Pascuzzi R M
Semin Neurol. 1998;18(3):415-8. doi: 10.1055/s-2008-1040891.
Patients having serious neurological diseases often wonder why clinical trials must use controls and double blinding in order to prove efficacy. Studies on the effect of examiner blinding in multiple sclerosis trials, as well as the published results of an unblinded uncontrolled clinical trial of Vitamin E therapy in patients with amyotrophic lateral sclerosis (including Lou Gehrig) provide clear illustrations of the impact of blinding and controls on outcome. These reports serve as a resource for physicians, patients and their families in discussing the rationale for controls and double blinding, and instill caution that should be used when judging results of studies which are unblinded or uncontrolled.
患有严重神经疾病的患者常常想知道,为什么临床试验必须采用对照和双盲法来证明疗效。关于检查者设盲在多发性硬化症试验中的效果研究,以及一项未设盲、无对照的维生素E疗法治疗肌萎缩侧索硬化症(包括卢伽雷氏症)患者临床试验的已发表结果,清楚地说明了设盲和对照对结果的影响。这些报告为医生、患者及其家属讨论对照和双盲法的基本原理提供了参考资料,并警示在评判未设盲或无对照研究的结果时应谨慎。