Evidence mapPaperPMID 33766992Full record

Trial reportNeurology2021

Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy.

Margot Geerts, Bianca T A de Greef, Maurice Sopacua, Sander M J van Kuijk, Janneke G J Hoeijmakers, Catharina G Faber, Ingemar S J Merkies

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02637700 (Intravenous Immunoglobulin Therapy for Small Fiber Neuropathy), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
6.3field-weighted citation impact, top 3% 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.

NCT02637700 phase2completednot on this map

Intravenous Immunoglobulin Therapy for Small Fiber Neuropathy: a Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety.

TypeinterventionalSponsorAcademisch Ziekenhuis MaastrichtRan2016 to 2019Enrolled60ConditionsSmall Fiber NeuropathyArmsIntravenous Immunoglobulin, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 72 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Advances in diagnosis and management of distal sensory polyneuropathies.Journal of neurology, neurosurgery, and psychiatry · 2023
    Review
  7. Article
  8. Review
  9. Review
  10. A role for pathogenic autoantibodies in small fiber neuropathy?Frontiers in molecular neuroscience · 2023
    Review
  11. Article
  12. Network autonomic analysis of post-acute sequelae of COVID-19 and postural tachycardia syndrome.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Margot GeertsFrom the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.
Bianca T A de GreefFrom the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.
Maurice SopacuaFrom the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.
Sander M J van KuijkFrom the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.
Janneke G J HoeijmakersFrom the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.
Catharina G FaberFrom the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao. c.faber@mumc.nl.
Ingemar S J MerkiesFrom the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.
Adelante · NLMaastricht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis is the first double-blind randomized controlled trial evaluating the efficacy and safety of IV immunoglobulin (IVIG) vs placebo in patients with idiopathic small fiber neuropathy (I-SFN).

methodsBetween July 2016 and November 2018, 60 Dutch patients with skin biopsy-proven I-SFN randomly received a starting dose of IVIG (2 g/kg body weight) or matching placebo (0.9% saline). Subsequently, 3 additional infusions of IVIG (1 g/kg) or placebo were administered at 3-week intervals. The primary outcome was a 1-point change in Pain Intensity Numerical Rating Scale score at 12 weeks compared to baseline.

resultsThirty patients received IVIG, and 30 received placebo. In both groups, 29 patients completed the trial. In 40% of patients receiving IVIG, the mean average pain was decreased by at least 1 point compared to 30% of the patients receiving placebo (

conclusionsThis randomized controlled trial showed that IVIG treatment had no significant effect on pain in patients with painful I-SFN. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT02637700, EudraCT 2015-002624-31. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with painful I-SFN, IVIG did not significantly reduce pain compared to placebo.

Indexed as

AdultDouble-Blind MethodFemaleHumansImmunoglobulins, IntravenousImmunologic FactorsMaleMiddle AgedNeuralgiaPain MeasurementSmall Fiber NeuropathyTreatment OutcomeImmunoglobulins, IntravenousImmunologic Factors

Identifiers

PMID33766992
PMCPMC8205474
OpenAlexW3137056193

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.