Efficacy of a Mixture of Palmitoyl ethonalamide, acetyl L Carnitine and Vitamin E as a Nutraceutical in Decreasing the Intensity of Chronic Pain – A Randomized Double Blinded Trial

Abstract

Background: Chronic pain poses a significant challenge to individuals worldwide, prompting a search for innovative therapies beyond traditional methods. This randomized double-blinded trial was carried out in a multi-specialty hospital in South India which explores the potential efficacy of a novel nutraceutical combination—palmitoyl ethanolamide (PEA), acetyl-L-carnitine (ALC), and vitamin E—in alleviating chronic pain. Methods: The study involved 51 participants with chronic pain persisting for more than three months, randomly assigned to either the treatment group (Group N) or the control group (Group C).Results: The nutraceutical intervention, known as Myofatige, demonstrated a substantial reduction in pain intensity, as evidenced by a significant decrease in both numerical rating scale (NRS) and Likert satisfaction scores. The VAS scores decreased from 6.76± 0.95 to 3.23± 0.99 in Group N (p value < 0.0001) while it was from 6.5 ±1.02 to 5.88± 1.07 in group C (p = 0.19). The pretreatment Likert scores of Group N decreased from 3.88± 0.65 to2.04 ± 0.84 while in Group C it was from 4.01 ±0.12 to 3.73± 1.00. The inter group difference was statistically significant (p value < 0.0001). Throughout the three-month trial, safety and compliance were meticulously monitored, with just two people in the treatment group experiencing temporary frequent stools. There were no major adverse events reported, which supports the safety profile of the nutraceutical combination.Conclusion: While acknowledging limitations such as a small sample size and a single-centre study, the findings suggest that the nutraceutical combination of PEA, ALC, and vitamin E as Myofatige holds promise as a therapeutic intervention for nociceptive pain. Further research is warranted to explore the specific contributions of each component and potential synergistic effects in a larger and more diverse population.