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• W2108139871 abstract "Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder characterized by abdominal pain and/or discomfort associated with altered defecation.1Longstreth G.F. Thompson W.G. Chey W.D. et al.Functional bowel disorders.Gastroenterology. 2006; 130: 1480-1491Abstract Full Text Full Text PDF PubMed Scopus (3990) Google Scholar Other common symptoms include bloating, straining, rectal urgency, and the sensation of incomplete evacuation. These symptoms occur in approximately 11% of the world’s population.2Lovell R.M. Ford A.C. Effect of gender on prevalence of irritable bowel syndrome in the community: systematic review and meta-analysis.Am J Gastroenterol. 2012; 107: 991-1000Crossref PubMed Scopus (279) Google Scholar, 3Hungin A.P. Chang L. Locke G.R. et al.Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact.Aliment Pharmacol Ther. 2005; 21: 1365-1375Crossref PubMed Scopus (397) Google Scholar, 4Hungin A.P. Whorwell P.J. Tack J. et al.The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40,000 subjects.Aliment Pharmacol Ther. 2003; 17: 643-650Crossref PubMed Scopus (633) Google Scholar Women report symptoms of IBS more frequently than men; likewise, younger people are more susceptible than older people. IBS negatively impacts health-related quality of life5Drossman D.A. Camilleri M. Mayer E.A. et al.AGA technical review on irritable bowel syndrome.Gastroenterology. 2002; 123: 2108-2131Abstract Full Text Full Text PDF PubMed Scopus (1215) Google Scholar and results in a significant financial burden through reduced work productivity and increased use of health-related resources.6Pare P. Gray J. Lam S. et al.Health-related quality of life, work productivity, and health care resource utilization of subjects with irritable bowel syndrome: baseline results from LOGIC (Longitudinal Outcomes Study of Gastrointestinal Symptoms in Canada), a naturalistic study.Clin Ther. 2006; 28 (discussion 1710–1711): 1726-1735Abstract Full Text PDF PubMed Scopus (156) Google Scholar The diagnosis of IBS is based on the presence of symptoms and, when clinically appropriate, exclusion of organic disease. In the absence of alarm symptoms (eg, rectal bleeding, unintentional weight loss, family history of colon cancer), diagnostic testing does not increase the sensitivity of the diagnosis.7Hammer J. Eslick G.D. Howell S.C. et al.Diagnostic yield of alarm features in irritable bowel syndrome and functional dyspepsia.Gut. 2004; 53: 666-672Crossref PubMed Scopus (142) Google Scholar, 8Vanner S.J. Depew W.T. Paterson W.G. et al.Predictive value of the Rome criteria for diagnosing the irritable bowel syndrome.Am J Gastroenterol. 1999; 94: 2912-2917Crossref PubMed Scopus (239) Google Scholar The current Rome III criteria for IBS require the presence of recurrent abdominal pain and/or discomfort at least 3 days per month in the past 3 months that is associated with 2 or more of the following: improvement with defecation, onset associated with a change in frequency of stool, or onset associated with a change in form (appearance) of stool. Further subclassification is based on the predominant stool consistency: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), IBS with mixed pattern (IBS-M), and unsubtyped IBS.1Longstreth G.F. Thompson W.G. Chey W.D. et al.Functional bowel disorders.Gastroenterology. 2006; 130: 1480-1491Abstract Full Text Full Text PDF PubMed Scopus (3990) Google Scholar Symptoms have to be present for at least 6 months. Current pharmacological treatments are generally aimed at improving one or more of the predominant symptoms, such as abdominal pain, constipation, or diarrhea. There is a lack of treatment data on IBS-M alone. In this technical review, the American Gastroenterological Association (AGA) reviews commonly used pharmacological therapies for IBS. Selecting appropriate therapy for patients with IBS is a common clinical dilemma, particularly in a heterogeneous patient population with a range of symptoms. This review provides evidence-based information to guide clinicians and patients to the most appropriate therapy. However, the list of therapies in this review is not exhaustive and does not include nonpharmacological and alternative therapies. In this technical review, the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to assess the quality of evidence for the most commonly used pharmacological therapies for IBS.9Dassopoulos T. Inadomi J.M. Lewis J.D. et al.The development of clinical guidelines by the American Gastroenterological Association.Gastroenterology. 2010; 138: 417-418Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar, 10Inadomi J.M. Weinberg D.S. How to recognize a good guideline.Gastroenterology. 2013; 145: 1179-1181Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar, 11Sultan S. Falck-Ytter Y. Inadomi J.M. The AGA institute process for developing clinical practice guidelines part one: grading the evidence.Clin Gastroenterol Hepatol. 2013; 11: 329-332Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar GRADE has been adopted by several national and international societies, including the AGA, and is becoming the common methodology for the streamlined development of clear, transparent, and actionable guidelines.9Dassopoulos T. Inadomi J.M. Lewis J.D. et al.The development of clinical guidelines by the American Gastroenterological Association.Gastroenterology. 2010; 138: 417-418Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar, 11Sultan S. Falck-Ytter Y. Inadomi J.M. The AGA institute process for developing clinical practice guidelines part one: grading the evidence.Clin Gastroenterol Hepatol. 2013; 11: 329-332Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar This technical review was conducted to inform the AGA guidelines for the management of IBS. Methods for deriving focused clinical questions, systematically reviewing and rating the quality of evidence for each outcome, and rating the overall quality of evidence were based on the GRADE framework, which has been described in more detail previously.12Guyatt G.H. Oxman A.D. Vist G. et al.GRADE guidelines: 4. Rating the quality of evidence—study limitations (risk of bias).J Clin Epidemiol. 2011; 64: 407-415Abstract Full Text Full Text PDF PubMed Scopus (1871) Google Scholar, 13Guyatt G.H. Oxman A.D. Sultan S. et al.GRADE guidelines: 9. Rating up the quality of evidence.J Clin Epidemiol. 2011; 64: 1311-1316Abstract Full Text Full Text PDF PubMed Scopus (847) Google Scholar, 14Guyatt G.H. Oxman A.D. Schunemann H.J. et al.GRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology.J Clin Epidemiol. 2011; 64: 380-382Abstract Full Text Full Text PDF PubMed Scopus (1794) Google Scholar, 15Guyatt G.H. Oxman A.D. Montori V. et al.GRADE guidelines: 5. Rating the quality of evidence—publication bias.J Clin Epidemiol. 2011; 64: 1277-1282Abstract Full Text Full Text PDF PubMed Scopus (1179) Google Scholar, 16Guyatt G.H. Oxman A.D. Kunz R. et al.GRADE guidelines: 7. Rating the quality of evidence—inconsistency.J Clin Epidemiol. 2011; 64: 1294-1302Abstract Full Text Full Text PDF PubMed Scopus (1451) Google Scholar, 17Guyatt G.H. Oxman A.D. Kunz R. et al.GRADE guidelines: 8. Rating the quality of evidence—indirectness.J Clin Epidemiol. 2011; 64: 1303-1310Abstract Full Text Full Text PDF PubMed Scopus (1172) Google Scholar, 18Guyatt G.H. Oxman A.D. Kunz R. et al.GRADE guidelines 6. Rating the quality of evidence—imprecision.J Clin Epidemiol. 2011; 64: 1283-1293Abstract Full Text Full Text PDF PubMed Scopus (1642) Google Scholar, 19Guyatt G.H. Oxman A.D. Kunz R. et al.GRADE guidelines: 2. Framing the question and deciding on important outcomes.J Clin Epidemiol. 2011; 64: 395-400Abstract Full Text Full Text PDF PubMed Scopus (1217) Google Scholar, 20Guyatt G.H. Thorlund K. Oxman A.D. et al.GRADE guidelines: 13. Preparing summary of findings tables and evidence profiles-continuous outcomes.J Clin Epidemiol. 2013; 66: 173-183Abstract Full Text Full Text PDF PubMed Scopus (437) Google Scholar, 21Guyatt G.H. Oxman A.D. Schunemann H.J. GRADE guidelines—an introduction to the 10th-13th articles in the series.J Clin Epidemiol. 2013; 66: 121-123Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar, 22Guyatt G.H. Oxman A.D. Santesso N. et al.GRADE guidelines: 12. Preparing summary of findings tables-binary outcomes.J Clin Epidemiol. 2013; 66: 158-172Abstract Full Text Full Text PDF PubMed Scopus (538) Google Scholar, 23Guyatt G. Oxman A.D. Sultan S. et al.GRADE guidelines: 11. Making an overall rating of confidence in effect estimates for a single outcome and for all outcomes.J Clin Epidemiol. 2013; 66: 151-157Abstract Full Text Full Text PDF PubMed Scopus (521) Google Scholar, 24Brunetti M. Shemilt I. Pregno S. et al.GRADE guidelines: 10. Considering resource use and rating the quality of economic evidence.J Clin Epidemiol. 2013; 66: 140-150Abstract Full Text Full Text PDF PubMed Scopus (173) Google Scholar, 25Andrews J.C. Schunemann H.J. Oxman A.D. et al.GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength.J Clin Epidemiol. 2013; 66: 726-735Abstract Full Text Full Text PDF PubMed Scopus (841) Google Scholar, 26Andrews J. Guyatt G. Oxman A.D. et al.GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations.J Clin Epidemiol. 2013; 66: 719-725Abstract Full Text Full Text PDF PubMed Scopus (891) Google Scholar Using the PICO format, which frames a clinical question by defining a specific patient population (P), intervention (I), comparator (C), and outcome(s), we outlined a total of 9 questions (see Table 1).Table 1PICO QuestionsPopulation(s)Intervention(s)ComparatorOutcome(s)Adults with IBS-CLinaclotidePlacebo or controlBeneficial1.Symptom relief (FDA responder)2.Global relief3.Abdominal pain4.CSBM or SBM5.IBS-QOLHarms6.Diarrhea leading to treatment discontinuationAdults with IBS-CLubiprostonePlacebo or controlBeneficial1.Symptom relief (FDA responder)2.Global relief3.Abdominal pain4.CSBM or SBM5.IBS-QOLHarms6.Diarrhea leading to treatment discontinuationAdults with IBSRifaximinPlacebo or controlBeneficial1.Symptom relief (FDA responder)2.Global relief3.Abdominal pain4.Bloating5.IBS-QOLHarms6.Adverse effects leading to treatment discontinuationAdults with IBSAlosetronPlacebo or controlBeneficial1.Global relief2.Abdominal pain3.Urgency4.Stool consistency5.IBS-QOLHarms6.Ischemic colitis7.Serious complications of constipationAdults with IBSTCAsPlacebo or controlBeneficial1.Global relief2.Abdominal painHarms3.Anticholinergic effectsAdults with IBSSSRIsPlacebo or controlBeneficial1.Global relief2.Abdominal painHarms3.Sexual dysfunctionAdults with IBSAntispasmodicsPlacebo or controlBeneficial1.Global relief2.Abdominal painHarms3.Adverse effects leading to treatment discontinuationAdults with IBSPEG laxativesPlacebo or controlBeneficial1.Symptom relief (FDA responder)2.Global relief3.Abdominal pain4.CSBM or SBM5.IBS-QOLHarms6.DiarrheaAdults with IBS-CLinaclotideLubiprostoneNo studies Open table in a new tab We included studies of adults (18 years of age and older) with IBS using symptom-based diagnostic criteria. The interventions were linaclotide, lubiprostone, polyethylene glycol (PEG) laxative, rifaximin, alosetron, loperamide, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and antispasmodics. The comparators were placebos. It should be noted that there is a lack of comparative effectiveness studies in IBS. Using the GRADE approach to specify and prioritize patient-important outcomes, each outcome was ranked as critical, important, or not important for decision making. Only critical and important outcomes were summarized in the evidence profiles (Table 2, Table 3, Table 4, Table 5, Table 6, Table 7, Table 8, Table 9, Table 10).Table 2Question: Should Linaclotide Be Used in Patients With IBS-C?Quality assessmentSummary of findingsNo. of participants (no. of studies), authors, follow-upRisk of biasInconsistencyIndirectnessImprecisionPublication biasOverall quality of evidenceStudy event rates (%)Relative effect (95% CI)Anticipated absolute effectsWith placeboWith linaclotideRisk with placeboRisk difference with linaclotide (95% CI)Failure of symptom relief (FDA responder) (critical outcome; assessed with patient diary) 1604 (2 studies), Chey et al,36Chey W.D. Lembo A.J. Lavins B.J. et al.Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.Am J Gastroenterol. 2012; 107: 1702-1712Crossref PubMed Scopus (348) Google Scholar Rao et al,37Rao S. Lembo A.J. Shiff S.J. et al.A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.Am J Gastroenterol. 2012; 107 (quiz 1725): 1714-1724Crossref PubMed Scopus (303) Google Scholar 12 wkNo serious risk of biasNo serious inconsistencyaThe I2 was >50%, but we did not rate down due to overlapping 95% CI.No serious indirectnessNo serious imprecisionUndetected⊕⊕⊕⊕ High659/798 (82.6)535/806 (66.4)RR, 0.80 (0.76–0.85)826 per 1000165 fewer per 1000 (from 124 fewer to 198 fewer)Failure of adequate global relief response (critical outcome; assessed with patient diary) 1773 (3 studies), Chey et al,36Chey W.D. Lembo A.J. Lavins B.J. et al.Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.Am J Gastroenterol. 2012; 107: 1702-1712Crossref PubMed Scopus (348) Google Scholar Rao et al,37Rao S. Lembo A.J. Shiff S.J. et al.A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.Am J Gastroenterol. 2012; 107 (quiz 1725): 1714-1724Crossref PubMed Scopus (303) Google Scholar Johnston et al,38Johnston J.M. Kurtz C.B. Macdougall J.E. et al.Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation.Gastroenterology. 2010; 139: 1877-1886.e2Abstract Full Text Full Text PDF PubMed Scopus (196) Google Scholar 12 wkNo serious risk of biasNo serious inconsistencyNo serious indirectnessNo serious imprecisionUndetected⊕⊕⊕⊕ High709/883 (80.3)530/890 (59.6)RR, 0.73 (0.65–0.82)803 per 1000217 fewer per 1000 (from 145 fewer to 281 fewer)Failure of adequate abdominal pain response (important outcome; assessed with patient diary) 1604 (2 studies), Chey et al,36Chey W.D. Lembo A.J. Lavins B.J. et al.Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.Am J Gastroenterol. 2012; 107: 1702-1712Crossref PubMed Scopus (348) Google Scholar Rao et al,37Rao S. Lembo A.J. Shiff S.J. et al.A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.Am J Gastroenterol. 2012; 107 (quiz 1725): 1714-1724Crossref PubMed Scopus (303) Google Scholar 12 wkNo serious risk of biasSerious inconsistencybWe rated down for inconsistency due to an I2 of 85%.No serious indirectnessNo serious imprecisionUndetected⊕⊕⊕⊝ ModeratebWe rated down for inconsistency due to an I2 of 85%. due to inconsistency612/798 (76.7)511/806 (63.4)RR, 0.83 (0.77–0.88)767 per 1000130 fewer per 1000 (from 92 fewer to 176 fewer)Failure of adequate CSBM response (important outcome; assessed with patient diary) 1775 (3 studies), Chey et al,36Chey W.D. Lembo A.J. Lavins B.J. et al.Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.Am J Gastroenterol. 2012; 107: 1702-1712Crossref PubMed Scopus (348) Google Scholar Rao et al,37Rao S. Lembo A.J. Shiff S.J. et al.A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.Am J Gastroenterol. 2012; 107 (quiz 1725): 1714-1724Crossref PubMed Scopus (303) Google Scholar Johnston et al,38Johnston J.M. Kurtz C.B. Macdougall J.E. et al.Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation.Gastroenterology. 2010; 139: 1877-1886.e2Abstract Full Text Full Text PDF PubMed Scopus (196) Google Scholar 12 wkNo serious risk of biasNo serious inconsistencyNo serious indirectnessNo serious imprecisionUndetected⊕⊕⊕⊕ High830/885 (93.8)712/890 (80)RR, 0.86 (0.83–0.89)938 per 1000131 fewer per 1000 (from 103 fewer to 159 fewer)Failure to achieve clinically meaningful improvement in IBS-QOL (important outcome; assessed with IBS-QOLcA clinically meaningful improvement was defined as an increase in IBS-QOL of ≥14 points.) 1659, (2 studies), Chey et al,36Chey W.D. Lembo A.J. Lavins B.J. et al.Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.Am J Gastroenterol. 2012; 107: 1702-1712Crossref PubMed Scopus (348) Google Scholar Rao et al,37Rao S. Lembo A.J. Shiff S.J. et al.A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.Am J Gastroenterol. 2012; 107 (quiz 1725): 1714-1724Crossref PubMed Scopus (303) Google Scholar 12 wkNo serious risk of biasSerious inconsistencydWe rated down for inconsistency due to an I2 of 78%.No serious indirectnessNo serious imprecisionUndetected⊕⊕⊕⊝ ModeratedWe rated down for inconsistency due to an I2 of 78%. due to inconsistency506/827 (61.2)399/832 (48)RR, 0.78 (0.72–0.86)612 per 1000135 fewer per 1000 (from 86 fewer to 171 fewer)Adverse events (diarrhea) leading to treatment discontinuation (important outcome) 1773 (3 studies), Chey et al,36Chey W.D. Lembo A.J. Lavins B.J. et al.Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.Am J Gastroenterol. 2012; 107: 1702-1712Crossref PubMed Scopus (348) Google Scholar Rao et al,37Rao S. Lembo A.J. Shiff S.J. et al.A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.Am J Gastroenterol. 2012; 107 (quiz 1725): 1714-1724Crossref PubMed Scopus (303) Google Scholar Johnston et al,38Johnston J.M. Kurtz C.B. Macdougall J.E. et al.Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation.Gastroenterology. 2010; 139: 1877-1886.e2Abstract Full Text Full Text PDF PubMed Scopus (196) Google Scholar 12 wkNo serious risk of biasNo serious inconsistencyNo serious indirectnessNo serious imprecisionUndetected⊕⊕⊕⊕ High2/883 (0.23)42/890 (4.7)RR, 14.8 (4–54)2 per 100031 more per 1000 (from 7 more to 120 more)a The I2 was >50%, but we did not rate down due to overlapping 95% CI.b We rated down for inconsistency due to an I2 of 85%.c A clinically meaningful improvement was defined as an increase in IBS-QOL of ≥14 points.d We rated down for inconsistency due to an I2 of 78%. Open table in a new tab Table 3Question: Should Lubiprostone Be Used in Patients With IBS-C?Quality assessmentSummary of findingsNo. of participants (no. of studies), author, follow-upRisk of biasInconsistencyIndirectnessImprecisionPublication biasOverall quality of evidenceStudy event rates (%)Relative effect (95% CI)Anticipated absolute effectsWith placeboWith lubiprostoneRisk with placeboRisk difference with lubiprostone (95% CI)Failure of symptom relief (FDA responder) (critical outcome) 452 (2 RCTs), Drosssman et al,47Drossman D.A. Chey W.D. Johanson J.F. et al.Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome—results of two randomized, placebo-controlled studies.Aliment Pharmacol Ther. 2009; 29: 329-341Crossref PubMed Scopus (328) Google Scholar 12 wkNo serious risk of biasNo serious inconsistencyNo serious indirectnessSerious imprecisionaThe upper boundary of the CI did not cross our minimal clinically important threshold of at least 10%; therefore, we rated down for imprecision.Undetected⊕⊕⊕⊝ ModerateaThe upper boundary of the CI did not cross our minimal clinically important threshold of at least 10%; therefore, we rated down for imprecision. due to imprecision138/163 (84.7)213/289 (73.7)RR, 0.88 (0.79–0.96)847 per 1000102 fewer per 1000 (from 34 fewer to 178 fewer)Failure of adequate relief response (global response)bAdequate relief response was based on the overall responder rate, which was defined as a monthly responder for at least 2 of 3 months. A monthly responder was defined as response of moderate relief or better for 4 of 4 weeks or response of significant relief. (critical outcome; assessed with weekly patient diary) 1154 (2 RCTscTwo separate, identically designed, multicenter studies were analyzed and reported together in a single paper.), Drosssman et al,47Drossman D.A. Chey W.D. Johanson J.F. et al.Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome—results of two randomized, placebo-controlled studies.Aliment Pharmacol Ther. 2009; 29: 329-341Crossref PubMed Scopus (328) Google Scholar 12 wkNo serious risk of biasNo serious inconsistencyNo serious indirectnessSerious imprecisionaThe upper boundary of the CI did not cross our minimal clinically important threshold of at least 10%; therefore, we rated down for imprecision.Undetected⊕⊕⊕⊝ ModerateaThe upper boundary of the CI did not cross our minimal clinically important threshold of at least 10%; therefore, we rated down for imprecision. due to imprecision346/385 (89.9)631/769 (82.1)RR, 0.93 (0.87–0.96)899 per 100063 fewer per 1000 (from 36 fewer to 117 fewer)Failure of adequate abdominal pain responsedData for this outcome was provided by the company as a post-hoc analysis of a subgroup. (important outcome) 452 (2 RCTs), Drosssman et al,47Drossman D.A. Chey W.D. Johanson J.F. et al.Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome—results of two randomized, placebo-controlled studies.Aliment Pharmacol Ther. 2009; 29: 329-341Crossref PubMed Scopus (328) Google Scholar 12 wkNo serious risk of biasNo serious inconsistencyNo serious indirectnessSerious imprecisionaThe upper boundary of the CI did not cross our minimal clinically important threshold of at least 10%; therefore, we rated down for imprecision.Undetected⊕⊕⊕⊝ ModerateaThe upper boundary of the CI did not cross our minimal clinically important threshold of at least 10%; therefore, we rated down for imprecision. due to imprecision122/163 (74.8)183/289 (63.3)RR, 0.85 (0.76–0.95)748 per 1000112 fewer per 1000 (from 37 fewer to 180 fewer)Failure of adequate SBM responsedData for this outcome was provided by the company as a post-hoc analysis of a subgroup.,eSBM was used to inform this outcome (as well as FDA responder outcome) because CSBM data was not obtained in the study. (important outcome) 505 (2 RCTs), Drosssman et al,47Drossman D.A. Chey W.D. Johanson J.F. et al.Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome—results of two randomized, placebo-controlled studies.Aliment Pharmacol Ther. 2009; 29: 329-341Crossref PubMed Scopus (328) Google Scholar 12 wkNo serious risk of biasNo serious inconsistencyNo serious indirectnessSerious imprecisionaThe upper boundary of the CI did not cross our minimal clinically important threshold of at least 10%; therefore, we rated down for imprecision.Undetected⊕⊕⊕⊝ ModerateaThe upper boundary of the CI did not cross our minimal clinically important threshold of at least 10%; therefore, we rated down for imprecision. due to imprecision99/180 (55.0)160/325 (49.2)RR, 0.90 (0.75–1.10)550 per 100055 fewer per 1000 (from 138 fewer to 55 more)Failure to achieve clinically meaningful improvement in IBS-QOL (important outcome) See textAdverse events leading to treatment discontinuation (important outcome) 1166 (2 RCTs), Drosssman et al,47Drossman D.A. Chey W.D. Johanson J.F. et al.Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome—results of two randomized, placebo-controlled studies.Aliment Pharmacol Ther. 2009; 29: 329-341Crossref PubMed Scopus (328) Google Scholar 12 wkNo serious risk of biasNo serious inconsistencyNo serious indirectnessSerious imprecisionUndetected⊕⊕⊕⊝ Moderate due to imprecision7/387 (1.8)5/779 (0.6)RR, 0.36 (0.11–1.12)18 per 1000615 more per 1000 (from 16 fewer to 2 more)a The upper boundary of the CI did not cross our minimal clinically important threshold of at least 10%; therefore, we rated down for imprecision.b Adequate relief response was based on the overall responder rate, which was defined as a monthly responder for at least 2 of 3 months. A monthly responder was defined as response of moderate relief or better for 4 of 4 weeks or response of significant relief.c Two separate, identically designed, multicenter studies were analyzed and reported together in a single paper.d Data for this outcome was provided by the company as a post-hoc analysis of a subgroup.e SBM was used to inform this outcome (as well as FDA responder outcome) because CSBM data was not obtained in the study. Open table in a new tab Table 4Question: Should PEG Laxatives Be Used in Patients With IBS-C?Quality assessmentSummary of findingsNo. of participants (no. of studies), author, follow-upRisk of biasInconsistencyIndirectnessImprecisionPublication biasOverall quality of evidenceStudy event rates (%)Relative effect (95% CI)Anticipated absolute effectsWith placeboWith PEGRisk with placeboRisk difference with PEG (95% CI)Failure of symptom relief (FDA responder) (critical outcome; assessed with patient diary) 122 (n, post-hoc analysis) (1 RCT), Chapman et al,50Chapman R.W. Stanghellini V. Geraint M. et al.Randomized clinical trial: macrogol/PEG 3350 plus electrolytes for treatment of patients with constipation associated with irritable bowel syndrome.Am J Gastroenterol. 2013; 108: 1508-1515Crossref PubMed Scopus (119) Google Scholar 4 wkSerious risk of biasaA post-hoc modified intention-to-treat analysis was performed in this single-center industry-sponsored study with a very short duration of treatment. We excluded one other study (Khoshoo et al) because a different population (adolescents) and comparator (PEG plus tegaserod) were used.No serious inconsistencyNo serious indirectnessSerious imprecisionbThe CI was very wide due to the small sample size and few events in the study.Undetected⊕⊕⊝⊝ LowaA post-hoc modified intention-to-treat analysis was performed in this single-center industry-sponsored study with a very short duration of treatment. We excluded one other study (Khoshoo et al) because a different population (adolescents) and comparator (PEG plus tegaserod) were used.,bThe CI was very wide due to the small sample size and few events in the study. due to risk of bias and imprecision49/62 (79.0)40/60 (66.7)RR, 0.90 (0.66–1.2)790 per 100079 fewer per 1000 (from 269 fewer to 158 more)Failure of adequate relief response (important outcome): not reportedFailure of adequate abdominal pain response (important outcome; assessed with patient diary) 122 (n, intention to treat analysis) (1 RCT), Chapman et al,50Chapman R.W. Stanghellini V. Geraint M. et al.Randomized clinical trial: macrogol/PEG 3350 plus electrolytes for treatment of patients with constipation associated with irritable bowel syndrome.Am J Gastroenterol. 2013; 108: 1508-1515Crossref PubMed Scopus (119) Google Scholar 4 wkSerious risk of biasaA post-hoc modified intention-to-treat analysis was performed in this single-center industry-sponsored study with a very short duration of treatment. We excluded one other study (Khoshoo et al) because a different population (adolescents) and comparator (PEG plus tegaserod) were used.No serious inconsistencyNo serious indirectnessSerious imprecisionbThe CI was very wide due to the small sample size and few events in the study.Undetected⊕⊕⊝⊝ Low aA post-hoc modified intention-to-treat analysis was performed in this single-center industry-sponsored study with a very short duration of treatment. We excluded one other study (Khoshoo et al) because a different population (adolescents) and comparator (PEG plus tegaserod) were used.,bThe CI was very wide due to the small sample size and few events in the study. due to risk of bias and imprecision37/62 (60.0)32/60 (53.3)RR, 0.93 (0.67–1.4)600 per 100042 fewer per 1000 (from 197 fewer to 239 more)Failure of adequate CSBM response (important outcome; assessed with patient diary): not reportedFailure to achieve clinically meaningful improvement in IBS-QOL (important outcome; assessed with SF-36cThe SF-36 instrument was used in the study, but raw data were not presented.): not reportedAdverse effects leading to treatment discontinuationdOnly 2 patients discontinued treatment due to adverse events. The study reported that 4.5% of patients in the PEG arm experienced abdominal pain (vs 3% in the placebo arm) and 4.5% experienced diarrhea (vs 4.3% in the placebo arm). (impor" @default.
• W2108139871 created "2016-06-24" @default.
• W2108139871 creator A5022692391 @default.
• W2108139871 creator A5037407546 @default.
• W2108139871 creator A5048152931 @default.
• W2108139871 date "2014-11-01" @default.
• W2108139871 modified "2023-09-30" @default.
• W2108139871 title "American Gastroenterological Association Institute Technical Review on the Pharmacological Management of Irritable Bowel Syndrome" @default.
• W2108139871 cites W1491518420 @default.
• W2108139871 cites W1532990492 @default.
• W2108139871 cites W1907042839 @default.
• W2108139871 cites W1963986741 @default.
• W2108139871 cites W1965194352 @default.
• W2108139871 cites W1969004532 @default.
• W2108139871 cites W1981680557 @default.
• W2108139871 cites W1987172422 @default.
• W2108139871 cites W1990941937 @default.
• W2108139871 cites W1991905967 @default.
• W2108139871 cites W1994824286 @default.
• W2108139871 cites W1997800332 @default.
• W2108139871 cites W1998159103 @default.
• W2108139871 cites W1999221921 @default.
• W2108139871 cites W2005575554 @default.
• W2108139871 cites W2008019573 @default.
• W2108139871 cites W2009326492 @default.
• W2108139871 cites W2010149513 @default.
• W2108139871 cites W2010780461 @default.
• W2108139871 cites W2011249355 @default.
• W2108139871 cites W2011319006 @default.
• W2108139871 cites W2011627484 @default.
• W2108139871 cites W2016404985 @default.
• W2108139871 cites W2018343808 @default.
• W2108139871 cites W2020305363 @default.
• W2108139871 cites W2021110625 @default.
• W2108139871 cites W2021642055 @default.
• W2108139871 cites W2033790931 @default.
• W2108139871 cites W2035844345 @default.
• W2108139871 cites W2035889417 @default.
• W2108139871 cites W2042335480 @default.
• W2108139871 cites W2043222610 @default.
• W2108139871 cites W2043360969 @default.
• W2108139871 cites W2046456501 @default.
• W2108139871 cites W2046549547 @default.
• W2108139871 cites W2047586716 @default.
• W2108139871 cites W2048374021 @default.
• W2108139871 cites W2049004338 @default.
• W2108139871 cites W2049943358 @default.
• W2108139871 cites W2053810512 @default.
• W2108139871 cites W2054014648 @default.
• W2108139871 cites W2056304431 @default.
• W2108139871 cites W2058710569 @default.
• W2108139871 cites W2060809912 @default.
• W2108139871 cites W2063330271 @default.
• W2108139871 cites W2064017014 @default.
• W2108139871 cites W2064201279 @default.
• W2108139871 cites W2064347247 @default.
• W2108139871 cites W2064484958 @default.
• W2108139871 cites W2066972781 @default.
• W2108139871 cites W2067661817 @default.
• W2108139871 cites W2068663235 @default.
• W2108139871 cites W2074762600 @default.
• W2108139871 cites W2075272700 @default.
• W2108139871 cites W2087399526 @default.
• W2108139871 cites W2088344246 @default.
• W2108139871 cites W2090072011 @default.
• W2108139871 cites W2090132603 @default.
• W2108139871 cites W2093043874 @default.
• W2108139871 cites W2096023882 @default.
• W2108139871 cites W2096074908 @default.
• W2108139871 cites W2099768372 @default.
• W2108139871 cites W2103771013 @default.
• W2108139871 cites W2105445407 @default.
• W2108139871 cites W2107021177 @default.
• W2108139871 cites W2109346853 @default.
• W2108139871 cites W2114792198 @default.
• W2108139871 cites W2118494319 @default.
• W2108139871 cites W2120648209 @default.
• W2108139871 cites W2121087428 @default.
• W2108139871 cites W2123514148 @default.
• W2108139871 cites W2126547777 @default.
• W2108139871 cites W2127837438 @default.
• W2108139871 cites W2130505437 @default.
• W2108139871 cites W2132145612 @default.
• W2108139871 cites W2136403658 @default.
• W2108139871 cites W2141397074 @default.
• W2108139871 cites W2144532030 @default.
• W2108139871 cites W2146147731 @default.
• W2108139871 cites W2149216059 @default.
• W2108139871 cites W2155854003 @default.
• W2108139871 cites W2156138052 @default.
• W2108139871 cites W2157852258 @default.
• W2108139871 cites W2159096930 @default.
• W2108139871 cites W2159718544 @default.
• W2108139871 cites W2159988048 @default.
• W2108139871 cites W2161151481 @default.
• W2108139871 cites W3023552461 @default.
• W2108139871 doi "https://doi.org/10.1053/j.gastro.2014.09.002" @default.
• W2108139871 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/25224525" @default.

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