A double-blind, randomized, versus-placebo study of palmitoylethanolamide in relapsing-remitting multiple sclerosis

A double-blind, randomized, versus-placebo study of palmitoylethanolamide in relapsing-remitting multiple sclerosis, by N Orefice, M Calabrese, A Carotenuto, et al; presented at 2014 Joint ACTRIMS-ECTRIMS Meeting (MSBoston 2014)

Many preclinical and clinical studies have shown that PEA exerts antiinflammatory, pain-relieving and neuroprotective effects. PEA has been reported to reduce inflammatory markers in animal models of multiple sclerosis (MS).
This small study served as a pilot study to evaluate:
1. the potential antiinflammatory effects of oral administration PEA and ots influence on the plasma levels of anandamide (AEA) and its congeners, Oleoylethanolamide (OEA) and PEA;
2. the plasma levels of pro-inflammatory cytokines as Interferon-y (INF-y) and Tumor Necrosis Factor-α (TNF-α), and
3. To evaluate its clinical effects.

Twenty-nine MS patients (17 Male, 12 Female; mean age 27±8 years), treated with interferon beta-1a 44 mcg (three times weekly) for at least 6 months, have been randomized in two group: interferon + PEA 600mg/day (group A), or interferon + placebo (600mg/day) (group B) for 12 months.

Parameters measured: plasma levels of PEA, AEA, OEA, INF-γ and TNF-a, and clinical assessment with the Expanded Disability Status Scale (EDSS) at baseline and every three months.

1. PEA administration significant increases AEA (p< 0.0001) and PEA (p< 0.0169) endogenous plasma levels compared vs placebo.
2. No statistical differences in OEA plasma levels have been observed. INF-y (p< 0.0001) decreased as well as and TNF-α (p< 0.0001)
3. no difference in EDSS score was observed.

PEA could be of use for decreasing the inflammatory load in MS patients, although the study population was too small to detect clinical effects.

Presented at the 2014 Joint ACTRIMS-ECTRIMS Meeting (MSBoston 2014) MS Journal Online: Poster Session 1

A double-blind, randomized, versusplacebo study of palmitoylethanolamide in subjects with relapsing-remitting multiple sclerosis- preliminary results

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