Clinical Center of Natural Medicine, S. Giuseppe Hospital, Empoli, Italy.
Evid Based Complement Alternat Med. 2011;2011:821392. doi: 10.1093/ecam/nen009. Epub 2010 Dec 23.
European Medicines Agency (EMEA) and the Committee on Herbal Medicinal Products (HMPC) on July 2006 have released an alert to get European sanitary authorities aware of 42 cases of suspected hepatotoxic reactions in patients consuming Cimicifuga racemosa rhizome. In the public statement EMEA itself considered reliable as hepatotoxic reactions only four cases, on the base of RUCAM score: two were considered possible and two probable. Lacking in almost all of them a precise description of cases, especially a botanical-chemical analysis of the suspected substance, we think there is no real proof of supposed C. racemosa rhizome hepatotoxicity. In our department we administer from about 10 years C. racemosa as special herbal dry extract as single substance or mixed with other medicinal plants at the dose of 500-1000 mg daily, for treatment of menopause related disorders without any reported adverse effect. After EMEA's official signal we have contacted all our patients using a C. racemosa rhizome herbal extract continuously from more than 12 months to verify possible hepatotoxic effects. We followed-up 107 women, and asked them by telephone (33/107) and/or after anamnesis and clinical examination (74/107) to undergo a blood sample examination. In all the patients there was no sign of hepatic disease, or worsening of already altered but stable parameters. We think on the base of these data and current literature C. racemosa rhizome extract should not be considered a potential hepatotoxic substance.
欧洲药品管理局（EMEA）和草药药物委员会（HMPC）于 2006 年 7 月发布警报，提醒欧洲卫生当局注意 42 例疑似食用黑升麻根茎的患者出现肝毒性反应的病例。在公开声明中，EMEA 本身认为只有 4 例肝毒性反应是可靠的，根据 RUCAM 评分：其中两例被认为是可能的，两例是可能的。几乎在所有病例中都缺乏对病例的准确描述，特别是对疑似物质的植物化学分析，我们认为没有真正证据证明黑升麻根茎具有肝毒性。在我们部门，我们大约 10 年来一直使用黑升麻特殊草药干提取物作为单一物质或与其他药用植物混合使用，剂量为每天 500-1000 毫克，用于治疗绝经相关疾病，没有任何不良反应报告。在 EMEA 发出官方信号后，我们联系了所有连续使用黑升麻根茎草药提取物超过 12 个月的患者，以验证可能的肝毒性作用。我们随访了 107 名女性，通过电话（33/107）和/或病史和临床检查（74/107）询问她们是否接受血液样本检查。在所有患者中，均未出现肝疾病迹象，或已改变但稳定的参数恶化。基于这些数据和当前文献，我们认为黑升麻根茎提取物不应被视为潜在的肝毒性物质。
