A multi-center, double-blind, randomised study of the Lavender oil preparatiom in comparison to
Lorazepam for generalized
anxiety disorder, 2010
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Conclusions:
Since lavender oil showed no sedative effects in our study
and has no potential for drug abuse, silexan appears to be an effective and
well tolerated alternative to benzodiazepines for amelioration of generalised
anxiety.
Abstract:
Generalized and persistent anxiety, accompanied by
nervousness and other symptoms (Generalised Anxiety Disorder, GAD) is frequent
in the general population and leads to benzodiazepine usage. Unfortunately,
these substances induce sedation and have a high potential for drug abuse, and
there is thus a need for alternatives. As the anxiolytic properties of lavender
have already been demonstrated in pharmacological studies and small-scale
clinical trials, it was postulated that lavender has a positive effect in GAD.
A controlled clinical study was then performed to evaluate the efficacy of
silexan, a new oral lavender oil capsule preparation, versus a benzodiazepine.
In this study, the efficacy of a 6-week-intake of silexan compared to lorazepam
was investigated in adults with GAD. The primary target variable was the change
in the Hamilton Anxiety Rating Scale (HAM-A-total score) as an objective
measurement of the severity of anxiety between baseline and week 6. The results
suggest that silexan effectively ameliorates generalized anxiety comparable to
a common benzodiazepine (lorazepam). The mean of the HAM-A-total score
decreased clearly and to a similar extent in both groups (by 11.3+/-6.7 points
(45%) in the silexan group and by 11.6+/-6.6 points (46%) in the lorazepam
group, from 25+/-4 points at baseline in both groups). During the active
treatment period, the two HAM-A subscores "somatic anxiety" (HAM-A
subscore I) and "psychic anxiety" (HAM-A subscore II) also decreased
clearly and to a similar extent in both groups. The changes in other subscores
measured during the study, such as the SAS (Self-rating Anxiety Scale), PSWQ-PW
(Penn State Worry Questionnaire), SF 36 Health survey Questionnaire and
Clinical Global Impressions of severity of disorder (CGI item 1, CGI item 2,
CGI item 3), and the results of the sleep diary demonstrated comparable
positive effects of the two compounds. In conclusion, our results demonstrate
that silexan is as effective as lorazepam in adults with GAD. The safety of
silexan was also demonstrated.
Since
lavender oil showed no sedative effects in our study and has no potential for
drug abuse, silexan appears to be an effective and well tolerated alternative
to benzodiazepines for amelioration of generalised anxiety.
Published:
Woelk, H., Schläfke, S. (2010). A multi-center,
double-blind, randomised study of the Lavender oil preparation Silexan in
comparison to Lorazepam for generalized anxiety disorder.
Phytomedicine, 17, 94-99.
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