Gonçalves Andre Leite, Martini Ferreira Adriana, Ribeiro Reinaldo Teixeira, Zukerman Eliova, Cipolla-Neto José, Peres Mario Fernando Prieto
Albert Einstein Hospital, São Paulo, Brazil Department of Neurology, UNIFESP, São Paulo, Brazil.
Albert Einstein Hospital, São Paulo, Brazil.
J Neurol Neurosurg Psychiatry. 2016 Oct;87(10):1127-32. doi: 10.1136/jnnp-2016-313458. Epub 2016 May 10.
Melatonin has been studied in headache disorders. Amitriptyline is efficacious for migraine prevention, but its unfavourable side effect profile limits its use.
A randomised, double-blind, placebo-controlled study was carried out. Men and women, aged 18-65 years, with migraine with or without aura, experiencing 2-8 attacks per month, were enrolled. After a 4-week baseline phase, 196 participants were randomised to placebo, amitriptyline 25 mg or melatonin 3 mg, and 178 took a study medication and were followed for 3 months (12 weeks). The primary outcome was the number of migraine headache days per month at baseline versus last month. Secondary end points were responder rate, migraine intensity, duration and analgesic use. Tolerability was also compared between groups.
Mean headache frequency reduction was 2.7 migraine headache days in the melatonin group, 2.2 for amitriptyline and 1.1 for placebo. Melatonin significantly reduced headache frequency compared with placebo (p=0.009), but not to amitriptyline (p=0.19). Melatonin was superior to amitriptyline in the percentage of patients with a greater than 50% reduction in migraine frequency. Melatonin was better tolerated than amitriptyline. Weight loss was found in the melatonin group, a slight weight gain in placebo and significantly for amitriptyline users.
Melatonin 3 mg is better than placebo for migraine prevention, more tolerable than amitriptyline and as effective as amitriptyline 25 mg.
褪黑素已在头痛疾病中得到研究。阿米替林对偏头痛预防有效，但其不良副作用限制了其使用。
开展了一项随机、双盲、安慰剂对照研究。纳入年龄在18 - 65岁之间、有或无先兆偏头痛、每月发作2 - 8次的男性和女性。在为期4周的基线期后，196名参与者被随机分为安慰剂组、25毫克阿米替林组或3毫克褪黑素组，178人服用研究药物并随访3个月（12周）。主要结局是基线期与最后一个月每月偏头痛头痛天数。次要终点是缓解率、偏头痛强度、持续时间和止痛药物使用情况。还比较了各组的耐受性。
褪黑素组平均头痛频率减少2.7个偏头痛头痛天数，阿米替林组为2.2个，安慰剂组为1.1个。与安慰剂相比，褪黑素显著降低了头痛频率（p = 0.009），但与阿米替林相比差异无统计学意义（p = 0.19）。在偏头痛频率降低超过50%的患者百分比方面，褪黑素优于阿米替林。褪黑素的耐受性优于阿米替林。褪黑素组出现体重减轻，安慰剂组有轻微体重增加，阿米替林使用者体重显著增加。
3毫克褪黑素在预防偏头痛方面优于安慰剂，耐受性比阿米替林更好，且与25毫克阿米替林效果相当。
