Evidence map›Paper›PMID 34687005›Full record

Trial reportCNS drugs2021

Effect of Cannabidiol on Interictal Epileptiform Activity and Sleep Architecture in Children with Intractable Epilepsy: A Prospective Open-Label Study.

Kerstin A Klotz, Daniel Grob, Jan Schönberger, Lea Nakamura, Birgitta Metternich, Andreas Schulze-Bonhage, Julia Jacobs

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in CNS drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 7% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Treatment of pediatric epilepsy.Pediatric investigation · 2026
    Review
  4. Sleep in Lennox-Gastaut Syndrome: A Scoping Review.Children (Basel, Switzerland) · 2025
    Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. The therapeutic potential of purified cannabidiol.Journal of cannabis research · 2023
    Review
  11. Review
  12. Review
  13. 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

7 authors at 2 institutions in 1 country.

Kerstin A KlotzFaculty of Medicine, Freiburg Epilepsy Center, Medical Center-University of Freiburg, University of Freiburg, Freiburg, Germany. kerstin.alexandra.klotz@uniklinik-freiburg.de.
Daniel GrobFaculty of Medicine, Freiburg Epilepsy Center, Medical Center-University of Freiburg, University of Freiburg, Freiburg, Germany.
Jan SchönbergerFaculty of Medicine, Freiburg Epilepsy Center, Medical Center-University of Freiburg, University of Freiburg, Freiburg, Germany.
Lea NakamuraFaculty of Medicine, Freiburg Epilepsy Center, Medical Center-University of Freiburg, University of Freiburg, Freiburg, Germany.
Birgitta MetternichFaculty of Medicine, Freiburg Epilepsy Center, Medical Center-University of Freiburg, University of Freiburg, Freiburg, Germany.
Andreas Schulze-BonhageFaculty of Medicine, Freiburg Epilepsy Center, Medical Center-University of Freiburg, University of Freiburg, Freiburg, Germany.
Julia JacobsDepartment of Neuropediatrics and Muscle Disorders, Faculty of Medicine, Center for Pediatrics, Medical Center-University of Freiburg, University of Freiburg, Mathildenstr. 1, 79106, Freiburg, Germany.
University Medical Center Freiburg · DEUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCannabidiol has been shown to be effective in seizure reduction in patients with Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis. However, very little is known about its potential to reduce interictal epileptiform activity and improve sleep architecture.

objectiveThe objective of this prospective study was to evaluate the influence of cannabidiol therapy on the frequency of interictal epileptiform discharges (IEDs) and sleep microstructure in a cohort of children with drug-resistant epilepsy.

methodsChildren with drug-resistant epilepsy were prospectively followed from November 2019 to January 2021 during an open-label trial of cannabidiol at a dose of 20 mg/kg/day (to a maximum of 50 mg/kg/day) and stable concomitant medication. Electroencephalograms were recorded at baseline (T0) and after 3 months (T1). Two independent raters, blinded to clinical outcome, evaluated 5-min segments of sleep stage 2 or low-noise awake state. IEDs were visually identified and rates per minute calculated. Sleep microstructure was considered improved if sleep structures were seen at T1 that were not present at T0. IED rates at T0 and T1 were compared and correlated with seizure outcome, cannabidiol dose, initial IED rate, and disease duration.

resultsIn total, 35 children (mean ± standard deviation age 10.1 ± 0.86) were included. The IED rate at T1 was significantly lower than at T0 (19.6 ± 19.5 vs. 36.8 ± 27.2, respectively; p < 0.0001). We found a moderate correlation between IED reduction and percentage of seizure reduction compared with baseline (Pearson's r = 0.39; p = 0.02), a moderate negative correlation between IED reduction and IED rate at T0 (r = - 0.34; p = 0.04), and a trend towards a moderate negative correlation between IED reduction and disease duration (r = - 0.32; p = 0.06). Sleep was recorded in 23 patients. Sleep microstructure was initially abnormal in 56.5% of sleep recordings and improved in 84.6% of those cases.

conclusionOur results strongly suggest the utility of cannabidiol in reducing IEDs and improving sleep microstructure in children with drug-resistant epilepsy. Larger controlled studies are needed to evaluate the clinical relevance of this effect in different epilepsy types.

trial registrationDRKS00013177; 25 June 2019.

Indexed as

Administration, OralAnticonvulsantsCannabidiolChildCohort StudiesDrug Resistant EpilepsyElectroencephalographyFemaleHumansMaleProspective StudiesSleepTreatment OutcomeAnticonvulsantsCannabidiol

Identifiers

PMID34687005
PMCPMC8551105
OpenAlexW3205422029

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.