Mitigating Adverse Effects of Antiseizure Medications in Pediatric Drug-Resistant Epilepsy: an open-label single-arm study of adjunctive Epilamba®

Background Managing the adverse effects associated with anti-seizure medications is essential for enhancing the quality of life and adherence to treatment in children with drug-resistant epilepsy. This study evaluated the potential of Epilamba®, a natural supplement, in mitigating treatment-related adverse effects. Methods Pediatric patients with drug-resistant epilepsy on polytherapy were enrolled to receive adjunctive Epilamba® (1 sachet/day) for six months. Assessments of seizure frequency, systemic and neurological toxicity, and gastrointestinal symptoms were conducted using standardized questionnaires at baseline (T0), three months (T1), and six months (T2). Data were analyzed using the Wilcoxon signed-rank test, with significance set at p<0.05. Results Twenty-five children (mean age 9.84±4.39 years) completed the study. No significant changes were observed in seizure frequency or semiology from baseline at either T1 (p=0.42) or T2 (p=0.23), indicating that Epilamba® did not interfere with ASM effectiveness. Systemic toxicity significantly improved at T1 (p=0.008) and T2 (p=0.02) compared to baseline, though no additional improvement was observed between T1 and T2 (p=0.62). Neurotoxicity also significantly decreased at T1 (p=0.009) and T2 (p=0.02), with stabilization thereafter (T1 vs. T2, p=0.6). Gastrointestinal symptoms, present in over 40% of participants at baseline, showed significant improvement only at T2 (p=0.04). Conclusions Epilamba® appears effective in reducing anti-seizure medications-related adverse effects in children with drug-resistant epilepsy, with peak benefits observed within three months of treatment, maintained during the follow-up, and without compromising seizure control. Further studies may contribute to assessing the effects of Epilamba® as adjunctive therapy in pediatric drug-resistant epilepsy management.