Assessing the Effectiveness of Add-On Therapy of Palmitoylethanolamide to Standard Therapy in Diabetic Peripheral Neuropathy
Abstract
Background: Diabetic Peripheral Neuropathy (DPN) is a common yet challenging complication of diabetes, particularly in managing neuropathic pain. Palmitoylethanolamide (PEA), a naturally occurring nutraceutical from the ALIAmides group, has demonstrated potential for pain modulation, inflammation reduction, and improving quality of life.
Method: A 9-month prospective observational study at PSG Hospital evaluated the impact of adding oral capsule PEA (708 mg in two divided doses) to standard therapy for DPN patients unresponsive to maximum tolerated dosages of Gabapentin, Pregabalin, amitriptyline, or duloxetine. The outcomes were the pain severity and quality of life. Pain was assessed using the Visual Analog Scale (VAS), sensitivity was evaluated via monofilament testing, and quality of life was measured using the American Chronic Pain Association (ACPA) Quality of Life Scale (QOLS).
Results: Sixty patients with DPN were treated with adjunctive PEA and monitored for 8 weeks. Pain scores decreased significantly (6.05±1.096 to 4.15±1.233 at 4 weeks and 3.57±1.155 at 8 weeks, p˂0.05). Sensitivity improved via monofilament testing (7.12±1.58 to 9.43±0.78). Quality of life scores rose from 7.67 to 9.41 at 4 weeks and 9.68 at 8 weeks, indicating notable benefits.
Conclusion: PEA proved effective as a supplemental treatment for nonresponsive DPN patients, yielding significant reductions in pain, enhanced sensitivity, and better quality of life. Importantly, no side effects were reported, affirming its tolerability and safety.