The Effect of Melatonin on Pediatric Drug-Resistant Epilepsy; a Randomized Double Blind Clinical Trial

Authors

1 Professor, Pediatric Neurologist, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.

2 Mashhad university of medical sciences

3 Pediatrician, Pediatric Researcher, Mashhad University of Medical Sciences, Mashhad, Iran.

4 Adult Gastroenterologist, Gastroenterology and Hepatology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.

Abstract

Background
About 15 to 40% of children with seizures are refractory to standard anti-epileptic drugs and for such patients, other treatments such as surgery and the ketogenic diet can reduce seizure frequency. Melatonin is a natural pineal gland hormone. The use of melatonin for controlling pediatric seizures is still controversial. This study aimed to evaluate the effect of melatonin on seizures, parent's satisfaction, sleep, and behavior in children with drug-resistant epilepsy.


Materials and Methods: In a pilot crossover study, children with drug-resistant epilepsy, who referred to the epileptic clinic of Ghaem Hospital, were randomly assigned to receive treatment with melatonin or a placebo for 4 weeks followed by a one-day washout period. Then patients who started with melatonin were switched to the placebo. Melatonin was administered 30 minutes before bedtime at a dose of 10 mg /m2 in 3mg tablets.
Results
Twenty patients, of which 11 (55%) were male, were enrolled into the study. The range and mean age of patients were 2 to 13 years and 7.28 ± 3.46 years, respectively. The mean number of diurnal seizures in the study group during placebo treatment was 11.05 and during melatonin treatment was 6.25, which was statistically significant (P=0.021). However, the reduction of the mean duration of diurnal seizures in the study groups was not statistically significant (P=0.386). There was no correlation between decreasing in number or duration of seizures with melatonin plasma levels. Drowsiness was the only side effect of melatonin, which occurred in three patients. 
Conclusion
Melatonin has probable beneficial effects on some epileptic patients with unclear mechanisms. Physicians can use it in selected epileptic children to improve seizures.

Keywords