Safety and Efficacy of Melatonin in Chronic Tension-Type Headache: A Post-Marketing Real-World Surveillance Program
Open accessAbstract
Tension-type headache (TTH) is the most prevalent primary headache. Every year, about 2–3% of patients with TTH progress to chronic TTH with daily or near-daily headache, warranting preventive treatment. The treatment of chronic TTH is complex and very often associated with significant tolerability issues. To date, melatonin has been studied in only a few small uncontrolled trials. The aim of this surveillance program was to evaluate the efficacy of melatonin (Melaxen ® ) in patients with TTH and disruption of circadian rhythms in real-world practice. Sixty-one patients with chronic TTH were enrolled. After the 30-day baseline period, patients took 3 mg of melatonin at bedtime for 30 days with a follow-up period of another 30 days. VAS pain intensity assessments, Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), HIT-6 and Levin sleep quality scores were obtained at the baseline visit, at month 1, and month 2. A significant decrease in the number of headache days per month, VAS pain intensity, HAM-A, HAM-D and HIT-6 scores, and an improvement in sleep quality were observed throughout the study. No treatment-emergent adverse events were reported. Melatonin is an effective and safe alternative for the treatment of chronic TTH.
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In a surveillance study of sixty-one patients diagnosed with chronic tension headaches, significant decreases in pain and tension headache-associated symptoms were observed after melatonin use.
“Overall, significant decreases in pain and tension headache-associated symptoms were observed after melatonin use.”
From Is Melatonin the “Next Vitamin D”?: A Review of Emerging Science, Clinical Uses, Safety, and Dietary Supplements (2022) · cites this paper as [111]
Sleep quality was also significantly improved during and after the study in patients with chronic tension headaches given melatonin.
“Sleep quality was also significantly improved during and after the study [110,111].”
From Is Melatonin the “Next Vitamin D”?: A Review of Emerging Science, Clinical Uses, Safety, and Dietary Supplements (2022) · cites this paper as [111]
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“Sleep quality was also significantly improved during and after the study [111,112].”
Background
- Authors
- Danilov, A. B., Danilov, A. B., Kurushina, O. V., Shestel, E. A., Zhivolupov, S. A., & Latysheva, N. V.
- Affiliations
- Sechenov University (RU)
- Volgograd State Medical University (RU)
- Venue
- Pain and Therapy
- Published
- 2020-10-16
- Volume
- 9
- Issue
- 2
- Pages
- 741-750
- ISSN
- 2193-651X (ISSN-L)
- 2193-8237
- PMC
- PMC7648782
- OpenAlex
- W3092955231
- Cited by
- 12
- References
- 30
- Citations by year
- 2026: 1 · 2024: 2 · 2023: 2 · 2022: 3 · 2021: 4
- FWCI
- 1.64
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Pain and Therapy (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Migraine and Headache Studies
- Health Sciences › Health Professions › Complementary and Manual Therapy › Temporomandibular Joint Disorders
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Keywords
- melatonin, chronic tension-type headache, primary headache, circadian rhythm disruption, headache prevention, sleep quality, anxiety, depression, treatment safety, real-world effectiveness
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