Evidence map›Paper›PMID 27796768›Full record

Observational studyDigestive diseases and sciences2017

Vedolizumab Therapy Is Associated with an Improvement in Sleep Quality and Mood in Inflammatory Bowel Diseases.

Betsy W Stevens, Nynke Z Borren, Gabriella Velonias, Grace Conway, Thom Cleland, Elizabeth Andrews, Hamed Khalili, John G Garber, Ramnik J Xavier, Vijay Yajnik and 1 more

Erratum issued Registry-linked trialOpen access · greenAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Digestive diseases and sciences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04733456 (Evaluation of Brain Activity and Oxygenation Using Near-infrared Spectroscopy), which is not on this map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
3.6field-weighted citation impact, top 7% 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.

NCT04733456 unknown statusnot on this mapstarted 2021, after this paper: background citation

Evaluation of Brain Activity and Oxygenation Using Near-infrared Spectroscopy (NIRS) in Inflammatory Bowel Disease (IBD) Patients

TypeobservationalSponsorUniversity of CalgaryRan2021 to 2026Enrolled40ConditionsIBD, Maladaptive Behavior Associated With Physical IllnessArmsQuality of life questionnaires, NIRS, Stool Collection, Blood and urine collection
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 63 citations in OpenAlex.

  1. Review
  2. Review
  3. Observational
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Examining the influence of inflammatory bowel disease medications on sleep quality.JGH open : an open access journal of gastroenterology and hepatology · 2023
    Article
  11. Review
  12. Systematic review and meta-analysis of sleep quality in inactive inflammatory bowel disease.JGH open : an open access journal of gastroenterology and hepatology · 2022
    Review
  13. Observational
  14. Review
  15. Article
  16. The Gut Microbiota in Inflammatory Bowel Disease.Frontiers in cellular and infection microbiology · 2022
    Review
  17. Review
  18. Psychological comorbidity in gastrointestinal diseases: Update on the brain-gut-microbiome axis.Progress in neuro-psychopharmacology & biological psychiatry · 2021
    Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 2 countries.

Betsy W StevensDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA.
Nynke Z BorrenDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA.
Gabriella VeloniasDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA.
Grace ConwayDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA.
Thom ClelandDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA.
Elizabeth AndrewsDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA.
Hamed KhaliliDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA.
John G GarberDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA.
Ramnik J XavierDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA.
Vijay YajnikDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA.
Ashwin N AnanthakrishnanDivision of Gastroenterology, Massachusetts General Hospital Crohn's and Colitis Centre, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA. aananthakrishnan@mgh.harvard.edu.
Massachusetts General Hospital · USHarvard University · USUniversity of Groningen · NL

Funding

Pilot & Feasibility ProgramP30DK043351 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Ramnik J Xavier · 1991 to 2026
$35.3M
Genetic predictors of anti-TNF treatment response and infections in IBDK23DK097142 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI ANANTHAKRISHNAN, ASHWIN N · 2012 to 2016
$846k
NIDDK NIH HHS K23 DK097142NIDDK NIH HHS P30 DK043351
6 · The paper itself

Abstract

introductionPoor sleep, depression, and anxiety are common in patients with inflammatory bowel diseases (IBD) and associated with increased risk of relapse and poor outcomes. The effectiveness of therapies in improving such psychosocial outcomes is unclear but is an important question to examine with increasing selectivity of therapeutic agents.

methodsThis prospective cohort enrolled patients with moderate-to-severe CD or UC starting biologic therapy with vedolizumab or anti-tumor necrosis factor α agents (anti-TNF). Sleep quality, depression, and anxiety were measured using validated short-form NIH PROMIS questionnaires assessing sleep and mood quality over the past 7 days. Disease activity was assessed using validated indices. Improvement in sleep and mood scores from baseline was assessed, and regression models were used to identify determinants of sleep quality.

resultsOur study included 160 patients with IBD (49 anti-TNF, 111 Vedolizumab) among whom half were women and the mean age was 40.2 years. In the combined cohort, we observed a statistically significant and meaningful decrease in mean scores from baseline (52.8) by week 6 (49.8, p = 0.002). Among vedolizumab users, sleep T-score improved from baseline (53.6) by week 6 (50.7) and persisted through week 54 (46.5, p = 0.009). Parallel reductions in depression and anxiety were also noted (p < 0.05 by week 6). We observed no difference in improvement in sleep, depression, and anxiety between vedolizumab and anti-TNF use at week 6.

conclusionsBoth vedolizumab and anti-TNF biologic therapies were associated with improvement in sleep and mood quality in IBD.

Indexed as

AffectSleepAdalimumabAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsAnxietyCertolizumab PegolCohort StudiesColitis, UlcerativeCrohn DiseaseDepressionFemaleGastrointestinal AgentsHumansAdalimumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsCertolizumab PegolGastrointestinal AgentsgolimumabInfliximabTumor Necrosis Factor-alphavedolizumabAnxietyBiologicsDepressionSleepVedolizumab

Identifiers

PMID27796768
PMCPMC5218976
OpenAlexW2544630376

What OpenQuestion holds

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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.