Danish Headache Center, Department of Neurology, Rigshospitalet -Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.
Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Denmark.
Cephalalgia. 2022 Jan;42(1):82-85. doi: 10.1177/03331024211029939. Epub 2021 Aug 18.
In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo.
To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with "scientific rigor" in the second step of these trials, and this design is not recommended.
在四项大型对照试验中，拉米地坦和乌布瑞肽安慰剂首先给药，以证明其对偏头痛发作的疗效。在相同的试验中，研究人员还提出了一个问题：对于第一剂药物无反应的患者，第二剂药物是否有效？在这一阶段，在试验的第一阶段接受安慰剂的患者在 2 小时后再次接受另一剂安慰剂。
为了符合伦理要求，临床研究需要在严格的科学与保护人类受试者之间取得平衡；我们认为，在这些试验的第二步中，安慰剂的使用是否具有“科学严谨性”是值得怀疑的，我们不建议采用这种设计。
