Palmitoylethanolamide (PEA) is an endogenous fatty acid amide analogue of the endocannabinoid anandamide . This compound has been micronized and intelligently formulated by the Italian company Epitech. In Europe it is registered as food for medical purposes or a supplement.

In 2010 a Spanish publication described clinical meaningful effects of the treatment of lumbosciatic pain with this endogenous cannabinoid, palmitoylethanolamide, PEA or Normast®. These results were published in Dolor (2010;25:35-42).

Palmitoylethanolamide (NORMAST®) effective in lumbosciatic pain 

The study was double blind, placebo controlled and two different dosages of palmitoylethanolamide (Normast) were evaluated in a three weeks treatment regime.^[1] Two different doses were compared, 300 mg and 600 mg daily and a third study arm was the placebo arm. Six hundred and thirty-six patients patients suffering from lumbosciatic pain due to radicular compression of the sciatic nerve and discopathy were included. 

Primary endpoint was measured via the the visual analogue scale (VAS), in order to quantify the intensity of the pain, and by the Roland- Morris disability questionnaire (RDQ) to evaluate the quality of life. There were only few dropouts; seventeen patients. At the end of the three weeks treatment period both the pain reduction and the quality of life were significantly different between the three treatment groups (ANOVA; p < 0.001), and the daily dose of 600 mg was the most effective dose.

The decrease on the VAS was in the highest dose group a reduction from 7.1 to 2.1, which is more than 50% pain reduction, this is in general considered as a robust clinical response. In the placebo arm the painscore did decrease from 6.6 to 4.6.  

Comment efficacy and safety Normast

The study seems to indicate that the endogenous Cannabinoid PEA has a relative quick action of onset as an analgesic drug in the treatment of the Lumbosacral Discogenic Pain Syndrome. Within 3 weeks both the 300 mg as well as the 600 mg dose decreased pain significantly more efficient as compared to placebo.

This is the first clinical study of sufficient magnitude, more than 600 patients entered the study, which was conducted in a number of Italian medical sites, supporting the efficacy of a natural supplement, PEA in a difficult to treat neuropathic pain syndrome.

Side effects were minor and this makes PEA a quite attractive molecule and a promising treament alternative, as side effects mostly limit the use of many analgesics in neuropathic pain, such as in amitriptyline and pregabaline. Normast therefore might become an interesting alternative in the treatment of neuropathic pain.

In our own clinic we started working with Normast some time ago, and in several patients suffering from neuropathic pain we found robust analgesic effects, without any side effects. Our dose regime was 600 mg twice daily.

Here a patient presentation of a MD suffering from severe sciatic pain due to a herniation L4/L5, not responding to Lyrica, and being a full responder on palmitoylethanolamide.