Efficacy of prophylactic sodium valproate in pediatric migraines: a systematic review of randomized clinical studies

Migraine is a neurological disorder that is chronic and presents with episodes of paroxysmal features consisting of multiphase attacks of head pain, along with other symptoms related to neurological dysfunction such as sensitivity to movement, photophobia, phonophobia, nausea, and vomiting. Antiseizure medications are frequently used for the treatment of migraine. Of the antiseizure medications, sodium valproate and topiramate have received approval from the Food and Drug Administration (FDA) to prevent adult migraine. More recently, topiramate gained approval for pediatric migraine, whereas sodium valproate did not. Nevertheless, the off-label utilization of these drugs for pediatric migraine is widespread. The objective of this review is to assess the prophylactic efficacy of sodium valproate in the management of pediatric migraines.

The protocol of this study was registered with PROSPERO (CRD42023454491). Therefore, this systematic review aims to assess the efficacy of sodium valproate as a prophylaxis treatment for pediatric migraine. A comprehensive unrestricted search of indexed databases, including PubMed, Embase, Web of Science, and Cochrane, was conducted without any restrictions until May 2024.

The review included five randomized controlled trials (RCTs). Among these, two exhibited a generally low risk of bias (RoB), while the remaining RCTs demonstrated a high risk for bias.

The findings from the current evidence suggest no significant differences in the effectiveness of sodium valproate compared to other frequently used medications in preventing pediatric migraine. Subsequent studies should maintain uniformity in their protocol design and introduce blinding methodologies across outcome assessment, participants, and researchers. These strategies hold significant importance in mitigating potential sources of bias.