Gencor expands Levagen+ benefits to migraine pain relief

Published in the journal Pharmaceuticals​, the research builds on past clinical trials that have demonstrated the benefits of the palmitoylethanolamide (PEA) ingredient across joint health, sleep, recovery, immunity, discomforts and inflammation.

“In the context of the current study on migraine pain, PEA is proposed to modulate pain by interacting with the endocannabinoid system and reducing inflammation,” the team of Australian researchers wrote. “When cells experience stress, PEA can be recruited to the site in response. This protective role suggests that PEA, especially in large enough concentrations, may be suitable for alleviating pain and symptoms of migraines.”

PEA for migraine pain relief​

The study noted that migraines are a common neurological disorder that affect young to middle-aged adults, occurring more often in women than men.  Symptoms range from neck pain, yawning, fatigue, mood changes and sensory sensitivity to debilitating headaches, nausea and vomiting that can last for days.

Treatment usually involves preventative or pain medication, however Gencor presents PEA as a natural alternative to prescription or over-the-counter drugs (e.g., triptans, paracetamol, ibuprofen, aspirin, beta-blockers or blood pressure medication) that may be accompanied by undesirable side effects. 

“Palmitoylethanolamide (PEA) is a signaling lipid known to have anti-inflammatory and analgesic properties,” the researchers wrote. “Previous prophylactic research has reported PEA supplementation to decrease pain associated with migraines.”

They cited a study showing that three months of 600 mg of ultra-micronized PEA (umPEA)​ supplementation decreased migraine frequency and intensity in children; a second study reporting that 1,200 mg of umPEA​ for 90 days taken with non-steroidal anti-inflammatory drugs (NSAIDs) reduced perceived pain, number of attacks and total days of pain in adults; and a third study combining 200 mg PEA with Scutellaria, Boswellia and Harpago​ that reduced the number of headache days, duration of medication use and reported pain severity in adults with episodic migraines.

“One of the main differences between the present study and previous studies is that we supplemented as a treatment (at first onset), whereas previous studies have supplemented as a prophylactic (typically over 3 months),” the researchers noted. “Despite this, both modes have proven to be beneficial in reducing migraine pain, frequency and severity.” 

Study details​

The double-blind, placebo-controlled clinical trial recruited 80 healthy adults between the ages of 19 and 65 years and provided them with either 600 mg of PEA (Levagen+) or a maltodextrin placebo to consume upon the onset of migraine symptoms over a maximum period of four months. During that time period, a total of 155 migraines were reported among 64 participants.

After taking the dose, participants recorded a visual analog scale (VAS) for pain every 30 minutes for four hours or until the migraine resolved. If symptoms did not resolve within two hours, they were instructed to take a second dose. The primary outcome was reduction in migraine pain, with decreased migraine duration and severity, reduction in rescue medication use, and gastrointestinal tolerability and safety as secondary outcomes.

Levagen+ supplementation resolved more headaches after two and eight hours, had a lower VAS for pain score at 1.5 and 4 hours, and reduced rescue medication use significantly more than a placebo, the researchers reported. No adverse events were observed in either group. 

“The results of this study further back PEA’s clinically validated benefits for its analgesic and inflammatory properties in addition to its neuroprotective effects,” said R.V. Venkatesh, co-founder and managing director at Gencor. “We are thrilled about the promising results and potential of Levagen+ to support those who suffer from migraine.” 

The researchers suggested that future studies should investigate the timing of the dose, the combination of a prophylactic and therapeutic dose for preventing migraine onset, and whether efficacy is dose dependent within toxicity limits.

Source: Pharmaceuticals​
doi: 10.3390/ph17020145​
“Effectiveness of Palmitoylethanolamide (Levagen+) Compared to a Placebo for Reducing Pain, Duration, and Medication Use during Migraines in Otherwise Healthy Participants—A Double-Blind Randomised Controlled Study”
Authors: David Briskey et al.