Add-on melatonin improves quality of life in epileptic children on valproate monotherapy: a randomized, double-blind, placebo-controlled trial

Melatonin as add-on treatment for epilepsy

“…After careful evaluation of titles and abstracts, we excluded 14 articles. We added two studies (Goldberg-Stern 2012;Jain 2015), to the four studies already included in the previous version of this review (Coppola 2004;Gupta 2004a;Gupta 2004b;Hancock 2005). Hence, six publications with 125 participants (mostly children) fulfilled the inclusion criteria of the present review.…”

“…Hence, six publications with 125 participants (mostly children) fulfilled the inclusion criteria of the present review. Four publications were randomized, double-blind, cross-over, placebo-controlled trials (Coppola 2004;Hancock 2005;Goldberg-Stern 2012;Jain 2015), and two studies were randomized, double-blind, parallel, placebo-controlled trials (Gupta 2004a;Gupta 2004b). …”

“…The principal investigator of Coppola 2004 indicated by mail (December 2011) that 21/25 participants who completed the study were aged under 18 years. The same group of investigators conducted two studies on children (Gupta 2004a;Gupta 2004b). When contacted by mail (29 December 2011), authors of one trial that also included adults specified that all participants enrolled (included participants lost to follow-up) except one were aged under 18 years old (Hancock 2005).…”

“…In this trial, all participants had epilepsy and were on concurrent AEDs. Five studies compared the efficacy of melatonin versus placebo (Coppola 2004;Gupta 2004a;Gupta 2004b;Goldberg-Stern 2012;Jain 2015), whereas Hancock 2005 compared two different doses of melatonin (5 mg versus 10 mg).…”

Health-Related Quality of Life in Children and Adolescents with Epilepsy: A Systematic Review

“…Adolescents with partial epilepsy treated with carbamazepine had significant improvements in epilepsy impact and health perception domain. In one RCT, the impact of adding melatonin to valproate on HRQOL was evaluated (Gupta et al, 2004). The findings suggest that significant improvements were found on cognitive (including attention, memory, language, and other cognitive processes) and general behavior after adding melatonin to valproate.…”