Palmitoylethanolamide in clinical trials and in experience

Palmitoylethanolamide (PEA) has been suggested to have useful analgesic properties and to be devoid of unwanted effects. Authors from the Department of Pharmacology and Clinical Neuroscience, Umeå University, Sweden 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.

They sadly enough did not include the more recent NNT analyses for PEA, where a NNT of 1.5 was documented based on a major clinical trial.

However, the authors were impressed by this compound and calledtThe clinical data clearly promising, but as ever pointed out that ‘more clinical trials are necessary’.

They also argued for a head to head comparison between various formulations, which is not a clever thing to do. One needs a very big patient population to do so, and testing non-inferiority between different formulations is waisting money on trivial matters. PEA will work, whatever its formulation, and trials in the past demonstrated efficacy of both the micronised as well as the non-micronised PEA.

It is important to point out that vast clinical experience has been gathered in Italy only with a patented formulation, Normast, as well as in the Netherlands, only with a different patented formulation, PeaPure. Clinical studies and clinical reports with other, non-patented formulations, or pirate preparations containing phantasy mixes, have not been tested at all.

PEA in the Netherlands is used in many 10 thousands of patients, many of those for 6 to 12 months or longer and seems very well tolerated.

To ask for more clinical data is a bit over the top and academic.

But patients will find their way into PEA regardless of what academic remark.

Gabrielsson L, Mattsson S, Fowler CJ. Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy. Br J Clin Pharmacol. 2016 May 24. doi: 10.1111/bcp.13020.

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