Blinding effectiveness and association of pretreatment expectations with pain improvement in a double-blind randomized controlled trial
Blinding effectiveness and association of pretreatment expectations with pain improvement in a double-blind randomized controlled trial
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DOI：
10.1016/s0304-3959(02)00060-x
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发表时间：
2002-09-01
期刊：
影响因子：
7.4
通讯作者：
Cardenas, DD
中科院分区：
文献类型：
--
作者：
Turner, JA;Jensen, MP;Cardenas, DD
患者、提供者和临床研究人员对治疗的期望被认为在患者反应中起着重要作用。这项研究考察了患者和研究护士/医生治疗前对疼痛缓解的期望与实际疼痛缓解之间的关系，患者和研究护士对患者用药分配的猜测的准确性，以及研究护士和患者在阿米替林与活性安慰剂治疗慢性疼痛和脊髓损伤(SCI)患者的随机双盲试验过程中疼痛缓解期望的变化。在服用阿米替林的患者中，患者对阿米替林缓解疼痛的期望与实际疼痛减轻显著相关，但与安慰剂无关。研究护士/医生的期望并不能预测患者疼痛的缓解。患者和研究护士都能够猜测患者的用药分配，其比率明显高于机会。在研究过程中，研究护士，而不是患者，对阿米替林止痛的期望显著降低。这些发现对未来的随机对照试验具有一定的指导意义。完全双盲的情况很难实现，评估患者和研究临床医生对药物分配的期望和猜测是有意义的。(C)2002年国际疼痛研究协会。爱思唯尔科学公司出版。版权所有。
Patient, provider, and clinical investigator expectations concerning treatments are believed to play important roles in patient response. This study examined the association of patient and research nurse/physician pretreatment expectations of pain relief with actual pain relief, the accuracy of patient and research nurse guesses about patient medication assignment, and changes in research nurse and patient pain relief expectations over the course of a randomized double-blind trial of amitriptyline versus an active placebo for patients with chronic pain and spinal cord injuries (SCI). Patient expectations of pain relief with amitriptyline were associated significantly with actual pain decrease for patients in the amitriptyline, but not placebo, condition. Research nurse/physician expectations did not predict patient pain relief. Both patients and the research nurse were able to guess patient medication assignment at a rate significantly greater than chance. The research nurse's, but not the patients', expectations of pain relief with amitriptyline decreased significantly over the course of the study. These findings have implications for future randomized controlled trials. Fully double-blind conditions are very difficult to achieve, and it is informative to assess patient and research clinician expectations and guesses regarding medication assignment. (C) 2002 International Association for the Study of Pain. Published by Elsevier Science B.V. All rights reserved.