Components of placebo effect: randomised controlled trial inpatients with irritable bowel syndrome
Components of placebo effect: randomised controlled trial inpatients with irritable bowel syndrome
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DOI：
10.1136/bmj.39524.439618.25
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发表时间：
2008-05-03
影响因子：
105.7
通讯作者：
Lembo, Anthony J.
中科院分区：
文献类型：
--
作者：
Kaptchuk, Ted J.;Kelley, John M.;Lembo, Anthony J.
目的研究安慰剂效应是否可以实验性地分为三个组成部分的反应-评估和观察，治疗仪式（安慰剂治疗），并支持患者-医生的关系，然后逐步结合，以产生增量临床改善肠易激综合征患者。设计一项为期六周的单盲三臂随机对照试验，地点：学术医学中心，参与者262名成人（76%的妇女），平均（SID）年龄39（14），诊断为罗马II标准和症状严重程度量表得分>= 150。（观察），单独的安慰剂针灸（“有限”），或安慰剂针灸与患者-医生关系增强的温暖，注意力和信心（“增强”）。在第三周，一半的患者被随机分配到他们最初分配的组中继续治疗三周。主要结果指标（范围1-7）、症状的充分缓解、症状严重程度评分和生活质量。总体改善量表评分分别为3.8（SID 1.0）v4.3（SD 1.4）v5.0（SID 1.3），等待名单与“有限”与“扩大”（P
Objective To investigate whether placebo effects can experimentally be separated into the response to three components-assessment and observation, a therapeutic ritual (placebo treatment), and a supportive patient-practitioner relationship-and then progressively combined to produce incremental clinical improvement in patients with irritable bowel syndrome. To assess the relative magnitude of these components.Design A six week single blind three arm randomised controlled trial.Setting Academic medical centre.Participants 262 adults (76% women), mean (SID) age 39 (14), diagnosed by Rome II criteria for and with a score of >= 150 on the symptom severity scale.Interventions For three weeks either waiting list (observation), placebo acupuncture alone ("limited"), or placebo acupuncture with a patient-practitioner relationship augmented by warmth, attention, and confidence ("augmented"). At three weeks, half of the patients were randomly assigned to continue in their originally assigned group for an additional three weeks.Main outcome measures Global improvement kale (range 1-7), adequate relief of symptoms, symptom severity score, and quality of life.Results At three weeks, scores on the global improvement scale were 3.8 (SID 1.0) v 4.3 (SD 1.4) v 5.0 (SID 1.3) for waiting list versus "limited" versus "augmented," respectively (P