INFLUENCE OF STUDY DESIGN ON TREATMENT RESPONSE IN ANXIETY DISORDER CLINICAL TRIALS.
INFLUENCE OF STUDY DESIGN ON TREATMENT RESPONSE IN ANXIETY DISORDER CLINICAL TRIALS.
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DOI：
10.1002/da.22433
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发表时间：
2015-12
影响因子：
7.4
通讯作者：
Roose SP
中科院分区：
文献类型：
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作者：
Rutherford BR;Bailey VS;Schneier FR;Pott E;Brown PJ;Roose SP
在社交焦虑症(SAD)、广泛性焦虑症(GAD)和惊恐障碍(PD)的临床试验中，研究了研究设计变量和发表年份对药物和安慰剂反应的影响。分层线性模型确定了发表年份、治疗分配(药物与安慰剂)、研究类型(安慰剂对照或主动对照)、研究持续时间和研究访问次数是否影响与药物和安慰剂相关的平均变化。在所考察的66项试验中，与药物和安慰剂相关的变化随着时间的推移而增加(t=4.23，df=39，P<；.001)，但药物和安慰剂的平均差异随着时间的推移而减少(t=−2.04，df=46，P=0.047)。更严重的基线疾病与5-羟色胺去甲肾上腺素再摄取抑制剂(SNRI，t=3.46，df=106，P=.001)和选择性5-羟色胺再摄取抑制剂(SSRI，t=10.37，df=106，P<；.001)的药物-安慰剂差异较大。与安慰剂对照试验相比，在主动对照研究中，药物治疗的改善明显更大(t=3.41，df=39，P=0.002)。与SAD(t=2.83，df=39，P=.008)和GAD(t=2.16，df=39，P=.037)相比，PD试验的研究访问次数越多，症状改善越明显。在SAD、GAD和PD试验中，安慰剂反应显著，随着时间的推移，安慰剂反应的增加与药物-安慰剂差异的缩小有关。在焦虑症试验中，影响治疗反应的研究设计特征包括患者预期、随访频率和基线疾病严重程度。
The influence of study design variables and publication year on response to medication and placebo was investigated in clinical trials for social anxiety disorder (SAD), generalized anxiety disorder (GAD), and panic disorder (PD). Hierarchical linear modeling determined whether publication year, treatment assignment (medication vs. placebo), study type (placebo-controlled or active comparator), study duration, and the number of study visits affected the mean change associated with medication and placebo. In the 66 trials examined, the change associated with both medication and placebo increased over time (t = 4.23, df = 39, P < .001), but average drug–placebo differences decreased over time (t = −2.04, df = 46, P = .047). More severe baseline illness was associated with greater drug–placebo differences for serotonin norepinephrine reuptake inhibitors (SNRIs, t = 3.46, df = 106, P = .001) and selective serotonin reuptake inhibitors (SSRI, t = 10.37, df = 106, P < .001). Improvement with medication was significantly greater in active-comparator studies compared to placebo-controlled trials (t = 3.41, df = 39, P = .002). A greater number of study visits was associated with greater symptom improvement in PD trials relative to SAD (t = 2.83, df = 39, P = .008) and GAD (t = 2.16, df = 39, P= .037). Placebo response is substantial in SAD, GAD, and PD trials, and its rise over time has been associated with diminished drug–placebo differences. Study design features that influence treatment response in anxiety disorder trials include patient expectancy, frequency of follow-up visits, and baseline illness severity.