咖啡因作为帕金森病的对症治疗（Café-PD）：一项随机试验。
Caffeine as symptomatic treatment for Parkinson disease (Café-PD): A randomized trial.
作者信息
Postuma Ronald B, Anang Julius, Pelletier Amelie, Joseph Lawrence, Moscovich Mariana, Grimes David, Furtado Sarah, Munhoz Renato P, Appel-Cresswell Silke, Moro Adriana, Borys Andrew, Hobson Douglas, Lang Anthony E
机构信息
From the Department of Neurology, Montreal General Hospital (R.B.P., A.P.), and Department of Epidemiology and Biostatistics (L.J.), McGill University, Montreal; Department of Neurology (J.A., A.B., D.H.), University of Manitoba, Winnipeg, Canada; Pontifical Catholic University of Parana (M.M., A.M.), Curitiba, Brazil; Department of Neurology (D.G.), Ottawa Hospital, University of Ottawa Brain and Mind Research Institute; Department of Neurology (S.F.), University of Calgary; Division of Neurology (R.P.M., A.E.L.), Toronto Western Hospital; and Department of Medicine, Division of Neurology, Djavad Mowafaghian Centre for Brain Health, and Pacific Parkinson's Research Centre (S.A.-C.), University of British Columbia, Vancouver, Canada.
出版信息
Neurology. 2017 Oct 24;89(17):1795-1803. doi: 10.1212/WNL.0000000000004568. Epub 2017 Sep 27.
OBJECTIVE
To assess effects of caffeine on Parkinson disease (PD).
METHODS
In this multicenter parallel-group controlled trial, patients with PD with 1-8 years disease duration, Hoehn & Yahr stages I-III, on stable symptomatic therapy were randomized to caffeine 200 mg BID vs matching placebo capsules for 6-18 months. The primary research question was whether objective motor scores would differ at 6 months (Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale [MDS-UPDRS]-III, Class I evidence). Secondary outcomes included safety and tolerability, motor symptoms (MDS-UPDRS-II), motor fluctuations, sleep, nonmotor symptoms (MDS-UPDRS-I), cognition (Montreal Cognitive Assessment), and quality of life.
RESULTS
Sixty patients received caffeine and 61 placebo. Caffeine was well-tolerated with similar prevalence of side effects as placebo. There was no improvement in motor parkinsonism (the primary outcome) with caffeine treatment compared to placebo (difference between groups -0.48 [95% confidence interval -3.21 to 2.25] points on MDS-UPDRS-III). Similarly, on secondary outcomes, there was no change in motor signs or motor symptoms (MDS-UPDRS-II) at any time point, and no difference on quality of life. There was a slight improvement in somnolence over the first 6 months, which attenuated over time. There was a slight increase in dyskinesia with caffeine (MDS-UPDRS-4.1+4.2 = 0.25 points higher), and caffeine was associated with worse cognitive testing scores (average Montreal Cognitive Assessment = 0.66 [0.01, 1.32] worse than placebo).
CONCLUSION
Caffeine did not provide clinically important improvement of motor manifestations of PD (Class I evidence). Epidemiologic links between caffeine and lower PD risk do not appear to be explained by symptomatic effects.
CLINICALTRIALSGOV IDENTIFIER
NCT01738178.
CLASSIFICATION OF EVIDENCE
This study provides Class I evidence that for patients with PD, caffeine does not significantly improve motor manifestations.
目的
评估咖啡因对帕金森病（PD）的影响。
方法
在这项多中心平行组对照试验中，病程为1 - 8年、 Hoehn & Yahr分期为I - III期且接受稳定症状治疗的帕金森病患者被随机分为两组，分别服用200毫克咖啡因，每日两次，或服用匹配的安慰剂胶囊，为期6 - 18个月。主要研究问题是6个月时客观运动评分是否会有差异（运动障碍协会赞助的统一帕金森病评定量表[MDS - UPDRS] - III，I类证据）。次要结局包括安全性和耐受性、运动症状（MDS - UPDRS - II）、运动波动、睡眠、非运动症状（MDS - UPDRS - I）、认知（蒙特利尔认知评估）和生活质量。
结果
60名患者接受咖啡因治疗，61名接受安慰剂治疗。咖啡因耐受性良好，副作用发生率与安慰剂相似。与安慰剂相比，咖啡因治疗并未改善帕金森运动症状（主要结局）（MDS - UPDRS - III量表上两组差异为 - 0.48[95%置信区间 - 3.21至2.25]分）。同样，在次要结局方面，任何时间点的运动体征或运动症状（MDS - UPDRS - II）均无变化，生活质量也无差异。在最初6个月嗜睡症状略有改善，但随时间推移有所减轻。咖啡因组的异动症略有增加（MDS - UPDRS - 4.1 + 4.2高0.25分），且咖啡因与较差的认知测试评分相关（平均蒙特利尔认知评估比安慰剂差0.66[0.01, 1.32]）。
结论
咖啡因并未对帕金森病的运动表现提供具有临床意义的改善（I类证据）。咖啡因与较低帕金森病风险之间的流行病学关联似乎无法用其症状性作用来解释。
临床试验注册编号
NCT01738178。
证据分类
本研究提供I类证据，表明对于帕金森病患者，咖啡因并不能显著改善运动表现。
Zotero 插件