Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial
Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial
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DOI：
10.1001/archpsyc.61.4.412
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发表时间：
2004-04-01
影响因子：
--
通讯作者：
Freed, CR
中科院分区：
文献类型：
--
作者：
McRae, C;Cherin, E;Freed, CR
内容：这项研究是一项大型双盲假手术对照试验的一部分，旨在确定将人胚胎多巴胺神经元移植到晚期帕金森病患者大脑中的有效性。本研究的这一部分调查了参与者在1年的双盲随访期间的生活质量（QOL）。目的：确定移植组的QOL是否比假手术组改善得更多，并调查基于感知治疗的第1年结局设计：参与者被随机分配接受移植手术或假手术。报告的结果来自1年的双盲期。设置：参与者从美国和加拿大各地招募。评估和手术在2个独立的大学医学中心进行。参与者：40名特发性帕金森病患者的志愿者样本参加了移植（“母体”）研究，30人同意参加相关的QOL研究：12人接受移植，18人接受假手术。干预：母体研究中的干预措施是移植和假脑手术。在基线和手术后4、8和12个月进行QOL评估。主要结果测量：比较实际移植组和假手术组与感知治疗组的QOL和医疗结果。我们还调查了随时间的变化。结果：有2个差异或随时间的变化，移植和假手术组。基于感知的治疗，或患者认为他们接受的治疗，随着时间的推移有许多差异和变化。在所有情况下，那些认为他们接受了移植的人报告了更好的分数。医务人员的盲法评分显示了类似的结果。结论：在这项研究中，安慰剂效应非常强，证明了安慰剂对照手术试验的价值。
Context: This study was part of a large double-blind sham surgery-controlled trial designed to determine the effectiveness of transplantation of human embryonic dopamine neurons into the brains of persons with advanced Parkinson's disease. This portion of the study investigated the quality of life (QOL) of participants during the 1 year of double-blind follow-up.Objectives: To determine whether QOL improved more in the transplant group than in the sham surgery group and to investigate outcomes at I year based on perceived treatment (the type of surgery patients thought they received).Design: Participants were randomly assigned to receive either the transplant or sham surgery. Reported results are from the 1-year double-blind period.Setting: Participants were recruited from across the United States and Canada. Assessment and surgery were conducted at 2 separate university medical centers.Participants: A volunteer sample of 40 persons with idiopathic Parkinson's disease participated in the transplant ("parent") study, and 30 agreed to participate in the related QOL study: 12 received the transplant and 18 received sham surgery.Interventions: Interventions in the parent study were transplantation and sham brain surgery. Assessments of QOL were made at baseline and 4, 8, and 12 months after surgery.Main Outcome Measures: Comparison of the actual transplant and sham surgery groups and the perceived treatment groups on QOL and medical outcomes. We also investigated change over time.Results: There were 2 differences or changes over time in the transplant and sham surgery groups. Based on perceived treatment, or treatment patients thought they received, there were numerous differences and changes over time. In all cases, those who thought they received the transplant reported better scores. Blind ratings by medical staff showed similar results.Conclusions: The placebo effect was very strong in this study, demonstrating the value of placebo-controlled surgical trials.