Cephalalgia ( IF 5.0 ) Pub Date : 2021-08-18 , DOI: 10.1177/03331024211029939 Peer Tfelt-Hansen 1 , Karsten Jørgensen 2, 3 , Hans-Christoph Diener 4
Purpose
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.
Conclusion
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.
中文翻译:
在最近的 lasmiditan 和 ubrogepant 治疗偏头痛发作的对照试验中,令人怀疑地使用安慰剂后使用安慰剂
目的
在 lasmiditan 和 ubrogepant 的四项大型对照试验中,第一步给予安慰剂以证明对偏头痛发作的影响。在同一项试验中,研究人员还提出了一个问题:第二剂药物对第一剂无反应者是否有效?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。
结论
为了符合伦理,临床研究需要在严谨的科学与对人类受试者的保护之间取得平衡;在我们看来,在这些试验的第二步是否以“科学严谨”的方式使用安慰剂是有问题的,因此不推荐这种设计。