在青少年中治疗ADHD的微量营养素 (MADDY) 研究:比较RCT和开放标签扩展结果
Brenda M Y Leung1, Priya Srikanth2, Lisa Robinette3
1Faculty of Health Sciences, University of Lethbridge, 4401 University Drive, Lethbridge, AB, Canada. brenda.leung@uleth.ca.
European child & adolescent psychiatry
|June 8, 2023
概括
这项研究发现,多种营养素改善了儿童的多动症症状,效益持续了16周. 较长时间的治疗没有增加不良事件,显示ADHD管理的安全概况.
科学领域:
- 儿童精神病学 儿童精神病学
- 营养神经科学 营养神经科学
- 临床试验研究 临床试验研究
背景情况:
- 年轻人注意力缺陷/多动障碍微量营养素 (MADDY) 研究研究了多营养素配方,用于患有多动症和情绪失调的儿童.
- 一个开放式延长期 (OLE) 阶段比较了8周和16周的治疗持续时间.
研究的目的:
- 评估多营养配方在ADHD儿童中的有效性和安全性.
- 为了比较延长治疗持续时间 (16周) 与标准持续时间 (8周) 对ADHD症状,生长和不良事件的影响.
主要方法:
- 患有多动症的6-12岁儿童参加了一项随机对照试验 (RCT),随后进行了OLE.
- 评估包括ADHD症状评级 (CASI-5),临床改善 (CGI-I),不良事件 (PAERS) 和人类测量.
主要成果:
- 从第8周到第16周,在两组中都观察到ADHD症状的显著改善.
- 与8周相比,接受16周多元营养素的儿童的身高增长略有增加.
- 在治疗期间之间没有发现不良事件的显著差异,这表明了有利的安全性.
结论:
- 对多种营养素对ADHD症状的积极反应持续了长达16周.
- 最初接受安慰剂治疗的儿童在8周的多营养素治疗后显著改善,接近于接受更长时间治疗的儿童的反应.
- 多营养成分配方在长时间使用时显示出可接受的安全性.
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