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Kava for generalised anxiety disorder: A 16-week double-blind, randomised, placebo-controlled study.
Aust N Z J Psychiatry. 2020 03; 54(3):288-297.AN

Abstract

OBJECTIVE

Previous randomised, double-blind, placebo-controlled studies have shown that Kava (a South Pacific medicinal plant) reduced anxiety during short-term administration. The objective of this randomised, double-blind, placebo-controlled study was to perform a larger, longer-term trial assessing the efficacy and safety of Kava in the treatment of generalised anxiety disorder and to determine whether gamma-aminobutyric acid transporter (SLC6A1) single-nucleotide polymorphisms were moderators of response.

METHODS

The trial was a phase III, multi-site, two-arm, 16-week, randomised, double-blind, placebo-controlled study investigating an aqueous extract of dried Kava root administered twice per day in tablet form (standardised to 120 mg of kavalactones twice/day) in 171 currently non-medicated anxious participants with diagnosed generalised anxiety disorder. The trial took place in Australia.

RESULTS

An analysis of 171 participants revealed a non-significant difference in anxiety reduction between the Kava and placebo groups (a relative reduction favouring placebo of 1.37 points; p = 0.25). At the conclusion of the controlled phase, 17.4% of the Kava group were classified as remitted (Hamilton Anxiety Rating Scale score < 7) compared to 23.8% of the placebo group (p = 0.46). No SLC6A1 polymorphisms were associated with treatment response, while carriers of the rs2601126 T allele preferentially respond to placebo (p = 0.006). Kava was well tolerated aside from poorer memory (Kava = 36 vs placebo = 23; p = 0.044) and tremor/shakiness (Kava = 36 vs placebo = 23; p = 0.024) occurring more frequently in the Kava group. Liver function test abnormalities were significantly more frequent in the Kava group, although no participant met criteria for herb-induced hepatic injury.

CONCLUSION

While research has generally supported Kava in non-clinical populations (potentially for more 'situational' anxiety as a short-term anxiolytic), this particular extract was not effective for diagnosed generalised anxiety disorder.

Authors+Show Affiliations

NICM Health Research Institute, Western Sydney University, Westmead, NSW, Australia. Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.Discipline of Psychiatry, School of Clinical Medicine, The University of Queensland, Brisbane, QLD, Australia.Departments of Medical Genetics, Psychiatry and Physiology & Pharmacology, University of Calgary, Calgary, AB, Canada. Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia. Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.Discipline of Psychiatry, School of Clinical Medicine, The University of Queensland, Brisbane, QLD, Australia.Discipline of Psychiatry, School of Clinical Medicine, The University of Queensland, Brisbane, QLD, Australia.Discipline of Psychiatry, School of Clinical Medicine, The University of Queensland, Brisbane, QLD, Australia.Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.Adjunct Senior Lecturer, Monash University, VIC, Australia.Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.Department of Psychiatry, ACT Health, Canberra, ACT, Australia.Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31813230

Citation

Sarris, Jerome, et al. "Kava for Generalised Anxiety Disorder: a 16-week Double-blind, Randomised, Placebo-controlled Study." The Australian and New Zealand Journal of Psychiatry, vol. 54, no. 3, 2020, pp. 288-297.
Sarris J, Byrne GJ, Bousman CA, et al. Kava for generalised anxiety disorder: A 16-week double-blind, randomised, placebo-controlled study. Aust N Z J Psychiatry. 2020;54(3):288-297.
Sarris, J., Byrne, G. J., Bousman, C. A., Cribb, L., Savage, K. M., Holmes, O., Murphy, J., Macdonald, P., Short, A., Nazareth, S., Jennings, E., Thomas, S. R., Ogden, E., Chamoli, S., Scholey, A., & Stough, C. (2020). Kava for generalised anxiety disorder: A 16-week double-blind, randomised, placebo-controlled study. The Australian and New Zealand Journal of Psychiatry, 54(3), 288-297. https://doi.org/10.1177/0004867419891246
Sarris J, et al. Kava for Generalised Anxiety Disorder: a 16-week Double-blind, Randomised, Placebo-controlled Study. Aust N Z J Psychiatry. 2020;54(3):288-297. PubMed PMID: 31813230.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Kava for generalised anxiety disorder: A 16-week double-blind, randomised, placebo-controlled study. AU - Sarris,Jerome, AU - Byrne,Gerard J, AU - Bousman,Chad A, AU - Cribb,Lachlan, AU - Savage,Karen M, AU - Holmes,Oliver, AU - Murphy,Jenifer, AU - Macdonald,Patricia, AU - Short,Anika, AU - Nazareth,Sonia, AU - Jennings,Emma, AU - Thomas,Stuart R, AU - Ogden,Edward, AU - Chamoli,Suneel, AU - Scholey,Andrew, AU - Stough,Con, Y1 - 2019/12/08/ PY - 2019/12/10/pubmed PY - 2021/3/30/medline PY - 2019/12/10/entrez KW - Generalised anxiety disorder KW - Kava KW - Piper methysticum KW - anxiety KW - gamma-aminobutyric acid KW - pharmacogenetics KW - polymorphisms SP - 288 EP - 297 JF - The Australian and New Zealand journal of psychiatry JO - Aust N Z J Psychiatry VL - 54 IS - 3 N2 - OBJECTIVE: Previous randomised, double-blind, placebo-controlled studies have shown that Kava (a South Pacific medicinal plant) reduced anxiety during short-term administration. The objective of this randomised, double-blind, placebo-controlled study was to perform a larger, longer-term trial assessing the efficacy and safety of Kava in the treatment of generalised anxiety disorder and to determine whether gamma-aminobutyric acid transporter (SLC6A1) single-nucleotide polymorphisms were moderators of response. METHODS: The trial was a phase III, multi-site, two-arm, 16-week, randomised, double-blind, placebo-controlled study investigating an aqueous extract of dried Kava root administered twice per day in tablet form (standardised to 120 mg of kavalactones twice/day) in 171 currently non-medicated anxious participants with diagnosed generalised anxiety disorder. The trial took place in Australia. RESULTS: An analysis of 171 participants revealed a non-significant difference in anxiety reduction between the Kava and placebo groups (a relative reduction favouring placebo of 1.37 points; p = 0.25). At the conclusion of the controlled phase, 17.4% of the Kava group were classified as remitted (Hamilton Anxiety Rating Scale score < 7) compared to 23.8% of the placebo group (p = 0.46). No SLC6A1 polymorphisms were associated with treatment response, while carriers of the rs2601126 T allele preferentially respond to placebo (p = 0.006). Kava was well tolerated aside from poorer memory (Kava = 36 vs placebo = 23; p = 0.044) and tremor/shakiness (Kava = 36 vs placebo = 23; p = 0.024) occurring more frequently in the Kava group. Liver function test abnormalities were significantly more frequent in the Kava group, although no participant met criteria for herb-induced hepatic injury. CONCLUSION: While research has generally supported Kava in non-clinical populations (potentially for more 'situational' anxiety as a short-term anxiolytic), this particular extract was not effective for diagnosed generalised anxiety disorder. SN - 1440-1614 UR - https://www.unboundmedicine.com/medline/citation/31813230/Kava_for_generalised_anxiety_disorder:_A_16_week_double_blind_randomised_placebo_controlled_study_ L2 - https://journals.sagepub.com/doi/10.1177/0004867419891246?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -