Evidence map›Paper›PMID 31454771›Full record

Trial reportNeurology(R) neuroimmunology & neuroinflammation2019

Randomized, controlled crossover study of IVIg for demyelinating polyneuropathy and diabetes.

Ari Breiner, Carolina Barnett Tapia, Leif Erik Lovblom, Bruce A Perkins, Hans D Katzberg, Vera Bril

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology(R) neuroimmunology & neuroinflammation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 39% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Spectrum of diabetic neuropathies.Diabetology international · 2020
    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 4 institutions in 1 country.

Ari BreinerFrom the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. abreiner@toh.ca.
Carolina Barnett TapiaFrom the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Leif Erik LovblomFrom the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Bruce A PerkinsFrom the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Hans D KatzbergFrom the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Vera BrilFrom the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Lunenfeld-Tanenbaum Research Institute · CAOttawa Hospital · CAMount Sinai Hospital · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine whether IV immunoglobulin (IVIg) is more effective than placebo at reducing disability in patients with diabetes and demyelinating polyneuropathy features.

methodsThis is a double-blinded, single-center, randomized, controlled crossover trial of IVIg treatment vs placebo. The primary outcome measure was the mean change in Overall Neuropathy Limitation Scale (ONLS) scores during the IVIg phasecompared with the placebo phase. Secondary outcomes include changes in the Rasch-built Overall Disability Scale, Medical Research Council sum scores, grip strength, electrophysiologic measurements, quality of life, and adverse effects.

resultsTwenty-five subjects were recruited between March 2015 and April 2017. The mean change in ONLS scores was -0.2 points during the IVIg phase and 0.0 points during the placebo phase (

conclusionsIVIg did not reduce disability, improve strength, or quality of life in patients with demyelinating polyneuropathy features and diabetes after 3 months of treatment in comparison with placebo. Therefore, careful consideration of the primary diagnosis is required before immunomodulatory therapy. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with diabetes and demyelinating polyneuropathy features, IVIg did not significantly reduce disability.

Indexed as

AgedCross-Over StudiesDiabetes MellitusDouble-Blind MethodElectrodiagnosisFemaleHumansImmunoglobulins, IntravenousMaleMiddle AgedPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingImmunoglobulins, Intravenous

Identifiers

PMID31454771
PMCPMC6943235
OpenAlexW2958990586

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.