Safety and efficacy of melatonin supplementation as an add‐on treatment for infantile epileptic spasms syndrome: A randomized, placebo‐controlled, double‐blind trial

作者：Yulin Sun, Jian Chen, Xiu‐Yu Shi, Zhichao Li, Lin Wan, Huimin Yan, Y Chen, Jiaxin Wang, Jing Wang, Li‐Ping Zou, Rüssel J. Reiter, Bo Zhang, Guang Yang · 发表于：Journal of Pineal Research · 年份：2023 · DOI：10.1111/jpi.12922 · 被引用次数：13 · 研究领域：Epilepsy research and treatment、Sleep and Wakefulness Research、Neonatal and fetal brain pathology

) for 2 weeks, and the treatment group also received melatonin (3 mg) between 20:00 and 21:00 daily, 0.5-1 h before bedtime. The study's primary endpoint was the average reduction rate in spasm frequency assessed by seizure diaries. Secondary endpoints included assessment of the response rate, EEG hypsarrhythmia (Kramer score), and psychomotor development (Denver Developmental Screening Test, DDST). Sleep quality was assessed by using the Brief Infant Sleep Questionnaire (BISQ), the Infant Sleep Assessment Scale (ISAS), and actigraphy. Safety parameters were also evaluated. Statistical analyses were conducted on intention-to-treat and per-protocol populations. The trial is registered at Clinicaltrials.gov (ChiCTR2000036208). Out of 119 screened patients, 70 were randomized and 66 completed treatments. In the intention-to-treat population, there were no significant differences in the average percentage reduction of spasm frequency (median [interquartile range, IQR: Q3-Q1], 100% [46.7%] vs. 66.7% [55.3%], p = .288), the 3-day response rate (51.4% vs. 37.1%, p = .229), the 28-day response rate (42.9% vs. 28.6%, p = .212), EEG Kramer scores (2 [3.5] vs. 2 [3], p = .853), or DDST comprehensive months (5 [2.5] vs. 6 [6], p = .239) between the melatonin (n = 35) and placebo (n = 35) groups. However, caregivers reported improved sleep quality after melatonin treatment, with 85.7% reporting regular sleep compared to 42.9% with placebo (42.9%, p < .001). The melatonin group had lower I...