Benefits and burdens of placebos in psychiatric research.
Benefits and burdens of placebos in psychiatric research.
复制标题
精神病学研究中安慰剂的益处和负担。
DOI：
10.1007/s00213-003-1458-2
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发表时间：
2003
影响因子：
3.4
通讯作者：
Kim,ScottYH
中科院分区：
文献类型：
--
作者：
Kim,ScottYH
RationaleThe debate over the use of placebos in clinical trials when proven treatments exist continues to be lively, especially in psychiatric research. Current practice permits placebos in such settings, as long as the benefits outweigh the risks and burdens.ObjectivesTo examine in depth the risk–benefit framework typically used to justify placebo controls in psychiatric drug development, by making explicit the implicit ethical tradeoffs.MethodsAnalysis informed by a review of currently available data on the benefits and burdens of exposing psychiatric research subjects to placebos.ResultsVarious risk/burden thresholds for limiting placebo controls have been proposed, ranging from the currently used standards of no increased mortality or permanent morbidity to more recent proposals of 'serious but reversible harm' and 'severe discomfort.' Placebo exposure in antidepressant and antipsychotic trials appears not to increase mortality by suicide. Direct data on long-term effects are lacking. Symptom-related burdens of placebos need to be better quantified and more integrated into the ethical analysis of placebos. While the perspective of those who benefit from the practice of using placebo controls is well represented, virtually no data from the perspective of potential subjects exist.ConclusionsThe ethical analysis of placebos in psychiatric research has an important but limited evidence base. Suggestions for areas of further inquiry to increase that evidence base are given.
