Department of Physiology and Pharmacology 'Vittorio Erspamer', Sapienza University of Rome, Rome, Italy.
National Centre for Drug Research and Evaluation, National Institute of Health, Rome, Italy.
Phytother Res. 2022 Jun;36(6):2583-2604. doi: 10.1002/ptr.7473. Epub 2022 May 7.
Herbal dietary supplements (HDS) used for dyslipidemia represent a category of concern in Italy for suspected adverse reactions (ARs). However, we cannot estimate their safety, as we do not know their commercial profile. Sales data of HDS, and particularly, those used for dyslipidemia, were monitored for 2 years in two pharmacies of Rome. Meanwhile, spontaneous reports of suspected ARs potentially related to dyslipidemia supplements were collected by the Italian Phytovigilance System. The 50% of the total dietary supplements are herbal-derived; the 9% of HDS are recommended for dyslipidemia. From our data, 113 different brands have claims for improving lipids profile and 91% of them are multiingredient preparations. Fifteen spontaneous reports of suspected ARs concerned HDS used, for dyslipidemia. The most frequent ARs were joint, abdominal, and muscles pain; vomiting; erythema and hematological disorders; nausea; and rhabdomyolysis. Our findings point out the limited compliance of commercial dyslipidemia-HDS and scientific research about their intrinsic safety. A wide range of ingredients could not support the risk/benefit profile of the supplement. The variable compositions of HDS do not assure the safety, as they do not support the reproducibility of their pharmacological activities. This study could contribute to optimize consumer guidance about what they purchase and consume.
用于血脂异常的草药膳食补充剂（HDS）在意大利是一类令人关注的产品，因为怀疑存在不良反应（ARs）。然而，由于我们不知道其商业产品的特性，因此无法评估其安全性。我们对 HDS 的销售数据进行了为期 2 年的监测，特别是用于血脂异常的 HDS，在罗马的两家药店进行了监测。同时，意大利植物药警戒系统收集了与血脂异常补充剂相关的疑似 ARs 的自发报告。50%的膳食补充剂是草药来源的；9%的 HDS 被推荐用于血脂异常。根据我们的数据，有 113 个不同的品牌声称可以改善血脂状况，其中 91%是多成分制剂。有 15 份与 HDS 用于血脂异常相关的疑似 ARs 的自发报告。最常见的不良反应是关节、腹部和肌肉疼痛、呕吐、红斑和血液系统紊乱、恶心和横纹肌溶解。我们的研究结果表明，商业血脂异常 HDS 的合规性有限，而且对其内在安全性的科学研究也很有限。如此广泛的成分并不能支持补充剂的风险/获益状况。HDS 的成分变化不能保证其安全性，因为它们不能支持其药理活性的重现性。本研究有助于优化消费者对他们购买和使用的产品的指导。
