Fixed combination of palmitoylethanolamide and melatonin in preventive therapy of migraine: results from a randomized clinical trial
Randomised controlled trialHumansWith melatonin
This study tested palmitoylethanolamide together with melatonin. Its results cannot be assigned to palmitoylethanolamide alone. More combination studies.
- Design
- Randomised controlled trial
- Subjects
- 60 adults with low-frequency episodic migraine randomised, 30 in each group. All completed.
- Dose used in the study
- 1,200 mg of palmitoylethanolamide with 0.2 mg of melatonin, once a day at bedtime
- Duration
- 3 months, after a 2-month run-in
- What was measured
- Migraine days per month; intensity, duration, disability, use of pain medication and associated symptoms
What the authors reported
This randomized trial found:
- Migraine days fell from 3.4 to 2.2 a month in the combination group, with no change in the placebo group.
- Duration and intensity of attacks and disability also fell.
- No adverse events were reported.
Limits of this study
Participants had low-frequency migraine, so the results may not apply to frequent migraine. The sample was small and the outcomes were self-reported. The authors name these limits. They reported no financial support.
Source
PubMed 40276532 · doi:10.3389/fnut.2025.1560654
Entry checked against the abstract on PubMed, and the full text at the publisher (Frontiers) on 2026-10-19. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.