Effects of open-label placebos in clinical trials: a systematic review and meta-analysis.

Effects of open-label placebos in clinical trials: a systematic review and meta-analysis.
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DOI:
10.1038/s41598-021-83148-6
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发表时间:
2021-02-16
期刊:
影响因子:
4.6
通讯作者:
Schmidt S
Schmidt S
中科院分区:
综合性期刊3区
文献类型:
--
作者:
von Wernsdorff M;Loef M;Tuschen-Caffier B;Schmidt S

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开放标签安慰剂(olp)是一种没有欺骗的安慰剂,因为患者知道他们服用的是安慰剂。我们研究的目的是系统地回顾和分析在临床试验中与不治疗相比,olp的效果。于2020年2月进行了系统的文献检索。纳入了将olp与未治疗进行比较的任何医疗状况或精神障碍的随机对照试验。独立评估数据提取和偏倚风险评级。1246份记录被筛选,13项研究被纳入系统评价。11项试验符合荟萃分析的条件。这些试验评估了olp对背痛、癌症相关疲劳、注意力缺陷多动障碍、过敏性鼻炎、重度抑郁症、肠易激综合征和更年期潮热的影响。所有研究的偏倚风险均为中等。我们发现OLP的总体效果显著(标准化平均差= 0.72,95% Cl 0.39-1.05, p < 0.0001, I2 = 76%)。因此,olp在不同的条件下似乎是一种很有希望的治疗方法,但相关的研究还处于起步阶段。需要进行更多的研究,特别是关于不同的医疗和精神障碍以及伴随OLP管理的指示,以及期望和心态的作用。
Open-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and thirteen studies were included into the systematic review. Eleven trials were eligible for meta-analysis. These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. Risk of bias was moderate among all studies. We found a significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions but the respective research is in its infancy. More research is needed, especially with respect to different medical and mental disorders and instructions accompanying the OLP administration as well as the role of expectations and mindsets.
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