: This systematic review discusses the available disease-specific outcome measures for assessment of FD symptoms with psychometric validation properties, strengths, and limitations. Moreover, recommendations for use of current available outcome measures are provided, and potential areas of future research are discussed.
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An epidemiological study about FGID´s in Mexico Libro que resume la Epidemiologia de los TFDs en Mexico.
Chapter
This chapter provides definition of functional dyspepsia (FD), evaluation, and diagnostic tests, methodology of clinical treatment trials with a focus on outcome measures used to determine the efficacy of treatments, and treatments including antacids, H2‐receptor antagonists (H2‐RAs), proton pump inhibitors (PPIs), prokinetic agents, anti‐Helicobacter therapy, antidepressant therapy, and psychological interventions. A problem in every day management of FD is that primary care physicians do not readily make a distinction between gastroesophageal reflux disease (GERD) and dyspepsia, as in both instances the most likely pharmacological therapy is to prescribe a PPI. Dividing FD into subgroups has become popular despite evidence of the existence of considerable overlap among them. The ROME II classification recognized four subgroups: ulcer‐like dyspepsia, reflux‐like dyspepsia, dysmotility‐like dyspepsia, and unclassified dyspepsia. The chapter summarizes the suggested treatment algorithm for FD. The evidence for use of tricyclic antidepressants, especially amitriptyline, is getting stronger and this also true for cognitive behavioral therapy.
Article
Background: Ghrelin has been indicated as one of the etiological factors in functional dyspepsia (FD). Methods: We analyzed 179 patients with FD (based on the Rome III criteria) and 103 asymptomatic healthy individuals (controls) who had undergone endoscopy at Seoul National University Bundang Hospital from February 2011 to June 2014. FD patients were classified into three groups by means of a self-reported questionnaire: patients with postprandial distress syndrome (PDS; n = 49), patients with epigastric pain syndrome (EPS; n = 45), and patients with a combination of these two types (mixed group; n = 85). The fasting blood levels of acyl ghrelin and desacyl ghrelin and messenger RNA (mRNA) expression of preproghrelin in the fundic mucosa were measured by ELISAs and reverse transcription quantitative real-time PCR, respectively. One year after participant enrollment, they were measured again in 79 participants and the changes in the values were compared according to Helicobacter pylori eradication or symptom response. Results: Plasma acyl ghrelin level was lower in the PDS group than in the control and EPS groups (control group 14.1 fmol/mL, PDS group 8.9 fmol/mL, EPS group 13.8 fmol/mL, mixed group 11.3 fmol/mL; P = 0.003 and P = 0.012, respectively). One year after the eradication of H. pylori, plasma acyl ghrelin level was increased and gastric preproghrelin mRNA expression was upregulated (P = 0.004 and P < 0.001, respectively). Patients with abatement of symptoms demonstrated an increase in plasma acyl ghrelin level (from 11.51 to 21.00 fmol/L, P = 0.040). Conclusions: Our results suggest that plasma acyl ghrelin plays a role in the development of PDS. H. pylori eradication upregulates preproghrelin mRNA expression and increases plasma acyl ghrelin level, contributing to the abatement of PDS symptoms.
Article
Dyspepsia is a constellation of symptoms referable to the gastroduodenal region of the upper gastrointestinal tract. Functional dyspepsia, a relapsing and remitting disorder, is the most common cause of these symptoms. The current standard for the diagnosis of functional dyspepsia is the Rome III criteria, developed by the Rome III Committees, a multinational group of experts in the field, first convened in 1990, that meets regularly to review and revise the diagnostic criteria for all functional gastrointestinal disorders. The Rome III criteria for functional dyspepsia consist of a sensation of pain or burning in the epigastrium, early satiety (inability to finish a normal-sized meal), fullness during or after a meal, or a combination of these symptoms (Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). Symptoms must be chronic, occurring at least weekly and over a period of at least 6 months, in the absence of an organic explanation. 1 The global prevalence of functional dyspepsia in the community according to this definition is between 5% and 11%.(2) Up to 40% of persons who have functional dyspepsia consult a physician,(3) and the condition negatively affects attendance and productivity in the workplace.(4) Functional dyspepsia has substantial financial implications for patients, health care organizations, and society as a whole; costs associated with the condition in the United States in 2009 were in excess of $18 billion.(5) It is therefore important that physicians be able to recognize functional dyspepsia, use investigations and diagnostic tests judiciously, and recommend effective treatments, in order to minimize the potential adverse social and economic effects of the condition.
Article
Dyspepsia (DP) is pain or discomfort in the upper abdomen. It may be uninvestigated dyspepsia or functional dyspepsia (FD) which is diagnosed after diagnostic tests such as upper endoscopy and occasionally upper abdominal ultrasound find no organic changes that explain the condition. Despite the wide dissemination of the classifications of dyspepsia, functional dyspepsia and postprandial dyspepsia, recent findings controvert these classifications. This article discusses the approach to patients with dyspepsia and the pathophysiology and drug treatment of functional dyspepsia. © 2014 Asociaciones Colombianas de Gastroenterología, Endoscopia digestiva, Coloproctología y Hepatología.
Article
Background Patient‐reported outcome measures (PROMs) are used to assess symptoms in patients with functional dyspepsia (FD). Current end‐of‐day questionnaires have several limitations including sensitivity to recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments across momentary states in daily life and therefore less sensitive to these limitations. This study describes the development of a novel PROM based on ESM technology. Methods An initial draft of the PROM was developed based on literature. Focus group interviews with FD patients according to Rome IV criteria, and an expert meeting with international opinion leaders in the field of functional gastrointestinal disorders were conducted in order to select items for the PROM. Cognitive interviews were performed to evaluate patients’ understanding of the selected items and to create the definitive PROM. Key results A systematic literature search revealed 59 items across four domains (ie, physical status; mood and psychological factors; context and environment; and nutrition, medication, and substance use). After patient focus group interviews and an international expert meeting, the number of items was reduced to 33. Cognitive interviews resulted in some minor linguistic changes in order to improve patients’ understanding. Conclusions and inferences A novel digital ESM‐based PROM for real‐time symptom assessment in patients with functional dyspepsia was developed. This novel PROM has the potential to identify individual symptom patterns and specific triggers for dyspeptic symptoms, and optimize treatment strategies.
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Goals: The goals of the study were to investigate in both postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS) the gastric electrical activity and the gastric emptying (GE) time together with the circulating concentrations of motilin, somatostatin, corticotrophin-releasing factor, and neurotensin, and to establish whether the genetic variability in the neurotensin system genes differs between these 2 categories of functional dyspepsia (FD). Background: The current FD classification is based on symptoms and it has been proven not to be completely satisfying because of a high degree of symptom overlap between subgroups. Study: Gastric electrical activity was evaluated by cutaneous electrogastrography: the GE time by C-octanoic acid breast test. Circulating concentrations of gut peptides were measured by a radioimmunoassay. NTS 479 A/G and NTSR1 rs6090453 SNPs were evaluated by PCR and endonuclease digestion. Results: Fifty-four FD patients (50 female/4 male) were studied. Using a symptom questionnaire, 42 patients were classified as PDS and 12 as EPS, although an overlap between the symptom profiles of the 2 subgroups was recorded. The electrogastrographic parameters (the postprandial instability coefficient of dominant frequency, the dominant power, and the power ratio) were significantly different between the subgroups, whereas the GE time did not differ significantly. In addition, EPS was characterized by a different gut peptide profile compared with PDS. Finally, neurotensin polymorphism was shown to be associated with neurotensin levels. This evidence deserves further studies in consideration of an analgesic role of neurotensin. Conclusions: Analysis of gut peptide profiles could represent an interesting tool to enhance FD diagnosis and overcome limitations due to a distinction based solely on symptoms.
Article
The present pathophysiological features and therapeutic methods are presented. A treatment and diagnostic algorithm is offered. New therapies in refractory functional dyspepsia are presented.
Article
Objectives: Rome III introduced a subdivision of functional dyspepsia (FD) into postprandial distress syndrome and epigastric pain syndrome, characterized by early satiation/postprandial fullness, and epigastric pain/burning, respectively. However, evidence on their degree of overlap is mixed. We aimed to investigate the latent structure of FD to test whether distinguishable symptom-based subgroups exist. Methods: Consecutive tertiary care Rome II FD patients completed the dyspepsia symptom severity scale. Confirmatory factor analysis (CFA) was used to compare the fit of a single factor model, a correlated three-factor model based on Rome III subgroups and a bifactor model consisting of a general FD factor and orthogonal subgroup factors. Taxometric analyses were subsequently used to investigate the latent structure of FD. Key results: Nine hundred and fifty-seven FD patients (71.1% women, age 41 ± 14.8) participated. In CFA, the bifactor model yielded a significantly better fit than the two other models (χ² difference tests both p < 0.001). All symptoms had significant loadings on both the general and the subgroup-specific factors (all p < 0.05). Somatization was associated with the general (r = 0.72, p < 0.01), but not the subgroup-specific factors (all r < 0.13, p > 0.05). Taxometric analyses supported a dimensional structure of FD (all CCFI<0.38). Conclusions and inferences: We found a dimensional rather than categorical latent structure of the FD symptom complex in tertiary care. A combination of a general dyspepsia symptom reporting factor, which was associated with somatization, and symptom-specific factors reflecting the Rome III subdivision fitted the data best. This has implications for classification, pathophysiology, and treatment of FD.
Article
Chronic unexplained gastrointestinal symptoms impact more than 1 in 5 Americans and their families; these disorders include the irritable bowel syndrome (IBS) and functional dyspepsia (FD), currently classified by Rome IV as functional gastrointestinal disorders. By definition, IBS and FD have no established pathology, but emerging evidence suggests this paradigm may need revision. Immune activation and, in subsets, subtle intestinal pathology have been identified in FD (most notably, postprandial distress syndrome) and IBS-diarrhea. A disease model is proposed that accounts for all of the intestinal and extraintestinal symptoms, relationship to food and infection, and the overlap with gastroesophageal reflux disease. It is speculated that antigen presentation to the mucosa (e.g., microbial antigens or food proteins after acute gastroenteritis) induces, in a genetically primed host, immune activation of the intestine with low-grade intestinal inflammation and subsequently neuronal structural and functional alterations, producing regional intestinal hypersensitivity and motor dysfunction. Immune activation may explain the female predominance and fluctuations in immune activity for symptom variability over time. In the future, as further evidence accumulates, the management paradigm may potentially shift to objective pathology-based subtyping based on serological, microbiological, and clinical assessments to identify when targeted therapies should be deployed in subsets. Potential targeted interventions may include therapies to dampen down immune activation or block release of key mediators such as histamine, specific microbial targeted treatments that may reverse disease, and dietary advice to eliminate relevant food antigens after objective in vivo testing. Only by identifying causation can we eventually anticipate cure, and as the true pathology unravels in subsets, this may become a reality.
Article
Background & aims: Histologic criteria have been refined for the diagnosis of gastroesophageal reflux disease (GERD). We aimed to evaluate these criteria for the assessment of GERD and to measure interassessor agreement. Methods: We performed a post hoc analysis of data from the Diamond study (NCT 00291746), conducted in Europe and Canada on adults with frequent upper gastrointestinal symptoms who had not taken a proton pump inhibitor in the previous 2 months. GERD was diagnosed based on the presence of 1 or more of the following: reflux esophagitis, pathologic esophageal acid exposure, and/or positive symptom-acid association probability. Nonerosive reflux disease was defined as the presence of pathologic esophageal acid exposure and/or a positive symptom-acid association probability, but no reflux esophagitis. Biopsies collected from 336 patients from 0.5 cm and 2.0 cm above the Z line were evaluable; they were analyzed independently at pathology centers in Germany and Italy (biopsies from 258 and 195 patients, respectively). The primary outcomes were the accuracy of histologic criteria for the diagnosis of GERD, defined by endoscopy and pH monitoring, and interassessor agreement on histologic criteria. Results: At the assessment site for basal cell layer thickness, total epithelial thickness was the best-performing criterion for diagnosis of investigation-defined GERD; it also identified nonerosive reflux disease, reflux esophagitis, and pathologic esophageal acid exposure at 0.5 cm and 2.0 cm above the Z line. Basal cell layer thickness and presence of dilated intercellular spaces did not identify patients with GERD. Among the criteria tested, the best agreement between assessments carried out at the 2 pathology centers was for total epithelial thickness at 0.5 cm and 2.0 cm above the Z line. Conclusions: Based on an analysis of 336 patients with frequent upper gastrointestinal symptoms, total epithelial thickness is a robust histologic marker for GERD.
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Background The purpose was to evaluate the overlap frequency of irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), and overactive bladder syndrome (OBS), as well as other gastrointestinal and systemic symptoms, in functional dyspepsia (FD). Additionally, we sought to determine whether adult Rome III FD subtypes were uniquely related to overlap syndromes or symptoms. Methods The study was a retrospective review of 100 consecutive pediatric patients, age 8–17 years, diagnosed with FD. All had completed a standardized medical history including gastrointestinal and systemic symptoms as well as specific symptoms related to GERD and OBS. The frequency of overlap with IBS, GERD, and OBS were determined for the whole group and for those fulfilling adult FD subtype criteria. Individual symptoms were also compared by FD subtype. Results Overlap IBS was present in 33 % of the FD patients. At least one GERD symptom was present in 74 % of patients with 41 % reporting heartburn. At least one OBS symptom was present in 44 % of patients with 29 % reporting urinary urgency. Other than pain, the most common reported gastrointestinal symptom was nausea (86 %). Systemic symptoms were common. Overlap syndromes/symptoms did not vary by FD subtype. Postprandial distress syndrome was associated with pain with eating, weight loss, and waking at night to have a stool. Conclusions FD is a heterogeneous condition in children and adolescents with significant variability in the presence of gastrointestinal and non-gastrointestinal symptoms and overlap syndromes. Varying symptom profiles need to be accounted for and analyzed in studies involving subjects with FD.
Article
Objectives: Gastro-oesophageal reflux and dyspepsia are felt to be separate upper gastrointestinal (GI) conditions. We aimed to measure the degree of overlap between them, and assess whether endoscopic findings differed. Material and methods: Demographic, symptom, upper GI endoscopy and histology data were collected from consecutive adults in secondary care. Patients were categorised according to whether they reported gastro-oesophageal reflux alone, dyspepsia alone or both, and patient demographics and endoscopic findings were compared. Results: Of 1167 patients, 97 (8.3%) had gastro-oesophageal reflux alone, 571 (48.9%) dyspepsia alone, and 499 (42.8%) overlap. Patients with overlap symptoms were more likely to smoke, compared with those with gastro-oesophageal reflux alone, or dyspepsia alone (p = .009), but there were no other differences. Patients with gastro-oesophageal reflux alone or overlap had a higher prevalence of erosive oesophagitis (18.6% and 15.4% respectively, p < .001), but this was still the commonest diagnosis among those with dyspepsia alone (7.2%). No significant differences were seen in prevalence of other endoscopic findings. Conclusions: Gastro-oesophageal reflux and dyspepsia symptoms commonly overlap. There were minimal differences in demographics or spectrum of underlying organic disease between various symptom groups, suggesting that restrictive classifications according to predominant symptom may not be clinically useful.
Chapter
Heartburn and acid regurgitation are the classic symptoms of gastroesophageal reflux disease (GERD). Heartburn is defined as a burning sensation in the retrosternal area (behind the breastbone) and regurgitation is the perception of flow of refluxed gastric content into the mouth or hypopharynx. GERD is the most prevalent acid-related disorder in Canada and affects 10–30% of the population in the United States and Europe. Assessment of the patient with heartburn requires knowledge of characteristic, atypical, and nonspecific symptoms, as well as the red flags that may indicate a more sinister underlying cause (e.g., gastric carcinoma) and require referral to a physician for further workup. It is important to determine if the patients’ heartburn symptoms could be caused by an underlying medical condition that, in some cases, could be life-threatening (e.g., cardiac chest pain). Patients presenting to the community pharmacist with classic heartburn or regurgitation in the absence of red flags can confidently self-treat their symptoms with various over-the-counter (OTC) acid-lowering products, including proton pump inhibitors (PPI), without requirement for further referral or investigation. Patients should be advised to follow-up with their pharmacist or physician if their symptoms persist after a 2–4-week trial of OTC therapy. Patients presenting with new epigastric pain as their predominant symptom (i.e., undiagnosed dyspepsia) should be referred to their physician for further assessment. Therapy for GERD is typically limited to 4–8 weeks, but chronic use of PPI therapy is common. In these situations, it is important to assess the patient history, as there are several indications where continued long-term PPI therapy is appropriate (e.g., Barrett’s esophagus, chronic NSAID users with bleeding risk, severe esophagitis, and documented history of bleeding ulcers). In the absence of these indications, lowering the dose or stopping PPI therapy may be appropriate.
Article
Dyspepsia is a complex of symptoms referable to the gastroduodenal region of the gastrointestinal tract and includes epigastric pain or burning, postprandial fullness, or early satiety. Approximately 80% of individuals with dyspepsia have no structural explanation for their symptoms and have functional dyspepsia. Functional dyspepsia affects up to 16% of otherwise healthy individuals in the general population. Risk factors include psychological comorbidity, acute gastroenteritis, female sex, smoking, use of non-steroidal anti-inflammatory drugs, and Helicobacter pylori infection. The pathophysiology remains incompletely understood, but it is probably related to disordered communication between the gut and the brain, leading to motility disturbances, visceral hypersensitivity, and alterations in gastrointestinal microbiota, mucosal and immune function, and CNS processing. Although technically a normal endoscopy is required to diagnose functional dyspepsia, the utility of endoscopy in all patients with typical symptoms is minimal; its use should be restricted to people aged 55 years and older, or to those with concerning features, such as weight loss or vomiting. As a result of our incomplete understanding of its pathophysiology, functional dyspepsia is difficult to treat and, in most patients, the condition is chronic and the natural history is one of fluctuating symptoms. Eradication therapy should be offered to patients with functional dyspepsia who test positive for Helicobacter pylori. Other therapies with evidence of effectiveness include proton pump inhibitors, histamine-2 receptor antagonists, prokinetics, and central neuromodulators. The role of psychological therapies is uncertain. As our understanding of the pathophysiology of functional dyspepsia increases, it is probable that the next decade will see the emergence of truly disease-modifying therapies for the first time.
Chapter
The term “dyspepsia” applies to a wide variety of upper abdominal symptoms. The criteria for functional dyspepsia (FD) have undergone multiple revisions in the interest of achieving a reliable and useful definition for diagnostic, treatment, and research purposes. FD still includes a heterogeneous assortment of conditions, but four main symptoms have been identified through factor analysis as being reliable features of this diagnosis: bothersome postprandial fullness, early satiation, epigastric pain, and epigastric burning. Two subgroups, postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), were proposed in Rome III (2006) and its recent successor, Rome IV (2016). PDS is characterized by postprandial fullness and early satiation, while EPS is characterized by epigastric pain and epigastric burning. Epigastric pain and burning occurring after a meal is now considered a PDS symptom in Rome IV. Prevalence of FD is approximately 10–20% in Asia and is similar throughout the world. FD overlaps, to some extent, with both irritable bowel syndrome (IBS) and gastroesophageal reflux disease (GERD). Pediatric FD is also defined by Rome IV.
Article
Functional dyspepsia (FD) is a highly prevalent disorder that affects more than 10% of the population. In the past decade, the conceptual underpinning of FD has begun to change, and new data are unraveling the underlying pathophysiological mechanisms of this disorder with a focus on the duodenum. The Rome IV criteria were published in 2016, and notably suggests that gastroesophageal reflux disease and irritable bowel syndrome may all be part of the same disease spectrum as FD. Helicobacter pylori explains a minority of FD cases and in Rome IV is considered a separate entity. Duodenal inflammation is likely to be an important with evidence that eosinophils (and mast cells) are increased and impair the intestinal barrier. Gastrointestinal infection is now an established risk factor for FD. Other risk factors for FD may include atopy, herbivore pets and antibiotic exposure. Gastroduodenal microbiome disturbances are an area of increasing interest in FD. Small bowel homing T cells and increased cytokines in the circulation occur in FD (correlating with slow gastric emptying), and an association with autoimmune rheumatological disease supports background immune activation. A genetic predisposition is possible. The link of FD to psychological disorders may indicate in some cases anxiety or depression causes FD while in others FD may induce psychological distress. Therapeutic options are limited, providing modest and temporary relief. Advances in the understanding of FD will likely alter clinical practice, and treatment of duodenal inflammation or microbiome alterations may lead to “cure” of a subset in the future.
Article
Two different subtypes of Functional Dyspepsia (FD) are recognized in adults: epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS). To assess the presence of FD subtypes in childhood at diagnosis and to observe changes at follow up. 100 patients with a diagnosis of FD based on pediatric Rome III criteria were consecutively enrolled. FD subtypes were successively classified through adult Rome III classification. Children were revaluated after 6 months of follow up (T1). At T0, 17 (17%) out of 100 patients were classified as EPS, while 47 (47%) out of 100 patients fulfilled criteria for PDS. In 36 (36%) out of 100 children an overlap between the two subtypes was identified. Nausea was significantly higher in PDS and overlap groups when compared with EPS (X = 21.7; p = 0.0001; X = 20.7; p = 0.0001). Headache was significantly increased in PDS and overlap groups compared to patients with EPS (X = 9.8, p = 0.001; X = 13.1, p = 0.0001, respectively). At T1 among children belonging to PDS group at enrolment, 9/47 (19.1%) changed to EPS group, and 9/47 (19.1%) changed to the overlap group. Five (29.4%) out of 17 patients and 2 (11.8%) out of 17 children diagnosed with EPS at T0 switched to PDS and overlap group, respectively. Of the 36 patients with overlap at enrollment, 11 (30.6%) satisfied criteria for PDS, and 7 (19.4%) switched to EPS group. Two distinct FD subtypes are identifiable in pediatric population. A high percentage of overlap and a variation of subtype over time were found suggesting a common pathophysiologic mechanism.
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While widely used in research, the 1991 Rome criteria for the gastroduodenal disorders, especially symptom subgroups in dyspepsia, remain contentious. After a comprehensive literature search, a consensus-based approach was applied, supplemented by input from international experts who reviewed the report. Three functional gastroduodenal disorders are defined. Functional dyspepsia is persistent or recurrent pain or discomfort centered in the upper abdomen; evidence of organic disease likely to explain the symptoms is absent, including at upper endoscopy. Discomfort refers to a subjective, negative feeling that may be characterized by or associated with a number of non-painful symptoms including upper abdominal fullness, early satiety, bloating, or nausea. A dyspepsia subgroup classification is proposed for research purposes, based on the predominant (most bothersome) symptom: (a) ulcer-like dyspepsia when pain (from mild to severe) is the predominant symptom, and (b) dysmotility-like dyspepsia when discomfort (not pain) is the predominant symptom. This classification is supported by recent evidence suggesting that predominant symptoms, but not symptom clusters, identify subgroups with distinct underlying pathophysiological disturbances and responses to treatment. Aerophagia is an unusual complaint characterized by air swallowing that is objectively observed and troublesome repetitive belching. Functional vomiting refers to frequent episodes of recurrent vomiting that is not self-induced nor medication induced, and occurs in the absence of eating disorders, major psychiatric diseases, abnormalities in the gut or central nervous system, or metabolic diseases that can explain the symptom. The current classification requires careful validation but the criteria should be of value in future research.
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A subset of functional dyspepsia patients respond to acid suppressive therapy, but the prevalence of non-erosive reflux disease in functional dyspepsia and its relevance to symptoms have never been established. The aim of the present study was to study 24 hour pH monitoring in consecutive functional dyspepsia patients. A total of 247 patients with dyspeptic symptoms (166 women, mean age 44 (SEM 1) year), with a negative upper gastrointestinal endoscopy and without dominant symptoms of heartburn participated in the study. In all patients, the severity of dyspeptic symptoms and the presence of heartburn was assessed by a questionnaire and a 24 hour oesophageal pH monitoring study was performed. All patients underwent a gastric emptying breath test and in 113 a gastric barostat study was performed. Abnormal pH monitoring (acid exposure >5% of time) was found in 58 patients (23%). Of 21 patients with a positive heartburn questionnaire, 76% had pathological pH monitoring, while this was the case in only 18.5% of patients with a negative heartburn questionnaire. Demographic characteristics and the prevalence of other pathophysiological mechanisms did not differ between heartburn negative patients with normal or abnormal acid exposure. Pathological acid exposure in heartburn negative patients was associated with the presence of epigastric pain (65 v 84%, p<0.005) and of moderate or severe pain (48 v 69%, p = 0.005). Pathological oesophageal acid exposure is only present in a subset of heartburn negative functional dyspepsia patients, which are characterised by a higher prevalence of epigastric pain.
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The treatment of patients with functional dyspepsia remains unsatisfactory. We assessed the efficacy of itopride, a dopamine D2 antagonist with anti-acetylcholinesterase [corrected] effects, in patients with functional dyspepsia. Patients with functional dyspepsia were randomly assigned to receive either itopride (50, 100, or 200 mg three times daily) or placebo. After eight weeks of treatment, three primary efficacy end points were analyzed: the change from baseline in the severity of symptoms of functional dyspepsia (as assessed by the Leeds Dyspepsia Questionnaire), patients' global assessment of efficacy (the proportion of patients without symptoms or with marked improvement), and the severity of pain or fullness as rated on a five-grade scale. We randomly assigned 554 patients; 523 had outcome data and could be included in the analyses. After eight weeks, 41 percent of the patients receiving placebo were symptom-free or had marked improvement, as compared with 57 percent, 59 percent, and 64 percent receiving itopride at a dose of 50, 100, or 200 mg three times daily, respectively (P<0.05 for all comparisons between placebo and itopride). Although the symptom score improved significantly in all four groups, an overall analysis revealed that itopride was significantly superior to placebo, with the greatest symptom-score improvement in the 100- and 200-mg groups (-6.24 and -6.27, vs. -4.50 in the placebo group; P=0.05). Analysis of the combined end point of pain and fullness showed that itopride yielded a greater rate of response than placebo (73 percent vs. 63 percent, P=0.04). Itopride significantly improves symptoms in patients with functional dyspepsia. (ClinicalTrials.gov number, NCT00272103.).
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A world-wide recognised and accepted definition and classification of gastroesophageal reflux disease (GERD) would be highly desirable for research and clinical practice. The purpose of this project was to develop such a generally accepted definition and classification that could be used equally by patients, physicians, and supervisory bodies. In order to ensure a consensus among the participating experts a modified delphi process with a step-wise selection modality was employed. For this the working group of five persons formulated a series of statements on the basis of a systematic search of the literature using three databases (Embase, Cochrane-Study register, Medline). Then these statements were developed further for two years, revised and finally passed as consensus. The consensus group consisted of 44 experts from 18 countries. Each key vote was held on the basis of a six-point scale. A "consensus" was considered to have been reached when two-thirds of the participants voted in favour of the respective statement. The level of agreement between the experts increased in the course of the multistep decision process, in the individual voting steps requiring at least two-thirds of the participants, the results were at first 86%, then 88% through to 94% and finally 100% in favour of the chosen statement. In the final voting, 94% of the final 51 statements were accepted by 90% of the consensus group. 90% of all statements were accepted unanimously or with only minor reservations. GERD was defined as a disease that is associated with troublesome symptoms and/or complications on account of reflux of stomach contents into the esophagus. The complaints are divided into esophageal and extra-esophageal syndromes. Among the novel aspects of this definition are the patient-orientated approach that is independent of endoscopic findings, the classification of the ailment into independent syndromes as well as the consideration of laryngitis, cough, asthma and dental problems as possible GERD syndromes. Furthermore, a new definition of suspected or demonstrated Barrett's esophagus is proposed. Irrespective of country-specific differences in terminology, language, prevalence and manifestations of this disease, evidence-based, world-wide valid consensus definitions are possible. A global consensus definition of GERD will simplify disease management, make mutual research possible and help in the design of generally valid studies. This will not only help the patient but also the physician and supervisory bodies.
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Critical needs for treatment trials in gastroesophageal reflux disease (GERD) include assessing response to treatment, evaluating symptom severity, and translation of symptom questionnaires into multiple languages. We evaluated the previously validated Reflux Disease Questionnaire (RDQ) for internal consistency, reliability, responsiveness to change during treatment and the concordance between RDQ and specialty physician assessment of symptom severity, after translation into Swedish and Norwegian. Performance of the RDQ after translation into Swedish and Norwegian was evaluated in 439 patients with presumed GERD in a randomized, double-blind trial of active treatment with a proton pump inhibitor. The responsiveness was excellent across three RDQ indicators. Mean change scores in patients on active treatment were large, also reflected in effect sizes that ranged from a low of 1.05 (dyspepsia) to a high of 2.05 (heartburn) and standardized response means 0.99 (dyspepsia) and 1.52 (heartburn). A good positive correlation between physician severity ratings and RDQ scale scores was seen. The internal consistency reliability using alpha coefficients of the scales, regardless of language, ranged from 0.67 to 0.89. The results provide strong evidence that the RDQ is amenable to translation and represents a viable instrument for assessing response to treatment, and symptom severity.
Article
The present survey aimed to clarify the prevalence of gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) in patients presenting with epigastric symptoms in Japan based on the Montreal definition and the Rome III criteria, respectively, and to determine the degree of overlap between the two disease entities and the validity of using these Western-developed diagnostic criteria in Japan. Patients presenting with epigastric symptoms for whom the first upper gastrointestinal endoscopy was scheduled from April through August 2007 at 55 institutions were asked to complete a questionnaire to ascertain the type, frequency, and severity of epigastric symptoms. The prevalence of esophageal mucosal damage was also determined from endoscopic findings. A total of 1,076 patients were included in the analysis population. There was a high degree of coincidence for all symptoms, with the mean number of symptoms per patient of 2.8. With strict application of the Montreal and Rome III definitions, symptomatic GERD accounted for 15.6% (168 patients), whereas FD accounted for 10.3% (111 patients), and the overlap between GERD and FD symptoms was less than 10%. However, when frequency and severity alone were considered in more broadly defined criteria, the overlap between GERD and FD symptoms was 30-40%. A highly specific disease classification is possible when the Montreal definition and the Rome III criteria are strictly applied. On the other hand, the present survey highlighted a problem with the criteria whereby a definitive diagnosis could not be made in a substantial number of patients. This problem will require further research.
Article
To determine the prevalence and symptom pattern of pathologic esophageal acid reflux (PEAR) in patients with functional dyspepsia (FD) using the Rome III criteria, and to explore the value of a proton pump inhibitor (PPI) test in distinguishing the patients with and those without PEAR among FD patients. Consecutive FD patients who fulfilled the Rome III criteria without predominant typical reflux symptoms (i.e., heartburn or regurgitation) were enrolled. All patients underwent upper endoscopy and an ambulatory 24-h pH monitoring. PEAR was defined as the percentage total time for which a pH value <4 was >4.2% in the distal esophagus. Then, patients were treated with rabeprazole 10 mg twice daily for 28 days. The symptom scores were measured by the frequency score multiplied by the severity scores of the predominant symptom before and at the end of the treatment, and the "PPI test" was defined as positive if the overall scores of the predominant dyspeptic symptom in the fourth week decreased by >50% compared with those of the baseline. One hundred eighty-six FD patients were enrolled, with predominant symptoms of epigastric pain (n=68), epigastric burning (n=47), bothersome postprandial fullness (n=54), and early satiation (n=17). The prevalence of PEAR was 31.7%, with the highest percentage (48.9%) in patients with epigastric burning as their predominant symptom. The prevalence of PEAR in patients with postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS) were 36.6% (26/71) and 28.7% (33/115), respectively. Overall, 63.4% were positive for the "PPI test"; the rates were 51.5, 85.0, 66.7, and 41.1% in patients with epigastric pain, epigastric burning, bothersome postprandial fullness, and early satiation as their predominant symptoms, respectively (χ(2)=17.59, P=0.001). The positive rates were 65.5 and 60.6% in patients with PDS and EPS, respectively (χ(2)=0.41, P=0.522). The sensitivity and specificity of the "PPI test" in distinguishing FD patients with PEAR was 83.1 and 45.7%, respectively. PEAR is present in almost one third of FD patients; the prevalence is ∼50% in those with epigastric burning. The "PPI test" has a limited value in distinguishing the FD patients with and those without PEAR.
Article
The aim of this study was to determine the accuracy of the diagnosis of gastro-oesophageal reflux disease (GORD) by the Reflux Disease Questionnaire (RDQ), family practitioners, gastroenterologists and a test of esomeprazole therapy. This was a single-blind, single-arm study over 3-4 weeks from September 2005 to November 2006. Each symptom-based diagnostic assessment was made blinded to prior diagnoses. Patients were those presenting to their family practitioner with troublesome upper gastrointestinal symptoms (n=308). The RDQ was completed and a symptom-based diagnosis was made by the family practitioner. Placebo esomeprazole was started. Gastroenterologists made a symptom-based diagnosis and then performed endoscopy with 48 h oesophageal pH and symptom association monitoring to determine the presence/absence of GORD. Symptoms were recorded during treatment with 40 mg of esomeprazole for 2 weeks. The main outcome measure was RDQ scoring for the presence of GORD compared with symptom-based diagnosis by family physicians and gastroenterologists. GORD was present in 203/308 (66%) patients. Only 49% of the patients with GORD selected either heartburn or regurgitation as the most troublesome symptom. Sensitivity and specificity, respectively, of the symptom-based diagnosis of GORD, were 62% and 67% for the RDQ, 63% and 63% for family practitioners, and 67% and 70% for gastroenterologists. Symptom response to esomeprazole was neither sensitive nor specific for the diagnosis of GORD. The RDQ, family practitioners and gastroenterologists have moderate and similar accuracy for diagnosis of GORD. Symptom response to a 2 week course of 40 mg of esomeprazole does not add diagnostic precision.
Article
The American Journal of Gastroenterology is published by Nature Publishing Group (NPG) on behalf of the American College of Gastroenterology (ACG). Ranked the #1 clinical journal covering gastroenterology and hepatology*, The American Journal of Gastroenterology (AJG) provides practical and professional support for clinicians dealing with the gastroenterological disorders seen most often in patients. Published with practicing clinicians in mind, the journal aims to be easily accessible, organizing its content by topic, both online and in print. www.amjgastro.com, *2007 Journal Citation Report (Thomson Reuters, 2008)
Article
All methods currently used to quantify the temporal relationships between symptoms and episodes of gastroesophageal reflux, as assessed by 24-hour pH monitoring, have major shortcomings. The aim of this study was to develop and validate a simple, all-comprising statistical method to calculate the probability that gastroesophageal reflux episodes and symptoms are associated. The 24-hour pH signal was divided into consecutive 2-minute periods. These periods and the 2-minute periods preceding the onset of symptoms were evaluated for the occurrence of reflux. Fisher's Exact Test was then applied to calculate the probability (P value) that reflux and symptom episodes were unrelated. Finally, the symptom-association probability (SAP) was calculated as (1.0 - P) x 100%. The SAP values found in 184 24-hour esophageal pH tests were compared with the symptom index and the symptom sensitivity index. Discordance between the SAP and the symptom index was found in 21 patients (11%) and discordance between the SAP and the symptom-sensitivity index in 28 (15%). False-positive and false-negative symptom index values occurred preferentially in patients with small and large numbers of symptom episodes during the test, respectively (P < 0.05). The SAP is a single, simple, quantitative measure of the strength of the association between symptoms and reflux episodes that is devoid of the disadvantages inherent to previously used methods.
Article
Brief, reliable, and valid self-administered questionnaires could facilitate the diagnosis of gastroesophageal reflux disease in primary care. We report the development and validation of such an instrument. Content validity was informed by literature review, expert opinion, and cognitive interviewing of 50 patients resulting in a 22-item survey. For psychometric analyses, primary care patients completed the new questionnaire at enrollment and at intervals ranging from 3 days to 3 wk. Multitrait scaling, test-retest reliability, and responsiveness were assessed. Predictive validity analyses of all scales and items used specialty physician diagnosis as the "gold standard." Iterative factor analyses yielded three scales of four items each including heartburn, acid regurgitation, and dyspepsia. Multitrait scaling criteria including internal consistency, item interval consistency, and item discrimination were 100% satisfied. Test-retest reliability was high in those reporting stable symptoms. Scale scores significantly changed in those reporting a global change. Regressing specialty physician diagnosis on the three scales revealed significant effects for two scales (heartburn and regurgitation). Combining the two significant scales enhanced the strength of the model. Symptom response to self-directed treatment with nonprescription antisecretory medications was highly predictive of the diagnosis also, although the item demonstrated poor validity and reliability. A brief, simple 12-item questionnaire demonstrated validity and reliability and seemed to be responsive to change for reflux and dyspeptic symptoms.
Article
Functional dyspepsia (FD) is considered a heterogeneous disorder with different pathophysiological mechanisms contributing to the symptom pattern. The Rome II committee proposed that subdividing patients with FD into groups with predominant pain versus discomfort might identify subgroups with homogeneous pathophysiological and clinical properties. The aim of this study was to analyze the relationship of predominant pain or discomfort with pathophysiological mechanisms and to evaluate whether considering individual predominant symptoms yields better results. Consecutive FD patients (n = 720; 489 women; mean age, 41.3 +/- 0.6 years) filled out a dyspepsia questionnaire and identified a single most bothersome symptom. We analyzed the association of this predominant symptom with demographic, clinical, and pathophysiological features (Helicobacter pylori status, gastric emptying in 592 patients, and gastric sensitivity and accommodation testing in 332 patients). According to Rome II criteria, 22% were pain predominant and 78% discomfort predominant. Patients with predominant pain had a higher prevalence of hypersensitivity (44% vs 25%) and delayed gastric emptying was observed less frequently in these patients (16% vs 26%), but there was major overlap. Detailed analysis showed that any of 8 dyspeptic symptoms could be predominant. Predominant early satiety or vomiting was associated with significantly higher prevalences of weight loss (89% and 75%, respectively) and of acute onset (61% and 60%, respectively). Impaired accommodation was found in 79% of patients with predominant early satiety. The highest prevalence of delayed emptying was found in predominant fullness (38%) and of hypersensitivity in predominant pain (44%). Subdividing FD patient groups according to the predominant symptom does not reliably identify subgroups with a homogeneous underlying pathophysiological mechanism.
Article
A numerically important group of patients with functional gastrointestinal disorders have chronic symptoms that can be attributed to the gastroduodenal region. Based on the consensus opinion of an international panel of clinical investigators who reviewed the available evidence, a classification of the functional gastroduodenal disorders is proposed. Four categories of functional gastroduodenal disorders are distinguished. The first category, functional dyspepsia, groups patients with symptoms thought to originate from the gastroduodenal region, specifically epigastric pain or burning, postprandial fullness, or early satiation. Based on recent evidence and clinical experience, a subgroup classification is proposed for postprandial distress syndrome (early satiation or postprandial fullness) and epigastric pain syndrome (pain or burning in the epigastrium). The second category, belching disorders, comprises aerophagia (troublesome repetitive belching with observed excessive air swallowing) and unspecified belching (no evidence of excessive air swallowing). The third category, nausea and vomiting disorders, comprises chronic idiopathic nausea (frequent bothersome nausea without vomiting), functional vomiting (recurrent vomiting in the absence of self-induced vomiting, or underlying eating disorders, metabolic disorders, drug intake, or psychiatric or central nervous system disorders), and cyclic vomiting syndrome (stereotypical episodes of vomiting with vomiting-free intervals). The rumination syndrome is a fourth category of functional gastroduodenal disorder characterized by effortless regurgitation of recently ingested food into the mouth followed by rechewing and reswallowing or expulsion. The proposed classification requires further research and careful validation but the criteria should be of value for clinical practice; for epidemiological, pathophysiological, and clinical management studies; and for drug development.
Article
Man should strive to have his intestines relaxed all the days of his life. Moses Maimonides, AD 1135–1204 A good set of bowels is worth more to a man than any quantity of brains. Josh Billings (Henry Wheeler Shaw), AD 1818–1885 For centuries, physicians and historians have recognized that it is common for maladies to afflict the intestinal tract, producing symptoms of pain, nausea, vomiting, bloating, diarrhea, constipation, difficult passage of food or feces, or any combination.1When these symptoms are experienced as severe, or when they impact on daily life, those afflicted often attribute the symptoms to an illness and seek medical care. Traditionally, the physicians caring for these patients will search for inflammatory, infectious, neoplastic, and other structural abnormalities to make a specific diagnosis and offer specific treatment. Yet as has been common in medical practice,2 when no structural etiology is found, the patient is diagnosed as having “functional” symptoms and is treated symptomatically. Until recently, the limited scientific knowledge about the pathophysiology of these symptoms, and the need to diagnose by excluding “organic” disease, has led physicians to feel uncertain about the legitimacy of these symptoms as bona fide disorders.3 Some have felt insecure in their ability to manage patients with these conditions, and might even avoid caring for patients with these complaints. But over the past two decades, two important processes have occurred to legitimize these conditions, and to increase attention toward the research and clinical care of patients with functional gastrointestinal disorders (FGID). The first has been a shift in conceptualizing these disorders from a disease-based, reductionistic model, where the effort is directed toward identifying a single underlying biological etiology, to a more integrated, biopsychosocial model of illness.4 5 The latter model allows for symptoms to be understood as physiologically …
Article
A globally acceptable definition and classification of gastroesophageal reflux disease (GERD) is desirable for research and clinical practice. The aim of this initiative was to develop a consensus definition and classification that would be useful for patients, physicians, and regulatory agencies. A modified Delphi process was employed to reach consensus using repeated iterative voting. A series of statements was developed by a working group of five experts after a systematic review of the literature in three databases (Embase, Cochrane trials register, Medline). Over a period of 2 yr, the statements were developed, modified, and approved through four rounds of voting. The voting group consisted of 44 experts from 18 countries. The final vote was conducted on a 6-point scale and consensus was defined a priori as agreement by two-thirds of the participants. The level of agreement strengthened throughout the process with two-thirds of the participants agreeing with 86%, 88%, 94%, and 100% of statements at each vote, respectively. At the final vote, 94% of the final 51 statements were approved by 90% of the Consensus Group, and 90% of statements were accepted with strong agreement or minor reservation. GERD was defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. The disease was subclassified into esophageal and extraesophageal syndromes. Novel aspects of the new definition include a patient-centered approach that is independent of endoscopic findings, subclassification of the disease into discrete syndromes, and the recognition of laryngitis, cough, asthma, and dental erosions as possible GERD syndromes. It also proposes a new definition for suspected and proven Barrett's esophagus. Evidence-based global consensus definitions are possible despite differences in terminology and language, prevalence, and manifestations of the disease in different countries. A global consensus definition for GERD may simplify disease management, allow collaborative research, and make studies more generalizable, assisting patients, physicians, and regulatory agencies.
Article
The reflux disease questionnaire (RDQ) is a short, patient-completed instrument. To investigate the psychometric characteristics of the RDQ in patients with heartburn-predominant (HB) and non-heartburn predominant (NHB) dyspepsia. HB (n = 388) and NHB (n = 733) patients were randomized to esomeprazole 40 mg daily or twice daily for 1 week, followed by 3 weeks of esomeprazole 40 mg daily. High factor loadings (0.78-0.86) supported the 'regurgitation' dimension of the RDQ. Overlapping factor loadings in the 'heartburn' and 'dyspepsia' dimensions suggested symptom overlap. All dimensions demonstrated high internal consistency (Cronbach's alpha: 0.79-0.90). Intra-class correlation coefficients over 4 weeks were good (0.66-0.85). The RDQ showed good responsiveness over 4 weeks of treatment, with high effect sizes (> or =0.80). Moderate or large symptom improvements were reported by 90% and 77% of HB and NHB patients, respectively, following treatment. Patients who responded to acid suppression also experienced symptom benefits in all RDQ dimensions. The RDQ is reliable, valid and responsive to change in HB and NHB patients. The symptom overlap is important but need not play a major role in determining treatment strategy as both patient groups benefited from proton pump inhibitor treatment.
Article
Functional dyspepsia (FD) is a common disorder but there is currently little efficacious drug therapy. Itopride, a prokinetic approved in several countries, showed promising efficacy in FD in a phase IIb trial. The aim of this study was to test the efficacy and safety of this drug in FD. Two similar placebo-controlled clinical trials were conducted (International and North America). Males and females, 18-65 years old, with a diagnosis of FD (Rome II) and the absence (by upper endoscopy) of any relevant structural disease were recruited. All were negative for Helicobacter pylori and, if present, heartburn could not exceed one episode per week. Following screening, patients were randomised to itopride 100 mg three times daily or identical placebo. The co-primary end points were: (1) global patient assessment (GPA) of efficacy; and (2) Leeds Dyspepsia Questionnaire (LDQ). Symptoms were evaluated at weeks 2, 4 and 8. Secondary measures of efficacy included Nepean Dyspepsia Index (NDI) quality of life. The GPA responder rates at week 8 on itopride versus placebo were similar in both trials (45.2% vs 45.6% and 37.8 vs 35.4%, respectively; p = NS). A significant benefit of itopride over placebo was observed for the LDQ responders in the International (62% vs 52.7%, p = 0.04) but not the North American trial (46.9% vs 44.8%). The safety and tolerability profile were comparable with placebo, with the exception of prolactin elevations, which occurred more frequently on itopride (18/579) than placebo (1/591). In this population with FD, itopride did not show a difference in symptom response from placebo.