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
The authors reported a fall in migraine days from 3.4 to 2.2 a month in the combination group, with no change in the placebo group. They also reported falls in the duration and intensity of attacks and in disability. 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
Entry checked against the full text at the publisher (Frontiers) on 2026-09-21. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.