Kava Anxiety Depression Spectrum Study (KADSS): A mixed methods RCT using an aqueous extract of Piper methysticum

Summary Objectives To report on the design, significance and potential impacts of the first documented human clinical trial assessing the anxiolytic and thymoleptic efficacy of an aqueous mono-extract of Piper methysticum (kava). The significance of the qualitative element of our clinical trial is a...

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Bibliographic Details
Published in:Complementary therapies in medicine 2009-06, Vol.17 (3), p.176-178
Main Authors: Sarris, J, Kavanagh, D.J, Adams, J, Bone, K, Byrne, G
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Anti-Anxiety Agents - therapeutic use
Anxiety
Anxiety - drug therapy
Anxiety Disorders - drug therapy
Aqueous extract
Clinical trials
Depression
Depression - drug therapy
Double-Blind Method
Drug therapy
Humans
Internal Medicine
KADSS
Kava
Medical Education
Methods
Middle Aged
Mixed methods research
Patient Satisfaction
Phytotherapy
Plant Extracts - therapeutic use
Qualitative research
Young Adult
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Summary:Summary Objectives To report on the design, significance and potential impacts of the first documented human clinical trial assessing the anxiolytic and thymoleptic efficacy of an aqueous mono-extract of Piper methysticum (kava). The significance of the qualitative element of our clinical trial is also explored. The Kava Anxiety Depression Spectrum Study (KADSS) is a 3-week placebo-controlled, double-blind, cross-over trial involving 60 adult participants (18–65) with elevated stable anxiety and varying levels of depressive symptoms. Aims The aims of KADSS are: (1) to determine whether an aqueous standardised extract of kava is effective for the treatment of anxiety; (2) to assess the effects of kava on differing levels of depression; and (3) to explore participants’ experience of taking kava via qualitative research. The study also provides preliminary assessment of the safety of an aqueous extract of kava in humans. Conclusion If results reveal that the aqueous kava preparation exerts significant anxiolytic effects and appears safe, potentially beneficial impacts may occur. Data supporting a safe and effective kava extract may encourage a re-introduction of kava to Europe, UK and Canada. This may provide a major socioeconomic benefit to Pacific Island nations, and to sufferers of anxiety disorders.
ISSN:0965-2299
1873-6963
DOI:10.1016/j.ctim.2009.01.001