The Effect of a Dispersible Palmitoylethanolamide (Levagen+) Compared to a Placebo for Reducing Joint Pain in an Adult Population – A Randomised, Double-Blind Study

David Briskey,Georgia Roche,Amanda Rao

doi:10.11648/j.ijnfs.20211001.12

Abstract

A commonality of all joint pain is the existence of inflammation. Palmitoylethanolamide (PEA) is an endogenous saturated fatty acid derivative that down-regulates multiple proinflammatory and nociceptive pathways and known to inhibit mast and glial cell activity. This study aimed to assess the efficacy of palmitoylethanolamide (LipiSperse®), for alleviating joint pain and improving quality of life in adults. A randomised, double blind, placebo-controlled study on adults reporting joint pain. 74 participants that received either LipiSperse® (n=35) or a placebo (n=39) daily for 2 weeks completed this study. The primary outcome was a self-assessed reduction in pain as assessed by a visual analogue scale (VAS) for pain, completed in the morning and evening. VAS pain scores reduced over the 2 weeks of treatment in both groups. Morning VAS scores were significantly reduced from baseline in the LipiSperse® and placebo groups from day 3 and 4 respectively. VAS scores were significantly lower in the LipiSperse® group compared to the placebo group on day 14 (P<0.05). Evening VAS scores were significantly reduced from baseline in both the LipiSperse® and placebo groups from day 3. Total mood scores for both groups were similar at baseline but was significantly different at the end of the study, with the PEA group decreasing and the placebo group increasing. This study demonstrates that LipiSperse® may be a safe and effective option for reducing joint pain. Further studies should investigate whether long-term supplementation can show further improvements in pain scores.

Highlights

Joint pain is a common yet complex condition experienced by people of any age to varying degrees [1,2,3,4], it is a leading contributor of disability worldwide [5] and significantly contributes to the global burden of disease [6]
This study was conducted in compliance with the current International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP), the Therapeutic Goods Administration (TGA) and was conducted in accordance with ethical approval from Bellberry Limited; an NHMRC accredited Human Research and Ethics Committee and registered on the ANZCTR (ACTRN12619001467123)
Morning visual analogue scale (VAS) score significantly reduced from baseline in the PEA group (p < 0.05) from day 3, and the placebo group from day 4 (p < 0.05)

Summary

Introduction

Joint pain is a common yet complex condition experienced by people of any age to varying degrees [1,2,3,4], it is a leading contributor of disability worldwide [5] and significantly contributes to the global burden of disease [6]. First line therapy to combat joint pain is over-the-counter pain-relieving medications, including paracetamol, non-steroidal anti-inflammatories and opioids [10]. The reliance on such products can result in unwanted gastric, renal and hepatic effects [11, 12], as well as leading to the development of medication tolerance and dependency [10, 13]. The demand for effective and well-tolerated pain relief is increasing

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