Philipps-University of Marburg, Department of Clinical Psychology and Psychotherapy, Marburg, Germany.
Justus-Liebig-University Giessen, Department of Clinical Psychology and Psychotherapy, Giessen, Germany.
J Psychosom Res. 2022 Jul;158:110923. doi: 10.1016/j.jpsychores.2022.110923. Epub 2022 Apr 20.
Open-label placebo (OLP) treatment seems to be effective in several medical conditions but has not yet been investigated in insomnia. Furthermore, it needs to be evaluated whether providing a plausible treatment rationale is essential to obtain OLP effects.
In two consecutive nights, the sleep of patients with primary insomnia (n = 45) was assessed via subjective and objective measures. Before the second night, they received a single OLP pill that was randomly provided either with a treatment rationale (OLP+) or without (OLP-). When (M)ANOVAs did not reveal differential effects between the two OLP groups, the OLP+ group was compared post-hoc to a formerly assessed no pill control sample (NPC; n = 23).
Neither the MANOVAs nor the ANOVAs revealed significant interaction effects of treatment group and assessment night. The OLP+ condition was superior neither to OLP- nor to NPC in improving the patients' sleep.
Our findings do neither confirm the general efficacy of OLP in primary insomnia nor differential effects depending on the treatment rationale. Possible explanations lie in the dosing scheme (i.e., single OLP application), the provision of the OLP rationale by video and the experimental instead of therapeutic character of our investigation. Trials with larger samples and longer-term OLP treatment in insomnia are needed. Providing the rationale face-to-face and in a clinical setting might be additionally beneficial.
开放性安慰剂（OLP）治疗似乎对多种医学病症有效，但尚未在失眠症中进行研究。此外，还需要评估提供合理的治疗原理是否对获得 OLP 效果至关重要。
在两个连续的晚上，通过主观和客观措施评估原发性失眠症患者（n=45）的睡眠情况。在第二个晚上之前，他们接受了单颗 OLP 药丸，该药丸随机提供了治疗原理（OLP+）或没有提供治疗原理（OLP-）。当（M）ANOVA 未显示两个 OLP 组之间的差异效应时，OLP+组在后测时与以前评估的无药丸对照组（NPC；n=23）进行了比较。
无论是 MANOVAs 还是 ANOVAs 都没有显示出治疗组和评估夜之间的显著交互效应。OLP+条件在改善患者睡眠方面既不比 OLP-条件好，也不比 NPC 条件好。
我们的发现既不证实 OLP 在原发性失眠症中的一般疗效，也不证实治疗原理的差异效应。可能的解释在于剂量方案（即单次 OLP 应用）、通过视频提供 OLP 原理以及我们研究的实验而非治疗性质。需要在失眠症中进行更大样本量和更长期 OLP 治疗的试验。面对面并在临床环境中提供原理可能会额外受益。
