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知情同意与临床试验：安慰剂效应何在？

Informed consent and clinical trials: where is the placebo effect?

作者信息

Blease C R, Bishop F L, Kaptchuk T J

机构信息

School of Philosophy, University College Dublin, Ireland

Program in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.

出版信息

BMJ. 2017 Feb 3;356:j463. doi: 10.1136/bmj.j463.

DOI:10.1136/bmj.j463
PMID:28159769
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6888513/
Abstract

Lack of knowledge about placebos affects participants’ understanding of trials and breaches the ethical obligations of researchers, argue , , and

摘要

[作者姓名1]、[作者姓名2]和[作者姓名3]认为，对安慰剂缺乏了解会影响参与者对试验的理解，并违背研究人员的道德义务。

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本文引用的文献

1
Problems with ethical approval and how to fix them: lessons from three trials in rheumatoid arthritis.伦理审批问题及解决方法：类风湿关节炎三项试验的经验教训
BMJ. 2016 Sep 9;354:i4626. doi: 10.1136/bmj.i4626.
2
Informing Patients About Placebo Effects: Using Evidence, Theory, and Qualitative Methods to Develop a New Website.向患者告知安慰剂效应：运用证据、理论和定性方法创建一个新网站。
JMIR Res Protoc. 2016 Jun 10;5(2):e106. doi: 10.2196/resprot.5627.
3
Examination of overall treatment effect and the proportion attributable to contextual effect in osteoarthritis: meta-analysis of randomised controlled trials.骨关节炎总体治疗效果及情境效应所占比例的研究：随机对照试验的荟萃分析
Ann Rheum Dis. 2016 Nov;75(11):1964-1970. doi: 10.1136/annrheumdis-2015-208387. Epub 2016 Feb 16.
4
Dispositional optimism and therapeutic expectations in early-phase oncology trials.早期肿瘤学试验中的性格乐观与治疗期望
Cancer. 2016 Apr 15;122(8):1238-46. doi: 10.1002/cncr.29908. Epub 2016 Feb 16.
5
Placebo Medication and Sham Surgery Responses in Benign Prostatic Hyperplasia Treatments: Implications for Clinical Trials.安慰剂药物及假手术在良性前列腺增生治疗中的反应：对临床试验的启示
Curr Urol Rep. 2015 Oct;16(10):73. doi: 10.1007/s11934-015-0544-4.
6
Placebo Effects in Medicine.医学中的安慰剂效应。
N Engl J Med. 2015 Jul 2;373(1):8-9. doi: 10.1056/NEJMp1504023.
7
Therapeutic misconception correlates with willingness to participate in clinical drug trials among patients with epilepsy; need for better counseling.治疗误解与癫痫患者参与临床药物试验的意愿相关；需要更好的咨询服务。
Epilepsy Behav. 2015 Jul;48:29-34. doi: 10.1016/j.yebeh.2015.05.013. Epub 2015 May 31.
8
Why is therapeutic misconception so prevalent?为什么治疗性误解如此普遍？
Camb Q Healthc Ethics. 2015 Apr;24(2):231-41. doi: 10.1017/S096318011400053X.
9
Placebo improvement in pharmacologic treatment of menopausal hot flashes: time course, duration, and predictors.安慰剂在绝经潮热药物治疗中的改善效果：时间进程、持续时间及预测因素
Psychosom Med. 2015 Feb-Mar;77(2):167-75. doi: 10.1097/PSY.0000000000000143.
10
Placebo-controlled clinical trials: how trial documents justify the use of randomisation and placebo.安慰剂对照临床试验：试验文件如何证明随机化和安慰剂使用的合理性。
BMC Med Ethics. 2015 Jan 11;16:2. doi: 10.1186/1472-6939-16-2.