A 5-week randomized, placebo-controlled, double-blind study was carried out to investigate the efficacy of kava-kava special extract
WS1490 in non-psychotic nervous anxiety, tension and
restlessness states. During the first 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
WS1490 or placebo. Outcome measures were the differences between baseline and end of treatment on the Hamilton Anxiety Scale (HAMA) and on a subjective well-being scale (Bf-S), as well as the
benzodiazepine withdrawal symptoms. Changes in the Erlanger Anxiety, Tension and Aggression Scale (EAAS) and Clinical Global Impressions (CGI) were analyzed as secondary measures. Treatment safety was checked by interviews, adverse event reports and laboratory investigations. Forty patients (2x20) were included into the study.
WS1490 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
WS1490 was not inferior to placebo. The study confirms the
anxiolytic efficacy and good tolerance of
WS1490 and shows that a further symptom reduction is possible after a change-over from
benzodiazepine treatment.