Trial reportFunctional neurology
Melatonin 4 mg as prophylactic therapy for primary headaches: a pilot study.
Trial report in Functional neurology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03150797 (Melatonin for Adolescent Migraine Prevention Study), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Melatonin for Adolescent Migraine Prevention Study (The MAP Study).
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.
- Efficacy and Safety of Melatonin as Prophylaxis for Migraine in Adults: A Meta-analysis.Journal of oral & facial pain and headache · 2022Pooled it
- Pooled it
- Nighttime Primary Headaches in Children: Beyond Hypnic Headache, a Comprehensive Review.Life (Basel, Switzerland) · 2025Review
- Serum melatonin levels and in a sample of Iranian patients with migraine.Scientific reports · 2024Article
- Significance of Melatonin in the Regulation of Circadian Rhythms and Disease Management.Molecular neurobiology · 2024Review
- Perceptions and attitudes regarding complementary, alternative, and integrative medicine among published neurology authors: a large-scale, international cross-sectional survey.BMC neurology · 2024Article
- Involvement of Oxidative Stress and Nutrition in the Anatomy of Orofacial Pain.International journal of molecular sciences · 2023Review
- The Pathogenetic Role of Melatonin in Migraine and Its Theoretic Implications for Pharmacotherapy: A Brief Overview of the Research.Nutrients · 2022Review
- Nutrients to Improve Mitochondrial Function to Reduce Brain Energy Deficit and Oxidative Stress in Migraine.Nutrients · 2021Review
- Melatonin Moderates the Triangle of Chronic Pain, Sleep Architecture and Immunometabolic Traffic.Biomedicines · 2021Review
- Nutraceuticals and Behavioral Therapy for Headache.Current neurology and neuroscience reports · 2021Review
- Safety and Efficacy of Melatonin in Chronic Tension-Type Headache: A Post-Marketing Real-World Surveillance Program.Pain and therapy · 2020Article
- Sleep Disorders and Headache: A Review of Correlation and Mutual Influence.Pain and therapy · 2020Review
- Complementary and Integrative Medicine for Episodic Migraine: an Update of Evidence from the Last 3 Years.Current pain and headache reports · 2019Review
- Melatonin and Comorbidities in Children with Autism Spectrum Disorder.Current developmental disorders reports · 2018Review
- Genetic and biochemical changes of the serotonergic system in migraine pathobiology.The journal of headache and pain · 2017Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
There is growing evidence that headaches are connected to melatonin secretion. Our aim was to assess the potential effectiveness of melatonin for primary headache prevention. Forty-nine patients (37 with migraine and 12 with chronic tension-type headache, TTH) were prescribed oral melatonin, 4 mg, 30 minutes before bedtime for six months. Forty-one (83.6%) of the 49 patients completed the study, while eight dropped out for personal reasons. A statistically significant reduction in headache frequency was found between baseline and final follow-up after six months of treatment (p=0.033 for TTH patients and p<0.001 for migraineurs). The Headache Impact Test score was significantly reduced in both groups of headache patients (p=0.002 and p<0.001, respectively). At baseline, melatonin levels, measured both during a headache attack and a pain-free period, did not differ between patients with TTH and migraineurs (p=0.539 and p=0.693, respectively), and no statistically significant differences in Hamilton Depression Rating Scale scores were found between the two groups. This pilot study shows promising results, in terms of headache frequency reduction and daily quality of life improvement, in both groups.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.