Evidence map›Paper›PMID 28849329›Full record

SynthesisDigestive diseases and sciences2017

Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders.

Byron Cryer, Douglas A Drossman, William D Chey, Lynn Webster, Sepideh Habibi, Martin Wang

Open access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in Digestive diseases and sciences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 6% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Guideline
  2. Review
  3. Review
  4. Management of Chronic Constipation: A Comprehensive Review.Internal medicine (Tokyo, Japan) · 2025
    Review
  5. Review
  6. Article
  7. Review
  8. Constipation and Fecal Incontinence in the Elderly.Current gastroenterology reports · 2020
    Review
  9. A preliminary study of the effect of naldemedine tosylate on opioid-induced nausea and vomiting.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Article
  10. Review
  11. Review
  12. Article
  13. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Byron CryerInternal Medicine, Veterans Affairs North Texas Health Care System, University of Texas Southwestern Medical School, 5323 Harry Hines Blvd, Dallas, TX, 75390, USA. Byron.cryer@UTSouthwestern.edu.
Douglas A DrossmanUNC Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, 55 Vilcom Center Drive, Suite 110, Chapel Hill, NC, 27514, USA.
William D CheyInternal Medicine, University of Michigan School of Medicine, 3912 Taubman Center SPC 5362, Ann Arbor, MI, 48109, USA.
Lynn WebsterPRA Health Sciences, 3838 S 700 E Suite 202, Salt Lake City, UT, 84106, USA.
Sepideh HabibiDrug Safety, Sucampo Pharma Americas, LLC, 4520 East-West Highway, Bethesda, MD, 20814, USA.
Martin WangBiostatistics, Sucampo Pharma Americas, LLC, 4520 East-West Highway, Bethesda, MD, 20814, USA.
PRA Health Sciences · USUniversity of Michigan–Ann Arbor · USUniversity of North Carolina at Chapel Hill · USVA North Texas Health Care System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLubiprostone is a ClC-2 chloride channel activator approved for the treatment of chronic idiopathic constipation (CIC) and opioid-induced constipation (OIC) in adults and irritable bowel syndrome with constipation (IBS-C) in women. Lubiprostone is generally well tolerated, with nausea being the most common adverse event.

aimsTo characterize nausea with lubiprostone using pooled results from clinical studies in patients with CIC, OIC, or IBS-C.

methodsData from three 3- and 4-week placebo-controlled studies and three long-term open-label studies were pooled for the CIC analysis. The OIC and IBS-C analyses each used pooled data from three 12-week placebo-controlled studies and one 36-week open-label extension study.

resultsThe populations included the following numbers of patients: CIC, 316 (placebo) and 1113 (lubiprostone 24 mcg twice daily [BID]); OIC, 652 (placebo) and 889 (lubiprostone 24 mcg BID); and IBS-C, 435 (placebo) and 1011 (lubiprostone 8 mcg BID). The incidence of nausea in lubiprostone-treated patients ranged from 11.4 to 31.1%, with the highest incidence in patients with CIC. Among patients with any nausea, most reported only mild or moderate severity (96.5-99.1% across indications) and only one event (83.6-88.7%); most events occurred within the first 5 days of treatment.

conclusionsNausea was the most common adverse event following the treatment with lubiprostone. Event rates varied by indication and dose, and the majority of nausea adverse events were mild to moderate in severity. Nausea events predominantly occurred early in the treatment period in all of the pooled study populations.

Indexed as

Chloride Channel AgonistsConstipationHumansLubiprostoneNauseaChloride Channel AgonistsLubiprostoneChronic idiopathic constipationIrritable bowel syndrome with constipationLubiprostoneNauseaOpioid-induced constipation

Identifiers

PMID28849329
PMCPMC5694526
OpenAlexW2748730319

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.