Juliane Hellhammer1, Melanie Schubert. 1. DAaCRO - Diagnostic Research and Clinical Research Organization, Science Park of Trier, Trier, Germany. hellhammer@daacro.de
Abstract
OBJECTIVES: Stress impacts on health, causing stress-related illness. The aim of this study was to investigate stress dampening effects of the homeopathic combination remedy dysto-loges(®) S on physiological and psychological measures during acute stress. Additionally, effects of the substance on sleep and life quality were investigated. DESIGN: This randomized, double-blind, placebo-controlled single center study had a total duration of 15 days for each participant. SETTING/LOCATION: The study was performed by Daacro, Trier, Germany. SUBJECTS: We included 40 women aged 30-50 years that regularly experienced impaired well-being when feeling stressed. INTERVENTION: Participants took three tablets daily for 14 days. On the final study day, participants took three pills in the morning and upon arrival at the study site. Thereafter, the Trier Social Stress Test (TSST) was performed. OUTCOME MEASURES: Primary endpoints were saliva cortisol responses to the stress test. Secondary biological endpoints were plasma cortisol, adrenocorticotrophic hormone, epinephrine, and norepinephrine (NE) and heart rates. Psychological secondary endpoints were well-being, anxiety, stress, and insecurity during the stress test as well as sleep and quality of life. RESULTS:Stress-induced cortisol levels did not differ between groups, but verum-treated participants were characterized by lower NE levels. Two weeks of treatment with the homeopathic substance resulted in a better sleep quality. Sleep improvement was associated with a higher hormonal response to the TSST in both groups. In addition, individuals with impaired sleep in the placebo group had higher unstimulated NE levels. CONCLUSIONS: This study provides preliminary evidence for beneficial effects of dysto-loges S on sleep quality. Improvement of sleep quality was positively associated with a normalized neuroendocrine stress response during acute stress, whereas an altered hormonal response was observed in participants with impaired sleep. We hypothesize that the test product may possibly reduce NE release.
RCT Entities:
OBJECTIVES: Stress impacts on health, causing stress-related illness. The aim of this study was to investigate stress dampening effects of the homeopathic combination remedy dysto-loges(®) S on physiological and psychological measures during acute stress. Additionally, effects of the substance on sleep and life quality were investigated. DESIGN: This randomized, double-blind, placebo-controlled single center study had a total duration of 15 days for each participant. SETTING/LOCATION: The study was performed by Daacro, Trier, Germany. SUBJECTS: We included 40 women aged 30-50 years that regularly experienced impaired well-being when feeling stressed. INTERVENTION: Participants took three tablets daily for 14 days. On the final study day, participants took three pills in the morning and upon arrival at the study site. Thereafter, the Trier Social Stress Test (TSST) was performed. OUTCOME MEASURES: Primary endpoints were saliva cortisol responses to the stress test. Secondary biological endpoints were plasma cortisol, adrenocorticotrophic hormone, epinephrine, and norepinephrine (NE) and heart rates. Psychological secondary endpoints were well-being, anxiety, stress, and insecurity during the stress test as well as sleep and quality of life. RESULTS: Stress-induced cortisol levels did not differ between groups, but verum-treated participants were characterized by lower NE levels. Two weeks of treatment with the homeopathic substance resulted in a better sleep quality. Sleep improvement was associated with a higher hormonal response to the TSST in both groups. In addition, individuals with impaired sleep in the placebo group had higher unstimulated NE levels. CONCLUSIONS: This study provides preliminary evidence for beneficial effects of dysto-loges S on sleep quality. Improvement of sleep quality was positively associated with a normalized neuroendocrine stress response during acute stress, whereas an altered hormonal response was observed in participants with impaired sleep. We hypothesize that the test product may possibly reduce NE release.
Authors: Miek C Jong; Lydia Ilyenko; Irina Kholodova; Cynthia Verwer; Julia Burkart; Stephan Weber; Thomas Keller; Petra Klement Journal: Evid Based Complement Alternat Med Date: 2016-05-08 Impact factor: 2.629