Fixed combination of palmitoylethanolamide and melatonin in preventive therapy of migraine: results from a randomized clinical trial.
Study Goal
The researchers aimed to assess the efficacy of hydrodispersible palmitoylethanolamide (PEA) combined with melatonin in reducing migraine frequency, intensity, duration, and disability.
Results Summary
The study found that the PEA-melatonin combination significantly reduced migraine frequency, duration, intensity, and disability after three months of treatment, with no reported adverse effects. A notable mitigation of migraine-related symptoms was also observed.
Population
60 migraine patients (30 in treatment group, 30 in placebo group) recruited by the I.N.B.B. Consortium in Italy.
Effective Dosage
1,200 mg PEA and 0.2 mg melatonin.
Duration
3 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
hydrodispersible PEA (1,200 mg) and melatonin (0.2 mg) (PEATONIDE®) | decrease | frequency of migraine attacks | patients with migraine | from 3.4 ± 0.5 MMDs to 2.2 ± 0.4 MMDs | displayed a significant reduction | #1 |
hydrodispersible PEA (1,200 mg) and melatonin (0.2 mg) (PEATONIDE®) | decrease | duration of migraine attacks | patients with migraine | - | displayed a reduction | #2 |
hydrodispersible PEA (1,200 mg) and melatonin (0.2 mg) (PEATONIDE®) | decrease | intensity of migraine attacks | patients with migraine | - | displayed a reduction | #3 |
hydrodispersible PEA (1,200 mg) and melatonin (0.2 mg) (PEATONIDE®) | decrease | grade of disability from migraine attacks | patients with migraine | - | displayed a reduction | #4 |
hydrodispersible PEA (1,200 mg) and melatonin (0.2 mg) (PEATONIDE®) | decrease | incidence of associated symptoms of migraine attacks | patients with migraine | - | displayed a reduction | #5 |
hydrodispersible PEA (1,200 mg) and melatonin (0.2 mg) (PEATONIDE®) | decrease | migraine-related symptomatology | patients with migraine | - | observed a significant mitigation | #6 |
hydrodispersible PEA (1,200 mg) and melatonin (0.2 mg) (PEATONIDE®) | no change | adverse effects | patients with migraine | - | No adverse effects were observed | #7 |
INTRODUCTION: Migraines are neurological disorders which significantly impact quality of life. Current pharmacological treatments often have adverse effects, prompting the search for alternatives with fewer side effects. Several studies have described the antimigraine properties of palmitoylethanolamide (PEA) and melatonin. MATERIALS AND METHODS: Our research assessed the efficacy of the association of hydrodispersible PEA (1,200 mg) and melatonin (0.2 mg) by a randomized, three-month, double-blind, placebo-controlled trial (PEATONIDE®; n = 30 patients; placebo; n = 30 patients). The participants were recruited by "I.N.B.B. Consortium" in Italy. The primary outcome was the reduction of migraine frequency, while secondary outcomes included the reduction of intensity, duration, and grade of disability. The parameters were assessed by a self-reported daily headache diary. RESULTS: The formulation displayed a significant reduction in frequency (T3 months: 2.2 ± 0.4 MMDs; T0 baseline: 3.4 ± 0.5 MMDs, ***p < 0.001 vs baseline T0) and duration, intensity, disability, and incidence of associated symptoms of migraine attacks after 3 months of treatment. No adverse effects were observed during the treatment. In addition, a significant mitigation of migraine-related symptomatology was observed. CONCLUSION: These findings suggest that PEATONIDE® may be a promising adjunctive approach for migraine management. However, given the relatively small sample size, further large-scale and multicenter trials are needed to confirm its clinical applicability in broader migraine population.