Does differential drop-out explain the influence of study design on antidepressant response? A meta-analysis.
Does differential drop-out explain the influence of study design on antidepressant response? A meta-analysis.
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DOI：
10.1016/j.jad.2012.01.031
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发表时间：
2012-09
影响因子：
6.6
通讯作者：
Roose, Steven P.
中科院分区：
文献类型：
--
作者：
Rutherford, Bret R.;Sneed, Joel R.;Roose, Steven P.
与安慰剂对照临床试验相比，活性比较器对抗抑郁药的反应更高。在对照试验中，患者期望增加的假设可以解释这一发现，但以前的分析没有解释在安慰剂对照试验中观察到的更多的脱落。进行了系统的文献综述，以确定已发表的抗抑郁药物临床试验，报告了关于意向治疗(ITT)的数据以及完整的患者群体。通过比较安慰剂对照和对照试验中抗抑郁药反应的独立多水平荟萃分析中的ITT和完整数据集，研究参与者退出对观察到的抗抑郁药反应的影响。18项安慰剂对照研究和18项积极对照研究可用于分析。使用意向治疗数据，对照试验中对药物有反应的几率是安慰剂对照试验中的1.9倍(95%CI=1.32.7，p=0.001)。在研究完成者中也得到了同样的规律，与安慰剂对照研究设计相比，对照组对抗抑郁药物的有效率高出1.9倍(95%CI=1.23.0，p=0.009)。发表偏倚、试验水平总结数据的使用以及ITT和完整患者群体之间未报告的临床或人口学差异可能影响了研究结果。在安慰剂对照和积极对照研究中，安慰剂对照和积极对照研究中的脱落率增加似乎不能解释这些研究类型之间的应答率差异。相反，在对照试验中，由于肯定接受积极药物而导致的患者预期增加，可能会导致更高的应答率。
Response to antidepressants is higher in active comparator relative to placebo-controlled clinical trials. Increased patient expectancy in comparator trials has been hypothesized to explain this finding, but previous analyses have not accounted for the increased dropout observed in placebo-controlled trials. A systematic literature review was conducted to identify published antidepressant clinical trials reporting data on intent-to-treat (ITT) as well as completer patient populations. The influence of participant drop-out on observed antidepressant response was investigated by comparing the ITT and completer data sets in separate multilevel meta-analyses of antidepressant response in placebo-controlled and comparator trials. 18 placebo-controlled and 18 active comparator studies were available for analysis. Using the intent-to-treat data, the odds of responding to medication in comparator trials were 1.9 times the odds in placebo-controlled trials (95% CI=1.3–2.7, p=0.001). The same pattern was obtained among study completers, in whom the odds of responding to antidepressant medication were 1.9 times higher in comparator as opposed to placebo-controlled study designs (95% CI=1.2–3.0, p=0.009). Publication bias, the use of trial-level summary data, and unreported clinical or demographic differences between the ITT and completer patient populations may have influenced the study results. Increased drop-out in placebo-controlled vs. active comparator studies of antidepressant medications does not appear to explain the difference in response rates between these study types. Rather, increased patient expectancy resulting from the certainty of receiving active medication in comparator trials may lead to improved response rates.
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