Double-blind, randomized, 8-week multicenter study of the efficacy and safety of STW 5-IIversus placebo in functional dyspepsia.

Background and Aim: Herbal products are widely used to treat patients with disorders of gut brain interaction but clinical efficacy and safety data for treatments lasting >4 weeks are widely lacking. We evaluated the efficacy and safety of 8 weeks of treatment with the herbal combination product STW 5-II for patients with functional dyspepsia (FD) meeting Rome II criteria. We also conducted a post hoc analysis including patients meeting Rome IV criteria for FD and evaluated the effect of the G-protein beta 3 (GNB3) subunit polymorphism (C825T) on therapeutic response. Methods: This multicenter, placebo-controlled, double-blind study included 272 FD patients meeting Rome II criteria in the intention-to-treat cohort and 266 meeting Rome IV criteria. We used the validated Gastrointestinal Symptom Score (GIS) to assess GI symptoms, defining response rate as the proportion of patients with ≥50% GIS improvement in at least three of four assessments. Results: After 8 weeks, the response rate was significantly higher in the STW 5-II group versus placebo (61.2% vs 45.1%, P = 0.008). Mean GIS non-significantly improved with STW 5-II treatment (7.9 ± 4.41 vs 6.7 ± 4.91 with placebo; P = 0.07). In the Rome IV subgroup analysis, STW 5-II yielded a better response rate (P = 0.01) versus placebo and greater postprandial distress symptom improvement (P = 0.04) versus placebo. Safety parameters did not differ between groups, and GNB3 status was not linked with therapeutic response. Conclusion: STW 5-II is efficacious, with no observed safety signals at up to 8 weeks of treatment in patients with FD meeting Rome II or IV criteria.

Worldwide population prevalence and impact of sub-diagnostic gastrointestinal symptoms.

BACKGROUND: The Rome Foundation Global Epidemiology Study (RFGES) found that 40.3% of adults in 26 internet-surveyed countries met Rome IV criteria for disorders of gut-brain interaction (DGBI). However, additional people not meeting DGBI criteria may also be burdened by frequent gastrointestinal symptoms. AIMS: To explore the prevalence and demographic distribution of sub-diagnostic gastrointestinal symptoms, and the hypothesised associated effects on quality of life (QoL), life functioning and healthcare needs. METHODS: We analysed data from the RFGES survey, which included the Rome IV diagnostic questionnaire and QoL, psychological, work productivity and healthcare questions. RESULTS: Of the 50,033 people without a history of organic gastrointestinal disorders, 25.3% classified in the sub-diagnostic group (no DGBI but one or more frequent gastrointestinal symptoms), 41.4% had DGBI and 33.4% had no frequent gastrointestinal symptoms (non-GI group). Sub-diagnostic prevalence in different world regions ranged from 22.2% (North America) to 30.5% (Middle East), was slightly higher among males than females and decreased with age. The sub-diagnostic group was intermediate between the non-GI and DGBI groups, and significantly different from both of them on QoL, anxiety, depression, somatisation, healthcare utilisation and life and work impairment. CONCLUSIONS: One in four adults without organic gastrointestinal disorders or DGBI report frequent gastrointestinal symptoms. This sub-diagnostic group has reduced QoL, greater psychological and non-GI bodily symptoms, impaired work productivity and life activities and greater healthcare use compared to non-GI individuals. This suggests that many in this sub-diagnostic group might benefit from healthcare services or symptom self-management advice.

FODMAP meal challenge test: a novel investigation to predict response to low-FODMAP diet in non-constipating irritable bowel syndrome.

BACKGROUND: Though a low-FODMAP diet improves 50% irritable bowel syndrome (IBS) patients, regional dietary variations, vegetarianism, and long-term nutritional consequences challenge its implementation. We aimed developing a FODMAP meal challenge test (FMCT). We prospectively studied whether (i) high- than low-FODMAP foods produce more breath H2 among IBS patients than controls; (ii) post-meal symptoms relate to breath H2 ; and (iii) novel FMCT predicts response to a low-FODMAP diet? METHODS: Forty Rome III IBS and 20 healthy controls underwent an eight-hour H2 breath test following a low- (rice, brinjal, corn, and banana [450 Kcal]) and a high-FODMAP meal (wheat, kidney bean, pulse, and card [450 Kcal]). Breath H2 (every 15 min) and symptoms following low- and high-FODMAP meals were recorded. IBS-symptom severity scores were recorded every month for 3-months on low-FODMAP diet. RESULTS: Forty Rome III IBS (19 Rome IV positive) were comparable to 20 controls in age and gender. IBS patients (n = 39 excluding one H2 non-producer) and controls produced more breath H2 after high- (greater in IBS) than low-FODMAP meal. Post-meal symptoms were commoner in IBS (4/40 [10%] and 27/40 [67.5%] with low- and high-FODMAP, respectively [P < 0.00001]; none in healthy). IBS patients developing post-high-FODMAP meal symptoms produced greater H2 (18 PPM [IQR 10.5-23] vs 6 [0-7.2]; P < 0.001). A positive FMCT (breath H2  > 10 PPM above basal with symptoms following high-FODMAP food) had sensitivity, specificity, and diagnostic accuracy of 78.6%, 66.6%, and 75.6%, respectively, to predict low-FODMAP diet response. CONCLUSIONS: The novel FMCT predicts response to a low-FODMAP diet in IBS.

Functional gallbladder disorder: Interim analysis of a prospective cohort study.

BACKGROUND: Functional gallbladder disorder (FGBD) remains a controversial indication for cholecystectomy. METHODS: A prospective cohort study enrolled patients strictly meeting Rome criteria for FGBD, and cholecystectomy was performed. They were assessed pre- and 3 and 6 months postoperatively with surveys of abdominal pain and quality of life (RAPID and SF-12 surveys, respectively). Interim analysis was performed. RESULTS: Although neither ejection fraction nor pain reproduction predicted success after cholecystectomy, the vast majority of enrolled patients had a successful outcome after undergoing cholecystectomy for FGBD: of a planned 100 patients, 46 were enrolled. Of 31 evaluable patients, 26 (83.9 â€‹%) reported RAPID improvement and 28 (93.3 â€‹%) SF12 improvement at 3- or 6-month follow-up. CONCLUSION: FGBD, strictly diagnosed, should perhaps no longer be a controversial indication for cholecystectomy, since its success rate for biliary pain in this study was similar to that for symptomatic cholelithiasis. Larger-scale studies or randomized trials may confirm these findings.

Pharmacological Management for Pediatric Irritable Bowel Syndrome: A Review.

Irritable bowel syndrome is a multifactorial disease with chronic symptoms that interfere with the quality of life of patients. It represents one of the most common causes of functional abdominal pain in the pediatric population. Various theses with little evidence tried to explain the pathophysiology of the disease. Neurological origin was one of the theories explaining the disease, either by the disturbance of neurotransmitters like dopamine, noradrenaline, and serotonin, which have some evidence of their relation to GI tract functions. Other factors like bio-psycho-social factors that affect the pediatric population are represented in bullying, unrealistic academic expectations from the parents, continuous educational stress, and difficult relationships with peers. Other factors may be genetic abnormalities of the receptors or visceral hypersensitivity. Treatment strategies for the disease varied from physical activity like yoga to a diet like a low-FODMAP diet. Pharmacological treatment of the disease targets the presenting symptoms, represented by antispasmodic drugs treating abdominal pain/discomfort, antipsychotics that regulate the disturbance in the brain-gut axis, and other drugs targeting diarrhea or constipation that present with the patient according to the type of IBS and the condition of the patient.

Diagnosis of Irritable Bowel Syndrome: Primary Care Physicians Compared with Gastroenterologists.

Objective: To examine disparities between primary care provider (PCP) and gastroenterologist diagnosis and management of irritable bowel syndrome (IBS).Design: Retrospective cross-sectional study.Setting: A 547-bed quaternary-care hospital within the Loyola University Healthcare System.Participants: 1000 patients aged 18-65 with an ICD-10 diagnosis of IBSMethods: We randomly selected 1000 patients aged 18 to 65 years within the Loyola University Healthcare System's electronic medical record with an ICD-10 diagnosis of IBS. Physician notes and diagnostic results were reviewed for documentation of symptoms fulfilling Rome IV criteria and resolution of symptoms. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of primary diagnoses assigned by PCPs and gastroenterologists were assessed along with number of diagnostic tests ordered.Results: The mean age (SD) was 45 (12) years, and 76.9% were female. Sensitivity of an IBS diagnosis by a PCP was 77.6% (95% CI 73.3-81.9), compared with 60.1% (95% CI 54.7-65.6) for a gastroenterologist. Specificity of an IBS diagnosis by a PCP was 27.5% (95% CI 23.5-31.5), compared with 71.1% (95% CI 64.6-77.5) for a gastroenterologist diagnosis of IBS. A gastroenterologist diagnosis of IBS carried a high PPV (77.3%, 95% CI 72.0-82.6) compared with 44.6% (95% CI 40.7-48.5) for a PCP. Of 180 patients with outcome data, 69.4% had resolution of symptoms at follow-up.Conclusion: The sensitivity of gastroenterologist diagnosis of IBS closely matches the sensitivity of Rome IV criteria in validation studies. The high specificity and PPV of gastroenterologists suggest more cautious diagnosis by gastroenterologists, with PCPs more likely to assign a diagnosis of IBS incorrectly or without sufficient documentation of symptoms fulfilling Rome IV criteria. Reported resolution rates suggest primary care management of IBS is appropriate, but PCPs may benefit from gastroenterologist consultation and diagnostic guidelines for greater specificity in diagnosing IBS.

Re-investigation of functional gastrointestinal disorders utilizing a machine learning approach.

BACKGROUND: Functional gastrointestinal disorders (FGIDs), as a group of syndromes with no identified structural or pathophysiological biomarkers, are currently classified by Rome criteria based on gastrointestinal symptoms (GI). However, the high overlap among FGIDs in patients makes treatment and identifying underlying mechanisms challenging. Furthermore, disregarding psychological factors in the current classification, despite their approved relationship with GI symptoms, underlines the necessity of more investigation into grouping FGID patients. We aimed to provide more homogenous and well-separated clusters based on both GI and psychological characteristics for patients with FGIDs using an unsupervised machine learning algorithm. METHODS: Based on a cross-sectional study, 3765 (79%) patients with at least one FGID were included in the current study. In the first step, the clustering utilizing a machine learning algorithm was merely executed based on GI symptoms. In the second step, considering the previous step's results and focusing on the clusters with a diverse combination of GI symptoms, the clustering was re-conducted based on both GI symptoms and psychological factors. RESULTS: The first phase clustering of all participants based on GI symptoms resulted in the formation of pure and non-pure clusters. Pure clusters exactly illustrated the properties of most pure Rome syndromes. Re-clustering the members of the non-pure clusters based on GI and psychological factors (i.e., the second clustering step) resulted in eight new clusters, indicating the dominance of multiple factors but well-discriminated from other clusters. The results of the second step especially highlight the impact of psychological factors in grouping FGIDs. CONCLUSIONS: In the current study, the existence of Rome disorders, which were previously defined by expert opinion-based consensus, was approved, and, eight new clusters with multiple dominant symptoms based on GI and psychological factors were also introduced. The more homogeneous clusters of patients could lead to the design of more precise clinical experiments and further targeted patient care.

Fecal microbiota transplant delivered via invasive routes in irritable bowel syndrome: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND AND AIMS: Irritable bowel syndrome (IBS) results in significant loss of quality of life. Management guidelines do not recommend fecal microbiota transplant (FMT) for IBS based on weak evidence as refined data is lacking. We performed a systematic review and meta-analysis to ascertain the pooled clinical outcomes of FMT in IBS, delivered via invasive routes. METHODS: Multiple databases were searched through January 2023 to identify studies that reported on FMT treatment in IBS by invasive routes. Standard meta-analysis methodology using the random-effects model was used. Heterogeneity was assessed by I2% and 95% predication interval. RESULTS: Five studies were included. As many as 377 IBS patients were assessed, of which 238 received FMT and 139 received placebo. One study used nasojejunal tubes, one esophagogastroduodenoscopy and three colonoscopy for FMT delivery. FMT via colonoscopy was performed as a one-time procedure instilled into the cecum. Two studies used 30 g of stool from a single universal donor and one study used 50-80 g of pooled donor feces. The pooled odds ratio of improvement in IBS symptoms with FMT was significantly better as compared to that of placebo OR = 2.9 (95% CI [1.6-5.2, I2 = 62%, p < 0.001]). This was true for studies that exclusively used colonoscopy (OR = 2.1 [1.1-4.2, p = 0.04]). In the FMT arm, 10 patients (10.6%) reported abdomen pain and worsening of symptoms with bloating and six patients (6.3%) reported diarrhea. CONCLUSION: FMT delivered via invasive routes, especially colonoscopy, demonstrated significant improvement in IBS symptoms. A single FMT consisting of 30 g or more of single universal donor feces instilled into the cecum is the predominant modality.

Indian consensus statements on irritable bowel syndrome in adults: A guideline by the Indian Neurogastroenterology and Motility Association and jointly supported by the Indian Society of Gastroenterology.

The Indian Neurogastroenterology and Motility Association (INMA), earlier named the Indian Motility and Functional Diseases Association developed this evidence-based practice guidelines for the management of irritable bowel syndrome (IBS). A modified Delphi process was used to develop this consensus containing 28 statements, which were concerning diagnostic criteria, epidemiology, etiopathogenesis and comorbidities, investigations, lifestyle modifications and treatments. Owing to the Coronavirus disease-19 (COVID-19) pandemic, lockdowns and mobility restrictions, web-based meetings and electronic voting were the major tools used to develop this consensus. A statement was regarded as accepted when the sum of "completely accepted" and "accepted with minor reservation" voted responses were 80% or higher. Finally, the consensus was achieved on all 28 statements. The consensus team members are of the view that this work may find use in teaching, patient care, and research on IBS in India and other nations.

A double-blind randomized clinical trial of Dracocephalum kotschyi Boiss. in the patients with diarrhea-predominant irritable bowel syndrome.

Background and purpose: Irritable bowel syndrome (IBS) is a disease that shows its impacts on many populations worldwide. It is known as a functional disorder of the gastrointestinal tract followed by diarrhea and fecal inconsistency. Due to the lack of treatment in the allopathic medicine system for IBS, people in the western world use different herbs as alternative medicine. In the present study, we evaluated the dried extract of Dracocephalum kotschyi against IBS. Experimental approach: In a randomized, double-blinded, placebo-controlled clinical trial, 76 diarrhea-predominant IBS patients were randomly assigned to two equal groups: the control group (given the placebo capsule containing 250 mg of dibasic calcium phosphate) and the treatment groups (given the capsule containing 75 mg of the dry extract of D. kotschyi and 175 mg of dibasic calcium phosphate as filler). The study was conducted based on Rome III criteria. We studied symptoms included in Rome III criteria and divided the study into the duration of drug administration and four weeks after drug administration. These groups were compared with those of the control group. Findings/Results: Significant improvements were found in the quality of life, temperament, and IBS symptoms throughout the treatment duration. Quality of life, temperature, and IBS symptoms were slightly decreased in the treatment group 4 weeks after stopping the treatment. While concluding the study, we found D. kotschyi effective against IBS. Conclusion and implications: Whole extract of D. kotschyi modulated symptoms of IBS patients and improved their quality of life.

Incidence of intestinal constipation during the COVID-19 pandemic period in medical students from a private institution in São Paulo, SP

Introduction: Chronic intestinal constipation (CIC) presents an incidence of 2.6 to 30.7% in the overall population and due to the social reality imposed by the coronavirus pandemic, some behavior changes in the Brazilian population occurred that might or not be associated with alterations of CIC prevalence. Objective: To assess CIC incidence in medical students before and during the COVID-19 pandemic in Brazil in a private higher educational institution in the city of São Paulo, state of São Paulo. Methods: Clinic data were collected through Google Forms software from the same students seeking to analyze the variables before (year of 2019) and during the coronavirus pandemic. The data were: age, sex, body mass index, constipation referred in a subjective way and confirmed through the ROME III criteria, feces consistency and anxiety and/or depression during the pandemic. Results: A total of 126 medical students from a private higher education institution from São Paulo, SP were included. The average age was 22.9 years old, 70.6% were female and the average BMI was 23.3 kg/m2. Regarding the ROME III criteria, 32.5% presented >2 in 2019 and 42.1% during the pandemic. Concerning the feces consistency, 31.75 and 35.71% presented dry Bristol 1 feces or in both periods, respectively. Conclusion: It was observed an increase in the prevalence of chronic intestinal constipation in medical students from a private higher education institution from São Paulo, state of São Paulo, during the COVID-19 pandemic, as well as dryness in the feces. (AU)

Comparison of Anorectal Manometry, Rectal Balloon Expulsion Test, and Defecography for Diagnosing Defecatory Disorders.

BACKGROUND & AIMS: The utility of high-resolution anorectal manometry (HR-ARM) for diagnosing defecatory disorders (DDs) is unclear because healthy people may have features of dyssynergia. We aimed to identify objective diagnostic criteria for DD and to ascertain the utility of HR-ARM for diagnosing DD. METHODS: Constipated patients were assessed with HR-ARM and rectal balloon expulsion time (BET), and a subset underwent defecography. Normal values were established by assessing 184 sex-matched healthy individuals. Logistic regression models evaluated the association of abnormal HR-ARM findings with prolonged BET and reduced rectal evacuation (determined by defecography). RESULTS: A total of 474 constipated individuals (420 women) underwent HR-ARM and BET, and 158 underwent defecography. BET was prolonged, suggesting a DD, for 152 patients (32%). Rectal evacuation was lower for patients with prolonged vs normal BET. A lower rectoanal gradient during evacuation, reduced anal squeeze increment, and reduced rectal sensation were independently associated with abnormal BETs; the rectoanal gradient was 36% sensitive and 85% specific for prolonged BET. A lower rectoanal gradient and prolonged BET were independently associated with reduced evacuation. Among constipated patients, the probability of reduced rectal evacuation was 14% when the gradient and BET were both normal, 45% when either was abnormal, and 75% when both variables were abnormal. CONCLUSIONS: HR-ARM, BET, and defecography findings were concordant for constipated patients, and reduced rectoanal gradient was the best HR-ARM predictor of prolonged BET or reduced rectal evacuation. Prolonged BET, reduced gradient, and reduced evacuation each independently supported a diagnosis of DD in constipated patients. We propose the terms probable DD for patients with an isolated abnormal gradient or BET and definite DD for patients with abnormal results from both tests.

Translational Gap between Guidelines and Clinical Medicine: The Viewpoint of Italian General Practitioners in the Management of IBS.

Irritable bowel syndrome (IBS) guidelines are generally developed by experts, with the possibility of a translational gap in clinical medicine. The aim of our study was to assess an Italian group of general practitioners (GPs) for their awareness and use of criteria for the diagnosis and management of IBS. For this purpose, a survey was carried out involving 235 GPs, divided into two groups according to their years of activity: 65 "junior general practitioners" (JGPs) (≤10 years) and 170 "senior general practitioners" (SGPs) (>10 years). JGPs were more familiar with the Rome IV Criteria and Bristol Scale than SGPs. Abdominal pain, bowel movement frequency and bloating were the symptoms most frequently used to make a diagnosis. The most probable causes of IBS were reported to be abnormal gastrointestinal motility and psychological triggers. SGPs reported more frequently than JGPs that challenging management and patient's request were motivations for a gastroenterological consultation. The practice of clinical medicine is still far from the guidelines provided by the specialists. Abdominal pain related to defecation and changes in bowel frequency are considered to be the more important symptoms for IBS diagnosis, but most GPs, both JGPs and SGPs, like to consider abdominal bloating as another useful symptom. Involving both gastroenterologists and GPs in developing shared guidelines would be highly desirable in order to improve IBS management strategies in everyday clinical practice.

Constipation Symptoms in Multiple System Atrophy Using Rome Criteria and Their Impact on Personalized Medicine.

Constipation is one of the most common non-motor symptoms in multiple system atrophy (MSA); however, it has not been evaluated according to the standard diagnostic criteria for constipation in patients with MSA. We evaluated the characteristics of constipation in patients with MSA by using Rome criteria (Rome III), which has been validated and the widely used for gastrointestinal disorders. Fifty-one patients with MSA (29 female) were enrolled in the study. Based on the Rome III criteria, constipation was diagnosed in 29 patients (56.9%); irritable bowel syndrome was not detected. Thirty-seven patients (72.5%) were aware of their constipation. The most common constipation symptom was the sensation of anorectal obstruction (68.6%). Patients' self-awareness of constipation was most strongly correlated to the sensation of incomplete evacuation (odds ratio: 7.377, 95% confidence interval: 1.402−38.817). The number of constipation-related symptoms was correlated with the total levodopa equivalent dose (p < 0.05). Rome criteria, which can detect various constipation symptoms, are useful for evaluating constipation in MSA, and these findings may greatly impact personalized medicine.

Epidemiology and Clinical Characteristics Based on the Rome III and IV Criteria of Japanese Patients with Functional Dyspepsia.

The subtypes of functional dyspepsia (FD) differ depending on whether the Rome III criteria or the Rome IV criteria are used. We investigated the ability to diagnose FD patients using the Rome III and IV criteria. The subtypes of FD were evaluated using the Rome questionnaire. The Gastrointestinal Symptom Rating Score, health-related quality of life (HR-QOL; SF-8), and psychological scores (HADS, STAI) were evaluated. The questionnaire was collected from a total of 205 patients, and 54.1% were FD patients. The ratio of FD patients under the Rome III criteria was 19% for epigastric pain syndrome (EPS), 38% for postprandial distress syndrome (PDS), and 43% for an overlap of EPS and PDS, but under the Rome IV criteria overlap decreased to 17% and PDS increased to 64%. Patients whose subtype changed from overlap under the Rome III criteria to PDS under the Rome IV criteria were compared with PDS patients whose subtype did not change between the Rome III and IV criteria. The comparison showed that the former had significantly lower early satiation rates and significantly higher acid reflux and abdominal pain scores, demonstrating that EPS symptoms due to acid reflux after meals were clearly present. As a result of changing from the Rome III criteria to the Rome IV criteria, the number of overlap patients decreased, and the number of PDS patients increased.

Prevalence and Risk Factors of Functional Constipation According to the Rome Criteria in China: A Systematic Review and Meta-Analysis.

BACKGROUND: Functional constipation (FC) is a common bowel disorder that prevails worldwide. In China, although a heterogeneous prevalence of constipation is expected, it is currently not demonstrated. In this study, we aimed to evaluate the prevalence and related risk factors of FC in the Chinese population, according to the Rome criteria. METHODS: We searched the PubMed, the Embase, the Cochrane Library, the Web of Science, the China National Knowledge Infrastructure (CNKI), the Wanfang data knowledge service platform, the VIP information resource integration service platform, and the Chinese Biomedical Literature Service System (SinoMed) databases from the inception of database to July 2021. Population-based cross-section studies that enrolled adults with FC, diagnosed by the Rome criteria, were deemed eligible. We summarized the overall prevalence and detected the subgroup effect per the Rome I, Rome II, Rome III, and Rome IV criteria. We used the generalized linear mixed model (GLMM) with a random-effect intercept to pool the prevalence and performed pairwise meta-analyses for prevalence comparisons by risk factors. RESULTS: We identified 3,213 records through our database search, and 39 studies from China, comprising 1,240,79 participants, met the eligibility criteria for our study. The pooled overall prevalence of FC using the Rome criteria was 8.5% in China. Heterogeneous prevalence was detected within the Rome criteria (Rome II: 10.6%, 95% CI: 7.2-15.4; Rome III: 6.5%, 95% CI: 3.4-12.0; Rome IV: 8.1%, 95% CI: 5.6-11.8). The prevalence increased between 1991 and 2020 (from 5.5% with 95% CI: 3.6-8.2 between 1991 and 2000 to 10.9% with 95% CI: 5.5-20.4 between 2011 and 2020). Higher prevalence was found in women [odds ratio (OR) = 1.53, 95% CI: 1.31-1.78] and the elderly (≥70 years vs. ≤ 29 years: OR = 3.38, 95% CI: 2.16-5.30) than in men and the younger population. A high-fiber diet was associated with lower prevalence (OR = 0.33, 95% CI: 0.15-0.75), whereas irregular bowel habit and inactivity were associated with higher prevalence (OR = 3.64, 95% CI: 2.64-5.03; OR = 1.97, 95% CI: 1.14-3.43). Unhealthy mental states, such as anxiety and depression, and poor sleep quality led to high prevalence (OR = 3.16, 95%C I: 1.96-5.11; OR = 2.74, 95% CI: 1.76-4.26; OR = 2.14, 95% CI: 1.69-2.72, respectively). CONCLUSION: Various types of FC prevail in China based on the different Rome criteria, personal characteristics, and habits. The prevalence also increased over the past three decades. The FC should be included under the primary care setting with uniform diagnosis criteria in China. SYSTEMATIC REVIEW REGISTRATION: http://www.crd.york.ac.uk/PROSPERO, CRD42021277172.

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

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

Diagnostic Yield of Colonoscopy in Patients With Symptoms Compatible With Rome IV Functional Bowel Disorders.

BACKGROUND & AIMS: There is little data on the diagnostic yield of colonoscopy in patients with symptoms compatible with functional bowel disorders (FBDs). Previous studies have only focused on diagnostic outcomes of colonoscopy in those with suspected irritable bowel syndrome using historic Rome I-III criteria, whilst having partially assessed for alarm features and shown markedly conflicting results. There is also no colonoscopy outcome data for other FBDs, such as functional constipation or functional diarrhea. Using the contemporaneous Rome IV criteria we determined the diagnostic yield of colonoscopy in patients with symptoms compatible with a FBD, stratified diligently according to the presence or absence of alarm features. METHODS: Basic demographics, alarm features, and bowel symptoms using the Rome IV diagnostic questionnaire were collected prospectively from adults attending out-patient colonoscopy in 2019. Endoscopists were blinded to the questionnaire data. Organic disease was defined as the presence of inflammatory bowel disease, colorectal cancer, or microscopic colitis. RESULTS: 646 patients fulfilled symptom-based criteria for the following Rome IV FBDs: IBS (56%), functional diarrhea (27%) and functional constipation (17%). Almost all had alarm features (98%). The combined prevalence of organic disease was 12%, being lowest for functional constipation and IBS-constipation (∼6% each), followed by IBS-mixed (∼9%), and highest amongst functional diarrhea and IBS-diarrhea (∼17% each); p = .005. The increased prevalence of organic disease in diarrheal versus constipation disorders was accounted for by microscopic colitis (5.7% vs. 0%, p < .001) but not inflammatory bowel disease (7.2% vs. 4.0%, p = .2) or colorectal cancer (4.2% vs. 2.3%, p = .2). However, 1-in-4 chronic diarrhea patients - conceivably at risk for microscopic colitis - did not have colonic biopsies taken. Finally, only 11 of 646 (2%) patients were without alarm features, in whom colonoscopy was normal. CONCLUSIONS: Most patients with symptoms of FBDs who are referred for colonoscopy have alarm features. The presence of organic disease is significantly higher in diarrheal versus constipation disorders, with microscopic colitis largely accounting for the difference whilst also being a missed diagnostic opportunity. In those patients without alarm features, the diagnostic yield of colonoscopy was nil.

Food Avoidance and Restriction in Irritable Bowel Syndrome: Relevance for Symptoms, Quality of Life and Nutrient Intake.

BACKGROUND & AIMS: Neither food intake nor the clinical characteristics of irritable bowel syndrome (IBS) patients with severe food avoidance and restriction have been investigated. The aim of our study was to identify those patients and to characterize their symptoms, quality of life, and nutrient intake. METHODS: IBS patients who completed the IBS Quality of Life Instrument (IBS-QOL) at our secondar and tertiary center were included. The 3 questions constituting the food domain were used to identify patients with reported severe food avoidance and restriction. The patients also completed validated questionnaires to assess stool form (Bristol Stool Form), gastrointestinal (GI) symptom severity (z score of IBS Severity Scoring System and Gastrointestinal Symptom Rating Scale-IBS), psychological distress (Hospital Anxiety and Depression Scale), GI-specific anxiety (Visceral Sensitivity Index), and somatic symptom severity (z score of Symptom Checklist-90-Revised and Patient Health Questionnaire-15). A 4-day food diary was used to analyze food intake in 246 patients. RESULTS: We included 955 IBS patients (75 % women; mean age 38.3 ± 13.3 years). In total, 13.2 % of the patients reported severe food avoidance and restriction, and in these patients all aspects of quality of life were lower (P < .01) and psychological, GI, and somatic symptoms were more severe (P < .05). Reported severe food avoidance and restriction was associated with lower total energy intake (P = .002) and lower intake of protein (P = .001) and carbohydrates (P = .005). In a logistic regression analysis, loose stools were found to be independently associated with reported severe food avoidance and restriction (R2 = 0.062). CONCLUSIONS: IBS patients with severe food avoidance and restriction constitute a subgroup with more severe symptoms overall, reduced quality of life, and reduced intake of nutrients. This needs to be acknowledged in the clinical management of these patients.