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精神药物临床试验中的安慰剂

Placebos in clinical trials of psychotropic medication.

作者信息

Addington D, Williams R, Lapierre Y, el-Guebaly N

机构信息

Department of Psychiatry, Foothills Hospital, Calgary AB.

出版信息

Can J Psychiatry. 1997 Apr;42(3):6p.. doi: 10.1177/070674379704200312.

Abstract

This paper represents the position of the Canadian Psychiatric Association on the ethical and scientific issues related to the use of placebos in the evaluation of new psychotropic drugs. The position taken by the Association is that new psychotropic medications must be shown to be effective and must be weighed against the best current interventions. Placebo controls may be appropriate under certain circumstances, even when an established intervention is effective. These include situations in which placebo response rates are high, variable, or close to response rates for effective therapies. Placebo controls are also appropriate when established interventions carry a high risk of side effects or are effective against only certain symptoms of the disorder.

摘要

本文阐述了加拿大精神病学协会在与使用安慰剂评估新型精神药物相关的伦理和科学问题上的立场。该协会的立场是,新型精神药物必须证明是有效的,并且必须与当前最佳干预措施进行权衡。在某些情况下,即使已有有效的干预措施,安慰剂对照可能也是合适的。这些情况包括安慰剂反应率高、变化不定或接近有效治疗反应率的情况。当已有干预措施有高副作用风险或仅对该疾病的某些症状有效时,安慰剂对照也是合适的。

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