Meta-analysis of placebo-controlled trials with mirtazapine using the core items of the Hamilton Depression Scale as evidence of a pure antidepressive effect in the short-term treatment of major depression.

P. Bech
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引用次数: 69

Abstract

When attempting to demonstrate a purely antidepressive effect of new antidepressants the HAMD depression factor has been found adequate in placebo-controlled trials. When attempting to demonstrate an early onset of action of amitriptyline the HAMD item of depressed mood has previously been found sufficient, using effect size as outcome statistic. Therefore, the HAMD depression factor as well as the HAMD item of depressed mood have been used separately in this meta-analysis to evaluate the pure antidepressive effect and early onset of action of mirtazapine when compared to placebo or amitriptyline. The results showed that in all placebo-controlled trials mirtazapine obtained an effect size of 0.42 on the HAMD depression factor subscale and 0.49 on the full HAMD. In the trials in which mirtazapine was compared to amitriptyline the effect sizes for the HAMD depression factor subscale were 0.40 and 0.57, respectively. This difference was not statistically significant. An early onset of action was found for the HAMD item of depressed mood as well as the total HAMD both for mirtazapine and amitriptyline when compared to placebo. As early as after 1 wk of therapy both drugs were significantly better than placebo. In conclusion, a purely antidepressive effect of mirtazapine has been demonstrated concerning both improvement after the acute therapy of major depression and early onset of action.
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使用汉密尔顿抑郁量表的核心项目对米氮平进行安慰剂对照试验的meta分析,作为重度抑郁症短期治疗中纯抗抑郁效果的证据。
当试图证明新抗抑郁药的纯粹抗抑郁效果时,在安慰剂对照试验中发现HAMD抑郁因子是足够的。当试图证明阿米替林的早期作用时,抑郁情绪的HAMD项目先前已经被发现是充分的,使用效应大小作为结果统计。因此,在本荟萃分析中,我们分别使用HAMD抑郁因子和抑郁心境的HAMD项目来评价米氮平与安慰剂或阿米替林相比的纯抗抑郁效果和早起效。结果显示,在所有安慰剂对照试验中,米氮平在HAMD抑郁因子亚量表上的效应量为0.42,在完整HAMD上的效应量为0.49。在米氮平与阿米替林比较的试验中,HAMD抑郁因子亚量表的效应量分别为0.40和0.57。这一差异无统计学意义。与安慰剂相比,发现米氮平和阿米替林在抑郁情绪的HAMD项目以及总HAMD方面起效早。早在治疗1周后,两种药物均明显优于安慰剂。总之,米氮平的纯抗抑郁作用已被证明涉及重度抑郁症急性治疗后的改善和早期起效。
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