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 LI150 in Generalized Anxiety Disorder (GAD; ICD-10: F41.1). Method: 129 out-patients received either 400 mg Kava LI150, 10 mg Buspirone or 100mg 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. Conclusion: Kava-Kava LI150 is well tolerated and as effective as Buspirone and Opipramol in the acute treatment of out-patients suffering from GAD.