American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome

INTRODUCTION Irritable bowel syndrome (IBS) is the most prevalent of the functional gastrointestinal disorders (FGIDs). Current estimates are that IBS affects up to 10–12% of adults in North America [1, 2]. Although it can affect all individuals regardless of age, creed, or gender, IBS is more common among women and is most commonly diagnosed in younger individuals ( 0.10 for the ÷2 test, was arbitrarily chosen to represent low levels of heterogeneity [29]. Review Manager version 5.3.5 (RevMan for Windows 2014, The Nordic Cochrane Centre, Copenhagen, Denmark) was used to generate Forest plots of pooled RRs and SMDs for primary and secondary outcomes with 95% CIs, as well as funnel plots. The latter were assessed for evidence of asymmetry, and therefore possible publication bias or other small study effects, using the Egger test [30], if there were sufficient (10 or more) eligible studies included in the meta-analysis, in line with published recommendations [31]. GRADEpro version 3.6 (GRADE working group 2004–2007) was used to grade the quality of the evidence. Consensus was reached using a consensus-oriented decision-making framework [32], culminating in a face-to-face meeting to discuss the evidence and reach a unanimous decision on the quality of evidence and strength of recommendation. EXERCISE, DIET AND DIETARY MANIPULATION Exercise We suggest exercise for overall symptom improvement in IBS patients. (Recommendation: weak; Quality of Evidence: very low) Exercise and physical fitness are key elements of maintaining physical and mental health [33, 34]. Studies from healthy volunteers and patients suggest that physical activity protects against gastrointestinal (GI) symptoms [35, 36], and bears an inverse relationship with colonic transit time [37]. Based upon these observations, it is reasonable to hypothesize that exercise might be beneficial to patients with IBS. To date, there have been few RCTs that have rigorously evaluated the benefits of exercise in IBS patients. Daley et al. invited 305 IBS patients to participate in a RCT that compared 12 weeks of an exercise intervention with usual care [38]. Fifty-six IBS patients (18%) agreed to participate. Quality of life (IBS-QOL) and IBS symptoms (Birmingham IBS symptoms questionnaire) were assessed before and after the interventions. Exercise led to statistically significant benefits for constipation (95% CI: -1.6 to -20.1) but not for other outcomes such as abdominal pain, diarrhea, total symptom score, or quality of life. In a second trial, Johannesson et al. randomized 102 IBS patients to a rigorous exercise program monitored by a physiotherapist or usual care for 12 weeks [39]. Seventy-five IBS patients completed the trial. IBS symptom severity scores improved to a greater degree in the exercise arm compared with the control arm (P = 0.003). The same authors reported long-term follow-up data (median follow-up 5.2 years) for 39 of the originally enrolled IBS patients [40]. Increases in physical activity and improvements in symptom scores compared with baseline were maintained at follow-up. Summary. Although it is clear that exercise offers general health benefits and, whenever possible, should be encouraged the Task Force did not feel that the weight or strength of available evidence justified a strong recommendation regarding exercise for IBS. Although encouraging, the Task Force feels that the current body of evidence should be viewed as hypothesis-generating, and in need of validation by methodologically rigorous, appropriately powered, RCTs. Diet and dietary manipulation for IBS We suggest a low FODMAP diet for overall symptom improvement in IBS patients. (Recommendation: weak; Quality of evidence: very low) We suggest against a gluten-free or exclusion diet based upon antibody or leukocyte activation test for overall symptom improvement in IBS patients. (Recommendation: weak; Quality of evidence: very low) The majority of IBS patients associate symptom onset or worsening with eating a meal. Although true food allergy is uncommon in IBS patients, perceived food intolerances or sensitivities are quite common. Up to 90% of IBS patients exclude certain foods in the hopes of avoiding or improving their GI symptoms [41]. Since the publication of the last IBS Task Force evidence-based review in 2014 [4], there have been numerous studies that have evaluated dietary therapies in IBS patients [42]. Although various diets have been suggested to benefit IBS patients, the largest body of evidence relates to two specific diets; a diet low in fermentable oligo-saccharides, di-saccharides, and mono-saccharides, and polyols (FODMAPs) and a gluten-free diet. We identified seven eligible RCTs (evaluating 397 participants) that provided dichotomous outcomes for a low FODMAP diet versus an alternative diet [43–49]. There was an overall effect of the low FODMAP diet in reducing IBS symptoms with a RR of remaining symptomatic on a low FODMAP diet of 0.69 (95% CI 0.54 to 0.88). The NNT was 5 (95% CI 3 to 11) (Table 1).Table 1: Summary of evidence from randomized controlled trials of pharmacological, psychological, and dietary therapies in irritable bowel syndromeSimilar to another recent systematic review [50], our analysis found that all trials were subject to high of the quality of the evidence was as very to from the small of patients included in the significant and trials in IBS patients compared the low FODMAP diet with an alternative diet two with usual diet and with a high FODMAP diet The trials that of and an alternative dietary intervention in the control arm statistically significant benefit of a low FODMAP diet = 95% CI = to with heterogeneity studies The of these trials are more to as were not but trials two dietary interventions. In of these the low FODMAP diet led to of IBS symptoms in of the patients. of the RCTs have evaluated the long-term or a low FODMAP or the diet that is after FODMAP should be with on quality of life and on the colonic on colonic health We identified two eligible trials a gluten-free diet in patients with IBS were trials IBS patients that reported that their symptoms were controlled with a gluten-free but in been rigorously were randomized to have diet with or the as a significant food group from the diet and it the of a There was statistically significant on IBS symptoms in the versus gluten-free diet = 95% CI to with significant heterogeneity studies = = (Table RCT evaluated patients with IBS randomized to exclude all foods for levels of or a diet patients were to a of but was not based upon the antibody test an of were for 12 weeks and of in the intervention arm a significant improvement in compared with of in the diet in was not statistically significant (P = The authors reported in that to their diet. more recent RCT leukocyte activation to a true diet in IBS patients study reported in the of patients with of their IBS symptoms (P = or quality of life (P = after weeks there was a greater in IBS improvement with the true diet (P = after Summary. therapies for IBS are of to patients, and the largest body of to the low FODMAP diet. The available evidence a possible benefit for overall IBS symptoms in of There are data for a gluten-free diet or diets based upon antibody or leukocyte activation there are or data that the or of dietary therapies for IBS. IBS We for overall symptom improvement in IBS patients. (Recommendation: Quality of evidence: We but not for overall symptom improvement in IBS patients. (Recommendation: Quality of evidence: The systematic review and on in IBS for identified patients was at low of bias There was a statistically significant effect in of compared with of IBS not improving = 95% CI to (Table There was significant heterogeneity = = studies used in a total of patients seven studies in a total of patients and the remaining studies used or significant effect on of IBS of IBS not improving = 95% CI to but was in IBS = 95% CI to The NNT with was (95% CI to on overall were provided by seven trials trials evaluated patients. total of of patients reported compared with of in the = 95% CI to There were data from studies to to of Summary. an evidence-based for IBS. and in and evidence for The low and of significant a reasonable for IBS patients and, in with the quality of is the of a strong recommendation. The to and for the of in patients with the evidence to is from AND and We suggest against the of and for overall symptom improvement in IBS patients. 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(Recommendation: weak; Quality of evidence: low) Since the a total of trials were identified in there were RCTs patients. trials were at low of with the There were RCTs patients that outcomes as a dichotomous were statistically to of IBS not improving = 95% CI to with a NNT of (95% CI 5 to (Table there was significant heterogeneity studies = and evidence of funnel or other small study test, = were assessed in patients, with a benefit of compared with = 95% CI to but with significant heterogeneity studies = and there was evidence of publication bias or other small study test, = to have beneficial on IBS symptom scores or abdominal scores = 95% CI to = 95% CI to and scores = 95% CI to with significant heterogeneity in of these were reported by RCTs patients. The RR of was not with 95% CI to We suggest the for in IBS as well as in IBS patients. (Recommendation: weak; Quality of evidence: We identified RCTs of in IBS the [4], there were a total of RCTs reported in trials improved IBS symptoms compared with of symptoms not improving = 95% CI to but with statistically significant heterogeneity studies = The NNT was (95% CI 5 to RCTs used the in patients of usual IBS patients there was a statistically significant benefit in of the = 95% CI to with significant heterogeneity the studies = = (Table The NNT was (95% CI to There was a patients with IBS and on was included an = 95% CI to but with significant heterogeneity studies = The NNT was (95% CI 5 to There were RCTs at low of patients and pooled data from these suggested was to in of improving IBS symptoms = 95% CI = to The quality of evidence was to the on IBS symptoms and heterogeneity pooled analysis in in and or in and There been with therapies for IBS to the of pooled analysis of the study and two of the 3 studies found in at study was from the study There was a of that In the 3 trial, a of was reported among the patients randomized to with In an to the of of there have been the of on the Studies have that a of but in of the studies from IBS patients that on the were and not Summary. the that patients and or or there are few data to their Although overall there was a benefit of the evidence was low quality and a recommendation. in study IBS and of as well as the small of of the study and a of a recommendation on of a or for the of or the most to Although to be beneficial in is The is the Task Force a the quality Although data from studies of and are should to these in patients of in the of IBS patients compared with healthy in the of the of and in the of AND IBS We suggest certain and for overall symptom improvement in IBS patients. 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(Recommendation: weak; Quality of evidence: low) We identified two studies of the There were therefore seven RCTs patients. In of there were dichotomous data but the authors and these There were two RCTs at low of bias There was a statistically significant effect in of compared with = 95% CI to The NNT with was (95% CI 3 to (Table there was significant heterogeneity = = There were few studies to for evidence of funnel on overall were provided by trials data were the of was not among compared with = 95% CI to Summary. Although have been a of IBS for based on the that or be to the of IBS and of in the evidence to their studies in IBS are small in and were before current for the of and of trials in were as a to benefits in IBS. analysis a benefit for in but recommendation is based on a small of trials very specific should not be to the other available a of that have not been to to be more common with been reported to effect as a of be an in an IBS the of symptom in the IBS but be by the of that more IBS We for overall symptom improvement in IBS patients. (Recommendation: Quality of evidence: We suggest for overall symptom improvement in IBS patients. 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(Recommendation: weak; Quality of evidence: very low) There were a total of on various therapies with control in the of symptom or for the of IBS in a total of patients. of these were identified the of the trials were to be at low of IBS patients with therapies were more to patients not with intervention = 95% CI to The NNT was (95% CI to (Table there was significant heterogeneity the studies = and funnel analysis test, possible publication and were all more control data from two or more RCTs were with of and the and and there was RCT for of these data were reported among Summary. therapies to be in IBS but the of studies is by the of a true control to for these interventions. benefits be and not be by a therapies not be available and can be time for the and the it is possible in the to be few RCTs We for overall symptom improvement in patients. 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The two 3 RCTs were low of bias data a effect of on IBS symptoms of remaining symptomatic = 95% CI to with significant and a NNT of (95% CI to (Table The quality of evidence was to the on IBS data were not available for the studies but were pooled for the two 3 trials with of patients to 3 of of randomized to of and of to of were reported for these two RCTs on the and were with with a RR of (95% CI to The was (95% CI to it is to the two available as the of as an the trials of and recent that the of for be to among published trials We for overall symptom improvement in patients. 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(Recommendation: weak; Quality of evidence: low) is an that is not in the and is for constipation been well in RCTs in patients with are Since the [4], trials were that there were two RCTs in IBS patients. In RCT at of bias patients, bowel from baseline for and statistically significant effect on bowel or or was reported the and In the second study was at of bias and patients with there was an in bowel compared with at Although scores from significant effect on abdominal or was with compared with There was a greater improvement in in the arm (P = were in patients compared with in RCT of were The most common symptoms were abdominal and Summary. improved of bowel in but not or other IBS We suggest against for overall symptom improvement in IBS patients. (Recommendation: weak; Quality of evidence: low) Based on studies in IBS as well as IBS in general that a of low or activation is in the that such as used in bowel might be in IBS been We identified RCTs of in IBS all of used and patients. RCTs were at low of bias used a of or used a of and the used studies were to their primary all of all data were pooled to for there was a significant effect of in reducing symptoms in IBS compared with of IBS symptoms not improving = 95% CI to and significant heterogeneity = = (Table The NNT with was (95% CI 5 to was not and, if primary were the were not statistically significant = 95% CI = to on overall were not reported in of the were reported in two trials but were and were more with Summary. Although our systematic review did suggest a benefit of in IBS on the and the Task Force that the data were to intervention in IBS. suggest that should be in RCTs in as there is a that these be in improving We are to for the for the and food of the as well as and the data with for these is by a for as for the and and for that the of the and diet in IBS. of the and the provided of systematic on and the on were completed by and authors in the these and provided a completed was and by all been provided to the for and from and The for and to of the from The analysis that and was on of the of for and by the Task Force on of Irritable and control of and was by the should that the of the systematic review was before was

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