A randomised clinical trial of efficacy of melatonin and amitriptyline in migraine prophylaxis of children
Iranian Journal of Child Neurology,
Vol. 12 No. 1 (2018),
1 January 2018
,
Page 47-54
https://doi.org/10.22037/ijcn.v12i1.12004
Abstract
Objective: No drugs have been approved for pediatric migraine prophylaxis by the Food and Drug Administration up to now. The aim of the present research was to compare effectiveness and tolerability of melatonin and amitriptyline in pediatric migraine prevention.
Materials & Methods: In a parallel single-blinded randomized clinical trial, 5-15 year old children with diagnosis of migraine that preventive therapy was indicated in whom and were referred to Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd-Iran from June 2013 to January 2014, were randomly allocated to receive 1mg/kg amitriptyline or 0.3 mg/kg melatonin for three consecutive months.
Primary outcomes were frequency of good response (more than 50 % of reduction in monthly headache frequency) and efficacy in reduction of severity, duration and disability of headache. Secondary outcome was drugs clinical adverse events.
Results: 41 girls (51.3%) and 39 boys (48.7%) with mean age of 10.44±2.26 years were evaluated. Good response was seen in 82.5% of amitriptyline and 62%.5 of melatonin groups and amitriptyline was statistically significant more effective. (P= 0.04)
Severity, duration and Pediatric Migraine Disability Assessment score (PedMIDAS) of headache reduced with melatonin from 6.05±1.63 to 4.03±1.54 scores, from 2.06±1.18 to 1.41± 0.41 hours, and from 33.13±9.17 to 23.38±9.51 scores, respectively. Severity, duration and PedMIDAS of headache decreased with amitriptyline from 6.41±1.67to 2.25±1.21, from 2.55 ±1.85to 0.56±0.51h, and from 31.4±9.33 to 8.28 ± 3.75, respectively. (All p < 0.05) Both drugs were effective in reduction of monthly frequency, severity, duration and disability of headache.
Daily sleepiness was seen in 7.5 % (N=3) of melatonin group as a side effect and adverse events were seen in 22.5% ( N=9) of amitriptyline group including daily sleepiness in four , constipation in three and fatigue in two children and melatonin was safer than amitriptyline (value = 0.04).
Conclusions: Amitriptyline and melatonin are effective and safe in pediatric migraine prophylaxis but amitriptyline can be considered as a more effective drug.
- Migraine
- Child
- Prevention
- Amitriptyline
- Melatonin
How to Cite
References
References
Antonaci F, Voiticovschi-Iosob C, Di Stefano AL, Galli F, Ozge A, Balottin U.The evolution of headache from childhood to adulthood: a review of the literature. J Headache Pain 2014, 18; 15:15.
Bonfert M, Straube A, Schroeder AS, Reilich P, Ebinger F, Heinen F. Primary headache in children and adolescents: update on pharmacotherapy of migraine and tension-type headache. Neuropediatrics 2013; 44(1):3-19.
Victor S, Ryan S. WITHDRAWN: Drugs for preventing migraine headaches in children. Cochrane Database Syst Rev 2014, Jul 11; 7:CD002761.
Bonfert M, Straube A, Schroeder AS, Reilich P, Ebinger F, Heinen F. Primary headache in children and adolescents: update on pharmacotherapy of migraine and tension-typeheadache. Neuropediatrics. 2013; 44(1):3-19.
Fallah R, Shoroki FF, Ferdosian F. Safety and efficacy of melatonin in pediatric migraine prophylaxis. Curr Drug Saf 2015;10(2):132-5
Miano S, Parisi P, Pelliccia A, Luchetti A, Paolino MC, Villa MP. Melatonin to prevent migraine or tension-type headache in children. Neurol Sci 2008; 29:285-7.
Oleson J. The International Classification of Headache Disorders: 2nd edition. Headache Classification Subcommittee of the International Headache Society. Cephalalgia 2004; 24, Suppl 1:9-160.
Fallah R, Divanizadeh MS, Karimi M, Mirouliaei M, Shamszadeh A. Topiramate and propranolol for prophylaxis of migraine. Indian J Pediatr 2013; 80 (11):920-4.
Hershey AD, Powers SW, Vockell ALB, LeCates SL, Kabbouche MA, Maynard MK. PedMIDAS: Development of a questionnaire to assess disability of migraines in children. Neurology 2001; 57:2034-2039.
Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health 1990; 13: 227-36.
Peres M , Gonçalves A. Double-blind, placebo controlled, randomized clinical trial comparing melatonin 3 mg, amitriptyline 25 mg and placebo for migraine prevention. Neurology February 12, 2013; 80(Meeting Abstracts 1).(Epub ahead of print)
Singh NN, Sahota P. Sleep-related headache and its management. Curr Treat Options Neurol 2013; 15(6):704-22.
Alstadhaug KB, Odeh F, Salvesen R, Bekkelund SI. Prophylaxis of migraine with melatonin: a randomized controlled trial. Neurology 2010, 75:1527-32.
Peres MF. Melatonin for migraine prevention. Curr Pain Headache Rep 2011; 15:334-5.
Sánchez-Barceló EJ, Mediavilla MD, Reiter RJ. Clinical uses of melatonin in pediatrics. Int J Pediatr 2011; 2011: 892624.
Waldron DL, Bramble D, Gringras P. Melatonin: prescribing practices and adverse events. Arch Dis Child 2005; 90:1206-7.
Banach M, Gurdziel E, Jędrych M, Borowicz KK. Melatonin in experimental seizures and epilepsy. Pharmacol Rep 2011; 63(1):1-11.
Lewis DW, Diamond S, Scott D, Jones V. Prophylactic treatment of pediatric migraine. Headache 2004; 44(3):230-7.
Hershey AD, Powers SW, Bentti AL, Degrauw TJ. Effectiveness of amitriptyline in the prophylactic management of childhood headaches. Headache 2000; 40(7):539-49.
Kalita J, Bhoi SK, Misra UK. Amitriptyline vs divalproate in migraine prophylaxis: a randomized controlled trial. Acta Neurol Scand 2013; 128(1):65-72.
Israil A, Ahmed S, Rahman KM, Uddin MJ, Dey SK, Battacharjee M, Mondal G, Ali MA, Alam MN, Miah AH, Uddin MS. Efficacy of amitriptyline, pizotifen and propranolol in the prevention of migraine. Mymensingh Med J 2013; 22(1):93-100.
Couch JR1; Amitriptyline Versus Placebo Study Group .Amitriptyline in the prophylactic treatment of migraine and chronic daily headache. Headache 2011; 51(1):33-51.
Hershey AD, Winner PK Pediatric migraine: recognition and treatment. J Am Osteopath Assoc 2005; 105(4 Suppl 2):2S-8S.
O'Brien HL, Kabbouche MA, Hershey AD. Treating pediatric migraine: an expert opinion. Expert Opin Pharmacother 2012; 13(7):959-66.
Nagata E. Antidepressants in migraine prophylaxis. Brain Nerve 2009; 61(10):1131-4. (Article in Japanese)
- Abstract Viewed: 566 times