Trial reportAlimentary pharmacology & therapeutics2016
Effects of baseline abdominal pain and bloating on response to lubiprostone in patients with irritable bowel syndrome with constipation.
Trial report in Alimentary pharmacology & therapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Efficacy and Safety of Probiotics in Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis.Frontiers in pharmacology · 2020Pooled it
- Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders.Digestive diseases and sciences · 2017Pooled it
- The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint.Journal of gastroenterology and hepatology · 2025Trial
- Randomised clinical trial: pregabalin vs placebo for irritable bowel syndrome.Alimentary pharmacology & therapeutics · 2019Trial
- 2025 Seoul Consensus on Clinical Practice Guidelines for Irritable Bowel Syndrome.Journal of neurogastroenterology and motility · 2025Review
- [Pharmacologic Treatment of Irritable Bowel Syndrome with Predominant Constipation].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025Review
- The Efficacy of Lubiprostone in Patients of Constipation: An Updated Systematic Review and Meta-Analysis.JGH open : an open access journal of gastroenterology and hepatology · 2025Review
- Relationship Between Colonic Transit Response to Eating With Self-reported Constipation Severity in Constipated Patients According to the Phenotype.Journal of neurogastroenterology and motility · 2024Article
- Review of the Patient Burden and Therapeutic Landscape of Irritable Bowel Syndrome with Constipation in the United States.Clinical and experimental gastroenterology · 2024Review
- Review
- Abdominal Pain in Inflammatory Bowel Disease: An Evidence-Based, Multidisciplinary Review.Crohn's & colitis 360 · 2023Article
- Methods of Determining Irritable Bowel Syndrome and Efficiency of Probiotics in Treatment: A Review.Current therapeutic research, clinical and experimental · 2023Review
- Abdominal Pain Severity Is Mainly Associated with Bloating Severity in Patients with Functional Bowel Disorders and Functional Abdominal Pain.Digestive diseases and sciences · 2022Article
- Management of scleroderma gastrointestinal disease: Lights and shadows.Journal of scleroderma and related disorders · 2022Review
- Present and Future Therapeutic Approaches to Barrier Dysfunction.Frontiers in nutrition · 2021Review
- Management of functional gastrointestinal disorders.Clinical medicine (London, England) · 2021Article
- Chinese Herbal Medicine for Irritable Bowel Syndrome: A Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials.Frontiers in pharmacology · 2021Article
- Chronic Constipation in the Elderly Patient: Updates in Evaluation and Management.Korean journal of family medicine · 2020Article
- Constipation and the Quality of Life in Conservatively Treated Chronic Kidney Disease Patients: A Cross-sectional Study.International journal of medical sciences · 2020Article
- Update on Pharmacotherapy for Irritable Bowel Syndrome.Current gastroenterology reports · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLubiprostone (8 μg b.d.) received US Food and Drug Administration (FDA) approval in 2008 for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) in women aged ≥18 years. In 2012, the FDA issued new guidance for IBS-C clinical trials, recommending a composite endpoint incorporating both abdominal pain and stool frequency.
aimIn a post hoc analysis, similar criteria were applied to data from two pivotal, phase 3, double-blind, randomised trials of lubiprostone in patients with IBS-C.
methodsIncluded patients had a baseline spontaneous bowel movement (SBM) frequency <3/week and abdominal pain or bloating ratings ≥1.36 on a 5-point scale [0 (absent) to 4 (very severe)]. Responders (composite endpoint) had a mean pain reduction ≥30% compared with baseline, and an increase from baseline of ≥1 SBM/week for ≥6 of the 12 treatment weeks. Lubiprostone effects on abdominal pain alone were also evaluated, as were bloating alone and in a composite endpoint with stool frequency.
resultsIn pooled data, 325 patients received lubiprostone and 180 received placebo. Rates of response were higher with lubiprostone vs. placebo for the composite endpoint of improved pain and stool frequency (26.3% vs. 15.3%, respectively; P = 0.008) and the composite endpoint of improved bloating and stool frequency (23.8% vs. 12.6%, respectively; P = 0.012). Response rates were also higher with lubiprostone vs. placebo for abdominal pain alone (P = 0.005) and bloating alone (P = 0.012).
conclusionLubiprostone was significantly more effective than placebo in improving abdominal pain or bloating, and also in composite endpoints that included stool frequency.
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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.