Safety and Efficacy of Melatonin in Chronic Tension-Type Headache: A Post-Marketing Real-World Surveillance Program.
Pain Ther. 2020 Dec ;9(2):741-750. Epub 2020 Oct 16. PMID: 33067764
Andrei B Danilov
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.