Department of Psychiatry, Faculty of Medicine, The University of Melbourne, Melbourne, Australia.
Planta Med. 2011 Jan;77(2):107-10. doi: 10.1055/s-0030-1250290. Epub 2010 Sep 2.
Kava (Piper methysticum) is an effective anxiolytic that has been withdrawn from various consumer markets in European countries due to concerns over its hepatotoxicity. It is plausible that the reported hepatotoxicity may be due in part to plant substitution, or an incorrect cultivar, or plant parts being used (such as leaves or bark); thus both the plant chemotype and the plant part used may be critical factors. If re-institution of kava in the EU is to occur, more evidence is required to determine its safety and efficacy. Furthermore, according to current evidence, the study of traditional water soluble rhizome extracts using a noble cultivar of kava may be advised. The Kava Anxiety-Lowering Medication (KALM) project is due to start in late 2010 to address these considerations. The KALM project uses an aqueous rhizome extract of a noble cultivar of kava in participants with generalised anxiety and Generalised Anxiety Disorder (GAD). The project comprises of 1) an acute RCT, kava (180 mg of kavalactones) versus oxazepam and placebo in 20 anxious people, testing effects on cognition, mood, anxiety, and driving; 2) an 8-week RCT comparing kava (120 mg kavalactones) versus placebo in 100 patients with GAD. To assess differences between dosages, non-responders at 3 weeks will be titrated to 240 mg of kavalactones. The project will also assess the effects of kava on liver function tests and its side effects profile. A novel component of the project is the pharmacogenomic exploration of phenotypical responses (GABA system and cytochrome P450 markers). The results of the study may be of benefit to sufferers of anxiety and the future economy of the Pacific islands, potentially providing an important step in the way forward with kava.
卡瓦（Piper methysticum）是一种有效的抗焦虑药物，由于其肝毒性问题，已在欧洲各国的消费市场撤出。据报道，其肝毒性可能部分归因于植物替代物，或使用了不正确的品种、植物部分（如叶或树皮）；因此，植物化学型和使用的植物部分都可能是关键因素。如果要在欧盟重新引入卡瓦，需要更多证据来确定其安全性和有效性。此外，根据目前的证据，建议使用优质品种的卡瓦研究传统的水溶性根茎提取物。卡瓦焦虑降低药物（KALM）项目将于 2010 年底启动，以解决这些问题。KALM 项目使用优质卡瓦的水基根茎提取物，用于广泛性焦虑症和广泛性焦虑症（GAD）患者。该项目包括 1）一项急性 RCT，在 20 名焦虑患者中，卡瓦（180 毫克卡瓦内酯）与奥沙西泮和安慰剂对照，测试对认知、情绪、焦虑和驾驶的影响；2）一项为期 8 周的 RCT，比较卡瓦（120 毫克卡瓦内酯）与安慰剂在 100 名 GAD 患者中的疗效。为了评估剂量差异，在第 3 周无反应的患者将滴定至 240 毫克卡瓦内酯。该项目还将评估卡瓦对肝功能测试和副作用的影响。该项目的一个新组成部分是对表型反应（GABA 系统和细胞色素 P450 标志物）的药物基因组学探索。该研究的结果可能对焦虑症患者和太平洋岛屿的未来经济有益，为卡瓦的未来发展提供了重要的一步。
