Kava-Kava extract LI 150 is as effective as Opipramol and Buspirone in Generalised Anxiety Disorder--an 8-week randomized, double-blind multi-centre clinical trial in 129 out-patients.
OBJECTIVE
An 8-week randomized, reference-controlled, double-blind, multi-centre clinical trial investigated Kava-Kava LI 150 in Generalized Anxiety Disorder (GAD; ICD-10: F41.1).


METHODS
129 out-patients received either 400 mg Kava LI 150, 10 mg Buspirone or 100 mg Opipramol daily for 8 weeks. At week 9, subjects were seen to check for symptoms of withdrawal or relapse. Primary outcome measures comprised the HAMA scale and the proportion of responders at week 8. Secondary measures were the Boerner Anxiety Scale (BOEAS), SAS, CGI, a self-rating scale for well-being (Bf-S), a sleep questionnaire (SF-B), a quality-of-life questionnaire (AL) and global judgements by investigator and patients.


RESULTS
In 127 patients (ITT) no significant differences could be observed regarding all efficacy and safety measures. About 75% of patients were classified as responders (50% reduction of HAMA score) in each treatment group, about 60% achieved full remission.


CONCLUSIONS
Kava-Kava LI150 is well tolerated and as effective as Buspirone and Opipramol in the acute treatment of out-patients suffering from GAD.
Boerner
R J
RJ
Department of Psychiatry, Ludwig-Maximilians-University, Munich, Germany. reinhard.boerner@psy.med.uni-muenchen.de
Sommer
H
H
Berger
W
W
Kuhn
U
U
Schmidt
U
U
Mannel
M
M
D000328:Adult; D000368:Aged; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000473:pathology; D002065:Buspirone / Q000008:administration & dosage / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005858:Germany; D006801:Humans; D020901:Kava; D008297:Male; D008347:Manifest Anxiety Scale; D008875:Middle Aged; D009888:Opipramol / Q000008:administration & dosage / Q000627:therapeutic use; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D011788:Quality of Life; D012890:Sleep; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D014151:Anti-Anxiety Agents; C476334:LI 150; D010936:Plant Extracts; D009888:Opipramol; D002065:Buspirone