Evidence of Clinically Relevant Efficacy for Dietary Supplements and Nutraceuticals
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THERAPEUTIC TRIALS (G MANCIA, SECTION EDITOR)
Evidence of Clinically Relevant Efficacy for Dietary Supplements and Nutraceuticals Arrigo F. G. Cicero & Claudio Borghi
Published online: 22 February 2013 # Springer Science+Business Media New York 2013
Abstract Beyond the well-known effects on blood pressure (BP) of the DASH and the Mediterranean diets, a large number of studies have investigated the possible a BPlowering effect from different dietary supplements and nutraceuticals, mostly antioxidant agents with a high tolerability and safety profile. In particular, a relatively large body of evidence support the use of potassium, L-arginine, vitamin C, cocoa flavonoids, coenzyme Q10, controlledrelease melatonin, and aged garlic extract. However there is a need for data about the long-term safety of a large part of these products. Moreover, further clinical research is advisable to identify between the available active nutraceuticals and those with the best cost-effectiveness and risk–benefit ratio for widespread use in a general population with low added cardiovascular risk related to uncomplicated hypertension. Keywords Hypertension . Blood pressure . BP . Dietary supplements . Nutraceuticals . Clinical evidence . Review
Introduction Despite the availability of many effective and well-tolerated pharmacological treatments, cardiovascular diseases remain the leading cause of death and disability in the developed countries.[1] Arterial hypertension is one of the most relevant independent risk factors for cardiovascular diseases, and its elevated prevalence is expected to increase all over the world over the next two decades.[2] In particular, the Framingham data indicate that the lifetime risk of A. F. G. Cicero : C. Borghi (*) Medical and Surgical Science Department, University of Bologna, Via Albertoni 15 – Pad. 2, 40138 Bologna, Italy e-mail: [email protected]
developing hypertension is a staggering 90 %, and it is estimated that the global burden of hypertension will increase to 1.56 billion afflicted individuals by 2025.[2] From a global perspective, suboptimal BP accounts annually for 7.6 million premature deaths and a loss of 92 million disability-adjusted life-years (1 disability-adjusted life-year is equivalent to 1 lost year of healthy life).[3] On the other hand, recent studies have shown that the maintenance of a normal blood pressure (BP) levels reduces the incidence of cardiovascular complications both in the hypertensive population and in subjects whose blood pressure values are only slightly elevated above the optimal range.[4] This would imply the importance of improving blood pressure control in the overall population of subjects. However, since it is not reasonable to actively treat all subjects with suboptimal BP control with antihypertensive drugs, the main international guidelines [5, 6] stress the preventive impact of an adequate dietary and lifestyle intervention in order to reach and maintain optimal BP levels. Beyond the well-known effects on BP of the DASH [7] and the Mediterranean
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