ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Melatonin Is Superior to Amitriptyline for Headache Prevention Based on the Proportion of Patients Who Improved >50% in Headache Frequency
Clinical Question In adults with migraine headaches, is melatonin superior than amitriptyline in preventing the frequency and intensity of migraine headaches?
Clinical Bottom Line For patients with migraine headaches, melatonin 3 mg is better than placebo for migraine prevention, more tolerable than amitriptyline, and as effective as amitriptyline 25 mg. Tolerability measures included the incidences of adverse events, including those that led to the premature withdrawal from the study as well as those that were life threatening.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 27165014Goncalves/2016178 men and women experiencing migraine headachesRandomized Controlled Trial
Key resultsThe primary outcome was the number of migraine headache days per month at baseline versus month 3. Secondary end points were responder rate, migraine intensity, duration and analgesic use. Melatonin 3 mg and amitriptyline 25 mg were comparable (p=0.19) in reducing headache frequency compared to the placebo (p=.009). While melatonin and amitriptyline were equally effective for the primary end point, for the secondary end point of responder rate (i.e., proportion of patients with greater than 50% improvement in headache frequency) melatonin was superior to amitriptyline (p<0.05) and placebo (p<0.01). Adverse events were mostly mild or moderate and occurred more frequently in the amitriptyline group compared with melatonin and placebo (p<0.03).
Evidence Search ("melatonin"[MeSH Terms] OR "melatonin"[All Fields]) AND ("migraine disorders"[MeSH Terms] OR ("migraine"[All Fields] AND "disorders"[All Fields]) OR "migraine disorders"[All Fields] OR "migraine"[All Fields])
Comments on
The Evidence
The randomized, double-blind placebo-controlled study is near the top of the evidence pyramid. The trial conformed to the Declaration of Helsinki, Good Clinical Practice guidelines and the International Organization for Standardization standards. The 12-week study period is a reasonable follow-up time for the intervention being measured, and no competing interests were declared. However, study completion ranged from 69% to 75% depending on the study group, which is low; this may have biased the results. The authors did not report the completion rate in each group.
Applicability According to the Frequent Headache Epidemiology study, BMI is a strong predictor of migraine headaches. There is a fivefold increased risk for chronic daily headaches with a BMI of 30 or greater. According to the Centers of Disease Control and Prevention, over 1/3 of U.S. adults are obese. Melatonin is readily available without a prescription in the US. It is also not expensive. There is little or no evidence of major toxicities with melatonin, even at high doses. Adverse affects of melatonin include dizziness, enuresis, excessive daytime somnolence, headache, nausea, and transient depression. Amitriptyline has a US box warning that states that antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18-24 years of age) with major depressive disorder and other psychiatric disorders.
Specialty/Discipline (Public Health) (General Dentistry)
Keywords Melatonin, migraine prevention, migraine headaches, migraine therapy
ID# 3159
Date of submission: 04/10/2017spacer
E-mail wesneski@livemail.uthscsa.edu
Author Katie Wesneski
Co-author(s)
Co-author(s) e-mail
Faculty mentor/Co-author Edward Wright, DDS, MS
Faculty mentor/Co-author e-mail WrightE2@uthscsa.edu
Basic Science Rationale
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