Phase IV study, randomized, placebo-controlled for the evaluation of efficacy and tolerability of arginine aspartate in patients with moderate to severe fatigue

Fatigue is a very frequent symptom and is present in 50% of patients that seek a doctor’s appointment. Fatigue could be defined as an oppressive feeling, sustained by exhaustion and reduced capacity of physical and mental works on the habitual level. Its defining characteristics include signs and symptoms that are linked to the control of body energy, to difficulty in doing daily normal activities, to verbalization of extreme exhaustion, and contribute to generation and establishment of lack of concentration, lack of interest, reduced libido and a feeling of guilt for not playing expected social roles. The L-arginin is a precursor in the synthesis of Nitric Oxide (NO). This Oxide is a molecule that plays different roles in the body. Among them is the stimulation of the immunological response mediated by lymphocytes and macrophages; the reduction of the blood platelet hiperaggregation and the maintenance of vascular tonus in the regulation of arterial pressure, that involves the dynamic equilibrium between NO and endothelins. The L-arginin is a semi-essential aminoacid produced by the body, although it is not an enough production for all what is needed for. The arginin aspartate can also decrease fatigue and acts in several types of asthenia, strengthening the muscular capacity and having a support role in the treatment of various processes including the ones caused by stress. In prolonged administration of arginin, there is an increase in the production of Nitric Oxide, and its supplementation has been related to an improvement of the contractile function of the skeletal muscle. The hypothesis that this improvement in muscular strength occurs in the short term has been related to the vasodilator effect of the NO with consequent improvement of muscular perfusion. If we take into consideration that fatigue is a sufficiently important symptom to compromise the quality of life, leading a person to feel limited in dealing with her daily chores since once she initiates her activities, she can feel tired prematurely; supplementation with arginin would increase the production of NO with improvement of muscular response to the daily life activities, this way, decreasing the intensity or even eliminating the symptom fatigue. The objective of this study is to find fatigue descrease by Piper Scale. The classification of the Piper scale has to decrease after 60 days of treatment comparing to basal classification (before treatment).