Effects of Add-On Ultramicronized N-Palmitol Ethanol Amide in Patients Suffering of Migraine With Aura: A Pilot Study

Abstract

Background: Palmitoyl ethanol amide (PEA) is an endogenously produced substance showing anti-nociceptive effect through both receptor and non-receptor mediated effects at the level of different cellular and tissue sites. This study showed the results of a single blind study that was conducted to evaluate both the safety and the efficacy of ultramicronized PEA (umPEA; 1,200 mg/day) for up 90 days in patients suffering of Migraine with Aura (MA) treated with NSAIDs.Methods: A total of 20 patients, 8 male (33–56-years, average 41.4 ± 7.8) and 12 female (19–61-years, average 38.5 ± 11.9) with MA were admitted to our observation and diagnosed according to ICHD-3 criteria, they received umPEA (1,200 mg/day) in combination with NSAIDs for up to 90 days. They were revaluated at 30, 60, and 90 days after treatment.Results: umPEA administration induced a statistically significant and time dependent pain relief. In particular, these effects were evident at 60 days (male P = 0.01189; female P = <0.01) and they lasted until the end of the study (male P = 0.0066; female P = 0.01473).Conclusion: Although further studies are needed, our findings indicate that in patients suffering of MA treatment with umPEA had good efficacy and safety which candidate this compound as a therapeutic tool in pain migraine management.

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

“…In line with the study of Chirchiglia et al, our pilot study showed that umPEA at low doses (600 mg/kg/day) for short period (three months) is effective in reducing migraine attacks frequency and intensity in pediatric patients [17]. Our study also confirms the safety of treatment with umPEA.…”

“…To date, only one study has been conducted to evaluate the role of PEA in migraine management in adults [17]. e authors demonstrated that umPEA administration to patients with MA (1,200 mg/day for up 90 days) treated with common NSAIDs induced a significant pain relief irrespective to age or gender.…”

“…In other pediatric diseases, such as acute respiratory infections, the dosage of 50 mg/kg (maximum ∼800 mg /day), for the age groups between 1 and 6 years and 11 and 16 years, was found to be safe and effective [22,23]. In addition, the only study of umPEA in migraine used the doses of 600 mg/kg/day [17].…”

“…However, to date, only one study has been conducted to evaluate the role of PEA in migraine management in adults with a statistically significant and time-dependent pain relief [17]. e aim of this open-label study was to evaluate the safety and the efficacy of um-PEA in terms of reducing the frequency and severity of migraine attacks in pediatric patients.…”

Role of N-Acylethanolamines in the Neuroinflammation: Ultramicronized Palmitoylethanolamide in the Relief of Chronic Pain and Neurodegenerative DiseasesRole of N-Acylethanolamines in the Neuroinflammation: Ultramicronized Palmitoylethanolamide in the Relief of Chronic Pain and Neurodegenerative Diseases

“…Contrariwise, Andresen and colleagues reported that um-PEA did not alleviate pain in patients with spinal cord injuryinduced neuropathic pain, compared to placebotreated patients [126]. The efficacy of PEA in clinical trials and meta-analysis is however reviewed [127,128]. The actions of PEA on the neuroinflammation processes urderlying chronic pain are summarized in Figure 1.…”