Ultra-micronized Palmitoylethanolamide: An Efficacious Adjuvant Therapy for Parkinson's Disease.
BACKGROUND
Parkinson's disease (PD) is the subject of intense efforts to develop strategies that slow down or stop disease progression and disability. Substantial evidence points to a prominent role for neuroinflammation in the underlying dopaminergic cell death. Ultramicronized palmitoylethanolamide (um-PEA) is well-known for its ability to promote the resolution of neuroinflammation and exert neuroprotection. This study was designed to assess the efficacy of um-PEA as adjuvant therapy in patients with advanced PD.


METHODS
Thirty PD patients receiving levodopa were included in the study. The revised- Movement Disorder Society/Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire was used to assess motor and non-motor symptoms. Clinical assessments were carried out before and after addition of um-PEA (600 mg). MDS-UPDRS questionnaire total score for parts I, II, III, and IV was analyzed using the Generalized Linear Mixed Model, followed by the Wilcoxon signed-rank test to evaluate the difference of each item's mean score between baseline and end of um-PEA treatment.


RESULTS
Addition of um-PEA to PD patients receiving levodopa therapy elicited a significant and progressive reduction in the total MDS-UPDRS score (parts I, II, III and IV). For each item, the mean score difference between baseline and end of um-PEA treatment showed a significant reduction in most nonmotor and motor symptoms. The number of patients with symptoms at basal was reduced after one year of um-PEA treatment. None of the participants reported side effects attributable to the addition of um-PEA.


CONCLUSIONS
um-PEA slowed down disease progression and disability in PD patients, suggesting that um-PEA may be an efficacious adjuvant therapy for PD.
Neurology Unit, - San Giuseppe Hospital - Viale Boccaccio - 55053 Empoli (FI). Italy.
Stefania
S
Brotini
Department of Statistical Sciences, University of Padua, Italy; Innovative Statistical Research, Padua. Italy.
Carlo
C
Schievano
Department of Neurology, Movement Disorder Center, San Giuseppe Hospital, Empoli, Florence. Italy.
Leonello
L
Guidi
D000368:Aged; D000369:Aged, 80 and over; D000577:Amides; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007980:Levodopa / Q000627:therapeutic use; D008297:Male; D010169:Palmitic Acids / Q000627:therapeutic use*; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology; D011446:Prospective Studies; D018709:Statistics, Nonparametric
D000577:Amides; D014150:Antipsychotic Agents; D004983:Ethanolamines; D010169:Palmitic Acids; D007980:Levodopa; C005958:palmidrol
Adjuvant therapy; Parkinson's disease; motor and non motor symptoms; neurodegeneration; neuroinflammation; ultra-micronized palmitoylethanolamide