Nocebo effect in randomized clinical trials of antidepressants in children and adolescents: systematic review and meta-analysis.
Nocebo effect in randomized clinical trials of antidepressants in children and adolescents: systematic review and meta-analysis.
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DOI：
10.3389/fnbeh.2014.00375
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发表时间：
2014
影响因子：
3
通讯作者：
Linnman C
中科院分区：
文献类型：
--
作者：
Rojas-Mirquez JC;Rodriguez-Zuñiga MJ;Bonilla-Escobar FJ;Garcia-Perdomo HA;Petkov M;Becerra L;Borsook D;Linnman C
目的：比较在接受抗抑郁治疗的抑郁儿童和青少年（C&A）中进行的随机临床试验中活性药物组和安慰剂组之间不良事件的发生率，以寻找两组之间的相似性，从而确定可能的反安慰剂效应。研究方法：系统性检索策略（1974年1月-2013年3月），在电子数据库、会议摘要和系统性综述参考文献列表中，并纳入研究，以确定抗抑郁药治疗C&A（<19岁）重度抑郁症的平行随机安慰剂对照试验，以及任何口服抗抑郁药的一种或多种干预措施。基于固定效应模型计算汇总不良事件，统计分析涉及不良事件的风险比（RR）和95%置信区间（95% CI）。结果：16项研究被纳入综述，其中7项研究的样本量为1911例患者，其数据可纳入荟萃分析。非活性药物组和活性药物组之间不良事件发生率的风险相似（总体RR 1.04，95% CI：0.97-1.11）。结论：抑郁性C&A被分配到安慰剂组或活性组发生不良事件的风险相似。这两个群体的相似性归因于反安慰剂效应。值得注意的是，在临床人群中定义“反安慰剂”效应具有挑战性，因为不良反应可能归因于干预或可能是疾病本身的表现。可能需要纳入非治疗组。当安慰剂的不良事件与活性治疗的不良事件相似时，可能会出现Nocebo效应，如此处的情况。
Objective: To compare the incidence of adverse events between active and placebo arms of randomized clinical trials in depressive children and adolescents (C&A) with antidepressant treatments, in order to look for similarities in both groups that allow to establish a possible nocebo effect. Methods: Systematic search strategy (January 1974–March 2013) in electronic databases, conference abstracts, and reference list of systematic reviews and included studies to identify parallel randomized placebo-controlled trials of antidepressants in C&A (<19 years) with major depressive disorder, and one or more interventions of any orally administered antidepressant. The pooled adverse events were calculated based on a fixed-effect model and statistical analysis involved the risk ratio (RR) of adverse events, with 95% confidence intervals (95% CI). Results: Sixteen studies were included in the review, of which seven studies with a sample of 1911 patients had data to include in the meta-analysis. There was similar risk for the incidence of adverse events between non-active and active group (global RR 1.04, 95% CI: 0.97–1.11). Conclusion: Depressive C&A allocated to placebo or active group had similar risk to develop adverse events. These similarities in both groups are attributed to the nocebo effect. It is of note that defining “nocebo” effects is challenging in clinical populations because adverse effects may be attributed to the intervention or may be manifestation of the disease itself. The inclusion of a no-treatment arm may be warranted. Nocebo effects are likely when adverse events of placebo mimic the adverse events of active treatment, as was the case here.
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DOI：
10.1016/0197-2456(86)90046-2
发表时间：
1986-09-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
DERSIMONIAN, R;LAIRD, N
通讯作者：
LAIRD, N
DOI：
10.1155/2013/574526
发表时间：
2013-01-01
期刊：
ISRN neuroscience
影响因子：
--
作者：
Ciaramella, A;Paroli, M;Poli, P
通讯作者：
Poli, P
影响因子：
4.4
作者：
Bohman, Hannes;Jonsson, Ulf;von Knorring, Anne-Liis
通讯作者：
von Knorring, Anne-Liis
DOI：
10.15171/ijhpm.2014.54
发表时间：
2014-06-01
影响因子：
3.5
作者：
Ashraf, Bushra;Saaiq, Muhammad;Khaleeq-Uz-Zaman
通讯作者：
Khaleeq-Uz-Zaman
DOI：
10.1353/sof.2010.0072
发表时间：
2010-09
期刊：
Social forces; a scientific medium of social study and interpretation
影响因子：
--
作者：
Bollen KA;Brand JE
通讯作者：
Brand JE