Zajicek J P, Sanders H P, Wright D E, Vickery P J, Ingram W M, Reilly S M, Nunn A J, Teare L J, Fox P J, Thompson A J
Department of Mathematics and Statistics, University of Plymouth, Room N16, ITTC Building, Tamar Science Park, Plymouth, Devon PL6 8BX, UK.
J Neurol Neurosurg Psychiatry. 2005 Dec;76(12):1664-9. doi: 10.1136/jnnp.2005.070136.
To test the effectiveness and long term safety of cannabinoids in multiple sclerosis (MS), in a follow up to the main Cannabinoids in Multiple Sclerosis (CAMS) study.
In total, 630 patients with stable MS with muscle spasticity from 33 UK centres were randomised to receive oral Delta(9)-tetrahydrocannabinol (Delta(9)-THC), cannabis extract, or placebo in the main 15 week CAMS study. The primary outcome was change in the Ashworth spasticity scale. Secondary outcomes were the Rivermead Mobility Index, timed 10 metre walk, UK Neurological Disability Score, postal Barthel Index, General Health Questionnaire-30, and a series of nine category rating scales. Following the main study, patients were invited to continue medication, double blinded, for up to 12 months in the follow up study reported here.
Intention to treat analysis of data from the 80% of patients followed up for 12 months showed evidence of a small treatment effect on muscle spasticity as measured by change in Ashworth score from baseline to 12 months (Delta(9)-THC mean reduction 1.82 (n = 154, 95% confidence interval (CI) 0.53 to 3.12), cannabis extract 0.10 (n = 172, 95% CI -0.99 to 1.19), placebo -0.23 (n = 176, 95% CI -1.41 to 0.94); p = 0.04 unadjusted for ambulatory status and centre, p = 0.01 adjusted). There was suggestive evidence for treatment effects of Delta(9)-THC on some aspects of disability. There were no major safety concerns. Overall, patients felt that these drugs were helpful in treating their disease.
These data provide limited evidence for a longer term treatment effect of cannabinoids. A long term placebo controlled study is now needed to establish whether cannabinoids may have a role beyond symptom amelioration in MS.
在多发性硬化症（MS）主要研究“大麻素治疗多发性硬化症（CAMS）”的后续研究中，测试大麻素治疗MS的有效性和长期安全性。
在主要为期15周的CAMS研究中，来自英国33个中心的630例患有肌肉痉挛的稳定型MS患者被随机分配接受口服Δ⁹-四氢大麻酚（Δ⁹-THC）、大麻提取物或安慰剂。主要结局是Ashworth痉挛量表的变化。次要结局包括Rivermead运动指数、10米定时步行、英国神经功能障碍评分、改良Barthel指数、一般健康问卷-30以及一系列九分类评定量表。在主要研究之后，邀请患者在本报告的后续研究中继续进行双盲用药，为期长达12个月。
对80%接受了12个月随访的患者进行意向性分析，结果显示，从基线到12个月时，以Ashworth评分变化衡量，大麻素对肌肉痉挛有较小的治疗效果（Δ⁹-THC平均降低1.82（n = 154，95%置信区间（CI）0.53至3.12），大麻提取物0.10（n = 172，95%CI -0.99至1.19），安慰剂 -0.23（n = 176，95%CI -1.41至0.94）；未对活动状态和中心进行校正时p = 0.04，校正后p = 0.01）。有提示性证据表明Δ⁹-THC对某些残疾方面有治疗效果。没有重大安全问题。总体而言，患者认为这些药物对治疗其疾病有帮助。
这些数据为大麻素的长期治疗效果提供了有限的证据。现在需要进行一项长期安慰剂对照研究，以确定大麻素在MS中除了改善症状之外是否可能发挥作用。
