Evidence map›Paper›PMID 32377286›Full record

Trial reportPain research & management2020

Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study.

Laura Papetti, Giorgia Sforza, Giulia Tullo, Pierfrancesco Alaimo di Loro, Romina Moavero, Fabiana Ursitti, Michela Ada Noris Ferilli, Samuela Tarantino, Federico Vigevano, Massimiliano Valeriani

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Pain research & management, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06562400 (Unraveling the Spectrum of Migraine Resistant to Treatments), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT06562400 recruitingnot on this mapstarted 2023, after this paper: background citation

Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)

Typeobservational_patient_registrySponsorIRCCS National Neurological Institute "C. Mondino" FoundationRan2023 to 2026Enrolled45ConditionsMigraine Disorders, Chronic Migraine, Episodic MigraineArmsPalmitoyl ethanolamide, Ketogenic diet
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Hallmarks of primary headache: part 1 - migraine.The journal of headache and pain · 2024
    Review
  9. Article
  10. Non-Pharmacological Treatments in Paediatric Migraine.Journal of clinical medicine · 2024
    Review
  11. Article
  12. UltramicronizedCurrent neuropharmacology · 2024
    Article
  13. Observational
  14. Review
  15. Review
  16. Review
  17. Palmitoylethanolamide: A Natural Compound for Health Management.International journal of molecular sciences · 2021
    Review
  18. Review
  19. 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

10 authors at 4 institutions in 2 countries.

Laura PapettiHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, Italy.
Giorgia SforzaChild Neurology Unit, Systems Medicine Department, Tor Vergata University Hospital of Rome, Rome, Italy.
Giulia TulloDepartment of Neurosciences, Mental Health, and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
Pierfrancesco Alaimo di LoroDepartment of Statistical Sciences, Sapienza University of Rome, Rome, Italy.
Romina MoaveroChild Neurology Unit, Systems Medicine Department, Tor Vergata University Hospital of Rome, Rome, Italy.
Fabiana UrsittiHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, Italy.
Michela Ada Noris FerilliHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, Italy.
Samuela TarantinoHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, Italy.
Federico VigevanoHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, Italy.
Massimiliano ValerianiHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, Italy.ORCID 0000-0001-6602-103X
Bambino Gesù Children's Hospital · ITUniversity of Rome Tor Vergata · ITAzienda Ospedaliera Sant'Andrea · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Palmitoylethanolamide (PEA) is emerging as a new therapeutic approach in pain and inflammatory conditions, and it has been evaluated in studies on various painful diseases. The aim of this open-label study was to evaluate the efficacy of ultramicronized PEA (umPEA) in the prophylactic treatment of migraine. Methods: The study included 70 patients with mean age of 10.3 ± 2.7 (24.5% M and 75.5% F). All patients had a diagnosis of migraine without aura (ICHD 3 criteria) and received umPEA (600 mg/day orally) for three months. We compared the attack frequency (AF) and attack intensity at baseline and after three months. Patients were asked to classify the intensity of the attack with a value ranging from 1 to 3, where 1 means mild attack, 2 moderate, and 3 severe attack. Results: Nine patients discontinued treatment before the target time of 12 weeks. After 3 months of treatment with umPEA, the headache frequency was reduced by >50% per month in 63.9% patients. The number of monthly attacks at Conclusions: Our preliminary data show that umPEA administered for three month reduces pain intensity and the number of attacks per month in pediatric patients with migraine. Although the small number of patients and the lack of control group do not allow us to consider these initial results as definitely reliable, they encourage us to expand the sample.

Indexed as

AmidesAnalgesicsChildEthanolaminesFemaleHumansMaleMigraine DisordersPalmitic AcidsPilot ProjectsTreatment OutcomeAmidesAnalgesicsEthanolaminespalmidrolPalmitic Acids

Identifiers

PMID32377286
PMCPMC7196162
OpenAlexW3019413723

What OpenQuestion holds

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LicenceCC BY
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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 OpenQuestion graph.