Add-on melatonin improves quality of life in epileptic children on valproate monotherapy: a randomized, double-blind, placebo-controlled trial
Madhur Gupta1, Satinder Aneja, Kamlesh Kohli
1Department of Pharmacology, Lady Hardinge Medical College and Associated Hospitals, New Delhi, India. madhurgupta@hotmail.com
Insights
This study explored melatonin
Area of Science:
- Pediatric Neurology
- Epilepsy Research
- Pharmacology
Background:
- Epileptic children on sodium valproate (VPA) monotherapy often experience diminished quality of life.
- Current treatment options may not fully address the multifaceted impact of epilepsy on children's well-being.
Purpose of the Study:
- To evaluate the efficacy of add-on melatonin in improving the quality of life for children with epilepsy on VPA monotherapy.
- To assess melatonin's impact on various quality of life domains, including physical, emotional, cognitive, social, and behavioral aspects.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 31 epileptic children aged 3-12 years.
- Participants received either add-on melatonin (n=16) or placebo (n=15) alongside their VPA monotherapy.
- Quality of life was assessed using the validated Quality of Life in Childhood Epilepsy parental questionnaire.
Main Results:
- The study utilized a reliable parental questionnaire with good internal consistency (Cronbach's alpha > 0.5).
- This is the first randomized, double-blind, placebo-controlled trial to investigate melatonin's effect on quality of life in pediatric epilepsy.
Conclusions:
- Melatonin shows potential as an adjunctive therapy for pediatric epilepsy due to its antioxidant, neuroprotective, and free radical scavenging properties.
- Its ability to improve sleep, safety profile, and blood-brain barrier penetration suggests it may enhance the quality of life in children with epilepsy.
Abstract:
This randomized, double-blind, placebo-controlled study in epileptic children aged 3-12 years evaluated the effects of add-on melatonin administration on the quality of life of these children on sodium valproate (VPA) monotherapy using a parental questionnaire. Quality of Life in Childhood Epilepsy is a questionnaire designed to assess a variety of age-relevant domains such as physical function, emotional well-being, cognitive function, social function, behavior, and general health. Of the 31 patients, 16 randomly received add-on melatonin (MEL), whereas 15 received add-on placebo (P). The questionnaire had good internal consistency reliability, because for most of the multi-item scales Cronbach's alpha reliability exceeded 0.5 (range: 0.59-0.94). To our knowledge, this is the first study assessing quality of life in epileptic children with add-on melatonin administration in the form of a randomized, double-blind, placebo-controlled trial. The study suggests a potential use of melatonin as an adjunct to antiepileptic therapy due to its diverse spectrum of action as an antioxidant, neuroprotector, and free radical scavenger, thus offering the advantage of reducing oxidant stress and subsequent damage. The beneficial effects of melatonin on sleep, its wide safety window, and its ability to cross the blood-brain barrier have the potential to improve quality of life in pediatric epilepsy.
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