Efficacy of Palmitoylethanolamide (Levagen+TM) Compared to Ibuprofen for Reducing Headache Pain Severity and Duration in Healthy Adults: A Double-Blind, Parallel, Randomized Clinical Trial ()
Affiliation(s)
1School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Australia.
2RDC Clinical, Newstead, Brisbane, Australia.
3Evidence Sciences, New Farm, Brisbane, Australia.
4Gencor Pacific Limited, Discovery Bay, Lantau Island, New Territories, Hong Kong, China.
ABSTRACT
Background: Palmitoylethanolamide (PEA) has shown promise as an analgesic for those
with chronic pain pathologies. With recently increased bioavailability, PEA may
also be a treatment for acute pain presentations such as tension-type
headaches. Aim: To assess the efficacy of a bioavailable PEA formulation
(Levagen+TM) for reducing the severity and duration of acute
episodes of tension-type headaches when compared to a standard treatment,
nonsteroidal anti-inflammatory drug (NSAID) (the comparator). Methods: The study was a double-blind, randomized, single site, comparator controlled
clinical study, with the cohort consisting of otherwise healthy adults, aged between 18 and 71, who experienced regular
tension-type headaches. 94 adults experiencing headaches were randomised
to receive either PEA (n = 47) or Ibuprofen comparator (n = 47). Upon headache
onset, participants consumed their allocated product, recorded pain levels
using a visual analogue scale (VAS) and continued to log their pain scores at
30-minute intervals for up to 4-hours. Results: Eighty-six participants
(44 active treatment and 42 comparator) recorded at least one headache with a
total of 271 tension-type headaches recorded (120 active treatment and 151
comparator). Most headaches were reduced in both treatment arms by 2 hours and
almost all by 4 hours; 90% in the PEA group, and 97% in comparator group, p
> 0.5. For moderate at onset headaches,
the comparator group had a greater percentage of pain-free events at
2-hours. However, the time taken to resolve severe headaches was significantly
lower in the PEA group than the comparator group (p < 0.05). Conclusions: These results place PEA as a potential treatment option for tension-type
headaches.
Share and Cite:
Briskey, D. , Ebelt, P. , Steels, E. , Subah, S. , Bogoda, N. and Rao, A. (2022) Efficacy of Palmitoylethanolamide (Levagen+
TM) Compared to Ibuprofen for Reducing Headache Pain Severity and Duration in Healthy Adults: A Double-Blind, Parallel, Randomized Clinical Trial.
Food and Nutrition Sciences,
13, 690-701. doi:
10.4236/fns.2022.137050.
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