Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study
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 tr...
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| Format: | Article |
| Language: | English |
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Wiley
2020-01-01
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| Series: | Pain Research and Management |
| Online Access: | http://dx.doi.org/10.1155/2020/3938640 |
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| author | Laura Papetti Giorgia Sforza Giulia Tullo Pierfrancesco Alaimo di Loro Romina Moavero Fabiana Ursitti Michela Ada Noris Ferilli Samuela Tarantino Federico Vigevano Massimiliano Valeriani |
| author_facet | Laura Papetti Giorgia Sforza Giulia Tullo Pierfrancesco Alaimo di Loro Romina Moavero Fabiana Ursitti Michela Ada Noris Ferilli Samuela Tarantino Federico Vigevano Massimiliano Valeriani |
| author_sort | Laura Papetti |
| collection | DOAJ |
| description | 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 T1 decreased significantly compared with the baseline assessment (from 13.9 ± 7.5 SD of T0 to 6.5 ± 5.9 SD of T1; p<0.001). The mean intensity of the attacks dropped from 1.67 ± 0.6 (T0) to 1.16 ± 0.5 (T1) (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. |
| format | Article |
| id | doaj-art-4b5dadfc79d04cce938c0c0671fa17ea |
| institution | Kabale University |
| issn | 1203-6765 1918-1523 |
| language | English |
| publishDate | 2020-01-01 |
| publisher | Wiley |
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| series | Pain Research and Management |
| spelling | doaj-art-4b5dadfc79d04cce938c0c0671fa17ea2025-08-20T03:36:27ZengWileyPain Research and Management1203-67651918-15232020-01-01202010.1155/2020/39386403938640Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot StudyLaura Papetti0Giorgia Sforza1Giulia Tullo2Pierfrancesco Alaimo di Loro3Romina Moavero4Fabiana Ursitti5Michela Ada Noris Ferilli6Samuela Tarantino7Federico Vigevano8Massimiliano Valeriani9Headache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, ItalyChild Neurology Unit, Systems Medicine Department, Tor Vergata University Hospital of Rome, Rome, ItalyDepartment of Neurosciences, Mental Health, and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, Sant’Andrea Hospital, Sapienza University, Rome, ItalyDepartment of Statistical Sciences, Sapienza University of Rome, Rome, ItalyChild Neurology Unit, Systems Medicine Department, Tor Vergata University Hospital of Rome, Rome, ItalyHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, ItalyHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, ItalyHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, ItalyHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, ItalyHeadache Center, Department of Neuroscience, Bambino Gesù Children Hospital in Rome, Rome, ItalyBackground. 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 T1 decreased significantly compared with the baseline assessment (from 13.9 ± 7.5 SD of T0 to 6.5 ± 5.9 SD of T1; p<0.001). The mean intensity of the attacks dropped from 1.67 ± 0.6 (T0) to 1.16 ± 0.5 (T1) (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.http://dx.doi.org/10.1155/2020/3938640 |
| spellingShingle | Laura Papetti Giorgia Sforza Giulia Tullo Pierfrancesco Alaimo di Loro Romina Moavero Fabiana Ursitti Michela Ada Noris Ferilli Samuela Tarantino Federico Vigevano Massimiliano Valeriani Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study Pain Research and Management |
| title | Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study |
| title_full | Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study |
| title_fullStr | Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study |
| title_full_unstemmed | Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study |
| title_short | Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study |
| title_sort | tolerability of palmitoylethanolamide in a pediatric population suffering from migraine a pilot study |
| url | http://dx.doi.org/10.1155/2020/3938640 |
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