title: Multicenter, open-label, exploratory clinical trial withRhodiola roseaextract in patients suffering from burnout symptoms.
abstract: OBJECTIVE
  This study is the first clinical trial aiming to explore the clinical outcomes in burnout patients treated withRhodiola rosea. The reported capacity ofR. roseato strengthen the organism against stress and its good tolerability offer a promising approach in the treatment of stress-related burnout. The aim of the treatment was to increase stress resistance, thus addressing the source rather than the symptoms of the syndrome and preventing subsequent diseases associated with a history of burnout. The objective of the trial was to provide the exploratory data required for planning future randomized trials in burnout patients in order to investigate the clinical outcomes of treatment withR. roseadry extract in this target group.
  
  
  METHODS
  The study was planned as an exploratory, open-label, multicenter, single-arm trial. A wide range of rating scales were assessed and evaluated in an exploratory data analysis to generate hypotheses regarding clinical courses and to provide a basis for the planning of subsequent studies. A total of 118 outpatients were enrolled. A daily dose of 400 mgR. roseaextract (WS®1375, Rosalin) was administered over 12 weeks. Clinical outcomes were assessed by the German version of the Maslach Burnout Inventory, Burnout Screening Scales I and II, Sheehan Disability Scale, Perceived Stress Questionnaire, Number Connection Test, Multidimensional Mood State Questionnaire, Numerical Analogue Scales for different stress symptoms and impairment of sexual life, Patient Sexual Function Questionnaire, and the Clinical Global Impression Scales.
  
  
  RESULTS
  The majority of the outcome measures showed clear improvement over time. Several parameters had already improved after 1 week of treatment and continued to improve further up to the end of the study. The incidence of adverse events was low with 0.015 events per observation day.
  
  
  CONCLUSIONS
  The trial reported here was the first to investigate clinical outcomes in patients suffering from burnout symptoms when treated withR. rosea. During administration of the study drug over the course of 12 weeks, a wide range of outcome measures associated with the syndrome clearly improved.
  
  
  CONCLUSIONS
  The results presented provide an encouraging basis for clinical trials further investigating the clinical outcomes ofR. roseaextract in patients with the burnout syndrome.
authors.affiliation: Universitätsklinik für Psychiatrie und Psychotherapie, Medizinische Universität Wien, Wien, Austria.
authors.forename: Siegfried
authors.initials: S
authors.lastname: Kasper
authors.affiliation: Dr Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.
authors.forename: Angelika
authors.initials: A
authors.lastname: Dienel
keywords: Rhodiola rosea; burnout; clinical study