Sandler A, Glesne C, Geller G
Olson Huff Center, Mission Children's Hospital, Asheville, NC, USA, and Department of Pediatrics, University of North Carolina at Chapel Hill, NC 28803, USA.
Child Care Health Dev. 2008 Jan;34(1):111-20. doi: 10.1111/j.1365-2214.2007.00743.x.
The purpose of this study was to examine the efficacy and acceptability of an open-label conditioned placebo dose reduction (CPDR) treatment in 70 children with attention deficit hyperactivity disorder (ADHD). This paper focuses on the qualitative data from the study.
Following a double-blind, crossover dose finding procedure to determine each subject's optimal dose of stimulant medication, subjects were randomized to the CPDR treatment or one of two control groups. Outcome measures included parent and teacher ratings of ADHD behaviours and stimulant side effects. Qualitative assessments were based on open-ended interviews of children and parents. Positive responders to CPDR and controls were followed for 3 months to assess persistence of treatment benefits.
Children randomized to CPDR showed an excellent treatment response, well maintained over time. Parents and children were generally accepting of the treatment. Most parents reported treatment benefits and 80% of the children found the placebo to be useful. Full disclosure of the placebo to parents and children did not appear to negate the placebo's effectiveness. Participation effects and changes in caregiver behaviour may have contributed to positive treatment outcomes.
Open-label use of placebos as part of CPDR treatment may represent an innovative, ethical way of harnessing the power of placebos in clinical therapeutics.
本研究旨在检验开放标签条件性安慰剂剂量减少(CPDR)疗法对70名注意力缺陷多动障碍(ADHD)儿童的疗效和可接受性。本文聚焦于该研究的定性数据。
在采用双盲交叉剂量查找程序确定每名受试者的最佳兴奋剂药物剂量后,将受试者随机分为CPDR治疗组或两个对照组之一。结果测量包括家长和教师对ADHD行为及兴奋剂副作用的评分。定性评估基于对儿童和家长的开放式访谈。对CPDR组和对照组的阳性反应者随访3个月,以评估治疗益处的持续性。
随机分配至CPDR组的儿童显示出良好的治疗反应,且随着时间推移保持良好。家长和儿童总体上接受该治疗。大多数家长报告了治疗益处,80%的儿童认为安慰剂有用。向家长和儿童完全披露安慰剂似乎并未否定安慰剂的有效性。参与效应和照料者行为的改变可能促成了积极的治疗结果。
将安慰剂作为CPDR治疗的一部分进行开放标签使用,可能代表了一种在临床治疗中利用安慰剂作用的创新且符合伦理的方式。