scholarly journals Shortcomings of Trials Assessing Antidepressants in the Management of Irritable Bowel Syndrome: A Critical Review

2020 ◽  
Vol 9 (9) ◽  
pp. 2933
Author(s):  
Sun Jung Oh ◽  
Will Takakura ◽  
Ali Rezaie
Keyword(s):  
Irritable Bowel Syndrome ◽  
Study Design ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Placebo Response ◽  
Careful Consideration ◽  
Selective Reporting ◽  
Fragility Index ◽  
Quality Reporting ◽  
Search Data ◽  
Irritable Bowel

Irritable bowel syndrome (IBS) is a common disorder requiring complex, multidisciplinary management. Antidepressants are commonly used and recommended in guidelines for the treatment of patients with IBS. We assessed randomized controlled trials (RCTs) on antidepressants in patients with IBS, with specific attention to study design and data quality/reporting characteristics. Following a comprehensive search, data and RCT characteristics were systematically summarized. Fragility index, representing the number of positive “events” that the study relies on for its significance, was calculated. Eighteen RCTs were included. Overall, tricyclic antidepressants (TCAs), but not selective serotonin reuptake inhibitors (SSRIs), appeared to be efficacious in IBS. Eight studies reported on adverse events (AEs), which were significantly greater in patients receiving antidepressants versus placebo. The median (mean) fragility index of TCA trials was 0 (1.5). RCTs with positive results had significantly lower placebo rates (20.8%) versus negative studies (45.7%; p < 0.0001). RCTs exhibited limitations related to study design (sample size and blinding), data analysis (outcomes and placebo response), and data reporting (selective reporting of AEs and publication bias). Careful consideration of limitations of RCTs on antidepressants in IBS is warranted to formulate a safe and beneficial treatment regimen for patients with IBS.

scholarly journals Management of irritable bowel syndrome with diarrhea: a review of nonpharmacological and pharmacological interventions

2019 ◽  
Vol 12 ◽  
pp. 175628481987895 ◽  
Author(s):  
David J. Cangemi ◽  
Brian E. Lacy
Keyword(s):  
Irritable Bowel Syndrome ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Lifestyle Modification ◽  
Behavioral Therapy ◽  
Management Plan ◽  
Pharmacological Interventions ◽  
Bile Acid Sequestrants ◽  
Psychological Therapies ◽  
Symptom Intensity ◽  
Irritable Bowel

Irritable bowel syndrome (IBS) is a common gastrointestinal (GI) condition involving numerous potential causative factors (e.g. alterations in gut microbiota, motility, brain–gut axis). Several interventions are available for the management of patients with IBS, but no universal management algorithm currently exists. The aim of this article is to review interventions that may be considered in the management of patients with IBS with diarrhea (IBS-D). Nonpharmacological interventions include dietary and lifestyle modification, which are generally used as first-line therapy. Probiotics have demonstrated efficacy and safety in patients with IBS, but studies are inconsistent in strains examined, dosing, and treatment duration. Psychological therapies (e.g. cognitive behavioral therapy, hypnotherapy) also may improve IBS symptoms. Pharmacological interventions for the management of IBS-D include the US Food and Drug Administration–approved agents eluxadoline, rifaximin, and alosetron, as well as loperamide, smooth muscle antispasmodics, bile acid sequestrants, and antidepressants (i.e. tricyclic antidepressants, selective serotonin reuptake inhibitors). Eluxadoline and rifaximin have been shown to improve abdominal pain and stool consistency in patients with IBS-D. In addition, data indicate that alosetron improves IBS symptoms; however, it is approved only for women with severe IBS-D. Of the three approved agents, rifaximin has the most favorable safety profile. The risk–benefit ratio is an important consideration with every medication, but is especially important in the treatment of functional GI disorders such as IBS-D. Thus, the most troublesome symptoms, quality of life, symptom intensity, and individual patient preferences should be considered when formulating a management plan for patients with IBS-D.

Evolution of Clinical Trials for Irritable Bowel Syndrome: Issues in End Points and Study Design

2010 ◽  
Vol 105 (4) ◽  
pp. 731-735 ◽  
Author(s):  
Ann Marie Trentacosti ◽  
Ruyi He ◽  
Laurie B Burke ◽  
Donna Griebel ◽  
Dianne L Kennedy
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Study Design ◽  
End Points ◽  
Irritable Bowel
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