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一项关于紫朱草水提取物治疗轻至中度重度抑郁症疗效的初步随机双盲临床试验。

A preliminary randomized double blind clinical trial on the efficacy of aqueous extract of Echium amoenum in the treatment of mild to moderate major depression.

作者信息

Sayyah Mehdi, Sayyah Mohammad, Kamalinejad Mohammad

机构信息

Department of Psychiatry, Psychiatric and Clinical Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Prog Neuropsychopharmacol Biol Psychiatry. 2006 Jan;30(1):166-9. doi: 10.1016/j.pnpbp.2005.10.005. Epub 2005 Nov 23.

DOI:10.1016/j.pnpbp.2005.10.005
PMID:16309809
Abstract

BACKGROUND

Based on a traditional belief, Echium amoenum (Boraginaceae) dried flowers are used in Iran as an anxiolytic remedy and also as a mood enhancer. In this study, efficacy of an aqueous extract of E. amoenum in patients with mild to moderate major depressive disorder (a score > or =18 on the Hamilton depression rating scale) was evaluated.

METHODS

35 patients were randomly assigned to receive daily either placebo or 375 mg of E. amoenum aqueous extract in a 6-week double blind, parallel-group trial. Patients were assessed in weeks 0, 1, 2, 4 and 6 by the Hamilton Rating Scale for Depression (HAM-D17), the Hamilton Rating Scale for Anxiety (HAM-A14), and a score sheet on adverse effects.

RESULTS

In week 4, the extract showed a significant superiority over placebo in reducing depressive symptoms. The effect on anxiety was not significant. Headache, somnolence, vomiting, dry mouth, constipation and blurred vision are the most commonly reported side effects. However, with regards to these side effects, no significant difference between placebo and drug treated groups was observed.

LIMITATIONS

This study is performed with a small sample size, only with one dose and for 6 weeks.

CONCLUSION

E. amoenum aqueous extract may have some antidepressant activity.

摘要

背景

基于传统观念,伊朗将紫朱草(紫草科)干花用作抗焦虑药物及情绪增强剂。本研究评估了紫朱草水提取物对轻度至中度重度抑郁症患者(汉密尔顿抑郁量表评分≥18分)的疗效。

方法

在一项为期6周的双盲平行组试验中,35名患者被随机分配,每天服用安慰剂或375毫克紫朱草水提取物。在第0、1、2、4和6周,通过汉密尔顿抑郁量表(HAM-D17)、汉密尔顿焦虑量表(HAM-A14)以及一份不良反应评分表对患者进行评估。

结果

在第4周,提取物在减轻抑郁症状方面显示出比安慰剂有显著优势。对焦虑的影响不显著。头痛、嗜睡、呕吐、口干、便秘和视力模糊是最常报告的副作用。然而,关于这些副作用,在安慰剂组和药物治疗组之间未观察到显著差异。

局限性

本研究样本量小,仅使用了一个剂量且为期6周。

结论

紫朱草水提取物可能具有一定的抗抑郁活性。

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