Evidence map›Paper›PMID 27995531›Full record

Trial reportCNS drugs2017

Effect on Cognition of Estroprogestins Combined with Interferon Beta in Multiple Sclerosis: Analysis of Secondary Outcomes from a Randomised Controlled Trial.

Laura De Giglio, Fabiana Marinelli, Valeria T Barletta, Veronica A Pagano, Floriana De Angelis, Fulvia Fanelli, Nikolaos Petsas, Patrizia Pantano, Valentina Tomassini, Carlo Pozzilli

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in CNS drugs, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00151801 (Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis), which is not on this map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
1.2field-weighted citation impact, top 20% 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.

NCT00151801 phase2unknown statusnot on this map

Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

TypeinterventionalSponsorS. Andrea HospitalRan2002 to 2008Enrolled200ConditionsMultiple SclerosisArmsestroprogestins, interferon-beta 1a
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Effects of the Menstrual Cycle on Neurological Disorders.Current neurology and neuroscience reports · 2021
    Review
  12. Review
  13. The effect of sex on multiple sclerosis risk and disease progression.Multiple sclerosis (Houndmills, Basingstoke, England) · 2020
    Review
  14. Article
  15. Article
  16. Pregnancy: Effect on Multiple Sclerosis, Treatment Considerations, and Breastfeeding.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2017
    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

10 authors at 3 institutions in 2 countries.

Laura De GiglioMS Centre Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy. laura.degiglio@uniroma1.it.
Fabiana MarinelliMS Centre Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Valeria T BarlettaMS Centre Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Veronica A PaganoTFS Trial Form Support S.L., Rome, Italy.
Floriana De AngelisMS Centre Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Fulvia FanelliMS Centre Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Nikolaos PetsasDepartment of Neurology and Psychiatry, Sapienza University of Rome, Viale dell'Università, 30, 00185, Rome, Italy.
Patrizia PantanoDepartment of Neurology and Psychiatry, Sapienza University of Rome, Viale dell'Università, 30, 00185, Rome, Italy.
Valentina TomassiniInstitute of Psychological Medicine and Clinical Neurosciences, Cardiff University School of Medicine, Cardiff, UK.
Carlo PozzilliMS Centre Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Sapienza University of Rome · ITAzienda Ospedaliera Sant'Andrea · ITCardiff University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCognitive impairment is a disabling symptom in multiple sclerosis (MS). While its management remains challenging, beneficial effects on cognition of interferon beta (IFN-β) have been reported and a positive effect from estroprogestins has been hypothesised, suggesting that the combination of the two medications in women with MS could offer a promising treatment strategy.

objectivesWe investigated whether a combination of estroprogestins and IFN-β can improve cognition in women with MS.

methodsWomen with relapsing-remitting (RR) MS were randomly assigned (1:1:1) to receive subcutaneous IFN-β-1a (Rebif

resultsAt baseline, there was no difference in the proportion of cognitively impaired patients. At month 24, the proportion of patients with cognitive impairment was lower in group 3 (34.8%) than in group 1 (47.6%) (p = 0.03). The risk of developing cognitive impairment over 24 months was lower in group 3 (p = 0.02). Mood and fatigue scores were comparable across the groups over time at both time points. However, at month 24, group 3 showed worsening on the sexual function subscale of the 54-item MS quality-of-life questionnaire (p = 0.03).

conclusionsThis study suggests that the combination of high-dose estroprogestins and IFN-β may have positive effects on cognition. However, the effect of this treatment on sexual function requires caution to be exercised. Protocol Number NCT00151801, registered in ClinicalTrials.gov.

Indexed as

AdultCognitive DysfunctionDesogestrelDose-Response Relationship, DrugDrug Therapy, CombinationEthinyl EstradiolFemaleFollow-Up StudiesHumansInterferon beta-1aMagnetic Resonance ImagingMultiple Sclerosis, Relapsing-RemittingQuality of LifeTime FactorsTreatment OutcomeYoung AdultDesogestrelEthinyl Estradiolethinyl estradiol-desogestrel combinationInterferon beta-1a

Identifiers

PMID27995531
OpenAlexW2564042682

What OpenQuestion holds

Textmetadata
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.