National Institute for Stroke and Applied Neurosciences, School of Public Health and Psychosocial Studies, Auckland University of Technology, Auckland.
Department of Psychology, University of Auckland, Auckland, New Zealand.
Eur J Neurol. 2018 Aug;25(8):1055-e82. doi: 10.1111/ene.13653. Epub 2018 Apr 27.
Treatments to facilitate recovery after traumatic brain injury (TBI) are urgently needed. We conducted a 9-month pilot, randomized placebo-controlled clinical trial to examine the safety and potential effects of the herbal supplement MLC901 (NeuroAiD II™) on cognitive functioning following TBI.
Adults aged 18-65 years at 1-12 months after mild or moderate TBI were randomized to receive MLC901 (0.8 g capsules 3 times daily) or placebo for 6 months. The primary outcome was cognitive functioning as assessed by the CNS Vital Signs online neuropsychological test. Secondary outcomes included the Cognitive Failures Questionnaire, the Rivermead Post-concussion Symptom Questionnaire (neurobehavioral sequelae), Quality of Life after Brain Injury, Hospital Anxiety and Depression Scale, Modified Fatigue Impact Scale and extended Glasgow Outcome Scale (physical disability). Assessments were completed at baseline and at 3-, 6- and 9-month follow-up. Linear mixed-effects models were conducted, with the primary outcome time-point of 6 months.
A total of 78 participants [mean age 37.5 ± 14.8 years, 39 (50%) female] were included in the analysis. Baseline variables were similar between groups (treatment group, n = 36; control group, n = 42). Linear mixed-effects models controlling for time, group allocation, repeated measurements, adherence and baseline assessment scores revealed significant improvements in complex attention (P = 0.04, d = 0.6) and executive functioning (P = 0.04, d = 0.4) at 6 months in the MLC901 group compared with controls. There were no significant differences between the groups for neurobehavioral sequelae, mood, fatigue, physical disability or overall quality of life at 6 months. No serious adverse events were reported.
MLC901 was safe and well tolerated post-TBI. This study provided Class I/II evidence that, for patients with mild to moderate TBI, 6 months of MLC901 improved cognitive functioning.
外伤性脑损伤（TBI）后需要迫切治疗以促进恢复。我们进行了一项为期 9 个月的试点、随机安慰剂对照临床试验，以研究草药补充剂 MLC901（NeuroAiD II™）对 TBI 后认知功能的安全性和潜在影响。
TBI 后 1-12 个月的 18-65 岁成年人被随机分为 MLC901（0.8 克胶囊，每日 3 次）或安慰剂组，治疗 6 个月。主要结局是通过 CNS Vital Signs 在线神经心理学测试评估的认知功能。次要结局包括认知失败问卷、Rivermead 脑震荡后症状问卷（神经行为后遗症）、脑损伤后生活质量量表、医院焦虑和抑郁量表、改良疲劳影响量表和扩展格拉斯哥结局量表（身体残疾）。评估在基线和 3、6 和 9 个月随访时进行。进行了线性混合效应模型分析，主要结局时间点为 6 个月。
共有 78 名参与者（平均年龄 37.5 ± 14.8 岁，39 名（50%）女性）纳入分析。组间基线变量相似（治疗组 n = 36；对照组 n = 42）。线性混合效应模型控制时间、分组分配、重复测量、依从性和基线评估分数，结果显示，与对照组相比，MLC901 组在 6 个月时复杂注意力（P = 0.04，d = 0.6）和执行功能（P = 0.04，d = 0.4）显著改善。两组在 6 个月时神经行为后遗症、情绪、疲劳、身体残疾或整体生活质量无显著差异。未报告严重不良事件。
MLC901 在 TBI 后安全且耐受良好。本研究提供了 I/II 级证据，表明对于轻度至中度 TBI 患者，6 个月的 MLC901 可改善认知功能。
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