The Comparative Efficacy of Palmitoylethanolamide (PEA) With the Combination of Pregabalin and Nortriptyline on Post-extraction Trigeminal Neuropathy by Using Magnetic Resonance (MR) Neurography: A Randomized Clinical Trial.

Abstract

Aim The aim of this randomized clinical trial is to compare the efficacy of palmitoylethanolamide (PEA) with the combination of pregabalin and nortriptyline in treating post-extraction trigeminal neuropathy using magnetic resonance neurography (MRN). Methods The present prospective, randomized controlled trial was conducted on 60 patients (20 in each group). In group I (positive control group), a combination of 75 mg of pregabalin and 10 mg of nortriptyline was administered once daily for the duration of 12 weeks. In group II, 600 mg of palmitoylethanolamide was given twice a day. In group III, a combination therapy of the abovementioned drugs was given. The efficacy of the drug was assessed by measuring pain intensity in terms of the numeric rating scale (NRS) (primary outcome)and changes (signal intensity and nerve thickness) in magnetic resonance neurography (secondary outcome) at various intervals of time. The data was collected and subjected to statistical analysis using the Statistical Package for Social Sciences (SPSS)version 25(IBM SPSS Statistics, Armonk, NY)at the significance level of P<0.05. Results A significant decrease in post-drug mean NRS scores was observed in all three groups. In terms of reduction in the mean NRS, the combination group showed the highest reduction. Palmitoylethanolamide significantly reduces pain scores with negligible side effects. Conclusion Palmitoylethanolamide helps in the reduction of mild to moderate pain of painful post-traumatic trigeminal neuropathy (PTTN) with minimal side effects, suggesting that it may be used where the use of the conventional drug is either contraindicated or not feasible.