Evidence map›Paper›PMID 27507402›Full record

Trial reportJPEN. Journal of parenteral and enteral nutrition2017

Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide.

Ken Fujioka, Khursheed Jeejeebhoy, Ulrich-Frank Pape, Benjamin Li, Nader N Youssef, Stéphane M Schneider

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in JPEN. Journal of parenteral and enteral nutrition, 2017. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.8field-weighted citation impact, top 15% 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.

NCT00081458 phase3completednot on this map

A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

TypeinterventionalSponsorShireRan2004 to 2007Enrolled84ConditionsShort Bowel SyndromeArmsPlacebo, Teduglutide 0.05 mg/kg/d, Teduglutide 0.1 mg/kg/d
NCT00798967 phase3completednot on this map

A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

TypeinterventionalSponsorShireRan2008 to 2011Enrolled86ConditionsShort Bowel SyndromeArmsteduglutide, placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Opioid misuse in gastroenterology and non-opioid management of abdominal pain.Nature reviews. Gastroenterology & hepatology · 2018
    Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 4 countries.

Ken Fujioka1 Department of Diabetes and Endocrinology, Scripps Clinic, San Diego, California, USA.
Khursheed Jeejeebhoy2 Department of Medicine, St. Michael's Hospital, Toronto, Ontario, Canada.
Ulrich-Frank Pape3 Department of Hepatology & Gastroenterology, Charité University Medicine, Berlin, Germany.
Benjamin Li4 Department of Statistics, NPS Pharmaceuticals, Inc., Lexington, Massachusetts, USA.
Nader N Youssef5 Clinical Research and Development, NPS Pharmaceuticals, Inc., Lexington, Massachusetts, USA.
Stéphane M Schneider6 Gastroenterology and Clinical Nutrition, University of Nice-Sophia Antipolis, Nice, France.
Amicus Therapeutics (United States) · USCharité - Universitätsmedizin Berlin · DEScripps Clinic · USSt. Michael's Hospital · CAUniversité Côte d'Azur · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNarcotic agents are frequently administered to manage increased intestinal motility in patients with short bowel syndrome, but long-term use is associated with gastrointestinal (GI) complaints. This analysis evaluated the incidence of narcotic use and abdominal adverse events among patients with short bowel syndrome receiving teduglutide. MATERIALS AND

methodsPooled data from patients who received ≥1 dose of teduglutide 0.05 mg/kg/d (n = 77) or placebo (n = 59) in either of 2 randomized, double-blind, phase III studies were analyzed.

resultsOf 136 patients, 52 (38%) received narcotics. GI adverse events occurred more often among patients who received narcotics than among those who did not (abdominal pain, 51% vs 21%; nausea, 42% vs 11%; abdominal distension, 17% vs 8%; vomiting, 19% vs 6%). Logistic regression analysis indicated that the probability of GI adverse events was significantly increased in patients with narcotic use ( P = .0009). In contrast, teduglutide treatment, as well as the interaction between teduglutide and narcotic use, did not affect the probability of GI adverse events.

conclusionsThese results suggest that patients with short bowel syndrome receiving narcotics have chronic GI complaints independent of teduglutide treatment. Data included in this analysis were derived from ClinicalTrials.gov NCT00081458 and NCT00798967 (EudraCT 2004-000438-35 and 2008-006193-15).

Indexed as

Abdominal PainAdministration, OralAdultDose-Response Relationship, DrugDouble-Blind MethodGastrointestinal AgentsHumansLogistic ModelsNarcoticsNauseaPeptidesShort Bowel SyndromeVomitingGastrointestinal AgentsNarcoticsPeptidesteduglutideintestinal absorptionintestinal failureperistalsis inhibition

Identifiers

PMID27507402
PMCPMC5703028
OpenAlexW2508152251

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.