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Normast in neuropathic sciatic pain: clinical results

 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. (G. Guida, A. de Fabiani, F. Lanaia, A. Alexandre, G.M. Vassallo, L. Cantieri, M. de Martino, M. Rogai, S. Petrosino; La palmitoiletanolamida (Normast) en el dolor neuropatico cronico por lumbociatalgia de tipo compresivo: estudio clinico multicentrico, Dolor;2010, 25:35-42)

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.

Also in elderly Normast 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. ][1] [2] [3].

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. (P,Deslo. Combination of pregabalin and palmitoylethanolamide (PEA) for neuropathic pain treatment.; Pathos, 2010, 17,4:9-14)

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. To date the following numbers of elderly patients treated with palmitoylethanolamide (Normast) have been evaluated in the double blind ischialgia study:

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. (Epitech data on file)
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: [4]:

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 ↓

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