Koponen Hannu, Lepola Ulla
Department of Psychiatry, University of Oulu, Finland.
Nord J Psychiatry. 2005;59(4):233-7. doi: 10.1080/08039480500213592.
The placebo-controlled trial has been the standard method to demonstrate efficacy and safety of drugs. The trials are regulated by standards and principles that aim to safeguard patient safety and to ensure the faultless availability of reliable information about the object of the survey. The use of a placebo group in clinical drug trials is still as well founded as ever, and is especially important in conditions where the severity of the disorder is associated with variation in time, the possibility of a spontaneous recovery, or in conditions involving a significant proportion of subjective experience. In this systematic review, the present guidelines for developing new compounds for psychiatric disorders are discussed.
安慰剂对照试验一直是证明药物疗效和安全性的标准方法。这些试验受旨在保障患者安全并确保关于调查对象的可靠信息无误可得的标准和原则的规范。在临床药物试验中使用安慰剂组仍然是有充分依据的,并且在疾病严重程度随时间变化、存在自发恢复可能性的情况,或者涉及很大比例主观体验的情况中尤为重要。在本系统评价中,讨论了目前用于开发治疗精神疾病新化合物的指南。