EFFICACY OF A SPECIAL KAVA EXTRACT (PIPER-METHYSTICUM) IN PATIENTS WITH STATES OF ANXIETY, TENSION AND EXCITEDNESS ON NONMENTAL ORIGIN - A DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF 4-WEEKS TREATMENT

In a randomized, placebo-controlled double-blind study two groups of 2 9 patients each with anxiety syndromes not caused by mental disorders were treated for four weeks with three daily doses of 100 mg of Kava e xtract WS 1490 (Laitan(R)) from Piper methysticum rhizoma or a placebo preparation. Therapeutic efficacy was assessed by the Hamilton Anxiet y Scale (main outcome variable), the Adjectives Check List and the Cli nical Global Impression Scale (secondary target variables) after 1, 2, and 4 weeks of treatment. The HAMA overall score of anxiety symptomat ology revealed a significant reduction in the drug group compared with the placebo group after one week of treatment. The difference between the two groups of patients increased during the course of the study. The results of the secondary target variables were in agreement with t he HAMA score and demonstrated the efficacy of WS 1490 in patients wit h anxiety disorders. No adverse reactions caused by the medication wer e noted during the four weeks WS 1490 was administered.