Safety and Efficacy of Melatonin in Chronic Tension-Type Headache: A Post-Marketing Real-World Surveillance Program

Autor: Andrei B. Danilov, Alexey B. Danilov, Olga V. Kurushina, Elena A. Shestel, Sergey A. Zhivolupov, Nina V. Latysheva
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Pain and Therapy, Vol 9, Iss 2, Pp 741-750 (2020)
Druh dokumentu: article
ISSN: 2193-8237
2193-651X
DOI: 10.1007/s40122-020-00207-y
Popis: Abstract Introduction 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. Methods 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. Results 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. Conclusions Melatonin is an effective and safe alternative for the treatment of chronic TTH.
Databáze: Directory of Open Access Journals
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