Evidence map›Paper›PMID 32876962›Full record

Trial reportEuropean journal of neurology2021

Randomized trial of intravenous immunoglobulin maintenance treatment regimens in chronic inflammatory demyelinating polyradiculoneuropathy.

K Kuitwaard, E Brusse, B C Jacobs, A F J E Vrancken, F Eftimov, N C Notermans, A J van der Kooi, W-J R Fokkink, D Nieboer, H F Lingsma and 2 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 21% 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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Review
  8. Novel Immunological and Therapeutic Insights in Guillain-Barré Syndrome and CIDP.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021
    Review
  9. 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

12 authors at 4 institutions in 2 countries.

K KuitwaardDepartment of Neurology, Erasmus MC University Medical Centre Rotterdam, Rotterdam, The Netherlands.ORCID 0000-0002-1003-500X
E BrusseDepartment of Neurology, Erasmus MC University Medical Centre Rotterdam, Rotterdam, The Netherlands.
B C JacobsDepartment of Neurology, Erasmus MC University Medical Centre Rotterdam, Rotterdam, The Netherlands.
A F J E VranckenDepartment of Neurology, Brain Centre Rudolf Magnus University Medical Centre Utrecht, Utrecht, The Netherlands.
F EftimovDepartment of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
N C NotermansDepartment of Neurology, Brain Centre Rudolf Magnus University Medical Centre Utrecht, Utrecht, The Netherlands.
A J van der KooiDepartment of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
W-J R FokkinkDepartment of Neurology, Erasmus MC University Medical Centre Rotterdam, Rotterdam, The Netherlands.
D NieboerDepartment of Public Health, Erasmus MC University Medical Centre Rotterdam, Rotterdam, The Netherlands.
H F LingsmaDepartment of Public Health, Erasmus MC University Medical Centre Rotterdam, Rotterdam, The Netherlands.
I S J MerkiesDepartment of Neurology, Curaçao Medical Centre Willemstad, Willemstad, Curaçao.
P A van DoornDepartment of Neurology, Erasmus MC University Medical Centre Rotterdam, Rotterdam, The Netherlands.
Erasmus MC · NLAmsterdam Neuroscience · NLUniversity Medical Center Utrecht · NLMaastricht University Medical Centre · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeHigh peak serum immunoglobulin G (IgG) levels may not be needed for maintenance intravenous immunoglobulin (IVIg) treatment in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and such high levels may cause side effects. More frequent lower dosing may lead to more stable IgG levels and higher trough levels, which might improve efficacy. The aim of this trial is to investigate whether high frequent low dosage IVIg treatment is more effective than low frequent high dosage IVIg treatment.

methodsIn this randomized placebo-controlled crossover trial, we included patients with CIDP proven to be IVIg-dependent and receiving an individually established stable dose and interval of IVIg maintenance treatment. In the control arm, patients received their individual IVIg dose and interval followed by a placebo infusion at half the interval. In the intervention arm, patients received half their individual dose at half the interval. After a wash-out phase patients crossed over. The primary outcome measure was handgrip strength (assessed using a Martin Vigorimeter). Secondary outcome indicators were health-related quality of life (36-item Short-Form Health Survey), disability (Inflammatory Rasch-built Overall Disability Scale), fatigue (Rasch-built Fatigue Severity Scale) and side effects.

resultsTwenty-five patients were included and were treated at baseline with individually adjusted dosages of IVIg ranging from 20 to 80 g and intervals ranging from 14 to 35 days. Three participants did not complete the trial; the main analysis was therefore based on the 22 patients completing both treatment periods. There was no significant difference in handgrip strength change from baseline between the two treatment regimens (coefficient -2.71, 95% CI -5.4, 0.01). Furthermore, there were no significant differences in any of the secondary outcomes or side effects.

conclusionsMore frequent lower dosing does not further improve the efficacy of IVIg in stable IVIg-dependent CIDP and does not result in fewer side effects.

Indexed as

Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingCross-Over StudiesHand StrengthHumansImmunoglobulins, IntravenousQuality of LifeImmunoglobulins, Intravenouschronic inflammatory demyelinatingcrossover studiesimmunoglobulinsintravenouspolyradiculoneuropathy

Identifiers

PMID32876962
PMCPMC7820989
OpenAlexW3082181141

What OpenQuestion holds

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LicenceCC BY-NC
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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.