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一项开放标签安慰剂对照与双盲安慰剂和常规治疗对照的过敏性鼻炎症状的随机对照试验。

A randomized controlled trial of effects of open-label placebo compared to double-blind placebo and treatment-as-usual on symptoms of allergic rhinitis.

机构信息

Medical School Berlin, Rüdesheimer Str. 50, 14197, Berlin, Germany.

SymbioPharm, 35745, Herborn, Germany.

出版信息

Sci Rep. 2023 May 24;13(1):8372. doi: 10.1038/s41598-023-34790-9.

Abstract

Placebo effects are known for numerous clinical symptoms. Until recently, deception of placebos was thought to be essential for placebo effects, but intriguing new studies suggest that even placebos without concealment (open-label placebos) may help patients with various clinical disorders. Most of those studies compared open-label placebo treatments with no treatment conditions (or treatment "as usual"). Given that open-label placebo studies obviously cannot be blinded, additional control studies are important to assess the efficacy of open-label placebos. The current study aimed to fil this gap by comparing open-label with conventional double-blind placebos and treatment as usual. Patients with seasonal allergic rhinitis were randomly divided in different groups. The first group received open-label placebos, the second double-blind placebos, and the third was treated as usual. After 4 weeks, results demonstrated that open-label placebos improved allergic symptoms more than treatment-as-usual and even more as double-blind placebos. In addition, we observed that allergic symptoms in general (and also the open-label placebo effects) were reduced by the Covid-19 pandemic. The results suggest that seasonal allergic symptoms may be relieved by open-label placebos. We discuss these results by addressing possible different mechanisms of open-label and conventionally concealed placebo treatments.

摘要

安慰剂效应在众多临床症状中都有体现。直到最近,人们还认为对安慰剂进行欺骗对于安慰剂效应是必不可少的,但有趣的新研究表明,即使是没有隐瞒的安慰剂(开放标签安慰剂)也可能对各种临床疾病的患者有所帮助。这些研究大多将开放标签安慰剂治疗与无治疗条件(或“常规”治疗)进行了比较。鉴于开放标签安慰剂研究显然不能设盲,因此进行额外的对照研究对于评估开放标签安慰剂的疗效非常重要。本研究旨在通过比较开放标签与传统双盲安慰剂和常规治疗来填补这一空白。季节性过敏性鼻炎患者被随机分为不同的组。第一组接受开放标签安慰剂,第二组接受双盲安慰剂,第三组接受常规治疗。4 周后,结果表明,开放标签安慰剂比常规治疗更能改善过敏症状,甚至比双盲安慰剂更能改善过敏症状。此外,我们观察到,一般的过敏症状(以及开放标签安慰剂的作用)因新冠疫情而减轻。这些结果表明,季节性过敏症状可能会被开放标签安慰剂缓解。我们通过探讨开放标签和传统隐蔽安慰剂治疗的可能不同机制来讨论这些结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b808/10209057/c787fa7ba5ab/41598_2023_34790_Fig1_HTML.jpg

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