Addington D
Department of Psychiatry, University of Calgary, Alberta.
Can J Psychiatry. 1995 May;40(4):171-6. doi: 10.1177/070674379504000403.
This review examines the scientific and ethical justification for the use of randomized concurrent placebo-controlled trials in the treatment of acute relapse in chronic schizophrenia. A literature search was conducted, and the national regulatory authority was consulted. Many placebo-controlled studies of acute or chronic schizophrenia are being published and it is the official position of both the Canadian and US regulatory authorities that such studies are required for both scientific and ethical reasons. The specific strengths and limitations of placebo-controlled studies are reviewed. Examples, drawn from Canadian studies, are presented to illustrate their benefits. It is concluded that the use of placebos in the particular situation of acute or chronic schizophrenia is ethically and scientifically justified. It forms an essential component of a comprehensive drug evaluation for new antipsychotic medications.
本综述探讨了在慢性精神分裂症急性复发治疗中使用随机同期安慰剂对照试验的科学及伦理依据。进行了文献检索，并咨询了国家监管机构。目前有许多关于急性或慢性精神分裂症的安慰剂对照研究正在发表，加拿大和美国监管机构的官方立场均认为，出于科学和伦理原因，此类研究是必要的。本文回顾了安慰剂对照研究的具体优势和局限性。列举了一些来自加拿大研究的例子来说明其益处。得出的结论是，在急性或慢性精神分裂症的特定情况下使用安慰剂在伦理和科学上是合理的。它构成了新型抗精神病药物综合药物评估的重要组成部分。
