Papadi Georgia, Bakhiya Nadiya, Ildico Hirsch-Ernst Karen
Department of Food Safety Federal Institute for Risk Assessment (BfR) Berlin Germany.
EFSA J. 2022 May 25;20(Suppl 1):e200415. doi: 10.2903/j.efsa.2022.e200415. eCollection 2022 May.
The current report summarises the work performed in the context of the European Food Risk Assessment Fellowship Programme (EU-FORA), which included the evaluation of health risks associated with the consumption of botanical preparations of (kratom). is a tree native to Southeast Asia, where its leaves and preparations of the leaves have been used for centuries, among others, as a stimulant or as a traditional herbal medicine. Preparations of the plant have recently gained increasing popularity in other parts of the world, and are presently also accessible via online platforms, e.g. as food supplements. Kratom has been considered a botanical of possible health concern by the FDA and EFSA, which together with its increasing popularity, makes kratom a subject of international concern. Major alkaloids of the plant, mitragynine and 7-hydroxymitragynine, are agonists of the μ-opioid human receptor and are assumed to be mainly responsible for its psychoactive effects. The aim of the present project was to conduct an assessment of potential health risks associated with oral use of kratom-based preparations. The animal and human data that were evaluated in the course of the current assessment indicate that kratom consumption has the potential to not only lead to adverse neurological effects, including addiction and withdrawal syndrome, but also to elicit distinct organ toxicity with respect to e. g. liver and kidney as target organs. Nevertheless, actual risk characterisation is impeded by considerable uncertainties. Such uncertainties, based on the variability in composition of kratom preparations, insufficient information on dose-response relationships and on limited data on long-term use effects, currently do not allow the derivation of distinct health based guidance values for kratom/kratom preparations. Further information from well-designed studies, conducted with kratom preparations that have been clearly defined with respect to their composition, would be required to enable a more refined risk assessment of this botanical.
本报告总结了在欧洲食品风险评估奖学金计划（EU - FORA）背景下开展的工作，其中包括对食用（ kratom）植物制剂相关健康风险的评估。kratom是一种原产于东南亚的树，其树叶及其制剂在当地已被使用了几个世纪，例如用作兴奋剂或传统草药。该植物的制剂最近在世界其他地区越来越受欢迎，目前也可通过在线平台获取，例如作为食品补充剂。美国食品药品监督管理局（FDA）和欧洲食品安全局（EFSA）已将kratom视为可能对健康有影响的植物，再加上其日益普及，使得kratom成为国际关注的对象。该植物的主要生物碱，即帽柱木碱和7 - 羟基帽柱木碱，是μ - 阿片类人体受体的激动剂，被认为主要是其精神活性作用的原因。本项目的目的是评估口服基于kratom的制剂潜在的健康风险。在本次评估过程中评估的动物和人体数据表明，食用kratom不仅有可能导致不良神经效应，包括成瘾和戒断综合征，而且还会对例如肝脏和肾脏等靶器官引发明显的器官毒性。然而，实际的风险特征描述受到相当大的不确定性的阻碍。基于kratom制剂成分的变异性、关于剂量 - 反应关系的信息不足以及关于长期使用效果的有限数据，目前无法得出基于健康的kratom/kratom制剂明确指导值。需要来自精心设计研究的更多信息，这些研究使用的kratom制剂在成分方面已得到明确界定，以便能够对这种植物进行更精确的风险评估。
