Phd in PHARMACOLOGY AND TOXICOLOGY

Thesis title: A descriptive study of commercial herbal dietary supplements used for dyslipidaemia and body weight loss

Dyslipidemia and overweight/obesity are two common risk factors of the metabolic syndrome leading to cardiovascular and other chronic diseases. The management of cardiometabolic risk factors with herbal dietary supplements (HDS) has become frequent though they don't claim therapeutic effects. So far, many spontaneous reports of suspected adverse reactions (ARs) collected from the Italian Phytovigilance System, concern herbal preparations used in dyslipidemia and body weight loss. Accordingly, the Italian Ministry of Health has paid attention to HDS containing red yeast rice, curcuma, garcinia, etc. A maximum daily intake and/or special warnings have been established for the respective labels. The purpose of this research was to provide an overview of the number and characteristics of HDS used in dyslipidemia and body weight loss through a preliminary study of pharmacies sales data. Hence, sales of dietary supplements were monitored from October 2018 to September 2020, in two pharmacies of Rome. Reports of suspected ARs potentially related to the use of dyslipidemia-HDS collected in the interim by the Phytovigilance System were described. Moreover, a survey was addressed to the pharmacies of the Lazio region in order to understand pharmacists’ awareness about Phytovigilance. Our findings point out the limited compliance between commercial dyslipidaemia-/body weight loss-HDS and scientific research of their intrinsic safety. In specific, (i) the variety of formulations mostly multi-ingredient without a rationale of use, (ii) the wide range of plant species not strictly claimed for the management of dyslipidaemia and/or body weight loss, (iii) variable standardisation and/or incomplete label’s information of botanicals, (iv) low adherence to report suspected ARs, highlight safety-profile uncertainties of dyslipidaemia-HDS and body weight loss-HDS. As reproducibility of their pharmacological activities is not supported, safety cannot be assured. Future efforts involving sales data of all territorial pharmacies and promotion of Phytovigilance are required. This study could contribute to optimise consumers guidance in order to protect their health.