Palmitoylethanolamide (PEA) is an endogenous endogenous compound. It is a fatty acid amide and present in many foodstuffs as well as in the human body. In Europe PEA is available as food supplement in Italy and Spain under the brandname Normast and in the Netherlands and elsewhere branded as PeaPure. 

PeaPure has the advantage of not containing farmaceutical and chemical excipients, nor sorbitol (present in Normast).

In 2010 a Spanish publication described clinical meaningful effects of the treatment of lumbosciatic pain with palmitoylethanolamide, PEA. These results were published in Dolor (2010;25:35-42). The final analysis of the Numbers Needed to Treat (less then 2!) as presented at the SIAARTI, was impressive: less then 2! For details see link.

In 2012 a separate study was published, also confirming positive effects for PEA in sciatic pain (see under)  

PEA is a safe compound, with virtually no side effects, and a ronus efficacy (NNT <2, see graph: NNT at week 3 is below 2). 

Palmitoylethanolamide (PEA) effective in lumbosciatic pain 

The study was double blind, placebo controlled and two different dosages of pure palmitoylethanolamide 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. As far as we could analyse the compound used was pure palmitoylethanolamide, and not a branded formulation.

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 PEA

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. 

Also in elderly PEA can be useful

Analgesic treatments with a low side effect profile such as palmitoylethalonamide are quite relevant for elderly patients, due to its benign side-effect profile. ^[2][3][4][5].

Especially the absence of sedative side effects is important. A great number of elderly patients have been treated without side effect or dose limiting problems, or interaction problems. Furthermore, combination therapy with pregabalin seems feasable and even clinically useful. ^[6]

Within the context of clinical studies more then 350 elderly patients have been treated with palmitoylethanolamide without side effect problems, and also in our hands, we did not detect any clinical relevant side effects, even not in a patient aged 90. A database analysis in 2011 resulted in the following numbers of elderly patients treated with palmitoylethanolamide:

• 111 patients between 65 and 70 years old
• 116 patientsbetween 71 and 75 y.o.
• 63 patients between 76 and 80 y.o.
• 45 patients between 81 and 85 y.o.
• 20 patients between 86 and 90 y.o. 

PEA seems to have a great many biological effects, and might be quite interestng for a number of varying disorders. Recently a review summerized all biological actions of PEA, and we quote:^[7]: 

Analgesia 

• Acute pain ↓
• Inflammatory pain ↓
• Neuropathic pain ↓

Anti-Inflammation 

•  Mast cell activation ↓
•  iNOS expression ↓
•  COX-2 expression ↓
•  Neutrophil influx ↓

Neuroprotection 

•  Convulsions ↓
•  Excitotoxicity ↓

Anti-viral 

• Incidences of acute  respiratory diseases ↓

Prof. dr. Jan M. Keppel Hesselink MD, and David J. Kopsky MD December 2010, revision march 2012, JMKH

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