Effects of a homeopathic combination remedy on the acute stress response, well-being, and sleep: a double-blind, randomized clinical trial.

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.