Palmitoylethanolamide: problems regarding micronization, ultra-micronization and additives.

Abstract

It can be established that at least two of the writers of the article published in 'Inflammopharmacology', title: 'Palmitoylethanolamide (PEA), a naturally occurring disease-modifying agent in neuropathic pain' have a direct connection to the companies Epitech and Innovet. These companies produce micronized and ultra-micronized PEA. Therefore it is of eminent importance to determine whether the statements in this paper have also taken into consideration the European guidelines for Good Clinical Practice and the codes of good scientific practices. This is very questionable. A minimum condition in clinical studies for proving the claim that PEA in its micronized and ultra-micronized formulations works better than in its pure form or in other formulations is that a comparison be made between: PEA in pure form or in other formulations, on the one hand; PEA in the micronized and ultra-micronized formulations, on the other hand. This minimum condition is not complied with. Based on additional studies discussed in this commentary and in view of the effects of ultra-micronization on the parameters discussed, as well as the potential side-effects of additives such as excipients and herbal extracts added to the products cited in the article, the preference should be for the time being to treat patients with pure PEA without any of these additives.