National Centre for Drug Research and Evaluation, National Institute of Health, Rome, Italy.
Department of Physiology and Pharmacology "Vittorio Erspamer", Sapienza University of Rome, Rome, Italy.
Phytother Res. 2021 Jun;35(6):3246-3261. doi: 10.1002/ptr.7040. Epub 2021 Feb 10.
Herbal tonic and adaptogens are often used to improve overall well-being. However, few clinical evidence supports their use and their safety is not known before marketing. In this context, the aim of our study was to analyze the spontaneous reports of suspected adverse reactions (ARs) to performance enhancing herbal dietary supplements collected by the Italian Phytovigilance System. Between March 2002 and September 2020, 110 spontaneous reports were collected, 58 of which related to products containing botanicals, alone or in association. Twenty-three serious reactions were reported, 21 of which required hospitalization, one was life-threatening and another caused disability. Dermatological and cardiovascular reactions were the most frequent. Hepatic ARs were the most serious (9 out of 10). A positive dechallenge was indicated in 69% of cases, while a positive rechallenge occurred in 15%. Concomitant use of other products was present in 18 reports (31%), while predisposing conditions were indicated in 17 (29%). Present data highlight safety concerns on herbal dietary supplements used as cognitive and physical performance enhancers, mainly due to their quality and use without expert supervision. Considering that postmarketing surveillance is not required for these products, spontaneous reports represent the only tool to point out risks related to food supplements.
草药滋补品和适应原常用于改善整体健康状况。然而，很少有临床证据支持其使用，且在上市前其安全性未知。在这种情况下，我们研究的目的是分析意大利植物药警戒系统收集的关于增强体力的草药膳食补充剂的可疑不良反应（ARs）自发报告。2002 年 3 月至 2020 年 9 月，共收集到 110 份自发报告，其中 58 份与单独或联合使用植物药的产品有关。报告了 23 例严重反应，其中 21 例需要住院治疗，1 例危及生命，另 1 例导致残疾。最常见的是皮肤和心血管反应。肝 ARs 是最严重的（9 例中有 10 例）。69%的病例提示停药后有改善，15%的病例提示再激发试验阳性。18 份报告（31%）中同时使用了其他产品，17 份报告（29%）中存在易患因素。目前的数据强调了作为认知和体力增强剂使用的草药膳食补充剂的安全性问题，主要是由于其质量和未经专家监督使用。考虑到这些产品不需要上市后监测，自发报告是指出与膳食补充剂相关风险的唯一工具。
