Efficacy of kava-kava in the treatment of non-psychotic anxiety, followingpretreatment with benzodiazepines

A 5-week randomized, placebo-controlled, double-blind study was carried out to investigate the efficacy of kava-kava special extract WS (R) 1490 in no n-psychotic nervous anxiety, tension and restlessness states. During the fi rst treatment week, the study dose drug was increased from 50 mg to 300 mg per day and pretreatment with benzodiazepines was tapered off over 2 weeks. These dosage adjustments were followed by 3 weeks of monotherapy with WS ( R) 1490 or placebo. Outcome measures were the differences between baseline and end of treatment on the Hamilton Anxiety Scale (HAMA) and on a subjecti ve well-being scale (Bf-S), as well as the benzodiazepine withdrawal sympto ms. Changes in the Erlanger Anxiety, Tension and Aggression Scale (EAAS) an d Clinical Global Impressions (CGI) were analyzed as secondary measures. Tr eatment safety was checked by interviews, adverse event reports and laborat ory investigations. Forty patients (2x20) were included into the study. WS (R) 1490 was superior to placebo regarding the HAMA (P=0.01) and Bf-S (P=0. 002) total scores and all secondary efficacy measures. The tolerance of WS (R) 1490 was not inferior to placebo. The study confirms the anxiolytic eff icacy and good tolerance of WS (R) 1490 and shows that a further symptom re duction is possible after a change-over from benzodiazepine treatment.