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FILE: Kava (Piper methysticum) Generalized Anxiety Disorder
HC 100234-252
Date: March 15, 2004
RE: Kava Extract for Generalized Anxiety Disorder – Comparison with Anti-anxiety Drugs
Boerner RJ, Sommer H, Berger W, Kuhn U, Schmidt U, Mannel M. 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. Phytomedicine 2003;10 (Suppl IV):38-49.
Generalized Anxiety Disorder (GAD) is characterized by uncontrollable, excessive worry or anxiety, which occurs on more days than not for at least six months. People with GAD experience feelings of worry for more than 50% of their waking day. Although pharmacological treatment is necessary, many individuals don't receive proper treatment. Many people are attracted to over-the-counter medicines that claim anxiolytic properties (relief of anxiety), including those containing kava (Piper methysticum). Prior clinical studies have either not used patients with only GAD, or they have used dosages of kava above the maximum daily dose recommended by the German Commission E monograph. The aim of this study was to investigate the efficacy and safety of a new kava formulation in the treatment of GAD and compare it to two commonly prescribed drugs, buspirone and opipramol.
A total of 129 patients (aged 25 to 65 years) with GAD met the inclusion criteria for this randomized, double-blind, parallel-group, multicenter trial; 119 completed the study. Patients received either 400 mg kava extract LI150 (Lichtwer Pharma AG, Berlin, Germany; standardized to 30% kavapyrones [120 mg], extraction solvent 96% ethanol in water, drug- extract ratio 13-20:1) once a day, 5 mg buspirone twice a day, or 50 mg opipramol twice a day for 8 weeks. Anxiety symptoms were rated with a battery of tests and safety was evaluated.
Sixty-two percent of the patients had never been on any anti-anxiety medication prior to entering the study. All three groups were similar at baseline. All three treatment arms had a high response rate. There were no significant differences between treatments in regard to efficacy. There was a trend towards more adverse events in patients taking kava. Kava may have gastrointestinal incompatibility in some patients. There was one serious adverse event in the study – a panic attack requiring stationary treatment which occurred in a patient taking kava. However, symptoms improved while the patient was in the hospital and the kava medication was not discontinued. No kava treated patient had significant adverse liver reactions.
The authors state that the high response rates could be attributed to the study population having moderate severity of illness, no inactive placebo control, and a very high number of previously untreated patients. Nonetheless, it is interesting that kava had a similar effect as the other two drugs. The overall safety was excellent for all three treatments. The authors conclude that patients suffering from GAD may benefit from an acute treatment with kava.
—Heather S. Oliff, Ph.D.
Enclosure: Referenced article reprinted with permission from Urban & Fischer Verlag.
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