PMID- 24456909
OWN - NLM
STAT- MEDLINE
DCOM- 20150122
LR  - 20211203
IS  - 1469-5111 (Electronic)
IS  - 1461-1457 (Linking)
VI  - 17
IP  - 6
DP  - 2014 Jun
TI  - Lavender oil preparation Silexan is effective in generalized anxiety disorder--a 
      randomized, double-blind comparison to placebo and paroxetine.
PG  - 859-69
LID - 10.1017/S1461145714000017 [doi]
AB  - The anxiolytic efficacy of the orally administered lavender oil preparation 
      Silexan was investigated in generalized anxiety disorder (GAD) in comparison to 
      placebo and paroxetine. In this randomized, double-blind, double-dummy trial 539 
      adults with GAD according to DSM-5 criteria and a Hamilton Anxiety Scale (HAMA) 
      total score ⩾ 18 points participated and received 160 or 80 mg Silexan, 20 mg 
      paroxetine, or placebo once daily for 10 wk. The primary efficacy endpoint was 
      the HAMA total score reduction between baseline and treatment end. The HAMA total 
      score decreased by 14.1 +/- 9.3 points for Silexan 160 mg/d, 12.8 +/- 8.7 points for 
      Silexan 80 mg/d, 11.3 +/- 8.0 points for paroxetine, and 9.5 +/- 9.0 points for 
      placebo (mean +/- s.d.). Silexan 160 and 80 mg/d were superior to placebo in 
      reducing the HAMA total score (p < 0.01) whereas paroxetine showed a trend 
      towards significance (p = 0.10) in the full analysis set. The difference between 
      paroxetine and placebo was more pronounced in the analysis of observed cases 
      (HAMA total score reduction: p < 0.01). In the Silexan 160 mg/d group 73/121 
      patients (60.3%) showed a HAMA total score reduction ⩾ 50% of the baseline value 
      and 56 (46.3%) had a total score <10 points at treatment end, compared to 70/135 
      (51.9%) and 45 (33.3%) for Silexan 80 mg/d, 57/132 (43.2%) and 45 (34.1%) for 
      paroxetine, and 51/135 (37.8%) and 40 (29.6%) for placebo. In addition, Silexan 
      showed a pronounced antidepressant effect and improved general mental health and 
      health-related quality of life. Incidence densities of adverse events (AEs) were 
      0.006 AEs/d for Silexan 160 mg/d, 0.008 AEs/d for 80 mg/d, 0.011 AEs/d for 
      paroxetine, and 0.008 AEs/d for placebo. In GAD Silexan is more efficacious than 
      placebo. AE rates for Silexan were comparable to placebo and lower than for the 
      active control paroxetine.
FAU - Kasper, Siegfried
AU  - Kasper S
AD  - Department of Psychiatry and Psychotherapy, Medical University of Vienna, 
      Wahringer Gurtel 18-20, 1090 Vienna, Austria.
FAU - Gastpar, Markus
AU  - Gastpar M
AD  - Fliedner Klinik Berlin, Charlottenstrasse 65, 10117 Berlin, Germany.
FAU - Muller, Walter E
AU  - Muller WE
AD  - Department of Pharmacology, Biocenter Goethe-University, Max-von-Laue-Strasse 9, 
      60438 Frankfurt, Germany.
FAU - Volz, Hans-Peter
AU  - Volz HP
AD  - Hospital for Psychiatry, Psychotherapy and Psychosomatic Medicine, Schloss 
      Werneck, Balthasar-Neumann-Platz 1, 97440 Werneck, Germany.
FAU - Moller, Hans-Jurgen
AU  - Moller HJ
AD  - Clinic for Psychiatry and Psychotherapy, Ludwig Maximilians University, 
      Nussbaumstrasse 7, Munich, Germany.
FAU - Schlafke, Sandra
AU  - Schlafke S
AD  - Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Strasse 4, 76227 Karlsruhe, 
      Germany.
FAU - Dienel, Angelika
AU  - Dienel A
AD  - Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Strasse 4, 76227 Karlsruhe, 
      Germany.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140123
PL  - England
TA  - Int J Neuropsychopharmacol
JT  - The international journal of neuropsychopharmacology
JID - 9815893
RN  - 0 (Anti-Anxiety Agents)
RN  - 0 (Antidepressive Agents)
RN  - 0 (Oils, Volatile)
RN  - 0 (Plant Oils)
RN  - 41VRH5220H (Paroxetine)
RN  - ZBP1YXW0H8 (lavender oil)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Anti-Anxiety Agents/*administration & dosage/adverse effects
MH  - Antidepressive Agents/administration & dosage/adverse effects
MH  - Anxiety Disorders/*drug therapy/psychology
MH  - Depression/drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Germany
MH  - Humans
MH  - Lavandula
MH  - Male
MH  - Middle Aged
MH  - Oils, Volatile/*administration & dosage/adverse effects
MH  - Paroxetine/*administration & dosage/adverse effects
MH  - Plant Oils/*administration & dosage/adverse effects
MH  - Psychiatric Status Rating Scales
MH  - Quality of Life
MH  - Remission Induction
MH  - Treatment Outcome
EDAT- 2014/01/25 06:00
MHDA- 2015/01/23 06:00
CRDT- 2014/01/25 06:00
PHST- 2014/01/25 06:00 [entrez]
PHST- 2014/01/25 06:00 [pubmed]
PHST- 2015/01/23 06:00 [medline]
AID - S1461145714000017 [pii]
AID - 10.1017/S1461145714000017 [doi]
PST - ppublish
SO  - Int J Neuropsychopharmacol. 2014 Jun;17(6):859-69. doi: 
      10.1017/S1461145714000017. Epub 2014 Jan 23.