Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2018
Factors Associated With Response to Placebo in Patients With Irritable Bowel Syndrome and Constipation.
Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 40 citations in OpenAlex.
- Trial
- Trial
- Effects of treatment with eluxadoline on abdominal pain in patients with IBS-D: Additional post hoc analyses of Phase 3 trials.Neurogastroenterology and motility · 2020Trial
- Randomized Clinical Trial: Crofelemer Treatment in Women With Diarrhea-Predominant Irritable Bowel Syndrome.Clinical and translational gastroenterology · 2019Trial
- Test-retest and interrater reliability of experimental within-subject variability of pain reports as assessed by the focused analgesia selection test.Pain reports · 2024Article
- Factors That Predict Magnitude, Timing, and Persistence of Placebo-Like Response in Patients With Irritable Bowel Syndrome.Gastro hep advances · 2024Article
- Clinical-functional brain connectivity signature predicts longitudinal symptom improvement after acupuncture treatment in patients with functional dyspepsia.Human brain mapping · 2023Article
- Placebo effects in functional dyspepsia: Causes and implications for clinical trials.Neurogastroenterology and motility · 2023Review
- Virtual Tai Chi program for patients with irritable bowel syndrome with constipation: Proof-of-concept feasibility trial.Neurogastroenterology and motility · 2022Article
- Baseline Predictors of Discontinuation of Prescription Drug Therapy for IBS-C: Cohort Analysis at an Integrated Healthcare System.Digestive diseases and sciences · 2022Article
- Targeted therapy of irritable bowel syndrome with anti-inflammatory cytokines.Clinical journal of gastroenterology · 2022Review
- The low-FODMAP diet and the gluten-free diet in the management of functional abdominal bloating and distension.Frontiers in nutrition · 2022Review
- Positive Treatment Expectations Shape Perceived Medication Efficacy in a Translational Placebo Paradigm for the Gut-Brain Axis.Frontiers in psychiatry · 2022Article
- Price Is Right: Exploring Prescription Drug Coverage Barriers for Irritable Bowel Syndrome Using Threshold Pricing Analysis.Digestive diseases and sciences · 2021Article
- Understanding the Placebo and Nocebo Effects in Patients With Irritable Bowel Syndrome.Gastroenterology & hepatology · 2020Article
- Placebo Responses and Placebo Effects in Functional Gastrointestinal Disorders.Frontiers in psychiatry · 2020Review
- Pharmacologic, Dietary, and Psychological Treatments for Irritable Bowel Syndrome With Constipation: Cost Utility Analysis.MDM policy & practiceArticle
Corrections and comments
- Commented on by
- Commented on byReply.2019
Authors and funding
11 authors at 2 institutions in 2 countries.
Funding
Abstract
BACKGROUND &
aimsA high proportion of patients with irritable bowel syndrome (IBS) respond to placebo in clinical trials (estimated at about 40%). We aimed to identify factors that contribute to the high placebo response rate using data from a placebo-controlled trial of patients with IBS.
methodsWe performed a retrospective analysis of 599 women with IBS with constipation who were in the placebo group of a 12-week, randomized, double-blind, phase 3 trial of the experimental medication renzapride. Primary analyses evaluated frequency of abdominal pain in patients who received placebo, defined as ≥30% pain improvement from baseline for ≥6 of the 12 study weeks. We performed backward elimination regression with bootstrapping to identify factors associated with response to placebo.
resultsIn the placebo group, 29.0% of the patients had an abdominal pain response. Factors associated with a response to placebo were baseline variation in abdominal pain (odds ratio [OR], 1.71), maximum baseline pain severity (OR, 1.34), and placebo response in study week 2 (OR, 2.23) or week 3 (OR, 3.69). Factors associated with lack of response to placebo were number of baseline complete spontaneous bowel movements (OR, 0.73; P = .019) and final baseline pain ratings (OR, 0.73; P < .001).
conclusionsWe identified factors associated with a response in abdominal pain to placebo using original data from an IBS clinical trial. Baseline factors associated with the placebo response in women with IBS and constipation included variation in baseline pain symptoms, severity of baseline symptoms, and early improvement of abdominal pain. These findings have significant implications for clinical trial design.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.