Trial reportPain medicine (Malden, Mass.)2014
A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain.
Trial report in Pain medicine (Malden, Mass.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 33 papers, 5 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.
A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation: A Multicenter, Randomized Controlled Trial
Who cites it
33 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Guideline
- MASCC recommendations on the management of constipation in patients with advanced cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Guideline
- Pharmacological Treatment of Opioid-Induced Constipation Is Effective but Choice of Endpoints Affects the Therapeutic Gain.Digestive diseases and sciences · 2019Pooled it
- Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders.Digestive diseases and sciences · 2017Pooled it
- Opioid-Induced Constipation and Bowel Dysfunction: A Clinical Guideline.Pain medicine (Malden, Mass.) · 2017Guideline
- Trial
- Early detection of opioid-induced constipation in patients initiating weak opioids for chronic non-cancer pain.Scientific reports · 2026Article
- 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
- Inadequate management of opioid-induced constipation in European cancer pain patients: results of a real-world, multicentre, observational study ("E-StOIC").Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024Observational
- Opioid-induced Constipation: Old and New Concepts in Diagnosis and Treatment.Journal of neurogastroenterology and motility · 2024Review
- Differences in efficacy and safety of lubiprostone used for idiopathic vs opioid-induced constipation: meta-analysis of East Asian and Western populations.Journal of clinical biochemistry and nutrition · 2020Review
- Opioid-induced constipation: a narrative review of therapeutic options in clinical management.The Korean journal of pain · 2019Article
- Clinical Overview and Considerations for the Management of Opioid-induced Constipation in Patients With Chronic Noncancer Pain.The Clinical journal of pain · 2019Review
- Pathophysiology and management of opioid-induced constipation: European expert consensus statement.United European gastroenterology journal · 2019Review
- American Gastroenterological Association Institute Technical Review on the Medical Management of Opioid-Induced Constipation.Gastroenterology · 2019Review
- New developments in the treatment of opioid-induced gastrointestinal symptoms.United European gastroenterology journal · 2018Review
- Article
- Clinical utility of plecanatide in the treatment of chronic idiopathic constipation.International journal of general medicine · 2018Review
- Opioids in Gastroenterology: Treating Adverse Effects and Creating Therapeutic Benefits.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2017Review
- Opioid-Related Constipation in Patients With Non-cancer Pain Syndromes: a Review of Evidence-Based Therapies and Justification for a Change in Nomenclature.Current gastroenterology reports · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation (OIC) in patients with chronic noncancer pain.
designProspective, randomized, double-blind, placebo-controlled trial.
settingSeventy-nine US and Canadian centers. SUBJECTS: Patients aged ≥ 18 years with OIC, defined as <3 spontaneous bowel movements (SBMs) per week.
methodsPatients received lubiprostone 24 mcg or placebo twice daily for 12 weeks. The primary endpoint was change from baseline in SBM frequency at week 8.
resultsAmong randomized patients (N=418; lubiprostone, N=210; placebo, N=208), most completed the study (lubiprostone, 67.1%; placebo, 69.7%). The safety and efficacy (intent-to-treat) populations included 414 (lubiprostone, N=208; placebo, N=206) and 413 (lubiprostone, N=209; placebo, N=204) patients, respectively. The mean (standard deviation) age was 50.4 (10.9) years; most patients were female (64.4%) and white (77.7%). Changes from baseline in SBM frequency rates were significantly higher at week 8 (P=0.005) and overall (P=0.004) in patients treated with lubiprostone compared with placebo. Pairwise comparisons showed significantly greater overall improvement for abdominal discomfort (P=0.047), straining (P<0.001), constipation severity (P=0.007), and stool consistency (P<0.001) with lubiprostone compared with placebo. Moreover, patients rated the effectiveness of lubiprostone as significantly (P<0.05) better than placebo for 11 of 12 weeks. The most common treatment-related adverse events (AEs) with lubiprostone and placebo were nausea (16.8% vs 5.8%, respectively), diarrhea (9.6% vs 2.9%), and abdominal distention (8.2% vs 2.4%). No lubiprostone-related serious AEs occurred.
conclusionLubiprostone effectively relieved OIC and associated signs and symptoms and was well tolerated in patients with chronic noncancer pain (http://clinicaltrials.gov/ct2/show/NCT00595946).
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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.