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Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy

Palmitoylethanolamide (PEA) has been suggested to have useful analgesic properties and to be devoid of unwanted effects. Here, we have examined critically this contention, and discussed available data concerning the pharmacokinetics of PEA and its formulation. Sixteen clinical trials, six case repor...

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Autores principales: Gabrielsson, Linda, Mattsson, Sofia, Fowler, Christopher J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5094513/
https://www.ncbi.nlm.nih.gov/pubmed/27220803
http://dx.doi.org/10.1111/bcp.13020
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author Gabrielsson, Linda
Mattsson, Sofia
Fowler, Christopher J.
author_facet Gabrielsson, Linda
Mattsson, Sofia
Fowler, Christopher J.
author_sort Gabrielsson, Linda
collection PubMed
description Palmitoylethanolamide (PEA) has been suggested to have useful analgesic properties and to be devoid of unwanted effects. Here, we have examined critically this contention, and discussed available data concerning the pharmacokinetics of PEA and its formulation. Sixteen clinical trials, six case reports/pilot studies and a meta‐analysis of PEA as an analgesic have been published in the literature. For treatment times up to 49 days, the current clinical data argue against serious adverse drug reactions (ADRs) at an incidence of 1/200 or greater. For treatment lasting more than 60 days, the number of patients is insufficient to rule out a frequency of ADRs of less than 1/100. The six published randomized clinical trials are of variable quality. Presentation of data without information on data spread and nonreporting of data at times other than the final measurement were among issues that were identified. Further, there are no head‐to‐head clinical comparisons of unmicronized vs. micronized formulations of PEA, and so evidence for superiority of one formulation over the other is currently lacking. Nevertheless, the available clinical data support the contention that PEA has analgesic actions and motivate further study of this compound, particularly with respect to head‐to‐head comparisons of unmicronized vs. micronized formulations of PEA and comparisons with currently recommended treatments.
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spelling pubmed-50945132016-11-09 Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy Gabrielsson, Linda Mattsson, Sofia Fowler, Christopher J. Br J Clin Pharmacol Reviews Palmitoylethanolamide (PEA) has been suggested to have useful analgesic properties and to be devoid of unwanted effects. Here, we have examined critically this contention, and discussed available data concerning the pharmacokinetics of PEA and its formulation. Sixteen clinical trials, six case reports/pilot studies and a meta‐analysis of PEA as an analgesic have been published in the literature. For treatment times up to 49 days, the current clinical data argue against serious adverse drug reactions (ADRs) at an incidence of 1/200 or greater. For treatment lasting more than 60 days, the number of patients is insufficient to rule out a frequency of ADRs of less than 1/100. The six published randomized clinical trials are of variable quality. Presentation of data without information on data spread and nonreporting of data at times other than the final measurement were among issues that were identified. Further, there are no head‐to‐head clinical comparisons of unmicronized vs. micronized formulations of PEA, and so evidence for superiority of one formulation over the other is currently lacking. Nevertheless, the available clinical data support the contention that PEA has analgesic actions and motivate further study of this compound, particularly with respect to head‐to‐head comparisons of unmicronized vs. micronized formulations of PEA and comparisons with currently recommended treatments. John Wiley and Sons Inc. 2016-06-29 2016-10 /pmc/articles/PMC5094513/ /pubmed/27220803 http://dx.doi.org/10.1111/bcp.13020 Text en © 2016 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of The British Pharmacological Society. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Reviews
Gabrielsson, Linda
Mattsson, Sofia
Fowler, Christopher J.
Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy
title Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy
title_full Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy
title_fullStr Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy
title_full_unstemmed Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy
title_short Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy
title_sort palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5094513/
https://www.ncbi.nlm.nih.gov/pubmed/27220803
http://dx.doi.org/10.1111/bcp.13020
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