School of Health Sciences, State University of Amazonas, Manaus, Amazon, Brazil.
Department of Neuroscience and Sciences of Behavior, Division of Neurology, Faculty of Medicine of Ribeirão Preto, University of São Paulo, São Paulo, Brazil.
Mov Disord. 2021 Jul;36(7):1711-1715. doi: 10.1002/mds.28577. Epub 2021 Mar 22.
REM sleep behaviour disorder (RBD) is a common non-motor feature of Parkinson's disease (PD). Cannabidiol (CBD) is one of the main non-psychoactive components of Cannabis sativa and may represent an alternative route for treating RBD.
This study assessed the efficacy and safety of CBD for RBD in PD.
We conducted a phase II/III, double-blind, placebo-controlled clinical trial in 33 patients with RBD and PD. Patients were randomized 1:1 to CBD in doses of 75 to 300mg or matched capsules placebo and were followed up for 14 weeks. The primary outcomes were the frequency of nights with RBD, CGI-I, and CGI-S.
CBD showed no difference to placebo for primary outcomes. Regarding secondary outcomes, we observed a significant improvement in average sleep satisfaction from the 4th to 8th week in the CBD versus placebo group with P = 0.049 and P = 0.038, respectively.
CBD, as an adjunct therapy, showed no reduction in RBD manifestations in PD patients. A transient improvement in sleep satisfaction with a dose of 300mg has been noted. © 2021 International Parkinson and Movement Disorder Society.
快速眼动睡眠行为障碍(RBD)是帕金森病(PD)的一种常见非运动特征。大麻二酚(CBD)是大麻的主要非精神活性成分之一,可能是治疗 RBD 的另一种途径。
本研究评估 CBD 治疗 PD 中 RBD 的疗效和安全性。
我们对 33 例 RBD 和 PD 患者进行了为期 14 周的 II/III 期、双盲、安慰剂对照临床试验。患者按 1:1 随机分为 CBD 剂量为 75 至 300mg 或匹配胶囊安慰剂组。
CBD 在主要结局方面与安慰剂无差异。关于次要结局,我们观察到 CBD 组与安慰剂组相比,从第 4 周到第 8 周平均睡眠满意度有显著改善,P 值分别为 0.049 和 0.038。
作为辅助治疗,CBD 并未减少 PD 患者的 RBD 表现。在 300mg 剂量下,睡眠满意度有短暂改善。 © 2021 国际帕金森病和运动障碍协会。