Bjerkenstedt Lars, Edman Gunnar V, Alken R Gisberth, Mannel Marcus
Department of Clinical Neuroscience, Psychiatry Section Karolinska Hospital, 17176, Stockholm, Sweden.
Eur Arch Psychiatry Clin Neurosci. 2005 Feb;255(1):40-7. doi: 10.1007/s00406-004-0532-z. Epub 2004 Nov 12.
Efficacy and tolerability of Hypericum LI 160 was compared to fluoxetine and placebo in mild to moderate Major Depression (DSM-IV) in a 4-week randomized, double-blind trial. One hundred and sixty-three outpatients from 15 general practitioner centers received either 900 mg Hypericum LI 160, 20 mg fluoxetine, or placebo daily. Amelioration was measured by the Hamilton and the Montgomery-Asberg Depression scales. Response and remission rates and global ratings by investigators and patients were measured. Adverse event reports, laboratory screening, vital signs, physical exams and ECG were collected. No significant differences could be observed regarding efficacy measures except for remission rate (Hypericum 24%; fluoxetine 28%; placebo 7 %). Hypericum was significantly better tolerated than fluoxetine. Hypericum LI 160 or fluoxetine were not more effective in short-term treatment in mild to moderate depression than placebo.
在一项为期4周的随机双盲试验中，将金丝桃属植物提取物LI 160与氟西汀及安慰剂相比较，评估其对轻度至中度重度抑郁症（DSM-IV）的疗效和耐受性。来自15个全科医生中心的163名门诊患者，每天分别服用900毫克金丝桃属植物提取物LI 160、20毫克氟西汀或安慰剂。采用汉密尔顿抑郁量表和蒙哥马利-阿斯伯格抑郁量表评估病情改善情况。测量了缓解率、有效率以及研究者和患者的整体评分。收集了不良事件报告、实验室检查、生命体征、体格检查和心电图结果。除缓解率外（金丝桃属植物提取物组为24%；氟西汀组为28%；安慰剂组为7%），在疗效指标方面未观察到显著差异。金丝桃属植物提取物的耐受性明显优于氟西汀。在轻度至中度抑郁症的短期治疗中，金丝桃属植物提取物LI 160或氟西汀并不比安慰剂更有效。
