In the current issue of JNNP, Gonçalves and colleagues have published a randomized control trial (RCT) comparing melatonin, amitriptyline and placebo for migraine prevention.
Migraine is a chronic neurological disease and has been ranked as the sixth disabling condition by World Health Organization (WHO). The goals of migraine prophylaxis are to reduce migraine attacks, limit the need for analgesic intake and improve the quality of life. However, despite the different pharmacological treatments available, only a small fraction of patients receive adequate preventive treatment, which amongst other reasons is related to unfavourable drug security profile.
In this study, after randomizing 196 patients into melatonin (3 mg), amitriptyline (25 mg) or placebo (randomization ratio 1:1:1) and following up for 12 weeks, the authors reported a significant reduction in the number of migraine headache days per month with melatonin or amitriptyline versus placebo. Even though melatonin and amitriptyline were equally effective for the primary endpoint, the number of patients with greater than 50% reduction in migraine headache days was significantly higher in the melatonin group. Moreover, the number of adverse effects was also significantly lower in this group compared with amitriptyline. These results support the efficacy and tolerability of melatonin as a prophylaxis therapy for migraine.
Melatonin is a hormone produced mainly in the pineal gland, and it plays an essential role as an endogenous synchronizer of internal circadian rhythms. Melatonin has demonstrated efficacy and safety in the treatment of nociceptive and neuropathic pain in several studies. Specifically in migraine, melatonin receptors have been described in the nuclei of the trigeminal nerve, suggesting that may decrease trigeminovascular nociception. Moreover, melatonin levels have been described to be reduced in migraine patients. Regarding the security profile, melatonin is remarkably well tolerated and it only has minor side effects such as daytime sleepiness, dizziness, and stomach pain. These features make melatonin a good candidate for migraine prophylaxis.
In short, this is an interesting article that has clear and immediate clinical application.
Read more at http://jnnp.bmj.com/content/87/10/1127.full.pdf