Clinical Neurology Research Group, Peninsula College of Medicine and Dentistry, University of Plymouth, Derriford, UK.
J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1125-32. doi: 10.1136/jnnp-2012-302468. Epub 2012 Jul 12.
Multiple sclerosis (MS) is associated with chronic symptoms, including muscle stiffness, spasms, pain and insomnia. Here we report the results of the Multiple Sclerosis and Extract of Cannabis (MUSEC) study that aimed to substantiate the patient based findings of previous studies.
Patients with stable MS at 22 UK centres were randomised to oral cannabis extract (CE) (N=144) or placebo (N=135), stratified by centre, walking ability and use of antispastic medication. This double blind, placebo controlled, phase III study had a screening period, a 2 week dose titration phase from 5 mg to a maximum of 25 mg of tetrahydrocannabinol daily and a 10 week maintenance phase. The primary outcome measure was a category rating scale (CRS) measuring patient reported change in muscle stiffness from baseline. Further CRSs assessed body pain, spasms and sleep quality. Three validated MS specific patient reported outcome measures assessed aspects of spasticity, physical and psychological impact, and walking ability.
The rate of relief from muscle stiffness after 12 weeks was almost twice as high with CE than with placebo (29.4% vs. 15.7%; OR 2.26; 95% CI 1.24 to 4.13; p=0.004, one sided). Similar results were found after 4 weeks and 8 weeks, and also for all further CRSs. Results from the MS scales supported these findings.
The study met its primary objective to demonstrate the superiority of CE over placebo in the treatment of muscle stiffness in MS. This was supported by results for secondary efficacy variables. Adverse events in participants treated with CE were consistent with the known side effects of cannabinoids. No new safety concerns were observed.
NCT00552604.
多发性硬化症（MS）与慢性症状有关，包括肌肉僵硬、痉挛、疼痛和失眠。在此，我们报告了多发性硬化症和大麻提取物（MUSEC）研究的结果，该研究旨在证实之前研究中基于患者的发现。
22 个英国中心的稳定多发性硬化症患者被随机分配至口服大麻提取物（CE）（N=144）或安慰剂（N=135），按中心、步行能力和抗痉挛药物使用情况分层。这是一项双盲、安慰剂对照、III 期研究，有一个筛选期、2 周剂量滴定期（从 5mg 增加到每天最多 25mg 四氢大麻酚）和 10 周维持期。主要结局测量指标是衡量患者肌肉僵硬从基线变化的类别评分量表（CRS）。进一步的 CRS 评估身体疼痛、痉挛和睡眠质量。三个经过验证的多发性硬化症患者报告的结局测量工具评估了痉挛、身体和心理影响以及行走能力的各个方面。
治疗 12 周后，CE 缓解肌肉僵硬的比例几乎是安慰剂的两倍（29.4%对 15.7%；OR 2.26；95%CI 1.24 至 4.13；p=0.004，单侧）。在 4 周和 8 周后也发现了类似的结果，并且所有进一步的 CRS 结果也是如此。MS 量表的结果支持了这些发现。
该研究达到了其主要目标，证明了 CE 在治疗多发性硬化症肌肉僵硬方面优于安慰剂。这得到了次要疗效变量的结果支持。接受 CE 治疗的参与者的不良事件与大麻素的已知副作用一致。未观察到新的安全问题。
NCT00552604。
