Friede M, Henneicke von Zepelin H H, Freudenstein J
Schaper & Brümmer GmbH & Co. KG, Salzgitter, Germany.
Pharmacopsychiatry. 2001 Jul;34 Suppl 1:S38-41. doi: 10.1055/s-2001-15459.
The purpose of this report was to evaluate specific depressive symptoms that are most suitable for a therapy with the Ze 117 St. John's wort extract. We examined the antidepressant efficacy and drug safety of Ze 117 and fluoxetine in a multicentric prospective randomized double-blind parallel group comparison according to generally accepted guidelines such as the Declaration of Helsinki and GCP. We treated outpatients (n = 240; Ze 117: 126; fluoxetine: 114) with mild to moderate depressive episodes (ICD-10: F 32.0, F 32.1; HAMD range: 16-24) with either two tablets St John's wort (Ze 117; 500 mg extract/day) or fluoxetine (20 mg/day) for 6 weeks. Antidepressant efficacy was evaluated with the validated HAMD psychometric method. A validated analysis of HAMD subscores was made to verify the efficacy for certain depressive symptoms. The main results were: * The HAMD responder rate was 60% in the Ze 117 group compared to 40% in the fluoxetine group (p = 0.005). * Particularly, there was a marked decrease of depressive agitation (pre-post comparison: 46%) and anxiety symptoms (44%) during the therapy with St. John's wort. Depressive obstruction (44%) and sleep disorders (43%) were reduced during the treatment, too. There were no statistically significant differences between the treatment groups. * Adverse events occurred in 28 patients (25%) in the fluoxetine group and in 18 (14%) of the St. John's wort group (p < 0.07). St. John's wort extract is a clinically effective equivalent to fluoxetine regarding overall depressive symptoms and main symptoms of depressive episodes. An especially interesting overall observation is that Ze 117 is particularly effective in depressive patients suffering from anxiety symptoms. St. John's wort revealed better safety and tolerability data than fluoxetine.
本报告的目的是评估最适合用泽117圣约翰草提取物进行治疗的特定抑郁症状。我们根据普遍认可的准则，如《赫尔辛基宣言》和《药物临床试验质量管理规范》（GCP），在一项多中心前瞻性随机双盲平行组对照研究中，考察了泽117和氟西汀的抗抑郁疗效及药物安全性。我们对患有轻度至中度抑郁发作（国际疾病分类第10版：F 32.0、F 32.1；汉密尔顿抑郁量表（HAMD）评分范围：16 - 24）的门诊患者（n = 240；泽117组：126例；氟西汀组：114例），给予两片圣约翰草（泽117；500毫克提取物/天）或氟西汀（20毫克/天）治疗6周。采用经过验证的HAMD心理测量方法评估抗抑郁疗效。对HAMD子评分进行了验证性分析，以验证对某些抑郁症状的疗效。主要结果如下：* 泽117组的HAMD有效率为60%，而氟西汀组为40%（p = 0.005）。* 特别地，在使用圣约翰草治疗期间，抑郁性激越（治疗前后比较：46%）和焦虑症状（44%）有显著下降。治疗期间抑郁性阻滞（44%）和睡眠障碍（43%）也有所减轻。治疗组之间无统计学显著差异。* 氟西汀组有28例患者（25%）发生不良事件，圣约翰草组有18例（14%）（p < 0.07）。就总体抑郁症状和抑郁发作的主要症状而言，圣约翰草提取物在临床上与氟西汀等效。一个特别有趣的总体观察结果是，泽117对伴有焦虑症状的抑郁患者特别有效。圣约翰草显示出比氟西汀更好的安全性和耐受性数据。
