Placebo Effect in Clinical Trial Design for Irritable Bowel Syndrome

Shah, Eric D.; Pimentel, Mark

doi:10.5056/jnm.20.2.163

Cited by 3 publications

(3 citation statements)

References 32 publications

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“…Several other tactics for improving IBS clinical trial design have also been suggested, such as including a third "no treatment" arm. 13 Interestingly, the actual WAP response rates observed for eluxadoline in IBS-D were similar to those seen for linaclotide in IBS-C trials, although the placebo response was notably lower in the linaclotide trials. [24][25][26] A further reason for the apparently small effect size may relate to challenges faced in the measurement of abdominal pain in IBS-D trials.…”

Section: Wap Responders By Different Baseline Periodsmentioning

confidence: 55%

“…Moreover, assessing the effect of new treatments on abdominal pain in clinical trials is difficult for a variety of reasons, including the subjective nature of patient-reported outcomes and high placebo response rates. 13,14 Eluxadoline is a mixed μ-and κ-opioid receptor agonist and δ-opioid receptor antagonist that acts locally in the gastrointestinal tract and has been shown to reduce visceral hypersensitivity and regulate intestinal motility. 15 It is approved by the US Food and Drug Administration (FDA) for IBS-D in adults.…”

Section: Introductionmentioning

confidence: 99%

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Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials

Lembo

Covington

Dove

et al. 2020

Neurogastroenterology Motil

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Background Recurring abdominal pain is a characteristic and often unpredictable and debilitating symptom of irritable bowel syndrome with diarrhea (IBS‐D). Measuring the effects of IBS‐D treatments on abdominal pain remains a significant challenge in clinical trials. Here, we aimed to examine the effect of eluxadoline through various post hoc analyses. Methods Data from two eluxadoline Phase 3 trials were pooled over 26 weeks, comparing eluxadoline 100 mg twice daily to placebo. Worst abdominal pain (WAP) was measured daily on a 0‐10 scale. WAP responder criteria were prospectively defined as a ≥30% improvement in daily WAP score on ≥50% of days. Pairwise, two‐sided Cochran‐Mantel‐Haenszel tests assessed treatment effects. Cumulative distribution functions were used to plot WAP response rates using variations on the response criteria. Key results Of 1615 patients with IBS‐D (66% female, mean age 46 years), 806 received eluxadoline and 809 received placebo; 48.3% and 44.0% were WAP responders (≥30% improvement), respectively (P value not significant). When the response threshold was increased to 50% daily WAP improvement from baseline, a significantly greater percentage of eluxadoline‐treated patients versus placebo‐treated patients were WAP responders (38.7% vs 32.5%, respectively; P = .009). At Week 26, average WAP changes from baseline were −3.4 and −3.0 points, respectively (P = .002). Conclusions and Inferences Despite small effect sizes, eluxadoline demonstrated consistent and sustained improvement in WAP compared to placebo across a range of prospective and post hoc analyses. Assessing WAP response across a range of measures is important for fully understanding a treatment's efficacy.

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Section: Wap Responders By Different Baseline Periodsmentioning

confidence: 55%

Section: Introductionmentioning

confidence: 99%

Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials

Lembo

Covington

Dove

et al. 2020

Neurogastroenterology Motil

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“…Greater response to treatment in women has also been observed with serotonergic agents, [53] The response to placebo was high in the present study. A high response rate to placebo can generally be observed in IBS [55,56].…”

Section: Discussionmentioning

confidence: 99%

Humic Acids in Patients with Diarrhoea-Predominant Irritable Bowel Syndrome: Results from A Randomised Controlled Trial

Haufe¹,

Gammel²,

Schiefke

2021

BJSTR

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Irritable bowel syndrome (IBS) is the most common functional gastrointestinal disorder. There is no definitive treatment for IBS and all medications implemented in its treatment have concerns of tolerability and safety associated with their use. The WH67®-R-2012 study was a randomised, double-blind, placebo-controlled clinical trial comparing the effect of humic acids versus placebo in patients with diarrhoeapredominant IBS (IBS-D). The primary endpoint of the study was an improvement of IBS symptoms measured with the irritable bowel syndrome severity scoring system (IBS-SSS). Secondary endpoints were improvements in quality of life (IBS-QOL), the Bristol Stool Form Scale (BSFS), and in the short form 36 (SF-36). Forty-six patients were recruited to participate in the study. No adverse events were reported and no patient discontinued the study. There was no main effect for treatment (F=1.56, p=0.221), centre (F=1.71, p=0.201), or sex (F=2.47, p=0.127). We defined a response to treatment as an improvement of at least 50 points on the IBS-SSS. 57.9% of patients responded to treatment with humic acids and 36.8% of patients responded to treatment with placebo (χ 2 =1. 69, p=0.194). In patients receiving humic acids, women were more likely to be responders than men (71.4% vs. 20.0%, χ 2 =4.00, p=0.045). This was the first study testing the effect of humic acids as a potential treatment for IBS-D. No adverse events were reported, reflecting the very good tolerability of humic acids. If proven efficacious in a larger study, humic acids could represent a novel treatment option, which is much-needed for IBS-D.

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The (R)Evolution of the Human Mind

Wellington¹

2019

The Transhumanism Handbook

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Placebo Effect in Clinical Trial Design for Irritable Bowel Syndrome

Cited by 3 publications

References 32 publications

Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials

Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials

Humic Acids in Patients with Diarrhoea-Predominant Irritable Bowel Syndrome: Results from A Randomised Controlled Trial

The (R)Evolution of the Human Mind

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