Jerome Sarris1,2, Gerard J Byrne3, Chad A Bousman4,5, Lachlan Cribb2, Karen M Savage2,6, Oliver Holmes6, Jenifer Murphy2, Patricia Macdonald3, Anika Short3, Sonia Nazareth3, Emma Jennings6, Stuart R Thomas7, Edward Ogden6, Suneel Chamoli8, Andrew Scholey6, Con Stough6. 1. NICM Health Research Institute, Western Sydney University, Westmead, NSW, Australia. 2. Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia. 3. Discipline of Psychiatry, School of Clinical Medicine, The University of Queensland, Brisbane, QLD, Australia. 4. Departments of Medical Genetics, Psychiatry and Physiology & Pharmacology, University of Calgary, Calgary, AB, Canada. 5. Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia. 6. Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia. 7. Adjunct Senior Lecturer, Monash University, VIC, Australia. 8. Department of Psychiatry, ACT Health, Canberra, ACT, Australia.
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.
RCT Entities:
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: Jerome Sarris; Wolfgang Marx; Melanie M Ashton; Chee H Ng; Nicole Galvao-Coelho; Zahra Ayati; Zhang-Jin Zhang; Siegfried Kasper; Arun Ravindran; Brian H Harvey; Adrian Lopresti; David Mischoulon; Jay Amsterdam; Lakshmi N Yatham; Michael Berk Journal: Can J Psychiatry Date: 2021-02-18 Impact factor: 4.356
Authors: Tengfei Bian; Pedro Corral; Yuzhi Wang; Jordy Botello; Rick Kingston; Tyler Daniels; Ramzi G Salloum; Edward Johnston; Zhiguang Huo; Junxuan Lu; Andrew C Liu; Chengguo Xing Journal: Nutrients Date: 2020-10-05 Impact factor: 5.717
Authors: Xuesen Li; Liankun Song; Shan Xu; Matthew Tippin; Shuan Meng; Jun Xie; Edward Uchio; Xiaolin Zi Journal: J Transl Genet Genom Date: 2021-05-28