Institute of Complementary Medicine, Department for Internal Medicine, University Hospital Zurich, Switzerland.
Phytother Res. 2009 Sep;23(9):1303-8. doi: 10.1002/ptr.2771.
Herbal drugs are often used in patients with somatoform disorders yet, the available evidence is limited. The aim of the present short-term study was to evaluate in a pharmaco-clinical trial the additional benefit of butterbur in a fixed herbal drug combination (Ze 185 = 4-combination versus 3-combination without butterbur and placebo) in patients with somatoform disorders.For a 2-week treatment in patients with somatization disorder (F45.0) and undifferentiated somatoform disorder (F45.1), 182 patients were randomized for a 3-arm trial (butterbur root, valerian root, passionflower herb, lemon balm leaf versus valerian root, passionflower herb, lemon balm leaf versus placebo). Anxiety (visual analogue scale - VAS) and depression (Beck's Depression Inventory - BDI) served as primary parameters, Clinical Global Impression (CGI) was a secondary parameter.The 4-combination was significantly superior to the 3-combination and placebo (4-combination > 3-combination > placebo) in all the primary and secondary parameters (PP-population). Analysis of the ITT population confirmed these results. As to safety, no serious adverse events occurred. In total 9 non-serious adverse events were documented but the distribution did not differ significantly between the treatment groups.This herbal preparation (Ze185) showed to be an efficacious and safe short-term treatment in patients with somatoform disorders.
草药药物常用于躯体形式障碍患者，但现有证据有限。本短期研究的目的是在一项药物临床试验中评估在固定草药药物组合（Ze185=4 组合与不含香蒲和安慰剂的 3 组合）中添加香蒲对躯体形式障碍患者的额外益处。对于躯体化障碍（F45.0）和未分化躯体形式障碍（F45.1）患者，182 名患者被随机分为 3 臂试验（香蒲根、缬草根、西番莲草、柠檬香脂叶与缬草根、西番莲草、柠檬香脂叶与安慰剂）。焦虑（视觉模拟量表-VAS）和抑郁（贝克抑郁量表-BDI）作为主要参数，临床总体印象（CGI）是次要参数。在所有主要和次要参数（PP 人群）中，4 组合均明显优于 3 组合和安慰剂（4 组合>3 组合>安慰剂）。意向治疗人群的分析证实了这些结果。关于安全性，未发生严重不良事件。总共记录了 9 例非严重不良事件，但治疗组之间的分布无显著差异。这种草药制剂（Ze185）在躯体形式障碍患者中显示出有效且安全的短期治疗效果。
