Danilov Andrei B, Danilov Alexey B, Kurushina Olga V, Shestel Elena A, Zhivolupov Sergey A, Latysheva Nina V
Department of Neurology, Institute for Professional Education, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
Department of Neurology, Volgograd State Medical University, Volgograd, Russia.
Pain Ther. 2020 Dec;9(2):741-750. doi: 10.1007/s40122-020-00207-y. Epub 2020 Oct 16.
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.
紧张型头痛（TTH）是最常见的原发性头痛。每年，约2%-3%的紧张型头痛患者会进展为慢性紧张型头痛，头痛发作频率为每日或接近每日发作，需要进行预防性治疗。慢性紧张型头痛的治疗较为复杂，且常常伴有显著的耐受性问题。迄今为止，仅在少数小型非对照试验中对褪黑素进行了研究。本监测项目的目的是在实际临床中评估褪黑素（美拉酮）对紧张型头痛患者及昼夜节律紊乱的疗效。
纳入61例慢性紧张型头痛患者。在30天的基线期后，患者于睡前服用3毫克褪黑素，持续30天，并进行为期30天的随访。在基线访视、第1个月和第2个月时获取视觉模拟评分（VAS）疼痛强度评估、汉密尔顿焦虑量表（HAM-A）、汉密尔顿抑郁量表（HAM-D）、HIT-6评分和莱文睡眠质量评分。
在整个研究过程中，每月头痛天数、VAS疼痛强度、HAM-A、HAM-D和HIT-6评分均显著降低，睡眠质量得到改善。未报告治疗期间出现的不良事件。
褪黑素是治疗慢性紧张型头痛的一种有效且安全的替代药物。
