Pycnogenol® in Metabolic Syndrome and Related Disorders.

The present review provides an update of the biological actions of Pycnogenol® in the treatment of metabolic syndrome and related disorders such as obesity, dyslipidaemia, diabetes and hypertension. Pycnogenol® is a French maritime pine bark extract produced from the outer bark of Pinus pinaster Ait. Subsp. atlantica. Its strong antioxidant, antiinflammatory, endothelium-dependent vasodilator activity, and also its anti-thrombotic effects make it appropriate for targeting the multifaceted pathophysiology of metabolic syndrome. Clinical studies have shown that it can reduce blood glucose levels in people with diabetes, blood pressure in mild to moderate hypertensive patients, and waist circumference, and improve lipid profile, renal and endothelial functions in metabolic syndrome. This review highlights the pathophysiology of metabolic syndrome and related clinical research findings on the safety and efficacy of Pycnogenol®. The results of clinical research studies performed with Pycnogenol® are discussed using an evidence-based, target-oriented approach following the pathophysiology of individual components as well as in metabolic syndrome overall.

Pycnogenol® in chronic venous insufficiency and related venous disorders.

The present review provides an update of the biological profile of Pycnogenol in the light of its use in the treatment of chronic venous insufficiency (CVI) and related venous disorders such as deep vein thrombosis (DVT), post-thrombotic syndrome, long haul air-travel-related leg oedema, venous ulcers and acute haemorrhoids. Pycnogenol is a French maritime pine bark extract produced from the outer bark of Pinus pinaster Ait. subsp. atlantica. Its strong antioxidant, anti-inflammatory and vasodilator activities, antithrombotic effects and collagen stabilizing properties make it uniquely able to target the multi facet pathophysiology of CVI and related venous disorders. Clinical studies have shown that it can reduce oedema of the legs in CVI, reduce the incidence of deep venous thrombosis during long haul flights and enhance the healing of venous ulcers and haemorrhoidal episodes by topical application and/or oral administration. This review highlights clinical research findings on the safety, compliance and efficacy of Pycnogenol, including its use in combination products.

Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products.

Nutraceuticals are food or food ingredients that have defined physiological effects. They do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two. These products in general terms cover health promotion, "optimal nutrition" the concept of enhanced performance--both physically and mentally--and reduction of disease risk factors. In this paper the focus is mainly on legislation governing botanical-sourced nutraceuticals in the European Union (EU). Nutraceutical concept in general has been defined. Different pieces of legislation influencing botanical nutraceuticals are described. The issue of the borderline between food and drug is discussed. The regulatory status of botanical nutraceuticals as food supplement, food ingredient, functional and fortified food, novel foods and foods for particular nutritional use in the diversified, complex and ever-changing European regulatory environment is described. Botanical nutraceuticals present additional problems because of their complex nature and composition particularly with respect to the quality aspects, which in turn affect safety parameters and overall efficacy of the products. Quality issues relating to botanical sources, growth conditions, end products, their specifications and other technical criteria are highlighted. Guiding principles to be observed for conducting in vitro, in vivo studies in animals and their impact on clinical safety data are discussed. Finally, health claims, their types and criteria of substantiation in light of ongoing discussions with regard to the EU frame work of regulation on nutrition and health claims and role of process for the assessment of scientific support for claims (PASSCLAIM) initiative is discussed. The concept of grading of evidence to substantiate different claims and to establish standards, which should not be revoked or reversed by emerging science at a later stage has been considered. These issues are crucial and are being discussed at EU Parliament and Commission level during the development of the health claim regulations.