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Face-to-face interviews versus Internet surveys: Comparison of two data collection methods in the Rome foundation global epidemiology study: Implications for population-based research.
Sperber, AD, Bor, S, Fang, X, Bangdiwala, SI, Drossman, DA, Ghoshal, UC, Simren, M, Tack, J, Whitehead, WE, Dumitrascu, DL, et al
Neurogastroenterology and motility. 2023;(6):e14583
Abstract
BACKGROUND AND AIMS The Rome Foundation Global Epidemiology Study (RFGES) assessed the prevalence, burden, and associated factors of Disorders of Gut-Brain Interaction (DGBI) in 33 countries around the world. Achieving worldwide sampling necessitated use of two different surveying methods: In-person household interviews (9 countries) and Internet surveys (26 countries). Two countries, China and Turkey, were surveyed with both methods. This paper examines the differences in the survey results with the two methods, as well as likely reasons for those differences. METHODS The two RFGES survey methods are described in detail, and differences in DGBI findings summarized for household versus Internet surveys globally, and in more detail for China and Turkey. Logistic regression analysis was used to elucidate factors contributing to these differences. RESULTS Overall, DGBI were only half as prevalent when assessed with household vs Internet surveys. Similar patterns of methodology-related DGBI differences were seen within both China and Turkey, but prevalence differences between the survey methods were dramatically larger in Turkey. No clear reasons for outcome differences by survey method were identified, although greater relative reduction in bowel and anorectal versus upper gastrointestinal disorders when household versus Internet surveying was used suggests an inhibiting influence of social sensitivity. CONCLUSIONS The findings strongly indicate that besides affecting data quality, manpower needs and data collection time and costs, the choice of survey method is a substantial determinant of symptom reporting and DGBI prevalence outcomes. This has important implications for future DGBI research and epidemiological research more broadly.
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Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study.
Sperber, AD, Bangdiwala, SI, Drossman, DA, Ghoshal, UC, Simren, M, Tack, J, Whitehead, WE, Dumitrascu, DL, Fang, X, Fukudo, S, et al
Gastroenterology. 2021;(1):99-114.e3
Abstract
BACKGROUND & AIMS Although functional gastrointestinal disorders (FGIDs), now called disorders of gut-brain interaction, have major economic effects on health care systems and adversely affect quality of life, little is known about their global prevalence and distribution. We investigated the prevalence of and factors associated with 22 FGIDs, in 33 countries on 6 continents. METHODS Data were collected via the Internet in 24 countries, personal interviews in 7 countries, and both in 2 countries, using the Rome IV diagnostic questionnaire, Rome III irritable bowel syndrome questions, and 80 items to identify variables associated with FGIDs. Data collection methods differed for Internet and household groups, so data analyses were conducted and reported separately. RESULTS Among the 73,076 adult respondents (49.5% women), diagnostic criteria were met for at least 1 FGID by 40.3% persons who completed the Internet surveys (95% confidence interval [CI], 39.9-40.7) and 20.7% of persons who completed the household surveys (95% CI, 20.2-21.3). FGIDs were more prevalent among women than men, based on responses to the Internet survey (odds ratio, 1.7; 95% CI, 1.6-1.7) and household survey (odds ratio, 1.3; 95% CI, 1.3-1.4). FGIDs were associated with lower quality of life and more frequent doctor visits. Proportions of subjects with irritable bowel syndrome were lower when the Rome IV criteria were used, compared with the Rome III criteria, in the Internet survey (4.1% vs 10.1%) and household survey (1.5% vs 3.5%). CONCLUSIONS In a large-scale multinational study, we found that more than 40% of persons worldwide have FGIDs, which affect quality of life and health care use. Although the absolute prevalence was higher among Internet respondents, similar trends and relative distributions were found in people who completed Internet vs personal interviews.
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Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults.
Kemppinen, A, Howell, C, Allgar, V, Dodd, M, Gregson, J, Knowles, C, McLaughlin, J, Pandya, P, Whorwell, P, Markaryan, E, et al
Trials. 2020;(1):122
Abstract
BACKGROUND Irritable bowel syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for new treatments, including drug-free treatments, which are easy to use and suitable for different patient groups. Currently available drug-free treatments include Enterosgel®, an intestinal adsorbent approved for use in IBS-D and acute diarrhoea and available over-the-counter in the UK and 30 countries worldwide. The aim of this randomised, double-blind, placebo-controlled, multi-centre study is to test the efficacy and safety of Enterosgel® compared to placebo in symptomatic treatment in IBS-D. METHODS/DESIGN We will recruit 430 participants with IBS-D from approximately 30 primary and secondary care sites in England. Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period will be randomly allocated to receive blinded treatment (Enterosgel® or placebo) for 8 weeks. This will be followed by an 8-week open-label treatment phase with Enterosgel®. Participants will be allowed to adjust their daily dosage during both phases based on their symptoms. Participants will then return to standard care and those who responded to treatment will receive a follow-up call 8 weeks later. Co-medication with loperamide will be permitted and use recorded. The primary outcome measure is the percentage of participants defined as responders for abdominal pain and stool consistency during at least 4 weeks in the 8-week blinded phase. Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use. Exploratory outcomes will be assessed in subsets of participants including qualitative and quantitative data on faecal microorganisms and biomarkers and gut-related measurements from magnetic resonance imaging data. DISCUSSION This is the first large scale randomised controlled trial investigating Enterosgel® in IBS-D. A study design with blinded phase followed by an open-label phase was chosen to encourage participation and study completion. Demonstrating that Enterosgel® is effective and safe in IBS-D could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions. TRIAL REGISTRATION ISRCTN17149988. Prospectively registered on 14 November 2017.
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European society of neurogastroenterology and motility guidelines on functional constipation in adults.
Serra, J, Pohl, D, Azpiroz, F, Chiarioni, G, Ducrotté, P, Gourcerol, G, Hungin, APS, Layer, P, Mendive, JM, Pfeifer, J, et al
Neurogastroenterology and motility. 2020;(2):e13762
Abstract
INTRODUCTION Chronic constipation is a common disorder with a reported prevalence ranging from 3% to 27% in the general population. Several management strategies, including diagnostic tests, empiric treatments, and specific treatments, have been developed. Our aim was to develop European guidelines for the clinical management of constipation. DESIGN After a thorough review of the literature by experts in relevant fields, including gastroenterologists, surgeons, general practitioners, radiologists, and experts in gastrointestinal motility testing from various European countries, a Delphi consensus process was used to produce statements and practical algorithms for the management of chronic constipation. KEY RESULTS Seventy-three final statements were agreed upon after the Delphi process. The level of evidence for most statements was low or very low. A high level of evidence was agreed only for anorectal manometry as a comprehensive evaluation of anorectal function and for treatment with osmotic laxatives, especially polyethylene glycol, the prokinetic drug prucalopride, secretagogues, such as linaclotide and lubiprostone and PAMORAs for the treatment of opioid-induced constipation. However, the level of agreement between the authors was good for most statements (80% or more of the authors). The greatest disagreement was related to the surgical management of constipation. CONCLUSIONS AND INFERENCES European guidelines on chronic constipation, with recommendations and algorithms, were developed by experts. Despite the high level of agreement between the different experts, the level of scientific evidence for most recommendations was low, highlighting the need for future research to increase the evidence and improve treatment outcomes in these patients.
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Systematic review: probiotics in the management of lower gastrointestinal symptoms - an updated evidence-based international consensus.
Hungin, APS, Mitchell, CR, Whorwell, P, Mulligan, C, Cole, O, Agréus, L, Fracasso, P, Lionis, C, Mendive, J, Philippart de Foy, JM, et al
Alimentary pharmacology & therapeutics. 2018;47(8):1054-1070
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Plain language summary
The role of the gut microbiota in health and disease is far reaching and there is a growing body of evidence on the therapeutic potential of probiotics in gastrointestinal (GI) disease. Patients with GI disease present with a variety of symptoms and current evidence suggests probiotics may play a role in ameliorating these adverse symptoms. The purpose of this review is to update the previous systematic review and incorporate new findings on the role of probiotics in adult patients presenting with a variety of GI symptoms. Based on the updated evidence, this study confirms the finding that specific probiotics are beneficial for certain lower GI problems. According to this review, the author deems this study useful for clinicians when recommending probiotics to patients.
Abstract
BACKGROUND In 2013, a systematic review and Delphi consensus reported that specific probiotics can benefit adult patients with irritable bowel syndrome (IBS) and other gastrointestinal (GI) problems. AIM: To update the consensus with new evidence. METHODS A systematic review identified randomised, placebo-controlled trials published between January 2012 and June 2017. Evidence was graded, previously developed statements were reassessed by an 8-expert panel, and agreement was reached via Delphi consensus. RESULTS A total of 70 studies were included (IBS, 34; diarrhoea associated with antibiotics, 13; diarrhoea associated with Helicobacter pylori eradication therapy, 7; other conditions, 16). Of 15 studies that examined global IBS symptoms as a primary endpoint, 8 reported significant benefits of probiotics vs placebo. Consensus statements with 100% agreement and "high" evidence level indicated that specific probiotics help reduce overall symptom burden and abdominal pain in some patients with IBS and duration/intensity of diarrhoea in patients prescribed antibiotics or H. pylori eradication therapy, and have favourable safety. Statements with 70%-100% agreement and "moderate" evidence indicated that, in some patients with IBS, specific probiotics help reduce bloating/distension and improve bowel movement frequency/consistency. CONCLUSIONS This updated review indicates that specific probiotics are beneficial in certain lower GI problems, although many of the new publications did not report benefits of probiotics, possibly due to inclusion of new, less efficacious preparations. Specific probiotics can relieve lower GI symptoms in IBS, prevent diarrhoea associated with antibiotics and H. pylori eradication therapy, and show favourable safety. This study will help clinicians recommend/prescribe probiotics for specific symptoms.
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Systematic review and meta-analysis: the effects of fermented milk with Bifidobacterium lactis CNCM I-2494 and lactic acid bacteria on gastrointestinal discomfort in the general adult population.
Eales, J, Gibson, P, Whorwell, P, Kellow, J, Yellowlees, A, Perry, RH, Edwards, M, King, S, Wood, H, Glanville, J
Therapeutic advances in gastroenterology. 2017;(1):74-88
Abstract
BACKGROUND It has been suggested that probiotics may improve gastrointestinal discomfort. Not all probiotics exhibit the same effects and consequently meta-analyses on probiotics should be confined to well-defined strains or strain combinations. The aim of this study was to evaluate the effectiveness of a probiotic fermented milk (PFM) that includes Bifidobacterium lactis (B. lactis) CNCM I-2494 and lactic acid bacteria on gastrointestinal discomfort in the general adult population. METHODS Double-blind randomized controlled trials in the general adult population comparing PFM with a control dairy product for at least 4 weeks were searched from multiple literature databases (up to February 2015). Meta-analyses using random-effects models, with individual participant data were undertaken to calculate an odds ratio (OR) or standard mean difference (SMD), with a 95% confidence interval (CI). RESULTS The search strategy identified 12,439 documents. Overall, three trials with a total of 598 adults (female = 96.5%) met the inclusion criteria. Consumption of the PFM product was associated with a significant improvement in overall gastrointestinal discomfort compared with the control product (OR = 1.48; 95% CI 1.07-2.05), with a number needed to treat (NNT) of 10.24 (95% CI 5.64-55.93). PFM was also superior to the control in reducing digestive symptoms, as measured using a composite score (SMD = -0.21; 95% CI -0.37 to -0.05). Sensitivity analyses produced similar results, and the heterogeneity between studies was minimal. CONCLUSIONS This meta-analysis shows that the consumption of PFM with B. lactis CNCM I-2494 and lactic acid bacteria is associated with a modest but consistent and significant improvement of outcomes related to gastrointestinal discomfort in healthy adults.
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Irritable bowel syndrome diagnosis and management: A simplified algorithm for clinical practice.
Moayyedi, P, Mearin, F, Azpiroz, F, Andresen, V, Barbara, G, Corsetti, M, Emmanuel, A, Hungin, APS, Layer, P, Stanghellini, V, et al
United European gastroenterology journal. 2017;(6):773-788
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BACKGROUND Effective management of irritable bowel syndrome (IBS), a common functional gastrointestinal disorder, can be challenging for physicians because of the lack of simple diagnostic tests and the wide variety of treatment approaches available. OBJECTIVE The objective of this article is to outline a simple algorithm for day-to-day clinical practice to help physicians navigate key stages to reaching a positive IBS diagnosis and guidance on how to prioritise the use of specific management strategies. METHODS This algorithm was based on the opinion of an expert panel evaluating current evidence. RESULTS The key principles forming the foundation of this evidence-supported algorithm are: confidently naming and explaining an IBS diagnosis for the patient, followed by assessment of key patient characteristics likely to influence the choice of therapy, such as predominant symptoms, and exploring the patient agenda and preferences. Consultation should always include education and reassurance with an explanatory model of IBS tailored to the patient. Individualised lifestyle changes, dietary modifications, pharmacological therapies, psychological strategies or a combination of interventions may be used to optimise treatment for each patient. CONCLUSION The simple visual tools developed here navigate the key stages to reaching a positive diagnosis of IBS, and provide a stepwise approach to patient-centred management targeted towards the most bothersome symptoms. Establishing a strong patient-physician relationship is central to all stages of the patient journey from diagnosis to effective management.
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Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice -- an evidence-based international guide.
Hungin, AP, Mulligan, C, Pot, B, Whorwell, P, Agréus, L, Fracasso, P, Lionis, C, Mendive, J, Philippart de Foy, JM, Rubin, G, et al
Alimentary pharmacology & therapeutics. 2013;(8):864-86
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BACKGROUND Evidence suggests that the gut microbiota play an important role in gastrointestinal problems. AIM: To give clinicians a practical reference guide on the role of specified probiotics in managing particular lower gastrointestinal symptoms/problems by means of a systematic review-based consensus. METHODS Systematic literature searching identified randomised, placebo-controlled trials in adults; evidence for each symptom/problem was graded and statements developed (consensus process; 10-member panel). As results cannot be generalised between different probiotics, individual probiotics were identified for each statement. RESULTS Thirty seven studies were included; mostly on irritable bowel syndrome [IBS; 19 studies; treatment responder rates: 18-80% (specific probiotics), 5-50% (placebo)] or antibiotic-associated diarrhoea (AAD; 10 studies). Statements with 100% agreement and 'high' evidence levels indicated that: (i) specific probiotics help reduce overall symptom burden and abdominal pain in some IBS patients; (ii) in patients receiving antibiotics/Helicobacter pylori eradication therapy, specified probiotics are helpful as adjuvants to prevent/reduce the duration/intensity of AAD; (iii) probiotics have favourable safety in patients in primary care. Items with 70-100% agreement and 'moderate' evidence were: (i) specific probiotics help relieve overall symptom burden in some patients with diarrhoea-predominant IBS, and reduce bloating/distension and improve bowel movement frequency/consistency in some IBS patients and (ii) with some probiotics, improved symptoms have led to improvement in quality of life. CONCLUSIONS Specified probiotics can provide benefit in IBS and antibiotic-associated diarrhoea; relatively few studies in other indications suggested benefits warranting further research. This study provides practical guidance on which probiotic to select for a specific problem.
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Role of alimentation in irritable bowel syndrome.
Dapoigny, M, Stockbrügger, RW, Azpiroz, F, Collins, S, Coremans, G, Müller-Lissner, S, Oberndorff, A, Pace, F, Smout, A, Vatn, M, et al
Digestion. 2003;(4):225-33
Abstract
BACKGROUND Different food items are made responsible for irritable bowel syndrome (IBS) symptoms, but the physiopathology of IBS remains unclear. AIMS During a meeting in Nice, France, experts of the European Working Team of the IBiS Club discussed selected data regarding the relationships between alimentation, food items (including fibers) and IBS symptoms. METHODS/RESULTS Food allergy remains a difficult diagnosis, but medical and general history, presence of general symptoms such as skin rash, and hypersensitivity tests may help in achieving a positive diagnosis. On the other hand, food intolerance is more confusing because of the subjectivity of the relationship between ingestion of certain foods and the appearance of clinical symptoms. Different food items which are commonly implicated in adverse reactions mimicking IBS were found to be stimulants for the gut, suggesting that patients with predominant diarrhea IBS have to be carefully questioned about consumption of different kinds of food (i.e., coffee, alcohol, chewing gum, soft drinks) and not only on lactose ingestion. Gas production is discussed on the basis of retention of intestinal gas as well as on malabsorption of fermentable substrates. The role of a large amount of this kind of substrate reaching the colon is suggested as a potential mechanism of IBS-type symptoms in overeating patients. Regarding the role of fiber in IBS, the expert group concluded that fibers are not inert substances and that they could trigger pain or bloating in some IBS patients. CONCLUSION Despite numerous reviews on this subject, it is very difficult to give general dietary advice to IBS patients, but dieteticians may have a positive role in managing such patients.