Effects of a fixed herbal drug combination (Ze 185) to an experimental acute stress setting in healthy men – An explorative randomized placebo-controlled double-blind study

• Published in: Phytomedicine (Stuttgart) Vol. 39; pp. 85 - 92
• Main Authors: Meier, Sibylle, Haschke, Manuel, Zahner, Catherine, Kruttschnitt, Esther, Drewe, Jürgen, Liakoni, Evangelia, Hammann, Felix, Gaab, Jens
• Format: Journal Article
• Language: English
• Published: Germany Elsevier GmbH 15-01-2018
• Subjects: Adult; Anxiety; Anxiety - drug therapy; Cortisol; Double-Blind Method; Humans; Hydrocortisone - metabolism; Male; Melissa - chemistry; Melissa officinalis; Passiflora incarnata; Petasites hybridus; Phytotherapy - methods; Plant Extracts - pharmacology; Plants, Medicinal - chemistry; Stress, Psychological - drug therapy; Treatment Outcome; Valerian - chemistry; Valeriana officinalis; FID; PP; STAI-state; AE; AUCI; AUCG; TSST; Passiflora incarnata; ITT; Petasites hybridus; Cortisol; DER; SD; STAI-trait; Valeriana officinalis; GABA; HPA; HMPC; Melissa officinalis; Anxiety; Ph. Eur; GC; HPLC; BMI
• ISSN: 0944-7113; 1618-095X
• DOI: 10.1016/j.phymed.2017.12.005

Considering the negative effects of stress on health, there is a growing interest in stress-reducing interventions. The present study examines the effects of a fixed combination of valerian, passion flower, lemon balm, and butterbur extracts (Ze 185) on biological and affective responses to a standardized psychosocial stress paradigm.
The aim of the present study was to investigate the efficacy of Ze 185 on cortisol and anxiety stress responses to acute psychosocial stress in healthy subjects.
This study was a randomized, placebo-controlled, double blind study with 3 parallel groups.
72 healthy male participants were randomized to 3 groups (Ze 185, placebo or no treatment) during 4 days prior to a standardized psychosocial stress paradigm. Principle outcomes were salivary cortisol and self-reported anxiety responses to stress assessed at the fourth day.
The stress paradigm induced significant and large cortisol and self-reported anxiety responses. Groups did not differ significantly in their salivary cortisol response to stress, but participants in the Ze 185 condition showed significantly attenuated responses in self-reported anxiety in comparison to placebo (F(3, 41) = 3.33, p = 0.03) and no treatment (F(3, 43) = 2.77, p = 0.05).
The results show that Ze 185 significantly attenuated the subjective emotional stress response during an acute stress situation, without affecting biological stress responses. Given that a circumscribed biological stress response is to be considered as an adaptive mechanism, Ze 185 reduces self-reported anxiety response to stress without affecting assumingly adaptive biological stress responses.
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