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Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study
Laura Papetti1, Giorgia Sforza2, Giulia Tullo3
1Headache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, Italy.
Insights
Ultramicronized Palmitoylethanolamide (umPEA) significantly reduced migraine attack frequency and intensity in pediatric patients. This prophylactic treatment shows promise for managing migraine in children.
Area of Science:
- Neuroscience
- Pharmacology
- Pain Management
Background:
- Palmitoylethanolamide (PEA) is an emerging therapeutic agent for pain and inflammation.
- PEA has demonstrated potential in managing various painful conditions.
Purpose of the Study:
- To evaluate the efficacy of ultramicronized PEA (umPEA) as a prophylactic treatment for migraine in pediatric patients.
- To assess the impact of umPEA on migraine attack frequency and intensity.
Main Methods:
- An open-label study involving 70 pediatric patients diagnosed with migraine without aura.
- Patients received 600 mg/day of oral umPEA for three months.
- Attack frequency and intensity were compared at baseline and after treatment.
Main Results:
- Over 63% of patients experienced a >50% reduction in monthly headache frequency.
- Significant decreases were observed in both monthly attack frequency (from 13.9 to 6.5) and mean attack intensity (from 1.67 to 1.16).
- A notable reduction in severe attacks and medication use for acute treatment was also recorded, with minimal side effects.
Conclusions:
- Preliminary findings suggest that three months of umPEA treatment effectively reduces migraine pain intensity and monthly attack frequency in children.
- While promising, the small sample size and lack of a control group necessitate further investigation with larger cohorts.
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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