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

Studi preclinici su piante medicinali utilizzate nel trattamento delle patologie prostatiche

La fitoterapia viene spesso impiegata nel trattamento e prevenzione di patologie prostatiche di grado lieve-moderato. L’eziopatogenesi delle prostatiti, dell’iperplasia e dell’ipertrofia prostatica benigna (IPB) può essere complessa e l’intervento è spesso multi-target. Scopo del presente elaborato è stato quello di analizzare i meccanismi d’azione delle piante medicinali più comunemente utilizzate. Le proprietà farmacologiche, esplicate a livello delle vie urinarie, più ricorrenti sono: anti-androgenica, antiestrogenica, anti-proliferativa, antiossidante ed antinfiammatori

The safety concern of plant‐based supplements: A public health topic

Nowadays, the use of food supplements has increased globally. Among them, there are also plant‐based supplements that contain phytochemical extracts with a pharmacological effect and consequently potential adverse reactions. We cannot estimate their safety profile as there are not required evidence‐based proofs before marketing. Though European Food Safety Authority is responsible for the risks derived from food supplements, there is not any centralized surveillance system of the commercialized supplements in Europe. Moreover, these products do not rely on a harmonised marketing legislation. The population is exposed unconsciously purchasing them in internet or other places that lack of a professional healthcare. Fragile subgroups like pregnant women, patients with concomitant therapies, are not aware of the risks of plant‐based supplements because the education strategies are not promoted enough. In the context of public health, the challenge is to implement measures in order to protect consumers against health risks. Future efforts are required to ensure standardised supplements. European regulatory programs should be harmonised. More clinical trials and toxicological studies should be conducted on commercial preparations. Accurate information sources could assure consumers about the correct use of botanicals

What do we know about phytotherapy of benign prostatic hyperplasia?

Benign prostatic hyperplasia (BPH) is one of the most common urological diseases in aging men. Because of its long latency, BPH is a good target for prevention. The aim of the study has been to review the various options of treatment, currently available, in the field of phytotherapy. Watchful waiting, pharmacological therapy, and surgery are also helpful, depending on the severity of the disease. Although drug therapy (alpha1-blockers, 5alpha-reductase inhibitors) and surgery (prostatectomy, transurethral resection, etc.) seem to be most effective for patients with moderate-severe BPH, herbal medicines (i.e., Serenoa repens, Pygeum africanum, Urtica dioica) are also commonly used in patients with mild-moderate symptoms. On the basis of preclinical studies several mechanisms of action have been postulated, including 5alpha-reductase inhibition, alpha-adrenergic antagonism, dihydrotestosterone and estrogen receptor inhibition. Randomized clinical trials indicate significant efficacy i

Safety of herbal dietary supplements used for weight loss: sales data and phytovigilance awareness

Purpose Overweight/obesity is a metabolic risk factor contributing to chronic diseases. People use herbal dietary supplements (HDS) to promote weight loss, convinced in embracing a healthy attitude. As in Italy warnings concern weight loss-HDS, the aim of the study was to contextualize their safety by investigating sales data and phytovigilance awareness in territorial pharmacies. Methods Sales of weight loss-HDS were monitored from October 2018 to September 2020 in two pharmacies of Rome. Independently, a survey about phytovigilance was addressed to pharmacy owners of the Lazio region. Results From the overall sales, 9% of HDS, consisting of 122 brands, claimed weight loss. Among them, 76% were multi-ingredient with up to 29 components. Moreover, 158 plant species with variable/missing standardization and 49 non-botanical ingredients were clustered. In the 29 participants of the questionnaire, 70% knew phytovigilance, but only 25% of them knew the tool to report the suspected adverse reactions (ARs). Conclusions Given the variety of multi-ingredient formulations and plant species not strictly claimed for the weight loss promotion, variable standardization of botanicals, and a low adherence of pharmacists to report suspected ARs, this study highlights safety uncertainties of weight loss-HDS. Future efforts involving sales data of all territorial pharmacies and promotion of phytovigilance are required

The use of herbal products during pregnancy: which is the risk perception?

The aim of the study was to assess women habits during pregnancy, the prevalence of use of herbal products and the awareness about the related risk of adverse reactions. A total of 279 interviewees, at Polyclinic Umberto I (Rome, Italy), completed the questionnaire that examined descriptive and analytical aspects about herbal products. The majority quit smoking and drinking alcohol, but consumed regularly herbal products, often associated with drug therapies. Pregnant women considered herbal products less dangerous than other medications, even if some dermatological and gastrointestinal adverse reactions were reported. Gynecologist and herbalist represent the primary source of information about herbal products, while the most common place of purchase is the pharmacy. Pregnant women appear mindful about the risks of smoking, alcohol and medications. On the contrary, their knowledge about the risk/benefit profile of herbal products is limited. Therefore, information strategies and surveillance programs about the safety of herbal products should be implemented in the context of public health

A descriptive study of commercial herbal dietary supplements used for dyslipidemia—Sales data and suspected adverse reactions

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

Nutraceutical treatment and prevention of benign prostatic hyperplasia and prostate cancer

During the last years, pharmaceutical innovations in primary care are dramatically less frequent and will be even more rare in the next future. In this context, preclinical and clinical research oriented their interest toward natural compounds efficacy and safety, supporting the development of a new "nutraceutical" science. Medicinal plants, in the form of plant parts or extracts of them, are commonly used for the treatment of prostate diseases such as benign hypertrophy, prostatitis and chronic pelvic pain syndrome. The pharmacological properties searched for the treatment of prostatic diseases are anti-androgenic, anti-estrogenic, antiproliferative, antioxidant and anti-inflammatory. The most studied and used medicinal plants are Serenoa repens, Pygeum africanum and Urtica dioica. Other promising plants are Cucurbita pepo, Epilobium spp, Lycopersum esculentum, Secale cereale, Roystonea regia, Vaccinium macrocarpon. In parallel, epidemiological studies demonstrated that diet may play an important role on incidence and development of prostatic diseases. The Mediterranean diet is rich of elements with anti-oxidant properties that act as a protective factor for prostatic cancer. Similarly, low intake of animal protein, high intake of fruits and vegetable, lycopene and zinc are a protective factor for benign prostatic hyperplasia (BPH). Serenoa repens in the treatment of symptoms of BPH has been tested either alone or, more frequently, in combination with other medicinal plants, alpha-blockers and inhibitors of 5alpha reductase (5-ARI). Recent meta-analyses found the effectiveness of Serenoa repens similar or inferior of that of finasteride and tamsulosin but clearly higher than that of placebo in the treatment of mild and moderate low urinary tract symptoms (LUTS), nocturia and discomfort. Clinical trials showed potential synergistic effect of Serenoa repens with other medicinal plants and drugs. In addition to Serenoa repens, there are many other medicinal plants for which clinical evidence is still controversial. Urtica dioica, Pygeum africanum and Curcubita pepo can be considered as an adjunct to the common therapies and their use is supported by studies showing improvement of symptoms and flowmetric indices. Lycopene and selenium are natural products with antioxidant and anti-inflammatory action. The combination of lycopene and selenium with Serenoa repens was able to reduce inflammation in histological prostate sections and to further improve symptom scores and urinary flow in patients with BPH on tamsulosin treatment. Similar effects could be obtained with the use of other carotenoids, such as astaxanthin, and/or zinc. Efficacy on symptoms of patients with BPH of some polyphenols such as quercitin, equol and curcumin have been demonstrated by clinical studies. Pollen extract is a mixture of natural components able to inhibit several cytokines and prostaglandin and leukotriene synthesis resulting in a potent anti-inflammatory effect. Pollen extracts significantly improve symptoms, pain, and quality of life in patients affected by chronic pelvic pain syndrome and chronic prostatitis. Beta-sitosterol is a sterol able to improve urinary symptoms and flow measures, but not to reduce the size of the prostate gland. Palmitoylethanolamide (PEA) is an endogenous fatty acid amide-signaling molecule with anti-inflammatory and neuroprotective effects that can have an interesting role in the management of chronic pelvic pain syndrome and chronic urological pain. Finally, several plant-based products have been subjected to preclinical, in vitro and in vivo, investigations for their potential pharmacological activity against prostate cancer. Some epidemiological studies or clinical trials evaluated the effects of beverages, extracts or food preparations on the risk of prostate cancer. Some plant species deserved more intense investigation, such as Camelia sinensis (green or black tea), Solanum lycopersicum (common tomato), Punica granatum (pomegranate), Glycine max (common soy) and Linum usitatissimum (linen)