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.
Highlights
Neuropathic pain is a frequent and serious complication of diabetic neuropathy which markedly impacts a patient’s quality of life and, in particular, sleep and daily activities [1]
Numerous studies have demonstrated that palmitoylethanolamide (PEA), a fatty acid amide of the N-acylethanolamine family, is capable of exerting important analgesic, anti-inflammatory, and neuroprotective effects acting on several molecular targets in both the central and peripheral nervous systems
15 males and 15 females, between the ages of 53 and 86 affected by Type II diabetes and complaining of neuropathic painful symptoms were enrolled in the study between March and November, 2010
Summary
Neuropathic pain is a frequent and serious complication of diabetic neuropathy which markedly impacts a patient’s quality of life and, in particular, sleep and daily activities [1]. Clinical results obtained in a large number of patients, suffering from neuropathic pain associated with pathologies of various etiology, provide ample support for the anti-inflammatory and analgesic effects of micronized PEA (PEA-m particle sizes 2,0 ÷ 10,0 μm) [25,26,27,28,29,30,31,32].
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