Micronized Palmitoylethanolamide Reduces the Symptoms of Neuropathic Pain in Diabetic Patients

Abstract

The present study evaluated the effectiveness of micronized palmitoylethanolamide (PEA-m) treatment in reducing the painful symptoms experienced by diabetic patients with peripheral neuropathy. PEA-m, a fatty acid amide of the N-acylethanolamine family, was administered (300 mg twice daily) to 30 diabetic patients suffering from painful diabetic neuropathy. Before treatment start, after 30 and 60 days the following parameters were assessed: painful symptoms of diabetic peripheral neuropathy using the Michigan Neuropathy Screening instrument; intensity of symptoms characteristic of diabetic neuropathic pain by the Total Symptom Score; and intensity of different subcategories of neuropathic pain by the Neuropathic Pain Symptoms Inventory. Hematological and blood chemistry tests to evaluate metabolic control and safety were also performed. Statistical analysis (ANOVA) indicated a highly significant reduction in pain severity (P < 0.0001) and related symptoms (P < 0.0001) evaluated by Michigan Neuropathy Screening instrument, Total Symptom Score, and Neuropathic Pain Symptoms Inventory. Hematological and urine analyses did not reveal any alterations associated with PEA-m treatment, and no serious adverse events were reported. These results suggest that PEA-m could be considered as a promising and well-tolerated new treatment for symptomatology experienced by diabetic patients suffering from peripheral neuropathy.

Oleoylethanolamine and palmitoylethanolamine modulate intestinal permeability in vitro via TRPV1 and PPARα

“…We also showed that inflammation significantly increased OEA levels in Caco‐2 cells, suggesting that these observations of the pharmacological effects of OEA have a physiologic relevance. Others have similarly shown that OEA is upregulated in response to inflammation (69) or by feeding (70), and this may be as a result of increased OEA synthesis or reduced degradation.…”

“…PEA is currently available as a nutraceutical food for medical purposes under the brand names Normast, Pelvilen, and PeaPure; has been studied in humans, mostly within trials on pain management; and is well tolerated (71). Several preclinical animal studies have shown that in vivo treatment with PEA reduces intestinal injury and inflammation via PPARα (47, 48) and also CB 2 and GPR55 (49).…”

Ultramicronized palmitoylethanolamide in spinal cord injury neuropathic pain: a randomized, double-blind, placebo-controlled trial

“…Case reports and open-label studies suggest an effect of ultramicronized PEA (PEA-um) on neuropathic pain, including central pain [7,12,16,32]. Recent systematic reviews in neuropathic pain and PEA [9,16,36] have only identified 2 randomized placebo-controlled trials, both showing efficacy of micronized PEA (PEA-m) in sciatic pain [6,11].…”

New Targets in Pain, Non-Neuronal Cells, and the Role of Palmitoylethanolamide

“…In particular, PEA treatment significantly reduced the severity and frequency of pain, burning, paraesthesia and numbness. Moreover, the study clearly demonstrated that the analgesic effect manifested itself as early as 30 days after treatment start, progressively increased over time and was maintained 1 month after treatment discontinuation [125].…”

“…[124] The results of an open study performed on 30 patients suffering from diabetic neuropathy were recently presented at the 2011 Congress of the European Shock Society. [125] Orally administered PEA (300 mg/twice daily for 60 days) significantly reduced the clinical sensory symptoms (p<0.001), as scored by the Michigan Neuropathy Screening Instrument, Total Symptom Score, and Neuropathic Pain Symptom Inventory. In particular, PEA treatment significantly reduced the severity and frequency of pain, burning, paraesthesia and numbness.…”