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Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture.不同的安慰剂对照信息披露是否会影响盲法和试验结果?一项基于针刺随机安慰剂对照试验参与者知情同意书的案例研究。
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本文引用的文献

1
Acupuncture in patients with tension-type headache: randomised controlled trial.紧张型头痛患者的针灸治疗:随机对照试验
BMJ. 2005 Aug 13;331(7513):376-82. doi: 10.1136/bmj.38512.405440.8F. Epub 2005 Jul 29.
2
Acupuncture in patients with osteoarthritis of the knee: a randomised trial.针刺治疗膝骨关节炎患者:一项随机试验。
Lancet. 2005;366(9480):136-43. doi: 10.1016/S0140-6736(05)66871-7.
3
A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia.一项比较针刺疗法与假针刺疗法治疗纤维肌痛的随机临床试验。
Ann Intern Med. 2005 Jul 5;143(1):10-9. doi: 10.7326/0003-4819-143-1-200507050-00005.
4
Acupuncture for patients with migraine: a randomized controlled trial.针刺治疗偏头痛患者:一项随机对照试验。
JAMA. 2005 May 4;293(17):2118-25. doi: 10.1001/jama.293.17.2118.
5
Expectancy and belief modulate the neuronal substrates of pain treated by acupuncture.预期和信念调节针刺治疗疼痛的神经基质。
Neuroimage. 2005 May 1;25(4):1161-7. doi: 10.1016/j.neuroimage.2005.01.016.
6
Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial.针刺作为膝骨关节炎辅助治疗的有效性:一项随机对照试验。
Ann Intern Med. 2004 Dec 21;141(12):901-10. doi: 10.7326/0003-4819-141-12-200412210-00006.
7
Sham procedures and the ethics of clinical trials.假手术与临床试验伦理
J R Soc Med. 2004 Dec;97(12):576-8. doi: 10.1177/014107680409701205.
8
How informed is consent in sham-controlled trials of acupuncture?在针刺假对照试验中,同意书提供了多少信息?
J Altern Complement Med. 2004 Apr;10(2):379-85. doi: 10.1089/107555304323062374.
9
Deception in the pursuit of science.科学探索中的欺骗行为。
Arch Intern Med. 2004 Mar 22;164(6):597-600. doi: 10.1001/archinte.164.6.597.
10
Ethical issues concerning research in complementary and alternative medicine.关于补充和替代医学研究的伦理问题。
JAMA. 2004 Feb 4;291(5):599-604. doi: 10.1001/jama.291.5.599.

针灸试验与知情同意。

Acupuncture trials and informed consent.

作者信息

Miller F G, Kaptchuk T J

机构信息

Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, Maryland, USA.

出版信息

J Med Ethics. 2007 Jan;33(1):43-4. doi: 10.1136/jme.2006.016535.

DOI:10.1136/jme.2006.016535
PMID:17209110
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2598073/
Abstract

Participants are often not informed by investigators who conduct randomised, placebo-controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent. Participants in placebo-controlled acupuncture trials should be provided an accurate disclosure regarding the use of sham acupuncture, consistent with the practice of placebo-controlled drug trials.

摘要

在进行随机、安慰剂对照针灸试验的研究者通常不会告知参与者他们可能会接受假针灸干预。相反,他们被告知研究中正在比较一种或多种形式的针灸。这种具有欺骗性的披露做法缺乏令人信服的方法学依据,并且违反了获得知情同意的伦理要求。与安慰剂对照药物试验的做法一致,安慰剂对照针灸试验的参与者应得到关于使用假针灸的准确披露。