Sham device versus inert pill: randomised controlled trial of two placebo treatments
Sham device versus inert pill: randomised controlled trial of two placebo treatments
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DOI：
10.1136/bmj.38726.603310.55
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发表时间：
2006-02-18
影响因子：
105.7
通讯作者：
Goldman, RH
中科院分区：
文献类型：
--
作者：
Kaptchuk, TJ;Stason, WB;Goldman, RH
目的探讨假针装置（经过验证的假针）对持续性手臂疼痛患者的安慰剂效应是否优于所有惰性药丸。设计一项单盲随机对照试验，在两周安慰剂磨合期中创建两个嵌套试验，将针灸和阿米替林与各自的安慰剂对照进行比较。使用安慰剂的参与者的比较在磨合期后一直持续到研究结束。设置学术医疗中心。参与者270名由于重复使用手臂疼痛的成年人，尽管治疗持续了至少三个月，并且得分！3油10分疼痛量表。干预措施：用假器械进行针灸，每周两次，持续六周，或服用安慰剂，每天一次，持续八周。主要观察指标：手臂疼痛以10分疼痛量表测量。次要结果为Levine症状严重程度量表测量的症状、Pransky上肢功能量表测量的功能和握力。结果在两周的安慰剂磨合期，假器械组和安慰剂丸组的疼痛均有所减轻，但组间变化无差异（- 0.14,95%可信区间- 0.52 ~ 0.25,P = 0.49）。两组之间手臂症状和握力严重程度评分的变化相似，但安慰剂组手臂功能改善更多（2.0,0.06至3.92,P = 0.04）。在整个治疗期间随访参与者的纵向回归分析显示，假器械组的10点手臂疼痛量表每周的下降幅度明显大于安慰剂组(- 0.33（- 0.40至- 0.26)v - 0.15 (- 0.2 t至0.09),P = 0.0001）和症状严重程度量表(- 0.07（- 0.09至- 0.05)v - 0.05(- 0.06至- 0.03),P = 0.02）。然而，在功能量表或g-撕裂强度方面差异不显著。两组报告的不良反应不同。结论：在整个治疗过程中，假装置在自我报告的疼痛和症状严重程度上比安慰剂药丸有更大的效果，但在安慰剂发作的两周内没有。安慰剂效应似乎是可塑的，并且取决于嵌入在医疗仪式中的行为。
Objective To investigate whether a sham device (a validated sham acupuncture needle) has a greater placebo effect than all inert pill in patients with persistent arm pain.Design A single blind randomised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls. Comparison of participants who remained oil placebo continued beyond the run-in period to the end of the Study.Setting Academic medical centre.Participants 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored ! 3 oil a 10 point pain scale.Interventions Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks.Main outcome measures Arm pain measured oil a 10 point pain scale. Secondary Outcomes were symptoms measured by the Levine symptom severity scale, function measured by Pransky's upper extremity function scale, and grip strength.Results Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups, but changes were not different between the groups (- 0.14, 95% confidence interval - 0.52 to 0.25, P = 0.49). Changes in severity scores for arm symptoms and grip strength were similar between groups, but arm function improved more in the placebo pill group (2.0, 0.06 to 3.92, P = 0.04). Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week oil the 10 point arm pain scale in the sham device group than in the placebo pill group (- 0.33 (- 0.40 to - 0.26) v - 0.15 (- 0.2 t to 0.09), P = 0.0001) and oil the symptom severity scale (- 0.07 (- 0.09 to - 0.05) v - 0.05 (- 0.06 to - 0.03), P 0.02). Differences were not significant, however, oil the function scale or for g-rip strength. Reported adverse effects were different in the two groups.Conclusions The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run ill. Placebo effects seem to be malleable and depend oil the behaviours embedded in medical rituals.