Fixed herbal drug combination with and without butterbur (Ze 185) for the treatment of patients with somatoform disorders: randomized, placebo-controlled pharmaco-clinical trial.
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.
Melzer
Jörg
J
Institute of Complementary Medicine, Department for Internal Medicine, University Hospital Zurich, Switzerland. joerg.melzer@usz.ch
Schrader
Ewald
E
Brattström
Axel
A
Schellenberg
Rüdiger
R
Saller
Reinhard
R
D000328:Adult; D001007:Anxiety; D003863:Depression; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D036901:Petasites / Q000737:chemistry*; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013001:Somatoform Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
D004338:Drug Combinations; D028321:Plant Preparations