Department of Physiology and Pharmacology 'Vittorio Erspamer', Sapienza University of Rome, Piazzale Aldo Moro 5, 00185, Rome, Italy.
Centre for Drug Research and Evaluation, National Institute of Health, Viale Regina Elena 299, 00161, Rome, Italy.
Eur J Clin Pharmacol. 2019 Nov;75(11):1599-1615. doi: 10.1007/s00228-019-02746-6. Epub 2019 Aug 19.
Overweight and obesity represent worldwide a rising health problem. In this context, dietary supplements and herbal preparations are often used as self-medication for weight loss. The aim of this study was to describe the safety profile of dietary supplements for weight control by analyzing spontaneous reports of suspected adverse reactions (ARs) received by the Italian Phytovigilance System, from July 2010 to October 2017.
The suspected ARs were collected using an ad hoc reporting form, registered in a database at the National Institute of Health and evaluated by a multidisciplinary group of experts. The causality assessment was performed using the WHO-UMC system or the CIOMS/RUCAM score. In case of serious adverse reactions, a feedback is provided to the reporter by e-mail.
Sixty-six spontaneous reports were collected. ARs involved cardiovascular system (26%), liver (14%), central nervous system (12%), skin (9%), gastrointestinal system (17%), thyroid (8%), kidney (4%), and other organs/systems (10%). In 64% of cases, the reaction was serious. Dechallenge was positive in 46 cases; three cases of positive rechallenge were reported. After the causality assessment, the association between the product intake and the adverse reaction was judged as possible in the majority of the cases (n = 43; 65%).
The data collected confirmed the existence of safety concerns on herbal dietary supplements used for body weight control, mainly related to quality of products and their use as self-medication. In this scenario, spontaneous reports represent the only tools available to monitor safety of these products.
超重和肥胖是全球范围内日益严重的健康问题。在这种情况下，膳食补充剂和草药制剂经常被用作减肥的自我药物治疗。本研究的目的是通过分析意大利植物药物警戒系统自 2010 年 7 月至 2017 年 10 月收到的疑似不良反应（ADR）自发报告，描述用于体重控制的膳食补充剂的安全性概况。
使用专门的报告表收集疑似 ADR，并在国家卫生研究所的数据库中注册，并由多学科专家组进行评估。使用世界卫生组织-UMC 系统或 CIOMS/RUCAM 评分进行因果关系评估。在发生严重不良反应的情况下，通过电子邮件向报告者提供反馈。
共收集了 66 份自发报告。ADR 涉及心血管系统（26%）、肝脏（14%）、中枢神经系统（12%）、皮肤（9%）、胃肠道系统（17%）、甲状腺（8%）、肾脏（4%）和其他器官/系统（10%）。64%的情况下反应是严重的。46 例停药后反应阳性，报告了 3 例阳性再激发反应。在因果关系评估后，产品摄入与不良反应之间的关联在大多数情况下（n=43；65%）被判断为可能。
所收集的数据证实，用于控制体重的草药膳食补充剂存在安全性问题，主要与产品质量及其作为自我药物治疗的使用有关。在这种情况下，自发报告是监测这些产品安全性的唯一可用工具。
