Informe del Comité Científico de la Agencia Española de Seguridad Alimentaria y Nutrición (AESAN) sobre el riesgo asociado al consumo de complementos alimenticios que contienen raíz/rizoma de Cimicifuga racemosa como ingrediente

Resumen

Extracts of the root or rhizome of Cimicifuga racemosa (L.) Nutt., also known as black cohosh, have traditionally been used for treating various conditions, including premenstrual syndrome, menopause and other gynaecological problems, uses that have been recognised by the World Health Organisation (WHO) and the European Medicines Agency (EMA). In Spain, products containing Cimicifuga racemosa are marketed either as herbal medicinal products or as food supplements. A non-exhaustive sampling of food supplements containing Cimicifuga racemosa registered in the General Health Register of Food and Food Companies (RGSEAA, as per its Spanish acronym), it showed such food supplements contained highly varying accounts of Cimicifuga racemosa, with no uniformity in their form of expression. In 2006, the Spanish Agency of Medicines and Medical Devices (AEMPS) published an information note on the possible association of the use of Cimicifuga racemosa rhizome extract with acute liver damage, and set out a series of recommendations in this regard. In this context, the Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) has carried out a review of the scientific evidence on the potential toxicity of the consumption of food supplements containing Cimicifuga racemosa among its ingredients. The effectiveness of Cimicifuga racemosa extracts compared to placebo in the treatment of menopausal symptoms was demonstrated in a recent meta-analysis. However, this scientific evidence has only been established for herbal medical products, but not for food supplements. In terms of safety, scientific literature indicates that standardised extracts of Cimicifuga racemosa are generally well tolerated. With regard to any potential hepatotoxic effects of Cimicifuga racemosa, scientific studies to date show no evidence in this regard. However, products labelled as “black cohosh” have been associated in clinical practice with several cases of liver injury, in which data on dosing, purity, origin and preparation of the products, as well as the time period between use and onset of symptoms, were scarce. Therefore, the relationship between Cimicifuga racemosa consumption and liver damage is controversial. The most recent data indicate that there is no cause-effect relationship between the consumption of Cimicifuga racemosa food supplements and the development of liver disease. However, in the absence of essays with an appropriate methodological design analysing the safety of the consumption of this type of supplements, it cannot be ruled out that these supplements, at the dosing and types of extract currently available on the market, are associated with hepatotoxicity and, therefore, their use is not recommended in people with impaired liver function. In addition, health professionals, researchers and users are required to report to the appropriate institutions any serious adverse effects that they believe may be causally related to these types of supplements. In addition, regulatory authorities should develop post-marketing surveillance systems. In addition, there is a need for standardisation of food supplements containing Cimicifuga racemosa in terms of composition and its declaration on the label to ensure consistency of such composition. Finally, it is necessary to promote clinical trials with an appropriate methodological design in order to draw conclusions regarding the efficacy and safety of food supplements containing Cimicifuga racemosa.