PDF(Pubmed)
Abstract：
Traumatic brain injury (TBI) is a leading cause of disability. Sequelae can include functional impairments and psychiatric syndromes such as post-traumatic stress disorder (PTSD), depression and anxiety. Special Operations Forces (SOF) veterans (SOVs) may be at an elevated risk for these complications, leading some to seek underexplored treatment alternatives such as the oneirogen ibogaine, a plant-derived compound known to interact with multiple neurotransmitter systems that has been studied primarily as a treatment for substance use disorders. Ibogaine has been associated with instances of fatal cardiac arrhythmia, but coadministration of magnesium may mitigate this concern. In the present study, we report a prospective observational study of the Magnesium-Ibogaine: the Stanford Traumatic Injury to the CNS protocol (MISTIC), provided together with complementary treatment modalities, in 30 male SOVs with predominantly mild TBI. We assessed changes in the World Health Organization Disability Assessment Schedule from baseline to immediately (primary outcome) and 1 month (secondary outcome) after treatment. Additional secondary outcomes included changes in PTSD (Clinician-Administered PTSD Scale for DSM-5), depression (Montgomery-Åsberg Depression Rating Scale) and anxiety (Hamilton Anxiety Rating Scale). MISTIC resulted in significant improvements in functioning both immediately (Pcorrected < 0.001, Cohen\'s d = 0.74) and 1 month (Pcorrected < 0.001, d = 2.20) after treatment and in PTSD (Pcorrected < 0.001, d = 2.54), depression (Pcorrected < 0.001, d = 2.80) and anxiety (Pcorrected < 0.001, d = 2.13) at 1 month after treatment. There were no unexpected or serious adverse events. Controlled clinical trials to assess safety and efficacy are needed to validate these initial open-label findings. ClinicalTrials.gov registration: NCT04313712 .
摘要：
创伤性脑损伤(TBI)是导致残疾的主要原因。后遗症可能包括功能障碍和精神综合征，如创伤后应激障碍(PTSD)，抑郁和焦虑。特种作战部队（SOF）退伍军人（SOV）可能会增加这些并发症的风险，导致一些人寻求未充分开发的治疗替代方案，如抗伊博加因，一种已知与多种神经递质系统相互作用的植物衍生化合物，主要作为物质使用障碍的治疗方法进行了研究。伊博加因与致命的心律失常有关，但是镁的共同管理可以减轻这种担忧。在本研究中,我们报告了一项关于镁-伊博加因的前瞻性观察性研究：中枢神经系统方案（MISTIC）的斯坦福创伤损伤，与补充治疗方式一起提供，在30名男性SOV中以轻度TBI为主。我们评估了世界卫生组织残疾评估计划从基线到立即（主要结果）和治疗后1个月（次要结果）的变化。其他次要结果包括PTSD的变化（DSM-5的临床医生管理的PTSD量表），抑郁（蒙哥马利-奥斯贝格抑郁量表）和焦虑（汉密尔顿焦虑量表）。MISTIC在治疗后立即（P校正<0.001，Cohen\sd=0.74）和1个月（P校正<0.001，d=2.20）以及PTSD（P校正<0.001，d=2.54）的功能方面均有显着改善，治疗后1个月，抑郁（P校正<0.001，d=2.80）和焦虑（P校正<0.001，d=2.13）。没有意外或严重的不良事件。需要进行对照临床试验来评估安全性和有效性，以验证这些最初的开放标签发现。ClinicalTrials.gov注册：NCT04313712。
