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Clinical Trial
. 2020 Apr 24:2020:3938640.
doi: 10.1155/2020/3938640. eCollection 2020.

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

Laura Papetti  1 , Giorgia Sforza  2 , Giulia Tullo  3 , Pierfrancesco Alaimo di Loro  4 , Romina Moavero  2 , Fabiana Ursitti  1 , Michela Ada Noris Ferilli  1 , Samuela Tarantino  1 , Federico Vigevano  1 , Massimiliano Valeriani  1   5
Affiliations
Clinical Trial

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

Laura Papetti et al. Pain Res Manag. .

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 T 1 decreased significantly compared with the baseline assessment (from 13.9 ± 7.5 SD of T 0 to 6.5 ± 5.9 SD of T 1; p < 0.001). The mean intensity of the attacks dropped from 1.67 ± 0.6 (T 0) to 1.16 ± 0.5 (T 1) (p < 0.001), and the percentage of patients with severe attacks decreased after treatment (from 8.2% to 1.6%; p < 0.05). The monthly assumptions of drugs for the attack reduced from 9.5 ± 4.4 to 4.9 ± 2.5 (p < 0.001). Only one patient developed mild side effects (nausea and floating).

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.

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Conflict of interest statement

All authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Comparison of frequency of migraine attacks before and after 12 weeks of treatment with umPEA.
Figure 2
Figure 2
Result of logistic regression for correlation between age and response to treatment.
Figure 3
Figure 3
Comparison of intensity of migraine attacks before and after 12 weeks of treatment with umPEA.
Figure 4
Figure 4
Comparison of monthly assumption of drugs for the attack before and after 12 weeks of treatment with umPEA.
See this image and copyright information in PMC

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