Evaluation of Harm in the Pharmacotherapy of Irritable Bowel Syndrome

Shah, Eric D.; Kim, Sharon; Chong, Kelly; Lembo, Anthony; Pimentel, Mark

doi:10.1016/j.amjmed.2011.08.026

Cited by 69 publications

(86 citation statements)

References 37 publications

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“…The safety of rifaximin was favorable and generally comparable with that of placebo; no Clostridium difficile-associated diarrhea was reported in the TARGET 1 and 2 studies. Regarding its safety profile, meta-analyses of rifaximin trials showed no difference in the overall incidence of AEs compared with placebo [Ford et al 2014a;Menees et al 2012;Shah et al 2012]. Furthermore, data indicated that 846 patients would benefit from rifaximin treatment for every 1 patient harmed (number needed to harm 8971; NNT 10.6) [Shah et al 2012].…”

Section: Targeting Gut Microbiotamentioning

confidence: 99%

New and emerging therapies for the treatment of irritable bowel syndrome: an update for gastroenterologists

Foxx‐Orenstein

2016

Therap Adv Gastroenterol

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Section: Targeting Gut Microbiotamentioning

confidence: 99%

New and emerging therapies for the treatment of irritable bowel syndrome: an update for gastroenterologists

Foxx‐Orenstein

2016

Therap Adv Gastroenterol

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“…This measure also accounts for differing culture and values in that the patient must weight benefit and risk. We conducted a meta-analysis 56 evaluating IBS therapies which received at least a Grade 1b from the ACG Task Force for IBS primary endpoints 43 for dropouts due to adverse events. For diarrhea-predominant IBS (IBS-D), antidepressant and alosetron therapy led to one dropout due to adverse events for only every 2.3 and 2.6 patients benefiting from therapy, respectively.…”

Section: Concerns With Existing Binary Patient-based Endpointsmentioning

confidence: 99%

Placebo Effect in Clinical Trial Design for Irritable Bowel Syndrome

Shah¹,

Pimentel²

2014

J Neurogastroenterol Motil

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Ongoing efforts to improve clinical trial design in irritable bowel syndrome have been hindered by high placebo response rates and ineffective outcome measures. We assessed established strategies to minimize placebo effect as well as the various approaches to placebo effect which can affect trial design. These include genetic markers such as catechol-O-methyltransferase, opioidergic and dopaminergic neurobiologic theory, pre-cebo effect centered on expectancy theory, and side effect unblinding grounded on conditioning theory. We reviewed endpoints used in the study of IBS over the past decade including adequate relief and subjective global relief, emphasizing their weaknesses in fully evaluating the IBS condition, specifically their motility effects based on functional net value and relative benefit-harm based on dropouts due to adverse events. The focus of this review is to highlight ongoing efforts to improve clinical trial design which can lead to better outcomes in a real-world setting.

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“…In the pooled analysis, the most common AEs with rifaximin 550 mg (n = 1008) vs. placebo (n = 829) were headache (5.5 vs. 6.2%), upper respiratory tract infection (4.5 vs. 5.7%), nausea (4.1 vs. 3.7%), and abdominal pain (4.0 vs. 4.7%) [110]. A meta-analysis determined that one individual with IBS-D would have an AE with rifaximin for every 846 individuals who would benefit (number needed to harm = 8,971; number needed to treat = 10.6) [111]. Because rifaximin is administered as short-course therapy (i.e.…”

Section: Antibioticsmentioning

confidence: 99%

Modulation of the gut microbiota: a focus on treatments for irritable bowel syndrome

Harris

Baffy

2017

Postgraduate Medicine

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Irritable bowel syndrome (IBS), which is characterized by recurrent abdominal pain and disordered bowel habits, is one of the most common functional bowel disorders. IBS is a substantial burden on both patient health-related quality of life and healthcare costs. Several pathophysiologic mechanisms have been postulated for the occurrence of IBS, including altered gastrointestinal motility, visceral hypersensitivity, changes in gut permeability, immune activation, gut-brain dysregulation, central nervous system dysfunction, and changes in the gut microbiota. Of note, both qualitative and quantitative differences have been observed in the gut microbiota of a population with IBS versus a healthy population. Because of the substantial interest in the gut microbiota and its role as a therapeutic target in IBS, this article provides an overview of specific interventions with the potential to modulate the gut microbiota in IBS, including elimination diets, prebiotics, probiotics, synbiotics, and nonsystemic antibiotics. Although probiotics and synbiotics are generally well tolerated, differences in the composition and concentration of different bacterial species and inclusion or exclusion of prebiotic components varies widely across studies and has prevented strong recommendations on their use in IBS. For nonsystemic antibiotics, rifaximin is indicated in the United States for the treatment of IBS with diarrhea in adults and has been shown to be efficacious and well tolerated in well-designed clinical trials. Overall, more consistent evidence is needed regarding the efficacy and safety of elimination diets, prebiotics, probiotics, and synbiotics for the treatment of patients with IBS. Furthermore, additional well-designed studies are needed that examine alterations in the gut microbiota that occur with these interventions and their potential associations with clinical symptoms of IBS. ARTICLE HISTORY

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Evaluation of Harm in the Pharmacotherapy of Irritable Bowel Syndrome

Cited by 69 publications

References 37 publications

New and emerging therapies for the treatment of irritable bowel syndrome: an update for gastroenterologists

New and emerging therapies for the treatment of irritable bowel syndrome: an update for gastroenterologists

Placebo Effect in Clinical Trial Design for Irritable Bowel Syndrome

Modulation of the gut microbiota: a focus on treatments for irritable bowel syndrome

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