Evidence map›Paper›PMID 16719908›Full record

Trial reportBMC neurology2006

Monthly intravenous methylprednisolone in relapsing-remitting multiple sclerosis - reduction of enhancing lesions, T2 lesion volume and plasma prolactin concentrations.

Florian Then Bergh, Tania Kümpfel, Erina Schumann, Ulrike Held, Michaela Schwan, Mirjana Blazevic, Axel Wismüller, Florian Holsboer, Alexander Yassouridis, Manfred Uhr and 4 more

Registry-linked trialOpen access · goldAbstract readClinical TrialComparative Study
In one paragraph

Trial report in BMC neurology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03492255 (CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid), which is not on this map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 9% 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.

NCT03492255 naterminatednot on this mapstarted 2018, after this paper: background citation

CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2018 to 2021Enrolled49ConditionsSystemic Lupus Erythematosus (SLE)ArmsCyclophosphamide, Methylprednisolone, Prednisone, Mycophenolate Mofetil
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 63 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Corticosteroids for the long-term treatment in multiple sclerosis.The Cochrane database of systematic reviews · 2008
    Pooled it
  4. Trial
  5. Review
  6. Article
  7. Observational
  8. Slowly eroding lesions in multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2017
    Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Adaptive immune responses in CNS autoimmune disease: mechanisms and therapeutic opportunities.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2013
    Review
  15. Neuroendocrine immunoregulation in multiple sclerosis.Clinical & developmental immunology · 2013
    Review
  16. Article
  17. Review
  18. Article
  19. Bone health in multiple sclerosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2011
    Review
  20. Article
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

14 authors at 5 institutions in 2 countries.

Florian Then BerghSection of Neurology, Max-Planck-Institut für Psychiatrie, München, Germany. ThenBerF@medizin.uni-leipzig.de
Tania Kümpfel
Erina Schumann
Ulrike Held
Michaela Schwan
Mirjana Blazevic
Axel Wismüller
Florian Holsboer
Alexander Yassouridis
Manfred Uhr
Frank Weber
Martin Daumer
Claudia Trenkwalder
Dorothee P Auer
Max Planck Institute of Psychiatry · DELudwig-Maximilians-Universität München · DESylvia Lawry Centre for Multiple Sclerosis Research · DEParacelsus Elena Klinik Kassel · DEUniversity of Nottingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntravenous methylprednisolone (IV-MP) is an established treatment for multiple sclerosis (MS) relapses, accompanied by rapid, though transient reduction of gadolinium enhancing (Gd+) lesions on brain MRI. Intermittent IV-MP, alone or with immunomodulators, has been suggested but insufficiently studied as a strategy to prevent relapses.

methodsIn an open, single-cross-over study, nine patients with relapsing-remitting MS (RR-MS) underwent cranial Gd-MRI once monthly for twelve months. From month six on, they received a single i.v.-infusion of 500 mg methylprednisolone (and oral tapering for three days) after the MRI. Primary outcome measure was the mean number of Gd+ lesions during treatment vs. baseline periods; T2 lesion volume and monthly plasma concentrations of cortisol, ACTH and prolactin were secondary outcome measures. Safety was assessed clinically, by routine laboratory and bone mineral density measurements. Soluble immune parameters (sTNF-RI, sTNF-RII, IL1-ra and sVCAM-1) and neuroendocrine tests (ACTH test, combined dexamethasone/CRH test) were additionally analyzed.

resultsComparing treatment to baseline periods, the number of Gd+ lesions/scan was reduced in eight of the nine patients, by a median of 43.8% (p = 0.013, Wilcoxon). In comparison, a pooled dataset of 83 untreated RR-MS patients from several studies, selected by the same clinical and MRI criteria, showed a non-significant decrease by a median of 14% (p = 0.32). T2 lesion volume decreased by 21% during treatment (p = 0.001). Monthly plasma prolactin showed a parallel decline (p = 0.027), with significant cross-correlation with the number of Gd+ lesions. Other hormones and immune system variables were unchanged, as were ACTH test and dexamethasone-CRH test. Treatment was well tolerated; routine laboratory and bone mineral density were unchanged.

conclusionMonthly IV-MP reduces inflammatory activity and T2 lesion volume in RR-MS.

Indexed as

GadoliniumTreatment OutcomeAdultAnalysis of VarianceAnti-Inflammatory AgentsBrainCross-Over StudiesDexamethasoneDrug Administration ScheduleFemaleHormonesHumansInjections, IntravenousMagnetic Resonance ImagingMaleMethylprednisoloneAnti-Inflammatory AgentsDexamethasoneGadoliniumHormonesMethylprednisoloneProlactinReceptors, Cytokine

Identifiers

PMID16719908
PMCPMC1501038
OpenAlexW1925874174

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.