贯叶连翘与氟西汀治疗轻至中度抑郁症的对比：巴西样本的随机双盲试验
Hypericum perforatum versus fluoxetine in the treatment of mild to moderate depression: a randomized double-blind trial in a Brazilian sample.
作者信息
Moreno Ricardo Alberto, Teng Chei Tung, Almeida Karla Mathias de, Tavares Junior Hildeberto
机构信息
Institute of Psychiatry, Clinical Hospital, Medical School, Universidade de São Paulo, São Paulo, SP, Brazil.
出版信息
Braz J Psychiatry. 2006 Mar;28(1):29-32. doi: 10.1590/s1516-44462006000100007. Epub 2006 Mar 24.
OBJECTIVE
Hypericum perforatum has demonstrated antidepressant efficacy when compared to placebo, but comparisons with other antidepressants remain controversial. We assessed the efficacy and safety of Hypericum perforatum in comparison with fluoxetine, in a 8-week double-blind trial in patients with mild to moderate depression.
METHOD
Seventy-two outpatients were randomly assigned to receive Hypericum perforatum 900 mg/day, fluoxetine 20 mg/day or placebo. Efficacy measures included the HAM-D21 scale, the Montgomery-Asberg Rating Scale, and the Clinical Global Impression. Safety was assessed with the UKU Side Effect Rating Scale.
RESULTS
Intention-to-treat analysis showed no differences between the mean scores of the three groups. In the analyses of observed cases, patients receiving Hypericum perforatum had the lowest remission rates (12%, p = 0.016) compared to fluoxetine (34.6%) and placebo (45%).
CONCLUSIONS
Hypericum perforatum was less efficacious than both fluoxetine and placebo. Both drugs were safe and well-tolerated. Larger trials are needed for definite conclusions.
目的
与安慰剂相比，贯叶连翘已显示出抗抑郁疗效，但与其他抗抑郁药的比较仍存在争议。我们在一项针对轻至中度抑郁症患者的为期8周的双盲试验中，评估了贯叶连翘与氟西汀相比的疗效和安全性。
方法
72名门诊患者被随机分配接受每日900毫克贯叶连翘、每日20毫克氟西汀或安慰剂治疗。疗效指标包括汉密尔顿抑郁量表（HAM-D21）、蒙哥马利-阿斯伯格抑郁量表和临床总体印象量表。使用乌普萨拉监测中心不良反应量表评估安全性。
结果
意向性分析显示三组的平均得分无差异。在实际观察病例分析中，与氟西汀组（34.6%）和安慰剂组（45%）相比，接受贯叶连翘治疗的患者缓解率最低（12%，p = 0.016）。
结论
贯叶连翘的疗效低于氟西汀和安慰剂。两种药物均安全且耐受性良好。需要进行更大规模的试验才能得出明确结论。
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