Does study design influence outcome?. The effects of placebo control and treatment duration in antidepressant trials.
Does study design influence outcome?. The effects of placebo control and treatment duration in antidepressant trials.
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DOI：
10.1159/000209348
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发表时间：
2009
影响因子：
22.8
通讯作者：
Roose SP
中科院分区：
文献类型：
--
作者：
Rutherford BR;Sneed JR;Roose SP
临床医生和研究人员综合抗抑郁药物随机对照试验（rct）的数据，得出抗抑郁药物疗效的结论。除了药物的特异性作用外，所有治疗都包括非特异性因素，研究设计可能通过非特异性因素影响患者的预后。本研究调查了安慰剂对照和治疗时间是否影响抗抑郁随机对照试验的结果。我们检索了Medline和Cochrane数据库，以确定fda批准的治疗重度抑郁症的抗抑郁药物的随机对照试验。纳入的研究纳入了年龄在18-65岁的门诊患者，持续6-12周，将抗抑郁药与安慰剂或另一种抗抑郁药进行比较，并在1985年后以英文发表。排除试验纳入住院患者、孕妇和精神病或躁狂症患者。混合效应逻辑回归模型包括研究类型（安慰剂对照或比较）和研究持续时间（6、8或12周）作为固定效应，确定这些因素是否影响反应和缓解率。在分析的90个试验中，与安慰剂对照试验相比，比较组抑郁反应（OR 1.79, 95% CI = 1.45 - 2.17, p < 0.001）和缓解（OR 1.53, 95% CI = 1.11 - 2.11, p < 0.001）的几率显著高于对照试验。8个（OR 1.37, CI 1.14 - 1.64, p = 0.001）和12个（OR 1.52, CI 1.12 - 2.07, p = 0.008）周试验的反应率显著高于6周试验，但两者之间没有差异。抗抑郁药的反应和缓解率受研究类型和持续时间的显著影响。临床医生和研究人员在解释和设计抗抑郁药物的随机对照试验时必须考虑研究设计。
Clinicians and researchers synthesize data from randomized controlled trials (RCTs) of antidepressants to make conclusions about the efficacy of medications for depression. All treatments include nonspecific factors in addition to the specific effects of drugs, and study design may influence patient outcomes via nonspecific factors. This study investigated whether placebo control and treatment duration affect outcome in antidepressant RCTs. Medline and the Cochrane Database were searched to identify RCTs of FDA-approved antidepressants for major depression. Included studies enrolled outpatient participants aged 18–65, lasted 6–12 weeks, compared an antidepressant to placebo or another antidepressant, and were published in English after 1985. Excluded trials enrolled inpatients, pregnant women, and subjects with psychosis or mania. Mixed effects logistic regression models including study type (placebo-controlled or comparator) and study duration (6, 8, or 12 weeks) as fixed effects determined whether these factors affected response and remission rates. In the 90 trials analyzed, the odds of depression response (OR 1.79, 95% CI = 1.45 – 2.17, p < 0.001) and remission (OR 1.53, 95% CI = 1.11 – 2.11, p < 0.001) were significantly higher in comparator relative to placebo-controlled trials. Eight (OR 1.37, CI 1.14 – 1.64, p = 0.001) and 12 (OR 1.52, CI 1.12 – 2.07, p = 0.008) week duration trials had significantly greater response rates than 6 week trials without differing themselves. Response and remission rates to antidepressants are significantly affected by study type and duration. Clinicians and researchers must consider study design when interpreting and designing RCTs of antidepressant medications.
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影响因子：
6.7
作者：
Christiansen, PE;Behnke, K;Nilsson, J
通讯作者：
Nilsson, J
影响因子：
2.9
作者：
Behnke, K;Sogaard, J;Vester-Blokland, ED
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Vester-Blokland, ED
影响因子：
3.2
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通讯作者：
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影响因子：
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作者：
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Amsterdam, JD
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作者：
BECK, AT;ERBAUGH, J;MENDELSOHN, M
通讯作者：
MENDELSOHN, M